BioXcel Therapeutics

BioXcel Therapeutics, Inc. is a commercial-stage biopharmaceutical company, which engages in utilizing artificial intelligence approaches to develop medicines in neuroscience and immuno-oncology. The firm offers IGALMI, a proprietary, sublingual film formulation of dexmedetomidine for the acute treatment of agitation associated with schizophrenia or bipolar disorder in adults. It also develops BXCL701, an investigational, orally administered, systemic innate immunity activator for the treatment of prostate cancer and solid tumors that are refractory to checkpoint inhibitors. The company was founded by Vimal D. Mehta on March 29, 2017 and is headquartered in New Haven, CT.

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BioXcel Therapeutics reports FDA approval milestone and financial resilience

BioXcel Therapeutics showcased strong financials with a net revenue of $238,000 and a net loss of $54.8 million, underpinned by a solid cash position of $193.7 million.
The FDA approval of IGALMI and upcoming clinical data announcements demonstrate progress in drug development and commercialization efforts.
While facing challenges such as slow product uptake and operating cost uncertainties, BioXcel has opportunities to drive market penetration through strategic initiatives.
The company's strengths lie in its innovative AI platform, strong cash reserves, and proactive approach to advancing its pipeline and commercialization strategies.

BioXcel Therapeutics reports Q1 progress, eyes revenue growth opportunities

BioXcel Therapeutics showcased strong commercial and clinical progress in Q1 2023 earnings call.
While facing challenges in dose selection and strategic options, the company remains optimistic about revenue growth.
Opportunities lie in maintaining commercial metrics, advancing clinical pipeline, and leveraging FDA-approved products.

BioXcel Therapeutics reports Q2 results, refocuses strategy for growth

BioXcel Therapeutics navigated challenges from investigator misconduct by refocusing on key therapeutic areas and strategic partnerships for financial stability.
Despite workforce reductions and operational changes, the company remains committed to advancing treatments for neurological disorders and sharing progress transparently.
Ongoing FDA discussions, positive trial results, and strategic reprioritization position BioXcel Therapeutics for potential growth and regulatory milestones.

BioXcel Therapeutics advances clinical programs and secures financial backing

BioXcel Therapeutics showcased progress in clinical programs and financial flexibility, with a focus on Alzheimer's-related opportunities.
Challenges include ongoing safety discussions, cash burn rate management, and logistical complexities in home setting trials.
Opportunities lie in targeting underserved markets, regulatory support, economic alleviation for hospitals, and efficient program advancement.
Balancing financial strategies and ensuring data integrity and regulatory alignment are key priorities for BioXcel's future success.

BioXcel Therapeutics reports strong Q4 results and advances clinical programs

BioXcel Therapeutics showcased positive financial performance and progress in late-stage clinical programs, indicating a promising outlook for the company's future.
While facing challenges such as trial timing reevaluation and funding uncertainties, the company's proactive approach and strategic focus present opportunities for growth and innovation.
By leveraging its strengths in program development and financial planning, BioXcel Therapeutics can navigate challenges and capitalize on opportunities to drive value for stakeholders.

BioXcel Therapeutics reports robust Q1 performance and advances late-stage programs

BioXcel Therapeutics demonstrated strong financial performance in Q1 2024, with notable revenue growth and reduced net losses. The company's focus on expanding market potential, advancing late-stage programs, and strengthening intellectual property positions it well for future growth. Challenges include sustaining commercialization success and managing expenses effectively.

BioXcel Therapeutics excels in Q2 with strong financial and clinical performance

BioXcel Therapeutics demonstrated strong financial and clinical performance in Q2 2024, with revenue growth, reduced expenses, and promising outcomes in key programs.
The company's strategic focus on expanding into home settings, addressing unmet needs, and exploring innovative therapies positions it well for sustained growth and value creation.
While facing challenges in execution and financial management, BioXcel Therapeutics has opportunities to leverage its strengths, drive innovation, and establish market leadership in mental health treatment.

BioXcel Therapeutics advances pivotal trials amidst financial challenges

BioXcel Therapeutics made notable progress in its clinical trials and received positive feedback from the FDA, indicating a strong focus on innovation and regulatory compliance.
While facing financial challenges with a net loss in Q3 2024, the company demonstrated cost management efforts through reduced expenses.
The company's ability to secure grants and maintain a healthy cash position positions it well to capitalize on opportunities for growth and development in the mental health therapeutics market.

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BioXcel Therapeutics, Inc. is a biopharmaceutical company, which engages in the development of artificial intelligence solutions in neuroscience and immuno-oncology. It also focuses on utilizing technology and research to develop therapeutics solutions. The company was founded by Vimal D. Mehta on March 29, 2017 and is headquartered in New Haven, CT.

NEW HAVEN, Conn., Nov. 22, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced the pricing of an underwritten public offering of 5,600,000 shares of its common stock, par value $0.001 per share (“Common Stock”), and accompanying warrants to purchase up to 5,600,000 shares of Common Stock, and, in lieu thereof to certain investors that so choose, pre-funded warrants to purchase up to 9,000,000 shares of Common Stock and accompanying warrants to purchase up to 9,000,000 shares of Common Stock, at a combined public offering price of $0.48 per share and accompanying warrant (or $0.479 per share underlying each pre-funded warrant and accompanying warrant, which equals the public offering price per share of Common Stock and accompanying warrant less the $0.001 exercise price per share of the pre-funded warrants). Gross proceeds to the Company from the offering are expected to be approximately $7.0 million, before deducting underwriting discounts and commissions and offering expenses, and excluding the exercise of any of the warrants.

BioXcel Therapeutics Announces Pricing of $7.0 Million Public Offering

NEW HAVEN, Conn., Nov. 21, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it has commenced an underwritten public offering of shares of its common stock, par value $0.001 per share (“Common Stock”), and accompanying warrants to purchase shares of Common Stock, and, in lieu thereof to certain investors that so choose, pre-funded warrants to purchase shares of Common Stock and accompanying warrants to purchase shares of Common Stock.

BioXcel Therapeutics Announces Proposed Public Offering

BioXcel Therapeutics, Inc. (BTAI) came out with a quarterly loss of $0.32 per share versus the Zacks Consensus Estimate of a loss of $0.50. This compares to loss of $1.72 per share a year ago.

BioXcel Therapeutics, Inc. (BTAI) Reports Q3 Loss, Lags Revenue Estimates

BioXcel Therapeutics, Inc. (NASDAQ:BTAI ) Q3 2024 Earnings Conference Call November 14, 2024 8:00 AM ET Company Participants Vimal Mehta - Chief Executive Officer Richard Steinhart - Chief Financial Officer Vincent O'Neill - Executive Vice President, Chief of Product Development and Medical Officer Rob Risinger - Chief Medical Officer, Neuroscience Conference Call Participants Matt Wiley - Senior Vice President and Chief Commercial Officer Frank Yocca - Chief Scientific Officer Operator Good morning, and welcome to the BioXcel Therapeutics Third Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode.

BioXcel Therapeutics, Inc. (BTAI) Q3 2024 Earnings Call Transcript

NEW HAVEN, Conn., Nov. 08, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it will release its third quarter 2024 financial results on Thursday, November 14, 2024, before the open of the U.S. financial markets. The Company's management team will also host a conference call and webcast at 8:00 AM ET that day to discuss these results and provide a general business update.

BioXcel Therapeutics to Report Third Quarter 2024 Financial Results on November 14, 2024

BioXcel Therapeutics (BTAI) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Will BioXcel Therapeutics, Inc. (BTAI) Report Negative Q3 Earnings? What You Should Know

NEW HAVEN, Conn., Oct. 29, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that Vimal Mehta, Ph.D., CEO, and Vincent J. O'Neill, M.D., Executive Vice President, Chief of Product Development and Medical Officer, will present at the ThinkEquity Conference in New York City. The presentation is set for Wednesday, October 30 at 2 p.m. ET.

BioXcel Therapeutics to Present at ThinkEquity Conference

Phase 2a efficacy and safety trial enrollment initiation expected in H1 2025 ~ 40 million Americans go to emergency department annually after a traumatic experience 1 Second externally funded stress-related trial for BXCL501 NEW HAVEN, Conn., Oct. 15, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced a collaboration with the University of North Carolina at Chapel Hill (UNC) on a grant awarded by the U.S. Department of Defense (DoD) to evaluate the efficacy and safety of BXCL501 as a potential treatment for acute stress disorder (ASD).

BioXcel Therapeutics Announces U.S. Department of Defense Grant to University of North Carolina to Fund Study of BXCL501 (Sublingual Dexmedetomidine) for Treating Acute Stress Disorder

Recently initiated SERENITY At-Home pivotal Phase 3 trial for agitation associated with bipolar disorders or schizophrenia

BioXcel Therapeutics Announces Clinical Prioritization and Update on BXCL501 Late-Stage Programs for Agitation

E stimated 23 million annual agitation episodes in the at-home setting 1-3   No FDA-approved therapies in the at-home setting for acute treatment of agitation associated with bipolar disorders or schizophrenia NEW HAVEN, Conn., Sept. 05, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced the initiation of patient enrollment in its SERENITY At-Home pivotal Phase 3 trial.

BioXcel Therapeutics Announces Initiation of SERENITY At-Home Pivotal Phase 3 Safety Trial of BXCL501 for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

BioXcel Therapeutics (BTAI) witnesses a hammer chart pattern, indicating support found by the stock after losing some value lately. This coupled with an upward trend in earnings estimate revisions could mean a trend reversal for the stock in the near term.

BioXcel Therapeutics (BTAI) May Find a Bottom Soon, Here's Why You Should Buy the Stock Now

BioXcel Therapeutics, Inc. (NASDAQ:BTAI ) Q2 2024 Earnings Conference Call August 8, 2024 8:00 AM ET Company Participants Vimal Mehta - Chief Executive Officer & Founder Vincent O'Neill - Executive Vice President, Chief of Product Development and Medical Officer Richard Steinhart - Senior Vice President and Chief Financial Officer Matt Wiley - Senior Vice President and Chief Commercial Officer Conference Call Participants Sumant Kulkarni - Canaccord Genuity Raghuram Selvaraju - H.C. Wainwright Operator Good morning, and welcome to the BioXcel Therapeutics Second Quarter 2024 Earnings Conference Call.

BioXcel Therapeutics, Inc. (BTAI) Q2 2024 Earnings Call Transcript

BioXcel Therapeutics, Inc. (BTAI) came out with a quarterly loss of $0.21 per share versus the Zacks Consensus Estimate of a loss of $0.76. This compares to loss of $1.83 per share a year ago.

BioXcel Therapeutics, Inc. (BTAI) Reports Q2 Loss, Tops Revenue Estimates

Focused market-access strategy generates estimated net revenue of approximately $1.1 million, highest quarterly net revenue since commercial launch

BioXcel Therapeutics Announces Preliminary Estimated Unaudited Second Quarter Net Revenues from Sales of IGALMI™ (dexmedetomidine) Sublingual Film

NEW HAVEN, Conn., May 28, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that CEO Vimal Mehta, Ph.D., will present at the Jefferies Global Healthcare Conference in New York City. The presentation is set for Wednesday, June 5 at 3 p.m. ET, and will highlight BioXcel Therapeutics' late-stage clinical programs with BXCL501 for the acute treatment of agitation associated with Alzheimer's dementia, bipolar disorders, and schizophrenia. Dr. Mehta will be joined by Vincent J. O'Neill, M.D., Executive Vice President, Chief of Product Development and Medical Officer.

BioXcel Therapeutics to Present at Jefferies Global Healthcare Conference

NEW HAVEN, Conn., May 21, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that Rob Risinger, M.D., Chief Medical Officer of Neuroscience, will deliver oral and poster presentations at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting. The meeting will take place May 28 to 31, 2024 in Miami Beach, FL.

BioXcel Therapeutics Announces Oral and Poster Presentations at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

BioXcel Therapeutics, Inc. (NASDAQ:BTAI ) Q1 2024 Results Earnings Conference Call May 9, 2024 8:00 AM ET Company Participants Vimal Mehta - Chief Executive Officer and Founder Vincent O'Neill - Executive Vice President and Chief of Product Development and Medical Officer Richard Steinhart - Senior Vice President and Chief Financial Officer Matt Wiley - Senior Vice President and Chief Commercial Officer Robert Risinger - Chief Medical Officer, Neuroscience Conference Call Participants Colin Bristow - UBS Ram Selvaraju - H.C. Wainwright Alec Stranahan - Bank of America Avantika Joshi - Mizuho Securities Sumant Kulkarni - Canaccord Genuity Samir Devani - Rx Securities Operator Good morning.

BioXcel Therapeutics, Inc. (BTAI) Q1 2024 Earnings Call Transcript

Advancing TRANQUILITY and SERENITY program plans for two pivotal Phase 3 trials to expand BXCL501 market potential in acute treatment of agitation

BioXcel Therapeutics Reports First Quarter 2024 Financial Results

NEW HAVEN, Conn., April 25, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that it will release its first quarter 2024 financial results on Thursday, May 9, 2024, before the open of the U.S. financial markets. BioXcel Therapeutics' management team will also host a conference call and webcast at 8:00 AM ET that day to discuss the Company's financial results and provide a general business update.

BioXcel Therapeutics to Report First Quarter 2024 Financial Results on May 9, 2024

Poster presentation scheduled for June 1, 2024, 1:30-4:30 PM CT /2:30-5:30 PM ET Trial being led by Georgetown University's Lombardi Comprehensive Cancer Center NEW HAVEN, Conn., April 24, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that a late-breaking abstract with preliminary findings from the Phase 2 investigator-sponsored trial of BXCL701 in combination with KEYTRUDA® (pembrolizumab) in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) has been selected for presentation in a poster session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

BioXcel Therapeutics Announces Late-Breaking Abstract on Preliminary Findings from Phase 2 Investigator-Sponsored Trial of BXCL701 and KEYTRUDA® in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) Selected for Presentation at 2024 ASCO Annual Meeting

Company plans to initiate SERENITY At-Home pivotal Phase 3 safety trial with 120 mcg dose following recent meeting with FDA

BioXcel Therapeutics Announces Plan for Evaluating BXCL501 in the At-Home Setting to Expand Its Market Potential

Company plans to initiate trial following recent meeting with FDA No FDA-approved therapies for acute treatment of AAD are currently available NEW HAVEN, Conn., April 10, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced details regarding the planned design of its upcoming TRANQUILITY In-Care Phase 3 trial to evaluate BXCL501, the company's investigational proprietary, orally dissolving film formulation of dexmedetomidine, as a potential acute treatment for agitation associated with Alzheimer's dementia (AAD) in the care setting.

BioXcel Therapeutics Announces TRANQUILITY In-Care Pivotal Phase 3 Trial Plan With BXCL501 for Agitation Associated With Alzheimer's Dementia

NEW HAVEN, Conn., March 25, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the “Company”) (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that it has entered into a securities purchase agreement with investors in a registered direct offering of 3,054,609 shares (the “Shares”) of common stock, par value $0.001 per share (“Common Stock”), and accompanying warrants (the “Accompanying Warrants”) to purchase up to 3,054,609 shares of Common Stock at a combined offering price of $2.901 per Share and Accompanying Warrant and pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 5,565,027 shares of Common Stock and Accompanying Warrants to purchase up to 5,565,027 shares of Common Stock at a combined offering price of $2.900 per share underlying each Pre-Funded Warrant and Accompanying Warrant, which equals the offering price per Share and Accompanying Warrant less the $0.001 exercise price per share of the Pre-Funded Warrants, for aggregate gross proceeds to the Company of approximately $25 million (excluding the proceeds, if any, from the exercise of the Pre-Funded Warrants and the Accompanying Warrants). The Pre-Funded Warrants have an exercise price of $0.001 per share of Common Stock and are exercisable at any time after the date of issuance, subject to certain ownership limitations. The Accompanying Warrants have an exercise price of $3.20 per share of Common Stock, are exercisable at any time after the date of issuance, subject to certain ownership limitations, and expire five years from the date of issuance.

BioXcel Therapeutics Announces $25 Million Registered Direct Offering

Newly granted patent aligns with Company's focus on expanding geographic coverage and strengthening intellectual property protection for BXCL501 Newly granted patent aligns with Company's focus on expanding geographic coverage and strengthening intellectual property protection for BXCL501

BioXcel Therapeutics Announces European Patent Office's Grant of Patent for Method of Treating Agitation in Dementia Using Sublingual Dexmedetomidine

BioXcel Therapeutics, Inc. (NASDAQ:BTAI ) Q4 2023 Earnings Conference Call March 12, 2024 8:00 AM ET Company Participants Vimal Mehta - Chief Executive Officer Vince O'Neill - Chief of Product and Development Medical Officer Richard Steinhart - Chief Financial Officer Robert Risinger - Chief Medical Officer, Neuroscience Matt Wiley - Chief Commercial Officer Conference Call Participants Greg Harrison - Bank of America Robyn Karnauskas - Truist Securities Graig Suvannavejh - Mizuho Securities Sumant Kulkarni - Canaccord Genuity Ram Selvaraju - H.C. Wainwright Colin Bristow - UBS Samir Devani - Rx Securities Operator Good morning, and welcome to the BioXcel Therapeutics Conference Call, which will include an update on the company's late stage clinical programs and the discussion of financial results for the fourth quarter and full-year 2023.

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