DRMA 10-K & 10-Q changes, risk factors and insider trading
Dermata Therapeutics, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1853816 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Disruptions to our distribution operations could adversely affect our ability to deliver our products to consumers and customers.”
New heading “Risks related to the skincare industry”
New heading “Our shift from an Rx regulatory framework to OTC monograph pathways could introduce significant regulatory risks that could delay or prevent product launches, require reformulation or relabeling, restrict indications or target populations, and materially increase costs.”
New heading “The skincare industry is highly competitive, and if we are unable to compete effectively, our results will suffer.”
New heading “Our business is dependent on the commercial success and our ability to launch and sell Tome skincare products, including our Foundational Treatment. If we are unable to successfully launch, commercialize and sell our Foundational Treatment, our results of operations and financial condition will be materially harmed.”
New heading “Our new product launch may not be as successful as we anticipate.”
New heading “Any damage to our reputation or brand may materially and adversely affect our business, financial condition and results of operations.”
New heading “Our success depends, in part, on the quality, efficacy and safety of our products.”
New heading “The illegal distribution and sale by third parties of counterfeit versions of our products or the unauthorized diversion by third parties of our products could have an adverse effect on our net sales and a negative impact on our reputation and business.”
New heading “Demand for our products may not increase as rapidly as we anticipate due to a variety of factors, including a weakness in general economic conditions and resistance to non-traditional treatment methods.”
New heading “We may experience declines in average selling prices of our products which may decrease our net revenues.”
New heading “Risks related to our growth and profitability”
New heading “We may not be able to successfully implement our growth strategy.”
New heading “Our growth and profitability are dependent on a number of factors.”
New heading “We may be unable to grow our business effectively or efficiently, which would harm our business, financial condition and results of operations.”
New heading “Acquisitions or investments could disrupt our business and harm our financial condition.”
New heading “We expect our future quarterly and annual operating results to fluctuate for a variety of reasons, particularly as we focus on increasing consumer demand for our products. Volatility in the financial markets could also have a material adverse effect on our business.”
New heading “Risks related to our business operations”
New heading “A disruption in our operations could materially and adversely affect our business.”
New heading “Our success depends, in part, on our retention of key members of our senior management team, whose continued service is not guaranteed, and ability to attract and retain qualified personnel.”
New heading “We rely on a number of third-party suppliers, distributors and other vendors, and they may fail to produce products or to provide services that are consistent with our standards or applicable regulatory requirements, which could harm our brand reputation, cause consumer dissatisfaction or require us to find alternative suppliers of our products or services.”
New heading “We are dependent on one supplier for the raw material used to produce the sponge powder used in our products. The termination of this contract would result in a disruption to product development, and our business will be harmed.”
New heading “We rely on third-party delivery service providers.”
New heading “A disruption in the operations of our primary freight carrier or higher shipping costs could cause a decline in our net revenues or a reduction in our earnings.”
New heading “If we fail to manage our inventory effectively, our results of operations, financial condition and liquidity may be materially and adversely affected.”
New heading “In order to build market penetration and raise awareness of our brand and products, we will have to spend substantial cash on marketing activities, which may not ultimately prove successful or an effective use of our resources.”
New heading “Any skincare professionals we may engage in the future will likely not be under any obligation to purchase any product from us, and business challenges at one or more of these providers could adversely affect our results of operations.”
New heading “Risks Related to Consumer Use Studies and Product Testing”
New heading “We may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships with third parties that may not result in the development of commercially viable products or product improvements or the generation of significant future revenues.”
New heading “Risks related to evolving laws and regulations and compliance with laws and regulations”
New heading “New laws, regulations, enforcement trends or changes in existing regulations governing the introduction, marketing and sale of our products to consumers could harm our business.”
New heading “New laws, regulations, enforcement trends, or changes in existing regulations could affect the ability of our aesthetician providers in certain states to provide our treatments to consumers, any of which could have a material adverse effect on our business, financial condition, and results of operation.”
New heading “Our business is subject to extensive and continuing regulatory compliance obligations. If we fail to obtain and maintain necessary market clearances from the FDA and other marketing authorizations or certifications from counterpart foreign regulatory authorities or notified bodies for our products and indications, if clearances or other marketing authorizations or certifications for future products and indications are delayed or not issued, if we or any third-party suppliers or manufacturers fail to comply with applicable regulatory requirements, or if there are U.S. federal or state level or comparable foreign regulatory changes, our commercial operations could be harmed.”
New heading “Our facilities are subject to regulation under the FDCA and FDA implementing regulations governing the manufacture of our products. If we fail to comply with federal, state and foreign regulations, our manufacturing operations could be halted, and our business would suffer.”
New heading “Government regulations and private party actions relating to the marketing and advertising of our products and services may restrict, inhibit, or delay our ability to sell our products and harm our business, financial condition and results of operations.”
New heading “Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.”
New heading “As compliance with healthcare regulations becomes more costly and difficult for us or our customers, we may be unable to grow our business.”
New heading “If we market products in a manner that violates healthcare laws, we may be subject to civil or criminal penalties.”
New heading “Government regulation of the Internet and e-commerce is evolving, and unfavorable changes or failure by us to comply with these regulations could substantially harm our business, financial condition and results of operations.”
New heading “Use of social media may materially and adversely affect our reputation or subject us to fines or other penalties.”
New heading “We expect that our business will rely heavily on email and other messaging services, and any restrictions on the sending of emails or messages or an inability to timely deliver such communications could materially adversely affect our net revenue and business.”
New heading “The increasing use of artificial intelligence (“AI”) in our operations and by third-party partners may create operational, compliance, and reputational risks that could adversely affect our business and results of operations.”
New heading “Risks Related to Termination of License Agreement”
New heading “The termination of our license agreement with Villani could negatively impact our operations.”
Removed heading “We will need to raise additional capital which may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates, and additional capital may not be available on favorable terms or at all which may force us to delay, reduce the scope of or eliminate our research and development programs, reduce our commercialization efforts or curtail our operations.”
Removed heading “We are exposed to risks related to foreign currency exchange rates.”
Removed heading “Risks Related to Development, Regulatory Approval and Commercialization”
Removed heading “Our business is dependent on the successful development, regulatory approval and commercialization of our product candidates, in particular XYNGARI™ and DMT410.”
Removed heading “Clinical drug development for our product candidates is very expensive, time-consuming and uncertain. Our clinical trials may fail to adequately demonstrate the safety and efficacy of our product candidates, which could prevent or delay regulatory approval and commercialization.”
Removed heading “Our industry is subject to extensive regulatory obligations and policies that may be subject to change, including due to judicial challenges.”
Removed heading “We face risks related to public health emergencies, epidemics and other outbreaks of communicable diseases, which could significantly disrupt our operations, including our clinical trials and preclinical studies, and adversely affect our business and results of operations.”
Removed heading “Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.”
Removed heading “Approval may be delayed or denied because we cannot satisfy FDA’s Chemistry, Manufacturing and Control Requirements.”
Removed heading “We may be unable to obtain regulatory approval for XYNGARI™, or our other early-stage product candidates under applicable regulatory requirements. The FDA and foreign regulatory bodies have substantial discretion in the approval process, including the ability to delay, limit or deny approval of product candidates. The delay, limitation or denial of any regulatory approval would adversely impact commercialization, our potential to generate revenue, our business and our operating results.”
Removed heading “We have completed enrollment of our first Phase 3 clinical trials for XYNGARI™, but that does not guarantee successful completion. We may be unable to successfully complete it or any future clinical trials.”
Removed heading “Even if our current product candidates or any future product candidates obtain regulatory approval, they may fail to achieve the broad degree of physician and patient adoption and use necessary for commercial success.”
Removed heading “We intend to seek NCE exclusivity for XYNGARI™ and future product candidates, and we may be unsuccessful in obtaining such exclusivity.”
Removed heading “Our product candidates, if approved, will face significant competition and our failure to effectively compete may prevent us from achieving significant market penetration.”
Removed heading “Any product candidates that we commercialize, or that any partner with which we may collaborate commercializes, will be subject to ongoing and continued regulatory review.”
Removed heading “We may in the future conduct clinical trials for our product candidates outside the United States and the FDA and applicable foreign regulatory authorities may not accept data from such trials.”
Removed heading “If we or any partners with which we may collaborate are unable to achieve and maintain coverage and adequate levels of reimbursement for any of our product candidates for which we receive regulatory approval, or any future products we may seek to commercialize, their commercial success may be severely hindered.”
Removed heading “Healthcare legislative or regulatory reform measures, including government restrictions on pricing and reimbursement, may have a negative impact on our business and results of operations.”
Removed heading “Development of test methodology for XYNGARI™ presents unique challenges due to the complex mixture of constituents in the product. Determination of appropriate assay(s) for release and quality control evaluations could require significant development time and cost to successfully complete and uncertain.”
Removed heading “We are dependent on one supplier for the raw material used to produce XYNGARI™ and DMT410. The termination of this contract would result in a disruption to product development and our business will be harmed.”
Removed heading “We have in the past relied and expect to continue to rely on third-party CROs and other third parties to conduct and oversee our clinical trials and other aspects of product development. If these third parties do not meet our requirements or otherwise conduct the trials as required, we may not be able to satisfy our contractual obligations or obtain regulatory approval for, or commercialize, our product candidates when expected or at all.”
Removed heading “We rely completely on third-party contractors to supply, manufacture and distribute clinical drug supplies for our product candidates, including certain sole-source suppliers and manufacturers, we intend to rely on third parties for commercial supply, manufacturing and distribution if any of our product candidates receive regulatory approval and we expect to rely on third parties for supply, manufacturing and distribution of preclinical, clinical and commercial supplies of any future product candidates.”
Removed heading “If we are not able to establish and maintain collaborations, we may have to alter our development and commercialization plans.”
Removed heading “Manufacturing and supply of the APIs and other substances and materials used in our product candidates is a complex and technically challenging undertaking, and there is potential for failure at many points in the manufacturing, testing, quality assurance and distribution supply chain, as well as the potential for latent defects after products have been manufactured and distributed.”
Removed heading “If we fail to comply with our obligations under our intellectual property license agreements, we could lose license rights that are important to our business.”
Largest changes
“We also plan to use third-party social media platforms as marketing tools. For example, we plan to maintain Facebook, TikTok, Instagram, and YouTube accounts, among others. As e-commerce and social media platforms continue to rapidly evolve, we must continue to maintain a presence on these platforms and establish presences on new or emerging popular social media platforms. If we are unable to cost-effectively use social media platforms as marketing tools, our ability to acquire new consumers and our financial condition may suffer. …”see in full comparison
“There has been an increase in regulatory activity and activism in the United States and abroad, and the regulatory landscape is becoming more complex with increasingly strict requirements. In addition, significant uncertainty exists during periods of political and governmental transition that may impact existing laws and regulations, as well as our ability to remain compliant. …”see in full comparison
“Additionally, regulatory clearances, approvals, or certifications to market a product can contain limitations on the indications for use of such product. Product clearances, approvals and certifications can be withdrawn due to failure to comply with regulatory standards or the occurrence of unforeseen problems following initial clearance, approval, or certification. …”see in full comparison
“Our facilities are subject to regulation under the FDCA and FDA implementing regulations. With respect to our OTC products, we are required to demonstrate and maintain compliance with the FDA’s current Good Manufacturing Practices. …”see in full comparison
“Our operations, including those of our third-party suppliers, brokers and delivery service providers, are subject to the risks inherent in such activities, including industrial accidents, supply chain disruptions, macroeconomic issues, environmental events, strikes and other labor disputes, disruptions in information systems, product quality control, safety, licensing requirements and other regulatory issues, changes in laws and regulatory requirements, as well as natural disasters, pandemics, border disputes, political crises, such as acts of terrorism, war and other political instability …”see in full comparison
“Participants in the healthcare industry are subject to extensive and frequently changing regulations under numerous laws administered by governmental entities at the federal, state, local and foreign levels, some of which are, and others of which may be, applicable to our business. Furthermore, our healthcare provider customers are also subject to a wide variety of laws and regulations that could affect the nature and scope of their relationships with us. The healthcare market itself is highly regulated and subject to changing political, economic and regulatory influences. …”see in full comparison
Full comparison: every changed paragraph (309)
Investing in our securities involves a high degree of risk. You should carefully consider the risks and uncertainties described below, together with all of the other information in this report, including the consolidated financial statements, the notes thereto and the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this report before deciding whether to invest in our securities. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of or that we deem immaterial may also become important factors that adversely affect our business. If any of the following risks actually occur, our business, financial condition, results of operations and future prospects could be materially and adversely affected. In that event, the market price of our common stock and/or Warrants could decline, and you could lose part or all of your investment. These disclosures reflect our beliefs and opinions as to factors that could materially and adversely affect us and our securities in the future. References to past events are provided by way of example only and are not intended to be a complete listing or a representation as to whether or not such factors have occurred in the past or their likelihood of occurring in the future.
We
are a clinicalpre-commercial stage pharmaceutical company with a limited operating history.
We
are a clinical-stagepre-commercial biopharmaceuticalstage company with a limited operating history upon which you can evaluate our business and prospects. We musthave completenever
sold clinicala studiescommercial product before and receivethere regulatoryis approvalno beforeguarantee commercialthat saleswe ofwill abe product can commence.successful. The likelihood of success of our business plan
must be considered in light of the problems, substantial expenses, difficulties, complications and delays frequently encountered in connection
with developing and expandingselling early-stageskincare businesses and the regulatoryproducts and competitive environment in which we plan to operate. Pharmaceutical product development is a highly speculative undertaking, involves a substantial degree of risk and is a capital-intensive business.
Accordingly, you should consider our prospects in light of the costs,
uncertainties, delays and difficulties frequently encountered by companies inlaunching thetheir earlyfirst stagescommercial of development, especially early stage clinical pharmaceutical companies such as ours.product. Potential investors
should carefully consider the risks and uncertainties that a company with a limited operating history will face. In particular, potential
investors should consider that we cannot assure you that we will be able to, among other things:
We
have never generated revenue from operations,operations areand unlikelymay tonot generate revenues for several months or years, andif ever. We are currently operating
at a loss and expect our operating costs will continue to increase significantly as we incur costs relatedattempt to preclinical development, the clinical trials forlaunch our drugfirst candidatescommercial product and continue
to operatingoperate as a public company. We expect to incur substantial expenses without corresponding revenues unless and until we are able to obtain regulatory approval and
successfully commercialize any of our drug candidates. We may never be able to obtain regulatory approval for the marketing of our drug candidates in any indication in the United States or internationally.products. Even if we are able to commercialize our drug candidates,products, there can be no assurance that we
will generate significant revenues or ever achieve profitability. We have incurred losses in each year since we commenced operations
in December 2014. We incurred net losses of approximately $12.3$7.8 million and approximately $7.8$12.3 million for the years ended December 31, 2024,
2025, and 2023,2024, respectively. As of December 31, 2024,2025, we had an accumulated deficit of approximately $65.7$73.2 million. The size of our
future net losses will depend, in part, on our future expenses and our ability to generate revenue, if any. Revenue from our current
and potential future collaborations is uncertain because milestones or other contingent payments under our agreements may not be achieved
or received.
As
of December 31, 2024,2025, we had capital resources consisting of cash and cash equivalents of $3.2$7.5 million. We will continue to expend substantial
cash resources for the foreseeable future for the clinical development of our product candidatesproducts and developmentcommercial launches of anyour other indications and product candidates we may choose to pursue.products. These expenditures
will include costs associated with research and development, conducting preclinical studies and clinical trials, manufacturing and supply, as well as marketing and selling any products approved for sale. In particular, our Phase 3 clinical studies for our product candidates will require substantial funds to complete. Because the conduct and results of any clinical trial are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of our current and any future product candidates.products.
We
will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete
the development and commercialization of our product candidates.products.
We
believe that our existing cash, together with interest thereon, will be sufficient to fund our operations into the thirdfirst quarter of 2025. 2027.
We have based these estimates, however, on assumptions that may prove to be wrong, and we could spend our available capital resources
much faster than we currently expect or require more capital to fund our operations than we currently expect. OurWe currentlyestimate that our existing
cash will cover the anticipated expenditures for the development of our product candidates, XYNGARI™ and DMT410,commercial exceedlaunch of our existingTome cash.Foundational WeTreatment,
but willwe may need to raise additional capital to fund our operations and continue to support our planned development and commercialization activities.
If
we are unable to raise additional capital when required or on acceptable terms, we may be required to significantly delay, scale back
or discontinue the development or commercialization of one or more of our product candidates,products, restrict our operations or obtain funds by entering
into agreements on unattractive terms, which would likely have a material adverse effect on our business, stock price and our relationships
with third parties with whom we have business relationships, at least until additional funding is obtained. If we do not have sufficient
funds to continue operations, we could be required to seek bankruptcy protection or other alternatives that would likely result in our
stockholders losing some or all of their investment in us. In addition, our ability to achieve profitability or to respond to competitive
pressures would be significantly limited.
We will need to raise additional capital which may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates, and additional capital may not be available on favorable terms or at all which may force us to delay, reduce the scope of or eliminate our research and development programs, reduce our commercialization efforts or curtail our operations.
To develop and bring our product candidates to market, we must commit substantial resources to costly and time-consuming research, preclinical studies and clinical trials and marketing activities. Until such time, if ever, as we can generate substantial product revenue, we expect to seek additional funding to meet our operational needs and capital requirements. While we believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements through the third quarter of 2025, we have based this estimate on assumptions that may prove to be wrong and we could exhaust our available capital resources sooner than we expect, including if our business or operations change in a manner that consumes available resources more rapidly than we anticipate. Our requirements for additional capital will depend on many factors including:
Our ability to continue operations after our current cash resources are exhausted depends on our ability to obtain additional financing or to achieve profitable operations, as to which no assurances can be given. Cash requirements may vary materially from those now planned because of changes in direction of our research and development programs, competitive and technical advances, patent developments, regulatory changes or other developments. If additional sources of financing are not available on favorable terms, or at all, including as a result of actions taken by central banks to counter inflation, volatility in the capital markets, liquidity concerns at and failures of banks and other financial institutions and related market uncertainty, or if we are unsuccessful in entering into partnership agreements for further development of our pipeline, management may need to curtail our development efforts and planned operations to conserve cash.
We expect to finance our operations through a combination of equity offerings, debt financings, government or private party grants, collaborations, strategic alliances and licensing arrangements. We currently have on file with the SEC a shelf registration statement on Form S-3 which allows us to offer and sell our registered common stock, preferred stock, debt securities and or warrants from time to time pursuant to one or more offerings at prices and terms to be determined at the time of sale. On June 7, 2024, we entered into an At The Market Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), pursuant to which, from time to time, we may offer and sell shares of the common stock registered under the shelf registration statement pursuant to one or more “at the market” offerings. As of December 31, 2024, we have sold $1.7 million in gross proceeds of our Common Stock pursuant to this ATM Agreement, which does not include $0.3 million of compensation to Wainwright, auditors, lawyers, and other administration fees. While we had no remaining capacity to sell shares of common stock under the ATM Agreement as of December 31, 2024, to the extent we have any capacity in the future, any future sales of our common stock under the ATM Agreement with Wainwright could be subject to business, economic or competitive uncertainties and contingencies, many of which may be beyond our control, and which could cause actual results from the sale of our common stock to differ materially from expectations.
To the extent additional capital is raised through the sale and issuance of shares or other securities convertible into shares, the ownership interest of our stockholders will be diluted. Future issuances of our common stock or other equity securities, or the perception that such sales may occur, could adversely affect the trading price of our common stock and impair our ability to raise capital through future offerings of shares or equity securities. No prediction can be made as to the effect, if any, that future sales of common stock or the availability of common stock for future sales will have on the trading price of our common stock.
We do not currently have any other committed external sources of funds. To the extent we raise additional capital through the sale of equity or convertible debt securities, our stockholders’ ownership interest will or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights as a common stockholder. In addition, if we obtain debt financing, a substantial portion of our operating cash flow may be dedicated to the payment of principal and interest on such indebtedness, thus limiting funds available for our business activities. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams or product candidates, grant licenses on terms that may not be favorable to us or commit to future payment streams.
For example, on July 4, 2025, H.R. 1, the “One Big Beautiful Bill Act” (the “OBBBA”) was signed into law in the United States. Among other changes, the OBBBA modifies key business tax provisions, including the restoration of 100% bonus depreciation under Section 168(k) of the United States Internal Revenue Code of 1986, as amended (the “IRC”), the restoration of the immediate deduction of U.S. domestic research and experimental expenditures under Section 174A of the IRC, the restoration of the EBITDA-based business interest expense limitation under Section 163(j) of the IRC, and changes to the computation of taxes related to international operations. Based on our current analysis of these provisions, we do not believe these provisions will have a material impact on our business and our results of operations. However, regulations and other U.S. Internal Revenue Service guidance implementing the OBBBA may give rise to new issues that we did not foresee, and further changes to tax laws may be implemented. Therefore, there can be no assurance that our business will not be adversely affected by the OBBBA or any other tax law changes.
We are exposed to risks related to foreign currency exchange rates.
Some of our costs and expenses are denominated in foreign currencies. Most of our foreign expenses are associated with our supply of our raw material for our XYNGARI™ and DMT410 product candidates. When the United States dollar weakens against the Euro, the United States dollar value of the foreign currency denominated expense increases, and when the United States dollar strengthens against the Euro, the United States dollar value of the foreign currency denominated expense decreases. Consequently, changes in exchange rates, and in particular a weakening of the United States dollar, may adversely affect our results of operations.
Furthermore,
inflation can adversely affect us by increasing the costs of clinical trials, the researchdevelopment and developmentmarketing of our product candidates,products, as well as administration and
other costs of doing business. We may experience increases in the prices of labor and other costs of doing business. In an inflationary
environment, cost increases may outpace our expectations, causing us to use our cash and other liquid assets faster than forecasted.
If this happens, we may need to raise additional capital to fund our operations, which may not be available in sufficient amounts or
on reasonable terms, if at all, sooner than expected.
Disruptions to our distribution operations could adversely affect our ability to deliver our products to consumers and customers.
Our ability to receive inventory and deliver products to distributors, customers, and consumers on a timely basis depends on the proper functioning of our manufacturing, supplier, and distribution operations, and interruptions or delays in these operations could adversely affect our business, results of operations, or financial condition. Distribution disruptions can occur for many reasons, including manufacturing or supplier disruptions, labor disputes or shortages, concentration or insolvency of distributors or logistics providers, site-specific incidents, natural disasters, political unrest, terrorist attacks, cybersecurity incidents, epidemics, pandemics, other unfavorable economic or market conditions, trade embargoes, customs and tax requirements and similar factors, increases in transportation or shipping costs, issues with overseas shipments, reductions in the transportation capacity of carriers, disruptions to transportation infrastructure, and other unexpected delivery interruptions or delays. We are also subject to risks of damage to, or loss of, our products while they are stored in our warehousing facilities or being delivered by our shipping vendors. Distributors, customers, and consumers rely on timely receipt of our products and any repeated, intermittent or long-term disruption to, or failure of, the operations of our warehousing and distribution facilities could lead to lower sales and profitability, excess inventory, reputational damage or loss of loyalty to our brands. In addition, as we continue to grow our business, we may need to continue to update or expand our warehousing and distribution facilities, which may require significant amounts of capital, or engage additional third-party distributors and shipping vendors, which may increase the risks to our business associated with reliance on third parties.
In
addition, the global macroeconomic environment could be negatively affected by, among other things, public health emergencies, pandemics
or epidemics, instability in global economic markets, increased U.S. trade tariffs and trade disputes with other countries and any resulting
trade wars, instability in the global credit markets, supply chain weaknesses, instability in the geopolitical environment as a result
of the withdrawal of the United Kingdom from the European Union, the Russianwar invasionbetween ofRussia and Ukraine, the ongoing conflicts in the Middle
East, and other political tensions, and foreign governmental debt concerns. Such challenges have caused, and may continue to cause, uncertainty
and instability in local economies and in global financial markets.
Risks related to the skincare industry
Our shift from an Rx regulatory framework to OTC monograph pathways could introduce significant regulatory risks that could delay or prevent product launches, require reformulation or relabeling, restrict indications or target populations, and materially increase costs.
Unlike prescription drugs, OTC products must be shown to be safe and effective for consumer self-selection and self-use without a healthcare professional’s supervision. For products marketed under the OTC monograph system (implemented through FDA administrative orders), our products must meet all applicable conditions for “generally recognized as safe and effective” (“GRASE”), including specific active ingredients, indications, strengths, dosage forms, dosing intervals, age ranges, warnings, and Drug Facts Labeling. If any aspect of our product(s)—such as an active ingredient, indication, combination of actives, strength, dosage form, route of administration, dosing directions, or age range—falls outside the applicable monograph conditions, we may be required to reformulate, relabel, narrow the intended population or indications, or submit a request for an amended administrative order supported by additional data. FDA may decline to modify the relevant administrative order, require more data than we anticipate, or take longer than expected to act on a request, any of which could delay launches or prevent us from marketing the product as designed. Evolving FDA orders or compliance sweeps, including changes to impurity limits (such as nitrosamines), new contraindications or age restrictions, or additional warnings, can also emerge late in development and force unplanned reformulation, relabeling, or withdrawal—resulting in write-offs of packaging or finished goods, extensions of stability programs, and missed commercialization timelines.
While we were pursuing XYNGARI as a prospective candidate for approval under the FDA New Drug Application process, we have since withdrawn the investigational new drug application for XYNGARI and no longer consider it an investigational product. While we believe that our prospective OTC acne kit is distinct from XYNGARI and will comply with the applicable OTC monograph, a form of our Bioneedle and H2O2 will be included as inactive ingredients in our OTC acne kit with no therapeutic claims. If the FDA determines that either or both substances are active ingredients in our OTC acne kit, our OTC acne kit will not fit within the OTC monograph and we may have to reformulate the kit or could be subject to enforcement action for marketing an unapproved new drug, which could result in consequences, including, but not limited to, a warning letter, product seizure, and/or civil or criminal penalties.
For products that do not fit within an OTC monograph or for which we seek novel claims, actives, or conditions of use, we may pursue an OTC NDA. OTC NDAs generally require consumer behavior evidence that differs from Rx approvals, including label comprehension, self-selection, and, in many cases, actual use studies, as well as human factors and packaging usability validation. If study participants misinterpret labeling, fail to self-select appropriately, make dosing errors, or misuse the product, we may need multiple iterative cycles of label revisions, packaging or device redesign, and retesting. The FDA may also require additional clinical or post marketing safety data to support broader, unsupervised consumer use; impose narrower indications, higher minimum ages, or dosing restrictions; or convene advisory committee review—all of which can delay approval or materially diminish the commercial viability of the product.
Any of these regulatory dynamics—alone or in combination—could delay or prevent product launches, require us to reformulate, relabel, restrict indications or target populations, write off inventory and packaging, expand study programs, or incur greater user fees and manufacturing costs. If we are unable to timely secure applicable administrative orders or if chosen, OTC NDA approvals, on commercially acceptable terms, or if we must significantly alter our products, labeling, or packaging to meet OTC requirements, our development timelines, revenue prospects, operating margins, inventory levels, and relationships with customers and channel partners could be materially adversely affected.
The skincare industry is highly competitive, and if we are unable to compete effectively, our results will suffer.
The skincare industry is highly competitive and can rapidly change due to consumer preferences and industry trends, such as the expansion of digital channels, DTC channels, new “disruptor” brands, and advances in technology such as artificial intelligence (“AI”). We face vigorous competition from companies throughout the world, including large multinational consumer products companies that have many skincare brands under ownership and standalone skincare brands, including those that may target the latest trends or specific distribution channels. Competition in the skincare industry is based on the introduction of new products, pricing of products, quality of products and packaging, brand awareness, perceived value and quality, innovation, in-store presence and visibility, promotional activities, advertising, editorials, e-commerce and mobile-commerce initiatives and other activities. We must compete with a high volume of new product introductions as well as existing products by diverse companies across several different distribution channels.
Many of the multinational consumer companies that we compete with have greater financial, technical or marketing resources, longer operating histories, greater brand recognition or larger customer bases than we do and may be able to respond more effectively to changing business and economic conditions than we can. Our competitors may attempt to gain market share by offering products at prices at or below the prices at which our products are typically offered, including through the use of large percentage discounts. Competitive pricing may require us to reduce our prices, which would decrease our profitability or result in lost sales. Our competitors may be better able to withstand these price reductions and lost sales.
It is difficult to predict the timing and scale of our competitors’ activities or whether new competitors will emerge in the skincare industry. In recent years, numerous online, “indie” and influencer-backed beauty health companies have emerged and garnered significant followings. Further technological breakthroughs, including new and enhanced technologies that increase competition in the online retail market, new product offerings by competitors and the strength and success of our competitors’ marketing programs may impede our growth and the implementation of our business strategy.
Our ability to compete depends on the continued strength of our brand and products, the success of marketing, innovation and execution strategies, the continued diversity of product offerings, the successful management of new product introductions and innovations, strong operational execution, including in order fulfillment, and success in entering new markets and expanding our business in existing geographies. If we are unable to continue to compete effectively, it could have a material adverse effect on our business, financial condition and results of operations. For more information about the competition we face, see “Business—Competition.”
Our business is dependent on the commercial success and our ability to launch and sell Tome skincare products, including our Foundational Treatment. If we are unable to successfully launch, commercialize and sell our Foundational Treatment, our results of operations and financial condition will be materially harmed.
Our business and our ability to generate revenue largely depends on our ability to successfully launch, commercialize and sell our Tome Foundational Treatment. Our ability to generate revenue depends on our ability to manufacture and sell high quality, reliable Foundational Treatment and execute on our commercialization plans, and the size of the market for, and the level of market acceptance of, our Foundational Treatment. If our Foundational Treatment are not accepted and adopted by our customers, our revenue and results of operations will be materially and adversely affected.
Our new product launch may not be as successful as we anticipate.
The skincare industry is driven in part by beauty and skincare trends, which may shift quickly. Our continued success depends on our ability to anticipate, gauge and react in a timely and cost-effective manner to changes in consumer preferences for skincare products, consumer attitudes toward our industry and brand, and where and how consumers shop for and use these products. We must continually work to develop, produce and market new products, maintain and enhance the recognition of our brand, maintain a favorable mix of products, and develop our approach as to how and where we market and sell our products.
We have established a process for the development, evaluation and validation of our new product concepts. Nonetheless, each new product launch involves risks, as well as the possibility of unexpected results. For example, the acceptance of new product launches and sales to our consumers may not be as high as we anticipate, due to lack of acceptance of the products themselves or their price, or limited effectiveness of our marketing strategies. In addition, our ability to launch new products may be limited by delays or difficulties affecting the ability of our suppliers or manufacturers to timely manufacture, distribute and ship new products. We may also experience a decrease in sales of certain existing products as a result of newly launched products.
Risks Related to Development, Regulatory Approval and Commercialization
Our business is dependent on the successful development, regulatory approval and commercialization of our product candidates, in particular XYNGARI™ and DMT410.
Our portfolio of product candidates includes one late-stage product candidate, XYNGARI™, a once weekly topical, naturally derived product candidate for the treatment of acne and psoriasis, and an early-stage candidate, DMT410, a combination treatment regimen to aid in the topical delivery of botulinum toxin for the treatment of hyperhidrosis and aesthetic skin conditions. The success of our business, including our ability to finance our company and generate any revenue in the future, will primarily depend on the successful development, regulatory approval and commercialization or partnering of our product candidates. In the future, we may also become dependent on just one of our product candidates or any future product candidates that we may in-license, acquire or develop. The clinical and commercial success of our product candidates will depend on a number of factors, including the following:
If we are unable to achieve one or more of the above factors, many of which are beyond our control, in a timely manner or at all, we could experience significant delays and increased costs or an inability to obtain regulatory approvals or commercialize our product candidates. Even if regulatory approvals are obtained, we may never be able to successfully commercialize any of our product candidates. Accordingly, we cannot assure you that we will be able to generate sufficient revenue through the sale of our product candidates or any future product candidates to continue operations.
Clinical drug development for our product candidates is very expensive, time-consuming and uncertain. Our clinical trials may fail to adequately demonstrate the safety and efficacy of our product candidates, which could prevent or delay regulatory approval and commercialization.
Clinical drug development for our product candidates is very expensive, time-consuming, difficult to design and implement and its outcome is inherently uncertain. Before obtaining regulatory approval for the commercial sale of a product candidate, we must demonstrate through clinical trials that a product candidate is both safe and effective for use in the target indication, which is impossible to predict. Most product candidates that commence clinical trials are never approved by regulatory authorities for commercialization. Our product candidates are in various stages of development and a failure of one more clinical trials can occur at any stage of testing or at any time during the trial process. We expect that clinical trials for these product candidates will continue for several years, but may take significantly longer than expected to complete.
We have not completed all clinical trials for the approval of any of our product candidates. In previous communications with the FDA they had asked us to show that hydrogen peroxide was not an active ingredient in our XYNGARI™ product. While FDA did not require us to test hydrogen peroxide as a third arm in our current XYNGARI™ Phase 3 clinical program, they may ask for additional evidence to support our belief that hydrogen peroxide is not an active ingredient in our XYNGARI™ product. If we fail to convince the FDA that hydrogen peroxide is not an active ingredient and merely a fluidizing agent, then we may have to alter our clinical plans or reformulate our product based on FDA feedback. If we chose to reformulate our lead product candidate, XYNGARI™, then we may decide to redo our Phase 2 and Phase 3 studies, which would be time consuming and expensive and there is no certainty of success.
We may experience delays in ongoing and future clinical trials for our product candidates and do not know if future clinical trials, if any, will begin on time, need to be redesigned, enroll adequate number of patients on time or be completed on schedule, if at all. In addition, we, any partner with which we currently or may in the future collaborate, the FDA, an IRB or other regulatory authorities, including state and local agencies and counterpart agencies in foreign countries, may suspend, delay, require modifications to or terminate our clinical trials at any time, for various reasons, including:
In the case of our topical product candidates, we are seeking to deliver sufficient concentrations of the active pharmaceutical ingredient, or API, through the skin barrier to the targeted dermal tissue to achieve the intended therapeutic effect. As a result, safety and efficacy can be difficult to establish. The topical route of administration may involve new formulations and dosage forms, which can be difficult to develop and manufacture and may raise novel regulatory issues and result in development or review delays. For example, the API for XYNGARI™ is a milled sponge powder, and we are not aware of previous FDA approvals of sponges as a prescription drug.
We or any partner with which we may collaborate may suffer significant setbacks in our clinical trials similar to the experience of a number of other companies in the pharmaceutical and biotechnology industries, even after receiving promising results in earlier trials. In the event that we or our potential partners abandon or are delayed in the clinical development efforts related to our product candidates, we may not be able to execute on our business plan effectively and our business, financial condition, operating results and prospects would be harmed.
Moreover, the development of our product candidates may be delayed by other events beyond our control. For example, action by the Trump administration to limit federal agency budgets or personnel, may result in reductions to the FDA’s budget, employees, and operations, which may lead to slower response times and longer review periods, potentially affecting our ability to progress development of our product candidates or obtain regulatory approval for our product candidates.
Our industry is subject to extensive regulatory obligations and policies that may be subject to change, including due to judicial challenges.
The U. S. pharmaceutical industry is highly regulated and subject to frequent and substantial changes, including as a result of new judicial or governmental actions. Legislative and regulatory agendas as they relate to the pharmaceutical industry are currently uncertain. Changes in the regulatory approval process, or substantial reductions in the personnel who oversee that process, could affect our ability to obtain regulatory approval for our product candidates or the timeline in which we can obtain that approval. We and/or our current and future third party collaborators may rely on government programs or agencies, such as the National Institutes for Health (“NIH), as a source of grant funding for scientific research relevant to our product candidates. Funding from government agencies such as the NIH can fluctuate and is subject to the political process, which is often unpredictable. Reductions in NIH grants to us or our third party collaborators may adversely impact our ability to develop our existing product candidates and our ability to identify new product candidates. In addition, on June 28, 2024, the U.S. Supreme Court issued an opinion holding that courts reviewing agency action pursuant to the Administrative Procedure Act “must exercise their independent judgment” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.” The decision could have a significant impact on how lower courts evaluate challenges to agency interpretations of law, including those by the FDA and other agencies with significant oversight of the pharmaceutical industry. The new framework may increase both the frequency of such challenges and their odds of success by eliminating one way in which the government previously prevailed in such cases. As a result, significant regulatory policies could be subject to increased litigation and judicial scrutiny. We cannot predict how other future federal or state legislative or administrative changes relating to healthcare reform or the pharmaceutical industry, or the regulatory agencies that oversee the pharmaceutical industry, will affect our business.
We face risks related to public health emergencies, epidemics and other outbreaks of communicable diseases, which could significantly disrupt our operations, including our clinical trials and preclinical studies, and adversely affect our business and results of operations.
Public health crises, could have an adverse effect our business. Quarantines, travel restrictions and other public health and safety measures implemented in response to a pandemic, including a resurgence of COVID-19, could adversely impact our operations, and the ultimate impact is highly uncertain and cannot be predicted with confidence. Effects of a pandemic, including a resurgence of COVID-19, that may delay or otherwise adversely affect our ongoing and planned preclinical activities, our planned clinical trials as well as our business generally, include:
Any of these effects, and other effects of a pandemic, including a resurgence of COVID-19, could have a material adverse effect on our business, financial condition, results of operations and prospects. Further, uncertainty around these and related issues could lead to adverse effects on the economy of the United States, Canada, and other economies, which could impact our ability to raise the necessary capital needed to develop and commercialize our programs and product candidates.
Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
As product candidates proceed through preclinical studies to late-stage clinical trials towards potential approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause our product candidates to perform differently and affect the results of planned clinical trials or other future clinical trials conducted with the altered materials. Such changes may also require additional testing, FDA notification or FDA approval. This could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials.
Approval may be delayed or denied because we cannot satisfy FDA’s Chemistry, Manufacturing and Control Requirements.
Formulation and manufacturing of drugs is another important step in development. Our applications must include information about the chemistry and physical characteristics of our products, and we must demonstrate that we have a reliable process for manufacturing the products in commercial quantities in accordance with FDA’s current Good Manufacturing Practices (“cGMP”) requirements. The manufacturing process must consistently produce quality batches of the product, and, among other things, the manufacturer must develop methods for testing the identity, strength, quality, and purity of the final product. In addition, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate the effectiveness of the packaging and that the compound does not undergo unacceptable deterioration over its shelf life. If we are unable to successfully complete any of these complex steps, approval of our product candidates may be delayed or denied.
We may be unable to obtain regulatory approval for XYNGARI™, or our other early-stage product candidates under applicable regulatory requirements. The FDA and foreign regulatory bodies have substantial discretion in the approval process, including the ability to delay, limit or deny approval of product candidates. The delay, limitation or denial of any regulatory approval would adversely impact commercialization, our potential to generate revenue, our business and our operating results.
We currently have no products approved for sale, and we may never obtain regulatory approval to commercialize any of our current or future product candidates. The research, testing, manufacturing, safety surveillance, efficacy, quality control, recordkeeping, labeling, packaging, storage, approval, sale, marketing, distribution, import, export, and reporting of safety and other post-market information related to our drug products are subject to extensive regulation by the FDA and other regulatory authorities in the United States and in foreign countries, and such regulations differ from country to country. We are not permitted to market any of our current product candidates in the United States until we receive approval of a new drug application, or NDA, or other applicable regulatory filing from the FDA. We are also not permitted to market any of our current product candidates in any foreign countries until we or our partners receive the requisite approval from the applicable regulatory authorities of such countries.
Management's Discussion & Analysis (MD&A)
New heading “Comparison of the Years Ended December 31, 2025, and 2024”
New heading “Selling, General and Administrative Expenses”
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Removed heading “Comparison of the Years Ended December 31, 2024, and 2023”
Largest changes
“Our second product candidate utilizing our Spongilla technology is DMT410. DMT410 is intended to consist of one treatment of our proprietary sponge powder followed by one topical application of botulinum toxin for delivery into the dermis. Currently, botulinum toxin is only approved to be delivered to the dermis by intradermal injections, which can be painful for the patient and time-consuming for the physician. …”see in full comparison
“We anticipate that we will continue to incur net losses for at least the next twelve months from the date of this filing. While we plan to launch our first DTC product in mid-2026, it is uncertain when we will generate operating income to sustain operations. These factors raise substantial doubt about our ability to continue as a going concern for the one-year period following the date that these financial statements were issued.”see in full comparison
“Our lead product candidate, XYNGARI™, is intended to utilize our Spongilla technology for the once weekly treatment of a variety of skin diseases, with our initial focus being the treatment of acne, which has a U.S. market size of approximately 30 million patients seeking treatment. In November 2024, we completed patient enrollment in the first of two Phase 3 clinical trials of XYNGARI™ in moderate-to-severe acne. We expect to receive top-line results from the first Phase 3 trial in March 2025. …”see in full comparison
“Our weekly Bioneedle treatment, aimed to help refine the appearance of a consumer’s skin will be used alongside a daily salicylic acid wipe to help fight the acne lesions. We believe the unique attributes of our clearing treatment used in tandem with an OTC monograph active ingredient (salicylic acid) could produce a superior OTC product unlike anything currently on the market. …”see in full comparison
Full comparison: every changed paragraph (69)
We are a scientific leader in skincare, dedicated to the development and commercialization of products that address common and underserved skin conditions. Dermata initially was founded with a focus on researching and developing prescription products subject to the FDA approval process. As part of this focus, we had one lead asset, referred to as XYNGARI, also known as DMT310, which we had been studying in clinical trials for the treatment of moderate-to-severe acne. In March 2025, we announced that we achieved statistically significant results from our Phase 3 STAR-1 clinical trial of XYNGARI, formerly our lead prescription (“Rx”) candidate incorporating our Spongilla lacustris for moderate-to-severe acne. XYNGARI demonstrated statistically significant results across all three co-primary endpoints at weeks 4, 8, and 12 when compared with placebo. Following the successful completion of the STAR-1 trial, we conducted a full assessment of the Rx acne landscape and the future Rx acne development pathway for XYNGARI. In September 2025, after an extensive review of current trends in dermatology, changing consumer preferences, additional non-clinical and clinical development costs, and go-to market costs for an Rx acne product, management, with support from our board of directors, determined that a strategic shift to developing and distributing DTC and B2B skincare products, that are backed by science, would be a better path to commercialization with potentially greater financial upside and faster time to market. We believe we can leverage our history and knowledge of Rx dermatology to create skincare products that are effective and safe, and available to consumers without the nuisance of obtaining a prescription. We believe this strategic repositioning will accelerate our path to commercialization, reduce our regulatory burden, and decrease development expenses, all while enabling us to address broad consumer segments in the skincare market.
We believe the skincare market, from a cosmetic, OTC, and Rx perspective, has seen a substantial shift towards consumers first relying upon multifaceted cosmetics and OTC products that simplify routines. Consumer preferences are changing to favor natural products that do more for their skin. There appears to be a resurgence of interest in traditional remedies to treat various conditions. We have also seen an increasing trend towards the use of OTC treatments for common skin diseases such as acne vulgaris (or “acne”), psoriasis vulgaris (or “psoriasis”), and acne rosacea (or “rosacea”). The causes, symptoms, and treatments for common skin issues, like acne, have over 50 million patients in the U.S., and are well researched by consumers due to the extensive publicly available information. Thus, we believe consumers are more willing to conduct and trust their own research and treat these diseases with OTC offerings prior to seeing a dermatologist. Over 70% of patients with acne first choose to try multiple OTC products to treat their acne before seeing a dermatologist. However, many of the currently available OTC acne products are mildly effective and have many tolerability issues that result in poor patient compliance. Consumers with acne that do not get satisfactory results, either due to lack of efficacy or tolerability issues, typically wait about one year before scheduling a visit with a dermatologist to seek alternative therapies. Additionally, due to the cost-effective pricing of OTC products, as compared to Rx products, a desire for self-administration, difficulty getting appointments with dermatologists, or insurance coverage for branded Rx products, many consumers are first relying on OTC products to fill their treatment needs. We believe that if we can provide consumers with a unique topical acne treatment, we have an opportunity to capture a large segment of acne patients prior to them seeking Rx products through a physician. While this is a major shift in strategy for our company, we believe pursuing the commercial sale of both cosmetic and OTC skincare products is the best path forward to meet our mission of providing consumers with efficacious and safe skincare treatment options.
We view this shift in consumer preferences as a significant benefit for our strategic repositioning. We have gained substantial clinical knowledge of various dermatology diseases and skin conditions. We plan to leverage this knowledge to create a whole product line of skincare treatments that consumers can access directly for each of their skincare needs. While our background is in clinical products, we plan to leverage the unique attributes of our hero ingredient, Spongilla lacustris, to develop both cosmetic and OTC skincare treatments. We plan to launch our first cosmetic product in the middle of 2026, with our first OTC acne product to follow shortly thereafter. In the future, we plan to offer additional products that target specific needs of consumers. For example, for consumers who want to improve the general appearance of their skin we plan to commercialize a once weekly foundational treatment for skin renewal. Consumers suffering from many common forms of acne, we plan to offer our OTC topical acne system. The foundational treatment will utilize our Bioneedle, which is 100% Spongilla lacustris powder, to provide a once weekly skin renewal routine that is simple addition to skincare routines. This kit will contain our Bioneedle which will be combined with a fluidizing agent for easy application.
We are a late-stage medical dermatology company focused on identifying, developing, and commercializing innovative pharmaceutical product candidates for the treatment of medical skin diseases and aesthetic applications we believe represent significant market opportunities.
Dermatological diseases such as acne, psoriasis vulgaris (or psoriasis), hyperhidrosis, and various aesthetic indications, affect millions of people worldwide each year which may negatively impact their quality of life and emotional well-being. While there are multiple current treatment options for these indications on the market, we believe that most have significant drawbacks, including underwhelming efficacy, cumbersome application regimens and varying negative side effects, all of which we believe lead to decreased patient compliance. A majority of these indications are first treated with topical therapy; however, many patients frequently switch treatments or discontinue treatment altogether due to patient dissatisfaction. This is primarily due to slow and modest response rates, early onset of negative side effects, daily application schedules and long duration of therapy. Given the limitations with current topical therapies, we believe there is a significant opportunity to address the needs of frustrated patients searching for topical products that satisfy their dermatological and lifestyle needs.
Our two product candidates, XYNGARI™ and DMT410, both incorporate our proprietary, multifaceted, Spongilla technology to topically treat a variety of dermatological conditions. Our Spongilla technologyBioneedle is derived from a naturallywildly grown freshwater
sponge, Spongilla lacustris or Spongilla, which is processed into a fine, purified powder thatand is mixedpackaged with ano fluidizing agent immediately prior to application to form an easily applicable paste. additives.
Spongilla is a unique freshwater sponge that only grows in commercial quantities in select regions of the world and under specific environmental conditions, all ofworld, which givegives itour
Bioneedle its distinctive anti-microbial, anti-inflammatory,organic and mechanical properties. The combination of these environmental conditions, thea proprietary harvesting protocolsprotocol, developed withby our exclusive
supplier, and ourthe post-harvest processing proceduresprocedures, produce aan pharmaceutical product candidateingredient that we believe optimizes the mechanical componentscomponents, which
are silica microstructures also called spicules, as well as the chemicalorganic components of theSpongilla, spongewhile eliminating any harmful bacteria
that could be found in many freshwater or marine sponges. Keeping our clinical roots in mind, we plan to createoffer aan productacne candidatesystem withthat multiplehas
been mechanismsdermatologist of action for the treatment of inflammatory skin conditions and aesthetic applications.tested.
Our weekly Bioneedle treatment, aimed to help refine the appearance of a consumer’s skin will be used alongside a daily salicylic acid wipe to help fight the acne lesions. We believe the unique attributes of our clearing treatment used in tandem with an OTC monograph active ingredient (salicylic acid) could produce a superior OTC product unlike anything currently on the market. We plan to develop and distribute a variety of cosmetic and OTC products that are backed by science and are easily accessible by consumers who are more comfortable treating their skin problems independently with readily available therapies. Our core values will remain unchanged during this strategic shift as we strive to provide consumers with affordable, safe, and effective treatment options, that can be obtained either through our DTC channels or through healthcare professionals, without having to get a prescription. We believe consumers are seeking greater flexibility and freedom in treating their skin and we believe we can offer them a solution.
In addition to the DTC channel for our products, we believe there is a market for our technology to aid in the intradermal delivery of macromolecules for various aesthetic conditions. Typically, for facial aesthetics, botulinum toxins are injected into facial muscles to reduce forehead, lateral canthal, and glabella deep lines. However, this is limited to the use of intradermal delivery of botulinum toxin for a variety of skin diseases and conditions. Botox is currently the only approved botulinum toxin for the treatment of axillary hyperhidrosis via intradermal injections. While effective, intradermal injections, including 10-15 per axilla, of Botox can be painful for patients and very time consuming for dermatologists. Therefore, we believe developing a less painful, less time-consuming topical delivery of botulinum toxin into the dermis for various aesthetic and medical skin diseases and conditions, would provide physicians with an attractive alternative to intradermal injections of botulinum toxins.
We believe our Bioneedle can increase the number of intradermal uses for botulinum toxin by leveraging the unique microstructure of our Bioneedle, to create microchannels into the dermis, enabling improved dermal penetration of botulinum toxins (i.e. Botox). Additionally, we believe our technology can allow for broader coverage of larger surface areas of the skin, which we believe will provide a better field effect of the botulinum toxin.
We plan to leverage our Bioneedle platform for broad applicability across dermatologic and aesthetic skin conditions, potentially allowing dermatologists and aestheticians to increase the use of botulinum toxin. We believe this non-invasive approach could meaningfully expand the therapeutic and aesthetic utility of botulinum toxin for conditions such as axillary, palmar, and plantar hyperhidrosis, acne, acne scars, rosacea, and improved facial aesthetics (including improvements in skin luminosity and brightness, reducing pore size and number of pores, reducing fine lines, and reducing skin oiliness by decreasing sebum production). We plan to continue to explore additional uses for this platform and look forward to getting our technology in the hands of aestheticians and dermatologists so they may better serve the medical and aesthetic needs of their patients.
We believe our Spongilla technology platform will enable us to develop and formulate singular and combination products that are able to target the topical delivery of chemical compounds into the dermis for a variety of dermatology indications. We believe the combination of Spongilla’s mechanical and chemical components (which we believe have demonstrated, in-vitro, anti-microbial and anti-inflammatory properties), add to the versatility of our Spongilla technology platform’s effectiveness as a singular product, in the treatment of a wide variety of medical skin diseases like acne and psoriasis. We also believe the mechanical properties of our Spongilla technology allows for the intradermal delivery of a variety of large molecules, like botulinum toxins, monoclonal antibodies, or dermal fillers, to target treatment sites, through topical application without the need for needles.
Our lead product candidate, XYNGARI™, is intended to utilize our Spongilla technology for the once weekly treatment of a variety of skin diseases, with our initial focus being the treatment of acne, which has a U.S. market size of approximately 30 million patients seeking treatment. In November 2024, we completed patient enrollment in the first of two Phase 3 clinical trials of XYNGARI™ in moderate-to-severe acne. We expect to receive top-line results from the first Phase 3 trial in March 2025. Both Phase 3 studies will be double blinded, randomized, placebo controlled, and enroll about 550 patients, age 9 years or older across sites in the United States and Latin America. The primary endpoints include absolute reduction in inflammatory and noninflammatory lesions and the improvement in investigators global assessment (IGA) of acne. Patients will be treated once a week for 12 weeks with either XYNGARI™ or placebo and will be evaluated monthly. As requested by the FDA, the second Phase 3 study will be followed by an extension study to follow patients for a 12-month total treatment period. Previously XYNGARI™ has shown its ability to treat the multiple causes of acne in a Phase 2b study where we initially saw a 45% reduction in inflammatory lesions after four treatments, with XYNGARI™ achieving statistically significant improvements at all time points for all three primary endpoints throughout the study (reduction in inflammatory lesions, reduction in non-inflammatory lesions, and improvement in IGA). In addition, based on the multiple mechanisms of action and anti-inflammatory effect seen with the XYNGARI™ acne trial, we completed a Phase 1b proof of concept, or POC, trial in psoriasis where we saw encouraging results warranting further investigation upon receipt of adequate funds.
XYNGARI™ consists of two grams of powder processed from the naturally grown freshwater sponge, Spongilla lacustris. The patient mixes the powder with a fluidizing agent (3% hydrogen peroxide) immediately prior to application by the patient to form an easy-to-apply paste. The paste is applied like a mud mask and is left on the skin for approximately ten to fifteen minutes, after which time it is washed off with water. Due to the unique combination of XYNGARI™’s mechanical components and chemical components, and based on our Phase 2 acne data, we believe patients will only need to apply XYNGARI™ once weekly to produce the desired treatment effect. The mechanical components of the Spongilla powder consist of many microscopic siliceous, needle-like spicules that, when massaged into the skin, penetrate the stratum corneum (the skin’s outermost protective layer) and create microchannels into the dermis where pro-inflammatory cytokines and bacteria reside. We believe that the penetration of the spicules also leads to the opening of microchannels, which allow oxygen to enter pilosebaceous glands, helping to kill C. acnes, which grow in an anaerobic (without oxygen) environment C. acnes is the bacteria that cause inflammatory lesions in acne patients). The spicules also cause rejuvenation of the top layer of dead skin, thereby increasing collagen production. Additionally, we believe the newly created microchannels provide a conduit for XYNGARI™’s naturally occurring chemical compounds to be delivered to the dermis and pilosebaceous glands, helping to kill the C. acnes and fight inflammation. In addition to these anti-microbial compounds, XYNGARI™ also appears to have anti-inflammatory chemical compounds, as demonstrated in in vitro experiments, that inhibit inflammation through the reduction of C.acnes stimulated IL-8 production and by inhibiting IL-17A and IL-17F expression in human cell lines. Also, during in vitro studies of XYNGARI™’s organic compounds, we observed the inhibition of the lipogenesis of sebocytes, which may translate to a reduction in sebum (an oily and waxy substance produced by the human body’s sebaceous glands) production and the oiliness of the skin in patients, which was observed by a number of clinical investigators in our Phase 2 acne studies. We believe the combination of these biological and mechanical effects could be important factors in treating multiple inflammatory skin diseases, as seen in our clinical trials.
Our second product candidate utilizing our Spongilla technology is DMT410. DMT410 is intended to consist of one treatment of our proprietary sponge powder followed by one topical application of botulinum toxin for delivery into the dermis. Currently, botulinum toxin is only approved to be delivered to the dermis by intradermal injections, which can be painful for the patient and time-consuming for the physician. However, we believe DMT410’s ability to topically deliver botulinum toxin into the dermis could have similar levels of efficacy to existing delivery techniques, with fewer tolerability issues, and a quicker application time, possibly replacing the need for intradermal injections. We first tested DMT410 in a Phase 1 POC trial of axillary hyperhidrosis patients, which saw 80% of patients achieve a reduction in gravimetric sweat production greater than 50% four weeks after a single treatment. With almost 40% of the hyperhidrosis market currently being treated with intradermal injections of botulinum toxin, we believe there could be significant opportunity for DMT410 to break into this market and replace intradermal injections of botulinum toxin. Based on DMT410’s ability to effectively deliver botulinum toxin to the dermis as observed in the Phase 1 axillary hyperhidrosis trial, we also conducted a Phase 1 POC trial of DMT410 for the treatment of multiple aesthetic skin conditions, including reduction of pore size, sebum production, and fine lines, among others. In November 2021, we announced top-line results from this trial, where we saw promising data that we believe warrants further investigation of DMT410. In January 2025, we entered into the Clinical Trial Agreement with Revance pursuant to which we in collaboration with Revance intend to conduct a multi-center Phase 2 clinical trial to evaluate the topical application of XYNGARI™, with DAXXIFY® (daxibotulinumtoxinA-lanm), Revance’s botulinum toxin type A, for the treatment of axillary hyperhidrosis.
We
have a limited operating history. Since our inception, our operations have focused on developing XYNGARI™ and DMT410, organizing
and staffing our company, raising capital, establishing our supply chain and manufacturing processes, further characterizing the multiple
mechanisms of action of our Spongilla technology,lacustris, building an intellectual property portfolio, and conducting non-clinical and clinical
trials. We do not have any productcommercial candidates approved for marketingproducts and have not generated any revenue from product sales. We have funded our operations primarily
through the sale of our equity securities and debt securities. Since inception, we have raised an aggregate of approximately $68.8$82.0 million
of gross proceeds from the sale of our debt and equity securities, including the securities sold in our initial public offering.
We
have not generated any revenue to date and have incurred significant operating losses. Our net losses were $12.3$7.6 million and $7.8$12.3 million
for forthe years ended December 31, 2024,2025, and 2023,2024, respectively, and as of December 31, 2024,2025, we had an accumulated deficit of $65.7$73.2 million.
We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses
will increase significantly in connection with our ongoing activities, as we:
Revenue
We have not generated any revenue since inception and do not expect to generate any revenue from the sale of products in the near future until we obtain regulatory approval of, and commercialize, our product candidates.
While research and development activities had been central to our business model, in September 2025, we made a strategic shift from researching and developing prescription products to becoming a science-driven leader in dermatologic solutions anticipating the launch of our first DTC product in mid-2026. Research and development costs primarily consist of salaries and related expenses for personnel, stock-based compensation expense, external research and development costs to conduct clinical studies, costs related to compliance with regulatory requirements, costs related to procuring components, manufacturing, and packaging our products, outsourced laboratory services, and other allocated expenses. In addition, there are numerous unknown expenses related to the commercialization of our products including continued OTC regulatory requirements, many of which cannot be determined with accuracy at this time. We expense research and development costs as incurred.
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of late-stage clinical trials. We expect research and development costs to increase significantly for the foreseeable future as our pipeline of product candidates progress further into clinical trials. However, we do not believe it is possible at this time to accurately project total program-related expenses to reach commercialization based on numerous factors. In addition, there are numerous unknown expenses related to the commercialization of our product candidates including continued regulatory requirements, many of which cannot be determined with accuracy at this time.
Research and development expenses consist of expenses incurred in connection with the development of our product candidates. We expense development costs as incurred. These expenses include:
The
successful development and commercialization of our product candidatesproducts is highly uncertain. At this time, we cannot reasonably estimate or know the nature,
timing and costs of the efforts that will be necessary to completegenerate therevenue remainderfrom ofour the development of,products, or when, if ever, material net cash inflows
may commence from our product candidates.products. This uncertainty is due to the numerous risks and uncertainties associated with thelaunching durationour first products
including our ability to secure contracts with key vendors with favorable terms, if ever, and costour ofability clinicalto trials,build whichinventory varyto significantlysupport
commercial oversales, theif life of a project as a result of many factors, including:any.
Our
expenditures are subject to additional uncertainties, including the terms and timing of regulatoryexpenditures approvals,in designing, packaging and manufacturing
our first products, and the expense of filing, prosecuting, defending, and enforcing any patent claims or other intellectual property
rights. We may never succeed in achieving regulatory approval for our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay, or modify clinical trials of our product candidates. A change in the outcome of any of these variables with respect to the development of aour product candidateproducts could mean a significant change
in the costs and timing associated with the development of thatour productproducts candidate. For example, ifor the FDAtiming or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in anydiscontinuation of our clinicalproduct trials, we could be required to expend significant additional financial resources and time on the completion of clinical development. Product commercialization will take several years and millions of dollars in development costs.launch.
Selling, General and Administrative Expenses
GeneralSelling,
general and administrative expenses consist principally of salaries and related costs for personnel in executiveexecutive, marketing, and administrative
functions, travel expenses and recruiting expenses. Other general and administrative expenses include stock-based compensation expenses, marketing expenses, professional fees for legal, accounting and tax related services, insurance
costs, as well as payments made to consultants. We expense all selling, general and administrative expenses as incurred.
We
anticipate that our selling, general and administrative expenses will increase as a result of increased marketing and advertising expenses
as we prepare to launch our first products, increased employee payroll, expanded infrastructure and highergreater consulting,consulting costs, legal and
tax related services associated with maintaining compliance with stock exchange listing and SEC requirements, accounting and investor
relations costs, and director and officer insurance premiums associated with being a public company.
Our expenditures are subject to additional uncertainties, including uncertainty around the number of employees or consultants we may need to support the launch of our first commercial products, if ever. We may not be able to build a sustainable infrastructure to support the operations, accounting, and revenue recognition of any commercial sales, if any. We may obtain unexpected results from our marketing studies, and we may elect to discontinue, delay, or modify the marketing studies of our products. It is result of these many variables that we are unable to estimate the expected increases in selling, general and administrative expenses.
Critical
Accounting Policies and Significant Judgments and Estimates
We have based our management’s discussion
and analysis of financial condition and results of operations on our financial statements, which have been prepared in accordance with
accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimatesestimates,
judgments, and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements as well
as the reported expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments,judgments includingthat thoseare related to accrued research and development expenses and warrants. We base our estimatesbased on
historical experience and on various other factorsassumptions that we believe to be appropriatereasonable under the circumstances. The result of these evaluations
forms the basis for making judgments about the carrying values of assets and liabilities and the reported amount of expenses that are
not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Management considers an accounting estimate to
be critical if it requires a significant level of estimation uncertainty, and changes in the estimate are reasonably likely to have a
material effect on our financial condition or results of operations. While our significant accounting policies are more fully described
in Note 2 to our audited financial statements appearing elsewhere in this Annual Report on Form 10-K, we believe the following critical
accounting policiesestimates are critical todescribe the process of makingmost significant judgments and estimates used in the preparation of our financial statements.
Accrued Research and Development Expenses
As part of the process of preparing our financial statements, we are required to record actual research and development expenses and to estimate accrued research and development expenses, current assets, and other current liabilities. This process involves reviewing open contracts and commitments, communicating with our personnel to identify services that have been performed for us and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accrued research and development expenses, current assets, and other current liabilities as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. Examples of estimated accrued research and development expenses, prepaid assets, and other current liabilities include fees paid to contract manufacturers made in connection with the manufacturing of clinical trials materials and contract research organizations made in connection the performance of clinical trials on our behalf.
We base our expenses related to clinical manufacturing and clinical trials on our estimates of the services performed pursuant to contracts with the entities performing those services on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. Payments under these types of contracts depend heavily upon the successful completion of many separate tasks involved in the manufacturing of drug product and the performance of clinical trials. In the case of clinical trials, a portion of the estimated cost normally relates to the projected cost to treat a patient in the trials, and this cost is recognized based on the number of patients enrolled in the trial. Other indirect costs are generally recognized on a straight-line basis over the estimated period of the study. As actual costs become known to us, we adjust our accruals. To date, our estimates have not differed materially from the actual costs incurred. However, subsequent changes in estimates may result in a material change in our accruals, which could also materially affect our balance sheet and results of operations.
We accrue and expense clinical trial activities performed by third parties based upon estimates of the proportion of work completed over the life of the individual clinical trial and patient enrollment rates in accordance with agreements established with clinical research organizations (“CROs”) and clinical trial sites. We determine the estimates by reviewing contracts, vendor agreements and purchase orders, and through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. However, actual costs and timing of clinical trials are highly uncertain, subject to risks and may change depending upon a number of factors, including our clinical development plan.
We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. If the actual timing of the performance of services or the level of effort varies from the estimate, we will adjust the accrual accordingly. Nonrefundable advance payments for goods and services, including fees for process development or manufacturing and distribution of clinical supplies that will be used in future research and development activities, are deferred and recognized as expense in the period that the related goods are consumed, or services are performed.
Warrants
We perform an assessment of warrants upon issuance to determine their proper classification in the financial statements based upon the warrant’s specific terms, in accordance with the authoritative guidance provided in Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”), and ASC 815-40, Derivatives and Hedging – Contracts in Entity’s Own Equity (“ASC 815-40”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480 and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed in our own Common Stock and whether the warrant holders could potentially require cash settlement of the warrants.
For issued or modified warrants that meet all the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital. For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be liability-classified and recorded at their initial fair value on the date of issuance and remeasured at fair value at each balance sheet date thereafter. We have performed an assessment of all warrants issued and modified and determined that our warrants are equity classified.
Comparison of the Years Ended December 31, 2024, and 2023
The following table summarizes our results of operations for the years ended December 31, 2024, and 2023, respectively:
As part of the process of preparing our financial statements, we are required to record actual research and development expenses and to estimate accrued research and development expenses. This process involves reviewing open contracts and commitments, communicating with our personnel to identify services that have been performed for us, and estimating the level of service performed, and the associated cost incurred, for the service when we have not yet been invoiced or otherwise notified of the actual cost. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. Nonrefundable advance payments for goods and services are deferred and recognized as expense in the period that the related goods are consumed, or services are performed. We make estimates of our accrued research and development expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. Examples of estimated accrued research and development expenses include fees paid to contract manufacturers made in connection with the manufacturing of clinical trials materials and contract research organizations made in connection with the performance of clinical trials on our behalf. We base our expenses related to clinical manufacturing and clinical trials on our estimates of the services performed pursuant to contracts with the entities performing those services on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. Payments under these types of contracts depend heavily upon the successful completion of many separate tasks involved in the manufacturing of drug products and the performance of clinical trials. In the case of clinical trials, we accrue and expense clinical trial activities performed by third parties based upon estimates of the proportion of work completed over the life of the individual clinical trial and patient enrollment rates in accordance with agreements established with clinical research organizations (“CROs”) and clinical trial sites. We determine the estimates by reviewing contracts and through discussions with internal clinical personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. However, actual costs and timing of clinical trials are highly uncertain, subject to risks and may change depending upon a number of factors, including our clinical development plan. If the actual timing of the performance of services or the level of effort varies from the estimate, we will adjust the accrual or prepaid accordingly. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period. To date, our estimates have not differed materially from the actual costs incurred.
Comparison of the Years Ended December 31, 2025, and 2024
The following table summarizes our results of operations for the years ended December 31, 2025, and 2024, respectively:
Research and development expenses increased by approximately $4.1 million from $4.1 million for the year ended December 31, 2023, to $8.2 million for the year ended December 31, 2024. The increase in research and development expense was the result of $4.9 million of increased clinical trial expenses, offset by approximately $0.2 million of decreased non-clinical expenses and approximately $0.6 million in decreased chemistry, manufacturing, and controls, or CMC, expenses. These increases were the result of our efforts dedicated to running the XYNGARI™ Phase 3 STAR-1 clinical trial.
General Research
and AdministrativeDevelopment Expenses
Research and development expenses decreased by approximately $5.3 million from $8.2 million for the year ended December 31, 2024, to $2.9 million for the year ended December 31, 2025. The decrease in research and development expenses primarily resulted from approximately $5.1 million of decreased clinical expenses from our STAR-1 acne study, which was completed during the second quarter of 2025. Other research and development activities, including chemistry, manufacturing and controls, or CMC, and non-clinical expenses also decreased by $0.1 million from the prior year as result of the Company’s pivot to focus on DTC product sales. The remaining decrease in research and development expenses of $0.1 million was related to personnel expenses, reflecting an increase in employee expenses of approximately $0.1 million offset by $0.2 million of decreased stock-based compensation expense. While we plan to initiate a user marketing study in the near term and continue to focus on designing, packaging, and manufacturing of our first products, we anticipate that research and development expenses will not materially increase as we prepare for launching our first products.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by approximately $0.5 million from $4.3 million for the year ended December 31, 2024, to $4.8 million for the year ended December 31, 2025. The increase in selling, general and administrative expenses was primarily attributable to $0.7 million of marketing expenses incurred during the year ended December 31, 2025, offset by approximately $0.2 million of decreased personnel expenses, reflecting an increase in employee expenses of approximately $0.1 million offset by $0.3 million of decreased stock-based compensation expense. We expect selling, general and administrative expenses to continue to increase related to marketing, advertising, and personnel expenses as we continue to prepare for our first product launches in mid-2026.
Interest income
General and administrative expenses increased by approximately $0.3 million from $4.0 million for the year ended December 31, 2023, to $4.3 million for the year ended December 31, 2024. The increase in general and administrative expenses was primarily attributable to $0.3 million of increased audit related fees as a result of changing auditors in late 2023.
Cash used in operations of $7.8 million for the year ended December 31, 2025, was the result of the net loss of approximately $7.6 million and a decrease in accounts payable of $0.4 million, partially offset by non-cash stock-based compensation of $0.1 million.
Cash used in operations of $6.4 million for the year ended December 31, 2023, was the result of the net loss of $7.8 million, offset by non-cash stock-based compensation of $0.5 million, an increase in accounts payable of $0.4 million and an increase in accrued and other current liabilities of $0.3 million, as well as a decrease in prepaid expenses and other current assets of $0.2 million.
Cash provided by financing activities of $12.1 million for the year ended December 31, 2025, was the result of several financings, including the January 2025 PIPE financing which raised net proceeds of approximately $2.2 million, the March 2025 Warrant Inducement financing which raised net proceeds of $5.7 million, the December 2025 PIPE financing which raised net proceeds of approximately $3.8 million, as well as proceeds from the sale of Common Stock from ATM sales during December 2025 which raised net proceeds of approximately $0.4 million.
Cash provided by financing activities of $7.6 million for the year ended December 31, 2023, was the result of $4.2 million of net proceeds received from the issuance of common stock and warrants issued in offering conducted in March 2023, $1.5 million of net proceeds received from the issuance of common stock and warrants in an offering conducted in May 2023, as well as $2.0 million of net proceeds from a warrant inducement offering conducted in November 2023.
Since our inception, we have not generated any revenue or commercialized
any products. As of December 31, 2024,2025, our cash and cash equivalents totaled $3.2$7.5 million, and we had an accumulated deficit of $65.7 $73.2
million. For the yearyears ended December 31, 2024,2025, and 2023,2024, we used cash in operations of approximately $11.1$7.8 million and $6.4$11.1 million,
respectively.
We anticipate that we will continue to incur net losses for at least the next twelve months from the date of this filing. While we plan to launch our first DTC product in mid-2026, it is uncertain when we will generate operating income to sustain operations. These factors raise substantial doubt about our ability to continue as a going concern for the one-year period following the date that these financial statements were issued.
Historically,
our principal sources of cash have included proceeds from the issuance of equity and debt.securities. Our principal uses of cash have includedbeen cash used in operations (including clinical development of our product candidatesfor
operations, and general and administrative expenses) and payments for license rights. Wewe expect that the principal uses of cash in the future will be for continuing operations, marketing and commercialization
activities for skincare products, funding of research and development, and general working capital requirements. We expect that as research and development marketing
expenses continue to grow for our Phase 3 development program,grow, we willmay need to raise additional capital to sustain operations and fund research and development activities, including our ongoing Phase 3 STAR-1 clinical study.operations.
In
June 2024, we entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright &Co., LLC (“Wainwright”),
as sales agent, pursuant to which we may offer and sell, from time to time through Wainwright, shares of our common stock for aggregate
proceeds of up to $1,662,761 (upon the terms and subject to the conditions and limitations set forth in the ATM Agreement). In the twelve
months ended December 31, 2024, we sold 550,02455,001 shares of common stock under the ATM Agreement, for net proceeds of $1.4 million, after
deducting $0.3 million of compensationexpenses, including approximately $126,000 paid to Wainwright,Wainwright auditors,as lawyers,sales and other administration fees.agent.
On November 7, 2025, we filed a prospectus supplement, pursuant to which we may offer and sell, from time to time through sales agent, shares of our Common Stock for aggregate proceeds of $4,159,390 (upon the terms and subject to the conditions and limitations set forth in the ATM Agreement). During December 2025, we sold 149,341 shares of common stock under the ATM Agreement, for net proceeds of $0.4 million, net of the approximately $15,000 fees paid to Wainwright as sales agent, leaving approximately $1.4 million of capacity under the ATM Agreement as of December 31, 2025.
In January 2026, we sold an additional 824,283 shares of our Common Stock under the ATM Agreement resulting in approximately $2.0 million of net proceeds after deducting approximately $67,000 of sales agent issuance costs. We do not have any capacity remaining under the ATM Agreement.
What changed in the latest 10-Q
Risk Factors
New heading “Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock.”
Largest changes
“Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock.”see in full comparison
In connection with the litigation, Villani sought a temporary restraining order (“TRO”) and preliminary injunctionsee in full comparisonagainst us.in the Lawsuit. On May 6, 2026, the Court denied the TRO in part related toathe breach of contract and conversion claims and granted the TRO in part on the false or misleading advertising statements, whichimposesimposed certain temporary restrictions on specific statements thetheCompanycancould make pending further proceedings.VillaniOnhasAugustalso5,requested a preliminary injunction, which, if granted, could extend or grant new restrictions imposed by2026, the Courtduringdenied Villani’s motion for a preliminary injunction and vacated thependencyinjunctive relief granted in the TRO, and the company is not currently subject to any injunctive restrictions. In denying the motion, the Court found that questions exist going to the merits ofanyVillani’sarbitrationbreachproceedingoforcontract claim,relatedbutlitigation.that Villani had not established a likelihood of immediate irreparable harm and that the balance of equities favored the Company. Villani continues to seek permanent injunctive relief in the Lawsuit and money damages in the Arbitration. Weintend toare vigorouslydefenddefending ourselves against these claims; however, litigation and arbitration proceedings are inherently uncertain, costly,costly,and time-consuming.
“Upon approval of the Securities and Exchange Commission, Nasdaq amended its listing rules on July 22, 2026, to provide that where a listed company fails to meet the continued listing requirement for market value of listed securities of at least $5 million for 30 consecutive business days, such deficiency will result in immediate suspension and delisting, bypassing typical grace periods and restricting appeal rights (the “MVLS Requirement”). …”see in full comparison
“A delisting could substantially decrease trading in our common stock, adversely affect the market liquidity of our common stock as a result of the loss of market efficiencies associated with Nasdaq and the loss of federal preemption of state securities laws, adversely affect our ability to obtain financing on acceptable terms, if at all, and may result in the potential loss of confidence by investors, suppliers, and employees and lead to fewer business development opportunities. …”see in full comparison
“In the event of a delisting, we anticipate that we would take actions to restore our compliance with the Nasdaq Capital Market or another national exchange’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to remain listed on the Nasdaq Capital Market, stabilize our market price, improve the liquidity of our common stock, or prevent future non-compliance with the Nasdaq Capital Market or another national exchange’s listing requirements.”see in full comparison
On April 23, 2026, Villani, Inc. (“Villani”) filed a complaint against us in the U.S. District Court for the Central District of California asserting claims for false advertising under the Lanham Act, breach of contract, and conversion, and seeking injunctivesee in full comparisonrelief.relief (the “Lawsuit”). On June 5, 2026, VillanihasfiledalsoastatedStatementthatofitClaimsintendswithtotheinitiateAmericananArbitrationarbitrationAssociation,proceeding against us seeking monetary damages. Although nocommencing arbitrationdemandbasedhasonbeentheservedsametoconductdate, we may become subject to additional claims, damages, costs, or other remediesalleged inconnectionthe Lawsuit (“Arbitration”). Villani alleges breach of contract, breachwithofanythesuchdutyproceeding.of good faith and fair dealing, false advertising under the Lanham Act 15 USC § 1125, violation of California Business and Professions Code §§ 17200, et seq., and conversion. Villani seeks money damages in the Arbitration.
Full comparison: every changed paragraph (9)
Our
operations and financial results are subject to various risks and uncertainties, including those described in Part I, Item 1A, “Risk
Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 26, 2026. No material
changes to such risk factors have occurred during the threesix months ended MarchJune 31,30, 2026, except as described below:
On
April 23, 2026, Villani, Inc. (“Villani”) filed a complaint against us in the U.S. District Court for the Central District
of California asserting claims for false advertising under the Lanham Act, breach of contract, and conversion, and seeking injunctive
relief.relief (the “Lawsuit”). On June 5, 2026, Villani hasfiled alsoa statedStatement thatof itClaims intendswith tothe initiateAmerican anArbitration arbitrationAssociation, proceeding against us seeking monetary damages. Although nocommencing
arbitration demandbased hason beenthe servedsame toconduct date, we may become subject to additional claims, damages, costs, or other remediesalleged in connectionthe Lawsuit (“Arbitration”). Villani alleges breach of contract, breach
withof anythe suchduty proceeding.of good faith and fair dealing, false advertising under the Lanham Act 15 USC § 1125, violation of California Business
and Professions Code §§ 17200, et seq., and conversion. Villani seeks money damages in the Arbitration.
In
connection with the litigation, Villani sought a temporary restraining order (“TRO”) and preliminary injunction against
us.in the
Lawsuit. On May 6, 2026, the Court denied the TRO in part related to athe breach of contract and conversion claims and granted the
TRO in
part on the false or misleading advertising statements, which imposesimposed certain temporary restrictions on specific statements
the the
Company cancould make pending further proceedings. VillaniOn hasAugust also5, requested a preliminary injunction, which, if granted, could extend
or grant new restrictions imposed by2026, the Court duringdenied Villani’s motion for a preliminary
injunction and vacated the pendencyinjunctive relief granted in the TRO, and the company is not currently subject to any injunctive
restrictions. In denying the motion, the Court found that questions exist going to the merits of anyVillani’s arbitrationbreach proceedingof orcontract
claim, relatedbut litigation.that Villani had not established a likelihood of immediate irreparable harm and that the balance of equities favored the
Company. Villani continues to seek permanent injunctive relief in the Lawsuit and money damages in the Arbitration. We intend to
are
vigorously defenddefending ourselves against these claims; however, litigation and arbitration proceedings are inherently uncertain,
costly, costly,
and time-consuming.
While
we are not currently restrained from manufacturing, promoting, advertising, using, selling, offering for sale, distributing, or delivering
delivering in commerce any product or regimen containing Spongilla, if Villani were to obtain injunctive relief at a preliminarylater injunction,stage of the Lawsuit,
an arbitration
award, or otherwise, we could be restricted or delayed in our ability to market, manufacture, distribute, advertise, sell,
or or
commercialize certain of our current or planned products, including products containing our Spongilla. Such restrictions could
could disrupt our planned product launches, impair relationships with suppliers, manufacturers, distributors, marketing partners, or customers,
customers, require us to modify our products, branding, formulations, or marketing claims, or otherwise adversely affect our
commercialization strategy.
In addition, defending this matter may require significant management attention and financial resources, result in substantial legal
expenses, expenses,
divert resources from our business operations and strategic initiatives, and expose us to reputational harm.
Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock.
Our common stock is currently listed on the Nasdaq Capital Market. Continued listing of a security on Nasdaq Capital Market is conditioned upon compliance with various continued listing standards. In the past, we have received notices from Nasdaq’s Listing Qualifications Department indicating that we had not complied with certain of the Nasdaq Capital Market’s continued listing standards. While we have regained compliance for each instance, there can be no assurance that we will continue to maintain compliance with the Nasdaq listing requirements.
Upon approval of the Securities and Exchange Commission, Nasdaq amended its listing rules on July 22, 2026, to provide that where a listed company fails to meet the continued listing requirement for market value of listed securities of at least $5 million for 30 consecutive business days, such deficiency will result in immediate suspension and delisting, bypassing typical grace periods and restricting appeal rights (the “MVLS Requirement”). On July 29, 2026, the SEC’s Division of Trading and Markets confirmed that it had received notices of intention to petition the full SEC for review of the approval, which automatically stayed the order implementing the rule pending further action from the SEC. This process is pending as of the filing date of this Quarterly Report on Form 10-Q with no prescribed timeline for SEC action. As of the time of this filing, our market value of listed securities is currently below $5 million. Because we are currently below the $5 million threshold, if and when the MVLS Requirement becomes effective, we may become subject to immediate suspension and delisting, without any opportunity to cure, if our market value of listed securities remains below $5 million for 30 consecutive business days.
A delisting could substantially decrease trading in our common stock, adversely affect the market liquidity of our common stock as a result of the loss of market efficiencies associated with Nasdaq and the loss of federal preemption of state securities laws, adversely affect our ability to obtain financing on acceptable terms, if at all, and may result in the potential loss of confidence by investors, suppliers, and employees and lead to fewer business development opportunities. Additionally, the market price of our common stock may decline further, and stockholders may lose some or all of their investment.
In the event of a delisting, we anticipate that we would take actions to restore our compliance with the Nasdaq Capital Market or another national exchange’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to remain listed on the Nasdaq Capital Market, stabilize our market price, improve the liquidity of our common stock, or prevent future non-compliance with the Nasdaq Capital Market or another national exchange’s listing requirements.
Management's Discussion & Analysis (MD&A)
New heading “Six Months Ended June 30, 2026, and 2025”
New heading “Research and Development Expenses”
New heading “Selling, General and Administrative Expenses”
New heading “Other Income and Expenses”
New heading “Investing activities”
Largest changes
In addition tosee in full comparisonthein-officeDTC channelapplication forourskinproducts,renewal, based on the mechanism of Bioneedle, we also believe there is a market for our technology to aid in the intradermal delivery ofmacromoleculesmacromolecules, like botulinum toxin, that must be applied by certified professionals. Currentlyfor various aesthetic conditions. Typically, for facial aesthetics,botulinum toxins areinjectedonlyintoapprovedfacialformusclesintramuscular injections of the face to reduce forehead, lateral canthal, and glabella deep lines. However,thiswe believe there islimitedantountappedtheaestheticusemarketofseekingintradermalneedledeliveryfree, topical applications of botulinum toxin forasuperficial aestheticvariety ofconditions,skinlikediseasesreducing fine lines, pore size, andconditions.sebumBotoxproductisorcurrentlyimprovingtheluminosity,only approved botulinum toxin for the treatment of axillary hyperhidrosis via intradermal injections. While effective, intradermal injections, including 10-15 per axilla, of Botox can be painful for patientsbrightness and overall aestheticvery time consuming for dermatologists.appearance. Therefore, we believe developing a less painful, less time-consuming topical delivery of botulinum toxin into the dermis for various aestheticand medical skin diseases andconditions, would provide physicians with an attractive alternative to intradermal injections of botulinum toxins. While we have no current timeline for the launch of this program we plan to continue to explore additional uses for this platform and look forward to getting our technology in the hands of aestheticians and dermatologists so they may better serve the medical and aesthetic needs of their patients.
“Selling, general and administrative expenses increased by $2.1 million from $2.2 million for the six months ended June 30, 2025, to $4.3 million for the six months ended June 30, 2026. The increase in selling, general and administrative expenses was primarily attributable to the Company’s decision to prioritize the commercial launch of its first product, resulting in significant pre-launch commercialization activities during the six months ended June 30, 2026. …”see in full comparison
“We plan to leverage our Bioneedle platform for broad applicability across dermatologic and aesthetic skin conditions, potentially allowing dermatologists and aestheticians to increase the use of botulinum toxin. …”see in full comparison
Selling, general and administrative expenses increased by approximatelysee in full comparison$0.5$1.6 million from$1.1$1.2 million for the three months endedMarchJune31,30, 2025, to$1.5$2.8 million for the three months endedMarchJune31,30, 2026. The increase in selling, general and administrative expenses was primarily attributable to$0.2the Company’s decision to prioritize the commercial launch of its first product, resulting in significant pre-launch commercialization activities during the three months ended June 30, 2026. This resulted in an increase of $0.6 million of marketing and other commercialization expensesincurred,and$0.2an increase of $0.3 million ofincreasedcompensationauditexpense primarily due to a reallocation of employee duties from research and development to selling, general and administrative expense, as a result of the shift in business focus towards commercialization. In addition, legal feesandincreased$0.1by $0.7 millionofduringincreasedthe three months ended June 30, 2026, due to ongoing litigation and other legalfees.matters. We anticipate that selling, general and administrative expenses will continue to increase related to marketing, branding, advertising, and personnel expenses as we continue to prepare for our first productlaunches and saleslaunch inmid-2026.the third quarter of 2026.
Full comparison: every changed paragraph (33)
We
are a scientific leader in skincare, dedicated to the development and commercialization of products that address common and underserved
skin conditions. Dermata initially was founded with a focus on researching and developing prescription products subject to the FDA approval
process. In September 2025, after an extensive review of current trends in dermatology, changing consumer preferences, additional non-clinical
and clinical development costs, and go-to market costs for ana Rxprescription, or Rx, acne product, management, with approval from our board
of directors,
determined that a strategic shift to developing and distributing DTC and B2B skincare products, that are backed by science,
would be
a better path to commercialization for the Company with potentially greater financial upside and faster time to market. We believe
we we
can leverage our history and knowledge of Rx dermatology to create skincare products that are effective and safe, and available to
consumers consumers
without the nuisance of obtaining a prescription. We believe this strategic repositioning will accelerate our path to commercialization,
reduce our regulatory burden, and decrease development expenses, all while enabling us to address broad consumer segments in the skincare
market.
We
believe the skincare market, from a cosmetic, and over-the-counter (“OTC”), and Rx perspective, has seen a substantial shift
towards consumers first relying upon multifaceted cosmetics and OTC products that simplify routines. Consumer preferences are changing
to favor natural products that do more for their skin. There appears to be a resurgence of interest in traditional remedies to help with
skin renewal and general cosmetic appearance. With consumers searching for multifunctional products to simplify their routines while
valuing brand loyalty and sustainable practices. We believe there remains a gap in the skincare market for in-office level treatments
that are available for home use and believe we have a product to fill this void. We believe that if we can provide consumers with a unique
topical skincare product, we have an opportunity to capture a large segment of consumers seeking to simplify their skincare routine without
needing to schedule an in-office visit.visit with an aesthetician or a dermatologist. While this is a major shift in strategy for our company,
we believe pursuing the commercial sale
of unique cosmetic skincare products is the best path forward to meet our mission of providing
consumers with efficacious and safe skincare
treatment options.
We
view this shift in consumer preferences as a significant benefit for our strategic repositioning. We have gained substantial clinical
knowledge of various dermatology diseases and skin conditions.conditions or our years of developing prescription products. We plan to leverage this
knowledge to create a wholediversified product line of skincare
treatments that consumers can access directly for each of their skincare needs.
While our background is in clinicalprescription products, we plan
to leverage the unique attributes of our hero ingredient, Spongilla lacustris,
to develop multiple skincare treatments.treatments for a variety of consumer and professional needs. We planexpect to launch
our first cosmetic product,
our theTome Foundational Treatment, inon theAugust middle25, of2026, 2026.with those on our waitlist being able to preorder early. In the future, we plan
to offer additional products that
target specific needs of consumers. For example, for consumers who have more sensitive skin, we may
plan to commercialize a milder version
of our Foundational Treatment that could be used more often.
Our
core products, like our Foundational Treatment, will utilize our Bioneedle, which is 100% Spongilla lacustris powder, to provide
a once weeklyonce-weekly, skin renewal routine that is a simple addition to skincare routines. This once weekly routine will contain our Bioneedle
which will be combined with a fluidizing agent for easy application. Our Bioneedle is derived from a wildlywild grownharvested freshwater sponge,
Spongilla lacustris or Spongilla, which is processed into a fine, purified powder and packaged with no additives. Spongilla
is a unique freshwater sponge that only grows in commercial quantities in select regions of the world, which gives our Bioneedle
its distinctive properties. The combination of a proprietary harvesting protocol, developed by our exclusive supplier,supplier over 20 plus years
of harvesting, and the post-harvest
processing procedures,procedures we developed, produces a cosmetic ingredient that we believe optimizes the
Bioneedle for a unique and simple skin renewal routine,
unlike most skincare on the market.
We also plan to sell directly to skincare professionals, like aestheticians and dermatologists, as we believe many consumers are still seeking professional expertise for their skincare. We believe our Foundational Treatment is safe enough to be used at home but also powerful enough for the office. This dual distribution channel will allow consumers to have the product applied in the manner they are most comfortable, while allowing skincare professionals to provide additional services to their clients. The unique once weekly application schedule provides flexibility to skincare professionals to tailor the treatment for each individual patient, whether that patient comes back weekly or once a month while completing weekly applications at home. We believe our Foundational Treatment will provide skincare professionals will a treatment option for patients that may be less intense than microneedling, lasers, or chemical peels, but offers patients the skin renewal results they seek.
In
addition to thein-office DTC channelapplication for ourskin products,renewal, based on the mechanism of Bioneedle, we also believe there is a market for our technology
to aid in the intradermal delivery of macromoleculesmacromolecules, like botulinum toxin, that must be applied by certified professionals. Currently
for various aesthetic conditions. Typically, for facial aesthetics, botulinum toxins are injectedonly intoapproved facialfor musclesintramuscular injections of the face to reduce forehead,
lateral canthal, and glabella deep lines.
However, thiswe believe there is limitedan tountapped theaesthetic usemarket ofseeking intradermalneedle deliveryfree, topical applications of botulinum toxin for asuperficial
aesthetic variety
ofconditions, skinlike diseasesreducing fine lines, pore size, and conditions.sebum Botoxproduct isor currentlyimproving theluminosity, only approved botulinum toxin for the treatment of axillary hyperhidrosis via
intradermal injections. While effective, intradermal injections, including 10-15 per axilla, of Botox can be painful for patientsbrightness and overall aesthetic
very time consuming for dermatologists.appearance. Therefore, we believe developing a less painful, less time-consuming topical delivery of botulinum
toxin into the dermis
for various aesthetic and medical skin diseases and conditions, would provide physicians with an attractive alternative
to intradermal injections of botulinum toxins.
While we have no current timeline for the launch of this program we plan to continue to explore additional uses for this platform and
look forward to getting our technology in the hands of aestheticians and dermatologists so they may better serve the medical and aesthetic
needs of their patients.
We
plan to leverage our Bioneedle platform for broad applicability across dermatologic and aesthetic skin conditions, potentially allowing
dermatologists and aestheticians to increase the use of botulinum toxin. We believe this non-invasive approach could meaningfully expand
the therapeutic and aesthetic utility of botulinum toxin for conditions such as axillary, palmar, and plantar hyperhidrosis, acne, acne
scars, rosacea, and improved facial aesthetics (including improvements in skin luminosity and brightness, reducing pore size and number
of pores, reducing fine lines, and reducing skin oiliness by decreasing sebum production). While we have no current timeline for the
launch of this program we plan to continue to explore additional uses for this platform and look forward to getting our technology in
the hands of aestheticians and dermatologists so they may better serve the medical and aesthetic needs of their patients.
We
have taken steps to secure inventory of Spongilla raw material in advance of the planned launch of our Tome skincare products.
We believe we have sufficient quantities of processed Spongilla raw material inventory on hand to support the anticipatedexpected mid-2026August
25, 2026, commercial launch and initial commercialization activities thereafter, based on our current operating plans, expected production
volumes volumes
and internal assumptions. We continue to evaluate additional inventory procurement opportunities and manufacturing planning activities
to support future commercial demand.
On August 5, 2026, we announced the planned commercial launch date of our first direct-to-consumer skincare product, Foundational Treatment. We expect to start selling the Foundational Treatment on August 25, 2026, with people on the waitlist getting early access to preorder. The Foundational Treatment will contain 4 weekly treatments and will be priced at $178.00 USD retail, or about $45 per treatment.
In
January 2026, we raised approximately $2.0 million of net proceeds from the sale of 824,283 shares of our Common Stock under our At
The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright &Co., LLC (“HCW”), as sales
agent. We paid HCW a fixed commission rate of 3% of approximately $67,000 and other transactional fees. We
have no capacity to sell shares pursuant to the ATM Agreement remaining.
Our
results of operations have fluctuated significantly from period to period in the past and are likely to continue to do so in the future.
We anticipate that our quarterly and annual results of operations will be impacted for the foreseeable future by several factors, including
the marketing expenses associated with the launch of our first Tome skincare products and resulting revenues, if any, in mid-2026.the second half
of 2026. Due
to these fluctuations, we believe that the period-to-period comparisons of our operating results are not a good indication
of our future
performance.
Three
Months Ended MarchJune 31,30, 2026, and 2025
Research
and development expenses decreased by $0.9$0.4 million from $1.3$0.6 million for the three months ended MarchJune 31,30, 2025, to $0.4$0.2 million for the
three months ended MarchJune 31,30, 2026. The decrease in research and development expenses resulted from $0.7 million of decreased clinical
expensesprimarily from the XYNGARI™Company’s STAR-1decision
to acne study, which was completed duringprioritize the secondcommercial quarterlaunch of 2025,its $0.1first millionproduct, ofresulting decreased
chemistry,in manufacturinga anddecrease controls, or CMC, and non-clinical expenses period over period as result of the Company’s pivot to
focus on DTC product sales, and $0.1 million of decreased personnel expenses, which resulted from the receipt of proceeds of the Employee
Retention Tax Credit refund which partially offset payroll taxes forin research and development employeesefforts during the firstthree
months quarterended ofJune 30, 2026.
While we continue to focus on designing, packaging, and manufacturing of our first commercial products, as
well as product development,
we anticipate that research and development expenses will continue to decrease as we prepare for launching
our first productcommercial salesproduct, in
mid-2026.expected on August 25, 2026.
Selling,
general and administrative expenses increased by approximately $0.5$1.6 million from $1.1$1.2 million for the three months ended MarchJune 31,30, 2025,
to $1.5$2.8 million for the three months ended MarchJune 31,30, 2026. The increase in selling, general and administrative expenses was primarily
attributable to $0.2the Company’s decision to prioritize the commercial launch of its first product, resulting in significant pre-launch
commercialization activities during the three months ended June 30, 2026. This resulted in an increase of $0.6 million of marketing and
other commercialization expenses incurred,and $0.2an increase of $0.3 million of increasedcompensation auditexpense primarily due to a reallocation of employee
duties from research and development to selling, general and administrative expense, as a result of the shift in business focus towards
commercialization. In addition, legal fees andincreased $0.1by $0.7 million ofduring increasedthe three months ended June 30, 2026, due to ongoing litigation
and other legal
fees. matters. We anticipate that selling, general and administrative expenses will continue to increase related to marketing,
branding, advertising,
and personnel expenses as we continue to prepare for our first product launches and saleslaunch in mid-2026.the third quarter
of 2026.
We
earn interest income via overnight deposits on our cash and cash equivalents. Interest income was $78,676$47,000 for the firstsecond quarter of 2026
compared to $36,216$72,000 for the firstsecond quarter of 2025. The increase of $42,460decrease in interest income resulted from increaseddecreased cash balances due
to financing proceeds related to the December 2025 PIPE and recent ATM sales during the fourth quarter of 2025 and first quarter of 2026,
respectively, as well as interest received related to the Employee Retention Tax Credit payments received during the first quarter of
2026.balances.
Six Months Ended June 30, 2026, and 2025
The following table summarizes our results of operations for the periods presented:
Research and Development Expenses
Research and development expenses decreased by $1.3 million from $1.9 million for the six months ended June 30, 2025, to $0.6 million for the six months ended June 30, 2026. The decrease in research and development expenses resulted from $0.6 million of decreased clinical expenses from the XYNGARI™ STAR-1 acne study, which was completed during the second quarter of 2025. Additionally, research and development expenses decreased another $0.7 million, as a result of the Company’s decision to prioritize the commercial launch of its first product, resulting in a decrease in research and development efforts during the six months ended June 30, 2026.
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by $2.1 million from $2.2 million for the six months ended June 30, 2025, to $4.3 million for the six months ended June 30, 2026. The increase in selling, general and administrative expenses was primarily attributable to the Company’s decision to prioritize the commercial launch of its first product, resulting in significant pre-launch commercialization activities during the six months ended June 30, 2026. This resulted in an increase of $0.9 million of marketing and other commercialization expenses and an increase of $0.3 million of compensation expense primarily due to a reallocation of employee duties from research and development to selling, general and administrative expense, as a result of the shift in business focus towards commercialization. In addition, legal fees increased by $0.8 million during the six months ended June 30, 2026, due to ongoing litigation and other legal matters, and audit fees increased by $0.1 million.
Other Income and Expenses
We earn interest income via overnight deposits on our cash and cash equivalents. Interest income was $125,000 for the six months ended June 30, 2026 compared to $108,000 for the six months June 30, 2025. The increase of $17,000 in interest income resulted primarily from interest received related to the Employee Retention Tax Credit payments received during the first quarter of 2026.
Cash
used in operations of approximately $2.5$4.9 million for the threesix months ended MarchJune 31,30, 2026, was the result of the net loss of $1.8$4.8 million
as well as increases in prepaid and other current assets of $0.1$0.3 million and increased inventoryinventories of $0.1 million, as well as decreasesa decrease
in accounts payable and accrued and other current liabilities of approximately $0.5 million, partially offset by an increase in accounts payable of $0.7 million
and non-cash stock-based compensation of $0.1 million.
Cash
used in operations of $1.9$4.6 million for the threesix months ended MarchJune 31,30, 2025, was the result of the net loss of $2.3$4.0 million,million offsetand decreases
by increases in accounts payable and accrued and other current liabilities of approximately $0.3$0.9 million, aspartially welloffset asby the decrease of prepaid
prepaid expenses and other current assets of approximately $0.2 million and non-cash stock-based compensation of $0.1 million.
Investing activities
Cash used in investing activities of $0.1 million for the six months ended June 30, 2026 consisted of the purchases of property and equipment.
Cash
provided by financing activities of $1.9 million for the threesix months ended MarchJune 31,30, 2026, was the result of approximately $2.0 million
in net proceeds from ATM sales during the first quarter of 2026, partially offset by approximately $0.1 million of payments for issuance-related
costs from the December 2025 PIPE financing.
Cash
provided by financing activities of $8.5$7.9 million for the threesix months ended MarchJune 31,30, 2025, was the result of the January 2025 PIPE financing
which raised net proceeds of $2.3$2.2 million, and the March 2025 Inducement financing which raised net proceeds of $6.2$5.7 million.
Since
our inception, we have not generated any revenue or commercialized any products. As of MarchJune 31,30, 2026, our cash and cash equivalents totaled
totaled $6.9$4.4 million, and we had an accumulated deficit of $75.1$78.0 million. For the threesix months ended MarchJune 31,30, 2026, and the year ended December
December 31, 2025, we used cash of $2.5$4.9 million and approximately $7.8 million, respectively, in operations. We expect our current cash resources
resources to fund operations into the firstfourth quarter of 2027.2026.
We
anticipate that we will continue to incur net losses for at least the next twelve months from the date of this filing. While we plan
to launch our first DTC productproduct, inexpected mid-2026,on August 25, 2026, it is uncertain when we will generate operating income to sustain operations, if
ever. These
factors raise substantial doubt about our ability to continue as a going concern for the one-year period following the date
that these
financial statements were issued.
We
believe that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements
into the firstfourth quarter of 2027.2026. We have based this estimate of cash runway on assumptions that may prove to be wrong, and we could utilize
our available capital resources sooner than we expect. We may require additional capital to continue to commercialize our Tome skincare
products, and to pursue in-licenses or acquisitions of other drug candidates. Accordingly, beyond our current cash and any proceeds from
the sales of our common stock pursuant to the ATM Agreement, if any, we will require substantial additional financing to support our
operations. We expect our expenses and capital requirements to increase in connection with our ongoing activities, including the commercial
launch of our first Tome skincare products.
Since
inception, we have devoted substantially all of our resources to research and development activities.activities, and during 2026, on marketing and
other pre-launch commercial activities in preparation of its first product launch. In September 2025, we made a strategic
pivot from
research and developing prescription products to becoming a science-driven leader in dermatologic solutions, anticipating
our first DTC
product launch from our Tome skincare brandbrand, inexpected mid-2026.on August 25, 2026. We have not generated revenues and have not yet achieved profitable operations,
operations, nor have we ever generated positive cash flow from operations. There is no assurance that profitable operations, if achieved,
could be
sustained on a continuing basis. In addition, we operate in an environment of rapid technological change, and we are largely dependent
dependent on the services of our employees and consultants. Further, our future operations are dependent on the success of our efforts
to raise
additional capital. These uncertainties raise substantial doubt about our ability to continue as a going concern for 12 months after
after the issuance date of our financial statements. The accompanying financial statements have been prepared on a going concern basis. The
The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of
of assets or the amounts and classification of liabilities that may result from the possible inability of the company to continue as
a going
concern, which contemplates the continuation of operations, realization of assets and liquidation of liabilities in the ordinary course
course of business. We incurred a net loss of $1.8$4.8 million for the quartersix months ended MarchJune 31,30, 2026, and had an accumulated deficit of $75.1$78.0 million
million as of MarchJune 31,30, 2026. We anticipate incurring additional losses until such time, if ever, we can generate sufficient revenue
from our
products currently in development, or products we are in the process commercializing. Our primary source of capital has been
the issuance
of equity and equity-linked securities.
DRMA insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 1 filing (1 insider, 1 trade date, 11 shares, about $13). Net open-market shares: -11 (purchases minus sales); net value about -$13.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-08-16 | Proehl Gerald T |
Grant/award | 170,068 | — | — |
| 2026-08-16 | Van Hoose Kyri K. |
Grant/award | 102,040 | — | — |
| 2026-06-16 | Scott Kathleen D. |
Open-market sale | 11 | $1.19 | $13 |
Well-known investors holding DRMA (13F)
None of the 59 investors we track reported a position in their latest 13F.