Brexanolone

SALT LAKE CITY, May 8, 2025 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced financial results for the first quarter ended March 31, 2025 and provided a corporate update. Neuroactive Steroids Lipocine has initiated an outpatient Phase 3 safety and efficacy study of LPCN 1154, a non-invasive, rapid onset, oral formulation of brexanolone for the treatment of postpartum depression (PPD). Dosing of the first patient is anticipated in the second quarter of 2025. The Phase 3 study is expected to support a 505(b)(2) New Drug Application (NDA) submission in 2026. Lipocine is exploring the possibility of partnering LPCN 1154 with a third party. LPCN 2401 for Obesity Management LPCN 2401 is targeted to be a once daily oral formulation comprising a proprietary anabolic androgen receptor agonist. It is expected to have a favorable benefit to risk profile as a non-invasive option for use as an adjunct to GLP-1 receptor agonist therapies and/or as a monotherapy post cessation of GLP-1 receptor agonist therapies with demonstrated benefits to the liver. Based on a pre-IND meeting and 2025 FDA draft guidance on Obesity and Overweight, the FDA recommends identifying the appropriate patient population for treatment, and also recommends that an approvable endpoint would be one that measures how a patient feels, functions, or survives. Therefore, in an upcoming proof-of-concept study of LPCN 2401 as an adjunct to GLP-1 agonist, Lipocine plans to target the elderly patient population, reportedly the population most vulnerable to lean mass and functionality loss while on GLP-1 agonist treatment, with plans to include functionality measures. Lipocine is exploring the possibility of partnering LPCN 2401 with a third party. TLANDO® Lipocine has an exclusive License Agreement with Verity Pharma (Verity), entered into in 2024, under which Verity has the rights to market TLANDO, its oral testosterone replacement therapy, in the United States and Canada, if approved. In April 2025, Lipocine entered into a license and supply agreement with Aché granting exclusive rights to market TLANDO® in Brazil. Aché is a Brazilian pharmaceutical company founded nearly 60 years ago with a mission to improve people's lives. Today, Aché's products reach more than 20 countries across Latin America, Africa, Asia, and Europe, in addition to its home base in Brazil. Lipocine continues to explore partnering TLANDO in territories outside the U.S., Canada, South Korea, the GCC countries and Brazil. First Quarter Ended March 31, 2025, Financial Results As of March 31, 2025, Lipocine had $19.7 million of unrestricted cash, cash equivalents and marketable investment securities compared to $21.6 million at December 31, 2024. Lipocine reported a net loss of $1.9 million, or ($0.35) per diluted share, for the quarter ended March 31, 2025, compared with net income of $3.5 million, or $0.66 per diluted share, for the quarter ended March 31, 2024. The company recognized royalty revenue from TLANDO sales of $94,000 during the quarter ended March 31, 2025, compared to royalty revenue of $117,000 during the quarter ended March 31, 2024. No license revenue was recognized during the quarter ended March 31, 2025, compared to $7.5 million in the quarter ended March 31, 2024. The license revenue in 2024 resulted from our license with Verity. Research and development expenses were $1.1 million and $2.8 million, respectively, for the quarters ended March 31, 2025 and 2024. The decrease in research and development expenses was primarily a result of a decrease in costs related to our LPCN 1154 clinical studies in 2025 as compared to 2024, a decrease related to the wind down of our LPCN 1148 study in 2024, and a decrease in TLANDO related costs in 2025. These were offset by an increase in other research and development related costs and supplies in 2025. General and administrative expenses were $1.1 million and $1.6 million, respectively, for the quarters ended March 31, 2025 and 2024. The decrease in general and administrative expenses primarily consisted of a decrease related to the one-time business development fees incurred in 2024 in conjunction with the Verity Pharmaceutical license agreement. About Lipocine Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs. Lipocine's clinical development candidates include: LPCN 1154, oral brexanolone, for the potential treatment of postpartum depression, LPCN 2101 for the potential treatment of epilepsy, LPCN 2203 an oral candidate targeted for the management of essential tremor, LPCN 2401 an oral proprietary anabolic androgen receptor agonist, as an adjunct therapy to incretin mimetics, as an aid for improved body composition in obesity management and LPCN 1148, a novel androgen receptor agonist prodrug for oral administration targeted for the management of symptoms associated with liver cirrhosis. Lipocine is exploring partnering opportunities for LPCN 1107, our candidate for prevention of preterm birth, LPCN 1154, for rapid relief of postpartum depression, LPCN 2401 for obesity management, LPCN 1148, for the management of decompensated cirrhosis, and LPCN 1144, our candidate for treatment of metabolic dysfunction-associated steatohepatitis (MASH). TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate developed by Lipocine, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. For more information, please visit . Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product candidates and related clinical trials, our development of our product candidates and related efforts with the FDA, including with respect to LPCN 1154, our P3 safety and efficacy study relating to LPCN 1154, the timing and potential results of the safety and efficacy study relating to LPCN 1154, potential partnering of our product candidates with third parties, and the potential uses and benefits of our product candidates. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that we may not be successful in developing product candidates, we may not have sufficient capital to complete the development processes for our product candidates or we may decide to allocate our available capital to other product candidates, we may not be able to enter into partnerships or other strategic relationships to monetize our non-core assets, safety and efficacy studies, including those relating to LPCN 1154, may not be successful or may not provide results that would support the submission of a NDA, the FDA may not approve any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals and our ability to utilize a streamlined approval pathway for LPCN 1154, the results and timing of clinical trials, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. SOURCE Lipocine Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE), today reported business highlights and financial results for the first quarter ended March 31, 2025. “We delivered strong growth in revenue and shipments of ZURZUVAE during the first quarter of 2025 through the team’s disciplined execution and unwavering commitment to bringing ZURZUVAE to more women with postpartum depression,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “We remain focused on establishing ZURZUVAE as the standard of care for women with postpartum depression and driving our business strategy forward with the goal of creating value for shareholders.” First Quarter 2025 Portfolio Updates ZURZUVAE ZURZUVAE was approved by the FDA in August 2023 as the first-and-only oral treatment indicated for adults with postpartum depression (PPD). ZURZUVAE was made commercially available in the U.S. in December 2023. The current commercialization investment plan includes recent joint sales force expansions and marketing tactics intended to further accelerate ZURZUVAE growth in PPD, along with expanded disease state awareness efforts to support increased PPD screening and diagnosis. The Company anticipates these investments will help support the goal of significant topline revenue growth in 2025. As of the first quarter ended March 31, 2025, the following results had been achieved: Shipped greater than 3,000 prescriptions to women with PPD, representing a 22% increase from the fourth quarter. Generated $13.8 million in collaboration revenue from ZURZUVAE, representing a 21% increase from the fourth quarter of 2024. Collaboration revenue represents 50% of the net revenue recorded when Biogen ships ZURZUVAE to the distributors. In terms of prescriber and patient trends: In the first quarter of 2025, OBGYNs accounted for almost 80% of all prescriptions. OBGYNs are, on average, increasing the number of women with PPD they treat once they have prescribed ZURZUVAE, which we believe reflects the high unmet need in PPD and potential value of ZURZUVAE. More than 70% of women prescribed ZURZUVAE are receiving it as their first new treatment for PPD. SAGE-319 SAGE-319 is an extrasynaptic-preferring GABAA receptor positive allosteric modulator (PAM) designed to have novel pharmacology and a differentiated clinical profile from other GABAA receptor PAMs in our portfolio. It is currently being investigated as a potential treatment for behavioral symptoms associated with certain neurodevelopmental disorders. The Company expects data from a Phase 1 multiple ascending dose (MAD) study by late 2025 and will evaluate next steps based on these data. Pre-Clinical The Company is continuing to explore targeted work within its NMDA receptor negative allosteric modulator (NAM) platform, focusing on potential treatments for neurodevelopmental disorders, with SAGE-817 and SAGE-039. Areas In Evaluation SAGE-324: The Company is evaluating potential indications, including seizures in developmental and epileptic encephalopathies (DEEs), and expects to provide an update on next steps, if any, in mid-2025. Strategic Alternatives Review Process As previously announced, Sage’s Board of Directors is evaluating a broad range of strategic alternatives to maximize value for shareholders. The Board’s review process remains ongoing. The Company has not set a timetable for the review process and does not intend to disclose further developments until it determines that disclosure is appropriate or necessary. FINANCIAL RESULTS FOR THE FIRST QUARTER 2025 Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2025, were $424 million compared to $504 million at December 31, 2024. Revenue: Collaboration revenue from sales of ZURZUVAE was $13.8 million in the first quarter of 2025 compared to $6.2 million for the same period in 2024. Reported collaboration revenue is 50% of the net revenue Biogen records for ZURZUVAE in the U.S. There was no net revenue from sales of ZULRESSO in the first quarter of 2025 compared to $1.7 million in the same period of 2024. Cost of Revenues: Cost of revenues were $0.7 million in the first quarter of 2025, which consisted of costs related to selling ZURZUVAE, compared to $1.3 million for the same period in 2024, which consisted of costs related to selling ZURZUVAE and ZULRESSO. R&D Expenses: Research and development expenses were $22.8 million, including $2.1 million of non-cash stock-based compensation expense, in the first quarter of 2025 compared to $71.7 million, including $5.0 million of non-cash stock-based compensation expense, for the same period in 2024. The decrease in R&D expenses in the first quarter of 2025 as compared to the same period in 2024 was primarily related to the 2024 and 2023 reorganization cost savings measures, including reduced headcount, budgeted expenditures, reprioritization of early-stage pipeline programs, and completion or cancellation of ongoing clinical trials. The reimbursement from Biogen to Sage for R&D expenses pursuant to the Sage/Biogen Collaboration and License Agreement was $0.2 million in the first quarter of 2025 compared to $5.7 million in the same period of 2024. The primary reason for the decrease in net reimbursement from Biogen to Sage was a decrease in the collaboration costs incurred by Sage for clinical trials. SG&A Expenses: Selling, general and administrative expenses were $57.6 million, including $4.9 million of non-cash stock-based compensation expense, in the first quarter of 2025 compared to $52.6 million, including $8.7 million of non-cash stock-based compensation expense, for the same period in 2024. The overall increase in SG&A expenses in the first quarter of 2025 as compared to the same period in 2024 was primarily related to increased collaboration commercialization efforts and legal expenses associated with the strategic alternatives review process. The reimbursement from Sage to Biogen for SG&A expenses pursuant to the Sage/Biogen Collaboration and License Agreement was $4.8 million in the first quarter of 2025 compared to $2.3 million in the same period of 2024. The primary reason for the increase in net reimbursement from Sage to Biogen was an increase in the collaboration costs incurred by Biogen in support of ongoing commercialization efforts for ZURZUVAE. Restructuring Expenses: Restructuring expenses were $0.5 million in the first quarter of 2025 due the October 2024 reorganization. Net Loss: Net loss was $62.2 million for the first quarter of 2025 compared to $108.5 million for the same period in 2024. FINANCIAL GUIDANCE Based on the Company’s current operating plan, Sage anticipates that its existing cash, cash equivalents, and marketable securities as of March 31, 2025, together with anticipated funding from ongoing collaborations and estimated revenues, excluding any potential milestone payments the Company may receive under its collaboration agreements, will support operations to mid-2027. While ZURZUVAE joint commercialization investment will increase in 2025, the Company anticipates overall operating expenses will substantially decrease in 2025 relative to 2024. Conference Call Information Sage will host a conference call and webcast today, April 29, 2025, at 4:30 p.m. ET to review its first quarter 2025 financial results and discuss recent corporate updates. The live webcast can be accessed on the investor page of Sage's website at investor.sagerx.com. A replay of the webcast will be available on Sage's website following the completion of the event and will be archived for up to 30 days. About Sage Therapeutics Sage Therapeutics (Nasdaq: SAGE) is a biopharmaceutical company committed to our mission of pioneering solutions to deliver life-changing brain health medicines, so every person can thrive. Sage developed the only two FDA-approved treatments indicated for postpartum depression and is advancing a pipeline to target unmet needs in brain health. Sage was founded in 2010 and is headquartered in Cambridge, Mass. Find out more at www.sagerx.com or engage with us on Facebook, LinkedIn, Instagram, and X. Forward-Looking Statements Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation our statements regarding: our plans, expectations and goals for commercialization of ZURZUVAE for the treatment of women with PPD, including our goals to establish ZURZUVAE as the standard of care for women with PPD and to bring ZURZUVAE to more women with PPD; our beliefs in the potential for ZURZUVAE, including that ZURZUVAE will be successful and gain market acceptance as a transformative treatment helping women with PPD and be instrumental in accelerating progress in maternal mental health; our belief that OBGYNs are increasing the number of PPD patients they treat on average after trying ZURZUVAE, and that drivers of this trend include high unmet need and the potential value demonstrated by ZURZUVAE; our investment plans for ZURZUVAE and our expectations regarding the impact of increased investment, including recent joint sales force expansions and planned marketing tactics, in support of our goals to accelerate market growth in PPD; our plans for expanded disease state awareness efforts to support increased PPD screening and diagnosis; our plans and other goals related to other aspects of commercialization; anticipated timelines for our clinical development efforts, including the expected timing of readout of the multiple ascending dose study for SAGE-319; our belief in the potential profile and benefit of our product candidates, including potential indications for our product candidates; our plans to evaluate SAGE-324 in additional indications, including seizures in DEEs, and the timing of our announcement of next steps regarding the SAGE-324 program; our plans to explore targeted work within our NMDA receptor NAM platform with SAGE-817 and SAGE-039; our expectations related to the October 2024 reorganization and our pipeline prioritization efforts, including timing and anticipated cost savings; our expectations regarding our plans to explore strategic alternatives; our belief as to the key business drivers for our business and potential value creation opportunities; and the mission and goals for our business. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: our commercialization efforts in the U.S. with respect to ZURZUVAE for the treatment of women with PPD may not be successful, and we may be unable to generate revenues from sales of ZURZUVAE at the levels or on the timing we expect or at levels or on the timing necessary to support our goals; the number of women with PPD, the unmet need for additional treatment options, and the potential market for ZURZUVAE for the treatment of women with PPD may be significantly smaller than we expect; early positive signs, including ZURZUVAE results in 2024 and the first quarter of 2025, may not be a signal of future success; ZURZUVAE may not achieve, or even if achieved, maintain, the clinical benefit, clinical use or market acceptance for the treatment of PPD that we expect, including among OBGYNs, or we may encounter reimbursement, market access, process-related, or other issues, including competition in the market, or issues with our distribution network that impact the success of our commercialization efforts; ZURZUVAE may never become the standard of care for women with PPD; we may encounter delays in initiation, conduct, completion of enrollment or completion and reporting of data with respect to any of our ongoing studies or clinical trials, such as the completion of the multiple ascending dose study for SAGE-319, including as a result of slower than expected site initiation, slower than expected enrollment, the need or decision to expand the trials or other changes, that may impact our ability to meet our expected timelines and may increase our costs; success in earlier non-clinical or clinical trials of any of our product candidates may not be repeated or observed in ongoing or future studies, and ongoing and future clinical trials may not meet their primary or key secondary endpoints, which may substantially impair development; unexpected concerns may arise from additional data, analysis or results from any of our completed studies; decisions or actions of the FDA or the timing of meetings with the FDA may affect the timing, design, size, progress, and cost of clinical trials or the timing of data readouts or our ability to proceed with further development or may impair the potential for successful development or the timing or success of filing for and gaining regulatory approval; we may encounter adverse events at any stage that negatively impact further development and the potential for approval of our product candidates or the potential for successful commercialization of any of our products or that require additional non-clinical and clinical work, which may not yield positive results; the need to align with our collaborators may hamper or delay our development and commercialization efforts for the products or product candidates that are part of the collaboration or increase our costs; the anticipated benefits of our ongoing collaborations, including the receipt of payments or the successful development or commercialization of products and generation of revenue, may never be achieved at the levels or timing we expect or at all; our business may be adversely affected and our costs may increase if any of our key collaborators fails to perform its obligations or terminates our collaboration; the internal and external costs required for our ongoing, planned, and other future activities, and the resulting impact on expenses and use of cash, may be higher than expected, which may cause us to use cash quicker than expected or change or curtail some of our plans or both; our expectations as to expenses, cash usage, potential revenue, funding from collaborations, including milestones, cash runway, and cash needs may prove not to be correct for other reasons, such as changes in plans or actual events being different than our assumptions; we may not achieve anticipated cost savings from our October 2024 reorganization and pipeline prioritization efforts at the levels we expect; we may be opportunistic in our future financing plans even if available cash is sufficient; we may not be successful in our efforts to gain regulatory approval of products beyond ZURZUVAE; we may not achieve revenues from our products that may be successfully developed in the future at levels we expect; our exploration of strategic alternatives could result in substantial costs and be a distraction to management and other employees, which could have an adverse effect on our business; the strategic alternatives review process may not result in any transaction or strategic outcome; if we determine to engage in a transaction as a result of our exploration and evaluation of strategic alternatives, our future business, prospects, financial position and operating results could be significantly different than those in historical periods or projected by our management; additional funding may not be available on acceptable terms when we need it, or at all, which could hamper our development and commercialization activities; any of the foregoing events could impair the drivers and value creation opportunities for our business; and we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates or the commercialization of any current or future marketed product, which may delay our timing or change our plans, increase our costs or otherwise negatively impact our business; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent annual or quarterly report filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements. Financial Tables $ 423,854 $ 504,418 469,669 547,222 59,821 82,133 409,848 465,089 2025 2024 $ - $ 1,690 - - 13,827 6,212 236 - 14,063 7,902 655 1,269 22,759 71,734 57,591 52,574 513 - 81,518 125,577 (67,455 ) (117,675 ) 5,223 9,204 18 (12 ) $ (62,214 ) $ (108,483 ) $ (1.01 ) $ (1.80 ) 61,857,573 60,136,198 SELECT IMPORTANT SAFETY INFORMATION FOR ZURZUVAE ZURZUVAE (zuranolone) CIV, is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression in adults. This does not include all the information needed to use ZURZUVAE safely and effectively. See full prescribing information for ZURZUVAE. ZURZUVAE may cause serious side effects, including decreased awareness and alertness, which can affect your ability to drive safely or safely do other dangerous activities. Do not drive, operate machinery, or do other dangerous activities until at least 12 hours after taking each dose. You may not be able to tell on your own if you can drive safely or tell how much ZURZUVAE is affecting you. ZURZUVAE may cause central nervous system (CNS) depressant effects including sleepiness, drowsiness, slow thinking, dizziness, confusion, and trouble walking. Taking alcohol, other medicines that cause CNS depressant effects such as benzodiazepines, or opioids while taking ZURZUVAE can make these symptoms worse and may also cause trouble breathing. ZURZUVAE is a federally controlled substance schedule IV because it contains zuranolone, which can be abused or lead to dependence. Tell your healthcare provider right away if you become pregnant or plan to become pregnant during treatment with ZURZUVAE. You should use effective birth control (contraception) during treatment with ZURZUVAE and for 1 week after the final dose. ZURZUVAE and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger. ZURZUVAE is not for use in children. The most common side effects of ZURZUVAE include sleepiness or drowsiness, dizziness, common cold, diarrhea, feeling tired, weak, or having no energy, and urinary tract infection.