BioXcel Therapeutics(BTAI) - 2025 Q3 - Quarterly Report

Financial Performance - Total current assets increased to $44,403,000 as of September 30, 2025, compared to $37,394,000 as of December 31, 2024, representing a 19% increase[27]. - Product revenue for the three months ended September 30, 2025, was $98,000, a decrease of 54% from $214,000 in the same period of 2024[29]. - Total operating expenses decreased to $14,326,000 for the three months ended September 30, 2025, down from $15,507,000 in 2024, a reduction of 8%[29]. - Net loss for the three months ended September 30, 2025, was $30,911,000, compared to a net loss of $13,650,000 for the same period in 2024, indicating a 126% increase in losses[29]. - Cash and cash equivalents increased to $36,176,000 as of September 30, 2025, from $29,854,000 at the end of 2024, reflecting a 21% increase[27]. - The company reported a basic and diluted net loss per share of $2.18 for the three months ended September 30, 2025, compared to $5.15 in the same period of 2024[29]. - The company reported net losses of $30,911 for the three months ended September 30, 2025, compared to $13,650 for the same period in 2024, and net losses of $57,352 for the nine months ended September 30, 2025, compared to $48,740 for the same period in 2024[43]. Expenses and Liabilities - Total liabilities as of September 30, 2025, were $133,711,000, slightly up from $131,439,000 as of December 31, 2024[27]. - Total debt liability as of September 30, 2025, was $112,156,000, an increase from $106,722,000 as of December 31, 2024, representing a rise of about 5.4%[68]. - The Company has a total debt of $109,125,000 as of September 30, 2025, after accounting for unamortized debt premiums, discounts, and issuance costs[68]. - The total stockholders' equity deficit improved to $(88,919,000) as of September 30, 2025, from $(93,101,000) at the end of 2024[27]. - The Company recorded total inventory of $459 as of September 30, 2025, down from $679 as of December 31, 2024, with inventory write-downs of $0 for the three months ended September 30, 2025[62]. - The Company’s total accrued expenses were $4,363 as of September 30, 2025, down from $5,762 as of December 31, 2024[64]. - The Company’s total property and equipment, net, was $249 as of September 30, 2025, compared to $475 as of December 31, 2024[63]. Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $23,550,000, compared to $24,534,000 in 2024, showing a decrease of 4%[29]. - The Company has deprioritized the development of certain indications for BXCL501 and BXCL701 to focus on core clinical programs[208][209]. - BXCL501 is being evaluated for treatment of opioid use disorder, acute stress disorder, and post-traumatic stress disorder in clinical trials[217]. - The SERENITY At-Home pivotal Phase 3 trial for BXCL501 met its primary endpoint, with plans for a supplemental new drug application (sNDA) submission in early Q1 2026[204]. - The SERENITY At-Home trial met its primary endpoint, supporting the sNDA submission for label expansion of IGALMI®[221]. Capital and Financing - The company is exploring various strategies to raise additional capital, including equity sales and collaborations[48][54]. - The Company entered into the Fourth Amendment to the Credit Agreement on March 20, 2024, which included a waiver of the "going concern" qualification in the independent auditor's report for the fiscal year ended December 31, 2023[80]. - The Fourth Amendment requires the Company to raise at least $25,000 in gross proceeds by April 15, 2024, and $50,000 by November 30, 2024, from stock issuance or partnering transactions[81]. - The Company has $80,000,000 in commitments under the Credit Agreement that remains unfunded as of September 30, 2025[70]. - The Company must maintain a minimum liquidity amount of $15,000,000, which can increase to $37,500,000 under certain conditions related to the sale of OnkosXcel[75]. Stock and Equity - The Company granted new warrants to the Lenders to purchase shares at an exercise price of $49.1568 per share, expiring on April 19, 2029[99]. - The Company issued a total of 3,179 warrants, with the most recent being the 2024 Warrants at a strike price of $7.68 per share[181]. - The Company recorded a termination gain of $369 related to the Option Warrants, which expired unexercised[115]. - The Company raised approximately $6.128 million from the November 2024 Offering after deducting underwriting discounts and commissions of $871[122]. - The Company recorded a net loss of $586 million for the three months ended September 30, 2025, related to the remeasurement of the BTI Warrants[173]. Workforce and Operations - The company reduced its workforce by approximately 15% on May 8, 2024, and by an additional 28% on September 17, 2024, to extend its cash runway and prioritize clinical development[58][59]. - The Company is maintaining IGALMI's market presence with minimal commercial resources while seeking potential commercial partners following its Clinical Prioritization in 2024[212]. Legal and Compliance - The Company is currently involved in multiple litigation matters, including a class action complaint filed on July 7, 2023, alleging violations of the Securities Exchange Act of 1934[189]. - The Company signed a commercial supply agreement with minimum annual payments totaling $10,000 over three years, with a reduced commitment of $1,000 for 2024 and $2,000 to $5,000 for subsequent years, contingent on FDA approvals[194].