BioXcel Therapeutics Aligns with FDA Recommendation for Phase 3 Trial for TRANQUILITY Program, Provides Update on Strategic Financing, and Reports Third Quarter 2023 Financial Results
Company plans to conduct Phase 3 trial of BXCL501 in the at-home setting for TRANQUILITY program to support potential sNDA for acute treatment of agitation associated with dementia due to probable Alzheimer’s disease
Potential market opportunity for BXCL501 to include acute treatment of agitation across full spectrum of Alzheimer’s-related dementia and agitation severity across all care settings
Based on FDA feedback, Company plans to conduct Phase 3 trial with 120 mcg (IGALMI™ approved dose) in the at-home setting for SERENITY III program for acute treatment of agitation in bipolar disorders or schizophrenia
Key financial terms agreed with Oaktree Capital Management and Qatar Investment Authority to enhance operational and financial flexibility
Conference call and webcast set for 8:00 a.m. ET today
NEW HAVEN, Conn., Nov. 14, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced alignment with the FDA’s recommendation for a Phase 3 trial in the TRANQUILITY program. In addition, the Company provided an update on strategic financing activities that would enable greater operational flexibility and reported its financial results for the third quarter ended Sept. 30, 2023.
“This is a time of tremendous progress and excitement for our company and stakeholders, especially as we report a clinical development path forward for our TRANQUILITY program,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “I am proud of the teamwork that enabled us to turn our focus to much larger potential opportunities for BXCL501 in at-home settings, beginning with agitation associated with Alzheimer’s dementia. Furthermore, we believe FDA feedback in the recent meeting focused on the SERENITY III program provides a clear path to develop BXCL501 for at-home use in the treatment of agitation associated with schizophrenia and bipolar disorders. When we couple these positive developments with revised terms with our strategic financing partners, we believe we have a strong foundation to deliver success.”
Progress on Two Late-Stage Clinical Programs
Strategic Financing Update: Oaktree Capital Management and Qatar Investment Authority
Third Quarter 2023 Financial Results
Net Revenue: Net revenue of IGALMI was approximately $341,000 for the quarter.
Research and Development (R&D) Expenses: R&D expenses were $19.6 million for the third quarter of 2023, compared to $22.1 million for the same period in 2022. The decreased expenses were primarily attributable to a decrease in expenses associated with the BXCL501 SERENITY III and TRANQUILITY II clinical trials.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $24.3 million for the third quarter of 2023, compared to $17.1 million for the same period in 2022. The increased expenses were primarily attributable to an increase in one-time legal and professional fees, costs associated with the OnkosXcel potential public offering as well as in personnel, and related costs to support commercialization of IGALMI in the U.S. prior to the Reprioritization.
Net Loss: BioXcel Therapeutics had a net loss of $50.5 million for the third quarter of 2023, compared to a net loss of $41.8 million for the same period in 2022. The Company used $37.6 million in operating cash during the third quarter.
Cash and cash equivalents totaled $90.0 million as of September 30, 2023. The Company has entered into a binding term sheet to restructure key financial terms in its agreements with Oaktree Capital Management and Qatar Investment Authority to provide for enhanced operational and financial flexibility, including the potential to access additional tranches of capital. The Company estimates that its current cash and cash equivalents will fund its operations through mid-2024. This estimated cash runway does not include potential additional capital that may become available under the amendments to the strategic financing agreements or resulting from any potential financing activities that may be undertaken by the Company.
Conference Call and Webcast
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About IGALMI™ (dexmedetomidine) sublingual film
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:
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 [email protected].
In indications other than those approved by the FDA as IGALMI™ BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BioXcel Therapeutics believes that BXCL501 potentially targets an important mediator of agitation, and the Company has observed anti-agitation results in multiple clinical studies across several neuropsychiatric disorders. BXCL501 is under investigation for the acute treatment of agitation associated with dementia due to probable Alzheimer’s disease 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 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. 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.
Source: BioXcel Therapeutics, Inc.
IGALMI™ is a trademark of BioXcel Therapeutics, Inc.