On August 10, 2021 BioXcel Therapeutics, Inc. ("BioXcel" or the "Company") (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, reported its financial results for the second quarter ended June 30, 2021 and provided an update on key strategic initiatives (Press release, BioXcel, AUG 10, 2021, View Source [SID1234586188]).
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"During the second quarter, we continued to successfully execute across our clinical, regulatory and commercial objectives for our neuroscience candidate, BXCL501, including furthering our plans for the pivotal Phase 3 program in dementia, executing on our global expansion strategy, and advancing through the regulatory review process," said Vimal Mehta, Ph.D., CEO of BioXcel. "With acceptance of our NDA by the FDA, we are one step closer to our first-ever product approval and making this innovative therapy available to patients suffering from acute agitation associated with schizophrenia and bipolar disorders. We continue to advance our commercial readiness strategy, if approved, and in parallel are advancing our strategic plans for geographic expansion."
Dr. Mehta added, "Looking ahead, we remain confident in the broad potential of BXCL501 across multiple indications where there is significant need for innovative treatments. We remain on track to commence our Phase 3 program for the acute treatment of agitation associated with dementia in the fourth quarter of this year and are exploring additional pipeline opportunities as growth drivers for this business. Looking beyond our neuroscience program, our Phase 1/2b study of BXCL701 for castrate resistant prostate cancer is advancing well, with additional efficacy data from the adenocarcinoma cohort expected in the third quarter 2021. We look forward to building on these successes during the second half of this year."
Company Highlights
Neuroscience Program
BXCL501 is an investigational proprietary, orally dissolving, thin film formulation of the adrenergic receptor agonist dexmedetomidine for the treatment of agitation resulting from neuropsychiatric disorders
Expect to commence the BXCL501 Phase 3 program for the acute treatment of agitation associated with dementia in Q4 2021, pending further feedback from the FDA.
Plan to report topline data from the 40 mcg Phase 2 trial of BXCL501 in patients with acute agitation associated with dementia during Q4 2021.
Received a Prescription Drug User Fee Act ("PDUFA") target action date of January 5, 2022 for the NDA for BXCL501 in the acute treatment of agitation associated with schizophrenia and bipolar disorders I & II.
Plans are underway for a Marketing Authorization Application ("MAA") with the European Medicines Agency ("EMA") of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I & II in 2H 2021.
Initiated pediatric study of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I & II.
Commercial Highlights
Held a Virtual Commercial Day on June 25, 2021, highlighting launch readiness plans in preparation for the potential approval of BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.
Continue to advance commercial readiness strategy for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II.
Medical Affairs Highlights
Presented data from the BXCL501 Phase 3 trials (SERENITY I & II) at the American Psychiatric Association Annual Meeting and at the International Society for Bipolar Disorders 2021 Global Annual Conference and additional data will be presented at a leading medical conference in 2H 2021.
Medical Science Liaison and Medical Manage Care teams continue to engage in scientific and medical-to-medical exchange with healthcare professionals and payers, respectively to provide key insights to support commercial strategy.
Immuno-Oncology Program
BXCL701 is an orally administered systemic innate immune activator for treatment of a rare form of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors.
Data readout from the adenocarcinoma cohort of the Phase 1b/2 trial of BXCL701 and pembrolizumab (KEYTRUDA) in aggressive forms of prostate cancer is planned for Q3 2021.
Corporate Highlights
In June 2021, the Company raised gross proceeds of approximately of $100 million in a common stock offering, providing sufficient cash runway to further fund ongoing clinical development studies and commercialization readiness preparations.
Second Quarter 2021 Financial Results
Research and Development Expenses: Research and development expenses were $13.5 million during the second quarter of 2021, as compared to $17.9 million for the same period in 2020. The decreased expenses were primarily attributable to a reduction in our SERENITY clinical trial costs offset in-part by an increase in personnel and related costs necessary to enlarge our development and medical teams. In addition, we experienced greater professional fees primarily due to increased toxicology studies, regulatory fees and consulting fees, all related to BXCL501.
General and Administrative Expenses: General and administrative expenses were $14.1 million for the second quarter of 2021, as compared to $3.5 million for the same period in 2020. The increase was primarily due to higher stock-based compensation and personnel costs due to our continuing efforts to expand our teams as well as increased marketing and commercial costs related to our preparation of the potential commercial launch of BXCL501 in the U.S., as well as increased legal, professional fees, and insurance costs.
Net Loss: BioXcel reported a net loss of $27.6 million for the second quarter of 2021, compared to a net loss of $21.4 million for the same period in 2020.
The second quarter 2021 results include approximately $6.8 million in non-cash stock-based compensation costs, compared to non-cash stock-based compensation of $2.0 million for the same period in 2020. As of June 30, 2021, cash and cash equivalents totaled approximately $273.1 million.
Conference Call
BioXcel will host a conference call and webcast today at 8:30 a.m. EDT. To access the call, please dial 877-407-2985 (domestic) and 201-378-4915 (international). A live webcast of the call will be available on the Investors section of the BioXcel website, and a replay of the call will be available through at least August 25, 2021. BioXcel’s website is available at www.bioxceltherapeutics.com.
BioXcel may use its website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors sections of its website at www.bioxceltherapeutics.com. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the "Email Alerts" option under the News / Events menu of the Investors section of its website at www.bioxceltherapeutics.com.