BioXcel Therapeutics, Inc. announced positive overall survival (OS) data from its Phase 2 trial of BXCL701, the Company's investigational oral innate immune activator, in combination with KEYTRUDA®? (pembrolizumab) in patients with metastatic castration-resistant prostate cancer (mCRPC) of adenocarcinoma phenotype, the most common form of the disease. In addition to the new OS data, the Company recently presented an update on response rate data from the Phase 2 adenocarcinoma cohort at the Prostate Cancer Foundation Annual Scientific Retreat.

BXCL701 has received Orphan Drug Designation from the U.S. Food & Drug Administration in four indications: acute myelogenous leukemia, pancreatic cancer, stage IIb to IV melanoma, and soft tissue sarcoma. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, its expected timing of, trial design and data results from, future clinical trials of BXCL701 with pembrolizumab, potential benefits from treatment with BXCL701, the company's planned discussions with FDA, the future clinical development of BXCL701, The Company's plans to evaluate strategic options for OnkosXcel Therapeutics and potential market size and opportunity for product candidates. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, the limited operating history; its incidence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its ability to successfully negotiate amended terms under the financing agreements to be able to access funding and to obtain relief under financial covenants; its significant indebtedness and potential payment obligations related to such indebtedness and other contractual obligations; risks associated with the strategic prioritization; its limited experience in drug discovery and drug development; risks related to the TANQUILITY II Phase 3 trial and related audit; its dependence on the success and commercialization of IGALMI??, BXCL501, BXCL502 BXCL701 and BXCL702 and other product candidates; its lack of experience in marketing and selling drug products; the risk that IGALMI or the Company's product candidates may not be accepted by physicians or the medical community in general; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company's product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; impacts from the COVID-19 pandemic; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; its ability to commercialize its product candidates; and the other important factors discussed under the caption "Risk Factors" in its Quarterly Report on Form Form Form.