BioXcel Therapeutics Strengthens Cash Position to Advance SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia
BioXcel Therapeutics (BTAI) has strengthened its financial position with approximately $35 million in cash following a successful $14 million equity financing closed on March 4, 2025. The funds will support the advancement of their pivotal Phase 3 SERENITY At-Home trial, evaluating BXCL501's safety for at-home treatment of agitation in patients with bipolar disorders or schizophrenia.
BXCL501 is the company's investigational orally dissolving film formulation of dexmedetomidine. The trial's topline data, expected in the second half of 2025, aims to support a potential supplemental New Drug Application (sNDA) to expand IGALMI's label for at-home use, potentially providing an acute treatment option for millions of additional patients.
BioXcel Therapeutics (BTAI) ha rafforzato la sua posizione finanziaria con circa 35 milioni di dollari in contante dopo una riuscita finanziamento azionario di 14 milioni di dollari concluso il 4 marzo 2025. I fondi supporteranno l'avanzamento del loro trial cruciale Phase 3 SERENITY At-Home, che valuta la sicurezza di BXCL501 per il trattamento a domicilio dell'agitazione nei pazienti con disturbi bipolari o schizofrenia.
BXCL501 è la formulazione in film orale dissolvibile di dexmedetomidina in fase di sperimentazione dell'azienda. I dati preliminari del trial, attesi nella seconda metà del 2025, mirano a supportare una potenziale domanda di autorizzazione supplementare per un nuovo farmaco (sNDA) per espandere l'etichetta di IGALMI per l'uso a domicilio, offrendo potenzialmente un'opzione di trattamento acuto per milioni di pazienti aggiuntivi.
BioXcel Therapeutics (BTAI) ha fortalecido su posición financiera con aproximadamente 35 millones de dólares en efectivo tras un exitoso financiamiento de capital de 14 millones de dólares cerrado el 4 de marzo de 2025. Los fondos apoyarán el avance de su ensayo crucial Phase 3 SERENITY At-Home, que evalúa la seguridad de BXCL501 para el tratamiento en casa de la agitación en pacientes con trastornos bipolares o esquizofrenia.
BXCL501 es la formulación de película disolvente oral de dexmedetomidina en investigación de la empresa. Los datos preliminares del ensayo, que se esperan en la segunda mitad de 2025, tienen como objetivo respaldar una posible Solicitud de Nuevo Medicamento Suplementaria (sNDA) para expandir la etiqueta de IGALMI para uso en casa, proporcionando potencialmente una opción de tratamiento agudo para millones de pacientes adicionales.
BioXcel Therapeutics (BTAI)는 2025년 3월 4일에 종료된 성공적인 1400만 달러의 주식 자금 조달 이후 약 3500만 달러의 현금으로 재무 상태를 강화했습니다. 이 자금은 양극성 장애나 정신분열증 환자의 집에서의 동요 치료를 위한 BXCL501의 안전성을 평가하는 중요한 3상 SERENITY At-Home 시험의 진행을 지원할 것입니다.
BXCL501은 회사의 연구 중인 경구용 용해 필름 제형의 덱스메데토미딘입니다. 시험의 초기 데이터는 2025년 하반기에 예상되며, IGALMI의 라벨을 집에서 사용하도록 확장하기 위한 잠재적인 보충 신약 신청(sNDA)을 지원하는 것을 목표로 하고 있으며, 이는 수백만 명의 추가 환자에게 급성 치료 옵션을 제공할 수 있습니다.
BioXcel Therapeutics (BTAI) a renforcé sa position financière avec environ 35 millions de dollars en espèces après un financement par actions de 14 millions de dollars réussi, clôturé le 4 mars 2025. Les fonds soutiendront l'avancement de leur essai crucial Phase 3 SERENITY At-Home, évaluant la sécurité de BXCL501 pour le traitement à domicile de l'agitation chez les patients souffrant de troubles bipolaires ou de schizophrénie.
BXCL501 est la formulation de film oral soluble expérimentale de dexmedetomidine de l'entreprise. Les données préliminaires de l'essai, attendues dans la deuxième moitié de 2025, visent à soutenir une éventuelle demande de médicament nouveau supplémentaire (sNDA) pour élargir l'étiquette d'IGALMI pour une utilisation à domicile, offrant potentiellement une option de traitement aigu pour des millions de patients supplémentaires.
BioXcel Therapeutics (BTAI) hat seine finanzielle Position mit etwa 35 Millionen Dollar in bar gestärkt, nachdem am 4. März 2025 eine erfolgreiche Finanzierungsrunde über 14 Millionen Dollar abgeschlossen wurde. Die Mittel werden den Fortschritt ihrer entscheidenden Phase 3 SERENITY At-Home-Studie unterstützen, die die Sicherheit von BXCL501 für die Behandlung von Unruhe bei Patienten mit bipolaren Störungen oder Schizophrenie zu Hause bewertet.
BXCL501 ist die experimentelle oral auflösbare Filmformulierung von Dexmedetomidin des Unternehmens. Die vorläufigen Daten der Studie, die in der zweiten Hälfte von 2025 erwartet werden, zielen darauf ab, einen möglichen Antrag auf eine ergänzende Zulassung für ein neues Medikament (sNDA) zu unterstützen, um die Kennzeichnung von IGALMI für die Anwendung zu Hause zu erweitern, was potenziell Millionen zusätzlicher Patienten eine akute Behandlungsoption bieten könnte.
- Secured $14M in new equity financing
- Strong cash position of $35M to advance Phase 3 trial
- Potential market expansion through label expansion for at-home use
- Clear timeline for topline data in H2 2025
- Additional equity financing may lead to shareholder dilution
- Results and potential FDA approval not guaranteed
Topline data expected in second half of 2025 to support potential sNDA submission for label expansion of IGALMI® in the home setting
Company has
NEW HAVEN, Conn., March 11, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that, following the successful raise of
“We are pleased the recent financing enables us to progress our SERENITY At-Home trial,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “Patient enrollment is continuing and topline data results expected in the second half of 2025 are intended to support a potential sNDA submission to expand the label for IGALMI® in the at-home setting. We are highly motivated by the prospect of bringing — for the first time — an acute treatment option for agitation to millions of additional patients in this setting.”
About the SERENITY At-Home Phase 3 Trial
The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the home setting. The trial is enrolling 200 patients with a history of agitation episodes residing at home either alone or with caregivers/informants. Patients will self-administer 120 mcg of BXCL501 or placebo when agitation episodes occur over the 12-week trial period, with safety data (adverse events) collected during the trial. Patients or caregivers/informants will complete a modified global impression of severity (mCGI-S) and a clinical global impression of change (mCGI-C) two hours after dosing as an exploratory endpoint to evaluate use in the outpatient setting.
About IGALMI® (dexmedetomidine) sublingual film
INDICATION
IGALMI® (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children.
IMPORTANT SAFETY INFORMATION
IGALMI can cause serious side effects, including:
Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint.
Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations.
Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI.
Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours.
The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing.
These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects.
Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids.
Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201- 1088 or medinfo@bioxceltherapeutics.com.
Please see full Prescribing Information.
About BXCL501
Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.
About BioXcel Therapeutics, Inc.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the Company’s planned advancement of its SERENITY program; the expected submission of an sNDA to expand the label for IGALMI® in the home setting; the expansion of IGALMI® market potential; bringing IGALMI® as a treatment option to additional patients in the home setting; ; the potential to bring new treatment options to patients, and statements regarding the Company’s operational progress. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY and SERENITY programs; its dependence on the success and commercialization of IGALMI®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; its lack of experience in marketing and selling drug products; the risk that IGALMI or the Company’s product candidates may not be accepted by physicians or the medical community in general; the Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors section of the Company’s website at www.bioxceltherapeutics.com. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.
Contact Information
Corporate/Investors
BioXcel Therapeutics
Erik Kopp
1.203.494.7062
Media
Russo Partners
David Schull
1.858.717.2310
Source: BioXcel Therapeutics, Inc.
IGALMI® is a registered trademark of BioXcel Therapeutics, Inc.
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