Biofrontera Inc. 10-K

Item 1A. Risk Factors Our business, results of operations and financial condition and the industry in which we operate are subject to various risks. We have listed below the most significant risk factors we believe to be applicable to us, but they do not constitute all of the risks that may be applicable to us. New risks may emerge from time to time, and it is not possible for us to predict all potential risks or to assess the likely impact of all risks. References to past events are examples only and are not intended to be a complete listing or to indicate the likelihood of similar events occurring in the future. You should read this summary together with the more detailed description of each risk factor contained below, as well as other information in this Form 10-K and our other filings with the SEC, including our financial statements and the related notes and the sections entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in such filings. These disclosures reflect the Company’s beliefs and opinions as to factors that could materially and adversely affect the Company and its securities in the future. Some of these material risks include: Summary of Material Risk Factors Risks Related to our Products ● If generic versions of Ameluz enter the market, we may need to reduce the price of Ameluz significantly, which would reduce revenues, and may cause us to lose significant market share. ● Our business depends substantially on the success of Ameluz. If we are unable to successfully obtain and maintain regulatory approvals or reimbursement for Ameluz for existing and additional indications, our business may be materially harmed. ● If we or our manufacturing partners, as applicable, fail to manufacture our products in sufficient quantities and at acceptable quality and cost levels, we may face a bar to, or delays in, the commercialization of those products or we will be unable to meet market demand and lose potential revenues. ● Breakdowns , failures, or suboptimal performance of our manufacturing equipment could disrupt operations, increase costs, impair product quality, and materially and adversely affect our business, financial condition, and results of operations. ● If our efforts to protect the proprietary nature of our intellectual property related to our products are not adequate, we may not be able to compete effectively in our market. ● We are currently and have been involved in intellectual property lawsuits related to our products. Similar suits may also arise in the future, which could be expensive, time-consuming and unsuccessful. ● Our international business dealings with our manufacturing partners may pose currency risks. ● Competing products and future emerging products may erode sales of our products. ● Geopolitical instability, trade disputes, and tariffs imposed on imports could materially increase our costs, disrupt our supply chain, and adversely affect our business, financial condition, and results of operations. 13 Risks Related to Our Business and Strategy ● Insurance coverage and medical expense reimbursement may be limited or unavailable in certain market segments for our products, which could make it difficult for us to sell our products. ● Healthcare legislative changes may have a material adverse effect on our business and results of operations. ● If we are unable to maintain effective marketing and sales capabilities we may be unable to generate revenue growth. ● If we are unable to establish and maintain relationships with GPOs, our future revenues and/or future profitability could be jeopardized. The United States market for Ameluz for the treatment of AK may be smaller than we have estimated. ● Even if we obtain additional regulatory approvals extending our products’ indications, they may not gain market acceptance or become widely accepted among members of the medical community. ● We are subject to healthcare laws and regulations. Our failure to comply with those laws and regulations could have a material adverse effect on our results of operations and financial condition. ● A recall of our drug or medical products, or the discovery of serious safety issues with our drug or medical products, could have a significant negative impact on us. ● We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may be unable to successfully implement our business strategy. ● We will need to grow our organization and we may experience difficulties in managing this growth. ● Our business and operations could suffer in the event of system failures or cyber-attacks. ● If lawsuits are brought against us, we may incur substantial liabilities. ● Our subsidiary and certain third-party employees are subject to foreign laws. ● Third party claims of intellectual property infringement may affect our ability to sell our products and may also prevent or delay our product discovery and development efforts. ● The results of our R&D efforts are uncertain. Risks Related to Our Financial Position and Capital Requirements ● There is substantial doubt about our ability to continue as a “going concern.” ● We have a history of operating losses and anticipate that we will continue to incur operating losses in the future and may never achieve profitability. ● If we fail to obtain additional financing, we may be unable to pursue our plans for strategic growth. ● Our existing and any future indebtedness could adversely affect our ability to operate our business. Risks Related to Clinical Trials and Regulatory Approvals of Indication Expansion ● Delay or termination of planned clinical trials would result in unplanned expenses and significantly and adversely impact our remaining developmental activities and potential commercial prospects. ● Our products may pose safety and other issues that could delay or prevent the regulatory approval of additional indications and result in significant negative consequences. ● If we are unable to obtain regulatory approval for additional indications of our products on a timely basis or at all, our business could be substantially harmed. ● If third parties conducting some of our clinical trials do not carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval to extend the indications of our products. Risks Related to Corporate Governance, Including Being a Public Company ● If we fail to maintain an effective system of internal controls, our ability to produce timely and accurate financial statements may be impaired, investors may lose confidence in our financial reporting, and the price of our common stock may decline. 14 Risks Related to Our Securities and the Ownership of Our Common Stock ● Our share price may be volatile, and you may be unable to sell your shares and/or warrants at or above the offering price. ● If we fail to maintain compliance with applicable listing standards, our common stock and publicly traded warrants could be delisted from Nasdaq. ● Warrants are exercisable for our common stock, which, if exercised, would result in dilution to our stockholders. ● Future sales and issuances of our common stock or rights to purchase our common stock could result in dilution and could cause the stock price of our common stock to decline. ● Certain provisions of our outstanding warrants, our charter documents, and Delaware law could prevent a takeover that stockholders consider favorable and could also reduce the market price of our stock. ● Many of our warrants are accounted for as a liability and recorded at fair value with changes in fair value each period, which may have an adverse effect on the market price of our common stock. Risks Related to Our Products Generic versions of Ameluz may enter the market following the expiration of our patents, which may lead to significant reductions in the price of Ameluz and significant decreases in our market share. The process of developing generic topical dermatological products presents specific challenges that may deter potential generic competitors. If generic competitors do enter the market, this may cause a significant drop in the price of Ameluz and our United States market share for Ameluz, materially and adversely impacting our results of operations, business, and stock price. We hold several patent families protecting our products, including 1) a patent family that protects the technology relating to nanoemulsions that expires in December 2027, 2) a patent family that protects the current Ameluz formulations (without propylene glycol) that expires in 2043, and 3) several patent families regarding illumination protocols used in or planned for Ameluz PDT and covering the RhodoLED Lamps. However, we cannot guarantee that these patents (or additional patents for which we have applied, if issued) will adequately protect us against copying by competitors. Our business depends substantially on the success of our principal product, Ameluz. If we are unable to successfully obtain and maintain regulatory approvals or reimbursement for Ameluz for existing and additional indications, our business may be materially harmed. Although we have received marketing approval in the United States for Ameluz for lesion- and field-directed treatment of AK in combination with PDT using the BF-RhodoLED Lamps, there remains a significant risk that we will fail to generate sufficient revenue or otherwise successfully commercialize the product in the United States. The success of Ameluz will depend on several factors, including: ● successful completion of further clinical trials; ● receipt of further regulatory approvals, including for the marketing of Ameluz for additional indications; ● any contract manufacturing facilities maintaining regulatory compliance; ● compliance with applicable law for our sales force and marketing efforts; ● any contract manufacturing facility producing sufficient quantities at acceptable quality; ● sourcing sufficient quantities of raw materials used to manufacture our products; ● continued acceptable safety and effectiveness profiles for our products; ● maintaining current reimbursement coverage for our existing indication, and expanding reimbursement to cover future indications; ● obtaining and maintaining patent and trade secret protection and regulatory exclusivity; and ● protecting our intellectual property rights. 15 If we do not achieve one or more of these factors in a timely manner, or at all, we could experience significant delays or an inability to successfully commercialize our products, which would materially harm our business and we may not be able to earn sufficient revenue and cash flows to continue our operations. Because we have received approval from the FDA to market in the United States Ameluz in combination with PDT using the BF-RhodoLED lamp series, any new lamp we may license would require new approval from the FDA. We cannot assure that we will develop any new lamps (beyond the BF-RhodoLED XL lamp, which was approved by the FDA on October 21, 2021), or obtain any such new approval. If we or our manufacturing partners, as applicable, fail to manufacture Ameluz, RhodoLED Lamps, or other marketed products in sufficient quantities and at acceptable quality and cost levels, or to fully comply with cGMP or other applicable manufacturing regulations, we may face a bar to, or delays in, the commercialization of our products or be unable to meet market demand, and lose potential revenues. The manufacture of our products requires significant expertise and capital investment. We would need to spend substantial time and expense to replace our respective contract manufacturers if any such contract manufacturer failed to deliver products in the quality and quantities we demand or failed to meet any regulatory or cGMP requirements. We take precautions to help safeguard their respective manufacturing facilities, including acquiring insurance and performing on site audits. However, vandalism, terrorism or a natural or other disaster, such as a fire or flood, could damage or destroy manufacturing equipment or the inventory of raw material or finished goods, cause substantial delays in operations, result in the loss of key information, and cause additional expenses. Our insurance may not cover losses related to our products in any particular case. In addition, regardless of the level of insurance coverage, damage to our facilities may have a material adverse effect on our business, financial condition and operating results. Furthermore, while we take reasonable precautions to ensure the successful production of our commercial products, our contract manufacturers may experience a myriad of business difficulties (i.e., workforce instability, supply chain issues, erosion of customer base, etc.) that could impact their financial solvency. Our manufacturing partners must comply with federal, state and foreign regulations, including FDA regulations governing cGMP enforced by the FDA through its facilities inspection program and by similar regulatory authorities in other jurisdictions where we do business. These requirements include, among other things, quality control, quality assurance and the maintenance of records and documentation. For our medical device products, we are required to comply with the FDA’s QSR which covers the methods and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our medical device products. Our facilities and our contract facilities have been inspected by the FDA for cGMP compliance. If our or our contract manufacturers do not successfully maintain cGMP compliance for these facilities, commercialization of our products could be prohibited or significantly delayed. Even after cGMP compliance has been achieved, the FDA or similar foreign regulatory authorities at any time may implement new standards or change their interpretation and enforcement of existing standards for manufacture, packaging, testing of or other activities related to our products. For our commercialized medical device product, the FDA audits compliance with the through periodic announced and unannounced inspections of manufacturing and other facilities. The FDA may conduct inspections or audits at any time. Similar audit rights exist in Europe and other foreign jurisdictions. Any failure to comply with applicable cGMP, QSR and other regulations may result in fines and civil penalties, suspension of production, product seizure or recall, imposition of a consent decree, or withdrawal of product approval, and would limit the availability of our product. Any manufacturing defect or error discovered after products have been produced and distributed also could result in significant consequences, including adverse health consequences, injury or death to patients, costly recall procedures, re-stocking costs, warning letters, Form 483 reports, civil monetary penalties, product liability, damage to our reputation and potential for product liability claims. If we are required to find a new manufacturer or supplier, the process would likely require prior FDA and/or equivalent foreign regulatory authority approval and would be very time consuming. An inability to continue manufacturing adequate supplies of our products at any contract facilities could result in a disruption in the supply of our products. Delay or disruption in our ability to meet demand may result in the loss of potential revenue. 16 In addition, we are subject to regulations in various jurisdictions, including the Federal Drug Quality and Security Act and the Drug Supply Chain Security Act in the United States, which require us to develop electronic systems to serialize, track, trace and authenticate units of our products through the supply chain and distribution system. Compliance with these regulations may result in increased expenses for our company or impose greater administrative burdens on our organization, and failure to meet these requirements could result in fines or other penalties. Failure to comply with all applicable regulatory requirements may subject our company to operating restrictions and criminal prosecution, monetary penalties and other disciplinary actions, including, sanctions, warning letters, product seizures, recalls, fines, injunctions, suspension, shutdown of production, revocation of approvals or the inability to obtain future approvals, or exclusion from future participation in government healthcare programs. Any of these events could disrupt our company’s business and, consequently, have a material adverse effect on our revenue, profitability and financial condition. Breakdowns, failures, or suboptimal performance of our manufacturing equipment could disrupt operations, increase costs, impair product quality, and materially and adversely affect our business, financial condition, and results of operations. Our manufacturing operations depend on the reliable performance and availability of our manufacturing equipment. Unplanned breakdowns, accelerated wear, and other performance issues can occur despite preventive maintenance and monitoring, resulting in production outages or slowdowns, yield losses, quality deviations, rework and scrap, missed delivery schedules, and higher costs for expedited freight, overtime, or alternative sourcing that compress margins. The timing and magnitude of equipment failures are inherently difficult to predict. Significant breakdowns or repeated failures can lead to extended downtime while we diagnose issues, procure spare parts, or obtain specialized third-party service. Lead times for critical components—particularly custom or long-lead items—can be lengthy and volatile, and repair vendors may have limited availability during peak periods. In some cases, replacement rather than repair may be required, resulting in substantial capital expenditures. If we are unable to timely repair or replace equipment, we could lose sales, incur contractual penalties or liquidated damages, or face increased warranty claims. Our insurance may not cover fully, or at all, lost production, margin shortfalls, replacement costs, or consequential damages, and any recoveries could be delayed, contested, or subject to deductibles and coverage limits. Any significant disruption in our manufacturing capability could have a material adverse effect on our business, financial condition, results of operations, and cash flows. If our efforts to protect the proprietary nature of our intellectual property related to our products are not adequate, we may not be able to compete effectively in our market. We rely upon a combination of patents, trade secret protection and confidentiality agreements to protect the intellectual property related to our products. Any disclosure to or misappropriation by third parties of their confidential proprietary information could enable competitors to quickly duplicate or surpass their technological achievements, thus eroding our competitive position in our market. In addition, the patent applications that we own may fail to result in issued patents in the United States. Even if the patents do successfully issue, third parties may challenge the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable. Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property or prevent others from designing around our claims. If the breadth or strength of protection provided by the issued patents and patent applications we hold with respect to our products is threatened, it could threaten our ability to commercialize our products. Further, if the clinical trials for our products are related, the period of time during which we could market our products under patent protection would be reduced. Since patent applications in the United States are confidential for a period of time after filing, we cannot be certain that we were the first to file any patent application related to our products. 17 In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable, processes for which patents are difficult to enforce and any other elements of our product discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. Although we may require our employees to assign their inventions to us to the extent permitted by law, and may require our employees, consultants, advisors and any third parties who have access to our proprietary know-how, information or technology to enter into confidentiality agreements, we cannot be certain that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Our trade secrets also could be independently discovered by our competitors, in which case, we would not be able to prevent use of such trade secrets by our competitors. The enforcement of a claim alleging that a party illegally obtained and was using our trade secrets could be difficult, expensive and time consuming and the outcome would be unpredictable. There exists a risk that we may not be able to detect when misappropriation of trade secrets has occurred or where a third party is using such trade secrets without our or their knowledge. The failure to obtain or maintain meaningful trade secret protection could adversely affect the competitive position of our products. Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States or the EU. As a result, we may encounter significant problems in protecting and defending our intellectual property in the United States, in the EU and in other countries. If we are unable to prevent unauthorized material disclosure of their intellectual property to third parties, we may not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results and financial condition. We are and have been involved in intellectual property lawsuits related to our products and we may become involved in similar suits in the future, which could be expensive, time-consuming and unsuccessful. Competitors may infringe upon the patents for our products. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that one or more of our patents is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation or defense proceedings, could put one or more of our patents at risk of being invalidated, held unenforceable, or interpreted narrowly and could put our patent applications at risk of not issuing. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim or counterclaim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure. Interference or derivation proceedings provoked by third parties or brought by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent applications. An unfavorable outcome in any patent related litigation could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. We may not be able to prevent misappropriation of our trade secrets or confidential information, particularly in countries where the laws may not protect those rights as fully as in the United States or the EU. Furthermore, because of the substantial amount of discovery that could be required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our securities. 18 Our international dealings may pose currency risks, which may adversely affect our operating results and net income. Our operating results may be affected by volatility in currency exchange rates and our ability to effectively manage our currency transaction risks. In general, we conduct our business with any third-party vendors in the local currency of the country in which such vendor operates. We do not manage our foreign currency exposure in a manner that would eliminate the effects of changes in foreign exchange rates. Therefore, changes in exchange rates between these foreign currencies, the dollar and the euro will affect our selling, general and administrative, related party, and the recorded levels of assets and liabilities held in a foreign currency and could result in exchange losses in any given reporting period. Given the volatility of exchange rates, we can give no assurance that we will be able to effectively manage our currency transaction risks or that any volatility in currency exchange rates will not have an adverse effect on our results of operations. Competing products and future emerging products may erode sales of our products. Reimbursement issues affect the economic competitiveness of our products as compared to other therapies. See the section entitled “ Insurance coverage and medical expense reimbursement may be limited or unavailable in certain market segments for our products, including with respect to future indications of our products, which could make it difficult for us to sell our products ” included below in this Item 1A. Our industry is subject to rapid, unpredictable and significant technological change and intense competition. Our competitors may succeed in developing, acquiring, or licensing on an exclusive basis, products that are safer, more effective or more desirable than our products. Many of our competitors have substantially greater financial, technical and marketing resources than we have. In addition, several of these companies have significantly greater experience than we do in developing products, conducting preclinical and clinical testing, obtaining regulatory approvals to market products for health care, and marketing healthcare products. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated in our competitors. Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries. We cannot guarantee that new drugs or future developments in drug technologies will not have a material adverse effect on our business. Increased competition could result in price reductions, lower levels of government or other third-party reimbursements, failure to achieve market acceptance and loss of market share, any of which could adversely affect our business, results of operations and financial condition. Further, we cannot give any assurance that developments by our competitors or future competitors will not render our technologies obsolete or less advantageous. If we are not able to compete effectively with the competitors and competing therapies, we may lose significant market share in the relevant markets, which could have a material adverse effect on our revenue, results of operations and financial condition. Geopolitical instability, trade disputes, and tariffs imposed on imports could materially increase our costs, disrupt our supply chain, and adversely affect our business, financial condition, and results of operations. Our business operates in a global trade environment that is subject to inherent and evolving geopolitical risks. Recent actions by the U.S. government, including the imposition of significant tariffs on imports from certain countries, have substantially heightened uncertainty in international trade. Because our products are exclusively imported from Europe, our business is particularly sensitive to any tariffs, duties, and other trade restrictions imposed on European goods entering the United States. Any such measures could materially increase the cost of our products and reduce our margins, particularly if we are unable to pass increased costs on to our customers through price adjustments or otherwise offset these impacts. In addition to direct tariff exposure, our business may be adversely affected by retaliatory trade measures imposed by foreign governments in response to U.S. trade policy, which could further disrupt global supply chains, increase the cost of raw materials and components sourced by our European suppliers, and create additional logistical and regulatory complexity. The trade policy landscape remains highly fluid and unpredictable. The uncertainty surrounding trade policy has contributed to significant volatility in the financial markets, which could adversely affect our stock price, increase our cost of capital, and limit our ability to access the capital markets on favorable terms. There can be no assurance that the current tariff regime will not be expanded or that additional trade restrictions will not be imposed that would further impact our business. We may be unable to fully mitigate the adverse effects of tariffs and trade restrictions, and any failure to do so could have a material adverse effect on our business, financial condition, results of operations, and prospects. 19 Risks Related to Our Business and Strategy Insurance coverage and medical expense reimbursement may be limited or unavailable in certain market segments for our products, including with respect to future indications of our products, which could make it difficult for us to sell our products. Patients who are provided medical treatment for their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment. As such, patients are unlikely to use our products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products. Therefore, adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and third-party payors, such as private health insurers and health maintenance organizations, is critical to product acceptance. Government authorities and third-party payors, decide which products they will cover and the amount of reimbursement. Such reimbursement may depend upon a number of factors, including the government or third-party payor’s determination that use of a product is: ● a covered benefit under its health plan; ● safe, effective and medically necessary; ● reasonable and appropriate for the specific patient; ● cost-effective; and ● neither experimental nor investigational. Coverage decisions may depend on clinical and economic standards that disfavor new products when more established or lower cost therapeutic alternatives are already available or subsequently become available. Third-party payors may refuse to include a particular branded product in their formularies or lists of medications for which third-party payors provide coverage and reimbursement, or otherwise restrict patient access through formulary controls or otherwise to a branded product when a less costly generic equivalent or alternative is available. Coverage may be more limited than the purposes for which a product is approved by the FDA or similar regulatory authorities outside the United States. Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time consuming and costly process that could require that we provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products. We may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement or a particular reimbursement amount. If reimbursement of future products or extended indications for existing products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, we may be unable to achieve or sustain profitability. Healthcare legislative changes may have a material adverse effect on our business and results of operations. In the United States and certain other countries, there have been a number of legislative and regulatory changes to the health care system that could impact our ability to sell our products profitably. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. We expect that additional federal, state and foreign healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and services, which could result in limited coverage and reimbursement and reduced demand for our products, once approved, or additional pricing pressures. Additionally, third-party payors, including governmental payors, managed care organizations and private health insurers, are increasingly challenging the prices charged for medical products and services and examining their cost effectiveness. The continuing efforts of governments, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect: ● the demand for our products, ● if we obtain regulatory approvals; ● our ability to set a price or obtain reimbursement that we believe is fair for our products; ● our ability to generate revenues and achieve or maintain profitability; and ● the level of taxes that we are required to pay. Any denial or reduction in reimbursement from Medicare or other programs or governments may result in a similar denial or reduction in payments from private payors, which may adversely affect our future profitability. 20 If we are unable to maintain effective marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may be unable to generate revenue growth. In order to grow the market for our products, we must continue to build our marketing, sales and distribution capabilities in the United States. The development and training of our sales force and related compliance plans to market our products are expensive and time consuming and can potentially delay the growth of sales of our products. In the event we are not successful in maintaining our marketing and sales infrastructure, we may not be able to successfully grow the market of our products, which would limit our revenue growth. If we are unable to establish and maintain relationships with group purchasing organizations, our future revenues and/or future profitability could be jeopardized. A growing number of end-users of our products have relationships with GPOs, whereby such GPOs provide such end-users access to a broad range of pharmaceutical and medical device products from multiple suppliers at competitive prices. Hospitals and other end-users contract with the GPO of their choice for their purchasing needs. In 2025, the amount of revenue we received from end-user customers that are members of GPOs increased significantly. Establishing and maintaining strong relationships with these GPOs will require us to be a reliable supplier, remain price competitive and comply with FDA regulations. The GPOs with whom we have relationships may have relationships with manufacturers that sell competing products, and such GPOs may earn higher margins from these products or combinations of competing products or may prefer products other than ours for other reasons. If we are unable to establish or maintain our GPO relationships, sales of our products and related revenues could be negatively impacted. The United States market size for Ameluz for the treatment of AK may be smaller than we have estimated. The public data regarding the market for AK treatments in the United States may be incomplete. Therefore, some of our estimates and judgments are based on various sources which we have not independently verified and which potentially include outdated information, or information that may not be precise or correct, potentially rendering the United States market size for treatment of AK with Ameluz smaller than we have estimated, which may reduce our potential and ability to increase sales of Ameluz and revenue in the United States. Although we have not independently verified the data obtained from these sources, we believe that such data provide the best available information relating to the present market for AK treatments in the United States, and we often use such data for our business and planning purposes. Even if we obtain additional regulatory approvals extending our products’ indications, they may not gain market acceptance or become widely accepted among hospitals, physicians, health care payors, patients and others in the medical community. Future indications for Ameluz may not receive wide acceptance among hospitals, physicians, health care payors, patients and others in the medical community. Market acceptance of any of these indications for our products depends on a number of factors, including: ● the product labeling, including warnings, precautions, side effects, and contraindications that the FDA or other regulatory authorities approve; ● the potential and perceived advantages of our product candidates over alternative products or therapies; ● relative convenience and ease of administration; ● the effectiveness and compliance of our sales and marketing efforts; ● acceptance by major operators of hospitals, physicians and patients of our products or candidates as a safe and effective treatment; ● the prevalence and severity of any side effects; ● product labeling or product insert requirements of the FDA or other regulatory authorities; ● any Risk Evaluation and Mitigation Strategy that the FDA might require for our drug product candidates; ● the timing of market introduction of our product or product candidates as well as competitive products; ● the perceived advantages of our products over alternative treatments; ● the cost of treatment in relation to alternative products; and ● the availability of adequate reimbursement and pricing by third party payors and government authorities, including any conditions for reimbursement required by such third-party payors and government authorities. 21 If future indications for Ameluz are approved but fail to achieve market acceptance among physicians, patients, payors, or others in the medical community in the United States, we may not be able to significantly increase our revenues, which could have an adverse effect on our business, prospects, financial condition and results of operations. We are subject to extensive laws and regulations. Our failure to comply with those laws and regulations could have a material adverse effect on our business, reputation, results of operations, and financial condition. We are subject to extensive laws and regulation by governmental authorities in the United States and Germany. Such laws and regulations relate to healthcare, manufacturing, state and federal anti-kickback rules, anti-corruption, federal false claims, privacy, security, financial disclosure, anti-trust, Physician Payment Sunshine Act reporting, fair trade, marketing, and advertising, among others. Any government investigation of alleged violations of laws or regulations could require that we expend significant time and resources in response and could generate negative publicity. If our operations are found to be in violation of any of such laws or any other governmental regulations that apply to us, we may be subject to penalties, including, but not limited to, civil and criminal penalties, sanctions. damages, fines, warning letters, product seizures, recalls, injunctions, suspension, shutdown of production, withdrawal or revocation of regulatory approvals, the curtailment or restructuring of our operations, the exclusion from participation in federal, state or other healthcare programs and imprisonment, any of which could adversely affect the value of our company, our results of operations and financial condition, and our ability to operate our business commercialize and generate revenues from our products. For a discussion of manufacturing regulations and requirements applicable to our business and related risks, see the section entitled “ If we or our manufacturing partners, as applicable, fail to manufacture Ameluz , RhodoLED Lamps, or other marketed products in sufficient quantities and at acceptable quality and cost levels, or to fully comply with cGMP or other applicable manufacturing regulations, we may face a bar to, or delays in, the commercialization of our products or be unable to meet market demand, and lose potential revenues ” included above in this Item 1A. A recall of our drug or medical device products, or the discovery of serious safety issues with our drug or medical device products, could have a significant negative impact on us. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of an unacceptable risk to health, component failures, manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of our products would divert managerial and financial resources and have an adverse effect on our reputation, financial condition and operating results, which could impair our ability to market, sell or produce our products in a cost-effective and timely manner. In February 2024, our former licensor of Ameluz, initiated a voluntary recall of a limited number of lots of Ameluz due to a manufacturing defect in the impacted product’s packaging, which is provided by an unaffiliated supplier. The licensor confirmed that the recalled product is not likely to cause adverse health consequences. We promptly notified all impacted physician customers of this recall and arranged for the prompt replacement of the recalled products. Further, under the FDA’s medical device reporting, or MDR, regulations, we are required to report to the FDA any event which reasonably suggests that our product may have caused or contributed to a death or serious injury or in which our product malfunctioned and, if the malfunction of the same or similar device marketed by us were to recur, would likely cause or contribute to death or serious injury. The FDA also requires reporting of serious, life-threatening, unexpected and other adverse drug experiences and the submission of periodic safety reports and other information. Product malfunctions or other adverse event reports may result in a voluntary or involuntary product recall and other adverse actions, which could divert managerial and financial resources, impair our ability to market, sell or manufacture our products in a cost-effective and timely manner and have an adverse effect on our reputation, financial condition and operating results. Any adverse event involving our products could result in future voluntary corrective actions, such as recalls or customer notifications, or regulatory agency action, which could include inspection, mandatory recall or other enforcement action. Any corrective action, whether voluntary or involuntary, will require the dedication of our time and capital, distract our management from operating their business and may harm our reputation and financial results as well as threaten our marketing authority for such products. We are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may be unable to successfully implement our business strategy. Our ability to compete in the highly competitive pharmaceutical industry depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel with specialized scientific and technical skills. We are highly dependent on our management, scientific, medical and operations personnel, including Prof. Dr. Hermann Luebbert, our Chief Executive Officer and Chairman and Fred Leffler, our Chief Financial Officer. The loss of the services of any of our executive officers or other key employees and our inability to find suitable replacements could potentially harm our business, prospects, financial condition or results of operations. Despite our efforts to retain valuable employees, members of our management team may terminate their employment with us on short notice. Although we have, or are in the process of negotiating, employment agreements with our key employees, these employees could leave our employment at any time, with certain notice periods. We do not maintain “key man” insurance policies on the lives of these individuals or the lives of any of our other employees. Our success also depends on our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers as well as junior, mid-level and senior scientific and medical personnel and sales representatives. Many of the other biotechnology and pharmaceutical companies that we compete against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than we do. They may also provide more diverse opportunities and better chances for career advancement. Some of these characteristics may be more appealing to high quality candidates than what we can offer. If we are unable to continue to attract and retain high quality personnel, our ability to commercialize our products will be limited. 22 We will need to grow the size of our organization and we may experience difficulties in managing this growth. As of December 31, 2025, we had 92 employees. In the longer term, as our development and commercialization plans and strategies develop, and as we continue operating as a public company, we expect to need additional managerial, operational, sales, marketing, financial and other personnel. Future growth would impose significant added responsibilities on members of management, including: ● identifying, recruiting, integrating, maintaining and motivating existing or additional employees; and ● improving our operational, financial and management controls, reporting systems and procedures. Our future financial performance and our ability to commercialize and market our products will depend, in part, on our ability to effectively manage any future growth, and our management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities. If we are not able to effectively expand our organization by hiring new employees and expanding our groups of consultants and contractors, we may not be able to successfully implement the tasks necessary to commercialize our products and, accordingly, may not achieve our commercialization goals. Due to our ongoing assessment of the size of the required sales force, we may be required to hire substantially more sales representatives to adequately support the commercialization and marketing of our products or we may incur excess costs as a result of hiring more sales representatives than necessary. We may be competing with companies that currently have extensive and well-funded marketing and sales operations. Our business and operations would suffer in the event of system failures or cyber-attacks. Despite the implementation of security measures, our internal computer systems and those of our current and future contract and research organizations, licensors, and other contractors and consultants are vulnerable to damage from breaches of information systems, attempts to access information, including customer and company information, information relating to our clinical trials, malicious code, theft, misuse, loss, release, or destruction of data (including confidential customer information), account takeovers, unavailability of service, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. Further, these risks may be exacerbated by recent developments in artificial intelligence and its increased use to produce sophisticated malware, phishing schemes, and other fraudulent activities. While we have not experienced any such material system failure or cyber-related incident, if such an event were to occur and cause interruptions in our operations, it could (i) materially disrupt our development programs. The proper functioning of our networks and systems and therefore our business operations and those of our customers; (ii) result in the unauthorized access to, and destruction, loss, theft, misappropriation, or release of confidential, sensitive, or otherwise valuable information of ours or our customers; (iii) result in a violation of applicable privacy, data protection, and other laws, subjecting us to additional regulatory scrutiny and exposing us to civil litigation, enforcement actions, governmental fines, and possible financial liability; (iv) require significant management attention and resources to remedy the damages that result; or (v) harm our reputation or cause a decrease in the number of customers that choose to do business with us. The occurrence of any of the foregoing could have a material adverse effect on our business, financial condition, and results of operations. Furthermore, in the event of a cyber-related incident, we may be delayed in identifying or responding to the incident, which could increase the negative impact of the incident on our business, financial condition, and results of operations. To the extent that any disruption or cyber-related incident were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development and commercialization of our products and product candidates could be delayed. 23 If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products. We face an inherent risk of product liability as a result of the clinical testing of our products and face an even greater risk if we commercialize our products on a larger scale. For example, we may be sued if our products allegedly cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing; defects in design; a failure to warn of dangers inherent in the product, negligence, strict liability; and a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our products and product candidates. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in: ● costs to defend litigation and other proceedings; ● a diversion of management’s time and our resources; ● decreased demand for our products; ● injury to our reputation; ● withdrawal of clinical trial participants; ● decreased enrollment rates of clinical trial participants; ● termination of clinical trial sites or entire trial programs; ● initiation of investigations by regulators; ● product recalls, withdrawals or labeling, marketing or promotional restrictions; ● loss of revenue; ● substantial monetary awards to trial participants or patients; ● exhaustion of any available insurance and our capital resources; ● the inability to commercialize our products; and ● a decline in our share price. We currently maintain product liability insurance. If such insurance is not sufficient, or if we are not able to obtain such insurance at an acceptable cost in the future, potential product liability claims could prevent or inhibit the commercialization of our products and any products we license in the future. A successful claim could materially harm our business, financial condition or results of operations. Additionally, we cannot guarantee that continued product liability insurance coverage will be available in the future at acceptable costs. 24 Our subsidiary and certain third-party employees are subject to foreign laws. All employees of our wholly owned subsidiary, Biofrontera Discovery GmbH, and a majority of the employees and former employees of Biofrontera AG, our former licensor, work in Germany and are subject to German employment law. Ideas, developments, discoveries and inventions made by such employees and consultants are subject to the provisions of the German Act on Employees’ Inventions, which regulates the ownership of, and compensation for, inventions made by employees. We face the risk that disputes can occur between us, our employees, Biofrontera AG, and/or Biofrontera AG’s former employees (many of whom are now employees of Biofrontera Discovery, GmbH) pertaining to alleged non-adherence to the provisions of this act that may impact our ability to commercialize our products. There is a risk that the compensation that we or Biofrontera AG provided to employees who assign patents may be deemed to be insufficient. German law may require that the compensation due to such employees for the use of the patents is increased. In those cases where employees have not assigned their interests, we may need to pay compensation for the use of those patents. If we are required to pay additional compensation or face other disputes under the German Act on Employees’ Inventions, the impact on us could adversely affect our results of operations. Third party claims of intellectual property infringement may affect our ability to sell our products and may also prevent or delay our product discovery and development efforts. Our commercial success depends in part on avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation involving patents and other intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference and reexamination proceedings before the USPTO, or oppositions and other comparable proceedings in foreign jurisdictions. Recently, following United States patent reform, new procedures including inter partes review and post grant review have been implemented. This reform includes changes in law and procedures that are untried and untested and will bring uncertainty to the possibility of challenge to our patents, as well as our ability to challenge the patents of others, in the future. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our products may give rise to claims of infringement of the patent rights of others. Third parties may assert that we are employing their proprietary technology without authorization. There may be third party patents of which we are currently unaware with claims to materials, formulations, devices, methods of manufacture or methods for treatment related to the use or manufacture of our products. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our products or product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringe upon such patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our pharmaceutical products and medical devices, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize our products unless we obtained a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our medical devices, formulations of our pharmaceutical products, processes for manufacture, or methods of use (including combination therapy or patient selection methods), the holders of any such patent may be able to block our ability to commercialize the product unless we obtained a license or until such patent expires or is finally determined to be held invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all. If we are unable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, our ability to commercialize our products may be impaired or delayed, which could in turn significantly harm our business. Parties making claims against us may seek and obtain injunctive or other equitable relief, which could effectively block our ability to sell our products and to further commercialize our products. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure. We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, we may need to obtain licenses from third parties to advance their research or allow commercialization of our products. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, we would be unable to further commercialize our products, which could harm our business significantly. Biofrontera has been served with complaints alleging patent infringement. See Note 20. Commitments and Contingencies – Legal Claims for more information regarding these cases . 25 The results of our R&D efforts are uncertain and there can be no assurance they will enhance the commercial success of our products. We believe that we will need to incur additional R&D expenditures to improve the capabilities of our RhodoLED Lamps to better fulfill the needs of dermatologists and may also incur R&D expenditures to develop new products. The products we are developing and may develop in the future may not be technologically successful. At this time, we have limited internal R&D personnel, which makes us dependent on consulting relationships. In addition, the length of our product development cycle may be greater than we originally expected, and we may experience delays in product development. If our resulting products are not technologically successful, they may not achieve market acceptance or compete effectively with our competitors’ products and services. Risks Related to Our Financial Position and Capital Requirements There is substantial doubt about our ability to continue as a “going concern”. In connection with our assessment of going concern considerations under applicable accounting standards, the Company’s management has determined that substantial doubt exists about our ability to continue as a going concern for at least one year from the date the consolidated financial statements were issued. The future viability of the Company is dependent on its ability to continue to execute its growth plan or raise additional capital or find financing until cash flow from operations is sufficient, if ever. As of March 11, 2026, our unaudited cash was $3.6 million. There can be no guarantee that the Company will be successful in raising additional capital or finding alternative methods of financing. If the Company is not successful in these endeavors, it would likely have a material adverse effect on the Company’s business, results of operations and financial condition. See Note 1. Organization and Business Overview - Liquidity and Going Concern for additional information. We have a history of operating losses and anticipate that we will continue to incur operating losses in the future and may never sustain profitability. We have incurred losses in each year since inception. As of December 31, 2025, we had an accumulated deficit of $127.9 million. Our ability to become profitable depends on our ability to further commercialize our principal product, Ameluz. Even if we are successful in increasing our product sales, we may never achieve or sustain profitability. In the long term, we anticipate increasing our sales and marketing expense as we attempt to exploit the regulatory approvals to market Ameluz in the United States for the PDT treatment of AKs of mild-to-moderate severity on the face and scalp. There can be no assurance that our sales and marketing efforts will generate sufficient sales to allow us to become profitable. Moreover, because of the numerous risks and uncertainties associated with commercializing pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if ever. 26 We will likely engage in additional equity or debt financing in the future, which could dilute the voting rights of stockholders and the value of their shares. If we are unable to achieve profitability over time or to obtain additional equity or debt financing in such a scenario, this would have a material adverse effect on our financial condition. If we fail to obtain additional financing, we may be unable to pursue our plans for strategic growth. Our operations have consumed substantial amounts of cash since inception. Going forward, we expect that we will require significant funds in order to pursue our plans for strategic growth, We have entered into various financing arrangements to raise capital since our inception. However, we will still need to raise additional capital through debt or equity financing in order to support our operating, investing and financing activities of the Company during the current fiscal year. Our future funding requirements, both near- and long-term, will depend on many factors, including, but not limited to: ● the effects of competing technological and market developments; ● the cost and timing of completion of commercial-scale manufacturing activities; ● the cost of establishing or maintaining sales, marketing and distribution capabilities for Ameluz PDT or other products or potential products in the United States ● the timing of regulatory approvals, demand for our products, our ability to market and sell our products and other matters. We cannot be certain that additional funding for any purpose will be available to us on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts and on terms acceptable to us, we may have to significantly delay, scale back or discontinue the commercialization of our products or other plans for strategic growth. We also could be required to license our rights to our products and product candidates to third parties on unfavorable terms. In addition, any equity financing would likely result in dilution to holders of our securities, and any debt financing would likely involve significant cash payment obligations and include restrictive covenants that may restrict our ability to operate our business. Any of the above events could prevent us from realizing business opportunities or prevent us from growing our business or responding to competitive pressures, which could have a material adverse effect on our business, prospects, financial condition and/or results of operations and could cause the price of our shares to decline. Our existing and any future indebtedness could adversely affect our ability to operate our business. The Company funds its operations, in part, with borrowed funds. Our existing and future indebtedness could have significant adverse consequences, including: ● requiring us to dedicate a portion of our cash to the payment of interest and principal, reducing money available for working capital, capital expenditure, product development and other general corporate purposes; ● increasing our vulnerability to adverse changes in general economic, industry and market conditions; ● increasing the risk of dilution to the holders of our shares in the event any note(s) are exercised for or converted into our ordinary shares; ● limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and ● placing us at a competitive disadvantage to competitors that are better capitalized than we are. The Notes contain restrictive covenants that, among other things, generally limit the ability of the Company and its subsidiaries to (i) create liens, (ii) pay dividends, acquire shares of capital stock and make payments on subordinated debt, (iii) incur indebtedness, or (iv) enter into transactions with affiliates. The foregoing restrictive covenants are subject to a number of important exceptions and qualifications, as set forth in the Notes. The Notes are secured by substantially all property of the Company, including but not limited to the Company’s assets, inventory, intellectual property and accounts. See Note 14. Debt , for additional information regarding our existing indebtedness . 27 Failure to make payments or comply with covenants under such debt could result in an event of default and acceleration of amounts due. If an event of default occurs and the lender or lenders accelerate the amounts due, we may not be able to make accelerated payments, and such lenders could file suit against us to collect the amounts due under such obligations or pursue other remedies. In addition, the covenants under such debt obligations could limit our ability to obtain additional debt financing. If we are unable to satisfy such debt obligations it could have material adverse effect on our business, prospects, financial condition and/or results of operations. Risks Related to Clinical Trials and Regulatory Approvals of Indication Expansion Delay or termination of planned clinical trials for expanding the indications of Ameluz would result in unplanned expenses and significantly and adversely impact our remaining developmental activities and potential commercial prospects with respect to, and ability to generate revenues from, such indications. We may experience delays in completing ongoing trials and initiating planned trials, and we cannot be certain whether these trials or any other future clinical trials for expanding the indications of Ameluz will be completed on schedule, if at all. Clinical trials can be delayed or terminated for a variety of reasons, including delays or failures related to: ● disagreements with regulators as to the design or implementation of our clinical trials; ● agreeing on acceptable terms with prospective CROs, clinical trial sites, and prospective strategic partners, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs, trial sites and partners; ● obtaining institutional review board (“IRB”) approval at each site; ● adverse events occurring in clinical studies; ● our ability to enroll a sufficient number of suitable patients who remain in the trial until its conclusion; ● having patients complete a trial or return for post-treatment follow-up; ● clinical sites deviating from trial protocols; ● how we address patient safety concerns that arise during the course of a trial; ●adding a sufficient number of clinical trial sites; ● manufacturing sufficient quantities of products for use in clinical trials; ● utilizing an adequate container and delivery device for the product; ● changes to our financial priorities or insufficient capital available to fund clinical trials; or ● suspension of trials by us, by the IRBs of the institutions in which such trials are being conducted, by the Data Safety Monitoring Board (“DSMB”), for such trial, or by regulatory authorities. If we experience delays in the completion of, or the termination of, our clinical trials, we may experience increased costs and/or have difficulty raising capital, either of which would cause us to have to delay our product development and regulatory approval process timelines. Further, the commercial prospects of the expanded indications of our products may be harmed, and our ability to generate product revenues from any of these indications could be delayed or not realized at all. Any of these occurrences may significantly harm our business, financial condition and prospects. 28 Our products may pose safety issues, cause adverse events, have side effects or have other properties that could delay or prevent the regulatory approval of additional indications, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of adverse events or unexpected characteristics. We, any partner with whom we may collaborate, or the FDA may suspend, delay, require modifications to or terminate our clinical trials at any time, for various reasons, including the discovery of serious or unexpected toxicities or other safety issues experienced by trial participants. In addition, adverse events caused by our products could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approvals by the FDA. Treatment-related adverse events could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. In addition, these adverse events may not be appropriately recognized or managed by the treating medical staff. Any of the foregoing events could prevent us from obtaining regulatory approval for expanded indications of our products and from achieving or maintaining market acceptance of our products for some or all indications, and may result in the failure to realize significant revenues, which would materially and adversely affect our results of operations and business. The regulatory approval processes of the FDA are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for additional indications of our products on a timely basis or at all, our business could be substantially harmed. We are not permitted to market any indication of our product in the United States for which we have not received applicable regulatory approval. The time required to obtain approval by the FDA is unpredictable, lengthy, and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of clinical testing for expanded indications. Prior to obtaining marketing approval for additional indications of a product in the United States, we must demonstrate, with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA, that the product is safe and effective for the target indication. The FDA can delay, limit or deny approval of additional indications of our products or require us to conduct costly additional clinical testing or abandon a program for many reasons, including: ● disagreements with regulators as to the design or implementation of our clinical trials; ● unfavorable or ambiguous results from our clinical trials; ● results that may not meet the level of statistical significance required by the FDA for approval; ● serious and unexpected drug-related adverse events experienced by participants in our clinical trials or by individuals using drugs similar to our products; ● our inability to demonstrate to the satisfaction of the FDA that our products are safe and effective for the proposed indication; ● the FDA’s disagreement with the interpretation of data from clinical trials; ● our inability to demonstrate that the clinical and other benefits of our products outweigh any safety or other perceived risks; ● the FDA’s disagreement regarding the formulation, container, dosing delivery device, labeling or the specifications of our products; ● the FDA’s failure to approve the manufacturing processes or facilities of third-party manufacturers with which we contract; or ● the potential for approval policies or regulations of the FDA to significantly change in a manner rendering our clinical data insufficient for approval. 29 Of the large number of drugs in development, only a small percentage successfully complete the FDA approval process and become commercialized. The lengthy approval process as well as the unpredictability of outcomes from future clinical trials may result in our failing to obtain regulatory approval to market our products for additional indications. The FDA also may approve a more limited indication than we target, and the FDA may not approve the labeling that we believe is necessary or desirable for the successful commercialization of our products. Any delay in obtaining, or inability to obtain, in whole or in part, applicable regulatory approval for additional indications we are targeting would hinder the commercialization of our products, which would limit our ability to increase our revenues, materially and adversely affecting our results of operations and business. We rely on third parties to conduct some of our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval to extend the indications of our products. The FDA requires us to comply with regulations and standards, commonly referred to as good clinical practice, or GCP, requirements for conducting, monitoring, recording and reporting the results of clinical trials, in order to ensure that the data and results are scientifically credible and accurate and that the trial subjects are adequately informed of the potential risks of participating in clinical trials. We rely on medical institutions, independent clinical investigators, contract laboratories and other third parties, such as CROs, to conduct GCP-compliant clinical trials on our products properly and on time. Although we rely on these third parties to conduct GCP-compliant clinical trials, we remain responsible for ensuring that each of our GCP clinical trials is conducted in accordance with its investigational plan and protocol and applicable laws and regulations. These third parties play a significant role in the conduct of these trials and the subsequent collection and analysis of data. While we have agreements governing their activities, we control only certain aspects of their activities and have limited influence over their actual performance or control over the amount or timing of resources that they devote to our programs. If the third parties conducting our GCP clinical trials do not perform their contractual duties or obligations, experience work stoppages, do not meet expected deadlines, terminate their agreements with us or otherwise need to be replaced, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical trial protocols or for any other reason, we may need to enter into new arrangements with alternative third parties. This could be difficult, costly or impossible, and our clinical trials may need to be extended, delayed, terminated or repeated. As a result, we may not be able to obtain regulatory approval in a timely fashion, or at all, for the applicable indication, our financial results and the commercial prospects for our products would be harmed, our costs could increase, and our ability to generate additional revenues could be delayed. In addition, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and may receive compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, or the FDA concludes that the financial relationships may have affected the interpretation of the trial, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection by the FDA of regulatory approval of additional indications. Any such delay or rejection could prevent us from commercializing expanded indications of our products. Risks Related to Corporate Governance, Including Being a Public Company If we fail to maintain an effective system of internal controls, our ability to produce timely and accurate financial statements may be impaired, investors may lose confidence in our financial reporting, and the price of our common stock may decline. We are subject to the reporting requirements of the Exchange Act and other laws and regulations applicable to public companies. These laws and regulations require, among other things, that we maintain effective procedures and internal control over financial reporting and disclosure controls. We engage in continuous improvement of our internal control over financial reporting, disclosure controls, and other procedures designed to provide assurance that information we disclose in our consolidated financial statements and in the reports that we file with the SEC is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and information required to be disclosed in reports under the Exchange Act is accumulated and communicated to our principal executive and financial officers. Our current controls and any new controls we develop may become inadequate because of changes in conditions in our business. If we identify material weaknesses in the future or otherwise fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and, as a result, our stock price. Any failure to develop or maintain effective internal control over financial reporting and disclosure controls, or any difficulties encountered in their implementation or improvement, could result in a restatement of our consolidated financial statements for prior periods, cause us to fail to meet our financial and other reporting obligations, result in an adverse opinion regarding our internal control over financial reporting from our independent registered public accounting firm, and lead to investigations or sanctions by regulatory authorities. Any of the foregoing could have a material adverse effect on our business, results of operations, and financial condition, and could cause our investors to lose confidence in the accuracy and completeness of our financial reports and the price of our common stock to decline. 30 Risks Related to Our Securities and Ownership of Our Common Stock Our share price may be volatile, and you may be unable to sell your shares and/or warrants at or above the offering price. The market price of our common stock is likely to be volatile and could be subject to wide fluctuations in response to many risk factors discussed in this section and elsewhere throughout this Form 10-K. More specifically, we expect our operating results to be subject to quarterly fluctuations due to (in part) seasonality in the demand for traditional PDT treatment using a lamp and the level of underlying demand for Ameluz and customers’ buying patterns. If our quarterly operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. Others factors beyond our control that may lead to volatility in our share price include: ● the success of existing or new competitive products or technologies; ● regulatory actions with respect to Ameluz, the BF-RhodoLED lamp (and its successors) or our competitors’ products; ● actual or anticipated fluctuations in our financial condition and operating results, including fluctuations in our quarterly and annual results; ● announcements of innovations by us or our competitors; ● overall conditions in our industry and the markets in which we operate; ● market conditions or trends in the biotechnology industry or in the economy as a whole; ● addition or loss of significant healthcare providers or other developments with respect to significant healthcare providers; ● changes in laws or regulations applicable to Ameluz, the BF-RhodoLED lamp (and its successors); ● actual or anticipated changes in our growth rate relative to our competitors; ● announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments; ● additions or departures of key personnel; ● issuance of new or updated research or reports by securities analysts; ● fluctuations in the valuation of companies perceived by investors to be comparable to us; ● disputes or other developments related to the patents covering our products, and our ability to obtain intellectual property protection for our products; ● security breaches; ● litigation matters; ● announcement or expectation of additional financing efforts; ● sales of our common stock by us or our stockholders; ● share price and volume fluctuations attributable to inconsistent trading volume levels of our shares; ● the expiration of contractual lock-up agreements with our executive officers, directors and stockholders; and ● general economic and market conditions. Furthermore, the stock markets have experienced price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies. These fluctuations often have been unrelated or disproportionate to the operating performance of those companies. These broad market and industry fluctuations, as well as general economic, political and market conditions such as recessions, interest rate changes or international currency fluctuations, may negatively affect the market price of our common stock. In the past, companies that have experienced volatility in the market price of their stock have been subject to securities litigation. This risk is especially relevant for biopharmaceutical companies, which have experienced significant stock price volatility in recent years. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which could seriously significantly harm our business. 31 If we fail to regain and maintain compliance with applicable listing standards, our common stock and publicly-traded warrants could be delisted from Nasdaq. Nasdaq requires listing issuers to comply with certain standards in order to remain listed on its exchange. The Company has, on multiple occasions, received notices of non-compliance from Nasdaq and each time been given the ability to regain compliance. On December 31, 2025, we received a letter (the “Notice”) from the Listing Qualifications Department of Nasdaq notifying the Company that the listing of its common stock was not in compliance with Nasdaq Listing Rule 5550(a)(2), as the closing bid price of the Company’s common stock was less than $1.00 per share for the previous 34 consecutive business days. Under Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until June 30, 2026, to regain compliance with Rule 5550(a)(2). To regain compliance, during this 180-day compliance period, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive business days. If, for any reason, Nasdaq should delist our common stock from trading on its exchange and we are unable to obtain listing on another reputable national securities exchange, a reduction in some or all of the following may occur, each of which could materially adversely affect our stockholders: ● the liquidity and marketability of our common stock and/or publicly traded warrants; ● the market price of our common stock; ● our ability to obtain financing for the continuation of our operations; ● the number of institutional and general investors that will consider investing in our common stock; ● the number of market makers in our common stock; ● the availability of information concerning the trading prices and volume of our common stock; and ● the number of broker-dealers willing to execute trades in shares of our common stock. In addition, if we fail to regain and maintain compliance to be eligible to trade on Nasdaq or obtain listing on another reputable national securities exchange, we may have to pursue trading on a less recognized or accepted market, such as the over the counter markets, our stock may be traded as a “penny stock” which would make transactions in our stock more difficult and cumbersome, and we may be unable to access capital on favorable terms or at all, as companies trading on alternative markets may be viewed as less attractive investments with higher associated risks, such that existing or prospective institutional investors may be less interested in, or prohibited from, investing in our common stock. This may also cause the market price of our common stock to further decline. We have issued several warrants, which are exercisable for our common stock, and issued Convertible Preferred Stock, which, if exercised or converted, as applicable, could substantially increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders. As of March 16, 2026, we have a total of 2,269,356 outstanding warrants which may each be exercised for one share of our common stock. In addition, we have shares of Series B-2 and Series B-3, Convertible Preferred Stock (“Series B Preferred Stock”), Series C Convertible Preferred Stock (“Series C Preferred Stock”) and Series D Convertible Preferred Stock (“Series D Preferred Stock”). See Note 17. Stockholders’ Equity and Note 19. Net Loss Per Share in our consolidated financial statements for additional details. All of the shares issuable upon exercise of these warrants or the conversion of the Series B Preferred Stock and Series C Preferred Stock have been registered on effective registration statements and therefore, when issued, will be freely tradable without restriction or further registration required under the Securities Act. Any shares of our common stock issued upon exercise of outstanding warrants or conversion of the Series B, Series C and Series D convertible preferred stock will result in dilution to the then existing holders of our common stock and increase the number of shares eligible for resale in the public market. Future sales and issuances of our common stock or rights to purchase our common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause the stock price of our common stock to decline. In the future, we may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. We also expect to issue common stock to employees, consultants and directors pursuant to our equity incentive plans. If we sell common stock, convertible securities or other equity securities in subsequent transactions, or common stock is issued pursuant to equity incentive plans or the Unit Purchase Option, investors may be materially diluted. New investors in such subsequent transactions could gain rights, preferences and privileges senior to those of holders of our common stock. 32 Certain provisions of our outstanding warrants, our charter documents, and Delaware law could prevent a takeover that stockholders consider favorable and could also reduce the market price of our stock. Our amended and restated certificate of incorporation and our amended and restated bylaws contain provisions that could delay or prevent a change in control of the Company. These provisions could also make it more difficult for stockholders to elect directors and take other corporate actions. These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management. Furthermore, certain provisions of our outstanding warrants could also make it more difficult or expensive for a third party to acquire us. The warrants prohibit us from engaging in certain transactions constituting “fundamental transactions” unless, among other things, the surviving entity assumes our obligations under the warrants. In addition, we are subject to the anti-takeover provisions contained in Section 203 of the Delaware General Corporation Law, or the DGCL. Under Section 203 of the DGCL, a corporation may not, in general, engage in a business combination with any holder of 15% or more of its capital stock unless the holder has held the stock for three years or, among other exceptions, the board of directors has approved the transaction. These and other provisions in our amended and restated certificate of incorporation and our amended and restated bylaws and under Delaware law could discourage potential takeover attempts, reduce the price investors might be willing to pay in the future for shares of our common stock and result in the market price of our common stock being lower than it would be without these provisions. Many of the warrants to purchase shares of our common stock are accounted for as a warrant liability and recorded at fair value with changes in fair value each period reported in earnings, which may have an adverse effect on the market price of our common stock. Under GAAP, we are required to evaluate the outstanding warrants to purchase our common stock to determine whether they should be accounted for as a warrant liability or as equity. At each reporting period (1) the accounting treatment of the warrants will be reevaluated for proper accounting treatment as a liability or equity and (2) the fair value of the liability of the warrants will be re-measured and the change in the fair value of the liability will be recorded as other income (expense) in our consolidated statement of operations. Such accounting treatment may adversely affect the market price of our securities. In addition, changes in the inputs and assumptions for the valuation model we use to determine the fair value of such liability may have a material impact on the estimated fair value of the warrant liability. As a result, our financial statements and results of operations will fluctuate quarterly, based on various factors, such as the share price of our common stock, many of which are outside of our control. If our share price is volatile, we expect that we will recognize non-cash gains or losses on our warrants or any other similar derivative instruments in each reporting period and that the amount of such gains or losses could be material. The impact of changes in fair value on earnings may have an adverse effect on the market price of our common stock. The warrants issued in connection with the private placement offerings (completed on December 1 , 2021, May 16, 2022, July 26, 2022, and November 2, 2023) (collectively, the “PIPE Warrants”) were accounted for as liabilities as these warrants provide for a redemption right in the case of a fundamental transaction which fails the requirement of the indexation guidance under ASC 815-40. The resulting warrant liabilities are re-measured at each balance sheet date until their exercise or expiration, and any change in fair value is recognized in the Company’s consolidated statement of operations. Refer to Note 3. Fair Value Measurements. As of the date of this Form 10-K, 2,192,736 liability classified Warrants remain outstanding. See Note 17. Stockholders’ Equity in our audited financial statements for the fiscal year ended December 31, 2025 and 2024 included in this Form 10-K for more information on the Warrants.