BioXcel Therapeutics(BTAI) - 2024 Q3 - Quarterly Report

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$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$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].