Core Viewpoint - BioXcel Therapeutics, Inc. reported a quarterly loss of $0.32 per share, which was better than the Zacks Consensus Estimate of a loss of $0.50, and a significant improvement from a loss of $1.72 per share a year ago, indicating a 36% earnings surprise [1] Financial Performance - The company posted revenues of $0.21 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 82.17%, and a decline from $0.34 million in the same quarter last year [2] - Over the last four quarters, the company has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [2] Stock Performance - BioXcel Therapeutics shares have lost about 79% since the beginning of the year, contrasting with the S&P 500's gain of 25.5% [3] - The current Zacks Rank for the stock is 4 (Sell), indicating expectations of underperformance in the near future [6] Earnings Outlook - The current consensus EPS estimate for the coming quarter is -$0.49 on revenues of $1.24 million, and for the current fiscal year, it is -$1.97 on revenues of $4.12 million [7] - The trend for estimate revisions ahead of the earnings release has been unfavorable, which could impact future stock movements [6] Industry Context - The Medical - Biomedical and Genetics industry is currently in the top 29% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8]

Financial Performance - Total revenues for the three months ended September 30, 2023, were $214,000, compared to $341,000 for the same period in 2022, representing a decrease of 37.3%[33]. - Operating expenses for the three months ended September 30, 2023, totaled $15,507,000, a decrease from $48,638,000 in the prior year, reflecting a reduction of 68.1%[33]. - The net loss for the three months ended September 30, 2023, was $13,650,000, compared to a net loss of $50,486,000 for the same period in 2022, indicating a 72.9% improvement[33]. - For the nine months ended September 30, 2024, the company reported a net loss of $48,740, a significant improvement compared to a net loss of $156,797 for the same period in 2023, representing a reduction of approximately 69%[46]. - The company recognized net losses of $13,650 and $50,486 for the three months ended September 30, 2024, and 2023, respectively, showing a 73% improvement in quarterly performance[46]. - Basic and diluted net loss per share for the nine months ended September 30, 2024, was $(1.29), an improvement from $(5.40) in the prior year[195]. Cash and Liquidity - As of September 30, 2024, cash and cash equivalents decreased to $40.387 million from $65.221 million as of December 31, 2023, indicating a decline of approximately 38.1%[30]. - The net cash used in operating activities for the nine months ended September 30, 2024, was $57,218, down from $128,143 in the prior year, indicating a decrease of about 55%[46]. - The company has significant indebtedness, with long-term debt amounting to $104.440 million as of September 30, 2024[31]. - The company has identified conditions that raise substantial doubt about its ability to continue as a going concern[10]. - The Company must maintain a minimum liquidity amount of $15,000, which can increase to $25,000 if certain gross proceeds from stock issuance are not met by September 30, 2024[133]. Debt and Financing - Total liabilities increased to $134.525 million from $130.210 million, reflecting an increase of approximately 3.4%[31]. - The Company entered into two strategic financing agreements providing up to $260,000 in gross funding to support commercial activities and clinical development efforts[115]. - The Company entered into a Second Amendment to the Credit Agreement, providing up to $202,319 in senior secured term loans, including an initial Tranche A of $70,000 funded on April 28, 2022[117]. - The remaining tranches available under the Credit Agreement include Tranche B of $20,000, Tranche C of $30,000, and Tranche D of $50,000, contingent upon meeting specific regulatory and financial milestones[120]. - The Company received $25,000 in gross proceeds from stock issuance on March 27, 2024, satisfying the April 15, 2024 covenant requirement[133]. Research and Development - The company is dependent on the success of IGALMITM and four product candidates: BXCL501, BXCL502, BXCL701, and BXCL702 for future growth[13]. - The company’s most advanced neuroscience clinical development program, BXCL501, is aimed at treating agitation associated with psychiatric and neurological disorders[42]. - The company’s immuno-oncology asset, BXCL701, is under investigation for treating a rare form of prostate cancer and advanced solid tumors[43]. - The Company recognizes research and development expenses as incurred, which include wages, benefits, and costs related to clinical trials[90]. Operational Challenges - The company has incurred significant operating losses since inception and anticipates continuing to incur substantial losses for the foreseeable future[8]. - The regulatory approval processes for product candidates are lengthy and unpredictable, which could substantially harm the business if approvals are not obtained[14]. - The company relies on third parties for the manufacture of clinical supplies and commercial supplies, which poses risks to its operations[22]. - Management has expressed substantial doubt about the company's ability to continue as a going concern for at least 12 months from the issuance date of the financial statements due to significant losses and negative cash flows[48]. Stock and Equity - The Company raised $32,687 from the issuance of common stock and warrants during the nine months ended September 30, 2024, compared to $24,657 in the same period of 2023, marking an increase of approximately 32%[46]. - The Company amended and restated the Original Warrants, reducing the exercise price from $20.04 to $3.6452 per share, and granted new warrants for 70 shares at the same exercise price[136]. - The Company recorded a fair value adjustment resulting in an unrealized gain of $16,412 for the nine months ended September 30, 2024, related to derivative liabilities[144]. - The Company had common stock equivalents outstanding of 16,222 shares as of September 30, 2024, compared to 5,688 shares in 2023[194]. Cost Management - Operating expenses for the three months ended September 30, 2023, totaled $15,507,000, a decrease from $48,638,000 in the prior year, reflecting a reduction of 68.1%[33]. - The total stock-based compensation expense recognized for the three months ended September 30, 2024, was $1,865, down from $4,014 in the same period of 2023[173]. - The Company recorded total restructuring costs of $4,163 for the year ended December 31, 2023, which included severance and benefit costs of $4,063 and contract termination costs of $100[104]. Strategic Focus - The company is focused on utilizing AI approaches to develop transformative medicines, aiming to reduce therapeutic development costs and accelerate timelines[39]. - BioXcel Therapeutics, Inc. focuses on developing transformative medicines in neuroscience and immuno-oncology using artificial intelligence[204]. - The company employs AI platforms to reduce therapeutic development costs and potentially accelerate development timelines[204]. - BioXcel aims to leverage existing approved drugs and big data to identify new therapeutic indications, addressing substantial unmet medical needs[204].

BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q3 2024 Earnings Conference Call November 14, 2024 8:00 AM ET Company Participants Vimal Mehta - Chief Executive Officer Richard Steinhart - Chief Financial Officer Vincent O'Neill - Executive Vice President, Chief of Product Development and Medical Officer Rob Risinger - Chief Medical Officer, Neuroscience Conference Call Participants Matt Wiley - Senior Vice President and Chief Commercial Officer Frank Yocca - Chief Scientific Officer Operator Good morning, and wel ...

Exhibit 99.1 BioXcel Therapeutics Reports Third Quarter 2024 Financial Results Advancing two pivotal Phase 3 trials of BXCL501 for acute treatment of agitation associated with bipolar disorders, schizophrenia, and Alzheimer's dementia Conference call set for 8:00 a.m. ET today NEW HAVEN, Conn., Nov. 14, 2024 — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced its financial results for ...

NEW HAVEN, Conn., Nov. 08, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it will release its third quarter 2024 financial results on Thursday, November 14, 2024, before the open of the U.S. financial markets. The Company’s management team will also host a conference call and webcast at 8:00 AM ET that day to discuss these results and provide a general ...

The market expects BioXcel Therapeutics, Inc. (BTAI) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended September 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other h ...

Phase 2a efficacy and safety trial enrollment initiation expected in H1 2025 ~40 million Americans go to emergency department annually after a traumatic experience 1 Second externally funded stress-related trial for BXCL501 NEW HAVEN, Conn., Oct. 15, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced a collaboration with the University of North Carolina at Chape ...

Recently initiated SERENITY At-Home pivotal Phase 3 trial for agitation associated with bipolar disorders or schizophrenia Submitted protocol to FDA for TRANQUILITY In-Care pivotal Phase 3 trial for agitation associated with Alzheimer's dementia Company to maintain IGALMI™ in the market without current commercial infrastructure NEW HAVEN, Conn., Sept. 19, 2024 (GLOBE NEWSWIRE) -- — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformat ...

Estimated 23 million annual agitation episodes in the at-home setting 1-3 No FDA-approved therapies in the at-home setting for acute treatment of agitation associated with bipolar disorders or schizophrenia NEW HAVEN, Conn., Sept. 05, 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 the initiation of patient enrollment in its SERENITY At-Ho ...

The price trend for BioXcel Therapeutics, Inc. (BTAI) has been bearish lately and the stock has lost 6.6% over the past two weeks. However, the formation of a hammer chart pattern in its last trading session indicates that the stock could witness a trend reversal soon, as bulls might have gained significant control over the price to help it find support. While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among ...