Exhibit 99.1 Provides update on two late-stage clinical programs for BXCL501 for potential treatment of agitation Conference call and webcast set for 8:00 a.m. ET today "We believe our late-stage programs evaluating BXCL501 for acute agitation associated with Alzheimer's dementia, bipolar disorders, and schizophrenia represent groundbreaking opportunities to bring much-needed treatment options to large numbers of patients and caregivers," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "We are pleased ...

NEW HAVEN, Conn., March 01, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its fourth quarter and full year 2023 financial results on Tues., March 12, 2024, before the open of the U.S. financial markets. BioXcel Therapeutics' management team will also host a conference call and webcast at 8:00 AM ET that day to discuss ...

NEW HAVEN, Conn., Feb. 13, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that it has terminated its proposed public offering of $60.0 million of shares of its common stock or, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock, previously announced on February 8, 2024. As a result of s ...

Designation for BXCL701 in combination with a checkpoint inhibitor (CPI) for treatment of patients with metastatic SCNC with progression on chemotherapy and no evidence of microsatellite instability BXCL701 is an investigational, oral innate immune activator designed to inflame the tumor microenvironment and augment CPI activity Company to discuss registration path at upcoming meeting with FDA NEW HAVEN, Conn., Feb. 12, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical c ...

BioXcel Therapeutics (NASDAQ:BTAI) stock is taking a beating on Friday after the commercial-stage biopharmaceutical company announced a proposed underwritten public offering for its shares.This public offering includes $60 million shares of BTAI stock. The company also intends to offer underwriters of the deal a 30-day option to acquire another $9 million of its shares. Underwriters include BofA Securities and Truist Securities.BioXcel Therapeutics says that it will use the funds from this offering for ongo ...

NEW HAVEN, Conn., Feb. 08, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the "Company") (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it has commenced an underwritten public offering of $60.0 million of shares of its common stock or, in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock. In addition, t ...

Human proof of concept portion of the trial expected to begin in H1 2024; led by Georgetown Lombardi Comprehensive Cancer Center BXCL701 in combination with checkpoint inhibitor in preclinical studies demonstrated encouraging results in pancreatic cancer Initial study data expected in 2024 NEW HAVEN, Conn., Feb. 06, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-on ...

Aligns with Company's strategic focus on bringing to market BXCL501 for potential acute treatment of agitation for Alzheimer's patients  IGALMI™ market exclusivity further strengthened with receipt of issue notification for additional method of use patent (total of 8 U.S. patents, including 4 method of use patents)  NEW HAVEN, Conn., Feb. 05, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in ...

Financial Data and Key Metrics Changes - Research and development expenses decreased to $19.6 million for Q3 2023 from $22.1 million in Q3 2022, primarily due to reduced costs associated with BXCL501 SERENITY III and TRANQUILITY II clinical trials [19] - The company reported a net loss of $50.5 million for Q3 2023, compared to a net loss of $41.8 million for the same period in 2022 [20] - Selling, general and administrative expenses increased to $24.3 million for Q3 2023 from $17.1 million in Q3 2022, attributed to one-time legal fees and costs related to OnkosXcel's potential public offering [26] - Cash and cash equivalents totaled $90 million as of September 30, 2023, with an estimated runway through mid-2024 [27] Business Line Data and Key Metrics Changes - Net revenue from IGALMI was approximately $341,000 for the quarter [25] - The company is focusing on enhancing operational and financial flexibility through strategic financing agreements with Oaktree Capital and Qatar Investment Authority [15] Market Data and Key Metrics Changes - The company is positioned to address a large and underserved market for the acute treatment of agitation associated with Alzheimer's disease, with no FDA-approved drugs currently available for this indication [10] Company Strategy and Development Direction - The company is advancing its late-stage clinical programs for BXCL501, specifically the TRANQUILITY and SERENITY III programs, with a focus on at-home treatment settings [8][14] - The company aims to leverage its unique use of artificial intelligence to drive drug innovation and enhance its clinical development programs [17] - The company is prioritizing the TRANQUILITY program due to its significant market opportunity and is actively working on protocol development for the upcoming trial [75] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the alignment with the FDA regarding the development paths for TRANQUILITY and SERENITY III, which are expected to create significant value [8][9] - The management highlighted the importance of the recent positive survival data for BXCL501 in trials for metastatic castrate-resistant prostate cancer, indicating potential strategic options for OnkosXcel [23] - Management emphasized the ongoing support from strategic financial partners and the positive implications of the recent financing agreement [15][63] Other Important Information - The company is conducting a NIDA-funded trial for BXCL501 aimed at treating opioid use disorder, which is considered an emerging national threat [17] - The issuance of a J-Code by CMS is expected to streamline the reimbursement process for IGALMI, potentially increasing its market access [16][91] Q&A Session Summary Question: Can you provide more color on the TRANQUILITY development strategy? - Management confirmed alignment with the FDA to conduct a home-setting trial, emphasizing the importance of providing access to a broad patient population [30] Question: What is the ultimate path forward for BXCL501 in chronic agitation? - Management stated that while there is potential for chronic treatment, the current focus remains on acute treatment in the home setting [39] Question: Can you clarify the safety long-term requirements for submission for the TRANQUILITY program? - Management indicated that long-term safety discussions will continue with the FDA, focusing on the episodic nature of agitation [82] Question: What is the expected impact of the J-Code on sales trajectory? - Management expressed optimism that the J-Code will alleviate economic concerns for hospitals and clinics, facilitating broader use of IGALMI [91]

Table of Contents ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 Delaware 82-1386754 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 555 Long Wharf Drive New Haven, CT 06511 (Address of principal executive offices) (Zip Code) (475) 238-6837 (Registrant's telephone number, including area code) N/A (Former name, former address and former fiscal year, if changed since ...