LPCN 10-K & 10-Q changes, risk factors and insider trading

LPCN 1154 is currently in development. There can be no assurance as to whether the results of the clinical trials in LPCN 1154 for postpartum depression will support ana 505(b)2 NDA submission submission, whether a paragraph IV patent certification will be required or whether an NDA submission will be accepted for reviewreview, or approved by the FDA for postpartum depression,FDA, including the oral route related brexanolone or its metabolites exposure profile relative to the reference injectable brexanolone. AlthoughDosing we have an agreement withand the FDAlast onpatient-last avisit 505(b)(2)in pathwaythe toPhase NDA submission, we will be required to undertake an additional3 safety and efficacy study in the patient population has andbeen possiblycompleted, additionalhowever clinical studie(s) including studies in addition to our pivotal study which was conducted in 2024 in post-menopausal women. Therethere can be no assurance that a safety and efficacy study will be initiated or that, if a study is completed, the results from the study will meet the primary endpoint. Further, there can be no assurance that additional studies will not be required, and if they are required that we will have sufficient resources to conduct conduct such additional studies to enable an NDA submission.

Commercialization of LPCN 1154 is likely highly dependent on us finding a partner to market and sell LPCN 1154, if approved. We are exploring the possibility of partnering LPCN 1154 to a third party for commercialization, however we may not be able to identify potential partners or successfully enter into partnership arrangements on terms favorable to us, if at all. We cannot be certain as to whether label language required by the FDA will require warnings, blackbox or otherwise, as to the safety or efficacy of LPCN 1154 which could negatively affect the commercialization of the LPCN 1154, if approved. If we are unable to successfully partner or otherwise commercialize, or develop and get a regulatory approval for LPCN 1154, LPCN 1154 may never be commercialized.

OurThere current LPCN 1154 505(b)(2) filing strategy includes referencing injectable brexanolone (Zulresso) as a listed drug. There can be no assurance there will not be any third-party patent infringement proceedings against us. Such proceedings could delay or prevent further development of LPCN 1154.

WeIn addition, we rely on thirda partythird-party vendorsvendor for our supply of brexanolone, the active pharmaceutical ingredient of LPCN 1154,1154. andIf our third-party supplier is not able to supply brexanolone on a third-partytimely manufacturer forbasis, or if the development and supplycost of commercialobtaining drugbrexanolone product of LPCN 1154. The loss of these third-party vendors could adversely affectincreases, our ability to successfully develop and commercialize LPCN 1154.1154 will be adversely affected.

Our oral NAS comprising program LPCN 2101 is in a very early stage of development and consequently the risk that we may fail to commercialize LPCN 2101 and related products is high. We have only conducted Phase 1 clinical studies of LPCN 2101 and the ultimate regulatory or technical success of the neuroactive steroidssteroid under investigation in thesethis programsprogram is uncertain. The current limited pre-clinical and phase 1 results results we have observed may not be replicated in larger studies, future PK, Phase 2, or pivotal studies with a potential “to be marketed marketed formulation.” We may not be able to further test in-clinic in a timely manner or at all due to other regulatory hurdles.

Our oral NAS comprising programs (includingprogram LPCN 2203) areis in a very early stage of development and consequently the risk that we may fail to commercialize LPCN 2203 and related products is high. We have only conducted Phase 1 clinical studies with the active pharmaceutical ingredient in LPCN 2203 and the ultimate regulatory or technical success of the neuroactive steroidssteroid under investigation in thesethis programs program is uncertain. The current limited pre-clinical and Phase 1 results we have observed may not be replicated in larger studies, future PK, Phase 2, or pivotal studies. We may not be able to further test in-clinic in a timely manner or at all due to other regulatory hurdles.

Our clinical product candidates are at an early stage of development and will require significant further investment and regulatory approvals prior to marketing and commercialization. As such, our product development processes for LPCN 1154, LPCN 2401,2201, LPCN 2101, LPCN 2203, andLPCN 2401, LPCN 1148, in addition to LPCN 1111, LPCN 1144, and LPCN 1107 are very risky and uncertain, and our product candidates may fail to advance beyond the current study. Even if we obtain required financing, we cannot ensure successful product development or that we will obtain regulatory approval or successfully commercialize or partner any of our product candidates and generate product revenues.

We areOur dependentbusiness depends, in part, on the commercial success of our licensed product, TLANDO, for royalty revenue and potential milestone payments.

TLANDO is currently our only product that has completed Phase 3 clinical trials. On February 1, 2024, we transitioned the commercialization of TLANDO to Verity from our previous licensee Antares. In January 2024, we entered into the Verity License Agreement with Verity, pursuant to which we granted Verity an exclusive, royalty-bearing, sublicensable right and license to develop and commercialize our TLANDO product with respect to TRT in the U.S. and Canada. None of our other products have been approved for sale. Therefore, at this stage, our ability to realize revenue depends on TLANDO’s successful commercialization. The commercial success of TLANDO in the U.S. and Canada depends almost entirely on Verity’s commercialization efforts and we have very limited ability to influence Verity’s efforts, including the amount and timing of resources they devote, if any, to the commercialization of TLANDO. On March 29, 2022, the FDA granted approval to TLANDO for testosterone replacement therapy in adult males indicated for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). Our ability to realize royalty revenue, will depend on the commercialization efforts of Verity. If Verity is not able to successfully commercialize TLANDO, we may not realize any royalty revenue under the Verity License Agreement and our business could be adversely affected. Additionally, regulatory approval of TLANDO may be withdrawn and the failure to maintain regulatory approvals would prevent TLANDO from being marketed and could have a material adverse effect on our business.

Under the PREA, our licensing partner, Verity, will need to address the PREA requirement to assess the safety and effectiveness of TLANDO in pediatric patients. The FDA required certain post-marketing studies including: (i) conducting an appropriately designed label comprehension and knowledge study that assesses patient understanding of key risk messages in the Medication Guide for TLANDO and (ii) conducting an appropriately designed one-year trial to evaluate development of adrenal insufficiency with chronic TLANDO therapy. Verity is responsible for conducting these post-marketing studies. The ramifications of the results of these studies conducted by Verity, or the ramifications of Verity’s inability or unwillingness to conduct these studies, are unknown to us and would be the between Verity and the FDA.

In September 2024, we entered into a distribution and license agreement for the development and commercialization of TLANDO in South Korea Korea with SPC andSPC, in October 2024, we entered into a distribution and supply agreement for TLANDO in the GCC countries with Pharmalink, and in PharmalinkApril Markets2025 we entered into a distribution and license agreement for the development and commercialization of TLANDO in Brazil. These markets for TLANDO outside the United States, including Canada, South Korea andKorea, the GCC countries.countries, Suchand marketsBrazil have requirements for approval of drug candidates with which our licensee(s) must comply prior to marketing. Obtaining regulatory approval for marketing of TLANDO in the United States or any other one country does not ensure we will be able to obtain regulatory approval in other countries, but a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in other countries.

If T-replacement T-replacement therapies are found, or are perceived, to create health risks, our ability to realize any revenue from TLANDO and LPCN 1111 could be materially adversely affected, and our business could be harmed. Physicians and patients may be deterred from prescribing and using T-replacement therapies, which could depress demand for TLANDO and compromise the successful commercialization of TLANDO.

TheOn March 29, 2022, the FDA approved TLANDO. As part of their approval, the FDA has also required that certain post-marketing studies be conducted to (i) assess patient understanding of key risks relating to TLANDO and (ii) evaluate development of adrenal insufficiency with chronic TLANDO therapy. Verity is responsible for conducting these post-marketing studies. Negative outcomes from such studies could adversely affect the ability of Verity to successfully commercialize TLANDO, which would adversely affect our ability to realize royalty revenue under the Verity License Agreement.

In addition, other legislative changes have been proposed and adopted since ACA was enacted. On August 2, 2011, the Budget Control Act of 2011, created, among other things, measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions reductions to Medicare payments to providers of up to 2% per fiscal year, starting in 2013. On January 2, 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. The Medicare Access and CHIP Reauthorization Act of 2015 was signed into law on April 16, 2015 and implemented the most significant change in Medicare reimbursement reimbursement since the ACA was enacted. This 2015 law authorizes a new Medicare pay –for-performancepay-for-performance reimbursement system for physicians, which will reward physicians for performance on metrics related to quality of care, resource use, meaningful use of electronic medical records, and clinical practice improvement activities. The Bipartisan Budget Act was enacted on November 2, 2015, and among provisions, restricts restricts the types of facilities that may receive hospital reimbursement under Medicare. The ACA also initially included premium tax credits that were designed to lower monthly insurance premiums for individuals and families. These newtax credits were initially expanded in 2021 and extended by the Inflation Reduction Act of 2022. However, these enhanced premium tax credits expired on December 31, 2025, and are expected to increase monthly health insurance premiums in the future for individuals and families. These laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on our customers and accordingly, our financial operations.

Furthermore, the Consolidated Appropriations Act, 2026, enacted in February 2026, introduced landmark federal PBM reforms. These include requirements for 100% rebate pass-through to certain plan sponsors and a transition toward de-linking PBM compensation from drug list prices in Medicare Part D. These shifts in PBM incentives may adversely affect our products’ formulary positioning and net pricing. The Centers for Medicare and Medicaid Services issued an interim final rule on November 20, 2020, that would tie prices for certain drugs under Medicare Part B to the lowest price for those drugs available in certain countries that are members of the Organization for Economic Co-operation Co-operation and Development. This rule was rescinded in December 2021.2021, but a similar rule was reproposed on December 23, 2025. If resurrected, any similar proposal could result in lower prices for pharmaceutical products in general.

The Inflation Reduction Act of 2022 (Pub. L. No. 117-169) was signed into law on August 16, 2022 and includes a number of provisions aimed at lowering prescription drug costs and reducing government spending on drugs. This includes a requirement that the Department of Health and Human Services negotiate a “maximum fair price” with drug manufacturers for certain single-source brand drugs or biologics without generic or biosimilar competitors that are covered under Medicare Part D and Part B. This pricing will beginbegan in 2026 for Medicare Part D and will begin in 2028 for Medicare Part B. An excise tax is imposed on drug manufacturers that fail to comply with the required negotiation process. In August 2023 the Biden Administration released the first round of drugs subject to this new Medicare Drug Pricing Negotiation Program. In addition, the law requires drug manufacturers to pay a rebate to the federal government if the price for almost all drugs covered under Medicare Part D (starting in 2022), and single-source drug or biologics covered under Medicare B (starting in 2023), increase greater than the inflation rate. The rebate amount equals the number of drug units sold in Medicare multiplied by the amount the drug’s price exceeds the inflation-adjusted price. The law also modifies the Medicare Part D benefit structure to cap the amount beneficiaries must spend on drug costs and increase the discounts manufacturers are required to pay. The Inflation Reduction Act of 2022 signals an increased desire to control the prices and costs associated with pharmaceutical products. A number of states have adopted drug affordability legislation legislation which permits a drug affordability board to implement or recommend upper payment limits for drugs identified as posing affordability challenges. As of January 1, 2026, the first round of ‘maximum fair prices’ negotiated under the Inflation Reduction Act became effective for ten high-spend Medicare Part D drugs. Additionally, several state-level Prescription Drug Affordability Boards have transitioned from study to enforcement, with states like Colorado and Maryland implementing their first “Upper Payment Limits” on specific therapies. The expansion of these federal and state pricing controls could significantly reduce our revenue potential. This legislation, as well as any future statutes or regulations at the federal or state level, may impact reimbursement for our product candidates and may challenge our ability to realize an appropriate return on our investment in research and product development. Any further legislative or administrative action to reduce reimbursement or health benefits to beneficiaries under the Medicare or Medicaid program could affect the payment we could collect from sale of any product in the United States.

Our Licensee partners’ ability to commercialize TLANDO or obtain marketing approval outside of the United States is uncertain. Our Licensee’sLicensees’ ability to successfully commercialize TLANDO is contingent upon numerous factors including, among other things, the completion of post-marketing studies, the availability of supplies, commercial acceptance by patients, the medical community, and third-party payors, and the resources that our Licensee devotes to the commercialization of TLANDO. In addition, our licensees’ commercialization activities may be adversely affected by tariffs and other restrictions on international trade, particularly with respect to the import of TLANDO for sale in the U.S. If our LicenseeLicensees isare unable to successfully commercialize TLANDO at scale, our business and operations could be adversely affected.

In order to market any products outside of the United States including South Korea andKorea, the GCC countries, weand Brazil, our licensees must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy.

Physicians often show a reluctance to switch their patients from existing drug products even when new and potentially more effective and convenient treatments enter the market. Also, physicians may be reluctant to switch patients if adequate reimbursement for new products is not available. In addition, patients often acclimate to the brand or type of drug product that they are currently taking and do not want to switch unless their physicians recommend switching products or they are required to switch drug treatments due to lack of reimbursement for existing drug treatments and only if the new product has adequate reimbursement. The existence of either or both of physician or patient reluctance in switching to our products wouldcould have an adverse effect on our operating results and financial condition.

Our licensing partner may face competition for TLANDO from lower priced T-replacement therapies from foreign countries that have placed price controls on pharmaceutical products. The Medicare Prescription Drug Improvement and Modernization Act of 2003 contains provisions that may change U.S. importation laws and expand pharmacists’ and wholesalers’ ability to import lower priced versions of an approved drug and competing products from Canada, where there are government price controls. These changes to U.S. importation laws will not take effect unless and until the Secretary of Health and Human Services certifies that the changes will pose no additional risk to the public’s health and safety and will result in a significant reduction in the cost of products to consumers. TheIn September 2020, the Secretary of Health and Human Services made the required certification, and the FDA subsequently issued a final rule to implement these importation Servicesprovisions. In January 2024, the FDA authorized the first state-run Section 804 Importation Program (“SIP”) for Florida. As of 2026, the FDA has notauthorized yetor announcedis anycurrently plansreviewing tosimilar makeprograms thisfor requiredseveral certification.other states, including Colorado and Maine.

A number of federal legislative proposals have been made to implement the changes to the U.S. importation laws without any certification and to broaden permissible imports in other ways. Even if the changes do not take effect, and other changes are not enacted, imports from Canada and elsewhere may continue to increase due to market and political forces, and the limited enforcement resources of the FDA, U.S. Customs and Border Protection and other government agencies. For example, Pub. L. No. 111-83, which was signed into law in October October 2009, provides appropriations for the Department of Homeland Security for the 2010 fiscal year, expressly prohibits U.S. Customs and and Border Protection from using funds to prevent individuals from importing from Canada less than a 90-day supply of a prescription drug drug for personal use, when the drug otherwise complies with the Federal Food, Drug, and Cosmetic Act. Further, several states and local governments governments have implemented importation schemes for their citizens, and,and infollowing the absenceFDA’s formal authorization of federalstate-run actionprograms, to curtail such activities,we we expect otheradditional states and local governments to seek and launch similar importation efforts. In April 2025, Executive Order 14273 further directed the FDA to streamline the SIP process to make it easier for states to obtain authorization, which may increase the volume of imported products entering the U.S. market.

On November 14, 2019, the Company and certain of its officers were named as defendants in a purported shareholder class action lawsuit, Solomon Abady v. Lipocine Inc. et al., 2:19-cv-00906-PMW, filed in the United States District Court for the District of Utah. The complaint alleges alleged that the defendants made false and/or misleading statements and/or failed to disclose that our filing of the NDA for TLANDO to the FDA contained deficiencies and as a result the defendants’ statements about our business and operations were false and misleading and/or lacked a reasonable basis in violation of federal securities laws. The lawsuit seekssought certification as a class action (for a purported class of purchasers of the Company’s securities from March 27, 2019 through November 8, 2019), compensatory damages in an unspecified amount, and unspecified equitable or injunctive relief. The Company filed a motion to dismiss the class action lawsuit on July 24, 2020. In response, the plaintiffs filed their response to the motion to dismiss the class action lawsuit on September 22, 2020 and the Company filed its reply to its motion to dismiss on October 22, 2020. A hearing on the motion to dismiss occurred on January 12, 2022. On April 14, 2023, a judgment was issued ordering the case dismissed with prejudice and closure of the action. Although this outcome was in favor of our current and former officers and directors, we incurred litigation costs and expended managerial resources defending ourselves against these allegations. In addition, there can be no assurance that we will not experience similar claims in the future.

Cyber security risks and the failure to maintain the integrity of company, employee or guestclinical data could expose us to data loss, litigation and liability, and our reputation could be significantly harmed.

Our drug development programs for our product candidates will require substantial additional cash to fund expenses. We have not yet established any collaborative arrangements relating to the development or commercialization of LPCN 1154, LPCN 2401,2201, LPCN 2101, LPCN 2203, LPCN 1144,2401, LPCN 1148, or LPCN 1107. We have entered into the Verity License Agreement for TLANDO and LPCN 1111 with respect to TRT in the U.S. and Canada. We intend to continue to develop our product candidates in the United States with or without a partner although our ability to advance these product candidates will depend on our capital resources and/or our ability to find a suitable partner to further develop our product candidates. In order to commercialize our TLANDO product candidates in the United States and Canada, we have partnered with Verity with respect to TLANDO and LPCN 1111 and we will likely look to establish partnership arrangements with respect to the development of some of our other product candidates. We may also seek to enter into collaborative arrangements to develop and commercialize our product candidates outside the United States and have partnered with SPC for South Korea andKorea, with Pharmalink for the GCC countries, countriesand with Aché for Brazil for TRT. We will face significant competition in seeking appropriate collaborators and these collaborations are complex and time-consuming to negotiate and document. We may not be able to negotiate collaborations on acceptable terms or in a timely manner, or at all. If that were to occur, we may have to curtail the development or delay commercialization of our product candidates in certain geographies, reduce the scope of our sales or marketing activities, reduce the scope of our development plans, or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities either inside or outside of the United States on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms, or at all.

Our ability to generate revenues from this and other collaborative arrangements, including with SPCSPC, Pharmalink, and Pharmalink,Aché will depend depend on our collaborators’ abilities and efforts to successfully perform the functions agreed to with them in these arrangements. License agreements and/or collaborations involving our drug candidates, such as our agreement with Verity, pose numerous risks to us, including the following:

We engaged a CRO to conduct our SOAR, DV and DF Phase 3 clinical studies for TLANDO, as well as the ABPM study for TLANDO. Additionally, we utilized a CRO for the Phase 2 LiFT clinical study for LPCN 1144, the Phase 2 clinical study for LPCN 1148 and the pilot, pivotal and futurePhase 3 studies for LPCN 1154. As a result, we have less direct control over the conduct of our clinical trials, the timing and completion of the trials and the management of data developed through the trials than if we were relying entirely upon our own staff. Communicating with outside parties can also be challenging, potentially leading to mistakes as well as difficulties in coordinating activities. Outside parties, including CROs, may:

We rely on limited suppliers for our supply of NAS, the active pharmaceutical ingredients of LPCN 1154, LPCN 2201, LPCN 2101, and LPCN 2203 and the loss of these limited suppliers could harm our business.

We rely on a limited third-party supplier for our supply of NAS, the active pharmaceutical ingredients of LPCN 1154, LPCN 2201, LPCN 2101, and LPCN 2203. Since there are only a limited number of NAS suppliers in the world, if a supplier ceases to provide us with NAS, we may be unable to procure NAS on developmental or commercially favorable terms. Furthermore, the limited number of suppliers of NAS may provide such such suppliers with a greater opportunity to raise their prices. If we are unable to obtain NAS in a timely manner and/or in sufficient quantities, our ability to develop and potentially commercialize LPCN 1154, LPCN 2201, LPCN 2101, and LPCN 2203 may be adversely affected.

As a public company, we incur significantly more legal, accounting and other expenses than as a private company. In addition, the Sarbanes-Oxley Act of 2002 and rules implemented by the SEC and U.S. stock exchanges impose numerous requirements on public companies, including requiring changes in corporate governance practices. Also, the Exchange Act requires, among other things, that we file annual, quarterly and current reports with respect to our business and operating results. Our management and other personnel will need to devote a substantial amount of time to compliance with these laws and regulations. These requirements have increased and willcould continue to increase our legal, accounting, and financial compliance costs and have made and will continue to make some activities more time-consuming and costly.

The stock prices of many companies in the biotechnology industry have experienced wide fluctuations that have often been unrelated to the operating performance of the companies. Following periods of volatility in the market price of a company’s securities, securities class action litigation often has been initiated against a company. For example, on July 1, 2016, the Company and certain of its officers were named as defendants in a purported shareholder class action lawsuit, David Lewis v. Lipocine Inc., et al., filed in the United States District Court for the District of New Jersey. This initial action was followed by additional lawsuits also filed in the District of New Jersey. David Lewis v Lipocine Inc., et al. was ultimately settled. Additionally on November 14, 2019, the Company and certain of its officers were named as defendants in a purported shareholder class action lawsuit, Solomon Abady v. Lipocine Inc. et al., 2:19-cv-00906-PMW, filed in the United District Court for the District of Utah. This initial action was followed by additional lawsuits also filed in the United States District Court for the District of Utah. Any future class action litigation that may be initiated against us may result in us incurring substantial costs and our management’s attention may be diverted from our operations, which could significantly harm our business. In addition, such litigation could lead to increased volatility in our share price.

The market price and trading volume of our common stock has been volatile over the past year, and it may continue to be volatile. During 2024,2025, our common stock has traded as low as $2.83$2.53 and as high as $10.69$8.03 per share. We cannot predict the price at which our common stock will trade in the future,future and it may decline. The price at which our common stock trades may fluctuate significantly and may be influenced by many factors, including our financial results; developments generally affecting our industry; general economic, industry and market conditions; the depth and liquidity of the market for our common stock; investor perceptions of our business; reports by industry analysts; announcements by other market participants, including, among others, investors, our competitors, and our customers; regulatory action affecting our business; and the impact of other “Risk Factors” discussed herein and in our Annual Report. In addition, changes in the trading price of our common stock may be inconsistent with our operating results and outlook. The volatility of the market price of our common stock may adversely affect investors’ ability to purchase or sell shares of our common stock.

We have focused a significant portion of our efforts on developing TLANDO and more recently on ourLPCN oral neuroactive steroids1154, LPCN 1154, LPCN 2101,1148 and LPCN 2203, in addition to LPCN 2401, and LPCN 1148.1144. We have funded our operations to date through sales of our equity securities, debt, and payments received under our license and collaboration arrangements. We have incurred losses in most years since our inception. As of December 31, 2024,2025, we had an accumulated deficit of $199.8 $209.4 million. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. These losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity and working capital.equity. We expect ourto continue to incur significant research and development expenses to increase in connection with clinical trials associated with our oral neuroactive steroids LPCN 1154, and potentially with LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148 and LPCN 2203,1107, and possible trials associated with LPCN 2401 and/or LPCN 1148, if further clinical trials are initiated. As a result, we expect to continue to incur significant operating losses for the foreseeable future as we evaluate further clinical development of LPCN 1154, LPCN 2401,2201, LPCN 2101, LPCN 2203, LPCN 2401, and possibly LPCN 1148 and LPCN 1107, in addition to our other programs and continued research efforts. Because of the numerous risks and uncertainties associated with developing pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if at all.

If any of our owned or licensed patents are found to be invalid or unenforceable, or if we are otherwise unable to adequately protect our rights, it could have a material adverse impact on our business and our ability to commercialize or license our technology and products. Additionally, we currently do not have patent protection for some of our product candidates in many countries, including large territories such as India, Russia, and China, and we will be unable to prevent unauthorized third parties from using our intellectual property in those countries unless we can file patent applications and obtain patents in those countries that cover our product candidates. Likewise, our United States patents covering certain technology used in our product candidates, including TLANDO,candidates are expected to expire on various dates through 2042. 2044. Upon the expiration of these patents, we will lose the right to exclude others from practicing these inventions to the extent that at those times we have no additional issued patents to protect our product candidates, including TLANDO. Additionally, if these are our only patents listed in the FDA Orange Book, should we have an FDA-approved and marketed product at that time, their expiration will mean that we lose certain advantages that come with Orange Book listing of patents. The expiration of these patents could also have a similar material adverse effect on our business, results of operations, financial condition and prospects. Moreover, if we are unable to commence or continue any action relating to the defense of our patents, we may be unable to protect our product candidates.

Our commercial success depends upon our ability and the ability of our collaborators to develop, manufacture, market and sell our product candidates and use our proprietary technologies without infringing the proprietary rights of third parties. Numerous U.S. and foreign patents and pending patent applications, which are owned by third parties, exist in the fields relating to our product candidates. As the biotechnology, pharmaceutical, and related industries expand and more patents are issued, the risk increases that others may assert that our product or product candidates infringe the patent rights of others. Moreover, it is not always clear to industry participants, including us, which patents cover various types of drugs, products or their formulations or methods of use. Thus, because of the large number of patents issued and patent applications filed in our fields, there may be a risk that third parties may allege they have patent rights encompassing our product, product candidates, technology, or methods. For example, on November 2, 2015, Clarus Therapeutics Holdings, Inc. (Clarus) filed a complaint against us in the United States District Court for the District of Delaware alleging that TLANDO would infringe the Clarus 428 Patent, and the complaint sought damages, declaratory and injunctive relief. On October 6, 2016, United States District Court of the District of Delaware granted our motion to dismiss the lawsuit filed by Clarus, because at the time there was no actionable infringement on Clarus’ 428 patent.

Periodic maintenance/annuity fees on our owned or licensed patents and patent applications are due to be paid to respective patent offices in several stages over the lifetime of the patents and applications. In addition, the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. There are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to enter the market and this circumstance wouldcould have a material adverse effect on our business.

This section and other parts of this report contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended,amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended,amended (the “Exchange Act”), that involve risks and uncertainties. Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Forward-looking statements may refer to such matters as products, product benefits, pre-clinical and clinical development timelines, clinical and regulatory expectations and plans, expected responses to regulatory actions, anticipated financial performance, future revenues or earnings, business prospects, projected ventures, new products and services, anticipated market performance, expected research and development and other expenses, future expectations for liquidity and capital resources needs and similar matters. Such words as “may”, “will”, “expect”, “continue”, “estimate”, “project”, and “intend” and similar terms and expressions are intended to identify forward looking statements. Forward-looking statements are not guarantees of future performance and our actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in Part I, Item 1A (Risk Factors) of this Form 10-K. Except as required by applicable law, we assume no obligation to revise or update any forward-looking statements for any reason.

We are a biopharmaceutical company focused on leveraging our proprietary Lip’raldrug delivery technology platform to develop differentiated products through through the oral delivery of previously difficult to deliver molecules. Our proprietary delivery technologies are designed to improve patient patient compliance and safety through orally available treatment options. Our primary development programs are based on oral delivery solutions solutions for poorly bioavailable drugs. We have a portfolio of differentiated innovative product candidates that target high unmet needs for neurological and psychiatric CNS disorders, liver diseases, and hormone supplementation for men and women.

We entered into aour first license agreement for the development and commercialization of our productproduct, candidate, TLANDO®,TLANDO, an oral testosterone replacement therapy comprised of testosterone undecanoate.undecanoate in October 2021. On March 28, 2022, the FDA approved TLANDO as a testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.hypogonadism and Onon June 7, 2022, our former commercial partner Antares (a wholly owned subsidiary of Halozyme) announced the commercial launch of TLANDO.

On January 12, 2024, we entered into the Verity License Agreement with Verity, pursuant to which we granted to Verity Pharma an exclusive, royalty-bearing, royalty-bearing, sublicensable right and license to develop and commercialize the TLANDO product for TRT in the Licensed Verity Territory.Territory and Verity Pharma filed a NDS for TLANDO in Canada in June 2025. Any FDA post-marketing studies required will also be the responsibility of our Licensee, Verity.Verity Pharma.

In September 2024, we entered into the SPC License Agreement for the development and commercialization of TLANDO with SPC, pursuant to which the Company granted to SPC a non-transferable, exclusive, royalty-bearing license to commercialize our TLANDO product for TRT in the SPC Territory. In October 2024, we entered into the Pharmalink Distribution Agreement with Pharmalink granting a non-transferable, exclusive, license license to commercialize our TLANDO product inspecific to the GCC, including Saudi Arabia, Kuwait, UAE, Qatar, Bahrain, and Oman (the “Pharmalink Territory”). Territory.In OurApril ex-U.S.2025, commercializationwe partnersentered areinto planningthe Aché License Agreement with Aché pursuant to filewhich marketingwe granted to approvalAché applicationsan inexclusive Canada,license to commercialize our TLANDO product with respect to the GCCField, countries,specific andto Souththe KoreaAché in 2025.Territory.

Additional clinical development pipeline candidates include: LPCN 1154 for PPD,postpartum depression (“PPD”), LPCN 2201 for Major Depressive Disorder (“MDD”), LPCN 2101 for epilepsy, and LPCN 2203 for essential tremor and LPCN 2401 for improved body composition in obesity management.tremor. In addition to our clinical development product candidates, we have assets for which we expect to seek partnerships to enable further development including TLANDO for territories outside of Norththe America, United States, Canada, South Korea, and the GCC, and Brazil, LPCN 2401 for improved body composition in GLP-1 agonist use such as obesity management, LPCN 1148 comprising a novel prodrug of testosterone, andtestosterone TL,laurate (“TL”), for the management of decompensated cirrhosis, LPCN 1144, an oral prodrug of androgen receptor modulator for the treatment of non-cirrhotic MASH which has completed Phase 2 testing, and LPCN 1107, potentially the first oral hydroxy progesterone caproate (“HPC”) product indicated for the prevention of recurrent PTB,preterm birth (“PTB”), which has completed a dose finding clinical study in pregnant women and has been granted orphan drug designation by the FDA.

To date, we have funded our operations primarily through the salesales of equity securities, debt and convertible debt and through up-front payments, research funding and royalty and milestone payments fromreceived under our license and collaboration arrangements. We have not generated any revenues from product sales and while we expect to generate royalties from our Licensee’s Licensees’ sales of TLANDO, we do not expect to generate revenue from product sales from our other product candidates unless and until approval.

We have incurred losses in most years since our inception. As of December 31, 2024,2025, we had an accumulated deficit of approximately $209.4 $199.8 million. Income and losses fluctuate year to year, primarily depending on the nature and timing of research and development occurring occurring on our product candidates. Our net incomeloss was approximately $8,000 for the year ended December 31, 2024, compared to approximately $16.4$9.6 million for the year ended December 31, 2023.2025, compared to net income of $8,000 for the year ended December 31, 2024. Substantially all of our operating losses resulted from expenses incurred in connection with our product candidate development programs, our research activities and general and administrative costs associated with our operations.

Advance LPCN 11541154, LPCN 2201, LPCN 2101, LPCN 2203 and other CNS product candidates. We intend to focus on the development of endogenous neuroactive steroids (“NASs ”) which have broad applicability in treating various CNS conditions where we can leverage our technology platform to develop highly differentiated oral therapeutics. Our priority is on the development of LPCN 1154, a 48-hour treatment duration, fast-acting oral antidepressant for PPD with potential for outpatient use. We are currently evaluating additional NAS candidates LPCN 2201, for MDD, and LPCN 2101, for epilepsy including Drug Resistant Epilepsy (“DRE”) and women with epilepsy (“WWE”).

Support our licensees,partners, Verity, SPC, Pharmalink and PharmalinkAché, in commercialization and/or development of our licensed oral TRT product.option. We believe the TRT market needs a differentiated, convenient oral option. We have exclusively licensed rights to TLANDO to Verity Pharma for commercialization of TLANDO in the Licensed Verity Territory, to SPC for commercialization in the SPC Territory, to Pharmalink in the Pharmalink Territory, and to PharmalinkAché in the PharmalinkAché Territory. We plan to support Verity’s, SPC’sSPC’s, Pharmalink’s, and Pharmalink’sAché’s efforts to effectively enable the availability of TLANDO to patients in a timely manner, in addition to receiving milestone payments,payments and royalty payments, and/or payments for product sales associated with TLANDO commercialization as agreed to in the Verity License Agreement, the SPC License AgreementAgreement, the Pharmalink Distribution Agreement, and the Pharmalink DistributionAché License Agreement.

Develop partnership(s) to continue the advancement of pipeline assets. We continuously strive to prioritize our resources in seeking partnerships of our pipeline assets. We are currently exploring partnerships for our liver programs LPCN 1144, our candidate for treatment of non-cirrhotic MASH and LPCN 1148 for the management of decompensated cirrhosis including prevention of the recurrence of overt hepatic encephalopathy; (“OHE”), and we are also exploring partnerships for LPCN 2401 for improved body composition in obesity management as an adjunct therapy to or as a monotherapy post cessation of incretin mimetics use; and LPCN 1107, our candidate for prevention of pre-term birth. We are also exploring the possibility of of licensing LPCN 1021 (known as TLANDO in the United States) to third parties outside of the Currently Licensed TLANDOVerity Territories,Territory, the SPC Territory, the Pharmalink Territory and the Aché Territory, although as of the date of this Annual Report,report, no additional licensing agreementsagreement havehas been entered into by the Company in any other territories.

To date, we have not generated any revenues from product sales and do not expect to do so until our FDA approved product receives regulatory approval inoutside the SPCU.S. Territoryand or the Pharmalink TerritoryCanada or until one of our other product candidates receives approval from the FDA. Revenues to date have been generated substantially from license fees, royalty and milestone payments and research support from our licensees. Since our inception through December 31, 2024,2025, we have generated $53.1$55.1 million in revenue under our various license and collaboration arrangements and from government grants. We have entered into the Verity License Agreement, the SPC License AgreementAgreement, the Pharmalink Distribution Agreement, and the Pharmalink DistributionAché License Agreement with the potential for revenue from future milestones, royalties, and/or product sales, but we may never generate revenues from any of our clinical or preclinical development programs or licensed products as we may never succeed in obtaining regulatory approval or commercializing any of these product candidates.

Research and development expenses consist primarily of salaries, benefits, stock-based compensation and related personnel costs, fees paid to external service providers such as contract research organizations and contract manufacturing organizations, contractual obligations for clinical development, clinical sites, manufacturing and scale-up for late stage clinical trials, formulation of clinical drug supplies, and expenses associated with regulatory submissions. Research and development expenses also include an allocation of indirect costs, such as those for facilities, office expense, and depreciation of equipment based on the ratio of direct labor hours for research and development personnel to total direct labor hours for all personnel. We expense research and development expenses as incurred. Since our inception, we have spent approximately $154.6 $163.2 million in research and development expenses through December 31, 2024.2025.

We expect to continue to incur significant costs inas we develop our product candidates, including our CNS product candidates, as well as the development of future pipeline product candidates.

Given the stage of clinical development and the significant risks and uncertainties inherent in the clinical development, manufacturingmanufacturing, and regulatory approval process, we are unable to estimate with any certainty the time or cost to complete the development of LPCN 1154, LPCN 2401,2201, LPCN 2101, LPCN 2203, LPCN 1148,2401, LPCN 1144,1148, LPCN 1107 and other product candidates. Clinical development timelines, the probability probability of successsuccess, and development costs can differ materially from expectations and results from our clinical trials may not be favorable. favorable. If we are successful in progressing LPCN 1154, LPCN 2401,2201, LPCN 2101, LPCN 22032203, or other future product candidates into later stage development, we will require additional capital. The amount and timing of our future research and development expenses for these product candidates will depend on the pre-clinical and clinical success of both our current development activities and potential development of new product candidates, as well as ongoing assessments of the commercial potential of such activities. We will continue efforts to enter into partnership arrangements for the continued development and/or marketing of LPCN 1144,1154, LPCN 2401, LPCN 1148, LPCN 2401,1107, LPCN 1107,and for the development and commercialization of TLANDO outside of the United States, Canada, South Korea, and the GCC countries and LPCN 1111 outside of the United States and Canada.Brazil.

We expect to incur significant research and development expenses in the future as we complete on-going clinical studies, including studies for CNS product candidates, and as we conduct future clinical studies, including when and if we conduct Phase 2 clinical studies with LPCN our2201, developmentLPCN product2101, candidatesLPCN 2203, LPCN 2401, and when and if we conduct/or Phase 3 clinical studies with LPCN 1144, LPCN 1148, and/or LPCN 1107. We are also exploring the possibility of licensing LPCNall 1144,of LPCNour 1148,product LPCNcandidates, 2401 and LPCN 1107, although we have not entered into a licensing agreement and no assurance can be given that any license agreement will be completed, or, if an agreement is completed, that such an agreement would be on terms favorable to us. If we are unable to raise additional capital or obtain non-dilutive financing, we may need to reduce research and development expenses in order to extend our ability to continue as a going concern.

General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensationcompensation, and outside consulting services related to our executive, finance, business development, and administrative support functions. Other general and administrative expenses include rent and utilities, travel expenses, and professional fees for auditing, tax, legal and various other services.

Other income and expense consists primarily of interest income earned on our cash, cash equivalents and marketable investment securities, imputedand, interest on minimum royalties under the Antares Licensing Agreement in 2023,2024, andincluded gainsa gain on our warrant liability.liability resulting from the expiration of the underlying warrants.

We recorded research and development expenses of $7.4$8.6 million and $10.2$7.4 million, respectively, for the years ended December 31, 20242025 and 2023.2024. The decreaseincrease in research and development expenses during the year ended December 31, 2024 was2025 primarily duerelates to aan $3.1$894,000 million decreaseincrease related to the completion ofin our LPCN 1148 Phase 2 POCclinical study in male patients with cirrhosis in 2023,costs, a $584,000 decrease in TLANDO related costs, and a $348,000 decrease in personnel related costs. These decreases were offset by a $996,000 increase in LPCN 1154 clinical studies, a $188,000$174,000 increase in other lab supplies and research costs,costs and a $46,000$164,000 increase in LPCNpersonnel-related 2401 costs.costs

We recorded general and administrative expenses of $5.0$3.8 million and $4.9$5.0 million, respectively, for the years ended December 31, 20242025 and 2023.2024. The increasedecrease in general and administrative expenses during the year ended December 31, 20242025 was primarily due to approximately a $800,000$1.3 increase million decrease in business development anddevelopment, strategic advisory servicesservices, relatedand expensescorporate legal fees incurred in connection with our various license agreements in 2024, a $121,000 decrease in estimated franchise taxes, a $55,000 decrease in other various professional fees, and a $53,000 increase in intellectual property and patent expenses, offset by a $222,000$47,000 decrease in corporate insurance expense, aoffset $208,000by decreasean increase of $165,000 in personnel related costs,expenses, a $161,000 decrease in$104,000 professional fees relating to our annual shareholder’s meeting and subsequent decision to enact a reverse stock split, a $146,000 decreaseincrease in otherpatent variousrelated consulting and professional fees,fees and a $20,000$25,000 decreaseincrease in other general and administrative expenses.

The decrease in interest and investment income of approximately $220,000$403,000 during the year ended December 31, 20242025 was mainly due to declining cash and marketable investment securities balances in fiscalthe year ended December 31, 20242025 compared to 2023.2024.

We recorded gainsa non-cash gain of approximately $17,000 and $213,000, respectively, on warrant liability during the fiscal years ended December 31, 2024 andrelated 2023 related to the change in the fair value of outstanding common stock warrants issued in November 2019.2019 as of December 31, 2024 as compared to December 31, 2023. The gain in fiscal year ended December 31, 2024 was attributable to the expiration in November 2024 expiration of the warrantwarrants issued in the November 2019 Offering. The gain in fiscal year ended December 31, 2023 was the result of a decreased stock price and shorter term remaining on the warrants as compared to the stock price and remaining term of the warrants as of December 31, 2022. There were no common stock warrants from the November 2019 Offering exercised during fiscal years ended December 31, 2024 or 2023.2024. The warrants were classified as a liability due to a provision contained within the warrant agreement which allowed the warrant holder the option to elect to receive an amount of cash equal to the value of the warrants as determined in accordance with the Black-Scholes option pricing model with certain defined assumptions upon a change of control.

Since our inception, our operations have been primarily financed through sales of our equity securities, issuances of debt and payments received under our license and collaboration arrangements. We have devoted our resources to funding research and development programs, including discovery discovery research, preclinical and clinical development activities. We have incurred operating losses in most years since our inception and we expect to continue to incur operating losses into the foreseeable future as we advance clinical development of LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401 and any other future product candidate,candidates, including continued research efforts.

In SeptemberApril 2024,2025, we entered into the SPCAché License Agreement with SPC.Aché pursuant to which we granted to Aché an exclusive license to commercialize our TLANDO product with respect to the Field, specific to Brazil. Under the termsagreement, of the SPC License Agreement, SPC paid us a non-refundable, non-creditable upfront fee in October 2024. We also received an additional payment for a non-refundable, non-creditable prepayment in consideration for TLANDO product inventory, andwe are eligibleentitled to receive fees additionalupon paymentsthe forachievement various marketingof authorizationcertain andregulatory milestones, royalties on net sales milestones and will supply TLANDO to SPCAché andat receivean a supplyagreed transfer price. In addition, we will receive royalties on net sales in the SPC Territory under the SPC License Agreement. Our ability to realize benefits from the SPCAché License Agreement, including milestone, product sale and royalty payments, is subject to a number of risks. We may not realize milestone, product sale or royalty payments in anticipated amounts, or at all.

On January 12, 2024, we entered into the Verity License Agreement with Verity, Verity Pharma, pursuant to which we granted to Verity Pharma an exclusive, royalty-bearing, sublicensable right and license to develop and commercialize our TLANDO product with respect to TRT in the Licensed Verity Territory. Upon execution of the Verity License Agreement in January 2024 and upon transition of the commercialization of TLANDO from Antares to Verity Pharma in February 2024, Verity Pharma paid to us an initial payment of $2.5 million, and subsequent payments of $5$2.5 million and $5 million, respectively. Verity Pharma also paid us $2.5 million inon FebruaryDecember 202430, 2024, and Decemberwe 2024, respectively. Verity has also agreed to make an additionalreceived payment tofor usthe final portion of $1the initial license of $1.0 million beforeon January 1,5, 2026. The Verity License Agreement also provides Verity Pharma with a license to develop and commercialize TLANDO XR (“LPCN 1111”), our potential next generation, once daily oral product candidate for testosterone replacement therapy comprised of testosterone tridecanoate,TT in the LicensedU.S. Verityand Territory.Canada. We are also eligible to receive milestone payments of up to $259 million in the aggregate, depending on the achievement of certain development milestones and sales milestones in a single calendar year with respect to all products licensed by Verity Pharma under the Verity License Agreement. In addition, we receive tiered royalty payments at rates ranging from percentages of 12% up to 18% of net sales of all products licensed to Verity Pharma in the Licensed Verity Territory. Our ability to realize benefits from the Verity License Agreement, including milestone and royalty payments, is subject to a number of risks. We may not realize milestone or royalty payments in anticipated amounts, or at all.

Previously on March 6, 2017, we entered into a sales agreement (“Cantor Sales Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) under which we agreed to sell shares of our common stock, having registered up to $50.0 million for sale under the Cantor Sales Agreement. During the year ended December 31, 2024, we sold 32,110 shares of our common stock under the Cantor Sales Agreement at a weighted-average sales price of $6.77 per share, resulting in net proceeds of approximately $209,000, which is net of approximately $8,000 in expenses. During the year ended December 31, 2023, we sold 81,000 shares of our common stock under the Cantor Sales Agreement at a weighted-average sales price of $5.36 per share, resulting in net proceeds of approximately $405,000, which is net of approximately $24,000 in expenses. On April 24, 2024, we terminated the Cantor Sales Agreement. From the inception to the termination of the Cantor Sales Agreement, we sold in aggregate 996,821 shares of our common stock for $33.5 million.

On April 26, 2024, we entered into a sales agreement (the “A.G.P. Sales Agreement”) with A.G.P./Alliance Global Partners (“A.G.P.”) pursuant to which we maycould issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to the the amount we registered on an effective registration statement pursuant to which the offering is being made. WeAs currentlyof February 26, 2026, we have registered up to $10,616,169 of shares$50,000,000 of common shares for sale under the A.G.P. Sales Agreement, pursuant to the Registration Statement on Form S-3, as amended (File No. 333-275716) (the “Form S-3”), through A.G.P. as sales agent. A.G.P. may sell our common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act, including sales made directly on or through the Nasdaq Capital Market or any other existing trade market for our common stock, in negotiated transactions at market prices prevailing at the time of sale or at prices related to prevailing market prices, or any other method permitted by law. A.G.P. will use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable law and regulations to sell shares under the A.G.P. Sales Agreement. We will pay A.G.P. 3.0% of the aggregate gross proceeds from each sale of shares under the A.G.P. Sales Agreement. In addition, we have also provided A.G.P. with customary indemnification rights. Our shares of common stock to be sold under the A.G.P. Sales Agreement will be sold and issued pursuant to the Form S-3, as amended, which was previously declared effective by the SEC, and the related prospectus and one or more prospectus supplements. We are not obligated to make any sales of our common stock under the A.G.P. Sales Agreement. The offering of common stock pursuant to the A.G.P. Sales Agreement will terminate upon the termination of the A.G.P. Sales Agreement as permitted therein. We and A.G.P. may each terminate the A.G.P. Sales Agreement Agreement at any time upon ten days’ prior notice. AsDuring ofthe year December 31, 2024,2025, we had not sold any806,878 shares of our common stock for gross proceeds of approximately $3.0 million and net proceeds of approximately $2.9 million under the A.G.P. Sales Agreement. Since December 31, 2025, we have sold 1,138,710 shares of our common stock for gross proceeds of approximately $10.9 million and net proceeds of $10.6 million under the A.G.P. Sales Agreement.

We believe that our existing capital resources, together with interest thereon, will be sufficient to meet our projected operating requirements through at least March 31, 20262027 which include a clinical study for LPCN 1154, research and development activities and compliance with regulatory requirements. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect if additional activities are performed by us including new clinical studies for LPCN 2401, 2201, LPCN 2101, LPCN 1148,2203, LPCN 1144,2401, LPCN 1148, and/or LPCN 1107. While we believe we have sufficient liquidity and capital resources to fund our projected operating requirements through at least March 31, 2026,2027, we will need to raise additional capital at some point through the equity or debt markets or through additional out-licensing activities, either before or after March 31, 2026,2027, to support our operations. If we are unsuccessful in raising additional capital as necessary, our ability to continue as a going concern will be limited. Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for product development, regulatory compliance and clinical trial activities sooner than planned. In addition, our capital resources may be consumed more rapidly if we pursue additional clinical studies for LPCN 1154, LPCN 2401,2201, LPCN 2101, LPCN 2203, LPCN 1148,2401, LPCN 1144,1148, and/or LPCN 1107. Conversely, our capital resources could last longer if we reduce expenses, reduce the number of activities currently contemplated under our operating plan or if we terminate, modify or suspend on-going and/or planned clinical studies. We can raise capital pursuant to the A.G.P. Sales Agreement but may choose not to issue common stock if our market price is too low to justify such sales in our discretion. There are numerous risks and uncertainties associated with the development and, subject to approval by the FDA, commercialization of our product candidates. There are numerous risks and uncertainties impacting our ability to enter into collaborations with third parties to participate in the development and potential commercialization of our product candidates. We are unable to precisely estimate the amounts of increased capital outlays and operating expenditures associated with our anticipated or unanticipated clinical studies and ongoing development efforts. All of these factors affect our need for additional capital resources. To fund future operations, we will need to ultimately raise additional capital and our requirements will depend on many factors, including the following:

Net cash used in operating activities during 2025 was primarily attributable to cash outlays primarily related to our LPCN 1154 Phase 3 clinical studies and expenses to support on-going operations, offset by cash provided by TLANDO license fees of $500,000 and royalties of $477,000. Net cash used in operating activities during 2024 was primarily attributable to cash outlays to support on-going operations, including research research and development expenses primarily related to our LPCN 1154 clinical studies and manufacturing scale up, in addition to general and administrative expenses. These cash outlays were offset by cash provided by license fees from the licensee and distribution agreements we entered into during 2024 of $11.2 million.$10.9 Duringmillion 2023,in we were performing activities mainly relatedaddition to ourroyalties LPCNreceived 1154of clinicalapproximately studies and our LPCN 1148 Phase 2 POC Study in male subjects with cirrhosis.$298,000.

During the years ended December 31, 20242025 and 2023,2024, net cash usedprovided inby investing activities was $2.4$5.9 million and $13.1$2.4 million.

Net cash provided by investing activities during 20242025 and 20232024 was primarily the result of the maturity of marketable investment securities of $35.4$20.6 million and $36.0of $35.4 million, respectively offset by the purchase of marketable investment securities of $32.9$14.7 million and $22.9$32.9 million, respectively. There were $90,000 and $13,000 inno capital expenditures for the yearsyear ended December 31, 2025. Capital expenditures during the year ended December 31, 2024 andwere 2023, respectively.$90,000.

During the years ended December 31, 20242025 and 2023,2024, net cash provided by financing activities was $209,000$2.9 million and $405,000,$209,000, respectively, and was the result of proceeds from the sales of our common stock under the CantorATM Salessales Agreement.agreements.

Net cash provided by financing activities during the year ended December 31, 2024 and 2023,2025 was related to the sale of 32,110806,878 shares of our common stock stockin 2025 for net proceeds of $209,000$2.9 andmillion 81,000under the AGP Sales Agreement. Net cash provided by financing activities in 2024 was related to the sale of 32,110 shares of our common stock for net proceeds of $405,000, respectively,$209,000 under the Cantor Sales Agreement, less associated costs.Agreement.

We enter into contracts and issue purchase orders in the normal course of business with clinical research organizations for clinical trials trials and clinical and commercial supply manufacturing and with vendors for preclinicalpre-clinical research studies, research supplies and other services and products for operating purposes. These contracts generally provide for termination on notice and are cancellable obligations.

In August 2004, we entered into an agreement to lease our facility in Salt Lake City, UtahUtah, consisting of office and laboratory space which serves as our corporate headquarters. On December 2,12, 2024,2025, we modified and extended the lease through February 28, 2026.2027.

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements which we have prepared in accordance with U.S. GAAP. In preparing our financial statements, we are required to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We concluded that licensing revenue recognized in conjunction with the Verity License Agreement, the SPC License Agreement andAgreement, the Pharmalink Distribution Agreement and the Aché License Agreement met the requirements under ASC 606, Revenue from Contracts with Customers. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. License revenue from payments to be received in the future will be recognized when it is probable that we will receive license payments under the terms of the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement or the Pharmalink DistributionAché Agreement.License Agreement .

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) with amendments in 2015 (ASU 2015-14) and 2016 (ASU 2016-8, ASU 2016-10, ASU 2016-12 and ASU 2016-20). The updated standard is a new comprehensive revenue recognition model that requires revenue to be recognized in a manner that depicts the transfer of goods or services to a customer at an amount that reflects the consideration expected to be received in exchange for those goods or services. The guidance also requires disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. We adopted this pronouncement effective January 1, 2017. We recognized license and royalty revenue of $2.0 million and $11.2 million during the yearyears ended December 31, 20242025 and a2024, net reversal of variable consideration revenue of $2.9 million during the year ended December 31, 2023. Net reversal of variable consideration revenue in 2023 was mainly attributable to the reversal of variable consideration revenue recognized for minimum guaranteed royalties in 2021 under the license agreement with Antares, offset by $110,000 in license revenue payments received from Spriaso under a licensing agreement in the cough and cold field.respectively.

We recognize stock-based compensation expense for grants of stock option awards, restricted stock units and restricted stock under our Incentive Plan to employees, nonemployees and nonemployee members of our board of directors based on the grant-date fair value of those awards. The grant-date fair value of an award is generally recognized as compensation expense over the award’s requisite service period. In addition, in the past we have granted performance-based stock option awards and restricted stock grants, which vest based upon our satisfying certain performance conditions. Potential compensation cost, measured on the grant date, related to these performance options or stock grants will be recognized only if, and when, we estimate that these options or stock grants will vest, which is based on whether we consider the options’ awards’ performance conditions to be probable of attainment. Our estimates of the number of performance-based options awards that willare expected to vest will be revised, if necessary, in subsequent periods.

The warrants issued under the November 2019 public offering expired in November 2024, and there were no warrants from the November 2019 offering outstanding as of December 31, 2024. As of December 31, 20242024, and 2023, the warrant liability was $0fully and $17,000, respectively.extinguished.

In addition to the other information set forth in this Quarterly Report on Form 10-Q, consider the risk factors discussed in Part 1, “Item 1A. Risk Factors” in the Company’s 2025 Form 10-K10-K, the risk factors discussed in Item 1A of the Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 filed with the SEC on May 7, 2026, and the risk factors discussed in Item 1A of this Quarterly Report on Form 10-Q, which could materially affect our business, financial condition or future results. The risks described in the aforementioned reports reports are not the only risks facing the Company. Additional risks and uncertainties not currently known to the Company or that it currently deems to be not material also may materially adversely affect the Company’s business, financial condition, and/or operating results.

As of MarchJune 31,30, 2026, our executive officers and directors beneficially owned approximately 4.7%6.9% of our common stock. These stockholders, if they act together, may be able to influence our management and affairs and all matters requiring stockholder approval, including significant corporate transactions. This concentration of ownership may have the effect of delaying or preventing a change in control and might affect the market price of our common stock.

The market price and trading volume of our common stock has been volatile over the past year and it may continue to be volatile. OverFor the past year,prior twelve months ending June 30, 2026, our common stock has traded as low as $2.53$1.94 and as high as $11.26 per share.share . We cannot predict the price at which our common stock will trade in the future and it may decline. The price at which our common stock trades may fluctuate significantly and may be influenced by many factors, including our financial results; developments generally affecting our industry; general economic, industry industry and market conditions, and our customers; the depth and liquidity of the market for our common stock; investor perceptions of our business; reports by industry analysts; announcements by other market participants, including, among others, investors, our competitors, and our customers; regulatory action affecting our business; and the impact of other “Risk Factors” discussed herein and in our 2025 Form 10-K. In addition, changes in the trading price of our common stock may be inconsistent with our operating results and outlook. outlook. The volatility of the market price of our common stock may be inconsistent with our operating results and outlook. The volatility of of the market price of our common stock may adversely affect investors’ ability to purchase or sell shares of our common stock.

We have focused a significant portion of our efforts on developing TLANDO and more recently on LPCN 1154, LPCN 1148,1154 and LPCN 1144. 1148. We have funded our operations to date through sales of our equity securities, debt and payments received under our license and collaboration collaboration arrangements. We have incurred losses in most years since our inception. As of MarchJune 31,30, 2026, we had an accumulated deficit of $213.1 $215.7 million. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations. These losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders’ equity. It is possible that we will continue to incur significant research and development expenses in connection with clinical trials associated with LPCN 1154, and potentially with LPCN 2201, LPCN 2101, 2203, LPCN 2203,2101, LPCN 2401, LPCN 1148, and LPCN 1107, if further clinical trials are initiated. As a result, we expect to continue to incur significant operating losses for the foreseeable future as we evaluate further clinical development of LPCN 1154, LPCN 2201, LPCN 2101, 2203, LPCN 2203,2101, LPCN 2401, and possibly LPCN 1148 and LPCN 1107, in addition to our other programs and continued research efforts. Because of the numerous risks and uncertainties associated with developing pharmaceutical products, we are unable to predict the extent of any future losses or when we will become profitable, if ever.

The following discussion of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and the related notes thereto and other financial information included elsewhere in this report. For additional context with which to understand our financial condition and results of operations, see management’s discussion and analysis of financial condition and results of operations included in our annual report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 10, 2026 (the “2025 Form 10-K”), our first quarter report on Form 10-Q filed with the SEC on May 7, 2026, as well as the financial statements and related notes contained therein.

This section and other parts of this report contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve risks and uncertainties. Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Forward-looking statements may refer to such matters as products, product benefits, pre-clinical and clinical development timelines, clinical and regulatory expectations and plans, expected responses to regulatory actions, anticipated financial performance, future revenues or earnings, business prospects, projected ventures, new products and services, anticipated market performance, expected research and development and other expenses, future expectations for liquidity and capital resources needs and similar matters. Such words as “may,” “will,” “expect,” “continue,” “estimate,” “project,” and “intend” and similar terms and expressions are intended to identify forward lookingforward-looking statements. Forward-looking statements are not guarantees of future performance and our actual results may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in Part I, Item 1A (Risk Factors) of our 2025 Form 10-K.10-K and Item 1A of our Form 10-Q for the quarter ended March 31, 2026 filed with the SEC on May 7, 2026. Except as required by applicable law, we assume no obligation to revise or update any forward-looking statements for any reason.

We are a biopharmaceutical company focused on leveraging our proprietary technology platform to develop innovative products with effective oral delivery of previously difficult to deliver molecules. Our proprietary delivery technologies are designed to improve patient compliance and safety through orally available treatment options. Our primary development programs are based on oral delivery solutions for poorly bioavailable drugs. We have a portfolio of differentiated innovative product candidates that target high unmet needs for neurological and psychiatric CNS disorders, liver disease, and hormone supplementation for men and women.supplementation.

In September 2024, we entered into the SPC License Agreement (the “SPC License Agreement”) for the development and commercialization of TLANDO with SPC Korea Limited (“SPC”), pursuant to which the Company granted to SPC a non-transferable, exclusive, royalty-bearing license to commercialize our TLANDO product for TRT in the SPC Territory. In October 2024, we entered into the Pharmalink Distribution Agreement with Pharmalink, granting a non-transferable, exclusive, license to commercialize our TLANDO product specific to the Gulf Cooperation Council (“GCC”), including Saudi Arabia, Kuwait, UAE, Qatar, Bahrain, and Oman (the “Pharmalink Territory”). On July 8, 2026, Pharmalink received product marketing authorization approval for TESTYRA® (TLANDO) in the UAE. In April 2025, we entered into a License and Supply Agreement (the “Aché License agreementAgreement”) with Aché Laboratórios Farmacêuticos S.A. (“Aché”) pursuant to which we granted to Aché an exclusive license to commercialize our TLANDO product with respect to the Field, specific to Brazil (the “Aché Territory”). Under the agreement, we are entitled to receive fees upon the achievement of certain regulatory milestones, royalties on net sales and will supply TLANDO to Aché at an agreed transfer price.

Additional clinical development pipeline candidates include: LPCN 1154 for postpartum depression (“PPD”); LPCN 2201 for major depressive disorder (“MDD”); LPCN 2203 for essential tremor; LPCN 2101 for epilepsy; LPCN 2401 for improved body composition in obesity management. In addition to our clinical development product candidates, we have assets for which we expect to seek partnerships to enable further development including TLANDO for territories outside of the United States, South Korea, the GCC and Brazil, LPCN 1148 comprising a novel prodrug of testosterone and testosterone laurate (“TL”), for the management of decompensated cirrhosis; and LPCN 1107, 1107, potentially the first oral hydroxy progesterone caproate (“HPC”) product indicated for the prevention of recurrent preterm preterm birth (“PTB”), which has completed a dose finding clinical study in pregnant women and has been granted orphan drug designation designation by the FDA.

Support our Licensees, Verity, SPC, Pharmalink and Aché, in commercialization of our licensed oral TRT product. We believe the TRT market needs a differentiated, convenient oral option. We have exclusively licensed rights to TLANDO to Verity for commercialization of TLANDO in the U.S. and Canada (the “Licensed Verity Territory”), to SPC for commercialization in South Korea (the “Licensed SPC Territory”),Korea, to Pharmalink in the GCC (the “Licensed Pharmalink Territory”) and to Aché in Brazil (the “Licensed Aché Territory”) (together, the “Currently Licensed TLANDO Territories”). We plan to support Verity’s, SPC’s, Pharmalink’s, and Aché’s efforts to effectively enable the availability of TLANDO to patients in a timely manner, in addition to receiving milestone, royalty payments and/or payments for product sales associated with TLANDO commercialization as agreed to in the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement and the Aché License Agreement.

Our pipeline of clinical development candidates includes LPCN 1154 for PPD, LPCN 2201 for MDD, LPCN 21012203 for epilepsy,essential tremor, and LPCN 22032101 for for essential tremor.epilepsy. We will continue to explore other product development candidates targeting CNS indications with a significant unmet need. need. We will also continue efforts to enter into partnership arrangements for the continued development and/or marketing of LPCN 1144, LPCN 1148, LPCN 2401, and LPCN 1107 as well as for the TRT assets outside of the Currently Licensed TLANDO Territories. We continually evaluate our pipeline product candidates and all strategic options available to us, which options may include, but are not limited to, continued development of LPCN 1154, including the potential submission of a validation study protocol, development of other product candidates, strategic transactions, partnerships, and other opportunities.

Proof-of-concept for TLANDO was initially established in 2006, and TLANDO was subsequently licensed in 2009 to Solvay Pharmaceuticals, Inc., which was then acquired by Abbott Products, Inc. (“Abbott”). Following a portfolio review associated with the spin-off of AbbVie Inc. by Abbott in 2011, we re-acquired the rights to TLANDO. All obligations under the prior license agreement have been completed except that Lipocine will owe Abbott a perpetual 1% royalty on net sales of TLANDO. Such royalties are limited to $1 million in the first two calendar years following product launch, after which period there is no cap on royalties and no maximum aggregate amount. If generic versions of any such product are introduced, then royalties will be reduced by 50%. TLANDO was commercially launched on June 7, 2022. During During the three months ended MarchJune 31,30, 2026 and 2025, we incurred royalty expense of approximately $10,000$16,000 and $8,000,$10,000, respectively, and during the six months ended June 30, 2026 and 2025, we incurred royalty expense of approximately $26,000 and $18,000, respectively.

Upon execution of the Pharmalink License Agreement, Pharmalink paid us a non-refundable, non-creditable upfront fee in October 2024. Under the Pharmalink License Agreement, we could receive additional payments in regulatory authorization milestones and we will supply TLANDO to Pharmalink at an agreed transfer price. On July 8, 2026, Pharmalink received product marketing authorization approval for TESTYRA® (TLANDO) in the UAE.

Our most advanced NAS candidate is LPCN 1154, a rapid onset, oral formulation of the neuroactive steroid brexanolone which we are developing for the treatment of PPD. We have completed clinical oral PK studies including a pilot food effect study and a pilot PK bridge study. In addition, as a prelude to a LPCN 1154 pivotalPhase 3 study, a multi-dose study was done confirming the dosing regimen for the PK bridge study using the scaled up “to be marketed” formulation required for New Drug Application (“NDA”) filing. In June 2024, we announced results from a dosing regimen confirmation study which demonstrated LPCN 1154 meets bioequivalence with comparator, IV brexanolone, meeting standard bioequivalence criteria and Ctrough criteria. LPCN 1154 treatment was well-tolerated with no sedation nor somnolence somnolence events observed in the dosing regimen confirmation study.

After completing PK studies and labeling studies such as a food effect study and PK profiling in women with PPD, we met with the FDA in the first quarter of 2025. In the meeting, we were advised that the FDA believes,believed, in addition to the previously completed PK dosing regimen confirmation data, an efficacy and safety study of oral LPCN 1154 in the target population willwould be required for 505(b)(2) NDA submission. Based on observed comparable exposure of LPCN 1154 and IV brexanolone in the dosing confirmation study, we have confirmed the target dosing regimen and we completed a Phase 3 safety and efficacy study.

We continue to explore thebusiness possibilitypartnerships of partnering with a third party foraround the further development, marketingapproval, and commercialization of BrlizioTM (LPCN LPCN1154) 1154,for although no partnering agreement has been entered into by the Company.PPD. No assurance can be given that any partnering agreement agreement will be completed, or, if an agreement is completed, that such an agreement would be on terms favorable to us.

In the aforementioned post hoc analysis of the Phase 3 PPD study, oral brexanolone also demonstrated that participants with a history of psychiatric conditions showed statistically significant and clinically meaningful reductions in HAM-D scores versus placebo, observed as early as hour 12 and sustained through day 30. We areplan currentlyto advancingadvance LPCN 2201, a unique oral brexanolone formulation, as a novel, rapid relief oral treatment option for MDD with the goal of improving outcomes without the limitations of existing therapies. LPCN 2201 is chemically identical to the endogenous human hormone hormone allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABAA) receptor. Post planned clinical assessment of unique unique formulations, we plan to submit a protocol for a Phase 2 study to the FDA, and we may initiate a study to evaluate LPCN 2201 for MDD, MDD, subject to resource prioritization.

To date, we have not generated any revenues from product sales and do not expect to do so until our FDA approved product receives regulatory approval outside the U.S. and Canada or until one of our product candidates receives approval from the FDA. Revenues to date have been generated substantially from license fees, royalty and milestone payments and research support from our licensees. Since our inception through MarchJune 31,30, 2026, we have generated $55.2$55.4 million in revenue under our various license and collaboration arrangements and from government government grants. We have entered into the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement and the Aché License Agreement with the potential for revenue from future milestones, royalties and/or product sales, but we may never generate revenues from any of our clinical or preclinical development programs or licensed products as we may never succeed in obtaining regulatory approval or commercializing any of these product candidates.

Research and development expenses consist primarily of salaries, benefits, stock-based compensation and related personnel costs, fees paid to external service providers such as contract research organizations and contract manufacturing organizations, contractual obligations for clinical development, clinical sites, manufacturing and scale-up for late stage clinical trials, formulation of clinical drug supplies, and expenses associated with regulatory submissions. Research and development expenses also include an allocation of indirect costs, such as those for facilities, office expense, and depreciation of equipment based on the ratio of direct labor hours for research and development personnel to total direct labor hours for all personnel. We expense research and development expenses as incurred. Since our inception, we have spent approximately $165.9$168.0 million in research and development expenses through MarchJune 31,30, 2026.

We expect to continue to incur significant research and development expenses in the future as we complete on-going clinical studies, including including studies for our CNS product candidates, including a possible confirmatoryadditional study for LPCN 1154, and as we conduct future clinical studies, when and if we conduct Phase 2 clinical studies with LPCN 1154, LPCN 2201, LPCN 2101,2203, LPCN 2203,2101, LPCN 2401, and/or development product candidates and when and if we conduct Phase 3 clinical studies with LPCN 1144,1148 LPCN 1148, andor LPCN 1107. We are also exploring the possibility of licensing all of our product candidates, although we have not entered into a licensing agreement and no assurance can be given that any license agreement will be completed, or, if an agreement is completed, that such agreement would be on terms favorable to us. If we are unable to raise additional capital or obtain non-dilutive financing, we may need to reduce research and development expenses in order to extend our ability to continue as a going concern.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025:

We recognized royalty revenue from TLANDO sales of $119,000$190,000 and $623,000 during the three months ended MarchJune 31,30, 2026,2026 comparedand to2025, respectively, which consists of royalty revenue from TLANDO sales of $94,000 $190,000 during the three months ended MarchJune 31,30, 2026, compared to licensing revenue of $500,000 and royalty revenue of $123,000 recognized during the three months ended June 30, 2025.

The increase in general and administrative expenses during the three months ended MarchJune 31,30, 2026 as compared to the three months ended MarchJune 31,30, 2025 primarily consists of a $43,000$58,000 increase in consulting and professional fees, a $34,000 increase in various general and administrative fees and a $8,000 increase in personnel related costs and a $39,000 increase in various professional and consulting fees.expense.

The decreaseincrease in interest and investment income during the three months ended MarchJune 31,30, 2026 compared to interest and investment income during the three months ended MarchJune 31,30, 2025 was primarily due to lowerhigher cash andbalances marketableavailable investmentto securitiesinvest balancesas a result of sales of our common stock under our ATM in the2026 first quarter of 2026 as compared to cash balances during the firstsecond quarter of 2025.

As of MarchJune 31,30, 2026, we had $24.7$23.3 million of unrestricted cash, cash equivalents and marketable investment securities compared to $14.9 million at December 31, 2025.

In October 2024, we entered into the Pharmalink Distribution Agreement with Pharmalink, pursuant to which we granted to Pharmalink a non-transferable, exclusive,exclusive license to commercialize our TLANDO product in the Pharmalink Territory. Pharmalink paid us a one-time non-refundable, non-creditable upfront fee. We are eligible to receive additional payments in regulatory authorization milestones related to the marketing approval in countries in the Pharmalink Territory under the Pharmalink Distribution Agreement and we have agreed to supply TLANDO to Pharmalink at a specified transfer price. Our ability to realize benefits from the Pharmalink Distribution Agreement, including milestone, product sale and royalty payments, is subject to a number of risks. We may not realize milestone, product sale, or royalty payments in anticipated amounts, or at all.

On April 26, 2024, we entered into a sales agreement (the “A.G.P. Sales Agreement”) with A.G.P./Alliance Global Partners (“A.G.P.”) pursuant to which we can issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to the amount we registered on an effective registration statement pursuant to which the offering is being made. As of February 26, 2026, we have registered up to $50,000,000 of common shares for sale under the A.G.P. Sales Agreement, pursuant to the Registration Statement on Form S-3, as amended (File No. 333-275716) (the “Form S-3”), through A.G.P. as sales agent. A.G.P. may sell our common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act, including sales made directly on or through the Nasdaq Capital Market or any other existing trade market for our common stock, in negotiated transactions at market prices prevailing at the time of sale or at prices related to prevailing market prices, or any other method permitted by law. A.G.P. will use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable law and regulations to sell shares under the A.G.P. Sales Agreement. We will pay A.G.P. 3.0% of the aggregate gross proceeds from each sale of shares under the A.G.P. Sales Agreement. In addition, we have also provided A.G.P. with customary indemnification rights. Our shares of common stock to be sold under the A.G.P. Sales Agreement will be sold and issued pursuant to the Form S-3, as amended, which was previously declared effective by the SEC, and the related prospectus and one or more prospectus supplements. We are not obligated to make any sales of our common stock under the A.G.P. Sales Agreement. The offering of common stock pursuant to the A.G.P. Sales Agreement will terminate upon the termination of the A.G.P. Sales Agreement as permitted therein. We and A.G.P. may each terminate the A.G.P. Sales Agreement at any time upon ten days’ prior notice. During the threesix months ended MarchJune 31,30, 2026, we sold 1,314,1382,083,276 shares of our common common stock for gross proceeds of approximately $12.3$13.9 million and net proceeds of $12.0$13.5 million under the A.G.P. Sales Agreement.

We believe that our existing capital resources, together with interest thereon, will be sufficient to meet our projected operating requirements through at least MayAugust 7,4, 2027, which include research and development activities and compliance with regulatory requirements. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect if additional activities are performed by us including new clinical studies for LPCN 1154, LPCN 2201, LPCN 2101,2203, LPCN 2203,2101, LPCN 2401, LPCN 1148, and/or LPCN 1107. While we believe we have sufficient liquidity and capital resources to fund our projected operating requirements through at least MayAugust 7,4, 2027, we will need to raise additional capital at some point through the equity or debt markets or through additional out-licensing activities, either before oractivities after MayAugust 7,4, 2027,2027 to support our operations. If we are unsuccessful in raising additional capital as necessary, our ability to continue as a going concern will be limited. Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for product development, regulatory compliance and clinical trial activities sooner than planned. In addition, our capital resources may be consumed more rapidly if we pursue additional clinical studies for LPCN 1154, LPCN 2201, LPCN 2101,2203, LPCN 2203,2101, LPCN 2401, LPCN 1148, and/or LPCN 1107. Conversely, our capital resources could last longer if we reduce expenses, reduce the number of activities currently contemplated under our operating plan or if we terminate, modify or suspend on-going clinical studies. We can raise capital pursuant to the A.G.P. Sales Agreement but may choose not to issue common stock if our market price is too low to justify such sales in our discretion. There are numerous risks and uncertainties associated with the development and, subject to approval by the FDA, commercialization of our product candidates. There are numerous risks and uncertainties impacting our ability to enter into collaborations with third parties to participate in the development and potential commercialization of our product candidates. We are unable to precisely estimate the amounts of increased capital outlays and operating expenditures associated with our anticipated or unanticipated clinical studies and ongoing development efforts. All of these factors affect our need for additional capital resources. To fund future operations, we will need to ultimately raise additional capital and our requirements will depend on many factors, including the following:

The following table provides a summary of our cash flows for the threesix months ended MarchJune 31,30, 2026 and 2025:

During the threesix months ended MarchJune 31,30, 2026 and 2025, net cash used in operating activities was $2.3$5.3 million and $2.0$3.9 million, respectively.

Net cash used in operating activities during the threesix months ended MarchJune 31,30, 2026, was primarily attributable to cash required to support our our LPCN 1154 clinical trial activities and our ongoing operations. Net cash used in operating activities during the threesix months ended June March 31,30, 2025, was primarily attributable to cash required to support ongoing operations.

During the threesix months ended MarchJune 31,30, 2026 and 2025, net cash used in investing activities was $9.9$8.4 million and $0.9net cash provided by investing activities was $3.6 million, respectively.

Net cash used in investing activities during the threesix months ended bothJune March 31,30, 2026 and 2025, was primarily the result of the purchases of marketable investmentsinvestment securities, net. Net cash provided by investing activities during the six months ended June 30, 2025 was primarily the result of the maturities of marketable investment securities, net. There were no capital expenditures during either the threesix months ended MarchJune 31,30, 2026 or 2025.

During the threesix months ended MarchJune 31,30, 2026 and 2025, net cash provided by financing activities was approximately $12.0$13.5 million and $0,$76,000, respectively.

Net cash provided by financing activities during the threesix months ended MarchJune 31,30, 2026 was primarily related to the sale of 2,083,276 shares of common stock for net proceeds of approximately $13.5 million under the A.G.P. Sales Agreement at a weighted average price of $6.67 per share pursuant to the A.G.P. Sales Agreement. Net cash provided by financing activities during the six months ended June 30, 2025 was related to the sale of 1,314,13823,739 shares of common stock forat neta proceedsweighted average price of approximately$3.29 $12.0per millionshare underpursuant to the A.G.P. Sales Agreement. No cash was provided by financing activities during the three months ended March 31, 2025.

There have been no significant and material changes in our critical accounting policies during the threesix months ended MarchJune 31,30, 2026, as compared to those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations-Critical Accounting Policies and Significant Judgments and Estimates” in our 2025 Form 10-K.