NEXGEL, INC. (NXGL) — 10-K

Filed 2026-03-31 · Period ending 2025-12-31 · 41,375 words · SEC EDGAR

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# NEXGEL, INC. (NXGL) — 10-K

**Filed:** 2026-03-31
**Period ending:** 2025-12-31
**Accession:** 0001493152-26-014377
**Source:** [SEC EDGAR](https://www.sec.gov/Archives/edgar/data/1468929/000149315226014377/)
**Origin leaf:** 09d0643f8911bb18251aa7efae6c73e6a9fb0e9a330c18680e6d8ae175e11b4f
**Words:** 41,375



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**UNITED
STATES**
**SECURITIES
AND EXCHANGE COMMISSION**
**WASHINGTON
D.C. 20549**
**FORM
10-K**
**(Mark
One)**
| 
| 
| 
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
**For
the fiscal year ended: December 31, 2025**
**OR**
| 
| 
| 
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
**For
the transition period from ___________ to ___________**
Commission
file number: **001-41173**
**NexGel,
Inc.**
(Exact
name of registrant as specified in its charter)
| 
Delaware | 
| 
26-4042544 | |
| 
(State
or other jurisdiction of
incorporation or organization) | 
| 
(I.R.S.
Employer
Identification
Number) | |
| 
2150
Cabot Blvd West, Suite B 
Langhorne, PA | 
| 
19047 | |
| 
(Address
of principal executive office) | 
| 
(Zip
Code) | |
Registrants
telephone number, including area code: **(215) 702-8550**
**Securities
registered pursuant to Section 12(b) of the Act:**
| 
Title
of each class | 
| 
Trading
Symbol(s) | 
| 
Name
of each exchange on which registered | |
| 
Common
Stock, par value $0.001 | 
| 
NXGL | 
| 
The
Nasdaq Capital Market LLC | |
| 
Warrants
to Purchase Common Stock | 
| 
NXGLW | 
| 
The
Nasdaq Capital Market LLC | |
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No 
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes No 
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes No 
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes No 
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of large accelerated filer, accelerated filer,
smaller reporting company, and emerging growth company in Rule 12b-2 of the Exchange Act.
| 
Large
accelerated filer | 
Accelerated
filer | |
| 
Non-accelerated
filer | 
| |
| 
Smaller
reporting company | 
Emerging
growth company | |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 
Indicate
by check mark whether the registrant has filed a report on and attestation to its managements assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. 
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. 
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrants executive officers during the relevant recovery period pursuant to 240.10D-1(b). 
Indicate
by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Exchange Act).
Yes
No 
The
aggregate market value of the voting stock held by non-affiliates of the registrant as of June 30, 2025, the last business day of the
registrants second fiscal quarter, was approximately $11,032,723 based on the price at which the registrant last sold common equity.
As
of March 31, 2026 the registrant had 8,475,693 shares of common stock outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions
of the registrants definitive proxy statement relating to its 2026 annual meeting of stockholders (the 2026 Proxy Statement)
are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. The 2026 Proxy Statement will be filed
with the U.S. Securities and Exchange Commission within 120 days after the end of the year to which this report relates.
| | |
**Table
of Contents**
| 
Part I | 
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Item
1 | 
Business | 
4 | |
| 
Item
1A | 
Risk Factors | 
9 | |
| 
Item
1B | 
Unresolved Staff Comments | 
18 | |
| 
Item
1C | 
Cybersecurity | 
18 | |
| 
Item
2 | 
Properties | 
18 | |
| 
Item
3 | 
Legal Proceedings | 
18 | |
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Item
4 | 
Mine Safety Disclosures | 
18 | |
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Part II | 
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| |
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| 
| |
| 
Item
5 | 
Market for Registrants Common Equity, Related Stockholder Matters | 
19 | |
| 
Item
6 | 
[Reserved] | 
19 | |
| 
Item
7 | 
Managements Discussion and Analysis of Financial Condition and Results of Operations | 
19 | |
| 
Item
7A | 
Quantitative and Qualitative Disclosures About Market Risk | 
23 | |
| 
Item
8 | 
Financial Statements and Supplementary Data | 
F-1 | |
| 
Item
9 | 
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 
24 | |
| 
Item
9A | 
Controls and Procedures | 
24 | |
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Part III | 
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Item
10 | 
Directors, Executive Officers and Corporate Governance | 
25 | |
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Item
11 | 
Executive Compensation | 
25 | |
| 
Item
12 | 
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 
25 | |
| 
Item
13 | 
Certain Relationships and Related Transactions, and Director Independence | 
25 | |
| 
Item
14 | 
Principal Accountant Fees and Services | 
25 | |
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Part IV | 
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Item
15 | 
Exhibits and Financial Statement Schedules | 
26 | |
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| 
Signatures | 
29 | |
| 2 | |
| Table of Contents | |
**Forward-Looking
Statements**
This
Annual Report on Form 10-K contains forward-looking statements, which include information relating to future events, future
financial performance, strategies, expectations, competitive environment and regulation. Words such as may, should,
could, would, predict, potential, continue, expect,
anticipate, future, intend, plan, believe, estimate,
and similar expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking statements should
not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will
actually be achieved. Forward-looking statements are based on information we have when those statements are made or our managements
good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance
or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could
cause such differences include, but are not limited to:
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our
ability to continue as a going concern; | |
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| |
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| 
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inadequate
capital; | |
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| |
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| 
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inadequate
or an inability to raise sufficient capital to execute our business plan; | |
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our
ability to comply with current good manufacturing practices; | |
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| |
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loss
or retirement of key executives; | |
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our
plans to make significant additional outlays of working capital before we expect to generate significant revenues and the uncertainty
regarding when we will begin to generate significant revenues, if we are able to do so; | |
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adverse
economic and geopolitical conditions, including the current conflict in Ukraine, and/or intense competition; | |
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loss
of a key customer or supplier; | |
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entry
of new competitors; | |
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adverse
federal, state and local government regulation; | |
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| |
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technological
obsolescence of our manufacturing process and equipment; | |
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| |
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technical
problems with our research and products; | |
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| |
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risks
of mergers and acquisitions including the time and cost of implementing transactions and the potential failure to achieve expected
gains, revenue growth or expense savings; | |
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| |
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price
increases for supplies and components; and | |
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the
inability to carry out our business plans. | |
For
a discussion of these and other risks that relate to our business and investing in shares of our common stock, you should carefully review
the risks and uncertainties described elsewhere in this Annual Report on Form 10-K. The forward-looking statements contained in this
Annual Report on Form 10-K are expressly qualified in their entirety by this cautionary statement. We do not undertake any obligation
to publicly update any forward-looking statement to reflect events or circumstances after the date on which any such statement is made
or to reflect the occurrence of unanticipated events.
There
may be other factors that may cause our actual results to differ materially from the forward-looking statements, including factors disclosed
under the section titled and Managements Discussion and Analysis of Financial Condition and Results of Operations
in this information statement. You should evaluate all forward-looking statements made in this information statement in the context of
these risks and uncertainties.
No
assurance can be given that any goal or plan set forth in any forward-looking statement can or will be achieved, and readers are cautioned
not to place undue reliance on such statements which speak only as of the date they are made. We do not undertake any obligation to update
or release any revisions to any forward-looking statement or to report any events or circumstances after the date of this information
statement or to reflect the occurrence of unanticipated events, except as required by law.
| 3 | |
| Table of Contents | |
**Item
1. Business**
**Our
Company**
We were incorporated in Delaware on January 13, 2009. We manufacture high
water content, electron beam cross-linked, aqueous polymer hydrogels, or gels, used for wound care, medical diagnostics, transdermal drug
delivery and cosmetics. We specialize in custom gels by capitalizing on proprietary manufacturing technologies. We distribute our products
as a contract manufacturer, supplying our gels to third parties who incorporate them into their own products. We also have a line of branded
consumer products sold direct to consumers and custom and white label opportunities, which focuses on combining our gels with proprietary
branded products and white label opportunities. All of our gel products are manufactured using proprietary and non-proprietary mixing,
coating and cross-linking technologies. Together, these technologies enable us to produce gels that can satisfy rigid tolerance specifications
with respect to a wide range of physical characteristics (e.g., thickness, water content, adherence, absorption, moisture vapor transmission
rate [a measure of the passage of water vapor through a substance] and release rate) while maintaining product integrity. Additionally,
we have the manufacturing ability to offer broad choices in the selection of liners onto which the gels are coated. Consequently, we and
our customers are able to determine tolerances in moisture vapor transmission rate and active ingredient release rates while personalizing
color and texture. In May 2023, we formed a joint venture with CG Laboratories, Inc. called CG Converting and Packaging, LLC, which is
located in Granbury, Texas and of which we own a 50% interest, allowing us to expand our ability to deliver finished goods to our growing
customer base.
****
**Contract
Manufacturing Business**
As
described above, we serve as a contract manufacturer, supplying our gels to third parties who incorporate them into
their own products. Our hydrogels are currently being marketed in the U.S. and abroad by our customers for the following applications:
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Drug
Delivery. We believe delivering medication through hydrogel patches has important advantages over traditional methods of drug
delivery. Hydrogel patches are less intrusive, painless, allow for pre-planned medication time periods, can potentially release medication
in a manner consistent with the bodys own glandular activity (by avoiding dosage spikes and/or digestive alteration), and
minimize side effects related to the medication via injection or ingestion. | |
| 
| 
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Other
Medical Applications. Hydrogel patches are being used for transdermal applications such as hormone replacement therapy and contraception,
treatment of acne, shingles, diabetes, motion sickness, treatment of angina with nitroglycerin and treatment of smoking addiction
using nicotine and palliatives (i.e., pain relievers). | |
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Non-Prescription
Therapeutic Applications. Hydrogel patches are also used in the medical community and are also directly marketed to consumers
for topical application of over the counter (OTC) drugs such as non-prescription acne treatments, pain relievers, diet
preparations, cough suppressants, treatment of warts, calluses and corns, and pain relief. | |
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| |
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Moist
Wound and Burn Dressings. Hydrogel dressings have long been used for treating wounds and burns. Clinical trials have demonstrated
the benefits of moist wound healing versus traditional dressings. Some of these benefits include immediate anti-inflammatory effects,
allowing for freer cell flow and less scarring, increased absorption of exudate, and accelerated healing. | |
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Components
of Medical Devices. Several medical devices utilize hydrogels as components. These devices include active drug delivery systems
such as iontophoresis, warming and cooling devices, medical electrodes and various medical products for sensitive skin. | |
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Cosmetic
Applications. Hydrogel patches and applications allow for delivery systems of cosmetic skin care products to consumers and skin
care providers for uses that include moisturizers, face masks, cooling masks and applicators. | |
We
believe our competitive advantage in each of the general hydrogel patch applications described above is that our hydrogel patches are
gentler to the skin because we do not use chemical cross-linking agents which are incorporated into other hydrogel patches. Once the
gels are manufactured according to a customers specifications, the gels are generally shipped to the customer via a contract carrier
(e.g., United Parcel Service, Inc.).
****
| 4 | |
| Table of Contents | |
****
**Our
Facilities**
We
manufacture our hydrogels at what we believe to be one of only two facilities that can produce state-of-theart hydrogel transdermal
products and we have successfully used over two hundred active ingredients combinations in our hydrogels to date. Our facility consists
of 13,500 square feet of manufacturing space, which we currently operate at approximately 15% to 20% capacity. Given the significant
unused capacity, we can expand rapidly to meet increased demand, including for our healthcare and consumer product lines as described
in more detail below. At full capacity, we estimate our existing facility would produce approximately 1.4 billion square inches of product
annually. In addition, we sublease approximately 6,200 square feet of a 12,000 square foot combined office and manufacturing facility
in Granbury, Texas, for our joint venture CG Converting and Packaging, LLC (JV). Our facilities are subject to stringent
FDA compliance requirements. We also believe our hydrogel facility creates a high barrier to entry into our hydrogel and consumer product
business.
**Consumer
Products**
Our branded consumer products
are marketed under a diverse portfolio of brands, including our Medagel family of products (SilverSeal, Hexagels, Turfguard), Kenkoderm,
and Silly George. These products are distributed through a multi-channel strategy that includes direct-to-consumer e-commerce, brick-and-mortar
retail partnerships, and specialized medical office channels.
The products we sell under our MedaGel brand primarily relate to
healthcare over-the-counter (OTC) remedy solutions, such as blister and pain applications and the Kenkoderm skincare line
provides gentle to the skin products for consumer with psoriasis. In May 2024, we added the Silly George brand, a beauty brand primarily
focused on false eyelashes and other eye related products. We continue to look for additional potential acquisitions as part of our consumer
product roll-up strategy.
Additionally,
we have several more products in our development pipeline. We intend for these products to address various market opportunities including
the OTC pharmaceutical drug delivery market, pain management, beauty and cosmetics, sports related applications, cannabinoids (CBD
and/or THC) and general podiatry.
**Custom
and White Label Opportunities**
We
are leveraging our hydrogel products and technologies by allowing other OTC brands to incorporate them into their products. We believe
our hydrogels, which do not use chemical cross-linking agents and can be made in paraben free formulations, will be attractive to other
OTC brands, especially in the beauty and cosmetics industry, and their customers. We believe these white labeling opportunities will
increase the markets awareness of us as a consumer-friendly and reliable supplier of customizable patches. Additionally, we created
a process where customers have the ability to create their own custom hydrogel products. Customers pay a development fee, eliminating
our financial risk in the success or failure of the custom product. As opposed to our contract manufacturing business, where we provide
bulk sale of roll stock hydrogel to our customers who then use it as one component in their products which they themselves then manufacture,
test, market and sell, our custom and white label business will provide customers with a finished product which they will then brand
and re-sell.
**Medical
Devices**
We
entered into the medical device development sector which a focus on analyzing, creating and developing devices and solutions that reduce
skin pain and irritation, improve and maintain skin integrity and provide greater comfort and safety for patients at the site of which
a medical device interfaces with the human body.
We
conducted proof of concept studies for the development of our first medical device, which we call NEXDrape and have filed for a patent
on this device under the Patent Cooperation Treaty which provides patent protection in the nations who are members of the treaty. The
NEXDrape device is an incise surgical drape designed for patients with impaired skin. The elderly, diabetics, trauma patients and those
with an adhesive sensitivity can have adverse events from the removal of adhesive drapes. Additionally, patients taking certain medications,
such as ELIQUIS and steroids, may experience impaired skin as well. These groups represent a sizable percentage of the
incise surgical drape market, a market we believe to be significant and growing. The incise surgical drape market is currently fragmented
with 3M Healthcare being the market leader. Skin tears, infections, rashes, and post-surgical site pain are some of the problems that
can occur as a result of the removal of adhesive drapes, and have been reported with other currently available surgical drapes.
| 5 | |
| Table of Contents | |
We
have conducted one animal and two human cadaver proof of concept studies with respect to NEXDrape. As a result of these studies, we believe
NEXDrape will represent a gentle to the skin alternative to the current adhesive based standard of care and will provide a unique solution
for patients with fragile or compromised skin. Additionally, we believe NEXDrape offers the following benefits over the current incise
surgical drape products: (i) no skin irritation; (ii) able to deliver a wide range of antiseptic and antibiotic agents; (iii) eliminates
air bubbles; and (iv) prevents dermis removal post-surgery, which reduces the risk of patient infection and discomfort. We intend to
file a 510(k) premarket submission with the Food and Drug Administration (FDA), which is an application to demonstrate
that NEXDrape is as safe and effective (or substantially equivalent to) a legally marketed surgical drape device. There can be no guarantee
that the FDA approves our application, if submitted.
We
are also in the process of developing a product we call NEXDerm which will be an adhesive tape designed to secure central lines and intravenous
tubes and devices to patients before, during and after medical treatment. We believe NEXDerm will be an attractive alternative to Tegaderm,
a 3M Healthcare product. Based on our discussion with medical professionals, Tegaderm is often difficult and painful to remove
after adhesion, particularly for comprised skin patients. NEXDerm, which will incorporate exclusively licensed technology owned by Noble
Fiber, is designed to create a gentle to skin surgical tape impregnated with antimicrobial X-Static silver fiber. We
believe NEXDerm, if successfully developed, will offer the following advantages over Tegaderm: (i) ability to easily reposition
the adhesive tape; (ii) pain-free removal; (iii) gentle to the skin; and (iv) increased infection prevention. As with NEXDrape, we intend
to file a 510(k) premarket submission with the FDA to demonstrate that NEXDerm is as safe and effective (or substantially equivalent
to) a legally marketed surgical drape device. There can be no guarantee that the FDA approves our application, if submitted.
Our
current intent with any medical devices will not be to commercialize due to the expense required but to potentially prepare them to go
to market and to identify and pursue licensing and partnering arrangements with third parties possessing the necessary resources and
capabilities to bring the devices to market.
**Sales
and Marketing**
*Contract
Manufacturing, Consumer Products and Customer and White Label Offerings*. We continue to focus on sales and marketing efforts in the
United States. We use commission-based, fractional sales personnel to supplement our in-house efforts.
*Medical
Devices*. We do not intend to spend efforts or resources on selling or marketing our medical device business. Our current intent with
any medical devices will not be to commercialize due to the expense required but to identify and pursue licensing arrangements with third
parties possessing the necessary resources and capabilities to bring the devices to market.
**Competition**
*Contract
Manufacturing*. To our knowledge, NexGel is one of two manufacturers using electron beam technology for high performance hydrogels
for the wound care, cosmetic and drug delivery industries. However, the other manufacture does not currently offer its products to the
outside consumer market and, as such, does not currently compete with us directly.
*Consumer
Products and Medical Devices.* As we expand our consumer products and medical device business, we will face a number of competitors.
Our competitors include numerous manufacturers; distributors; marketers; online, specialty, mass, and other retailers; and physicians
that actively compete for the business of consumers both in the United States and abroad, including companies such as Johnson & Johnson,
Pfizer Consumer Healthcare and Procter & Gamble. Most of our competitors have longer operating histories, significantly greater resources,
better developed and more innovative sales and distribution channels and platforms, greater name recognition, and larger established
customer bases than we do. Therefore, a strategic partnership will be critical to our success in the medical device business. We also
face similar challenges with our own consumer branded products and may pursue similar strategic partnerships, though direct to consumer
marketing and selling is more feasible.
| 6 | |
| Table of Contents | |
*Custom
and White Label Offerings*. As our custom and white label offering business will provide customers with a finished product which they
will then brand and re-sell, the competition will depend, to a great deal, on the type of product the customer request and will not result
in direct competition to us.
**Sources
and Availability of Raw Materials; Principal Suppliers**
In
general, raw materials essential to our business are readily available from multiple sources. For reasons of quality assurance, availability,
or cost effectiveness, certain components and raw materials are available only from a sole supplier. The principal suppliers for our
raw materials are Berry Global, Inc., DeWolf Chemical, Inc., and Univar, Inc. Our policy is to maintain sufficient inventory of components
and raw materials so that our production will not be significantly disrupted even if a particular component or material is not available
for a period of time.
Because
we have no direct control over these suppliers, interruptions or delays in the products and services provided by these parties may be
difficult to remedy in a timely fashion. In addition, if such suppliers are unable or unwilling to deliver the necessary components or
raw materials, we may be unable to redesign or adapt our technology to work without such components or raw materials or find alternative
suppliers or manufacturers. In such events, we could experience interruptions, delays, increased costs, quality control problems, and
or be unable to sell the applicable products, all of which could have a significant adverse impact on our revenue.
Other
than as discussed above, we believe that, due to the size and scale of production of our suppliers, there should be an adequate supply
of components and raw materials from our other suppliers.
**Customers**
During
the year ended December 31, 2025 and 2024, no customers accounted for 10% of our revenue.
**Patents,
Proprietary Rights and Trademarks**
We
own or license trademarks covering our company and our products. We filed for a patent on NEXDrape under the Patent Cooperation Treaty
which provides patent protection in the nations who are members of the treaty. We also rely upon trade secrets and continuing technological
innovations to develop and maintain our competitive position. We also hold certain intellectual property that is not material to our
current business and prospects, including patent rights to one patent in Europe, which covers the use of lignin for inhibiting restenosis
and thrombosis formation, and coated medical devices where the coating includes lignin. This patent is set to expire in the near future,
however we believe the expiration of these patents will not have an adverse impact on our overall business. We hold an exclusive license
with right to sub-license from Specialty Pharmaceutical Products, L.L.C. (which was held by our former parent, Adynxx, Inc.) to two issued
patents, one in the U.S. and one in Europe, which cover technology relating to a transdermal patch containing transcutol. The transdermal
patch is effective to deliver lidocaine to a patient. Neither of these patent rights are material to our current business and prospects.
These licensed patent rights are expected to expire in April 2032.
**Government
Regulation**
*Product
Regulation*. Under the Federal Food, Drug and Cosmetic Act, medical devices are classified by the FDA into one of three classes-Class
I, Class II or Class III-depending on the degree of risk associated with each medical device and the extent of control
needed to ensure safety and effectiveness. While some applications of hydrogels fall under the jurisdiction of the FDA, hydrogels are
generally classified as Class I exempt devices and the majority of the hydrogel products that we manufacture are thereby exempt from
the FDA filing of any regulatory submissions and/or pre-market notification requirements. To the extent that any FDA regulatory submissions
are required, we will be required to file these submissions and maintain all appropriate documentation. With respect to registering the
manufacturing facility with the FDA under the Code of Federal Regulations, 21 CFR 820.1, Scope: Part A, it is stated that the regulation
does not apply to manufacturers of component parts of finished devices. Currently, hydrogels are sold as component parts to various medical
device/cosmetic manufacturers.
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| Table of Contents | |
*Quality
Assurance Requirements*. The FDA enforces regulations to ensure that the methods used in, and the facilities and controls used for,
the manufacture, processing, packing and holding of drugs and medical devices conform with current good manufacturing practice (cGMP).
The cGMP regulations enforced by the FDA are comprehensive and cover all aspects of manufacturing operations, from receipt of raw materials
to finished product distribution, insofar as they bear upon whether drugs meet all the identity, strength, quality and purity characteristics
required of them. The cGMP regulations for devices, called the Quality System Regulation, are also comprehensive and cover all aspects
of device manufacture, from pre-production design validation to installation and servicing, insofar as they bear upon the safe and effective
use of the device and whether the device otherwise meets the requirements of the Federal Food, Drug and Cosmetic Act. To assure compliance
requires a continuous commitment of time, money and effort in all operational areas.
The
FDA also conducts periodic inspections of drug and device registered facilities to assess their current cGMP status. If the FDA were
to find serious non-compliant manufacturing or processing practices during such an inspection, it could take regulatory actions that
could adversely affect our business, results of operations, financial condition and cash flows. With respect to domestic establishments,
the FDA could initiate product seizures or in some instances require product recalls and seek to enjoin a products manufacture
and distribution. In certain circumstances, violations could support civil penalties and criminal prosecutions. In addition, if the FDA
concludes that a company is not in compliance with cGMP requirements, sanctions may be imposed that include preventing that company from
receiving the necessary licenses to export its products and classifying that company as an unacceptable supplier, thereby
disqualifying that company from selling products to federal agencies.
We
conduct audits of our outside manufacturers and believe that we and our suppliers and outside manufacturers are currently in compliance
with cGMP requirements. We are currently registered as a device manufacturer and distributor with the FDA and we intend to register as
a drug facility with the FDA when we are required to do so.
*Environmental
Regulation*. We are subject to various laws and governmental regulations concerning environmental matters and employee safety and
health in the U.S. and other countries. We have made, and continue to make, significant investments to comply with these laws and regulations.
We cannot predict the future capital expenditures or operating costs required to comply with environmental laws and regulations. We believe
that we are currently compliant with applicable environmental, health and safety requirements in all material respects. However, we cannot
assure you that current or future regulatory, governmental, or private action will not have a material adverse effect on our performance,
results or financial condition.
In
the future, if a loss contingency related to environmental matters, employee safety, health or conditional asset retirement obligations
is recognized, we would record a liability for the obligation and it may result in a material impact on net income for the annual or
interim period during which the liability is recorded. The investigation and remediation of environmental obligations generally occur
over an extended period of time, and therefore we do not know if these events would have a material adverse effect on our financial condition,
liquidity, or cash flow, nor can we assure you that such liabilities would not have a material adverse effect on our performance, results
or financial condition.
*Federal
and State Anti-kickback, Self-referral, False Claims and Similar Laws*. Our relationships with physicians, hospitals and the marketers
of our products are subject to scrutiny under various federal anti-kickback, self-referral, false claims and similar laws, often referred
to collectively as healthcare fraud and abuse laws. Healthcare fraud and abuse laws are complex, and even minor, inadvertent violations
can give rise to claims that the relevant law has been violated. Certain states have similar fraud and abuse laws, imposing substantial
penalties for violations. Any government investigation or a finding of a violation of these laws would likely result in a material adverse
effect on the market price of our common stock, as well as our business, financial condition and results of operations. We believe that
we are currently compliant with applicable anti-kickback, self-referral, false claims in all material respects.
****
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****
**Research
and Development Costs**
For
the years ended December 31, 2025 and 2024, we incurred approximately $2 thousand and $78 thousand, respectively, in research and development
costs. We expect to incur increased costs in the future for our medical device business. Research and development will be an important
component in the growth of our business.
**Human
Capital**
As
of December 31, 2025, we had 19 full-time employees. Our employees are not represented by a labor union or other collective bargaining
groups, and we consider relations with our employees to be good. We currently plan to retain and utilize the services of outside consultants
for additional research, testing, regulatory, accounting and tax services, legal compliance, and other services on an as needed basis.
We
recognize and value our people as our most important asset in achieving our strategic goals. We are continually working on a human resources
strategy that helps drive the right culture, leadership, talent management, performance, reward and recognition, personal development,
and ways of working to ensure we achieve our strategic goals while our people benefit from an exceptional experience. Our efforts in
creating a working environment that draws out the best in our employees and allows them to fulfil their potential and support our goals
focus on the following:
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| 
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Attract,
identify, develop and retain high-performing employees across all areas. | |
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| 
Develop
and support the growth of management and leadership. | |
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Enable
the development of a high-performance culture in which staff performance can be supported, rewarded, enhanced and managed effectively. | |
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Foster
a values-based culture focused on diversity, equity, inclusion, well-being, and positive staff engagement. | |
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Develop
a total reward approach which is valued by staff and facilitates company objectives. | |
****
**Properties**
We
maintain a combined corporate office and manufacturing facility in Langhorne, Pennsylvania, where we lease approximately 16,500 square
feet of office and manufacturing space which expires on January 31, 2031. In addition, we sublease approximately 6,200 square feet of
a 12,000 square foot combined office and manufacturing facility in Granbury, Texas, for our JV. The lease expires in March 2028.
We
believe that our facilities are well maintained and are suitable and adequate for our current needs.
**Legal
Proceedings**
From
time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. However,
litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may
harm our business. We are currently not aware of any such legal proceedings or claims.
There
are no material proceedings in which any of our directors, officers or affiliates or any registered or beneficial shareholder of more
than 5% of our common stock is an adverse party or has a material interest adverse to our interest.
**Contractual
Obligations**
The
Company is a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and is not required
to provide the information under this item.
**Item
1A. Risk Factors**
*You
should carefully consider the risks described below and elsewhere in this Annual Report on Form 10-K before making an investment decision.
Our business, financial condition or results of operations could be materially adversely affected by any of these risks. Our common stock
is considered speculative and the trading price of our common stock could decline due to any of these risks, and you may lose all or
part of your investment. The following risk factors are not the only risk factors facing the Company. Additional risks and uncertainties
not presently known to us or that we currently deem immaterial may also affect our business.*
**Risks
Relating to Our Business**
**Our
future success depends upon market acceptance of our existing and future products.**
We
believe that our success will depend in part upon the acceptance of our existing and future products by the medical community, hospitals
and physicians and other health care providers, third-party payers, and end-users. Such acceptance may depend upon the extent to which
the medical community and end-users perceive our products as safer, more effective or cost-competitive than other similar products. Ultimately,
for our products to gain general market acceptance, it may also be necessary for us to develop marketing partners for the distribution
of our products. There can be no assurance that our products will achieve significant market acceptance on a timely basis, or at all.
Failure of some or all of our future products to achieve significant market acceptance could have a material adverse effect on our business,
financial condition, and results of operations.
****
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****
**Our
suppliers may fail to deliver components and raw materials and parts according to schedules, prices, quality and volumes that are acceptable
to us, or we may be unable to manage these components and raw materials effectively.**
Our
products contain materials and parts purchased globally from many suppliers, including single-source direct suppliers, which exposes
us to potential component shortages or delays. Unexpected changes in business conditions, materials pricing, labor issues, wars such
as the current conflict in Ukraine, trade policies, natural disasters, health epidemics, trade and shipping disruptions, port congestions
and other factors beyond our or our suppliers control could also affect these suppliers ability to deliver components to
us or to remain solvent and operational. Additionally, if our suppliers do not accurately forecast and effectively allocate production
or if they are not willing to allocate sufficient production to us, it may reduce our access to components and raw materials, thus requiring
us to search for new suppliers. The unavailability of any component or supplier could result in production delays, idle manufacturing
facilities, product design changes and loss of access to important technology and tools for producing and supporting our products. Our
suppliers may not be willing or able to sustainably meet our timelines or our cost, quality and volume needs, or to do so may cost us
more, which may require us to replace them with other sources. While we believe that we will be able to secure additional or alternate
sources for most of our components, there is no assurance that we will be able to do so quickly or at all.
As
the scale of production of our products, we will also need to accurately forecast, purchase, warehouse and transport components at high
volumes to our manufacturing facilities. If we are unable to accurately match the timing and quantities of component purchases to our
actual needs or successfully implement automation, inventory management and other systems to accommodate the increased complexity in
our supply chain and parts management, we may incur unexpected production disruption, storage, transportation and write-off costs, which
may harm our business and operating results.
**We
rely heavily on the Amazon and Shopify marketplaces for the sales and distribution of our consumer products, and if we are unable to
maintain a good relationship with Amazon and/or Shopify or if Amazon and/or Shopify experience disruptions, our business will suffer.**
We
rely heavily on the Amazon and Shopify marketplaces for the sales and distribution of our consumer products to our end consumers. We
believe that we have good relationships with both Amazon and Shopify. However, if we or any of our partners, (or if Amazon and/or Shopify
believe we or any of our partners have violated) its terms of service, either Amazon and/or Shopify could limit or terminate its relationship
with us. Any limitation or termination of our relationship with Amazon and/or Shopify could materially adversely affect our business,
financial condition and our results of operations. Additionally, any prolonged disruption of Amazons and/or Shopifys websites
or its or their delivery and distribution of our consumer products could materially adversely impact our business.
**We
have no contracts in place with our customers in either our contract manufacturing or consumer products business. The absence of such
contracts could result in periods during which we must continue to pay costs without revenues.**
Our
sales are made on a purchase order basis, we do not have contracts with our customers in either our contract manufacturing or consumer
products business. Accordingly, our customers are not required to purchase a minimum amount of our products, and we therefore could have
periods during which we have no or limited orders for our products, which will make it difficult for us to operate as we will have to
continue paying our expenses. We cannot provide assurance that we will be able to timely locate new customers, if at all, when our existing
customers are not placing orders. The periods in which we have no or limited purchase orders for our products would have a material adverse
effect on our business and financial condition.
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**We
operate in a highly competitive industry.**
Competition
from other hydrogel manufacturers is intense. There can be no assurance that we can develop products that are more effective or achieve
greater market acceptance than competitive products, or that our competitors will not succeed in developing or acquiring products and
technologies that are more effective than those being developed by us, that would render our products and technologies less competitive
or obsolete.
Our
competitors enjoy several competitive advantages over us, including some or all of the following:
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large
and established distribution networks in the U.S. and/or in international markets; | |
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greater
financial, managerial and other resources for products, research and development, sales and marketing efforts and protecting and
enforcing intellectual property rights; | |
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significantly
greater name recognition; | |
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more
expansive portfolios of intellectual property rights; and | |
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greater
experience in obtaining and maintaining regulatory approvals and/or clearances from the FDA and other regulatory agencies. | |
Our
competitors products will compete directly with our products. In addition, our competitors, as well as new market entrants, may
develop or acquire new products that will compete directly or indirectly with our products. The presence of this competition in our market
may lead to pricing pressure which would make it more difficult to sell our products at a price that will make us profitable or prevent
us from selling our products at all. Our failure to compete effectively would have a material and adverse effect on our business, results
of operations and financial condition.
**As
we enter the consumer product business sector to a larger extent, our failure to compete successfully could materially harm our business,
financial condition, and operating results.**
The
business of developing and marketing consumer and personal care products is highly competitive and sensitive to the introduction of new,
competitive products, which may rapidly capture a significant share of the applicable market. Our competitors include numerous manufacturers;
distributors; marketers; online, specialty, mass, and other retailers; and physicians that actively compete for the business of consumers
both in the United States and abroad. Most of our competitors have longer operating histories, significantly greater resources, better-developed
and more innovative sales and distribution channels and platforms, greater name recognition, and larger established customer bases than
we do. Our present and future competitors may be able to better withstand reductions in prices or other adverse economic or market conditions
than we can; develop products that are comparable or superior to those we offer; adapt more quickly or effectively to new technologies,
changing regulatory requirements, evolving industry trends and standards, and customer requirements than we can; and/or devote greater
resources to the development, promotion, and sale of their products than we do. In addition, because the industry in which we operate
is not particularly capital intensive or otherwise subject to high barriers to entry, it is relatively easy for new competitors to emerge
that will compete with us. Accordingly, competition may intensify, and we may not be able to compete effectively in our markets. If we
are not able to compete successfully in the consumer products sector, our business, financial condition, and operating results would
be materially adversely affected.
**Our
failure to appropriately respond to changing consumer trends, preferences, and demand for new products and product enhancements could
materially harm our business, financial condition, and operating results.**
Our
consumer products business is subject to rapidly changing consumer trends and preferences and product introductions. Our success will
depend in part on our ability to anticipate and respond to these changes and introductions, and we may not respond or develop new products
or product enhancements in a cost-effective, timely, or commercially appropriate manner. The success of our new product offerings and
enhancements depends on a number of factors, including our ability to:
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accurately
anticipate consumer needs; | |
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innovate
and develop new products and product enhancements that meet these needs; | |
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| |
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successfully
commercialize new products and product enhancements; | |
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| |
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price
our products competitively; | |
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| |
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manufacture
and deliver our products in sufficient volumes and in a cost-effective and timely manner; and | |
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| |
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differentiate
our product offerings from those of our competitors and successfully respond to other competitive pressures, including technological
advancements, evolving industry standards, and changing regulatory requirements. | |
Our
failure to accurately predict changes in consumer demand and technological advancements could negatively impact consumer opinion of our
products or our business. In addition, if we do not introduce new products or make enhancements to meet the changing needs of our customers
in a cost-effective, timely, and commercially appropriate manner, or if our competitors release new products or product enhancements
before we do, some of our product offerings could be rendered obsolete, which could cause our market share to decline and negatively
impact our business, financial condition, and operating results.
**If
we fail to further penetrate existing markets, the sales of our consumer products, along with our operating results, could be negatively
impacted.**
The
success of our consumer product business will be to a large extent contingent on our ability to penetrate existing markets, which is
subject to numerous factors, many of which are out of our control. Moreover, our growth in existing markets will depend upon our ability
to achieve brand awareness. Therefore, we cannot assure you that our general efforts to achieve market penetration in existing markets
will be successful. If we are unable to further penetrate existing markets, our business, financial condition, and operating results
could materially suffer.
**We
are subject to governmental regulations in all aspects of our business.**
Like
other companies in the healthcare industry, we are subject to extensive regulation, investigations and legal action, by national, state
and local government agencies in the U.S. Regulatory issues regarding compliance with cGMP by manufacturers of medical devices and consumer
products can lead to fines and penalties, product recalls, product shortages, interruptions in production, delays in new product approvals
and litigation. In addition, the marketing, pricing and sale of our products are subject to regulation, investigations and legal actions
including under the Federal Food, Drug, and Cosmetic Act, federal and state false claims acts, state unfair trade practices acts and
consumer protection laws. Scrutiny of health care industry business practices by government agencies and state attorneys general in the
U.S., and any resulting investigations and prosecutions, carry risk of significant civil and criminal penalties.
**As
we continue to develop our medical devices, if we fail to protect our intellectual property in the future, our ability to compete could
be negatively affected, which could materially harm our financial condition and operating results.**
As
we continue to develop our medical devices, such as NEXDrape, our future success and the market for our products will depend to a significant
extent upon the goodwill associated with our trademark and tradenames and our ability to protect our proprietary rights in our innovative
products and product enhancements. We own, or have licenses to use, the material trademark and trade name rights used in connection with
the packaging, marketing, and distribution of our products in the markets where those products are sold. Therefore, trademark and trade
name protection are important to our business. Although most of our trademarks are filed in the United States, we may not be successful
in asserting trademark or trade name protection or obtaining new trademark registrations.
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We
will attempt to protect our innovative products and product enhancements under a combination of patents, trademarks, and trade secret
laws, confidentiality procedures, and contractual provisions. However, monitoring infringement or misappropriation of intellectual property
can be difficult and expensive, and we may not be able to detect every infringement or misappropriation of our proprietary rights or
to prevent third parties from infringing upon or misappropriating our proprietary rights or from independently developing non-infringing
products that are competitive with, equivalent to, or superior to our products. Even if we do detect infringement or misappropriation
of our proprietary rights, litigation to enforce these rights could cause us to divert financial and other resources away from our business
operations and may result in the impairment or loss of all or portions of our proprietary rights. As a result, we cannot assure you that
we will be able to adequately protect our intellectual property in any jurisdiction. The loss or infringement of our trademarks, tradenames,
or other proprietary rights could impair the goodwill associated with our brands and harm our reputation, which could materially harm
our business, financial condition, and operating results.
**We
have limited sales, marketing and distribution capabilities.**
We
currently have limited sales, marketing and distribution capabilities. We must either develop our own sales, marketing and distribution
capabilities, which will be expensive and time-consuming, or make arrangements with third parties to perform these services for us. If
we enter into third party arrangements, the third parties may not be capable of successfully selling any of our products. If we decide
to market any of our products on our own, we will have to commit significant resources to developing a marketing and sales force and
supporting distribution capabilities. If we decide to enter into arrangements with third parties for performance of these services, we
may find that they are not available on terms acceptable to us, or at all. If we are not able to establish and maintain successful arrangements
with third parties or build our own sales and marketing infrastructure, our business and financial condition will be adversely affected.
**Our
products risk exposure to product liability claims.**
We
are exposed to potential product liability risks, which are inherent in the testing, manufacturing and marketing of our products. We
may incur significant expense investigating and defending any product liability claims, even if they do not result in liability. Moreover,
even if no judgments, fines, damages or liabilities are imposed on us, our reputation could suffer, which could have a material adverse
effect on our business, financial condition and results of operations.
**We
are reliant upon two manufacturers for key ingredients used to manufacture of our hydrogels.**
The
Dow Chemical Company and the BASF Corporation are the principal manufacturers of the two polymers, polyethylene oxide and polyvinylpyrrolidone,
respectively, that we primarily use in the manufacture of hydrogels. Although we have not experienced significant production delays attributable
to supply changes, we believe that developing alternative sources of supply for the polymers used to make our current hydrogels would
be difficult over a short period of time. Because we have no direct control over its third-party suppliers, interruptions or delays in
the products and services provided by these third parties may be difficult to remedy in a timely fashion. In addition, if such suppliers
are unable or unwilling to deliver the necessary raw materials or products, we may be unable to redesign or adapt our technology to work
without such raw materials or products or find alternative suppliers or manufacturers. In such events, we could experience interruptions,
delays, increased costs or quality control problems, which would have a material and adverse effect on our business, results of operations
and financial condition.
**We
have a history of operating losses and may require but have difficulty or be unsuccessful in raising potentially needed capital in the
future to continue to operate as a going concern.**
Currently
we do not have sufficient cash resources to meet our plans for the next twelve months from the issuance of the financial statements included
herein. Our recurring losses from operations, negative cash flows and potential need for additional capital raise substantial doubt about
our ability to continue as a going concern. If we do require additional financing to fund our operations, such funds may not be available
on acceptable terms, if at all, and such availability will depend on a number of factors, some of which are outside of our control, including
general capital markets conditions and investors view of our prospects and valuation. In addition, our ability to raise capital
in the public capital markets, including through our at-the-market equity offerings, may in the future be limited by, among other things,
SEC rules and regulations impacting the eligibility of smaller companies to use Form S-3 for primary offerings of securities. In general,
under the baby shelf rules if our public float is less than $75 million at the time we file our Annual Report on Form 10-K
to update our Form S-3 and our public float remains less than $75, we may not sell more than the equivalent of one-third of our public
float during any 12 consecutive months pursuant to the baby shelf rules. Alternative public and private transaction structures may require
additional time and cost, may impose operational restrictions on us, and may not be available on attractive terms. Further, investors
perception of our ability to continue as a going concern may make it more difficult for us to obtain financing, or necessitate that we
obtain financing on terms that are more favorable to investors, and could result in the loss of confidence by investors, suppliers and
employees. If we do require but are not able to acquire sufficient additional funding or alternative sources of capital to meet our working
capital needs, we will have to substantially curtail or discontinue our operations.
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| Table of Contents | |
**Our
ability to provide customers with competitive services is dependent on our ability to attract and retain qualified personnel, including
our senior management team.**
Our
ability to grow and provide our customers with competitive services is partially dependent on our ability to attract and retain highly
motivated people with the skills necessary to serve our customers. Personnel with the requisite skills or qualifications may be in short
supply or generally unavailable. The loss of personnel could impair our ability to perform under certain contracts, which could have
a material adverse effect on our consolidated financial position, results of operations, prospects and cash flows.
**Changes
in accounting standards and subjective assumptions, estimates and judgments by management related to complex accounting matters could
significantly affect our financial results or financial condition.**
GAAP
and related accounting pronouncements, implementation guidelines and interpretations with regard to a wide range of matters that are
relevant to our business, including but not limited to revenue recognition, business combinations, impairment of goodwill, indefinite-lived
intangible assets and long-lived assets, inventory and equity-based compensation, are highly complex and involve many subjective assumptions,
estimates and judgments. Changes in these rules or their interpretation or changes in underlying assumptions, estimates or judgments
could significantly change our reported or expected financial performance or financial condition.
**Our
ability to pursue strategic partnerships may impact our ability to compete in the markets we serve or desire to enter.**
We
have entered into, and expect to seek to enter into, additional strategic partnerships with other industry participants as part of an
effort to expand our business. However, we may be unable to identify attractive strategic partnership candidates or complete such partnerships
on terms favorable to us. In addition, if we are unable to successfully implement our partnership strategies or our strategic partners
do not fulfill their obligations or otherwise do not prove advantageous to our business, our investments in such partnerships and our
anticipated business expansion could be adversely affected.
Achieving
our growth objectives may prove unsuccessful. We may be unable to identify future attractive strategic partnerships, which may adversely
affect our growth. In addition, our ability to consummate or implement our strategic partnerships may be materially and adversely affected.
**Risks
Relating to our Common Stock and Capital Structure**
**An
active trading market may not develop or be sustained, and our stock price may fluctuate significantly once we do trade.**
Our
common stock and certain of our warrants trade on The Nasdaq Capital Market under the symbols NXGL and NXGLW,
respectively.
We
cannot predict the prices at which our common stock may trade. The market price of our common stock may fluctuate widely, depending on
many factors, some of which may be beyond our control, including:
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actual
or anticipated fluctuations in our operating results due to factors related to our business; | |
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success
or failure of our business strategies; | |
| 
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our
quarterly or annual earnings, or those of other companies in our industry; | |
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our
ability to obtain financing as needed; | |
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announcements
by us or our competitors of significant acquisitions or dispositions; | |
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| 
changes
in accounting standards, policies, guidance, interpretations or principles; | |
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| 
the
failure of securities analysts to cover our common stock after we commence trading; | |
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| 
changes
in earnings estimates by securities analysts or our ability to meet those estimates; | |
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| 
the
operating and stock price performance of other comparable companies; | |
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| 
overall
market fluctuations; | |
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| 
results
from any material litigation or government investigation; | |
| 
| 
| 
changes
in laws and regulations (including tax laws and regulations) affecting our business; | |
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| Table of Contents | |
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changes
in capital gains taxes and taxes on dividends affecting stockholders; and | |
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| 
| 
general
economic conditions and other external factors, including wars such as the current conflict in Ukraine and other geopolitical risks. | |
Furthermore,
our business profile and market capitalization may not fit the investment objectives of some of our stockholders and, as a result, these
stockholders may sell their shares of our common stock if we are able to list our common stock on The Nasdaq Capital Market. Substantial
sales of our common stock may occur, which could cause our stock price to decline. Low trading volume for our stock, which may occur
if an active trading market does not develop, among other reasons, would amplify the effect of the above factors on our stock price volatility.
**Our
failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our common stock and warrants.**
If
we fail to continue to satisfy the continued listing requirements of The Nasdaq Stock Market, LLC such as the corporate governance requirements,
the stockholders equity requirement or the minimum closing bid price requirement, Nasdaq may take steps to delist our common stock
and warrants. Such a delisting or even notification of failure to comply with such requirements would likely have a negative effect on
the price of our common stock and warrants and would impair your ability to sell or purchase our common stock and warrants when you wish
to do so. In the event of a delisting, we expect that we would take actions to restore our compliance with Nasdaqs listing requirements,
but we can provide no assurance that any such action taken by us would allow our common stock and warrants to become listed again, stabilize
the market price or improve the liquidity of our common stock and warrants, prevent our common stock from dropping below the Nasdaq minimum
bid price requirement or prevent future non-compliance with Nasdaqs listing requirements.
**We
cannot assure you that we will pay dividends on our common stock, and our indebtedness may limit our ability to pay dividends on our
common stock.**
The
timing, declaration, amount and payment of future dividends to stockholders will fall within the discretion of our Board of Directors.
Our Board of Directors decisions regarding the payment of future dividends will depend on many factors, including our financial
condition, earnings, capital requirements of our business and covenants associated with debt obligations, as well as legal requirements,
regulatory constraints, industry practice and other factors that our Board of Directors deems relevant. There can be no assurance that
we will pay a dividend in the future or continue to pay any dividend if we do commence paying dividends.
**The
interests of our principal stockholders, officers and directors, who collectively beneficially own approximately 16.3% of our stock,
may not coincide with yours and such stockholders will have the ability to control decisions with which you may disagree.**
As
of March 31, 2026, our principal stockholders, officers and directors beneficially owned approximately 16.3% of our common stock. As
a result, our principal stockholders, officers and directors will have the ability to substantially influence matters requiring stockholder
approval, including the election of directors and approval of significant corporate transactions. In addition, this concentration of
ownership may delay or prevent a change in control of our company and make some future transactions more difficult or impossible without
the support of our controlling stockholders. The interests of such stockholders may not coincide with your interests or the interests
of other stockholders.
**We
have identified material weaknesses in connection with our internal control over financial reporting which, if not remediated, could
adversely affect our business, reputation and stock price.**
Our
executive management and Audit Committee have concluded that we have material weaknesses in our internal control over financial reporting.
Specifically, management has concluded that its internal control over financial reporting was not effective as of December 31, 2025 to
provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance
with accounting principles generally accepted in the United States of America due to not maintaining proper segregation of duties, including:
(i) we have not designed controls to ensure all accounting journals entries are reviewed and approved and (ii) we have one individual
in our accounting department who has super user access and security administration rights to the financial reporting systems.
To
remediate these material weaknesses, we are working to do the following: (i) implementing appropriate controls for accounting journal
entry approvals, including the approval of our chief financial officer, and (ii) either actively monitoring any accounting user with
elevated rights or assigning another employee outside of an accounting and reporting role with elevated access. We will not be able to
fully remediate the material weakness until the actions discussed above have been implemented and operated effectively for a sufficient
period of time.
While
we are designing and implementing measures to remediate the material weaknesses, we cannot predict the success of such measures or the
outcome of our assessment of these measures at this time. We can give no assurance that these measures will remediate the weakness in
internal control or that additional material weaknesses or significant deficiencies in our internal control over financial reporting
will not be identified in the future. Our failure to implement and maintain effective internal control over financial reporting could
result in errors in our financial statements that may lead to restatements of our financial statements, cause us to fail to meet our
reporting obligations, or prevent fraud. Any such failure could also lead to reputational damage and a decrease in the market price of
our stock
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**If
securities or industry analysts do not publish research about our business, or publish negative reports about our business, our share
price and trading volume could decline.**
The
trading market for our common stock, to some extent, may at some point depend on the research and reports that securities or industry
analysts publish about our business. We do not have any control over these analysts. If one or more of the analysts elect to cover us
and downgrade our shares or lower their opinion of our shares, our share price would likely decline. If one or more of these analysts
elect to cover us and subsequently cease coverage of our company or fail to regularly publish reports on us, we could lose visibility
in the financial markets, which could cause our share price or trading volume to decline.
**Future
sales or potential sales of our common stock in the public market could cause our share price to decline.**
If
the existing holders of our common stock, particularly our directors and officers, sell a large number of shares, they could adversely
affect the market price for our common stock. Sales of substantial amounts of our common stock in the public market, or the perception
that these sales could occur, could cause the market price of our common stock to decline.
**We
may issue additional securities in the future upon conversion or exercise of outstanding securities which would result in dilution to
our stockholders.**
As
described elsewhere in this Form 10-K, we have previously issued warrants, restricted stock units, and stock options to fund our operations,
pay for services rendered and incentivize our employees and directors. The conversion or exercise of these securities would result in
substantial dilution to our stockholders. As of the date of the filing of this Form 10-K, we may be required to issue:
| 
| 
| 
907,111
shares of common stock issuable upon the exercise of outstanding stock options at a weighted average exercise price of $2.940267
per share; | |
| 
| 
| 
| |
| 
| 
| 
5,142,940
shares of common stock issuable upon the exercise of warrants at a weighted average exercise price of approximately $5.111123; and | |
| 
| 
| 
| |
| 
| 
| 
35,494
shares of restricted common stock issuable upon vesting and another 24,962 shares of vested shares of restricted common stock. | |
**We
are an emerging growth company and a smaller reporting company and may elect to comply with reduced public
company reporting requirements applicable to emerging growth companies, and are subject to lesser public company reporting requirements
applicable to smaller reporting companies, which could make our common stock less attractive to investors.**
We
are an emerging growth company, as defined in the JOBS Act, and we may take advantage of certain exemptions from various
reporting requirements that are applicable to other public companies that are not emerging growth companies including reduced
disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements
of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously
approved. We may take advantage of these reporting exemptions until we are no longer an emerging growth company. We will
remain an emerging growth company until the earliest of (i) the last day of the fiscal year in which we have total annual
gross revenues of$1.07 billion or more; (ii) the fifth anniversary of the Distribution; (iii) the date on which we have issued
more than $1.0 billion in nonconvertible debt during the previous three years; or (iv) the date on which we are deemed to be a large
accelerated filer under the Exchange Act. We cannot predict if investors will find our common stock less attractive because we
may rely on these exemptions. In addition, we are a smaller reporting company and accordingly are required to provide less
public disclosure than larger public companies. If some investors find our common stock less attractive as a result, there may be a less
active trading market for our common stock and our stock price may be more volatile.
| 16 | |
| Table of Contents | |
**We
will incur costs as a result of operating as a public company, and our management will be required to devote substantial time to new
compliance initiatives.**
As
a public reporting company, and particularly after we are no longer an emerging growth company, we will incur significant legal, accounting
and other expenses. The Sarbanes-Oxley Act and rules subsequently implemented by the SEC, have imposed various requirements on public
companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices.
Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these
rules and regulations will entail significant legal and financial compliance costs and will make some activities more time consuming
and costly. For example, we expect that these rules and regulations may make it difficult and expensive for us to obtain director and
officer liability insurance, and we may be required to accept low policy limits and coverage.
**Provisions
in our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws and of Delaware law may prevent or delay an
acquisition of our company, which could decrease the trading price of our common stock.**
Several
provisions of our Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws and Delaware law may discourage, delay
or prevent a merger or acquisition that stockholders may consider favorable. These include provisions that:
| 
| 
| 
permit
us to issue blank check preferred stock as more fully described under Description of Our Capital Stock Anti-Takeover Effects
of Various Provisions of Delaware Law and Our Amended and Restated Articles of Incorporation and Amended and Restated Bylaws; | |
| 
| 
| 
require
stockholders to follow certain advance notice and disclosure requirements in order to propose business or nominate directors at an
annual or special meeting; and | |
| 
| 
| 
limit
our ability to enter into business combination transactions with certain stockholders. | |
These
and other provisions of our Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws and Delaware law may discourage,
delay or prevent certain types of transactions involving an actual or a threatened acquisition or change in control of us, including
unsolicited takeover attempts, even though the transaction may offer our stockholders the opportunity to sell their shares of our common
stock at a price above the prevailing market price. See Description of Our Capital Stock Anti-Takeover Effects of Various Provisions
of Delaware Law and Our Amended and Restated Articles of Incorporation and Amended and Restated Bylaws for more information.
**Our
Amended and Restated Bylaws include a forum selection clause, which could limit our stockholders ability to obtain a favorable
judicial forum for disputes with us.**
Our
Amended and Restated Bylaws provide that, unless we consent in writing to the selection of an alternative forum, the sole and exclusive
forum for (i) any internal corporate claims within the meaning of the Delaware General Corporation Law (DGCL), (ii) any
derivative action or proceeding brought on our behalf, (iii) any action asserting a claim of breach of a fiduciary duty owed by any of
our directors, officers, or employees to us or to our stockholders, or (iv) any action asserting a claim arising pursuant to any provision
of the DGCL, will be a state court located within the State of Delaware (or, if no state court located within the State of Delaware has
jurisdiction, the federal court for the District of Delaware). Specifically, the sole and exclusive forum for such legal actions shall
be (i) first, the Court of Chancery of the State of Delaware, (ii) second, if the Court of Chancery of the State of Delaware lacks jurisdiction,
the Superior Court of the State of Delaware, or (iii) third, if the Superior Court of the State of Delaware lacks jurisdiction, the United
States District Court for the District of Delaware, in all cases subject to the courts having personal jurisdiction over the indispensable
parties named as defendants. This exclusive forum provision will apply to state and federal law claims, including claims under the federal
securities laws (including actions arising under the Exchange Act or the Securities Act), although our stockholders will not be deemed
to have waived our compliance with the federal securities laws and the rules and regulations thereunder. Section 22 of the Securities
Act, however, creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created
by the Securities Act or the rules and regulations thereunder. Accordingly, there is uncertainty as to whether a court would enforce
such a forum selection provision as written in connection with claims arising under federal securities laws. Any person or entity purchasing
or otherwise acquiring any interest in shares of our capital stock is deemed to have notice of and consented to the foregoing provisions.
This forum selection provision in our bylaws may limit our stockholders ability to obtain a favorable judicial forum for disputes
with us. It is also possible that, notwithstanding the forum selection clause included in our bylaws, a court could rule that such a
provision is inapplicable or unenforceable.
| 17 | |
| Table of Contents | |
**Item
1B. Unresolved Staff Comments**
None.
**Item
1C. Cybersecurity**
****
**Cybersecurity
Risk Management and Strategy**
We
have developed and implemented a cybersecurity risk management program intended to protect the confidentiality, integrity, and availability
of our critical systems and information.
We
have implemented a number of security measures designed to protect our systems and data, including firewalls, antivirus and malware detection
tools, patches, log monitors, and routine back-ups,. In addition, we have continued our efforts to migrate our platforms to cloud-based
computing, which is designed to further strengthen our security posture.
Our
cybersecurity risk management program is integrated into our overall enterprise risk management program and shares common methodologies,
reporting channels, and governance processes that apply across the enterprise risk management program to other legal, compliance, strategic,
operational, and financial risk areas.
Our
cybersecurity risk management program includes the following:
| 
| 
| 
the
use of external service providers, where appropriate, to assess, test, or otherwise assist with aspects of our security controls;
and | |
| 
| 
| 
| |
| 
| 
| 
cybersecurity
awareness training of our employees, incident response personnel, and senior management | |
There
can be no assurance that our cybersecurity risk management program and processes, including our policies, controls or procedures, will
be fully implemented, complied with or effective in protecting our systems and information.
**Cybersecurity
Governance**
****
Our
Board considers cybersecurity risks as part of its risk oversight.
The
Board oversees managements implementation of our cybersecurity risk management program and receives updates on the cybersecurity
risk management program from management at least annually. In addition, management updates the Board regarding any material or significant
cybersecurity incidents, as well as incidents with lesser impact potential as necessary.
**Ongoing
Risks**
We
have not experienced any material cybersecurity incidents. We have not identified risks from known cybersecurity threats, including as
a result of any prior cybersecurity incidents, that have materially affected us, including our operations, business strategy, results
of operations, or financial condition.
**Incident
Response and Assessment Policies and Procedures**
We
align with industry-standard cybersecurity frameworks designed to protect the company and customer data from unintentional disclosure,
cybersecurity events, and other threats of all severity levels. As part of our alignment with these frameworks we are in the process
of implementing a Cybersecurity Incident Response Plan that outlines actions to be taken after identifying a suspected information security
breach and the people responsible for managing those actions. Additionally, this plan will outline communication responsibilities during
incidents of all severity levels.
**Item
2. Properties**
We
maintain a combined corporate office and manufacturing facility in Langhorne, Pennsylvania, where we lease approximately 16,500 square
feet of office and manufacturing space which expires on January 31, 2031. In addition, we sublease approximately 6,200 square feet of
a 12,000 square foot combined office and manufacturing facility in Granbury, Texas for our JV. The lease expires in March 2028. We believe
that our facilities are well maintained and are suitable and adequate for our current needs.
**Item
3. Legal Proceedings**
From
time to time, we may become involved in lawsuits, investigations and claims that arise in the ordinary course of business. As of the
date of this information statement, we are not a party to any litigation whereby the outcome of such litigation, if determined adversely
to us, would materially affect our financial position, results of operations or cash flows.
**Item
4. Mine Safety Disclosure**
Not
applicable.
| 18 | |
| Table of Contents | |
**Part
II**
**Item
5. Market for the Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities**
**Market
Information**
Our
common stock is traded on NASDAQ Capital Markets under the symbol NXGL and certain warrants to purchase our common stock
issued on December 27, 2021 are trade on NASDAQ Capital Markets under the symbol NXGLW.
**Holders**
As
of March 31, 2026, there were over 983 shareholders of record and 8,163,458 shares of common stock outstanding.
**Sales
of Unregistered Securities during the Fiscal Year Ended December 31, 2025**
The
Company did not sell any unregistered securities during the fiscal year ended December 31, 2025.
**Issuer
Repurchases of Securities during the Fiscal Year Ended December 31, 2025**
The
Company did not repurchase any of its securities during the fiscal year ended December 31, 2025.
**Item
6. [Reserved]**
The
Company is a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and is not required to provide
the information under this item.
**Item
7. Managements Discussion and Analysis of Financial Condition and Results of Operations**
*The
following discussion and analysis are intended to help prospective investors understand our business, financial condition, results of
operations, liquidity and capital resources. You should read this discussion in conjunction with our consolidated financial statements
and related notes thereto included elsewhere in this information statement.*
*The
statements in this discussion regarding industry outlook, expectations regarding our future performance, liquidity and capital resources
and other non-historical statements are forward-looking statements. These forward-looking statements are subject to numerous risks and
uncertainties, including, but not limited to, the risks and uncertainties described in Special Note Regarding Forward-Looking
Statements. Actual results may differ materially from those contained in any forward-looking statements.*
*The
NexGel Financial Statements, discussed below, reflect the NexGel financial condition, results of operations, and cash flows. The financial
information discussed below and included in this information statement, however, may not necessarily reflect what the NexGel financial
condition, results of operations, or cash flows would have been had NexGel been operated as a separate, independent entity during the
years presented, or what the NexGel financial condition, results of operations, and cash flows may be in the future.*
**Overview**
We manufacture high water content,
electron beam cross-linked, aqueous polymer hydrogels, or gels, used for wound care, medical diagnostics, transdermal drug delivery and
cosmetics. We specialize in custom gels by capitalizing on proprietary manufacturing technologies. We distribute our products as a contract
manufacturer, supplying our gels to third parties who incorporate them into their own products. We also have a line of branded consumer
products sold direct to consumers and custom and white label opportunities, which focuses on combining our gels with proprietary branded
products and white label opportunities. All of our gel products are manufactured using proprietary and non-proprietary mixing, coating
and cross-linking technologies. Together, these technologies enable us to produce gels that can satisfy rigid tolerance specifications
with respect to a wide range of physical characteristics (e.g., thickness, water content, adherence, absorption, moisture vapor transmission
rate [a measure of the passage of water vapor through a substance] and release rate) while maintaining product integrity. Additionally,
we have the manufacturing ability to offer broad choices in the selection of liners onto which the gels are coated. Consequently, we and
our customers are able to determine tolerances in moisture vapor transmission rate and active ingredient release rates while personalizing
color and texture. Our joint venture with CG Laboratories, Inc. called CG Converting and Packaging, LLC, which is located in Granbury,
Texas in which we own a 50% interest, allowing us to expand our ability to deliver finished goods to our growing customer base.
| 19 | |
| Table of Contents | |
**Lines
of Business**
****
We
have four distinct lines of business; Contract Manufacturing, Custom & White Label, Consumer Branded Products, and Medical Devices/Other.
**
*Contract
Manufacturing*
Customers
order rolls of gel (rollstock). The rollstock is shipped to our customers, which they package into finished goods. Historically,
this has been the Companys primary source of revenue.
*Custom
& White Label*
These
products often infuse various ingredients into our base gel to develop unique product offerings to satisfy market demand (e.g. aloe infused
into the gel for a beauty mask). The rollstock is converted and packaged into salable units. The finished goods are shipped to the customer,
who is ultimately responsible for product distribution. Frequently these products started as development deals, in which the customer
paid the company a small fee to develop a specific product. Once completed, the customer places a large order for newly developed product.
*Consumer
Branded Products*
These
products are finished goods marketed and sold directly to the customer by the Company through online and retail channels. We are responsible
for sales, marketing, and distribution. The products we sell under our MedaGel brand primarily relate to healthcare over-the-counter
(OTC) remedy solutions, such as blister and pain applications. In December 2023 we added a second consumer product brand
when we completed the purchase of the Kenkoderm brand. The Kenkoderm skincare line was originally developed by a dermatologist to provide
gentle to the skin products for consumer with psoriasis. In May 2024, we added our third consumer product brand with the purchase of
the Silly George brand. Silly George is a beauty brand primarily focused on false eyelashes and other eye related products. We continue
to look for additional potential acquisitions as part of our consumer product roll-up strategy.
**
| 20 | |
| Table of Contents | |
**
*Medical
Devices/Other*
Medical
Devices are a hybrid business, combining elements of Custom & White Label and Consumer Branded Products. Medical Devices, which are
not yet marketed, are expected to be distributed through strategic partnerships. We will manufacture and possibly convert/package the
device while the strategic partner brings the product to market. Small market Medical Devices could be launched by us, but also be offered
to a distributor to reach the full scale of the market.
Other
includes freight charged to customers who purchase the Companys branded consumer products through their Shopify stores.
****
**Results
of Operations**
The
following sections discuss and analyze the changes in the significant line items in our statements of operations for the comparison years
identified.
**Year
Ended December 31, 2025 Compared to the Year Ended December 31, 2024 ($ in thousands)**
**Revenues,
net**
| 
| | 
Year Ended December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Revenues, net | | 
$ | 11,421 | | | 
$ | 8,688 | | |
For
the year ended December 31, 2025 revenues were $11,421 and increased by $2,733, or 31.5%, when compared to $8,688 for the year ended
December 31, 2024. The increase in our overall revenues was primarily due to sales growth in our branded consumer products, as the prior
year period included gross revenue for a partial year from Silly George from May 15, 2024 through December 31, 2024.
| 21 | |
| Table of Contents | |
****
Cost
of revenues are as follows for the years ended December 31, 2025 and 2024 ($ in thousands):
| 
| | 
Year Ended December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Cost of revenues | | 
$ | 6,912 | | | 
$ | 5,940 | | |
Cost of revenues increased by $972 or 16.4%, to $6,912 for the year ended
December 31, 2025, as compared to $5,940 for the year ended December 31, 2024. The increase in cost of revenues is primarily aligned with
sales of branded consumer products and the acquisition of Silly George in the prior year period which increased by 50.8%.
**Gross
profit (loss)**
Our gross profit was $4,509 for the year ended December 31, 2025 compared
to a gross profit of $2,748 for the year ended December 31, 2024 The increase of $1,761 in gross profit recorded for the year ended December
31, 2025, as compared to December 31, 2024, was primarily due to an increase in branded consumer products. Gross profit was approximately
39.5% for the year ended December 31, 2025 compared to a gross profit of 31.6% for the year ended December 31, 2024.
**Selling,
general and administrative expenses**. Selling, general and administrative expenses are as follows for the years ended December 31,
2025 and 2024 ($ in thousands):
| 
| | 
Year Ended December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Selling, general and administrative expenses | | 
$ | 7,859 | | | 
$ | 6,224 | | |
Selling, general and administrative expenses increased by $1,635 or 26.3%,
to $7,859 for the year ended December 31, 2025, as compared to $6,224 for the year ended December 31, 2024. The increase in Selling, general
and administrative expenses is primarily attributable to an increase in compensation and benefits (including share-based benefits) of
$816, advertising and marketing increases of $282, an increase in professional and consulting fees of $258, and other expense of $205.
**Research
and development expenses**
Research
and development expenses decreased by $76 to $2 for the year ended December 31, 2025 from $78 for the year ended December 31, 2024. Research
and development expenses are related to research costs incurred for potential products for existing or new customers.
**Liquidity
and Capital Resources**
**Cash
Flow (in thousands)**
| 
| 
| 
Years Ended December 31, | 
| |
| 
| 
| 
2025 | 
| 
| 
2024 | 
| |
| 
Net cash used in operating activities | 
| 
$ | 
(1,311 | 
) | 
| 
$ | 
(3,867 | 
) | |
| 
Net cash provided by (used in) investing activities | 
| 
| 
(68 | 
) | 
| 
| 
(775 | 
) | |
| 
Net cash provided by financing activities | 
| 
| 
630 | 
| 
| 
| 
3,749 | 
| |
| 
Net increase (decrease) in cash and cash equivalents | 
| 
| 
(749 | 
) | 
| 
| 
(893 | 
) | |
| 
Cash and cash equivalents at beginning of year | 
| 
| 
1,807 | 
| 
| 
| 
2,700 | 
| |
| 
Cash and cash equivalent, and restricted cash at end of year | 
| 
$ | 
1,058 | 
| 
| 
$ | 
1,807 | 
| |
As of December 31, 2025, we had $317 of cash and cash equivalents and $741
of restricted cash compared to $1,807 thousand of cash and cash equivalents at December 31, 2024. Net cash used in operating activities
was $1,311 thousand and $3,867 thousand for the years ended December 31, 2025 and 2024, respectively.
Net
cash used in investing activities was $68 thousand and $775 thousand for the years ended December 31, 2025 and 2024, respectively. Net
cash used in investing activities for 2025 was attributable to the purchases of capital equipment while net cash used in investing activities
for 2024 was attributable to the sales of marketable securities of $68 thousand, offset by purchases of capital equipment of $443 thousand
and the investment in the subsidiary Semmens Online of $400 thousand.
Net cash provided by financing activities for year ended December 31, 2025
was $630 thousand which was attributable to the proceeds from rights offering of $963 thousand, offset by principal payments of notes
payments of $97 thousand, and change in contingent consideration of $177 thousand made on the operating lease liability, and $59 thousand
of principal payment of financing lease liability.
Net
cash provided by financing activities for year ended December 31, 2024 was $3,749 thousand which is attributable to the proceeds from
rights offering of $3,772 thousand, proceeds from non-controlling interest of $38 thousand, and proceeds from margin line of credit of
$345 thousand, offset by principal payments of notes payments of $77 thousand, and change in contingent consideration of $279 thousand
made on the operating lease liability, and $50 thousand of principal payment of financing lease liability.
| 22 | |
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At December 31, 2025, current assets totaled $4,477 thousand and current
liabilities totaled $3,095 thousand, as compared to current assets totaling $5,114 thousand and current liabilities totaling $2,470 thousand
at December 31, 2024. As a result, we had working capital of $1,382 thousand at December 31, 2025, compared to a working capital of$2,644
thousand at December 31, 2024. The decrease in the working capital as of December 31, 2025 is primarily attributable to the loss from
operations of $3,352 thousand and proceeds from rights offering of $963 thousand and proceeds from Stada of $1,000 thousand.
We
have never declared or paid any cash dividends on our common stock. For the foreseeable future, we anticipate that all available funds
and any earnings generated in our business will be used to finance the growth of our business and will not be paid out as dividends to
our shareholders. Any future determination related to our dividend policy will be made at the discretion of our Board of Directors and
will depend upon, among other factors, our results of operations, financial condition, capital requirements, contractual restrictions,
business prospects and other factors our Board of Directors may deem relevant.
Management
is exploring new product channel sales in consumer products, such as cosmetics, athletic products, and proprietary medical devices. The
Company has increased its focus on sales and developing a sales pipeline for potential customers. This customer base expansion will enable
us to provide financial stability for the foreseeable future, expand our current processes, and position us for long-term shareholder
value creation.
Our
recent capital raise which closed on or about August 5, 2025 provides working capital necessary to continue our strategic objectives (discussed
further within Note 14). We intend to maintain and attempt to grow our existing contract manufacturing business. We also plan to continue
building and developing our catalogue of consumer products for sale to branding partners and to use our in-house capabilities to create
and test market additional branded products. These products will be target marketed and sold online through social media, television
and online marketplaces. Furthermore, the Company plans to develop its own proprietary medical devices and explore drug delivery programs
for its technology. Additionally, the Company continues to evaluate strategic initiatives (e.g., acquisitions) and additional capital
raises through debt or equity may be necessary to achieve these objectives.
We
expect to continue incurring losses for the near-term future. Our ability to continue to operate as a going concern in the long term
is dependent upon our ability to manage and grow our current products and to ultimately achieve profitable operations. Management may
consider various options to raise capital to fund potential acquisitions through equity or debt offerings. There can be no assurances,
however, that management will be able to obtain sufficient additional funds, if needed, or that such funds, if available, will be obtained
on terms satisfactory to us. The financial statements do not include any adjustments relating to the recoverability and classification
of recorded assets and liabilities that might be necessary should we be unable to continue as a going concern.
Additionally,
it is reasonably possible that estimates made in the financial statements have been, or will be, materially and adversely impacted in
the near term as a result of these conditions, including the recoverability of long-lived assets.
**Off
Balance Sheet Arrangements**
As
of December 31, 2025, we had no off-balance sheet arrangements in the nature of guarantee contracts, retained or contingent interests
in assets transferred to entities (or similar arrangements serving as credit, liquidity or market risk support to entities for any such
assets), or obligations (including contingent obligations) arising out of variable interests in entities providing financing, liquidity,
market risk or credit risk support to us, or that engage in leasing, hedging or research and development services with us.
**Critical
Accounting Policies and Estimates**
The
preparation of our accompanying consolidated financial statements in accordance with generally accepted accounting principles is based
on the selection and application of accounting policies that require us to make significant estimates and assumptions about the effects
of matters that are inherently uncertain. We consider the accounting policies discussed below to be critical to the understanding of
our Financial Statements. Actual results could differ from our estimates and assumptions, and any such differences could be material
to our Financial Statements.
**
*Share-based
compensation* We utilize share-based compensation in the form of incentive stock options. The fair values of incentive stock
option award grants are estimated as of the date of grant using a Black-Scholes option valuation model. Compensation expense is recognized
in the statements of operations on a straight-line basis over the requisite service period, which is generally the vesting period required
to obtain full vesting. The expected term of the awards granted is estimated using the simplified method which computes the expected
term as the sum of the awards vesting term plus the original contractual term divided by two.
*Warrant
Liability* Warrants to purchase common stock were issued in connection with equity financing raises which occurred during
2019 through 2021. The fair values of the warrants are estimated as of the date of issuance and again at each year end using a Black-Scholes
option valuation model. At issuance, the fair value of the warrant is recognized as an equity issuance cost within additional paid-in-capital.
Fair value adjustments to the warrant liability are recognized in other income (expense) in the statements of operations. The expected
term of the awards granted are based on either the three-year or five-year contractual expiration date.
*Black
Scholes Inputs -*The fair value of each stock option award and warrant issued was estimated on the date of grant using a Black-Scholes
option-valuation model, which requires management to make certain assumptions regarding: (i) fair value of the common stock that underlies
the stock option; (ii) the expected volatility in the market price of our common stock; (iii) dividend yield; (iv) risk-free interest
rates; and (iv) the period of time employees are expected to hold the award prior to exercise (referred to as the expected term). Under
the Black-Scholes option-valuation model, entities typically estimate the expected volatility based on historical volatilities of the
entitys own common stock. Based on the lack of historical data of volatility for the Companys common stock, the Company
based its estimate of expected volatility on a weighted average of the historical volatility of comparable public companies that manufacture
similar products and are similar in size, stage of life cycle, and financial leverage. The fair value of the common stock that underlies
the stock option is estimated by the Company considering the price of the most recent issuance of the Companys common stock. The
dividend yield is based upon the assumption that the Company will not declare a dividend over the life of the options. The risk-free
interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for bonds with maturities consistent with the
expected term of the related award.
**Item
7A. Quantitative and Qualitative Disclosures About Market Risk**
Not
required.
| 23 | |
| Table of Contents | |
**Item
8. Financial Statements and Supplementary Data**
**FINANCIAL
STATEMENTS - TABLE OF CONTENTS**
**For
the Years Ended December 31, 2025 and 2024**
| 
| 
Page(s) | |
| 
Report of Independent Registered Public Accounting Firm (PCAOB ID: 76) | 
F-2 | |
| 
| 
| |
| 
Consolidated
Financial Statements: | 
| |
| 
| 
| |
| 
Consolidated Balance Sheets at December 31, 2025 and 2024 | 
F-3 | |
| 
| 
| |
| 
Consolidated Statements of Operations for the years ended December 31, 2025 and 2024 | 
F-4 | |
| 
| 
| |
| 
Consolidated Statements of Stockholders Equity for the years ended December 31, 2025 and 2024 | 
F-5 | |
| 
| 
| |
| 
Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024 | 
F-6 | |
| 
| 
| |
| 
Notes to Consolidated Financial Statements | 
F-7 | |
| F-1 | |
| Table of Contents | |
*
**REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM**
To
the Board of Directors and Stockholders of
NexGel,
Inc.
**Opinion
on the Financial Statements**
****
We
have audited the accompanying consolidated balance sheets of NexGel, Inc. and its subsidiaries (the Company) as of December
31, 2025 and 2024, and the related consolidated statements of operations, stockholders equity, and cash flows for the years then
ended, and the related notes to consolidated financial statements (collectively referred to as the financial statements).
In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December
31, 2025 and 2024, and the results of its operations and its cash flows for each of the years then ended, in conformity with accounting
principles generally accepted in the United States of America.
**Explanatory
Paragraph Going Concern**
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note
2 of the financial statements, the Company expects to continue incurring operating losses and generating negative cash flows from operations
for the foreseeable future. Additionally, the Company has a significant working capital deficiency, accumulated deficit and net loss
for the year. These conditions raise substantial doubt about its ability to continue as a going concern. Managements plans in
regard to these matters are also described in Note 2 to the financial statements. The financial statements do not include any adjustments
that might be necessary should the Company be unable to continue as a going concern.
**Basis
for Opinion**
****
These
financial statements are the responsibility of the Companys management. Our responsibility is to express an opinion on the Companys
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits,
we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion
on the effectiveness of the Companys internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits
provide a reasonable basis for our opinion.
/s/
Turner, Stone & Company, L.L.P.*
Turner, Stone & Company, L.L.P.
We
have served as the Companys auditor since 2019.
Dallas,
Texas
March
31, 2026
*
| F-2 | |
| Table of Contents | |
**NEXGEL,
INC**
**CONSOLIDATED
BALANCE SHEETS**
(in
thousands, except share and per share data)*
| 
| | 
December 31, 2025 | | | 
December 31, 2024 | | |
| 
ASSETS: | | 
| | | | 
| | | |
| 
Current Assets: | | 
| | | | 
| | | |
| 
Cash | | 
$ | 317 | | | 
$ | 1,807 | | |
| 
Restricted cash | | 
| 741 | | | 
| - | | |
| 
Accounts receivable, net | | 
| 673 | | | 
| 933 | | |
| 
Inventory | | 
| 2,111 | | | 
| 1,751 | | |
| 
Prepaid expenses and other current assets | | 
| 496 | | | 
| 623 | | |
| 
Total current assets | | 
| 4,338 | | | 
| 5,114 | | |
| 
Goodwill | | 
| 1,128 | | | 
| 1,128 | | |
| 
Intangibles, net | | 
| 681 | | | 
| 807 | | |
| 
Property and equipment, net | | 
| 1,955 | | | 
| 2,211 | | |
| 
Operating lease - right of use asset | | 
| 2,015 | | | 
| 1,628 | | |
| 
Investment in NexGelRx | | 
| 249 | | | 
| - | | |
| 
Other assets | | 
| 95 | | | 
| 95 | | |
| 
Total assets | | 
$ | 10,461 | | | 
$ | 10,983 | | |
| 
| | 
| | | | 
| | | |
| 
LIABILITIES AND STOCKHOLDERS EQUITY | | 
| | | | 
| | | |
| 
Current Liabilities: | | 
| | | | 
| | | |
| 
Accounts payable | | 
$ | 723 | | | 
$ | 761 | | |
| 
Accounts payable related party | | 
| 566 | | | 
| 531 | | |
| 
Accrued expenses and other current liabilities | | 
| 460 | | | 
| 310 | | |
| 
Deferred revenue | | 
| 2 | | | 
| 179 | | |
| 
Current portion of note payable | | 
| 99 | | | 
| 97 | | |
| 
Partnership accrued advance | | 
| 731 | | | 
| - | | |
| 
Warrant liability and contingent consideration liability | | 
| - | | | 
| 296 | | |
| 
Current portion of finance lease liability | | 
| 65 | | | 
| 59 | | |
| 
Current portion of operating lease liability | | 
| 310 | | | 
| 237 | | |
| 
Total current liabilities | | 
| 2,956 | | | 
| 2,470 | | |
| 
Operating lease liability, net of current portion | | 
| 1,883 | | | 
| 1,538 | | |
| 
Finance lease liability, net of current portion | | 
| 242 | | | 
| 307 | | |
| 
Notes payable, net of current portion | | 
| 489 | | | 
| 588 | | |
| 
Total liabilities | | 
| 5,570 | | | 
| 4,903 | | |
| 
| | 
| | | | 
| | | |
| 
Commitments and Contingencies (Note 18) | | 
| - | | | 
| - | | |
| 
| | 
| | | | 
| | | |
| 
STOCKHOLDERS EQUITY | | 
| | | | 
| | | |
| 
| | 
| | | | 
| | | |
| 
Preferred stock, par value $0.001 per share, 5,000,000 shares authorized, no shares issued and outstanding | | 
| - | | | 
| - | | |
| 
Common stock, par value $0.001 per share, 25,000,000 shares authorized; 8,143,133 and 7,638,497 shares issued and outstanding as of December 31, 2025 and 2024, respectively | | 
| 8 | | | 
| 8 | | |
| 
Additional paid-in capital | | 
| 25,447 | | | 
| 23,743 | | |
| 
Accumulated deficit | | 
| (20,996 | ) | | 
| (17,996 | ) | |
| 
Total NexGel stockholders equity | | 
| 4,459 | | | 
| 5,755 | | |
| 
Non-controlling interest in joint venture | | 
| 432 | | | 
| 325 | | |
| 
Total stockholders equity | | 
| 4,891 | | | 
| 6,080 | | |
| 
Total liabilities and stockholders equity | | 
$ | 10,461 | | | 
$ | 10,983 | | |
The
accompanying notes are an integral part of these consolidated financial statements.
| F-3 | |
| Table of Contents | |
**NEXGEL,
INC.**
**CONSOLIDATED
STATEMENTS OF OPERATIONS**
*(in
thousands, except share and per share data)*
| 
| | 
2025 | | | 
2024 | | |
| 
| | 
Year Ended December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Revenues, net | | 
$ | 11,421 | | | 
$ | 8,688 | | |
| 
| | 
| | | | 
| | | |
| 
Cost of revenues | | 
| 6,912 | | | 
| 5,940 | | |
| 
| | 
| | | | 
| | | |
| 
Gross profit | | 
| 4,509 | | | 
| 2,748 | | |
| 
| | 
| | | | 
| | | |
| 
Operating expenses: | | 
| | | | 
| | | |
| 
Research and development | | 
| 2 | | | 
| 78 | | |
| 
Selling, general and administrative | | 
| 7,859 | | | 
| 6,224 | | |
| 
Total operating expenses | | 
| 7,861 | | | 
| 6,302 | | |
| 
| | 
| | | | 
| | | |
| 
Loss from operations | | 
| (3,352 | ) | | 
| (3,554 | ) | |
| 
| | 
| | | | 
| | | |
| 
Other income (expense) | | 
| | | | 
| | | |
| 
Change in fair value of warrant liability, net of warrant modification expense | | 
| 118 | | | 
| 28 | | |
| 
Realized gain on investments in marketable securities | | 
| - | | | 
| 68 | | |
| 
Interest expense, net | | 
| (34 | ) | | 
| (81 | ) | |
| 
Change in fair value of contingent consideration | | 
| - | | | 
| (18 | ) | |
| 
Gain in spin-off of NexGelRx | | 
| 162 | | | 
| - | | |
| 
Other expense | | 
| (73 | ) | | 
| (4 | ) | |
| 
Other income | | 
| 286 | | | 
| 98 | | |
| 
Total other income (expense), net | | 
| 459 | | | 
| 91 | | |
| 
Loss before income taxes | | 
| (2,893 | ) | | 
| (3,463 | ) | |
| 
Income tax expense | | 
| - | | | 
| - | | |
| 
Net loss | | 
| (2,893 | ) | | 
| (3,463 | ) | |
| 
Less: Loss attributable to non-controlling interest in joint venture | | 
| (107 | ) | | 
| 182 | | |
| 
Net loss attributable to NexGel stockholders | | 
$ | (3,000 | ) | | 
$ | (3,281 | ) | |
| 
| | 
| | | | 
| | | |
| 
Net loss per common share basic and diluted | | 
$ | (0.38 | ) | | 
$ | (0.50 | ) | |
| 
| | 
| | | | 
| | | |
| 
Weighted average shares used in computing net loss per common share basic and diluted | | 
| 7,854,288 | | | 
| 6,511,574 | | |
The
accompanying notes are an integral part of these consolidated financial statements.
| F-4 | |
| Table of Contents | |
****
**NEXGEL,
INC.**
**CONSOLIDATED
STATEMENTS OF STOCKHOLDERS EQUITY**
Years
Ended December 31, 2025 and 2024
*(in
thousands, except share data)*
| 
| | 
Shares | | | 
Amount | | | 
Capital | | | 
Interest | | | 
Deficit | | | 
Equity | | |
| 
| | 
Common Stock | | | 
Additional Paid-in | | | 
Non-controlling | | | 
Accumulated | | | 
Total Stockholders | | |
| 
| | 
Shares | | | 
Amount | | | 
Capital | | | 
Interest | | | 
Deficit | | | 
Equity | | |
| 
Balance, December 31, 2023 | | 
| 5,741,838 | | | 
$ | 6 | | | 
$ | 19,406 | | | 
$ | 469 | | | 
$ | (14,715 | ) | | 
$ | 5,166 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Stock-based compensation | | 
| 90,860 | | | 
| - | | | 
| 280 | | | 
| - | | | 
| - | | | 
| 280 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Restricted stock issuances | | 
| 53,410 | | | 
| - | | | 
| 87 | | | 
| - | | | 
| - | | | 
| 87 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Shares issued in acquisition | | 
| 89,892 | | | 
| - | | | 
| 200 | | | 
| - | | | 
| - | | | 
| 200 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Exercise of warrants | | 
| 5,439 | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | | 
| - | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Issuance of securities | | 
| 1,657,058 | | | 
| 2 | | | 
| 3,770 | | | 
| - | | | 
| - | | | 
| 3,772 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Non-controlling interest contribution | | 
| - | | | 
| - | | | 
| - | | | 
| 38 | | | 
| - | | | 
| 38 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Net loss | | 
| - | | | 
| - | | | 
| - | | | 
| (182 | ) | | 
| (3,281 | ) | | 
| (3,463 | ) | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Balance, December 31, 2024 | | 
| 7,638,497 | | | 
$ | 8 | | | 
$ | 23,743 | | | 
$ | 325 | | | 
$ | (17,996 | ) | | 
$ | 6,080 | | |
| 
| | 
Common Stock | | | 
Additional Paid-in | | | 
Non-controlling | | | 
Accumulated | | | 
Total Stockholders | | |
| 
| | 
Shares | | | 
Amount | | | 
Capital | | | 
Interest | | | 
Deficit | | | 
Equity | | |
| 
Balance, December 31, 2024 | | 
| 7,638,497 | | | 
$ | 8 | | | 
$ | 23,743 | | | 
$ | 325 | | | 
$ | (17,996 | ) | | 
$ | 6,080 | | |
| 
Balance | | 
| 7,638,497 | | | 
$ | 8 | | | 
$ | 23,743 | | | 
$ | 325 | | | 
$ | (17,996 | ) | | 
$ | 6,080 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Stock-based compensation | | 
| 6,825 | | | 
| - | | | 
| 475 | | | 
| - | | | 
| - | | | 
| 475 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Restricted stock issuances | | 
| 39,116 | | | 
| - | | | 
| 179 | | | 
| - | | | 
| - | | | 
| 179 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Issuance of securities | | 
| 458,695 | | | 
| - | | | 
| 963 | | | 
| - | | | 
| - | | | 
| 963 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Warrants issued in conjunction with NexgelRx | | 
| - | | | 
| - | | | 
| 87 | | | 
| - | | | 
| - | | | 
| 87 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Net loss | | 
| - | | | 
| - | | | 
| - | | | 
| 107 | | | 
| (3,000 | ) | | 
| (2,893 | ) | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Balance, December 31, 2025 | | 
| 8,143,133 | | | 
$ | 8 | | | 
$ | 25,447 | | | 
$ | 432 | | | 
$ | (20,996 | ) | | 
$ | 4,891 | | |
| 
Balance | | 
| 8,143,133 | | | 
$ | 8 | | | 
$ | 25,447 | | | 
$ | 432 | | | 
$ | (20,996 | ) | | 
$ | 4,891 | | |
The
accompanying notes are an integral part of these consolidated financial statements.
| F-5 | |
| Table of Contents | |
**NEXGEL,
INC.**
**CONSOLIDATED
STATEMENTS OF CASH FLOWS**
*(in
thousands)*
| 
| | 
2025 | | | 
2024 | | |
| 
| | 
Year Ended December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Operating Activities | | 
| | | | 
| | | |
| 
Net loss | | 
$ | (2,893 | ) | | 
$ | (3,463 | ) | |
| 
Adjustments to reconcile net loss to net cash used in operating activities: | | 
| | | | 
| | | |
| 
Depreciation and amortization | | 
| 450 | | | 
| 436 | | |
| 
Share-based compensation | | 
| 654 | | | 
| 367 | | |
| 
Realized gain on investment in marketable securities | | 
| - | | | 
| (68 | ) | |
| 
Change in fair value of warrant liability | | 
| (118 | ) | | 
| (28 | ) | |
| 
Change in fair value of contingent consideration | | 
| - | | | 
| 18 | | |
| 
Amortization of right of use asset | | 
| 290 | | | 
| 227 | | |
| 
Gain in spin-off of NexGelRx | | 
| (162 | ) | | 
| - | | |
| 
Changes in operating assets and liabilities: | | 
| | | | 
| | | |
| 
Accounts receivable, net | | 
| 260 | | | 
| (300 | ) | |
| 
Inventory | | 
| (360 | ) | | 
| (432 | ) | |
| 
Prepaid expenses and other current assets | | 
| 127 | | 
| (223 | ) | |
| 
Accounts payable | | 
| (38 | ) | | 
| 182 | | |
| 
Accounts payable related party | | 
| 35 | | 
| (123 | ) | |
| 
Accrued expenses and other current liabilities | | 
| 150 | | | 
| (434 | ) | |
| 
Partnership advance | | 
| 731 | | 
| - | | |
| 
Deferred revenue | | 
| (177 | ) | | 
| 159 | | |
| 
Operating lease liability | | 
| (260 | ) | | 
| (185 | ) | |
| 
Net Cash Used in Operating Activities | | 
| (1,311 | ) | | 
| (3,867 | ) | |
| 
| | 
| | | | 
| | | |
| 
Investing Activities | | 
| | | | 
| | | |
| 
Purchases of equipment | | 
| (68 | ) | | 
| (443 | ) | |
| 
Investment in subsidiary | | 
| - | | | 
| (400 | ) | |
| 
Proceeds from sales of marketable securities | | 
| - | | | 
| 68 | | |
| 
Net Cash Provided by (Used in) Investing Activities | | 
| (68 | ) | | 
| (775 | ) | |
| 
| | 
| | | | 
| | | |
| 
Financing Activities | | 
| | | | 
| | | |
| 
Payment of contingent consideration | | 
| (177 | ) | | 
| (279 | ) | |
| 
Proceeds from rights offering | | 
| 963 | | | 
| 3,772 | | |
| 
Principal payments of notes payable | | 
| (97 | ) | | 
| (77 | ) | |
| 
Proceeds from non-controlling interest | | 
| - | | | 
| 38 | | |
| 
Principal payment of financing lease liability | | 
| (59 | ) | | 
| (50 | ) | |
| 
Proceeds from margin line of credit | | 
| - | | | 
| 345 | | |
| 
Net Cash Provided by Financing Activities | | 
| 630 | | | 
| 3,749 | | |
| 
| | 
| | | | 
| | | |
| 
Net Increase (Decrease) in Cash (*) | | 
| (749 | ) | | 
| (893 | ) | |
| 
Cash and restricted cash Beginning of year | | 
| 1,807 | | | 
| 2,700 | | |
| 
Cash and restricted cash End of year | | 
$ | 1,058 | | | 
$ | 1,807 | | |
| 
(*) $1,490 relates to decrease in cash
and $741 relates to increase in restricted cash | | 
| | | 
| | |
| 
| | 
| | | | 
| | | |
| 
Supplemental Non-cash Investing and Financing Activities | | 
| | | | 
| | | |
| 
Warrants issued in conjunction with investment in NexgelRx | | 
$ | 87 | | | 
$ | 200 | | |
| 
Additional ROU assets and operating lease liabilities from lease modification | | 
$ | 677 | | | 
$ | - | | |
| 
Shares issued in conjunction with asset acquisition | | 
$ | - | | | 
$ | 200 | | |
| 
Property and equipment financed under notes payable | | 
$ | - | | | 
$ | 169 | | |
| 
Property and equipment financed under financing leases | | 
$ | - | | | 
$ | 416 | | |
The
accompanying notes are an integral part of these consolidated financial statements.
| F-6 | |
| Table of Contents | |
**NEXGEL,
INC.**
**NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS**
*(in
thousands, except share and per share data)*
**1.
Description of Business and Basis of Presentation**
NexGel,
Inc. (NexGel or the Company) manufactures high water content, electron beam cross-linked, aqueous polymer
hydrogels, or gels, used for wound care, medical diagnostics, transdermal drug delivery and cosmetics. The Company specializes in custom
gels by capitalizing on proprietary manufacturing technologies. The Company has historically served as a contract manufacturer, supplying
our gels to third parties who incorporate them into their own products. Beginning in 2020, we created two new lines of business for the
Company. First, we launched our own line of branded consumer products sold direct to consumers. Second, we expanded into custom and white
label opportunities, which focuses on combining our gels with proprietary branded products and white label opportunities. All of our
gel products are manufactured using proprietary and non-proprietary mixing, coating and cross-linking technologies. Together, these technologies
enable us to produce gels that can satisfy rigid tolerance specifications with respect to a wide range of physical characteristics (e.g.,
thickness, water content, adherence, absorption, moisture vapor transmission rate [a measure of the passage of water vapor through a
substance] and release rate) while maintaining product integrity. Additionally, we have the manufacturing ability to offer broad choices
in the selection of liners onto which the gels are coated. Consequently, the Company and its customers are able to determine tolerances
in moisture vapor transmission rate and active ingredient release rates while personalizing color and texture.
NexGel
was previously known as AquaMed Technologies, Inc. (AquaMed) before changing its name to NexGel, Inc. on November 14, 2019.
On
May 15, 2024, the Company purchased substantially all of the assets from Semmens Online Pty Ltd as Trustee for Semmens Business Trust
(the SG Seller) related to the SG Sellers eyeliner, fake eyelashes, lash serum and mascara business operating under
the tradename Silly George (collectively, the Silly George Business).
****
**Basis
of Presentation**
The
consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the
United States of America (GAAP) and are presented in US dollars.
**Principles
of Consolidation**
The
accompanying consolidated financial statements include the accounts of the Company and the fifty percent (50%) owned JVs (see Note 7).
| F-7 | |
| Table of Contents | |
**2.
Going Concern**
The
accompanying consolidated financial statements have been prepared in conformity with GAAP, which
contemplate continuation of the Company as a going concern. As of December 31, 2025, the Company had a cash balance of $317 thousand.
For the year ended December 31, 2025, the Company incurred a net loss attributable to NexGel stockholders of$3.0 million and
had net usage of cash in operating activities of $1.3 million. In addition, the Company had a working capital of $1.4 million as of December
31, 2025. These conditions raise substantial doubt about the Companys ability to continue as a going concern. The Companys
cash balance of $317 thousand as of December 31, 2025 does not include $741 thousand in partnership restricted cash. See Note 18 for
additional information regarding partnership restricted cash.
Management
is exploring new product channel sales in adjacent industries, such as cosmetics, athletic products, and proprietary medical devices.
The Company has increased focus on sales and developing a sales pipeline for potential customers. This customer base expansion will enable
us to provide financial stability for the foreseeable future, expand our current processes, and position us for long-term shareholder
value creation.
We
intend to maintain and attempt to grow our existing contract manufacturing business. We also plan to continue building and developing
our catalogue of consumer products for sale to branding partners and to use our in-house capabilities to create and test market additional
branded products. These products will be target marketed and sold online through social media and online advertising and marketplaces.
Furthermore, the Company plans to develop its own proprietary medical devices and explore drug delivery programs for its technology.
Additionally, the Company continues to evaluate strategic initiatives (e.g., acquisitions), and additional capital raises through debt
or equity may be necessary to achieve these objectives.
We
expect to continue incurring losses for the near-term. Our ability to continue to operate as a going concern in the long-term is dependent
upon our ability to manage and grow our current products and to ultimately achieve profitable operations. Management may consider various
options to raise capital to fund our current business activities and potential acquisitions through equity or debt offerings. There can
be no assurances, however, that management will be able to obtain sufficient additional funds, if needed, or that such funds, if available,
will be obtained on terms satisfactory to us. The consolidated financial statements do not include any adjustments relating to the recoverability
and classification of recorded assets and liabilities that might be necessary should we be unable to continue as a going concern. Additionally,
it is reasonably possible that estimates made in the consolidated financial statements have been, or will be, materially and adversely
impacted in the near term as a result of these conditions, including the recoverability of long-lived assets.
**3.
Significant Accounting Policies and Estimates**
*Use
of Estimates*
The
preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions
that affect the amounts reported in the consolidated financial statements and accompanying notes. These estimates and assumptions
include allowances for doubtful accounts, inventory reserves, deferred taxes and related valuation allowances, share-based compensation and fair value of long-lived assets. Actual results could differ from the estimates.
| F-8 | |
| Table of Contents | |
*Segment
Reporting*
**
The
Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) Topic 280, *Segment
Reporting*, requires that an enterprise report selected information about reportable segments in its financial reports issued to its
stockholders. The Company has two reportable segments - the NexGel segment and the CGN segment.
The
NexGel segment is comprised of the manufacturing of ultra-gentle, high-water-content hydrogel products for healthcare and consumer applications,
which is based in Langhorne, Pennsylvania as well as the Kenkoderm acquisition, the Silly George acquisition and the Enigma JV. However,
the Enigma JV was dissolved on December 23, 2024.
The
CGN segment is comprised of the CGN JV used for the Companys converting and packaging business, which is based in
Granbury, Texas.
*Cash
and cash equivalents and restricted cash*
Cash
and cash equivalents is comprised of cash in banks and highly liquid investments, including U.S. treasury bills purchased with an original
maturity of three months or less as well as investments in money market funds for which the carrying amount approximates fair value,
due to the short maturities of these investments.
The
Company also maintains restricted cash under a Partnership Agreement (see Note 18). As of December 31, 2025, restricted cash totaled
$741 thousand, representing
funds that are contractually restricted from use for general operating purposes and may be utilized only in accordance with the terms
of the Partnership Agreement. Restricted cash is included in total cash, cash equivalents, and restricted cash as presented in the statement
of cash flows.
*Accounts
Receivable, net*
Trade
accounts receivable are stated at the amount the Company expects to collect and do not bear interest. The Company evaluates the collectability
of accounts receivable and records a provision to the allowance for credit losses based on factors including the length of time the receivables
are past due, the customers payment history, the credit quality of the customer and other factors that may affect the customers
ability to pay. Provisions to the allowances for credit losses are recorded in selling, general and administrative expenses. Account
balances are charged off against the allowance when it is probable that the receivable will not be recovered. The allowance for credit
losses was $9 thousand and $5 thousand as of December 31, 2025 and 2024, respectively.
*Inventory
and Cost of Revenues*
The
inventory balance is stated at the lower of cost, the value determined by the first-in, first-out method, or net realizable value. The
Company evaluates inventories for excess quantities, obsolescence, and shelf-life expiration. This evaluation includes an analysis of
historical sales levels by product, projections of future demand, the risk of technological or competitive obsolescence for products,
general market conditions, and a review of the shelf-life expiration dates for products. These factors determine when, and if, the Company
adjusts the carrying value of inventory to estimated net realizable value.
The
Company produces proprietary branded products and white label opportunities in our manufacturing of consumer products. In our contract
manufacturing, the Company builds its products based on customer orders and immediately ships the products upon completion of the production
process.
| F-9 | |
| Table of Contents | |
The
inventory balance is made up of raw materials, work-in-progress, and finished goods. Inventory is maintained at the Companys warehouses,
third party warehouses and at fulfilment centers owned by Amazon, Walmart and CVS.
The
Cost of revenues line item in the consolidated statements of operations is comprised of the book value of inventory
sold to customers during the reporting period. When circumstances dictate that we use net realizable value as the basis for
recording inventory, we base our estimates on expected future selling prices less expected disposal costs. The reserve recorded
against inventories was $271 thousand and $46 thousand as of December 31, 2025 and 2024, respectively.
*Research
and Development*
Our
research and development activities focus on new and innovative products designed to support revenue growth. Research and development
expenses consist primarily of contracted development and testing efforts associated with development of products. Research and development
costs are expensed as incurred.
*Property
and Equipment, net*
Property
and equipment is recorded at historical cost, net of accumulated depreciation and amortization. Depreciation is provided over the assets
useful lives on a straight-line basis. Leasehold improvements and right-of-use assets under financing lease arrangements are amortized
on a straight-line basis over the shorter of their estimated useful lives or lease terms. Repairs and maintenance costs are expensed
as incurred.
Management
periodically assesses the estimated useful life over which assets are depreciated or amortized. If the analysis warrants a change in
the estimated useful life of property and equipment, management will reduce the estimated useful life and depreciate or amortize the
carrying value prospectively over the shorter remaining useful life.
The
carrying amounts of assets sold or retired and the related accumulated depreciation are eliminated in the year of disposal and any resulting
gains and losses are included in the results of operations during the same year.
*Impairment
of Long-Lived Assets*
The
Company reviews its property and equipment and any identifiable intangibles with definite lives for impairment whenever events or changes
in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is
measured by a comparison of the carrying amount of an asset to the future undiscounted operating cash flow expected to be generated by
the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying
amount of the asset exceeds the fair value of the asset. Long-lived assets to be disposed of are reported at the lower of carrying amount
or fair value less costs to sell.
*Goodwill
and Intangible Assets*
In
applying the acquisition method of accounting, amounts assigned to identifiable assets and liabilities acquired were based on estimated
fair values as of the date of acquisition, with the remainder recorded as goodwill. Identifiable intangible assets are initially recorded
at fair value using generally accepted valuation methods appropriate for the type of intangible asset. Identifiable intangible assets
with definite lives are amortized over their estimated useful lives and are reviewed for impairment if indicators of impairment arise.
Intangible assets with indefinite lives are tested for impairment within one year of the acquisition date or annually as of December
31, and whenever indicators of impairment exist. The fair value of intangible assets is compared with their carrying values, and an impairment
loss would be recognized for the amount by which carrying amount exceeds its fair value.
The
Company performed the annual assessment and concluded it is more likely than not that the fair value exceeds the carrying value and no
impairments were recognized in the year ended December 31, 2025 and 2024.
| F-10 | |
| Table of Contents | |
*Prepaid
Expenses and Other Current Assets*
Prepaid
expenses and other current assets are recorded at historical cost and are primarily made up of $45 thousand and $46 thousand of prepaid
insurance, and $451 thousand and $577 thousand general prepaid expenses and other current assets as of December 31, 2025 and 2024, respectively.
*Other
Assets*
Other
assets are recorded at historical costs, and as of December 31, 2025 and 2024, the balance is primarily comprised of spare parts for
manufacturing equipment. The Company maintains spare parts for either repair and maintenance, which is expensed as incurred, or replacement
of capitalized equipment. Capitalized equipment spare parts are not subject to depreciation until such time that they are placed into
service and the part that is being replaced is disposed.
*Fair
Value Measurements*
The
Company utilizes the fair value hierarchy to apply fair value measurements. The fair value hierarchy is based on inputs to valuation
techniques that are used to measure fair values that are either observable or unobservable. Observable inputs reflect assumptions market
participants would use in pricing an asset or liability based on market data obtained from independent sources, while unobservable inputs
reflect a reporting entitys pricing based upon its own market assumptions. The basis for fair value measurements for each level
within the hierarchy is described below:
*Level
1* Quoted prices for identical assets or liabilities in active markets.
*Level
2* Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities
in markets that are not active; or model-derived valuations whose inputs are observable or whose significant value drivers are observable.
*Level
3* Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable.
The
Company considers the carrying amounts of its financial instruments (cash, accounts receivable and accounts payable, notes payable and
convertible notes payable) in the consolidated balance sheet to approximate fair value because of the short-term or highly liquid nature
of these financial instruments.
The
following table classifies the Companys assets and liabilities measured at fair value on a recurring basis into the fair value
hierarchy as of December 31, 2025 and 2024 (in $ thousands):
Schedule
of Assets and Liabilities Measured at Fair Value On a Recurring Basis Into the Fair Value
Hierarchy
| 
| | 
| | | | 
| | | | 
| | | | 
| | | |
| 
| | 
Fair value measured at December 31, 2025 | | |
| 
| | 
Fair value at December 31, 2025 | | | 
Quoted prices in active markets (Level 1) | | | 
Significant other observable inputs (Level 2) | | | 
Significant unobservable inputs (Level 3) | | |
| 
Investment in NexGelRx | | 
$ | 249 | | | 
$ | - | | | 
$ | 249 | | | 
$ | - | | |
| 
Total fair value | | 
$ | 249 | | | 
$ | - | | | 
$ | 249 | | | 
$ | - | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | |
| 
| | 
Fair value measured at December 31, 2024 | | |
| 
| | 
Fair value at December 31, 2024 | | | 
Quoted prices in active markets (Level 1) | | | 
Significant other observable inputs (Level 2) | | | 
Significant unobservable inputs (Level 3) | | |
| 
Warrant liability | | 
$ | 296 | | | 
$ | - | | | 
$ | - | | | 
$ | 296 | | |
| 
Total fair value | | 
$ | 296 | | | 
$ | - | | | 
$ | - | | | 
$ | 296 | | |
*Warrant
Liability*
Warrants
to purchase common stock were issued in connection with equity financing raises, which occurred during 2019 through 2025. The fair values
of the warrants are estimated as of the date of issuance and again at each reporting period using a Black-Scholes option valuation model.
At issuance, the fair values of the warrant are recognized as an equity issuance cost within additional paid-in-capital. Fair value adjustments
to the warrant liability are recognized in other income (expense) in the consolidated statements of operations.
*Equity
Classified Warrants*
**
Warrants
that meet all necessary criteria to be accounted for as equity in accordance with ASC 815-40, *Derivatives and HedgingContracts
in Entitys Own Equity*, are presented within additional paid-in capital within the Companys consolidated statements
of changes in stockholders equity and consolidated balance sheets. Warrants classified as equity are initially measured at fair
value using a Black-Scholes option valuation model. Subsequent changes in fair value are not recognized as long as the warrants continue
to be classified as equity.
**
*Offering
Costs*
The
Company complies with the requirements of ASC 340-40*, Other Assets and Deferred Cost,* with regards to offering costs. Prior to the completion of an offering, offering costs
will be capitalized as deferred offering costs on the balance sheet. The deferred offering costs will be charged to stockholders
equity upon the completion of an offering or to expense if the offering is not completed.
*Revenue
Recognition*
The
Company records revenue in accordance with ASC Topic 606, *Revenue from Contracts with Customers* (ASC 606). The core
principle of ASC 606 requires that an entity recognize revenue to depict the transfer of promised goods or services to customers in an
amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. ASC 606 defines
a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within
the revenue recognition process than required under existing GAAP including identifying performance obligations in the contract, estimating
the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance
obligation.
| F-11 | |
| Table of Contents | |
The
Company currently recognizes revenue predominately from three sources: contract manufacturing, custom and white label finished goods
manufacturing (Custom and white label), and our branded consumer products. Contract manufacturing and Custom and white
label revenues are recognized at the point where the customer obtains control of the goods and the Company satisfies its performance
obligation, which generally is at the time the customer receives the product. Branded consumer product revenue is derived from direct-to-consumer
purchases through websites like Amazon and through our Shopify stores. Revenue is recognized upon shipment to the end customer.
The
Companys customers consist of other life sciences companies and Amazon retail customers. Revenues are predominately concentrated
in the United States, but with the Silly George acquisition, have expanded into Europe and Asia. Payment terms, excluding branded consumer
products, vary by the type and location of customer and may differ by jurisdiction and customer but payment is generally required in
a term ranging from 30 to 60 days from date of shipment. Branded consumer products are purchased and paid for by the consumer at the
time the transaction is completed.
Estimates
for product returns, allowances and discounts are recorded as a reduction of revenue and are established at the time of sale. Returns
are estimated through a comparison of historical return data and are determined for each product and adjusted for known or expected changes
in the marketplace specific to each product, when appropriate. Historically, sales return provisions have not been material. Amounts
accrued for sales allowances and discounts are based on estimates of amounts that are expected to be claimed on the related sales and
are based on historical data. Payments for allowances and discounts have historically been immaterial.
Disaggregated
revenue by sales type ($ in thousands):
Schedule of Disaggregated Revenue by Sales Type
| 
| | 
2025 | | | 
2024 | | |
| 
| | 
Year Ended | | |
| 
| | 
December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Contract manufacturing | | 
$ | 3,657 | | | 
$ | 2,841 | | |
| 
Custom and white label finished goods manufacturing | | 
| 27 | | | 
| 42 | | |
| 
Consumer branded products | | 
| 7,320 | | | 
| 5,483 | | |
| 
Other | | 
| 417 | | | 
| 322 | | |
| 
Total | | 
$ | 11,421 | | | 
$ | 8,688 | | |
**Contract
Liabilities**
As
of December 31, 2025 and 2024, the Company did not have any contract assets or contract liabilities from contracts with customers and
there were no remaining performance obligations that the Company had not satisfied except for deferred revenue of $2 and $179 thousand
at December 31, 2025 and 2024, respectively, that the Company had not satisfied as of the end of the respective period.
The
following table provides information about contract liabilities from contracts with our customers ($ in thousands).
Schedule of Contract Liabilities From Contract With Customers
| 
| | 
2025 | | | 
2024 | | |
| 
| | 
Year Ended | | |
| 
| | 
December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Deferred revenue | | 
$ | 2 | | | 
$ | 179 | | |
| 
Total Deferred revenue | | 
$ | 2 | | | 
$ | 179 | | |
Significant
changes in the contract liabilitiesbalance during the period are as follows:
Schedule of Contract Liabilities Balance
| 
| 
| 
Contract
liabilities | 
| |
| 
Balance,
December 31, 2024 | 
| 
$ | 
179 | 
| |
| 
Non-cancelable
contracts with customers entered during the period | 
| 
- | 
| |
| 
Revenue
recognized related to non-cancelable contracts with customers during the period | 
| 
| 
(177 | 
) | |
| 
Balance,
December 31, 2025 | 
| 
$ | 
2 | 
| |
****
The
Company has four distinct lines of business; Contract Manufacturing, Custom and White Label, Branded Consumer Products, and Medical Devices/Other.
*Contract
Manufacturing*
Customers
order rolls of gel (rollstock). The rollstock is shipped to our customers, which they package into
finished
goods. Historically, this has been the Companys primary source of revenue.
*Custom
and White Label*
These
products often infuse various ingredients into our base gel to develop unique product offerings to satisfy market demand (e.g. aloe infused
into the gel for a beauty mask). The rollstock is converted and packaged into salable units. The finished goods are shipped to the customer,
who is ultimately responsible for product distribution. Frequently these products started as development deals, in which the customer
paid the Company a small fee to develop a specific product. Once completed, the customer places an order for newly developed product.
| F-12 | |
| Table of Contents | |
*Consumer
Branded Products*
These
products are finished goods marketed and sold directly to consumers by the Company through online and retail channels. We are responsible
for sales, marketing, and distribution. The products we sell under our MedaGel brand primarily relate to healthcare over-the-counter
(OTC) remedy solutions, such as blister and applications. In December 2023 we added a second consumer product brand when
we completed the purchase of the Kenkoderm brand. The Kenkoderm skincare line was originally developed by a dermatologist to provide
gentle to the skin products for consumer with psoriasis. In May 2024, we added our third consumer product brand with the purchase of
the Silly George brand. Silly George is a beauty brand primarily focused on false eyelashes and other eye related products. We continue
to look for additional potential acquisitions as part of our consumer product roll-up strategy.
*Medical
Devices/Other*
Medical
Devices are a hybrid business, combining elements of Custom & White Label and Consumer Branded Products. Medical Devices, which are
not yet marketed, are expected to be distributed through strategic partnerships. We will manufacture and possibly convert/package the
device while the strategic partner brings the product to market. Small market Medical Devices could be launched by us, but also be offered
to a distributor to reach the full scale of the market.
Other
includes freight charged to customers who purchase the Companys branded consumer products through their Shopify stores.
*Shipping
and Handling Revenue and Expense*
Shipping
and handling revenue and expense are included in our consolidated statements of operations in revenues and cost of revenues, respectively.
The Company accounts for shipping activities, consisting of direct costs to ship products performed after the risk of loss passes to
the customer. Shipping revenue and expense are primarily generated through the Amazon marketplace and Silly George direct customer sales.
*Share-based
Compensation*
On
August 28, 2019, the Company adopted the 2019 Long-Term Incentive Plan, as amended (the 2019 Plan). See Note 15 for further
details regarding the 2019 Plan.
The
2019 Plan provides certain employees, contractors, and outside directors with share-based compensation in the form of incentive stock
options, non-qualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance awards, dividend
equivalent rights and other awards. The fair values of incentive stock option award grants are estimated as of the date of grant using
a Black-Scholes option valuation model. Compensation expense is recognized in the consolidated statements of operations on a straight-line
basis over the requisite service period, which is generally the vesting period.
*Income
Taxes*
Income
taxes are accounted for using an asset and liability approach that requires the recognition of deferred tax assets and liabilities for
the expected future tax consequences of temporary differences between the financial statement and tax bases of assets and liabilities
at the applicable tax rates. Deferred tax assets are reduced by a valuation allowance when it is more likely than not that some portion
or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in
tax laws and rates.
Tax
benefits are recognized from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon
examination by a tax authority and based upon the technical merits of the tax position. The tax benefit recognized in the consolidated
financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized upon settlement.
An unrecognized tax benefit, or a portion thereof, is presented in the consolidated financial statements as a reduction to a deferred
tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward if such settlement is required or expected
in the event the uncertain tax position is disallowed.
**
| F-13 | |
| Table of Contents | |
**
*Leases*
We
account for our leases in accordance with ASC 842, *Leases.* We determine whether an arrangement is an operating or financing lease
at contract inception. Operating leases, requires recognition of leases on the consolidated balance sheets as right-of-use (ROU)
assets and lease liabilities. ROU assets represent the Companys right to use underlying assets for the lease terms and lease liabilities
represent the Companys obligation to make lease payments arising from the leases. Operating lease ROU assets and operating lease
liabilities are recognized based on the present value and future minimum lease payments over the lease term at commencement date. As
the Companys leases do not provide an implicit rate, the Company used its estimated incremental borrowing rate based on the information
available at commencement date in determining the present value of lease payments. A number of the lease agreements contain options to
renew and options to terminate the leases early. The lease term used to calculate ROU assets and lease liabilities only includes renewal
and termination options that are deemed reasonably certain to be exercised.
The
Company recognized lease liabilities, with corresponding ROU assets, based on the present value of unpaid lease payments for existing
operating leases longer than twelve months. The ROU assets were adjusted per ASC 842 transition guidance for existing lease-related balances
of accrued and prepaid rent, and unamortized lease incentives provided by lessors. Operating lease cost is recognized as a single lease
cost on a straight-line basis over the lease term and is recorded in cost of revenues and selling, general and administrative expenses.
Variable lease payments for common area maintenance, property taxes and other operating expenses are recognized as expense in the year
when the changes in facts and circumstances on which the variable lease payments are based occur. The Company has elected not to separate
lease and non-lease components for all property leases for the purposes of calculating ROU assets and lease liabilities.
Financing
leases are those that transfer substantially all of the risks and rewards of ownership to the Company. At the lease commencement date,
the Company recognizes a financing lease ROU asset and a corresponding lease liability measured at the present value of future lease
payments. The ROU asset is subsequently amortized on a straight-line basis over the shorter of the lease term or the useful life of the
underlying asset, while the lease liability is increased by interest expense and reduced by lease payments made. Interest expense on
the lease liability and amortization of the ROU asset are presented separately in the consolidated statements of operations, resulting
in a front-loaded expense pattern over the lease term. Financing lease ROU assets are included in property and equipment, net, and the
related lease liabilities are included within current and long-term debt, as applicable.
*Variable
Interest Entity*
**
The
Company reviews each legal entity formed by parties related to the Company to determine whether or not the Company has a variable interest
in the entity and whether or not the entity would meet the definition of a variable interest entity (VIE) in accordance
with ASC Topic 810, *Consolidation*. In assessing whether the Company has a variable interest in the entity as a whole, the Company
considers and makes judgements regarding the purpose and design of the entity, the value of the licensed assets to the entity, the value
of the entitys total assets and the significant activities of the entity. If the Company has a variable interest in the entity
as a whole, the Company assesses whether or not the Company is a primary beneficiary of that VIE, based on a number of factors, including:
(i) which party has the power to direct the activities that most significantly affect the VIEs economic performance, (ii) the
parties contractual rights and responsibilities pursuant to the collaboration agreement, and (iii) which party has the obligation
to absorb losses of or the right to receive benefits from the VIE that could be significant to the VIE.
If
the Company determines that it is the primary beneficiary of a VIE at the onset of the collaboration, the collaboration is treated as
a business combination and the Company consolidates the financial statements of the VIE into the Companys consolidated financial
statements. On a quarterly basis, the Company will evaluate whether it continues to be the primary beneficiary of the consolidated VIE.
If the Company determines that it is no longer the primary beneficiary of a consolidated VIE, it deconsolidates the VIE in the period
in which the determination is made.
Assets
and liabilities recorded as a result of consolidating the financial results of the VIE into the Companys consolidated balance
sheet do not represent additional assets that could be used to satisfy claims against the Companys general assets or liabilities
for which creditors have recourse to the Companys general assets.
**
*Recently
Issued Accounting Standards*
From
time to time, new accounting pronouncements are issued by the FASB, or other standard setting bodies and adopted by us as of the specified
effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material
impact on our consolidated financial position or results of operations upon adoption.
| F-14 | |
| Table of Contents | |
In
July 2025, the FASB issued Accounting Standards Update (ASU) 2025-05,*Financial InstrumentsCredit Losses
(Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets*, which amends the guidance related to the measurement
of credit losses for accounts receivable and contract assets. The amendments are effective for annual reporting periods beginning after
December 15, 2025, and interim reporting periods within those annual reporting periods. Early adoption is permitted. The Company adopted
this new standard during the year ended December 31, 2025 with no material impact to the financial statements.
In
November 2023, the FASB issued ASU 2023-07*, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures*. This
ASU includes amendments that expand the existing reportable segment disclosure requirements and requires disclosure of (i) significant
expense categories and amounts by reportable segment as well as the segments profit or loss measure(s) that are regularly provided
to the chief operating decision maker (the CODM) to allocate resources and assess performance; (ii) how the CODM uses each
reported segment profit or loss measure to allocate resources and assess performance; (iii) the nature of other segment balances contributing
to reported segment profit or loss that are not captured within segment revenues or expenses; and (iv) the title and position of the
individual or name of the group or committee identified as the CODM. This guidance requires retrospective application to all prior periods
presented in the financial statements and is effective for fiscal years beginning after December 15, 2023 and interim periods within
fiscal years beginning after December 15, 2024. The guidance resulted in the Company being required to include enhanced disclosures relating
to its reportable segments. The Company adopted this new standard during the year ended December 31, 2024.
In
June 2023, the FASB issued ASU 2023-05, *Business Combinations
(ASC Topic 805): Joint Venture Formations*, which provides guidance on accounting for joint ventures established through new entities.
The update mandates the application of the acquisition method of accounting for such transactions, requiring parties to recognize and
measure identifiable assets and liabilities based on fair values at the acquisition date and establishes a measurement period for adjustments.
The amendments in this Update are effective prospectively for all joint venture formations with a formation date on or after January
1, 2025. The adoption of ASU 2023-05 had no material impact to the financial statements.
In December 2023, the FASB issued ASU 2023-09, *Income
Taxes (Topic 740): Improvements to Income Tax Disclosures*. This update requires disaggregated information about a reporting entitys
effective tax rate reconciliation as well as additional information on income taxes paid. The Company adopted this standard effective
January 1, 2025. As the Company maintains a full valuation allowance against its deferred tax assets, the adoption did not have a material
impact on the Companys consolidated financial statements or disclosures.
*Accounting
Pronouncements Issued But Not Yet Adopted*
InDecember 2025*,*the FASB issued
ASU*2025*-*12,**Codification Improvements*to make improvements to the Codification arising from technical
corrections, unintended application of the Codification, and clarifications. For all entities, the amendments in this Update are effective
for annual reporting periods beginning after*December 15, 2026,*including interim periods within those annual reporting
periods. Early adoption is permitted. The Company is currently evaluating the impact this new guidance will have on its financial statements
and disclosures.
**
In
November 2024, the FASB issued the ASC 2024-03, *Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures
(Subtopic 220-04) Disaggregation of Income Statement Expenses,* which requires additional disclosure of the nature of expenses included
in the income statement in response to requests from investors for more information about an entitys expenses. The new standard
requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement
as disclosures about selling expenses. The guidance is effective for annual reporting periods beginning after December 15, 2026 and interim
reporting periods within annual reporting periods beginning after December 15, 2027. The requirements will be applied prospectively with
the option for retrospective application. Early adoption is permitted. The Company is currently evaluating the impact this new guidance
will have on its financial statements and disclosures.
****
| F-15 | |
| Table of Contents | |
**4.
Business Segments**
The
Companys CODM evaluates the financial performance of the Companys segments based upon segment operating income or
(loss) as the profitability measure. The Company has identified its Chief Executive Officer as the CODM. Items outside of operating
income or (loss) are not reported by segment, since they are excluded from the single measure of segment profitability reviewed by
the CODM.
Summarized
financial information concerning the Companys reportable segments for the years ended December 31, 2025 and 2024 is presented
below.
Schedule of Reportable Segments
**For
Year Ended December 31, 2025 ($ in thousands)**
| 
| | 
NexGel | | | 
CG Labs | | | 
Total | | |
| 
Revenues | | 
| 8,613 | | | 
| 2,808 | | | 
| 11,421 | | |
| 
| | 
| | | | 
| | | | 
| | | |
| 
Cost of sales | | 
| 4,921 | | | 
| 1,991 | | | 
| 6,912 | | |
| 
| | 
| | | | 
| | | | 
| | | |
| 
Advertising, marketing and amazon fees | | 
| 2,502 | | | 
| - | | | 
| 2,502 | | |
| 
General and administrative | | 
| 4,815 | | | 
| 542 | | | 
| 5,357 | | |
| 
Total Selling, general and administrative | | 
| 7,317 | | | 
| 542 | | | 
| 7,859 | | |
| 
| | 
| | | | 
| | | | 
| | | |
| 
Research and development | | 
| 2 | | | 
| - | | | 
| 2 | | |
| 
| | 
| | | | 
| | | | 
| | | |
| 
Operating expenses | | 
| 7,319 | | | 
| 542 | | | 
| 7,861 | | |
| 
| | 
| | | | 
| | | | 
| | | |
| 
Loss from operations | | 
$ | (3,627 | ) | | 
$ | 275 | | | 
$ | (3,352 | ) | |
****
**For
Year Ended December 31, 2024 ($ in thousands)**
| 
| | 
NexGel | | | 
CG Labs | | | 
Total | | |
| 
Revenues | | 
| 6,631 | | | 
| 2,057 | | | 
| 8,688 | | |
| 
| | 
| | | | 
| | | | 
| | | |
| 
Cost of sales | | 
| 4,209 | | | 
| 1,731 | | | 
| 5,940 | | |
| 
| | 
| | | | 
| | | | 
| | | |
| 
Advertising, marketing and amazon fees | | 
| 2,220 | | | 
| - | | | 
| 2,220 | | |
| 
General and administrative | | 
| 3,409 | | | 
| 595 | | | 
| 4,004 | | |
| 
Total Selling, general and administrative | | 
| 5,629 | | | 
| 595 | | | 
| 6,224 | | |
| 
| | 
| | | | 
| | | | 
| | | |
| 
Research and development | | 
| 78 | | | 
| - | | | 
| 78 | | |
| 
| | 
| | | | 
| | | | 
| | | |
| 
Operating expenses | | 
| 5,707 | | | 
| 595 | | | 
| 6,302 | | |
| 
| | 
| | | | 
| | | | 
| | | |
| 
Loss from operations | | 
$ | (3,285 | ) | | 
$ | (269 | ) | | 
$ | (3,554 | ) | |
**As
of December 31, 2025 ($ in thousands)**
****
| 
| | 
NexGel | | | 
CG Labs | | | 
Total | | |
| 
Total Assets | | 
$ | 6,777 | | | 
$ | 3,684 | | | 
$ | 10,461 | | |
****
**As
of December 31, 2024 ($ in thousands)**
****
| 
| | 
NexGel | | | 
CG Labs | | | 
Total | | |
| 
Total Assets | | 
$ | 7,721 | | | 
$ | 3,262 | | | 
$ | 10,983 | | |
| F-16 | |
| Table of Contents | |
**5.
Acquisition**
*Silly
George Acquisition*
On
May 15, 2024, the Company entered into and closed a transaction related to an Asset Purchase Agreement dated May 15, 2024 (the SG
Purchase Agreement) with Semmens Online Pty Ltd as Trustee for Semmens Business Trust, an Australian proprietary limited company
(the SG Seller), whereby the Company purchased the Silly George assets (the Silly George acquisition). The
Company believes the Silly George assets will be accretive and synergistic to its existing health and beauty customer product brands.
Under
the terms of the SG Purchase Agreement on May 15, 2024, the Company paid the SG Seller a cash payment of $400 thousand and issued $200
thousand in shares of the Companys common stock based on the 10-Day VWAP (as defined in the SG Purchase Agreement), or 89,892
of shares of the Companys common stock. Additionally, the Company will pay the Seller a cash earn-out based on 20% of the Net
Profit (as defined in the SG Purchase Agreement) related to the Silly George assets for the fiscal quarterly period beginning June 30,
2024 and ending on June 30, 2028. Per the scope exception under ASC 815, the Company has not accrued the contingent consideration.
The
table below shows an analysis for the Silly George acquisition ($ in thousands):
Schedule of Business Acquisitions
| 
Purchase consideration at preliminary fair value: | | 
| | |
| 
Purchase price | | 
$ | 600 | | |
| 
Consideration paid | | 
$ | 600 | | |
| 
Trademark related intangibles | | 
| 600 | | |
| 
Intangible assets acquired | | 
$ | 600 | | |
The
unaudited pro-forma results of operations are presented for information purposes only. The unaudited pro-forma results of operations
are not intended to present actual results that would have been attained had the Silly George acquisitions been completed as of January
1, 2024 or to project potential operating results as of any future date or for any future periods ($ in thousands except share and per
share amounts):
Schedule of Unaudited Pro-Forma Results of Operations
| 
| | 
| | | 
| | |
| 
| | 
For the Years Ended December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Revenues, net | | 
$ | 11,421 | | | 
$ | 9,261 | | |
| 
Net loss allocable to common shareholders | | 
$ | (3,000 | ) | | 
$ | (3,245 | ) | |
| 
Net loss per share | | 
$ | (0.38 | ) | | 
$ | (0.50 | ) | |
| 
Weighted average number of shares outstanding | | 
| 7,854,288 | | | 
| 6,511,574 | | |
| F-17 | |
| Table of Contents | |
**6.
Investment in NexGelRx**
On
December 11, 2025, the Company completed the disposition of a controlling interest in its dormant subsidiary, NexgelRX, Inc. (NexgelRX), and retained a 19.99% non-controlling interest through a convertible preferred stock holding, which is non-dilutive up to $8.0 million
of third-party capital raised. NexgelRX focuses exclusively on developing and commercializing prescription drug delivery solutions utilizing
the Companys proprietary hydrogel technology. At the time of the disposition, NexgelRX raised approximately $1.25 million from
third-party investors. In connection with the transaction, the Company granted NexgelRX a license to its technology and is entitled to
receive a 5% royalty on future product sales.
The
Company evaluated NexgelRX under ASC 810 and concluded that it is not a variable interest entity because it has sufficient substantive
equity investment at risk, including third-party equity, to finance its activities without additional subordinated financial support.
The Company uses the measurement alternative for equity investments with no readily determinable fair value and the investment is reported
at cost, adjusted for impairments or any observable price changes in ordinary transactions with identical or similar investments. The
Company valued its convertible preferred stock interest at $249 thousand, which is reported on the Consolidated Balance
Sheets and a gain on spin-off of NexGelRx for the year ended December 31, 2025.
As
part of the transaction, the Company issued 125,000
warrants to purchase its common stock at an exercise price
of $4.00
per share, with a five-year term. The warrants represent approximately
10% warrant coverage relative to the Investees capital raise and were classified as equity under ASC 815-40. The warrants were
valued at $87 thousand using the Black-Scholes option model, and such amount was recorded as additional paid-in capital with
a corresponding decrease in the gain in spin-off of NexGelRx.
**7.
Variable interest entities**
*Interest
in Joint Venture CGN*
On
March 1, 2023, the Company acquired a 50% interest in the CGN JV (see Note 1). The CGN JV is owned 50% by the Company and 50% by CG Labs.
CG Labs contributed its existing converting and packaging division to the CGN JV, including, but not limited to, its facilities, equipment,
employees, and customers. The Company will contribute $500 thousand to the CGN JV, on a schedule to be determined, to be used for equipment
and facility upgrades as well as general corporate purposes for the CGN JV.
The
CGN JV is considered to be a VIE and we have consolidated the CGN JV, because we believe we are the primary beneficiary and we
meet the power and the economics criteria.
*Interest
in Joint Venture Enigma*
On
January 6, 2023, the Company acquired a
50% interest in a newly formed joint venture (the Enigma JV) to pursue branded consumer product retail
opportunities and the development of new patch products. The Enigma JV agreement was effective January 6, 2023. As a result of this
transaction, the Company owned 50%
of the Enigma JV, with the remaining 50%
held by Moiety. However, the Enigma JV was dissolved on December 23, 2024. As of December 31, 2024, the Company had contributed
$20
thousand and the non-controlling interest portion of Enigma JV had contributed $37
thousand.
| F-18 | |
| Table of Contents | |
The
Enigma JV was considered to be a VIE and was consolidated because we believed we were the primary beneficiary and we met the
power and the economics criteria.
The
following table presents the assets and liabilities of the CGN JV included in the consolidated balance sheet as of December 31, 2025
and 2024. The assets and liabilities presented below include only the third-party assets and liabilities of the consolidated VIE and
excludes any intercompany balances, which were eliminated upon consolidation.
Schedule of Consolidated Variable Interest Entities
| 
| | 
December 31, 2025 | | | 
December 31, 2024 | | |
| 
ASSETS: | | 
| | | | 
| | | |
| 
Current Assets: | | 
| | | | 
| | | |
| 
Cash | | 
$ | 94 | | | 
$ | 26 | | |
| 
Accounts receivable, net | | 
| 519 | | | 
| 764 | | |
| 
Inventory | | 
| 841 | | | 
| 646 | | |
| 
Prepaid expenses and other current assets | | 
| 11 | | | 
| 45 | | |
| 
Total current assets | | 
| 1,465 | | | 
| 1,481 | | |
| 
Intangibles, net | | 
| 32 | | | 
| 122 | | |
| 
Property and equipment, net | | 
| 1,314 | | | 
| 1,421 | | |
| 
Operating lease - right of use asset | | 
| 873 | | | 
| 283 | | |
| 
Total assets | | 
$ | 3,684 | | | 
$ | 3,307 | | |
| 
| | 
| | | | 
| | | |
| 
LIABILITIES | | 
| | | | 
| | | |
| 
Current Liabilities: | | 
| | | | 
| | | |
| 
Accounts payable | | 
$ | 87 | | | 
$ | 912 | | |
| 
Accounts payable related party | | 
| 477 | | | 
| 528 | | |
| 
Accounts payable | | 
| 477 | | | 
| 528 | | |
| 
Accrued expenses and other current liabilities | | 
| 1 | | | 
| 51 | | |
| 
Deferred revenue | | 
| - | | | 
| 179 | | |
| 
Current portion of note payable | | 
| 93 | | | 
| 85 | | |
| 
Finance lease liability, short term | | 
| 65 | | | 
| 59 | | |
| 
Operating lease liability, current portion | | 
| 84 | | | 
| 30 | | |
| 
Total current liabilities | | 
| 807 | | | 
| 1,844 | | |
| 
Operating lease liability, net of current portion | | 
| 790 | | | 
| 260 | | |
| 
Finance lease liability, long term | | 
| 242 | | | 
| 307 | | |
| 
Notes payable, net of current portion | | 
| 228 | | | 
| 320 | | |
| 
Total liabilities | | 
$ | 2,067 | | | 
$ | 2,731 | | |
The
amounts above represent the assets and liabilities of the VIE described above, for which we are the primary beneficiary. The
assets of the CGN JV consolidated VIE can only be used to settle the obligations of the VIE. All of the liabilities are non-recourse
to us as of December 31, 2025 and December 31, 2024.
**8.
Operating Leases**
The
Company has an operating lease for a commercial manufacturing facility and administrative offices located in Langhorne, Pennsylvania
that runs through January 2031. There are two options that can extend the lease term for five years each. The exercise of the lease options
to renew is solely at the Companys discretion.
The
Company also has a sublease for office and manufacturing space in Granbury, Texas that runs through February 2028. The Company modified
the lease agreement through July 2035.
The
following table presents information about the amount and timing of the liability arising from the Companys operating lease as
of December 31, 2025 ($ in thousands):
Schedule of Future Minimum Operating Lease Payments
| 
Maturity of Lease Liability | | 
Operating Lease Liability | | |
| 
2026 | | 
$ | 363 | | |
| 
2027 | | 
| 374 | | |
| 
2028 | | 
| 381 | | |
| 
2029 | | 
| 388 | | |
| 
2030 | | 
| 395 | | |
| 
Thereafter | | 
| 481 | | |
| 
Total undiscounted operating lease payments | | 
$ | 2,382 | | |
| 
Less: Imputed interest | | 
| (189 | ) | |
| 
Present value of operating lease liability | | 
$ | 2,193 | | |
| 
Weighted average remaining lease term | | 
| 6.9 years | | |
| 
Weighted average discount rate | | 
| 2.6 | % | |
| F-19 | |
| Table of Contents | |
Total
operating lease expense for the years ended December 31, 2025, and 2024, was $314
thousand and $287
thousand, respectively, and is recorded in cost of goods sold
and selling, general, and administrative expenses in the accompanying consolidated statements of operations. The weighted average
discount rate was 2.6% and 3.0% and the weighted average remaining lease term was 6.9 years and 6.4 years at December 31, 2025 and 2024,
respectively.
Supplemental
cash flows information related to operating leases was as follows:
Schedule
of Supplemental Cash Flows Information Related to Operating Leases
| 
| | 
December 31, | | | 
December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Cash paid for amounts included in the measurement of lease liability ($ in thousands): | | 
| | | | 
| | | |
| 
Operating cash flows from operating leases | | 
$ | 262 | | | 
$ | 245 | | |
| 
ROU assets obtained in exchange for lease liabilities | | 
$ | 677 | | | 
$ | - | | |
**9.
Financing Lease**
In
February 2024, the CGN JV entered into a lease agreement for certain equipment under separate non-cancelable equipment loan and
security agreements. The agreement matures in January 2030. The agreements require monthly payments of principal and interest
through maturity and are secured by the assets under the lease. As of December 31,
2025, $419
thousand is included in the property and equipment on the balance sheet. The weighted average interest rate was 9.1%
and 9.1% and the weighted average remaining lease term was 4.1 years and 5.1 years at
December 31, 2025 and 2024, respectively.
The
following table presents information about the amount and timing of the liability arising from the Companys financing lease as
of December 31, 2025 ($ in thousands):
Schedule of Future Minimum Financing Lease Payments
| 
Maturity of Lease Liability | | 
Financing Lease Liability | | |
| 
2026 | | 
$ | 91 | | |
| 
2027 | | 
| 90 | | |
| 
2028 | | 
| 90 | | |
| 
2029 | | 
| 90 | | |
| 
2030 | | 
| 8 | | |
| 
Total undiscounted financing lease payments ` | | 
| 369 | | |
| 
Less: Imputed interest | | 
| (62 | ) | |
| 
Present value of financing lease liability | | 
$ | 307 | | |
| 
Weighted average remaining lease term | | 
| 4.1 years | | |
| 
Weighted average discount rate | | 
| 9.1 | % | |
Supplemental cash flows information related to financing
lease was as follows:
Schedule of Supplemental Cash Flows Information Related to Financing
Lease
| 
| | 
December 31, | | | 
December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Cash paid for amounts included in the measurement of lease liability ($ in thousands): | | 
| | | | 
| | | |
| 
Operating cash flows from financing lease | | 
$ | 90 | | | 
$ | 83 | | |
**10.
Inventory**
Inventory
consists of the following ($ in thousands):
Schedule of Inventory
| 
| | 
December 31, | | | 
December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Raw materials | | 
$ | 1,374 | | | 
$ | 769 | | |
| 
Work-in-progress | | 
| 47 | | | 
| 25 | | |
| 
Finished goods | | 
| 961 | | | 
| 1,003 | | |
| 
Inventory, gross | | 
| 2,382 | | | 
| 1,797 | | |
| 
Less: Inventory reserve for excess and slow moving inventory | | 
| (271 | ) | | 
| (46 | ) | |
| 
Total | | 
$ | 2,111 | | | 
$ | 1,751 | | |
Inventory
is maintained at the Companys warehouses and at fulfillment centers owned by Amazon, Walmart and Borderless. The Company builds
its contract manufacturing products based on customer orders and immediately ships the products upon completion of the production process.
****
****
| F-20 | |
| Table of Contents | |
****
****
**11.
Property and Equipment, Net**
Property
and equipment consist of the following ($ in thousands):
Schedule of Property and Equipment
| 
| 
| 
Useful
Life | 
| 
December
31, | 
| 
| 
December
31, | 
| |
| 
| 
| 
(Years) | 
| 
2025 | 
| 
| 
2024 | 
| |
| 
Machinery
and equipment | 
| 
3
- 10 | 
| 
$ | 
2,161 | 
| 
| 
$ | 
2,118 | 
| |
| 
Office
furniture and equipment | 
| 
3
- 10 | 
| 
| 
197 | 
| 
| 
| 
187 | 
| |
| 
Leasehold
improvements | 
| 
6 | 
| 
| 
419 | 
| 
| 
| 
419 | 
| |
| 
Construction
in progress | 
| 
N/A | 
| 
| 
547 | 
| 
| 
| 
532 | 
| |
| 
Property and equipment, gross | 
| 
| 
| 
| 
3,324 | 
| 
| 
| 
3,256 | 
| |
| 
Less:
accumulated depreciation and amortization | 
| 
| 
| 
| 
(1,369 | 
) | 
| 
| 
(1,045 | 
) | |
| 
Property
and equipment, net | 
| 
| 
| 
$ | 
1,955 | 
| 
| 
$ | 
2,211 | 
| |
Depreciation
expense for the years ended December 31, 2025 and 2024 was $324 thousand and $319 thousand, respectively.
**12.
Intangible Assets**
The
following provides a breakdown of identifiable intangible assets as of December 31, 2025 and 2024 ($ in thousands):
Schedule of Breakdown of Identifiable Intangible Assets
| 
| | 
December 31, | | | 
December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Product/Technology Related | | 
| | | | 
| | | |
| 
Identifiable intangible assets, gross | | 
$ | 325 | | | 
$ | 325 | | |
| 
Accumulated amortization | | 
| (289 | ) | | 
| (191 | ) | |
| 
Product/technology related identifiable intangible assets, net | | 
| 36 | | | 
| 134 | | |
| 
Marketing Related | | 
| | | | 
| | | |
| 
Customer related intangible asset, gross | | 
| 17 | | | 
| 17 | | |
| 
Tradename related intangible asset, gross | | 
| 713 | | | 
| 713 | | |
| 
Accumulated amortization | | 
| (85 | ) | | 
| (57 | ) | |
| 
Marketing related identifiable intangible assets, net | | 
| 645 | | | 
| 673 | | |
| 
Total identifiable intangible assets, net | | 
$ | 681 | | | 
$ | 807 | | |
In
connection with the May 15, 2024 acquisition of Silly George, the Company identified intangible assets of $600thousand representing
trademark related intangibles with indefinite lives.
Intangible
assets with indefinite lives are tested for impairment within one year of the acquisition date or annually as of December 31, and whenever
indicators of impairment exist.
The
intangible assets with definite lives are being amortized on a straight-line basis over their weighted average estimated useful life
of 1.5 years and amortization expense amounted to $126 and $119 thousand for the nine months ended December 31, 2025 and 2024, respectively.
As
of December 31, 2025, the estimated annual amortization expense for each of the next five fiscal years is as follows ($ in thousands):
Schedule of Estimated Annual Amortization Expense
| 
| 
| 
| 
| 
| |
| 
2026 | 
| 
$ | 
63 | 
| |
| 
2027 | 
| 
| 
13 | 
| |
| 
2028 | 
| 
| 
2 | 
| |
| 
2029 | 
| 
| 
2 | 
| |
| 
2030 | 
| 
| 
1 | 
| |
| 
Subtotal | 
| 
| 
81 | 
| |
| 
Indefinite
lived intangible assets (subject to impairment analysis) | 
| 
| 
600 | 
| |
| 
Total | 
| 
$ | 
681 | 
| |
| F-21 | |
| Table of Contents | |
****
**13.
Accrued Expenses and Other Current Liabilities**
Accrued
expenses and other current liabilities consist of the following ($ in thousands):
Schedule of Accrued Expenses and Other Current Liabilities
| 
| | 
December 31, | | | 
December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Salaries, benefits, and incentive compensation | | 
$ | 126 | | | 
$ | 242 | | |
| 
Other | | 
| 334 | | | 
| 68 | | |
| 
Total accrued expenses and other current liabilities | | 
$ | 460 | | | 
$ | 310 | | |
**14.
Common Stock**
At
December 31, 2025, the Company has reserved common stock for issuance in relation to the following:
Schedule of Reserved Common Stock For Issued Securities in Relation
| 
Share-based
compensation plan | 
| 
| 
907,111 | 
| |
| 
Warrants
to purchase common stock | 
| 
| 
5,142,940 | 
| |
| 
Restricted
stock units | 
| 
| 
60,456 | 
| |
The
Companys issuance of common stock and warrant for the two years ended December 31, 2025 are as follows:
Schedule
of issuance of common stock and warrant
| 
| | 
| | | 
| | | 
| | | 
| | | 
Placement Agent | | |
| 
Financing Closing Date | | 
Shares Issued | | | 
Warrants Issued | | | 
Warrants Exericise Price | | | 
Total Proceeds | | | 
Warrants | | | 
Exercise Price | | |
| 
| | 
| | | 
| | | 
| | | 
| | | 
| | | 
| | |
| 
August 5, 2025 | | 
| 413,043 | | | 
| 206,521 | | | 
$ | 4.25 | | | 
$ | 949,999 | | | 
| 33,044 | | | 
$ | 4.25 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
July 31, 2025 | | 
| 45,652 | | | 
| 22,286 | | | 
$ | 4.25 | | | 
$ | 105,000 | | | 
| - | | | 
| - | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
November 20, 2024 | | 
| 727,272 | | | 
| 363,636 | | | 
$ | 4.25 | | | 
$ | 1,999,998 | | | 
| 58,182 | | | 
$ | 4.25 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
August 23, 2024 | | 
| 444,000 | | | 
| 222,000 | | | 
$ | 4.25 | | | 
$ | 1,110,000 | | | 
| 33,360 | | | 
$ | 4.25 | | |
| 
| | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
March 1, 2024 | | 
| 485,782 | | | 
| 242,891 | | | 
$ | 4.00 | | | 
$ | 1,025,000 | | | 
| 27,725 | | | 
$ | 4.00 | | |
Generally,
the Company enters into subscription agreements with investors for the sale of its common stock, accompanied with the issuance warrants
to acquire common stock.
Subject
to certain ownership limitations, each of the warrants will become exercisable on the respective closing date and will expire after five
years. The warrants may only be exercised on a cashless basis if there is no registration statement registering, or the prospectus contained
in the registration statement is not available for the issuance or resale of shares of common stock underlying the warrants to or by
the holder. The holder of a warrant is prohibited from exercising any such warrants to the extent that such exercise would result in
the number of shares of common stock beneficially owned by such holder and its affiliates exceeding 4.99% of the total number of shares
of common stock outstanding immediately after giving effect to the exercise, which percentage may be increased or decreased at the holders
election not to exceed 9.99%.
The
gross proceeds to the Company from the common stock issuances were intended to be used for working capital and for general corporate purposes.
The
Company retained Alere Financial Partners, LLC (a division of Cova Capital Partners, LLC) (Alere) to act as the placement
agent for August 5, 2025, November 20, 2024, August 23, 2024, and March 1, 2024 common stock issuances. The Company pays Alere a cash
fee ranging from 3% to 6% of the gross proceeds received, based on the individual deal and whether the issuances are made to insiders
or outsiders of the Company. Additionally, the Company granted Alere warrants exercisable for a period of five years from the closing
date for each of the issuances.
**15.
Share-based Compensation**
The
2019 Plan provides for the granting of incentive stock options, nonqualified stock options, restricted stock, stock appreciation rights
(SARs), restricted stock units, performance awards, dividend equivalent rights and other awards, which may be granted singly,
in combination, or in tandem, and which may be paid in cash, shares of common stock of the Company or a combination of cash and shares
of common stock of the Company. Effective as of May 26, 2020, May 3, 2021, and March 23, 2023 respectively, the Board approved an increase
of the number of authorized shares of common stock reserved under the 2019 Plan from 57,143
shares of common stock to 485,715,
from 485,715
shares of common stock to 571,429
shares of common stock, and from 571,429
shares of common stock to 785,715,
all of which may be delivered pursuant to incentive stock options.
On
December 31, 2024, the Board approved an additional 780,000 shares of common stock to be reserved under the 2019 Plan, bringing the total number of shares underlying the Plan to 1,651,429 of which 793,735 shares have already been awarded or exercised. The Companys
stockholders approved the 780,000 share increase at the Companys 2025 Annual Meeting of Stockholders held on June 17, 2025. Subject
to adjustments pursuant to the 2019 Plan, the maximum number of shares of common stock with respect to which stock options or SARs may
be granted to an executive officer during any calendar year is 14,286 shares of common stock.
| F-22 | |
| Table of Contents | |
The
following table contains information about the 2019 Plan as of December 31, 2025:
Schedule of Information about Incentive Plan
| 
| | 
Awards | | | 
| | | 
| | | 
Awards | | |
| 
| | 
Reserved for | | | 
Awards | | | 
Awards | | | 
Available for | | |
| 
| | 
Issuance | | | 
Issued | | | 
Exercised | | | 
Grant | | |
| 
2019 Plan(1) | | 
| 1,651,429 | | | 
| 1,132,774 | | | 
| 173,915 | | | 
| 518,655 | | |
| 
Awards issued in excess of 2019 Plan(2) | | 
| - | | | 
| 100,821 | | | 
| 92,113 | | | 
| - | | |
| 
(1) | 
Includes
incentive stock options and restricted stock units discussed below. | |
| 
| 
| |
| 
(2) | 
Includes
shares of restricted common stock granted outside of the 2019 Plan to our Chief Executive Officer, Adam Levy. | |
*Stock-Options*
The
following table summarizes the Companys incentive stock option activity for the two years ended December 31, 2025:
Schedule of Incentive Stock Option Activity
| 
| | 
| | | 
| | | 
Weighted | | |
| 
| | 
| | | 
Weighted | | | 
Average | | |
| 
| | 
| | | 
Average | | | 
Contractual | | |
| 
| | 
Number of | | | 
Exercise | | | 
Term in | | |
| 
| | 
Options | | | 
Price | | | 
Years | | |
| 
Outstanding at January 1, 2024 | | 
| 560,650 | | | 
$ | 2.35 | | | 
| 7.95 | | |
| 
Granted | | 
| 172,000 | | | 
| 2.68 | | | 
| 10.00 | | |
| 
Exercised | | 
| (90,860 | ) | | 
| 1.01 | | | 
| | | |
| 
Forfeited | | 
| | | | 
| | | | 
| | | |
| 
Cancelled | | 
| (39,107 | ) | | 
| 1.01 | | | 
| | | |
| 
Expired | | 
| (14,286 | ) | | 
| 5.25 | | | 
| | | |
| 
Outstanding at December 31, 2024 | | 
| 588,397 | | | 
| 2.67 | | | 
| 7.81 | | |
| 
Granted | | 
| 400,000 | | | 
| 3.26 | | | 
| 8.13 | | |
| 
Exercised | | 
| (6,825 | ) | | 
| 2.04 | | | 
| | | |
| 
Forfeited | | 
| | | | 
| | | | 
| | | |
| 
Cancelled | | 
| (60,175 | ) | | 
| 2.01 | | | 
| | | |
| 
Expired | | 
| (14,286 | ) | | 
| 5.25 | | | 
| | | |
| 
Outstanding at December 31, 2025 | | 
| 907,111 | | | 
$ | 2.94 | | | 
| 7.03 | | |
| 
Exercisable at December 31, 2025 | | 
| 515,863 | | | 
$ | 2.38 | | | 
| 6.90 | | |
| F-23 | |
| Table of Contents | |
As
of December 31, 2025 and 2024, vested outstanding stock options had $88 thousand and $1,151 thousand of intrinsic value as the exercise
price is greater than the estimated fair value of the underlying common stock, respectively. As of December 31, 2025 and 2024, there
were $609 thousand and $179 of unrecognized share-based compensation related to unvested stock options, which the Company expects to
recognize over the next 36 months excluding options fully contingent upon certain sales-based milestones being achieved within 18 to
36 months of commercial release.
The
Company recognizes compensation expense for stock option awards on a straight-line basis over the applicable service period of the award.
The service period is generally the vesting period. The following assumptions were used to calculate share-based compensation expense
for year ended December 31, 2025 and 2024:
Schedule of Assumptions used in Share-based Compensation
| 
| 
| 
2025 | 
| 
| 
2024 | 
| |
| 
Volatility | 
| 
| 
76.26-108.75 | 
% | 
| 
| 
277.56-279.29 | 
% | |
| 
Risk-free
interest rate | 
| 
| 
3.83-4.38 | 
% | 
| 
| 
3.44-3.67 | 
% | |
| 
Dividend
yield | 
| 
| 
0.0 | 
% | 
| 
| 
0.0 | 
% | |
| 
Expected
term | 
| 
| 
5.00-5.5
years | 
| 
| 
| 
5.00
years | 
| |
The
Company does not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting
employment termination behavior. Accordingly, the Company has elected to use the simplified method to estimate the expected
term of its share-based awards. The simplified method computes the expected term as the sum of the awards vesting term plus the
original contractual term divided by two.
The
Company estimated the expected volatility input for the Black-Scholes model using the historical volatility of its own publicly traded
common stock over a period commensurate with the expected term of the option.
The
Company recognizes compensation expense for stock option awards on a straight-line basis over the applicable service period of the award.
The service period is generally the vesting period.
*Restricted
stock awards*
The
following table summarizes the Companys restricted stock awards activity for the year ended December 31, 2025:
Schedule of Restricted Stock Units Granted
| 
| | 
Number of | | | 
Weighted Average Grant Date | | |
| 
| | 
Units | | | 
Fair Value | | |
| 
Outstanding at December 31, 2023 | | 
| 64,562 | | | 
$ | 1.82 | | |
| 
Granted | | 
| 57,972 | | | 
| 2.46 | | |
| 
Exercised and converted to common shares | | 
| (62,910 | ) | | 
| 2.08 | | |
| 
Forfeited | | 
| (3,750 | ) | | 
| 2.30 | | |
| 
Outstanding at December 31, 2024 | | 
| 55,874 | | | 
| 2.16 | | |
| 
Granted | | 
| 45,198 | | | 
| 3.57 | | |
| 
Exercised and converted to common shares | | 
| (39,116 | ) | | 
| 3.39 | | |
| 
Forfeited | | 
| (1,500 | ) | | 
| 2.72 | | |
| 
Outstanding at December 31, 2025 | | 
| 60,456 | | | 
$ | 2.41 | | |
| 
Exercisable at December 31, 2025 | | 
| 24,962 | | | 
$ | 2.62 | | |
| F-24 | |
| Table of Contents | |
Compensation
expense will be recognized ratably over the total vesting schedule. The Company will periodically adjust the cumulative compensation
expense for forfeited awards. The Company recognizes the reversal of any previously recognized compensation expense on forfeited awards
in the period the awards are forfeited. As of December 31, 2025, there was $38 thousand unrecognized share-based compensation related
to unvested RSUs, which the Company expects to recognize through December 2027.
Share-based
compensation of $654 thousand and $367 thousand has been recorded for the year ended December 31, 2025 and 2024, respectively.
**
*Warrants*
The
following table shows a summary of common stock warrants for the years ended December 31, 2025 and 2024.
Schedule of Common Stock Warrants
| 
| 
| 
| 
| 
| 
Weighted | 
| 
| 
Weighted | 
| |
| 
| 
| 
| 
| 
| 
Average | 
| 
| 
Average | 
| |
| 
| 
| 
Number
of | 
| 
| 
Exercise | 
| 
| 
Contractual | 
| |
| 
| 
| 
Warrants | 
| 
| 
Price | 
| 
| 
Term
in Years | 
| |
| 
Outstanding
at December 31, 2023 | 
| 
| 
3,442,904 | 
| 
| 
| 
5.41 | 
| 
| 
| 
2.87 | 
| |
| 
Warrants
2021 IPO(1) | 
| 
| 
387,750 | 
| 
| 
| 
5.50 | 
| 
| 
| 
2.99 | 
| |
| 
Outstanding
at January 1, 2024 (corrected) | 
| 
| 
3,830,654 | 
| 
| 
| 
5.42 | 
| 
| 
| 
2.88 | 
| |
| 
Granted | 
| 
| 
947,792 | 
| 
| 
| 
4.18 | 
| 
| 
| 
5.00 | 
| |
| 
Exercised | 
| 
| 
(5,439 | 
) | 
| 
| 
2.80 | 
| 
| 
| 
| 
| |
| 
Forfeited | 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| |
| 
Cancelled | 
| 
| 
(7,802 | 
) | 
| 
| 
2.80 | 
| 
| 
| 
| 
| |
| 
Expired | 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| |
| 
Outstanding
at December 31, 2024 | 
| 
| 
4,765,205 | 
| 
| 
| 
5.18 | 
| 
| 
| 
2.42 | 
| |
| 
Granted | 
| 
| 
387,392 | 
| 
| 
| 
4.17 | 
| 
| 
| 
5.00 | 
| |
| 
Exercised | 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| |
| 
Forfeited | 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| |
| 
Cancelled | 
| 
| 
(9,657 | 
) | 
| 
| 
2.80 | 
| 
| 
| 
| 
| |
| 
Expired | 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| |
| 
Outstanding
at December 31, 2025 | 
| 
| 
5,142,940 | 
| 
| 
$ | 
5.11 | 
| 
| 
| 
1.93 | 
| |
| 
Exercisable
at December 31, 2025 | 
| 
| 
5,142,940 | 
| 
| 
$ | 
5.11 | 
| 
| 
| 
1.93 | 
| |
| 
| 
(1) | 
The
warrants outstanding have been corrected to reflect 387,750 additional warrants related to the December 27, 2021 unit offering not
previously included in the prior year warrant schedule. | |
As
of December 31, 2025, vested outstanding warrants had no intrinsic value as the exercise price is greater than the estimated fair value
of the underlying common stock.
As
of December 31, 2024, vested outstanding stock options had $300thousand intrinsic value as the exercise price is greater than the
estimated fair value of the underlying common stock.
**16.
Notes Payable**
*CGN
Segment*
The
CGN JV has entered into a $231 thousand promissory note agreement for certain equipment. The equipment was installed in December 2023.
The promissory note has a term of five years beginning on March 13, 2024. The promissory note accrues interest at 8% and requires interest
only payments through March 13, 2024 and monthly payments of $4 thousand thereafter. The principal balance amounted to $156 thousand
and $198 thousand as of December 31, 2025 and 2024, respectively.
| F-25 | |
| Table of Contents | |
The
CGN JV has entered into a $237 thousand promissory note agreement for certain equipment. The funding advances of $153 thousand and $84
thousand have been issued in February 2024 and December 2023, respectively. The promissory note has a term of five years beginning on
March 13, 2024. The promissory note accrues interest at 8% and requires interest only payments through March 13, 2024 and monthly payments
of $5 thousand thereafter. The principal balance amounted to $163 thousand and $207 thousand as of December 31, 2025 and 2024, respectively.
*NexGel
Segment*
The
Company has entered into a $13 thousand promissory note agreement for certain leasehold improvements. The leasehold improvements were
installed in February 2024. The promissory note has a term of two years beginning on February 11, 2024. The promissory note accrues interest
at 0% and requires monthly payments of less than $1 thousand. The outstanding principal balance was $1 thousand and $8 thousand as of
December 31, 2025 and 2024, respectively.
*Economic
Injury Disaster Loan*
On
May 28, 2020, the Company entered into the standard loan documents required for securing a loan (the EIDL Loan) from the
SBA under its Economic Injury Disaster Loan (EIDL) assistance program in light of the impact of the COVID-19 pandemic on
the Companys business. Pursuant to that certain Loan Authorization and Agreement (the SBA Loan Agreement), the principal
amount of the EIDL Loan is up to $260,500, with proceeds to be used for working capital purposes. Interest accrues at the rate of 3.75%
per annum. Installment payments, including principal and interest, are due monthly beginning May 28, 2021 (twelve months from the date
of the SBA Note) in the amount of $1,270. The balance of principal and interest is payable thirty years from the date of the SBA Note.
In connection therewith, the Company received an $8 thousand advance, which does not have to be repaid. On March 26, 2021, the SBA announced
that all EIDL loans issued in 2020 will start repayment 24 months from the date of the SBA Note. The SBA has since extended the repayment
start to 30 months from the date of the SBA Note. The Company made its first payment in December 2022. The balances of the principal
and accrued interest amounted to $267 thousand and $272 thousand as of December 31, 2025 and 2024, respectively.
The
future annual principal amounts and accrued interest to be paid as of December 31, 2025 are as follows:
Schedule of Debt Instruments
| 
| | 
Amount | | |
| 
For the year ending December 31 ($ in thousands): | | 
| | | |
| 
2026 | | 
$ | 99 | | |
| 
2027 | | 
| 106 | | |
| 
2028 | | 
| 114 | | |
| 
2029 | | 
| 24 | | |
| 
2030 | | 
| 6 | | |
| 
Thereafter | | 
| 239 | | |
| 
Total | | 
$ | 588 | | |
| 
Less: current portion of notes payable | | 
| 99 | | |
| 
Long-term portion of notes payable | | 
$ | 489 | | |
**17.Warrant
Liability**
The
Company issued approximately 265,000 warrants in 2019, 2020 and 2021 as equity issuance consideration, in connection with equity offerings
of the Companys common stock. The warrants entitle the holder to purchase one share of our common stock at an exercise price equal
to $0.49 to $5.25 per share at any time on or after their issuance date and on or prior to the close of business three to five years
after the issuance date (the Termination Date). The Company determined that these warrants are free standing financial
instruments that are legally detachable and separately exercisable from the common stock included in the public share offering. Management
also determined that the warrants required classification as a liability pursuant to ASC 815, *Derivatives and Hedging*. In accordance
with the accounting guidance, the outstanding warrants are recognized as a warrant liability on the balance sheet and are measured at
their inception date fair value and subsequently re-measured at each reporting period with changes being recorded as a component of other
income (expense) in the consolidated statements of operations.
| F-26 | |
| Table of Contents | |
The
warrants outstanding and fair values at each of the respective valuation dates are summarized below:
Schedule of Warrant Liability
| 
Warrant
Liability | 
| 
Warrants
Outstanding | 
| 
| 
Fair
Value
per
Share | 
| 
| 
Fair
Value | 
| |
| 
Fair
value as of 12/31/2023 | 
| 
| 
71,019 | 
| 
| 
$ | 
2.05 | 
| 
| 
$ | 
146 | 
| |
| 
Exercise
of warrants | 
| 
| 
(13,242 | 
) | 
| 
| 
| 
| 
| 
| 
(12 | 
) | |
| 
Change
in fair value of warrant liability | 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
(16 | 
) | |
| 
Fair
value as of 12/31/2024 | 
| 
| 
57,777 | 
| 
| 
$ | 
2.04 | 
| 
| 
$ | 
118 | 
| |
| 
Change
in fair value of warrant liability | 
| 
| 
| 
| 
| 
| 
| 
| 
| 
| 
(118 | 
) | |
| 
Fair
value as of 12/31/2025 | 
| 
| 
57,777 | 
| 
| 
$ | 
0.02 | 
| 
| 
$ | 
| 
| |
The
following assumptions were used to calculate the warrant liability as of December 31, 2025 and 2024, respectively:
Schedule of Assumptions Used in Warrant Liability
| 
| 
| 
2025 | 
| 
| 
2024 | 
| |
| 
Exercise
price | 
| 
$ | 
2.80
to $5.25 | 
| 
| 
$ | 
2.80
to $5.25 | 
| |
| 
Share
price | 
| 
$ | 
1.57
- $2.98 | 
| 
| 
$ | 
2.16
- $4.46 | 
| |
| 
Volatility | 
| 
| 
52.78%
- 84.02 | 
% | 
| 
| 
92.34%
- 283.32 | 
% | |
| 
Risk-free
interest rate | 
| 
| 
3.48%
- 4.41 | 
% | 
| 
| 
3.66%
- 5.09 | 
% | |
| 
Dividend
yield | 
| 
| 
0.0 | 
% | 
| 
| 
0.0 | 
% | |
| 
Expected
term | 
| 
| 
0.09
to 1.43 years | 
| 
| 
| 
0.073
to 2.43 years | 
| |
The
warrant liabilities are considered Level 3 liabilities on the fair value hierarchy as the determination of fair value includes various
assumptions about future activities and the Companys stock prices and historical volatility of guideline public companies as inputs.
****
**18.
Commitments and Contingencies**
****
*Partnership
Advance*
On
July 14, 2025, the Company expanded its partnership with STADA Arzneimittel AG (STADA), a European leader in
consumer health. The expansion included a $1 million advance from STADA to the Company in non-dilutive capital to support product launches
and marketing efforts under the Master Distribution Agreement between the parties and relates to the planned launch of digestive enzyme
formulas and solutions targeting scars and stretch marks. As of December 31, 2025, the Company maintained $741 thousand of the advance
in partnership restricted cash related to the advance with $731 thousand also classified as a current liability under partnership accrued
advance The advance is subject to contractual restrictions on use and will be applied against eligible project costs as incurred in accordance
with the terms of the Master Distribution Agreement, as amended.
*Litigation*
The
Company may be subject to legal proceedings and claims that arise in the ordinary course of business. Management is not currently aware of any matters that will or may have a material
effect on the financial position, results of operations, or cash flows of the Company.
****
**19.
Concentrations of Risk**
For
the years ended December 31, 2025 and 2024, the Company had no revenue from customers that approximated 10% of total revenue.
The
Company had one customer with accounts receivable balances that was 50% of total accounts receivable as of December 31, 2025. The Company
had three customers with accounts receivable balances that were 50%, 10% and 22% of the total accounts receivable as of December 31,
2024.
The
Companys financial instruments that are exposed to concentrations of credit risk consist primarily of cash, cash equivalents,
restricted cash, and marketable securities. Cash balances are maintained principally at major U.S. financial institutions and are insured
by the Federal Deposit Insurance Corporation (FDIC) up to regulatory limits. As of December 31, 2025, there is no balance
exceeding such limit. The Company has not experienced any credit losses associated with its cash balances in the past. The Company invests
its cash equivalents in U.S. treasury bills with original maturities of three months or less.
Marketable
securities are comprised of U.S. treasury bills with original maturities greater than three months. The Company has not experienced any
losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash, cash equivalents, and marketable
securities and performs periodic evaluations of the credit standing of such institutions.
| F-27 | |
| Table of Contents | |
****
**20.
Related Party Transactions**
Accounts
payable related party
As
of December 31, 2025, and 2024, the Company had outstanding balances of $456 thousand and $494 thousand, respectively, due to C.G. Laboratories,
Inc., a related party. Additionally, as of December 31, 2025 and 2024, the Company had an outstanding balance of $17 thousand and $37
thousand due to the CEO of CG Labs. These balances primarily relate to transactions for contract manufacturing, packaging, and other
services provided by CG Laboratories, Inc.
As of December 31, 2025, the Company had outstanding
balances due to Achieving Consulting Excellence, LLC, a company owned by the Companys Chief Financial Officer, of $93 thousand
related to consulting services.
**21.
Income Taxes**
The
Company has established a full valuation allowance for its deferred tax assets based on managements belief that it is more likely
than not that the related deferred tax assets will be realized. For the years ended December 31, 2025 and 2024, there was no income tax
expense or benefit.
At
December 31, 2025 and 2024, the Company had no recorded tax liabilities for uncertain tax positions. The Company does not expect any
significant changes to the estimate amount of liabilities associated with uncertain tax positions in the next 12 months.
The
income tax (benefit) provision consists of the following ($ in thousands):
Schedule of Income Tax (Benefit) Provision
| 
| | 
| | | 
| | |
| 
| | 
For The Years Ended | | |
| 
| | 
December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Federal: | | 
| | | | 
| | | |
| 
Current | | 
$ | (425 | ) | | 
$ | (640 | ) | |
| 
Deferred | | 
| 425 | | | 
| 640 | | |
| 
State and local: | | 
| | | | 
| | | |
| 
Current | | 
| (104 | ) | | 
| (161 | ) | |
| 
Deferred | | 
| 104 | | | 
| 161 | | |
| 
Income tax provision | | 
$ | | | | 
$ | | | |
| F-28 | |
| Table of Contents | |
For
the years ended December 31, 2025 and 2024, the expected tax benefit based on the statutory rate reconciled with the actual benefit is
as follows:
Schedule of Effective Income Tax Rate Reconciliation
| 
| | 
| | | | 
| | | | 
| | | | 
| | | |
| 
| | 
For The Years Ended December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
U.S. federal statutory rate | | 
$ | (608 | ) | | 
| 21.0 | % | | 
$ | (727 | ) | | 
| 21.0 | % | |
| 
State tax rate, net of federal benefit | | 
| (153 | ) | | 
| 5.3 | % | | 
| (184 | ) | | 
| 5.3 | % | |
| 
Permanent differences: | | 
| | | | 
| | | | 
| | | | 
| | | |
| 
Non-deductible expenses | | 
| 78 | | | 
| (2.7 | )% | | 
| 111 | | | 
| (3.2 | )% | |
| 
Timing differences | | 
| 151 | | | 
| (5.2 | )% | | 
| (1 | ) | | 
| | % | |
| 
Change in valuation allowance | | 
| 532 | | | 
| (18.4 | )% | | 
| 801 | | | 
| (23.1 | )% | |
| 
Income tax provision | | 
$ | | | | 
| | % | | 
$ | | | | 
| | % | |
For
the years ended December 31, 2025 and 2024, differences between the expected tax expense based on the federal statutory rate and the
actual tax expense is primarily attributable to the net losses incurred and the corresponding increase to the valuation allowance.
As
of December 31, 2025 and 2024, the Companys deferred tax assets consisted of the effects of temporary differences attributable
to the following ($ in thousands):
Schedule of Deferred Tax Assets and Liabilities
| 
| | 
| | | 
| | |
| 
| | 
As of December 31, | | |
| 
| | 
2025 | | | 
2024 | | |
| 
Deferred tax assets: | | 
| | | | 
| | | |
| 
Net operating loss carryforwards | | 
$ | 6,193 | | | 
$ | 5,661 | | |
| 
Other | | 
| 12 | | | 
| 7 | | |
| 
Total deferred tax assets | | 
| 6,205 | | | 
| 5,668 | | |
| 
Valuation allowance | | 
| (6,205 | ) | | 
| (5,668 | ) | |
| 
Deferred tax assets, net of valuation allowance | | 
$ | | | | 
$ | | | |
As
of December 31, 2025 and 2024, the Company has approximately $23.6 million and $21.5 million of federal NOL carryovers, respectively,
which begin to expire in 2029 through 2037. Similarly, the subsidiarys Pennsylvania state returns reported state NOL carryovers
of approximately $23.6 million and $21.5 million, as of December 31, 2025 and 2024, respectively. However, these loss carryforwards on
a separate company basis may be subject to limitations on the amounts that may be utilized pursuant to Internal Revenue Code section
382 and applicable state law. Section 382 imposes significant limitations on the utilization of net operating losses after certain changes
of corporate ownership. The Company will need to determine the amount of loss carryforwards that may be utilized in the future as necessary.
In
assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of
the deferred tax assets will be realized. The ultimate realization of the deferred tax assets is dependent upon the future generation
of taxable income during the years in which those temporary differences become deductible. Management considers the scheduled reversal
of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. After consideration
of all the evidence, both positive and negative, management has recorded a full valuation allowance against net deferred tax assets at
December 31, 2025 and 2024 because management has determined that it is more likely than not that these deferred tax assets will not
be realized.
The
Company is subject to taxation in the U.S. and various states. Based on the history of net operating losses all jurisdictions and tax
years are open for examination until the operating losses are utilized or the statute of limitations expires. As of December 31, 2025
and 2024, the Company does not have any significant uncertain tax positions.
****
| F-29 | |
| Table of Contents | |
****
**22.
Subsequent Events**
****
In
accordance with ASC 855, *Subsequent Events*, the Company evaluated subsequent events after December 31, 2025, through the date
these Consolidated Financial Statements were issued and has no transactions or events requiring disclosure except as disclosed below.
**
*Securities
Purchase Agreement*
On
February 9, 2026, the Company entered into a Securities Purchase Agreement with a certain institutional investor (the Investor)
named therein (the Purchase Agreement) providing for the purchase by the Investor of a 10%
original issue discount (OID) convertible note facility in up to the aggregate original principal amount of $56,667,667
(the Convertible Note Facility), providing for
the purchase by the Investor, in one or more closings, of (i) series A senior secured convertible notes up to an aggregate original principal
amount of up to $1,797,381
(the Series A Convertible Notes, and the shares
of common stock, par value $0.001
per share (Common Stock) issuable pursuant to
the terms of the Series A Convertible Notes (the Series A Conversion Shares) in a registered direct pursuant to a currently
effective shelf registration statement on Form S-3 (File No. 333-264282), which has been declared effective by the SEC on June 7, 2023 and (ii) series B senior secured convertible notes up to an aggregate
original principal amount of up to $54,869,286
(or such other amount as the Company and the Investor shall
mutually agree in writing) (the Series B Convertible Notes, together with the Series A Convertible Notes, the Convertible
Notes) and the shares of common stock issuable pursuant to the terms of the Series B Convertible Notes (the Series B Conversion
Shares, and collectively with the Series A Conversion Shares, the Conversion Shares)), in reliance upon the exemption
from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the Securities Act),
and Rule 506(b) of Regulation D as promulgated by the SEC under the Securities Act.
The
Series A Convertible Notes were issued on February 10, 2026, and the Company received gross proceeds of $1,797,381
before deducting expenses, which proceeds shall be subject
to the terms of a deposit account control agreement. The Company is required to use the net proceeds from the offering of the Series
A Convertible Notes primarily for an approved future acquisition as further described in the Purchase Agreement (the Approved
Acquisition). The Company agreed not to use the net proceeds for certain purposes, including satisfaction of other indebtedness
(except as specifically permitted), redemption or repurchase of securities (except as permitted), or settlement of outstanding litigation.
If the Company consummates the Approved Acquisition no later than April 15, 2026, subject to certain other conditions, the Investor will
be required to purchase Series B Convertible Notes in up to an aggregate original principal amount of $14,869,286
at an additional closing pursuant to the Purchase Agreement,
all of which proceeds will be used for the Approved Acquisition, except for certain expenses payable on behalf of the Investor.
The
Purchase Agreement contains representations and warranties of the Company typical for transactions of this type, including representations
and warranties relating to organization and authorization, issuance and validity of the securities, compliance with securities laws and
effectiveness of the registration statement, absence of conflicts, SEC filings and financial statements, capitalization, absence of litigation,
and other customary matters. The Purchase Agreement also contains representations and warranties of the Investor, including that each
Investor is a qualified institutional investor or institutional accredited investor acquiring the securities for investment purposes.
The
Purchase Agreement also contains customary affirmative and negative covenants, including covenants relating to filing and maintenance
of registration statements, listing of securities, reservation of shares, restrictions on issuance of competing securities during specified
periods, and participation rights in certain subsequent financings. The Purchase Agreement also obligates the Company to indemnify the
Investor and its affiliates for certain losses resulting from any breach of representations, warranties or covenants in the transaction
documents, or any third-party claims arising out of the execution or performance of the transaction documents or the Investors
status as investors in the Company.
| F-30 | |
| Table of Contents | |
Palladium
Capital Group the Placement Agent) acted as the Companys placement agent with respect to the Convertible Notes.
The Company agreed to pay to the a cash fee equal to 7%
of the aggregate gross proceeds raised from the Convertible Notes at the time and if the Company consummates the Approved Acquisition;provided,however,
the Placement Agent has agreed to convert 25% of this cash fee into a form of convertible promissory note to be agreed to between the
Company and the Placement Agent. Additionally and at the time and if we consummate the Approved Acquisition, the Company agreed to issue
to Placement Agent warrants to purchase that number of shares of Common Stock of the equal to 7%
of the aggregate number of shares of Common Stock (or Common Stock equivalent, if applicable) sold in the offering (the Placement
Agent Warrants). The Placement Agent Warrants will (x) provide for cashless exercise, (y) have an exercise price equal to the
offering price per share in at closing and (z) expire on the five (5) year anniversary from issuance.
**
*Convertible
Notes*
Pursuant
to the Purchase Agreement, the Company will issue the two series of convertible notes in this offering: (i) Series A Convertible Notes
issued in a registered direct offering pursuant to the Companys effective shelf registration statement on Form S-3 and a related
prospectus supplement and (ii) Series B Convertible Notes to be issued, in one or more closings, in a private placement pursuant to Section
4(a)(2) of the Securities Act, and Regulation D promulgated thereunder
The
Convertible Notes are issued pursuant to substantially identical forms, with certain provisions applicable only to one series or the
other. Specifically, the Series A Convertible Notes, and the Series A Conversion Shares were registered at issuance under the prospectus
supplement and the Series B Conversion Shares will be freely transferable by the holders, while the Series B Convertible Notes will be
issued in a private placement and accordingly the Series B Conversion Shares are subject to transfer restrictions under applicable securities
laws. The Company entered into a Registration Rights Agreement (as defined below) with the Investor, pursuant to which the Company is
obligated to file a registration statement registering the Series B Conversion Shares and maintain its effectiveness in accordance with
the terms of such agreement. Certain provisions in the forms of Convertible Notes, such as events of default relating to registration
statement effectiveness and obligations to deliver unlegended shares, apply only to the Series B Convertible Notes.
Except
as otherwise specified, references to the Convertible Notes in this Annual Report on Form 10-K apply to both the Series
A Convertible Notes and the Series B Convertible Notes, and the description of the terms of the Convertible Notes set forth below applies
equally to both series unless otherwise indicated.
The
Convertible Notes bear interest at a rate of 10% per annum (increasing to 18% per annum upon the occurrence and during the continuance
of an Event of Default), with interest payable monthly on the first Trading Day of each calendar month commencing May 1, 2026. Each Convertible
Note will mature on the two (2) year anniversary of the applicable issuance date, subject to adjustment if certain conditions with respect
to the Approved Acquisition are not met.
| F-31 | |
| Table of Contents | |
The
Series A Convertible Notes are convertible into shares of Common Stock at a fixed Conversion Price of $1.244 per share, subject to adjustment
as provided in the Series A Convertible Notes. The holder may elect to convert the Convertible Notes at an Alternate Conversion Price,
subject to certain conditions, which provides for conversion at a discounted price based on recent trading VWAP. The Alternate Optional
Conversion Price is equal to the lower of (i) the Conversion Price or (ii) the greater of (x) the Floor Price (as defined below) or (y)
95% of the average VWAP during the ten (10) consecutive Trading Day period ending on the trading day immediately preceding delivery of
the conversion notice. The Alternate Event of Default Conversion Price is equal to the lower of (i) the Conversion Price or (ii) the
greater of (x) the Floor Price or (y) 80% of the average VWAP during the ten (10) consecutive trading day period ending on the trading
day immediately preceding delivery of the conversion notice. The Floor Price is $0.2488 per share, subject to adjustment.
Pursuant
to the Purchase Agreement, the issuance of the Series B Convertible Notes at the Companys option shall be subject to and conditioned
on the Company receiving the required stockholder approval for the following matters: (i) the redomestication of the Company to the State
of Nevada, (ii) the approval of one or more reserve stock splits over the next twelve (12) months up to an aggregate ratio of 250 shares-to-1
share, (iii) approval of the increase of the authorized shares of Common Stock of the Company from 25,000,000 to 250,000,000, and (iv)
the approval of the issuance of all of the Securities in compliance with the rules and regulations of Nasdaq Capital Markets.
**
*Asset
Purchase and Exclusive License Agreement*
On
March 6, 2026, the Company entered into an Asset Purchase and Exclusive License Agreement (the License Agreement) with
Celularity Inc., a Delaware corporation (the Licensor), whereby the Licensor agreed to grant to the Company an exclusive
license to its commercial-stage biomaterials portfolio and certain development-stage programs as more fully described in the Agreement
and the Licensor agreed to sell to the Company assets related to the portfolio (collectively, the Business).
Pursuant to the License Agreement, consideration
for the Business will consist of up to $35.0 million in cash, subject to certain adjustments, which will include (i) a $15.0 million
upfront payment and (ii) an additional $20.0 million in potential milestone payments based on net sales targets related to the Business.
Each partys obligation to consummate the transaction
is subject to customary conditions as set out in the Agreement, including the Companys receipt of financing in an amount sufficient
to pay the initial $15.0 million upfront payment. In addition, the Agreement contains customary termination rights of the parties.
****
The
Agreement contains customary representations, warranties, covenants, indemnifications, and agreements. Among other ancillary agreements,
the Agreement contemplates that the parties will enter into a contract manufacturing agreement and sublease agreement related to the
Business.
| F-32 | |
| Table of Contents | |
****
**Item
9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure**
None.
**Item
9A. Controls and Procedures**
**Disclosure
Controls and Procedures**
As
of December 31, 2025, we conducted an evaluation of the effectiveness of our disclosure controls and procedures (Disclosure
Controls), as defined by Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the Exchange
Act). The Disclosure Controls evaluation was done under the supervision and with the participation of management, including our
chief executive officer and chief financial officer. There are inherent limitations to the effectiveness of any system of disclosure
controls and procedures. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving
their control objectives. Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated
the effectiveness of our disclosure controls and procedures as of December 31, 2025. Based on that evaluation, our CEO and CFO concluded
that our disclosure controls and procedures were not effective as of December 31, 2025, due to material weaknesses in our internal control
over financial reporting, which are described below in Managements Annual Report on Internal Control over Financial Reporting.
**Managements
Annual Report on Internal Control over Financial Reporting and Attestation Report of the Registered Accounting Firm**
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f)
under the Exchange Act). Management conducted an assessment of the effectiveness of our internal control over financial reporting based
on the criteria set forth in Internal ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (2013 framework). Because of its inherent limitations, internal control over financial reporting is not intended to provide
absolute assurance that a misstatement of our financial statements would be prevented or detected. Based on that assessment, management
has concluded that its internal control over financial reporting was not effective as of December 31, 2025 to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements in accordance with accounting principles
generally accepted in the United States of America. Specifically, management has concluded that its internal control over financial reporting
was not effective as of December 31, 2025 to provide reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements in accordance with accounting principles generally accepted in the United States of America due to not maintaining
proper segregation of duties, including: (i) we have not designed controls to ensure all accounting journals entries are reviewed and
approved and (ii) we have one individual in our accounting department who has super user access and security administration
rights to the financial reporting systems.
To
remediate these material weaknesses, we are working to do the following: (i) implementing appropriate controls for accounting journal
entry approvals, including the approval of our chief financial officer, and (ii) either actively monitoring any accounting user with
elevated rights or assigning another employee outside of an accounting and reporting role with elevated access. We will not be able to
fully remediate the material weakness until the actions discussed above have been implemented and operated effectively for a sufficient
period of time.
Given
we are neither an accelerated filer nor a large accelerated filer, we are not required to include an attestation report regarding the
effectiveness of our internal controls over financial reporting of our independent registered public accounting firm in our Annual Report.
**Financial
Reporting Process**
We
have not designed controls to ensure the financial reporting process is operating effectively, as noted above. We intend to design controls
to ensure the financial information is accurate, complete, and recorded in the correct period.
**Change
in Internal Control over Financial Reporting**
There
have been no changes in our internal control over financial reporting during the fiscal year ended December 31, 2025 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
**Item
9B. Other Information**
Rule
10b5-1 Trading Plans.
During
the three months ended December 31, 2025, no director or officer of the Companyadopted
, modified orterminateda Rule
10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement, as each term is defined in Item 408(a) of Regulation
S-K.
**Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections**
Not
applicable.
| 24 | |
| Table of Contents | |
**Part
III.**
**Item
10. Directors, Executive Officers and Corporate Governance.**
The
information required by this Item is set forth under the headings Directors, Executive Officers and Corporate Governance
and Section 16(a) Beneficial Ownership Reporting Compliance in the Companys 2026 Proxy Statement to be filed with
the SEC within 120 days after December 31, 2025 in connection with the solicitation of proxies for the Companys 2025 annual meeting
of shareholders and is incorporated herein by reference. The Company hasadoptedan insider trading policy which governs transactions
in our securities by the Company and its directors, officers, employees, any applicable consultants and contractors (as determined by
the Company), and each of their respective family members, and is designed to promote compliance with insider trading laws, rules and
regulations applicable to the Company. A copy of our insider trading policy is filed with this Annual Report on Form 10-K as Exhibit
19.1.
The
Company has adopted a Code of Business Conduct and Ethics applicable to all officers, directors and employees, which is available on
the Companys website (https://ir.nexgel.com/corporate-governance/governance-documents) under Governance Documents.
The Company intends to satisfy the disclosure requirement under Item5.05 of Form 8-K regarding amendment to, or waiver from, a
provision of its Code of Conduct by posting such information on the website address and location specified above.
**Item
11. Executive Compensation**
The
information required by this Item is set forth under the heading Executive Compensation and under the subheadings Board
Oversight of Risk Management, Compensation of Directors, Director Compensation-2025 and Compensation
Committee Interlocks and Insider Participation under the heading Directors, Executive Officers and Corporate Governance
in the Companys 2026 Proxy Statement to be filed with the SEC within 120 days after December 31, 2025 and is incorporated herein
by reference.
**Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters**
The
information required by this Item is set forth under the headings Security Ownership of Certain Beneficial Owners and Management
and Equity Compensation Plan Information in the Companys 2026 Proxy Statement to be filed with the SEC within 120
days after December 31, 2025 and is incorporated herein by reference.
**Item
13. Certain Relationships and Related Transactions and Director Independence**
The
information required by this Item is set forth under the heading Review, Approval or Ratification of Transactions with Related
Persons and under the subheading Board Committees under the heading Directors, Executive Officers and Corporate
Governance in the Companys 2026 Proxy Statement to be filed with the SEC within 120 days after December 31, 2025 and is
incorporated herein by reference.
**Item
14. Principal Accountant Fees and Services.**
Our
independent public accounting firm is Turner Stone & Company, L.L.P., Dallas, Texas, PCAOB Auditor ID 76.
The
information required by this Item is set forth under the subheadings Fees Paid to Auditors and Policy on Audit Committee
Pre-Approval of Audit and Non-Audit Services Performed by the Independent Registered Public Accounting Firm under the proposal
Ratification of Appointment of Independent Registered Public Accounting Firm in the Companys 2026 Proxy Statement
to be filed with the SEC within 120 days after December 31, 2025 and is incorporated herein by reference.
| 25 | |
| Table of Contents | |
****
**Part
IV.**
**Item
15. Exhibits and Financial Statement Schedules**
The
following documents are filed as part of this report:
(1)
Financial Statements
The
following financial statements are included herein:
| 
Report of Independent Registered Public Accounting Firm (PCAOB ID: 76) | 
F-2 | |
| 
Consolidated Balance Sheets as of December 31, 2025 and 2024 | 
F-3 | |
| 
Consolidated Statements of Operations for the years ended December 31, 2025 and 2024 | 
F-4 | |
| 
Consolidated Statements of Stockholders Equity for the years ended December 31, 2025 and 2024 | 
F-5 | |
| 
Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024 | 
F-6 | |
| 
Notes to Consolidated Financial Statements | 
F-7 | |
(2)
Financial Statement Schedules
None.
(3)
Exhibits
| 
3.1 | 
| 
Certificate
of Incorporation of AquaMed Technologies, Inc. (incorporated by reference to Exhibit 3.1 to Form S-1, filed with the SEC on January
9, 2019). | |
| 
| 
| 
| |
| 
3.2 | 
| 
Certificate
of Amendment to Certificate of Incorporation of AquaMed Technologies, Inc. (incorporated by reference to Exhibit 3.2 to Form S-1,
filed with the SEC on January 9, 2019). | |
| 
| 
| 
| |
| 
3.3 | 
| 
Amended
and Restated Certificate of Incorporation of AquaMed Technologies, Inc. (incorporated by reference to Exhibit 3.3 to Amendment No.
1 to Form S-1, filed with the SEC on March 11, 2019). | |
| 
| 
| 
| |
| 
3.4 | 
| 
Certificate
of Amendment to the Amended and Restated Certificate of Incorporation of AquaMed Technologies, Inc. (incorporated by reference to
Exhibit 3.1 to the Current Report on Form 8-K, filed with the SEC on November 14, 2019). | |
| 
| 
| 
| |
| 
3.5 | 
| 
Certificate
of Amendment to the Amended and Restated Certificate of Incorporation of NexGel, Inc. (incorporated by reference to Exhibit 3.1 to
the Current Report on Form 8-K, filed with the SEC on May 29, 2020). | |
| 
3.6 | 
| 
Certificate
of Amendment to the Amended and Restated Certificate of Incorporation of NexGel, Inc. (incorporated by reference to Exhibit 3.6 to
Form S-1, filed with the SEC on December 2, 2021) | |
| 
| 
| 
| |
| 
3.7 | 
| 
Amended
and Restated Bylaws of AquaMed Technologies, Inc. (incorporated by reference to Exhibit 3.5 to Amendment No. 1 to Form S-1, filed
with the SEC on March 11, 2019). | |
| 
| 
| 
| |
| 
4. | 
| 
First
Common Stock Purchase Warrant, dated March 11, 2021, issued to Auctus Fund, LLC (incorporated by reference to Exhibit 4.2 to the
Current Report on Form 8-K filed with the SEC on March 17, 2021). | |
| 
| 
| 
| |
| 
4.3 | 
| 
Second
Common Stock Purchase Warrant, dated March 11, 2021, issued to Auctus Fund, LLC (incorporated by reference to Exhibit 4.3 to the
Current Report on Form 8-K filed with the SEC on March 17, 2021). | |
| 26 | |
| Table of Contents | |
| 
4.4 | 
| 
Form
of Common Stock Purchase Warrant, dated September 2, 2021 (incorporated by reference to Exhibit 4.2 to the Current Report on Form
8-K filed with the SEC on September 8, 2021) | |
| 
| 
| 
| |
| 
4.5 | 
| 
Warrant
Agency Agreement (including form of Common Warrant) dated December 27, 2021 by and between NexGel, Inc. and Continental Stock Transfer
& Trust Company (incorporated by reference to Exhibit 10.1 to Form 8-K, filed with the SEC on December 27, 2021). | |
| 
| 
| 
| |
| 
4.6 | 
| 
Form
of February 2024 Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the SEC on February
21, 2024). | |
| 
| 
| 
| |
| 
4.7 | 
| 
Form
of August 2024 Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the SEC on August 13,
2024). | |
| 
| 
| 
| |
| 
4.8 | 
| 
Form
of November 2024 Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the SEC on November
12, 2024). | |
| 
| 
| 
| |
| 
10.1 | 
| 
Assignment
and Amended and Restated Lease, dated as of January 25, 2002, by and between 2150 Cabot LLC, Embryo Development Corporation and Hydrogel
Design Systems, Inc. (incorporated by reference to Exhibit 10.1 to Form S-1, filed with the SEC on January 9, 2019). | |
| 
| 
| 
| |
| 
10.2 | 
| 
Amendment
to Lease, dated as of February 23, 2007, by and between 2150 Cabot LLC and Hydrogel Design Systems, Inc. (incorporated by reference
to Exhibit 10.2 to Form S-1, filed with the SEC on January 9, 2019). | |
| 
| 
| 
| |
| 
10.3 | 
| 
Third
Amendment to Lease, dated as of February 27, 2009, by and between Exeter 2150 Cabot, L.P and Hydrogel Design Systems, Inc. (incorporated
by reference to Exhibit 10.3 to Form S-1, filed with the SEC on January 9, 2019). | |
| 
| 
| 
| |
| 
10.4 | 
| 
Assignment
and Assumption of Lease Agreement, dated as of February 27, 2009, by and among Exeter 2150 Cabot, L.P, Hydrogel Design Systems, Inc.
and Aquamed Technologies, Inc. (incorporated by reference to Exhibit 10.4 to Form S-1, filed with the SEC on January 9, 2019). | |
| 
| 
| 
| |
| 
10.5 | 
| 
Fourth
Amendment to Lease, dated as of July 24, 2013, by and between Exeter 2150 Cabot, L.P and Aquamed Technologies, Inc. (incorporated
by reference to Exhibit 10.5 to Form S-1, filed with the SEC on January 9, 2019). | |
| 
| 
| 
| |
| 
10.6 | 
| 
Form
of 2019 Incentive Plan (incorporated by reference to Exhibit 10.22 to Amendment No. 3 to Form S-1, filed with the SEC on April 19,
2019). | |
| 
| 
| 
| |
| 
10.7 | 
| 
Form
of Incentive Option Agreement under 2019 Incentive Plan (incorporated by reference to Exhibit 10.23 to Amendment No. 3 to Form S-1,
filed with the SEC on April 19, 2019). | |
| 
10.8 | 
| 
Form
of Nonqualified Stock Option Agreement under 2019 Incentive Plan (incorporated by reference to Exhibit 10.24 to Amendment No. 3 to
Form S-1, filed with the SEC on April 19, 2019). | |
| 
| 
| 
| |
| 
10.9 | 
| 
Securities
Purchase Agreement, dated March 11, 2021, between NexGel, Inc. and Auctus Fund, LLC (incorporated by reference to Exhibit 10.1 to
the Current Report on Form 8-K filed with the SEC on March 17, 2021). | |
| 
| 
| 
| |
| 
10.10 | 
| 
Registration
Rights Agreement, dated March 11, 2021, between NexGel, Inc. and Auctus Fund, LLC (incorporated by reference to Exhibit 10.3 to the
Current Report on Form 8-K filed with the SEC on March 17, 2021). | |
| 27 | |
| Table of Contents | |
| 
10.11 | 
| 
First
Amendment to the Senior Secured Promissory Note, Warrants, and Securities Purchase Agreement (March 11, 2021) dated August 13, 2021
by and between NexGel. Inc. and Auctus Fund, LLC (incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q
filed with the SEC on August 16, 2021). | |
| 
| 
| 
| |
| 
10.12 | 
| 
Form
of Securities Purchase Agreement, dated September 2, 2021 (incorporated by reference to Exhibit 10.1 to the Current Report on Form
8-K filed with the SEC on September 8, 2021). | |
| 
| 
| 
| |
| 
10.13 | 
| 
Form
of Registration Rights Agreement, dated September 2, 2021 (incorporated by reference to Exhibit 10.4 to the Current Report on Form
8-K filed with the SEC on September 8, 2021). | |
| 
| 
| 
| |
| 
10.14 | 
| 
Second
Amendment to the Senior Secured Promissory Note, Warrants, and Securities Purchase Agreement (March 11, 2021) dated October 28, 2021
by and between NexGel. Inc. and Auctus Fund, LLC (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed
with the SEC on November 3, 2021). | |
| 
| 
| 
| |
| 
10.15 | 
| 
Third
Amendment to the Senior Secured Promissory Note, Warrants, and Securities Purchase Agreement (March 11, 2021) dated December 10,
2021 by and between NexGel. Inc. and Auctus Fund, LLC (incorporated by reference to Exhibit 10.23 to Form S-1, filed with the SEC
on December 10, 2021). | |
| 
| 
| 
| |
| 
10.16 | 
| 
Asset
Purchase Agreement dated November 30, 2023 between NexGel, Inc. and Olympus Trading Company, LLC (incorporated by reference to Exhibit
10.1 to the Current Report on Form 8-K filed with the SEC on December 5, 2023). | |
| 
10.17 | 
| 
Asset
Purchase Agreement dated May 15, 2024 between NexGel, Inc. and Semmens Online Pty Ltd as Trustee for Semmens Business Trust (incorporated
by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the SEC on May 20, 2024). | |
| 
| 
| 
| |
| 
10.18 | 
| 
2025
Executive Employment Agreement dated December 30, 2024 between NexGel, Inc. and Joseph F. McGuire (incorporated by reference to Exhibit
10.2 to the Current Report on Form 8-K filed with the SEC on January 6, 2025). | |
| 
| 
| 
| |
| 
10.19 | 
| 
2025
Executive Employment Agreement dated December 30, 2024 between NexGel, Inc. and Adam Levy (incorporated by reference to Exhibit 10.1
to the Current Report on Form 8-K filed with the SEC on January 6, 2025). | |
| 
| 
| 
| |
| 
19.1* | 
| 
NexGel, Inc.s Insider Trading Policy | |
| 
| 
| 
| |
| 
21.1* | 
| 
Subsidiaries | |
| 
| 
| 
| |
| 
23.1* | 
| 
Consent of Turner, Stone & Company, L.L.P. | |
| 
| 
| 
| |
| 
31.1* | 
| 
Rule 13a-14(a) Certification of Principal Executive Officer | |
| 
| 
| 
| |
| 
31.2* | 
| 
Rule 13a-14(a) Certification of Principal Financial Officer | |
| 
| 
| 
| |
| 
32.1** | 
| 
Section 1350 Certification of Principal Executive Officer | |
| 
| 
| 
| |
| 
32.2** | 
| 
Section 1350 Certification of Principal Financial Officer | |
| 
| 
| 
| |
| 
97 | 
| 
NexGel,
Inc. Policy for the Recovery of Erroneously Awarded Compensation (incorporated by reference to Exhibit 97 to the Annual Report on
Form 10-K filed with the SEC on April 10, 2024). | |
| 
| 
| 
| |
| 
101.INS* | 
| 
Inline
XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within
the Inline XBRL document | |
| 
| 
| 
| |
| 
101.SCH* | 
| 
Inline
XBRL Taxonomy Extension Schema Document | |
| 
| 
| 
| |
| 
101.CAL* | 
| 
Inline
XBRL Taxonomy Extension Calculation Linkbase Document | |
| 
| 
| 
| |
| 
101.DEF* | 
| 
Inline
XBRL Taxonomy Extension Definition Linkbase Document | |
| 
| 
| 
| |
| 
101.LAB* | 
| 
Inline
XBRL Taxonomy Extension Labels Linkbase Document | |
| 
| 
| 
| |
| 
101.PRE* | 
| 
Inline
XBRL Taxonomy Extension Presentation Linkbase Document | |
| 
| 
| 
| |
| 
104 | 
| 
Cover
Page Interactive Data File (embedded within the Inline XBRL document). | |
****
*****Filed herewith.
**
Furnished herewith.
| 28 | |
| Table of Contents | |
**Signatures**
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
| 
| 
NexGel,
Inc. | |
| 
| 
| 
| |
| 
Date:
March 31, 2026 | 
By: | 
/s/
Adam Levy | |
| 
| 
| 
Adam
Levy | |
| 
| 
| 
Chief
Executive Officer and President | |
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
Registrant and in the capacities indicated as of the dates set forth below.
| 
Signature | 
| 
Date | 
| 
Title | |
| 
| 
| 
| 
| 
| |
| 
/s/
Adam Levy | 
| 
March
31, 2026 | 
| 
Chief
Executive Officer and President (Principal Executive Officer) and Director | |
| 
Adam
Levy | 
| 
| 
| 
| |
| 
| 
| 
| 
| 
| |
| 
/s/
Adam Drapczuk | 
| 
March
31, 2026 | 
| 
Chief
Financial Officer (Principal Accounting and Financial Officer) | |
| 
Adam
Drapczuk | 
| 
| 
| 
| |
| 
| 
| 
| 
| 
| |
| 
/s/
Steven Glassman | 
| 
March
31, 2026 | 
| 
Director | |
| 
Steven
Glassman | 
| 
| 
| 
| |
| 
| 
| 
| 
| 
| |
| 
/s/
Scott Henry | 
| 
March
31, 2026 | 
| 
Director | |
| 
Scott
Henry | 
| 
| 
| 
| |
| 
| 
| 
| 
| 
| |
| 
/s/
Steven Ciardiello | 
| 
March
31, 2026 | 
| 
Director | |
| 
Steven
Ciardiello | 
| 
| 
| 
| |
| 
| 
| 
| 
| 
| |
| 
| 
| 
| 
| 
| |
| 
/s/
Jerome B. Zeldis | 
| 
March
31, 2026 | 
| 
Director | |
| 
Jerome
B. Zeldis | 
| 
| 
| 
| |
| 29 | |