Hartford Business Journal

HBJ110325UF

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16 HARTFORDBUSINESS.COM | NOVEMBER 3, 2025 Member FDIC At NBT Bank, our goal is to help you reach yours. Our relationship managers provide the expert guidance and custom solutions it takes to help grow your business. Our local commitment builds strong, long-lasting partnerships that maximize your potential for success. Maureen Kennedy, Dante Fazzina, Deb Oakliff, Nicole Chase, Andreas Kapetanopoulos, Kate VanValkenburg, Michael Hogan, Dale Stewart Let our experienced Connecticut commercial banking team create real opportunity for your business. www.nbtbank.com/ct Fraud Protection & Secure Banking Solutions Local Perspective & Decision-Making Capital & Treasury Management Solutions In the wake of the disclosures, about a half-dozen class action lawsuits were filed in late 2023 and early 2024 in federal courts in Connecticut and Delaware, where BioXcel is incor- porated. The lawsuits allege that company officials misled shareholders. One case was dismissed in June 2024 after a judge ruled the plaintiffs failed to show BioXcel intentionally deceived investors. In August 2023, the company announced plans to cut its work- force from 190 to 80 employees and suspend noncore programs in an effort to stabilize finances. BioXcel down- sized again in 2024 — trimming its headcount to about 30 people, elimi- nating executive roles, and reducing pay for its three top officers. In September 2024, BioXcel filed another SEC notice stating that it faced possible delisting from Nasdaq for failing to meet minimum requirements for share price and market value. Safe at home In early February of this year, BioXcel implemented a 1-for-16 reverse stock split after its shares had fallen as low as 18 cents. The move succeeded in lifting the stock price above $1, restoring compliance with Nasdaq's listing rules. BioXcel now trades comfortably above $2 per share. The following month, the company closed a $14 million registered direct offering of 4 million shares, providing fresh capital as it released a series of encouraging clinical results. In September, BioXcel reported positive findings from a pivotal study showing that Igalmi can be used safely by patients at home without medical supervision. With that data, BioXcel plans to file a supplemental new-drug application with the FDA in the first quarter of 2026 to expand Igalmi's approved use, Mehta said. "That will be done in Q1 of 2026, and then we expect that approval can happen later in the year," he said. When Igalmi was first developed, the company estimated it could address about 23 million "episodes" of agitation each year in hospitals and healthcare facilities. Approval for home use would vastly expand that market. "Now we project there will be about 55 to 77 million episodes" annually, Mehta said. "So, it's a pretty large opportunity, a huge unmet need." If cleared, Igalmi would become the first drug approved for at-home treat- ment of agitation tied to schizophrenia and bipolar disorder. September's announcement of the in-home trial results — combined with BioXcel's restored compliance with Nasdaq listing standards — prompted the exchange to invite company officials back to ring the closing bell on Oct. 14. Leigh Hixon, Nasdaq's vice president of listings, welcomed BioXcel officials. "Today's ceremony marks a moment of reflection and momentum, and this is a time for each of you to celebrate those milestones achieved and the breakthroughs yet to come," she said. "Your team's dedication to scientific rigor and patient-centric innovation is so inspiring, and we are absolutely proud to be your partner today to cele- brate your continued mission with that." For his part, Mehta believes the contro- versy made the company stronger. "I think our data is positive," he said. "And the investment community sees that." He said he's also proud that, despite all the challenges, his core team has stayed with the company. "We believe there is a better way, and we are committed to making that better way a reality," he said. BioXcel employees rang the Nasdaq Stock Market closing bell on Oct. 14. Contributed Photo Trial Tested Continued from page 15

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