BTAI — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• Due to the fact that we were unable to generate sufficient cash flows from operations or obtain sufficient funding to sustain operations and debt service obligations, management and our board of directors determined that it was in the best interests of the stockholders to seek strategic options. We …

• On April 6, 2022, we announced that the FDA approved IGALMI® (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. IGALMI® is approved to

• be self-administrated by patients under the supervision of a health care provider. On July 6, 2022, we announced that IGALMI® was commercially available in doses of 120 and 180 micrograms (“mcg”).

• On August 27, 2025, we announced that the SERENITY At-Home Pivotal Phase 3 trial evaluating the safety of BXCL501, as an acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting, met its primary objective. This study was designed and implemented to remo…

• The commercial opportunity assessment was based on recently completed market research leveraging an updated Target Product Profile based on results from the SERENITY At-Home clinical study. The assessment incorporated

Text removed vs the prior filing · source: 10-Q · 2026-05-15

• On April 6, 2022, we announced that the FDA approved IGALMI® (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. IGALMI® is approved to be self-administrated by patients under the supervision of a health care pro…

• On August 27, 2025, we announced that the SERENITY At-Home Pivotal Phase 3 trial evaluating the safety of BXCL501, as an acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting, met its primary objective. The data from this study formed the basis of th…

• The commercial opportunity assessment was based on recently completed market research leveraging an updated Target Product Profile based on results from the SERENITY At-Home clinical study. The assessment incorporated interviews with 15 prescribers and 5 payers with leadership responsibility at larg…

• On January 20, 2026, we announced we submitted a supplemental New Drug Application, or sNDA, to the FDA for IGALMI® in the at-home use setting for the acute treatment of agitation associated with bipolar disorders or schizophrenia. This sNDA submission seeks to expand IGALMI’s label to include the b…

• On March 5, 2026 we announced positive topline results from a Phase 2 investigator-sponsored trial (IST) evaluating BXCL501 for the treatment of opioid withdrawal symptoms in adults with opioid use disorder (OUD) undergoing a methadone taper.

Text added vs the prior filing · source: 10-Q · 2026-08-13

• We are substantially restricted in our corporate activities by our existing debt facilities and are considering all strategic alternatives. If we do not properly service and/or restructure our debt facilities or achieve an alternative strategic transaction, substantial doubt exists about our ability…

• Our consolidated financial statements are prepared using the generally accepted accounting principles applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, as shown in our consolidated financial statement…

• Due to the fact that we were unable to generate sufficient cash flows from operations or obtain sufficient funding to sustain operations and debt service obligations, management and our board of directors determined that it was in the best interests of the stockholders to seek a strategic options. W…

• alternatives. If we cannot continue as a viable entity, we may be required to seek relief under the U.S. Bankruptcy Code. There can be no guarantees that if we file for bankruptcy we will emerge from bankruptcy as a going concern or that holders of our common stock will receive any recovery from any…

• If we do not complete a strategic transaction, or do not receive sufficient financing from other sources of equity or debt financings, we may be required to seek relief under the U.S. Bankruptcy Code. Even if we are successful in raising additional capital, we will require substantial additional fin…

Text removed vs the prior filing · source: 10-Q · 2026-05-15

• Our Credit Agreement (as defined below) contains, among other things, a covenant requiring that our audited annual financial statements be delivered without a “going concern” or like qualification or exception. On March 27, 2026, we entered into the Ninth Amendment to the Credit Agreement (the “Nint…

• Agreement (“Capital Raise Activities”), make a prepayment of the loans under the Credit Agreement in an aggregate principal amount equal to 50% of such gross cash proceeds, together with accrued interest thereon and any fees or premia (including prepayment premium) payable in connection therewith; p…

• We have been and may continue to be required to expend significant funds to continue to commercialize IGALMI® in the U.S. and advance the development of BXCL501, BXCL701, BXCL502 and our other product candidates. In

• addition, while we may seek one or more collaborators for future development of our current product candidates or any future product candidates that we may develop for one or more indications, we may not be able to enter into a collaboration for any of our product candidates for such indications on …

• Management believes that the Company’s cash, cash equivalents and restricted cash of $17.2 million as of March 31, 2026, plus the $2.7 million of gross proceeds from sales pursuant to the Company ATM Program after March 31, 2026, will allow the Company to fund its operations and meet its liquidity r…

Text added vs the prior filing · source: 10-Q · 2026-08-13

• On August 12, 2026, the Board of the Company increased the size of the board of directors from eight (8) directors to nine (9) directors. Following the increase in the size of the Board, the Board appointed Susan Atkins to serve as a member of the Board as an independent director of the Company, as …

• Ms. Atkins has over 40 years of experience leading complex corporate restructurings, with deep expertise in corporate finance, risk management, strategy, and governance. She previously served as Global Head of Wholesale Restructuring at JPMorgan Chase & Co. until September 2023. She currently serves…

• several companies, including Jefferson Capital, Inc. (NASDAQ: JCAP). Ms. Atkins received a Bachelor of Science in Education at the University of Wisconsin-Madison and an MBA in Finance from the Carlson School of Management at the University of Minnesota. The Company believe Ms. Atkins’ extensive exp…

• On August 12, 2026, Ms. Atkins and the Company entered into an Independent Director Agreement in connection with her appointment to serve as an independent director on the Company’s Board. The agreement provides for compensation of $25,000 per calendar month, subject to a minimum four-month payment …

• On August 12, 2026, Ms. Atkins and the Company also entered into an indemnification agreement, which is materially similar to Company’s standard indemnification agreement for directors and officers.

Text removed vs the prior filing · source: 10-Q · 2026-05-15

• (c) During the three months ended March 31, 2026, none of our directors or “officers” (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.