Lipocine Inc.

Previous wording

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”), as well as the financial statements and related notes contained therein.

Current wording

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.

Previous wording

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 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. Except as required by applicable law, we assume no obligation to revise or update any forward-looking statements for any reason.

Current wording

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-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 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.

Previous wording

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.

Current wording

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.

Previous wording

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”). In April 2025, we entered into a License and Supply Agreement (the “Aché License agreement”) 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.

Current wording

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 Agreement”) 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.

Previous wording

**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”), 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.

Current wording

**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, to Pharmalink in the GCC and to Aché in Brazil (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.

Previous wording

Our pipeline of clinical development candidates includes LPCN 1154 for PPD, LPCN 2201 for MDD, LPCN 2101 for epilepsy, and LPCN 2203 for essential tremor. We will continue to explore other product development candidates targeting CNS indications with a significant unmet 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.

Current wording

Our pipeline of clinical development candidates includes LPCN 1154 for PPD, LPCN 2201 for MDD, LPCN 2203 for essential tremor, and LPCN 2101 for epilepsy. We will continue to explore other product development candidates targeting CNS indications with a significant unmet need. We will also continue efforts to enter into partnership arrangements for the continued development and/or marketing of 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.

Previous wording

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 the three months ended March 31, 2026 and 2025, we incurred royalty expense of approximately $10,000 and $8,000, respectively.

Current wording

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 the three months ended June 30, 2026 and 2025, we incurred royalty expense of approximately $16,000 and $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.

Previous wording

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.

Current wording

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.

Previous wording

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 pivotal 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 events observed in the dosing regimen confirmation study.

Current wording

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 Phase 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 events observed in the dosing regimen confirmation study.

Previous wording

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, in addition to the previously completed PK dosing regimen confirmation data, an efficacy and safety study of oral LPCN 1154 in the target population will 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 completed a Phase 3 safety and efficacy study.

Current wording

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 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 would 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.

Previous wording

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

Current wording

We continue to explore business partnerships around the development, approval, and commercialization of Brlizio TM (LPCN 1154) for PPD. No assurance can be given that any partnering agreement will be completed, or, if an agreement is completed, that such an agreement would be on terms favorable to us.

Previous wording

We are currently advancing 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 allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABAA) receptor. Post planned clinical assessment of 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, subject to resource prioritization.

Current wording

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 plan to advance 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 allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABAA) receptor. Post planned clinical assessment of 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, subject to resource prioritization.

Previous wording

Essential Tremor is one of the most common movement disorders in the United States, affecting an estimated 7 million in the U.S. For ET patients, uncontrollable shaking of the hands, head, voice, or legs creates difficulty eating, dressing, writing, and pursuing other day-to-day tasks. The etiology of ET is largely unknown, but reduced GABAA receptor levels and decreased GABAergic activity have been observed in ET.

Current wording

Essential Tremor is one of the most common movement disorders affecting an estimated 7 million in the U.S. For ET patients, uncontrollable shaking of the hands, head, voice, or legs creates difficulty eating, dressing, writing, and pursuing other day-to-day tasks. The etiology of ET is largely unknown, but reduced GABAA receptor levels and decreased GABAergic activity have been observed in ET.

Previous wording

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 March 31, 2026, we have generated $55.2 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 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.

Current wording

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 June 30, 2026, we have generated $55.4 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 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.

Previous wording

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 million in research and development expenses through March 31, 2026.

Current wording

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 $168.0 million in research and development expenses through June 30, 2026.

Previous wording

Given the stage of clinical development and the significant risks and uncertainties inherent in the clinical development, manufacturing, and regulatory approval process, we are unable to estimate with any certainty the time or cost to complete the development of LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, LPCN 2401, LPCN 1148, LPCN 1107 and other product candidates. Clinical development timelines, the probability of success, and development costs can differ materially from expectations and results from our clinical trials may not be favorable. If we are successful in progressing LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, 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 1154, LPCN 2401, LPCN 1148, LPCN 1107, and for the development and commercialization of TLANDO outside of the United States, Canada, South Korea, the GCC countries and Brazil.

Current wording

Given the stage of clinical development and the significant risks and uncertainties inherent in the clinical development, manufacturing, and regulatory approval process, we are unable to estimate with any certainty the time or cost to complete the development of LPCN 1154, LPCN 2201, LPCN 2203, LPCN 2101, LPCN 2401, LPCN 1148, LPCN 1107 and other product candidates. Clinical development timelines, the probability of success, and development costs can differ materially from expectations and results from our clinical trials may not be favorable. If we are successful in progressing LPCN 1154, LPCN 2201, LPCN 2203, LPCN 2101, 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 1154, LPCN 2401, LPCN 1148, LPCN 1107, and for the development and commercialization of TLANDO outside of the United States, Canada, South Korea, the GCC countries and Brazil.

Previous wording

We expect to continue to incur significant research and development expenses in the future as we complete on-going clinical studies, including studies for our CNS product candidates, including a possible confirmatory 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, LPCN 2203, LPCN 2401, and/or development product candidates and when and if we conduct Phase 3 clinical studies with LPCN 1144, LPCN 1148, and 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.

Current wording

We expect to continue to incur significant research and development expenses in the future as we complete on-going clinical studies, including studies for our CNS product candidates, including a possible additional study for LPCN 1154, and as we conduct future clinical studies, when and if we conduct Phase 2 clinical studies with LPCN 2201, LPCN 2203, LPCN 2101, LPCN 2401, and/or development product candidates and when and if we conduct Phase 3 clinical studies with LPCN 1148 or 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.

Previous wording

We recognized royalty revenue from TLANDO sales of $119,000 during the three months ended March 31, 2026, compared to royalty revenue of $94,000 during the three months ended March 31, 2025.

Current wording

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

Previous wording

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

Current wording

The increase in general and administrative expenses during the three months ended June 30, 2026 as compared to the three months ended June 30, 2025 primarily consists of a $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 expense.

Previous wording

The decrease in interest and investment income during the three months ended March 31, 2026 compared to interest and investment income during the three months ended March 31, 2025 was due to lower cash and marketable investment securities balances in the first quarter of 2026 as compared to the first quarter of 2025.

Current wording

The increase in interest and investment income during the three months ended June 30, 2026 compared to interest and investment income during the three months ended June 30, 2025 was primarily due to higher cash balances available to invest as a result of sales of our common stock under our ATM in 2026 as compared to cash balances during the second quarter of 2025.

Previous wording

The increase in research and development expenses during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025 consists of an approximately $1.7 million increase in costs related to our LPCN 1154 clinical study in 2026 which had not yet started in 2025 and a $28,000 increase in personnel related costs, offset by a $54,000 decrease in other research and development related costs and supplies from 2025.

Current wording

The increase in research and development expenses during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025 consists of an increase of approximately $1.7 million resulting from our LPCN 1154 study in 2026 and a $27,000 increase in personnel expense, offset by a $168,000 decrease in various research and development costs.

Previous wording

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 research, and 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 the clinical development of LPCN 1154, LPCN 2201, LPCN 2101, LPCN 2203, and any other future product candidates, including continued research efforts.

Current wording

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 research, and 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 the clinical development of LPCN 1154, LPCN 2201, LPCN 2203, LPCN 2101, and any other future product candidates, including continued research efforts.

Previous wording

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

Current wording

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

Previous wording

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 three months ended March 31, 2026, we sold 1,314,138 shares of our common stock for gross proceeds of approximately $12.3 million and net proceeds of $12.0 million under the A.G.P. Sales Agreement.

Current wording

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 six months ended June 30, 2026, we sold 2,083,276 shares of our common stock for gross proceeds of approximately $13.9 million and net proceeds of $13.5 million under the A.G.P. Sales Agreement.

Previous wording

We believe that our existing capital resources, together with interest thereon, will be sufficient to meet our projected operating requirements through at least May 7, 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, LPCN 2203, 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 May 7, 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 May 7, 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, LPCN 2203, 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:

Current wording

We believe that our existing capital resources, together with interest thereon, will be sufficient to meet our projected operating requirements through at least August 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 2203, LPCN 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 August 4, 2027, we will need to raise additional capital at some point through the equity or debt markets or through additional out-licensing activities after August 4, 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 2203, LPCN 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:

Previous wording

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

Current wording

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

Previous wording

During the three months ended March 31, 2026 and 2025, net cash used in operating activities was $2.3 million and $2.0 million, respectively.

Current wording

During the six months ended June 30, 2026 and 2025, net cash used in operating activities was $5.3 million and $3.9 million, respectively.

Previous wording

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

Current wording

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

Previous wording

During the three months ended March 31, 2026 and 2025, net cash used in investing activities was $9.9 million and $0.9 million, respectively.

Current wording

During the six months ended June 30, 2026 and 2025, net cash used in investing activities was $8.4 million and net cash provided by investing activities was $3.6 million, respectively.

Previous wording

Net cash used in investing activities during the three months ended both March 31, 2026 and 2025, was primarily the result of the purchases of marketable investments securities, net. There were no capital expenditures during either the three months ended March 31, 2026 or 2025.

Current wording

Net cash used in investing activities during the six months ended June 30, 2026 was primarily the result of the purchases of marketable investment 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 the six months ended June 30, 2026 or 2025.

Previous wording

During the three months ended March 31, 2026 and 2025, net cash provided by financing activities was approximately $12.0 million and $0, respectively.

Current wording

During the six months ended June 30, 2026 and 2025, net cash provided by financing activities was approximately $13.5 million and $76,000, respectively.

Previous wording

Net cash provided by financing activities during the three months ended March 31, 2026 was related to the sale of 1,314,138 shares of common stock for net proceeds of approximately $12.0 million under the A.G.P. Sales Agreement. No cash was provided by financing activities during the three months ended March 31, 2025.

Current wording

Net cash provided by financing activities during the six months ended June 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 23,739 shares of common stock at a weighted average price of $3.29 per share pursuant to the A.G.P. Sales Agreement.

Previous wording

There have been no significant and material changes in our critical accounting policies during the three months ended March 31, 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.

Current wording

There have been no significant and material changes in our critical accounting policies during the six months ended June 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.