BioXcel Therapeutics(BTAI) - 2025 Q2 - Quarterly Report

Financial Performance - For the three months ended June 30, 2025, product revenue was $120,000, a decrease of 89% compared to $1,104,000 for the same period in 2024[27]. - The net loss for the three months ended June 30, 2025, was $19,187,000, compared to a net loss of $8,299,000 for the same period in 2024, indicating a significant increase in losses[27]. - The Company reported a basic and diluted net loss per share of $(2.45) for the three months ended June 30, 2025, compared to $(3.30) for the same period in 2024[27]. - For the six months ended June 30, 2025, net losses were $26,441, a decrease of 24% compared to $35,090 for the same period in 2024[41]. - The consolidated net loss for the six months ended June 30, 2025, was $26,441 million, compared to a net loss of $35,090 million for the same period in 2024, indicating a 25% improvement[197]. Operating Expenses - Total operating expenses for the three months ended June 30, 2025, were $15,972,000, down from $18,400,000 in the same period of 2024, representing a decrease of 7.7%[27]. - Research and development expenses for the three months ended June 30, 2025, were $10,256,000, an increase of 27.7% from $8,032,000 in the same period of 2024[27]. - Total research and development costs for the three months ended June 30, 2025, were $10,256 million, compared to $8,032 million for the same period in 2024, reflecting a 28% increase[197]. Cash and Liquidity - Cash and cash equivalents as of June 30, 2025, were $17,435,000, down from $29,854,000 as of December 31, 2024, reflecting a decrease of 41.5%[25]. - The Company had net cash used in operating activities of $24,618 for the six months ended June 30, 2025, down from $40,880 in the same period of 2024, reflecting a 40% improvement[41]. - The Company is evaluating various strategies to improve liquidity, including raising funding through equity securities and establishing collaborations with potential partners[46][53]. - Management has assessed 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[43]. Debt and Liabilities - Total liabilities increased to $133,456,000 as of June 30, 2025, compared to $131,439,000 as of December 31, 2024, showing a slight increase of 1.5%[25]. - Total debt as of June 30, 2025, is $108,685 million, an increase from $102,508 million on December 31, 2024, representing a 6.3% increase[66]. - The Company is required to maintain a minimum cash balance of $15,000 million, increasing to $20,000 million upon funding of Tranche B[74]. - The Credit Agreement matures on April 19, 2027, with an option to extend to April 19, 2028, subject to certain conditions[72]. Workforce and Cost Management - The Company reduced its workforce by approximately 15% on May 8, 2024, and an additional 28% on September 17, 2024, to extend its cash runway and prioritize clinical development[56][57]. - Accrued expenses decreased from $5,762 as of December 31, 2024, to $5,090 as of June 30, 2025, indicating a reduction in liabilities[62]. Product Development and Clinical Trials - The company completed the last patient last visit in the pivotal Phase 3 SERENITY At-Home clinical trial for BXCL501, with topline data expected in August 2025[209]. - BXCL501 is being evaluated for treatment of agitation associated with bipolar disorders or schizophrenia in the outpatient or at-home setting[220]. - The independent Data Safety Monitoring Board recommended continuing the SERENITY At-Home trial without modification on May 27, 2025, and July 1, 2025[223]. - The SERENITY At-Home pivotal Phase 3 trial is evaluating a 120 mcg dose of BXCL501 in over 200 patients[223]. Strategic Initiatives - The company utilized an AI platform to potentially reduce therapeutic development costs and accelerate timelines, focusing on neuroscience and immuno-oncology[34]. - The Company is maintaining IGALMI's market presence with minimal commercial resources while seeking potential commercial partners[216]. - The company has deprioritized the development of certain indications for BXCL501 and BXCL701 to focus on core clinical programs[212][213]. Stock and Equity - The Company granted new warrants to the Lenders to purchase an aggregate of 313 shares of common stock at an exercise price of $0.16 per share as part of the Fifth Amendment[104]. - The Company received $25,000 in gross proceeds from the issuance of its common stock, warrants, and pre-funded warrants on March 27, 2024, satisfying the April 15, 2024 covenant requirement of the Fourth Amendment[84]. - The Company sold 97 shares of its common stock for a gross amount of $139 under the Canaccord At-the-Market Program, incurring issuance costs of $4, leading to net proceeds of $135 for the three months ended June 30, 2025[133].