Brexanolone

Dr. Quirk brings more than 20 years of neuroscience drug discovery and development experience to lead Relmada’s sepranolone program, building on his tenure as Chief Scientific Officer at Sage Therapeutics. CORAL GABLES, Fla., June 11, 2026 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada” or the “Company”), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, today announced the appointment of Michael Quirk, PhD, as Senior Advisor – Sepranolone Program. Dr. Quirk’s deep expertise in CNS translational science, neuroactive steroid biology, and clinical development will be instrumental in advancing sepranolone, Relmada’s GABA A receptor modulator program targeting Prader-Willi Syndrome and other CNS indications. “We are very pleased to welcome Mike to the Relmada team. His distinguished career in CNS drug discovery and development, including his leadership of research and scientific strategy at Sage Therapeutics, gives him a unique and highly relevant perspective on neuroactive steroid biology that we believe will be invaluable to the sepranolone program,” said Sergio Traversa, Chief Executive Officer of Relmada Therapeutics . “Sepranolone's mechanism of action – selectively antagonizing the effects of allopregnanolone at GABA-A receptors without broadly disrupting GABAergic signaling – represents a precise and elegant approach to modulating neural circuits that are dysregulated in compulsivity-related disorders like Prader-Willi syndrome,” said Dr. Quirk, Senior Advisor – Sepranolone Program. “I believe sepranolone has the potential to be a genuinely differentiated medicine for patients who currently have very limited options. I am excited to join the Relmada team and contribute to advancing this program toward clinical proof-of-concept.” About Michael Quirk, PhD Michael Quirk is a trained neurophysiologist and translational scientist with 20 years of diverse biopharmaceutical industry experience. Most recently, Mike served as Chief Scientific Officer and interim Head of R&D at Sage Therapeutics (Sage) where he worked on the first medicines approved for the treatment of Postpartum Depression and helped to build a portfolio targeting a range of brain health conditions with a specific interest in indications at the intersection of neuroscience and women’s health. Prior to joining Sage in 2014, Mike was a Director within the Neuroscience Innovative Medicine group at AstraZeneca working on a variety of programs within psychiatry and neurology. Mike holds both an S.B. degree in Cognitive Science and a Ph.D. in Systems Neuroscience from the Massachusetts Institute of Technology and completed his post-doctoral training at Cold Spring Harbor Laboratory in New York studying neural mechanisms of decision-making and goal-directed behavior. About Sepranolone and GABA Modulation Sepranolone, a synthetic isoallopregnanolone, selectively modulates GABA A receptors by antagonizing allopregnanolone (ALLO), without disrupting GABA signaling. It targets disorders linked to excess GABAergic activity such as Prader-Willi syndrome, Tourette syndrome, and obsessive-compulsive disorder (OCD). More than 335 patients have been treated with sepranolone in clinical trials to date, with an excellent safety profile. About Prader-Willi Syndrome (PWS) PWS is a rare genetic disorder caused by chromosomal deletions on chromosome 15, leading to neurodevelopmental and behavioral complications. Global prevalence is estimated to be 350,000-400,000 patients. Current treatments address symptoms but do not modify the underlying neurobehavioral pathology. About Relmada Therapeutics, Inc. Relmada Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for oncology and central nervous system conditions. Its lead candidates, NDV-01 and sepranolone, are advancing through mid-stage clinical development with the potential to address significant unmet needs. For more information, visit Forward-Looking Statements: The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “if”, “may”, “expects”, “anticipates”, “believes”, “will”, “will likely result”, “will continue”, “plans to”, “potential”, “promising”, and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including potential for Relmada’s product candidates to fail to progress, potential for Phase 2 NDV-01 data to fail to continue to deliver positive results supporting further development, potential for clinical trials to fail to deliver statistically and/or clinically significant evidence of efficacy and/or safety, failure of interim or top-line results to accurately reflect the complete results of the trial, failure of planned or ongoing preclinical and clinical studies to demonstrate expected results, potential failure to continue to secure FDA agreement on the regulatory path for NDV-01 and/or sepranolone, or that future NDV-01 and/or sepranolone clinical results will be acceptable to the FDA, failure to secure adequate NDV-01 and/or sepranolone drug supply, failure of pending patent applications to result in issued patents, or issued patents being challenged and invalidated by third parties or not providing us with any competitive advantages, the Company’s cash runway and sufficiency of the Company’s cash resources and uncertainties inherent in estimating the Company’s cash runway, future expenses and other financial results, including its ability to fund future operations, including clinical trials, and the other risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein are not a complete list. Investor Contact: Brian Ritchie LifeSci Advisors britchie@lifesciadvisors.com Media Inquiries: Corporate Communications media@relmada.com

New data from Phase 1 trial of GlyphAgo TM build upon previously reported topline data and further demonstrate GlyphAgo TM can achieve therapeutic exposures of agomelatine at doses projected to avoid liver enzyme elevations and reduce or eliminate the need for liver function testing Enrollment in Phase 2b BUOY-1 trial of GlyphAllo TM is on track with topline data expected in 1H 2027; Seaport dosed first participant in Phase 1 driving simulation trial of GlyphAllo TM , with data expected in 2H 2026 Dr. Sharon Mates, Co-Founder, Chair, and CEO of Intra-Cellular Therapies until its acquisition by Johnson & Johnson for $14.6 billion, was appointed to Board of Directors Upsized IPO generated $260.0 million in gross proceeds; in addition to $212.6 million on hand as of March 31, 2026, total cash, cash equivalents, and investments expected to fund operations into 2029 BOSTON--(BUSINESS WIRE)-- Seaport Therapeutics, Inc. , (Nasdaq: SPTX) (“Seaport” or the “Company”), a clinical-stage therapeutics company that is inventing and developing novel neuropsychiatric medicines, today announced financial results for the first quarter of 2026 and highlighted recent corporate and clinical progress. “The first quarter of 2026 was filled with meaningful progress for Seaport, and we significantly advanced the clinical development of our lead GlyphAllo TM and GlyphAgo TM programs,” said Daphne Zohar, Co-Founder and Chief Executive Officer at Seaport Therapeutics. “We previously reported data from the single-ascending dose and crossover portions of the Phase 1 proof-of-concept trial of GlyphAgo TM , which we believe substantially derisk future clinical development of the program. Today, we announced new multiple-ascending dose data from this trial, which further reinforce the ability of GlyphAgo TM to achieve therapeutic exposures of agomelatine at doses projected to avoid liver enzyme elevations. We continue to progress our potentially registration-enabling Phase 2b BUOY-1 trial of GlyphAllo TM and anticipate topline data from that trial in the first half of next year. With a pipeline of novel programs based on clinically validated mechanisms, an experienced team with a track record of success in neuropsychiatry, and a strong balance sheet bolstered by our recent IPO, we look forward to executing on our mission to transform the treatment of neuropsychiatric disorders and improve patients’ lives.” Recent Business Updates and Anticipated Milestones GlyphAllo TM (SPT-300 or Glyph Allopregnanolone) Program for Patients with Major Depressive Disorder (MDD) Enrollment on Track in Phase 2b BUOY-1 Trial in MDD. Seaport is actively enrolling patients in BUOY-1, a two-arm, global, randomized, double-blind, placebo-controlled, potentially registration-enabling Phase 2b trial investigating the safety and efficacy of GlyphAllo TM in patients with MDD with or without anxious distress. Topline data from the BUOY-1 trial are expected in the first half of 2027. Given the strength in enrollment and to maximize the likelihood that the BUOY-1 trial could be used to support registration, the Company plans to enroll the full prespecified target sample size of approximately 360 patients and no longer intends to perform a sample size re-estimation (SSRE). Dosed First Participant in Phase 1 Driving Simulation Trial. This randomized, double-blind, placebo-controlled Phase 1 trial is designed to evaluate the potential impact of multiple dose levels of GlyphAllo TM on simulated driving performance in healthy volunteers. GlyphAllo TM will be dosed in the evening, and simulated driving performance will be assessed the following morning, approximately nine hours following GlyphAllo TM administration, as is typical in driving simulation trials. Topline data from the driving simulation trial are expected in the second half of 2026, in advance of the expected topline readout of the BUOY-1 trial. Phase 1 and Phase 2a and Preclinical Data Published in Science Translational Medicine . This publication details the design, optimization, preclinical evaluation, and Phase 1 and 2a clinical development of GlyphAllo TM in healthy volunteers. In Phase 1 and 2a trials, GlyphAllo TM was generally well-tolerated following single- and multiple-ascending oral doses ranging from 70–1000 mg, provided dose-dependent, therapeutically relevant plasma exposures of allopregnanolone, demonstrated pharmacodynamic effects in the brain, and potently blunted the acute physiological stress response on a validated clinical model of anxiety. GlyphAgo TM (SPT-320 or Glyph Agomelatine) Program for Patients with Generalized Anxiety Disorder (GAD) New Data Reported from Multiple-Ascending Dose (MAD) Portion of Phase 1 Proof-of-Concept Trial in Healthy Volunteers New data demonstrate that seven-day dosing of GlyphAgo TM achieved therapeutic exposures of agomelatine at doses projected to avoid liver enzyme elevations and reduce or eliminate the need for liver function testing. GlyphAgo TM AUC 0-24 and Cmax increased dose-dependently over the range of doses studied, and agomelatine exposures following GlyphAgo TM administration were consistent with data from the single-ascending dose (SAD) and crossover portions of the trial. There was no unmodified agomelatine arm in the MAD portion. Repeat dosing of GlyphAgo TM confirms favorable safety, tolerability, and pharmacokinetics across the Phase 1 program, with no serious or liver-related adverse events observed. In April 2026, Seaport reported results from the head-to-head crossover portion of the trial, in which GlyphAgo TM demonstrated a statistically significant 6.8-fold increase in bioavailability compared to unmodified agomelatine in healthy volunteers, exceeding the program’s two-fold target to mitigate liver exposure. GlyphAgo TM also showed significantly lower (10-fold) PK variability compared to unmodified agomelatine. The crossover portion included participants who were taking estrogen-containing oral contraceptives that are known to increase agomelatine exposure due to liver drug-drug interaction. In contrast, GlyphAgo TM exposure was unaffected by oral contraceptives, further supporting the ability of GlyphAgo TM to bypass first-pass liver metabolism. GlyphAgo TM demonstrated a 9.6 to 14.5-fold increase in dose-normalized exposure compared to agomelatine in a separate SAD portion of the trial in which no participants were on oral contraceptives. GlyphAgo TM was well-tolerated across all evaluated doses, and no serious or severe adverse events or liver-related adverse effects were reported. Results support dose selection and planned advancement into two parallel Phase 2 trials in patients with GAD. Company Expects to Initiate a Phase 2a Proof-of-Pharmacology Trial in the Second Half of 2026. This randomized, double-blind trial of two dose levels of GlyphAgo is designed to demonstrate proof-of-pharmacology by characterizing the potential benefits of GlyphAgo TM on sleep, including objective measures of sleep architecture, in patients with GAD and sleep disturbance. Topline data from this trial are expected in early 2028. Company Expects to Initiate a Phase 2b Trial in the First Half of 2027. This randomized, double-blind, placebo-controlled, potentially registration-enabling trial is designed to evaluate the efficacy and safety of GlyphAgo TM in patients with GAD. Topline data from this trial are expected by year-end 2028. Preclinical and Discovery Programs Glyph2BLSD TM (SPT-348 or Glyph 2-bromo-LSD) Program on Track. Seaport is developing Glyph2BLSD TM for depressive disorders, including treatment-resistant depression, post-traumatic stress disorder, and headache disorders with significant unmet need. Glyph2BLSD is a non-hallucinogenic neuroplastogen designed to harness the pharmacology of a psychedelic without the hallucination, or “trip.” Completion of first-in-human-enabling studies is expected by year-end 2027. Seaport and Monash Institute of Pharmaceutical Sciences Awarded Up to $15 Million from ARPA-H. Advanced Research Projects Agency for Health (ARPA-H) award supports the development of GlyphCele TM or Cele-Pro TM , an oral prodrug designed using Seaport’s proprietary Glyph TM platform to address dysfunctional gut lymphatics and local inflammation linked to metabolic disease and pancreatic cancer. Corporate Upsized IPO Raising $260.0M Completed. Seaport closed its upsized initial public offering (IPO) in May 2026, and the Company raised gross proceeds of $260.0 million, before deducting underwriting discounts, commissions, and other offering expenses. The net proceeds from the offering together with the Company’s current cash, cash equivalents and investments are expected to support Seaport’s current operating plans into 2029, which includes multiple anticipated topline data readouts, including the Phase 2b BUOY-1 trial of GlyphAllo TM in patients with MDD, the Phase 2a trial of GlyphAgo TM in patients with GAD and sleep disturbance, and the Phase 2b trial of GlyphAgo TM in patients with GAD. Sharon Mates, Ph.D. Appointed to Board of Directors. Dr. Mates served as Co-Founder, Chairman, and Chief Executive Officer of Intra-Cellular Therapies, Inc., which she co-founded in 2002, until its acquisition by Johnson & Johnson (J&J) for $14.6 billion in 2025. Under Dr. Mates’ leadership, Intra-Cellular Therapies developed medicines for mental health disorders including bipolar disorder, depression, and schizophrenia, and received U.S. Food and Drug Administration (FDA) approval for its novel antipsychotic CAPLYTA®, which generated greater than $1.5 billion in sales prior to the company’s acquisition by J&J, and continued its commercial growth thereafter driven by expanded market reach and additional FDA approvals. In connection with Seaport’s IPO, Robert Nelson, Eric Elenko, Ph.D., and Robert Lyne transitioned off of the Company’s Board of Directors. First Quarter 2026 Financial Results Cash Position: Cash, cash equivalents, and investments totaled $212.6 million as of March 31, 2026. Subsequent to March 31, 2026, Seaport completed its IPO, in which the Company raised gross proceeds of an additional $260.0 million, before deducting underwriting discounts, commissions, and other offering expenses. Seaport expects its current cash, cash equivalents, and investments to support its current operating plans into 2029. R&D Expenses: Research and development (R&D) expenses were $21.4 million for the quarter ended March 31, 2026 as compared with $10.5 million for the quarter ended March 31, 2025. The increase in R&D expenses of $10.9 million was primarily due to increases in clinical development expenses of GlyphAllo TM and GlyphAgo TM as they advanced into later stage development, and related personnel costs to support the Company’s R&D operations. G&A Expenses: General and administrative (G&A) expenses were $6.1 million for the quarter ended March 31, 2026 as compared with $5.7 million for the quarter ended March 31, 2025. The increase in G&A expenses of $0.5 million was primarily due to increased personnel costs and was partially offset by reduced professional fees, as compared to the same period in the prior year. Net Loss: Net loss was $25.4 million for the first quarter of 2026, as compared to a net loss of $13.1 million for the first quarter of 2025. About Seaport Therapeutics Seaport Therapeutics (Nasdaq: SPTX) is a clinical-stage therapeutics company focused on inventing and developing new medicines for patients with depression, anxiety, and other debilitating neuropsychiatric disorders. Through its differentiated approach, the Company identifies clinically validated mechanisms with established efficacy and safety which had historically been limited by high first-pass metabolism, low bioavailability, and/or side effects. Seaport applies its proprietary Glyph TM platform to overcome those limitations and invent innovative oral therapies. With an experienced team of industry leaders, Seaport has a proven track record in neuropsychiatry drug discovery and development and delivering successful business outcomes. Seaport aims to develop novel, leading treatment options that will make a significant impact for patients and their families. For more information, please visit . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding our product candidates, including the ongoing Phase 2b trial of GlyphAllo, enrollment status and anticipated timing of topline data in the first half of 2027, the Phase 1 driving simulation trial for GlyphAllo in healthy volunteers and timing of results in the second half of 2026, the ongoing Phase 1 trial of GlyphAgo, results related thereto, and anticipated Phase 2a proof-of-pharmacology and Phase 2b trials and related data in 2028, preclinical and clinical development activities and timelines, including preclinical and first-in-human-enabling activities for Glyph2BLSD (SPT-348), and our expectations regarding uses of capital, expenses and financial results, including the expected cash runway and financial performance. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect Seaport Therapeutics’ business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company’s research and development activities; risks that interim results are not predictive of final results in a clinical trial, Seaport Therapeutics’ ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to preclinical and clinical development activities; the Company’s dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; Seaport Therapeutics’ ability to attract, integrate and retain key personnel; risks related to the Company’s financial condition and need for substantial additional funds in order to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Seaport Therapeutics’ intellectual property protections; and risks related to the competitive landscape for Seaport Therapeutics’ product candidates; as well as other risks described in “Risk Factors,” in Seaport Therapeutics’ Registration Statement on Form S-1 filed with the Securities and Exchange Commission (SEC), as well as subsequent filings with the SEC. Seaport Therapeutics expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Seaport uses and intends to continue to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts. Seaport Therapeutics, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) Three Months Ended March 31, 2026 2025 Operating expenses: Research and development (including stock-based compensation expense of $0.9 million and $0.5 million for three months ended March 31, 2026 and 2025, respectively) $ 21,431 $ 10,534 General and administrative (including stock-based compensation expense of $1.7 million and $1.1 million for the three months ended March 31, 2026 and 2025, respectively) 6,112 5,651 Total operating expenses 27,543 16,185 Loss from operations (27,543 ) (16,185 ) Total other income, net 2,654 3,091 Loss before income taxes (24,889 ) (13,094 ) Income tax provision 519 31 Net loss $ (25,408 ) $ (13,125 ) Net loss per share, basic and diluted $ (10.34 ) $ (5.65 ) Weighted-average common shares outstanding, basic and diluted 2,456,766 2,323,724 Seaport Therapeutics, Inc. Selected Condensed Consolidated Balance Sheet Data (In thousands) (Unaudited) March 31, December 31, 2026 2025 Cash, cash equivalents and investments $ 212,642 $ 233,653 Working capital $ 174,118 $ 210,448 Total assets $ 227,673 $ 249,009 Total stockholders' deficit $ (115,621 ) $ (92,545 ) The above balance sheet data do not reflect the Company’s upsized initial public offering (IPO) in May 2026. In the IPO, the Company raised gross proceeds of $260.0 million, before deducting underwriting discounts, commissions, and other offering expenses. Contacts Seaport Therapeutics Media Contact: Shannon Costello Vice President, Communications publicrelations@seaporttx.com Investor Contact: Adam Bero, Ph.D. Head of Investor Relations ir@seaporttx.com