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”), 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.

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, our second quarter report on Form 10-Q filed with the SEC on August 4, 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 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.

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 and Item 1A of our Form 10-Q for the quarter ended June 30, 2026 filed with the SEC on August 4, 2026. Except as required by applicable law, we assume no obligation to revise or update any forward-looking statements for any reason.

Previous wording

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

Current wording

On January 12, 2024, we entered into the Verity License Agreement with Verity, pursuant to which we granted to Verity an exclusive, royalty-bearing, sublicensable right and license to develop and commercialize the TLANDO product for TRT in the Licensed Verity Territory. Any FDA post-marketing studies required will also be the responsibility of our licensee, Verity. On September 29, 2026, Verity Pharma received Notice of Compliance (“NOC”) from Health Canada that TLANDO had been approved for commercialization in Canada.

Previous wording

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, potentially the first oral hydroxy progesterone caproate (“HPC”) product indicated for the prevention of recurrent preterm birth (“PTB”), which has completed a dose finding clinical study in pregnant women and has been granted orphan drug designation by the FDA.

Current wording

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; and 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, potentially the first oral hydroxy progesterone caproate (“HPC”) product indicated for the prevention of recurrent preterm birth (“PTB”), which has completed a dose finding clinical study in pregnant women and has been granted orphan drug designation by the FDA.

Previous wording

Our goal is to become a leading biopharmaceutical company focused on leveraging our proprietary drug delivery technology platform to develop differentiated products through oral delivery of previously difficult to deliver molecules. The key components of our corporate strategy are to:

Current wording

Our goal is to become a leading biopharmaceutical company focused on leveraging our proprietary drug delivery technology platform to develop differentiated products through oral delivery of previously difficult to deliver molecules. The key components of our corporate strategy are:

Previous 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.

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, 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 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.

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. 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 September 30, 2026 and 2025, we incurred royalty expense of approximately $16,000 and $10,000, respectively, and during the nine months ended September 30, 2026 and 2025, we incurred royalty expense of approximately $42,000 and $28,000, respectively.

Previous wording

Upon execution of the Verity License Agreement, Verity Pharma paid us an initial payment of $2.5 million which was received on signing of the License Agreement and $5 million which was received on February 1, 2024. Verity Pharma also paid an additional payment of $2.5 million to us on December 30, 2024, and we received an additional payment of $1 million on January 5, 2026. We are also eligible to receive milestone payments of up to $259 million in the aggregate, depending on the achievement of certain sales milestones in a single calendar year and/or development milestones with respect to products licensed by Verity Pharma under the Verity License Agreement. In addition, we will receive tiered royalty payments at rates ranging from 12% up to 18% of net sales of all products licensed under the Verity License Agreement in the Licensed Verity Territory.

Current wording

Upon execution of the Verity License Agreement, Verity Pharma paid us an initial payment of $2.5 million which was received on signing of the License Agreement and $5 million which was received on February 1, 2024. Verity Pharma also paid an additional payment of $2.5 million to us on December 30, 2024, and we received an additional payment of $1 million on January 5, 2026. We are also eligible to receive milestone payments of up to $259 million in the aggregate, depending on the achievement of certain sales milestones in a single calendar year and/or development milestones with respect to products licensed by Verity Pharma under the Verity License Agreement. In addition, we will receive tiered royalty payments at rates ranging from 12% up to 18% of net sales of all products licensed under the Verity License Agreement in the Licensed Verity Territory. On September 29, 2026, Verity Pharma received an NOC from Health Canada that TLANDO had been approved for commercialization in Canada.

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. On July 8, 2026, Pharmalink received product marketing authorization approval for TESTYRA® (TLANDO) in the UAE.

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 plan to 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

In April 2026, we released the topline results from our Phase 3 placebo-controlled trial for post-partum depression. LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D total score compared to placebo at hour 60 in the full analysis set and the primary endpoint was not met. The results showed LPCN 1154 to be well tolerated and the treatment demonstrated a favorable safety profile to support outpatient administration without the need for healthcare provider monitoring. No treatment-related severe or serious adverse events (SAEs) were reported; no cases of excessive sedation or loss of consciousness were observed; and no treatment-related discontinuations were reported.

Current wording

In April 2026, we released the topline results from a Phase 3 placebo-controlled trial for post-partum depression. LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D total score compared to placebo at hour 60 in the full analysis set and the primary endpoint was not met. The results showed LPCN 1154 to be well tolerated and the treatment demonstrated a favorable safety profile to support outpatient administration without the need for healthcare provider monitoring. No treatment-related severe or serious adverse events (SAEs) were reported; no cases of excessive sedation or loss of consciousness were observed; and no treatment-related discontinuations were reported.

Previous wording

We believe that exclusion of the data from this outlier site signals LPCN 1154’s treatment effect – a rapid, sustained, and clinically meaningful improvement in depression symptoms - not only based on HAM-D findings, but also other scales such as MADRS and HAM-A. The results with the exclusion of this outlier site align with the known antidepressant profile of IV brexanolone, indicating a potential development path for LPCN 1154.

Current wording

We believe that exclusion of the data from this outlier site signals LPCN 1154’s treatment effect – a rapid, sustained, and clinically meaningful improvement in depression symptoms - not only based on HAM-D findings, but also other scales such as MADRS and HAM-A. The results with the exclusion of this outlier site align with the known antidepressant profile of IV brexanolone, indicating a potential development path for LPCN 1154. However, because this analysis was conducted post hoc and excludes data from a clinical trial site that did not meet its prespecified primary endpoint, these findings should be considered exploratory and may not be predictive of results in subsequent clinical trials.

Previous 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.

Current wording

We continue to explore business partnerships around the development, approval, and commercialization of Brlizio TM (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.

Previous 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.

Current wording

In the aforementioned post hoc analysis of the Phase 3 PPD study, oral brexanolone also signaled 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

(1) Ref: Louis ED, Ottman R. Tremor Other Kyperkinet Mov (NY). 2014;4:259.

Current wording

(1) Ref: Louis ED, Ottman R. Tremor Other Hyperkinetic Mov (NY). 2014;4:259.

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 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.

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 September 30, 2026, we have generated $57.7 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 $168.0 million in research and development expenses through June 30, 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 $170.1 million in research and development expenses through September 30, 2026.

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 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.

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, 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 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.

Current wording

We recognized revenue of $2.3 million and $115,000 during the three months ended September 30, 2026 and 2025, respectively, which consists of a one-time collaboration fee of $1.5 million, licensing revenue of $600,000 and royalty revenue from TLANDO sales of $190,000 during the three months ended September 30, 2026, compared to royalty revenue of $115,000 recognized during the three months ended September 30, 2025.

Previous wording

The decrease in research and development expenses during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025 consists of a decrease of approximately $96,000 in various research and development costs, with minimal change during the three months ended June 30, 2026 in expenses related to LPCN 1154 compared to the three months ended June 30, 2025, with the completion of our Phase 3 study in 2026 compared and startup costs of the same study during the three months ended June 30, 2025.

Current wording

The decrease in research and development expenses during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025 consists of a decrease of approximately $508,000 related to our LPCN 2401 study that was placed on hold in 2025, a $352,000 decrease in expenses related to LPCN 1154 resulting from the decrease in 2026 from clinical costs incurred for the previous Phase 3 study during the three months ended September 30, 2025 which completed in the first half of 2026, and a $17,000 decrease in other research and development costs, offset by a $240,000 increase in personnel costs.

Previous 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.

Current wording

The increase in general and administrative expenses during the three months ended September 30, 2026 as compared to the three months ended September 30, 2025 primarily consists of a $170,000 increase in personnel costs and a $139,000 increase in legal fees protecting our intellectual property and promoting our corporate strategy, and a $12,000 increase in other various general and administrative costs.

Previous 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.

Current wording

The increase in interest and investment income during the three months ended September 30, 2026 compared to interest and investment income during the three months ended September 30, 2025 was primarily due to higher cash balances available to invest as compared to cash balances during the third quarter of 2025.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025:

Previous wording

We recognized revenue of $309,000 and $717,000 during the six months ended June 30, 2026 and 2025, respectively, which consists of royalty revenue from TLANDO sales of $309,000 during the six months ended June 30, 2026, compared to licensing revenue of $500,000 and royalty revenue of $217,000 recognized during the six months ended June 30, 2025.

Current wording

We recognized revenue of $2.6 million and $831,000 during the nine months ended September 30, 2026 and 2025, respectively, which consists of a one-time collaboration fee of $1.5 million, licensing fee revenue of $600,000, and royalty revenue from TLANDO sales of $500,000 during the nine months ended September 30, 2026, compared to licensing revenue of $500,000 and royalty revenue of $331,000 recognized during the nine months ended September 30, 2025.

Previous 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.

Current wording

The increase in research and development expenses during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025 consists of a $703,000 increase in costs primarily related to our LPCN 1154 studies and other clinical trial costs and a $267,000 increase in personnel expense.

Previous wording

The increase in general and administrative expenses during the six months ended June 30, 2026 as compared to the six months ended June 30, 2025 primarily consists of a $97,000 increase in consulting and professional fees, a $51,000 increase in personnel expense, and a $34,000 increase in various general and administrative fees.

Current wording

The increase in general and administrative expenses during the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025 primarily consists of a $259,000 increase in legal fees related to protecting our intellectual property and promoting our corporate strategy, a $221,000 increase in personnel expense, a $37,000 increase in estimated corporate taxes, offset by a $15,000 decrease in other general and administrative expenses.

Previous 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.

Current wording

As of September 30, 2026, we had $21.5 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 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.

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. up to 3.0% of the aggregate gross proceeds from each sale of shares under the A.G.P. Sales Agreement, subject to adjustment by the Company and the Sales Agent. 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 nine months ended September 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. Subsequent to the quarter ended September 30, 2026, we sold 2,827,977 shares of our common stock for gross proceeds of approximately $7.9 million and net proceeds of $7.8 million under the A.G.P. Sales Agreement. As of November 4, 2026, we had $25.2 million available for sale under the Sales Agreement.

Previous wording

Funding may not be available to us on favorable terms, or at all. Also, market conditions may prevent us from accessing the debt and equity capital markets, including sales of our common stock through the A.G.P. Sales Agreement. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our clinical studies, research and development programs or, if any of our product candidates receive approval from the FDA, commercialization efforts. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, including the Sales Agreement, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. These arrangements may not be available to us or available on terms favorable to us. To the extent that we raise additional capital through marketing and distribution arrangements, other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences, warrants or other terms that adversely affect our stockholders’ rights or further complicate raising additional capital in the future. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable, for any reason, to raise needed capital, we will have to reduce costs, delay research and development programs, liquidate assets, dispose of rights, commercialize products or product candidates earlier than planned or on less favorable terms than desired or reduce or cease operations.

Current wording

Funding may not be available to us on favorable terms, or at all. Also, market conditions may prevent us from accessing the debt and equity capital markets, including sales of our common stock through the A.G.P. Sales Agreement. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our clinical studies, research and development programs or, if any of our product candidates receive approval from the FDA, commercialization efforts. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, including the A.G.P. Sales Agreement, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. These arrangements may not be available to us or available on terms favorable to us. To the extent that we raise additional capital through marketing and distribution arrangements, other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we do raise additional capital through public or private equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences, warrants or other terms that adversely affect our stockholders’ rights or further complicate raising additional capital in the future. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable, for any reason, to raise needed capital, we will have to reduce costs, delay research and development programs, liquidate assets, dispose of rights, commercialize products or product candidates earlier than planned or on less favorable terms than desired or reduce or cease operations.

Previous wording

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

Current wording

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

Previous 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.

Current wording

During the nine months ended September 30, 2026 and 2025, net cash used in operating activities was $7.1 million and $6.8 million, respectively.

Previous 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.

Current wording

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

Previous 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.

Current wording

During the nine months ended September 30, 2026 and 2025, net cash used in investing activities was $9.0 million and net cash provided by investing activities was $4.3 million, respectively.

Previous 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.

Current wording

Net cash used in investing activities during the nine months ended September 30, 2026 was primarily the result of the purchases of marketable investment securities, net. Net cash provided by investing activities during the nine months ended September 30, 2025 was primarily the result of the maturities of marketable investment securities, net. There were no capital expenditures during the nine months ended September 30, 2026 or 2025.

Previous 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.

Current wording

During the nine months ended September 30, 2026 and 2025, net cash provided by financing activities was approximately $13.5 million and $217,000, respectively.

Previous 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.

Current wording

Net cash provided by financing activities during the nine months ended September 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 nine months ended September 30, 2025 was related to the sale of 68,691 shares of common stock at a weighted average price of $3.26 per share pursuant to the A.G.P. Sales Agreement.

Previous wording

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 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 and the Aché License Agreement (see Footnote 7 – Contractual Agreements for disclosure regarding the SPC License Agreement, the Pharmalink Distribution Agreement, and the Aché License Agreement).

Current wording

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 account for revenue from our license and collaboration agreements in accordance with ASC 606, Revenue from Contracts with Customers. Upfront license and collaboration fees are recognized when the applicable performance obligation is satisfied. Contingent milestone payments represent variable consideration and are recognized when the applicable milestone is achieved and the related consideration is no longer constrained, provided the applicable performance obligation has been satisfied and collectability is reasonably certain. See Note 7 – Contractual Agreements for additional information regarding the Verity License Agreement, the SPC License Agreement, the Pharmalink Distribution Agreement and the Aché License Agreement.

Previous 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.

Current wording

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