BTAI

Teva Pharmaceutical Industries stock has delivered a very strong 284.4% gain over the past 5 years, yet current checks send mixed signals as the Discounted Cash Flow (DCF) estimate points to undervaluation while market based multiples screen the shares as expensive. Investors looking at Teva today see a stock with powerful recent momentum against a low overall value score that suggests it is not a straightforward bargain. A 284.4% return over 5 years highlights how much Teva has already rewarded long term holders, which can make fresh entry points more sensitive to valuation. Recent moves to expand the neuroscience portfolio, including the agreed acquisition of BioXcel Therapeutics' dexmedetomidine sublingual film and the FDA priority review for ecopipam in pediatric Tourette syndrome, can support expectations for future cash flows, while ongoing patent litigation outcomes and generic competition risk may still weigh on how durable those cash flows are seen to be. Teva scores 2 out of 6 on a broad value screen, which leans expensive overall even though the intrinsic value estimate suggests the share price trades at a 43.7% discount. The issue now is whether Teva Pharmaceutical Industries' current price already reflects the recent progress and pipeline news, or if the gap to the intrinsic value estimate leaves room for further upside. Spot opportunities beyond Teva Pharmaceutical Industries by scanning our hand picked list of 44 high quality undervalued stocks that also combine strong recent momentum with discounted cash flow support. The Discounted Cash Flow (DCF) model values Teva Pharmaceutical Industries by projecting future free cash flows and discounting them back to today. Teva currently reports latest twelve month free cash flow of about $1.37b, and the model assumes these cash flows continue to grow rather than contract over the coming decade. On this basis, the DCF framework points to an estimated intrinsic value of about $64.78 per share in $ terms. That compares to the current share price, which implies the stock trades at roughly a 43.7% discount and appears undervalued on this metric. The FDA priority review for ecopipam helps explain why some investors may already be optimistic, yet the share price still sits well below what the cash flow projections support. Overall, the DCF work suggests Teva Pharmaceutical Industries stock currently appears undervalued relative to its projected cash generation. Our Discounted Cash Flow (DCF) analysis suggests Teva Pharmaceutical Industries is undervalued by 43.7%. Track this in your watchlist or portfolio, or discover 44 more high quality undervalued stocks. Head to the Valuation section of our Company Report for more details on how we arrive at this Fair Value for Teva Pharmaceutical Industries. P/E is often the go to check for Teva Pharmaceutical Industries because earnings are a key focus for established pharmaceutical businesses. On this measure, Teva trades on a P/E of about 60.1x, which is far above both the pharmaceuticals industry average of 16.7x and a peer group average of 19.3x. The tailored fair P/E ratio for Teva is estimated at 34.1x, which already reflects its sector, risk profile and business mix. The current 60.1x multiple sits well above that level. As a result, the stock screens as expensive compared with what this framework would typically support for Teva. On the P/E check, Teva Pharmaceutical Industries stock appears overvalued relative to both its fair multiple and its sector benchmarks. See what the numbers say about this price — find out in our valuation breakdown. Simply Wall St Narratives for Teva Pharmaceutical Industries pick up where this valuation puzzle leaves off and explain what future growth, margins and earnings would need to look like for the stock to be worth materially more or materially less than today's price. Each Narrative links a fair value to a specific storyline about Teva Pharmaceutical Industries' potential catalysts and risks so you can track which scenario seems to be unfolding over time on the Community page. Community narratives on Teva Pharmaceutical Industries sit far apart, with one side focused on a portfolio and margin story and the other on concentration and execution risk. Bull case: 11% undervalued Read the full Bull Case to see why Teva Pharmaceutical Industries could be undervalued Bear case: 10% overvalued Read the full Bear Case to see why Teva Pharmaceutical Industries could be overvalued Do you think there's more to the story for Teva Pharmaceutical Industries? Head over to our Community to see what others are saying! Teva Pharmaceutical Industries presents a split picture. The Discounted Cash Flow (DCF) work points to meaningful intrinsic value upside, while the P/E based view screens the stock as overvalued compared with sector and tailored fair multiples. That mismatch reflects a cash flow story that looks stronger than what current earnings multiples imply. However, the broader low value score signals that most other checks are not supportive. The key question from here is whether Teva can deliver the cash flow, margin and pipeline execution needed to close that gap, or whether the current discount to intrinsic value is the market pricing in ongoing risk around competition and legal outcomes. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include TEVA. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

BioMarin Pharmaceutical (BMRN) came out with quarterly earnings of $1.2 per share, beating the Zacks Consensus Estimate of $0.96 per share. This compares to earnings of $1.44 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +25.00%. A quarter ago, it was expected that this rare disease biopharmaceutical would post earnings of $0.94 per share when it actually produced earnings of $0.76, delivering a surprise of -19.15%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. BioMarin, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $989.71 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 7.31%. This compares to year-ago revenues of $825.41 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. BioMarin shares have added about 0.8% since the beginning of the year versus the S&P 500's gain of 12.8%. While BioMarin has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for BioMarin was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $1.49 on $1.04 billion in revenues for the coming quarter and $4.95 on $3.86 billion in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. BioXcel Therapeutics, Inc. (BTAI), another stock in the same industry, has yet to report results for the quarter ended June 2026. This company is expected to post quarterly loss of $0.51 per share in its upcoming report, which represents a year-over-year change of +79.2%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. BioXcel Therapeutics, Inc.'s revenues are expected to be $0.34 million, up 183.3% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report BioMarin Pharmaceutical Inc. (BMRN) : Free Stock Analysis Report BioXcel Therapeutics, Inc. (BTAI) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

FDA accepted sNDA for IGALMI® use in at-home (outpatient) setting; set Nov. 14, 2026, as PDUFA date Advancing BXCL501 as a potential acute treatment for agitation associated with Alzheimer’s dementia Evaluating strategic options with an advisor to maximize shareholder value and advance the commercial and development plans for IGALMI NEW HAVEN, Conn., May 15, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today provided a business update and reported financial results for the first quarter of 2026. In the quarter ended on March 31, the FDA accepted the Company’s supplemental New Drug Application (sNDA) for IGALMI® for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia and assigned a PDUFA target action date of November 14, 2026. “The first quarter was marked by tremendous progress, achieving a major regulatory milestone and developing the IGALMI commercial launch plan for the at-home setting,” said Vimal Mehta, Ph.D., Chief Executive Officer of BioXcel Therapeutics. “We are very pleased with the recent approval of another product in Alzheimer’s agitation, in an area adjacent to our focus on the acute treatment of agitation in Alzheimer’s dementia with BXCL501. Our first-in-class mechanism has the potential to make a transformative impact on the lives of a large patient population in this disease area. We are actively pursuing strategic options to maximize shareholder value for the IGALMI franchise.” Strategic Options Exploring Value-Maximizing Options: The Company engaged MTS Health Partners as an advisor for evaluation of strategic options to maximize shareholder value and advance the commercial and development plans for IGALMI, which may include, but are not limited to, a sale of the Company, a merger or other business combination, a collaboration, joint venture, royalty or license agreement of all or a portion of our assets, a recapitalization or other financing transaction, or continued execution of our standalone operating plan. We have not made a decision to pursue any specific transaction or strategic option, no set timetable has been established for the completion of this process, and there can be no assurance that the process will result in any transaction or other particular outcome. BXCL501 Late-Stage Clinical Programs SERENITY Program FDA Acceptance of IGALMI At-Home sNDA: The FDA recently accepted the Company’s sNDA seeking to expand the IGALMI label for the at-home treatment of acute agitation in bipolar disorder and schizophrenia. The FDA has assigned a PDUFA target action date of November 14, 2026, which, if approved, would represent the first FDA-approved treatment option for acute agitation associated with bipolar disorders or schizophrenia in the at-home setting. Commercial Launch Readiness: The Company has been preparing for the commercial launch and has developed a comprehensive launch plan, informed by a third-party market assessment highlighting a large total addressable market for IGALMI in the at-home setting. The Company recently hosted a virtual event, held by a covering analyst, to present the launch plans and discuss the market opportunity with investors. TRANQUILITY Program TRANQUILITY In-Care Phase 3 Trial: The TRANQUILITY In-Care trial is designed as a double-blind, placebo-controlled study to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for the acute treatment of agitation associated with Alzheimer’s dementia. The Company remains focused on BXCL501’s potential in this disease, supported by a favorable regulatory environment following a recent FDA approval in an adjacent indication, which is further reinforcing the need in this therapeutic area. First Quarter 2026 Financial Results Net revenue from IGALMI® was $206,000 for the first quarter of 2026, compared to $168,000 for the same period in 2025. The Company is focused on preparing for IGALMI’s launch in the at-home setting and maintaining IGALMI’s brand awareness with minimal commercial resources. Cost of Goods Sold for the first quarter of 2026 was $283,000, compared to $14,000 for the same period in 2025. The increase in Cost of Goods Sold for the first quarter is primarily the result of higher charges for reserves for excess or obsolete inventory compared to the same respective period in 2025. Research and Development (R&D) expenses were $3.0 million for the first quarter of 2026, compared to $4.6 million for the same period in 2025. The decreased expenses for the first quarter of 2026 were primarily due to the completion of the SERENITY At-Home pivotal Phase 3 safety trial in 2025. Selling, General and Administrative (SG&A) expenses were $7.2 million for the first quarter of 2026, compared to $5.7 million for the same period in 2025. The increased costs for the first quarter of 2026 were primarily attributable to an increase in professional fees. Net Loss: BioXcel Therapeutics reported an operating loss of $10.2 million and a net loss of $12.7 million for the first quarter of 2026, compared to an operating loss of $10.1 million and net loss of $7.3 million for the same period in 2025. Cash and cash equivalents and restricted cash totaled $17.2 million as of March 31, 2026. The Company remains in compliance with the covenants in its Credit Agreement. About BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. About BXCL501 Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. About IGALMI® (dexmedetomidine) sublingual film IGALMI® (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children. IMPORTANT SAFETY INFORMATION IGALMI can cause serious side effects, including: Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint. Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations. Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI. Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours. The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing. These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects. Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids. Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or [email protected]. Please see full prescribing information at Igalmi.com. About the SERENITY At-Home Phase 3 Trial The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120-mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The trial is designed to evaluate 200 patients with a history of agitation episodes residing at home either alone or with caregivers/informants. Patients are self-administering 120-mcg of BXCL501 or placebo when agitation episodes occur over the 12-week trial period, with safety data (adverse events) collected during the trial. In addition, patients or caregivers/informants will complete a modified global impression of severity (mCGIs) and a clinical global impression of change (mCGI-C) two hours after dosing as an exploratory endpoint to evaluate use in the outpatient setting. About the TRANQUILITY In-Care Phase 3 Trial The TRANQUILITY In-Care trial is designed as a double-blind, placebo-controlled study to evaluate the efficacy and safety of a 60-mcg dose of BXCL501 over a 12-week period for agitation associated with Alzheimer’s dementia in the care setting. The trial is expected to enroll approximately 150 patients 55 years and older who have mild, moderate, or severe dementia with mini-mental state examination scores of 0 to 25 and who reside in skilled nursing facilities, memory care units, or assisted living facilities. Patients will self-administer 60-mcg of BXCL501 or placebo when episodic agitation episodes occur over the trial period. The primary endpoint is expected to be a change from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at two hours post-first dose. Additional PEC and Clinical Global Impressions – Improvement Scale measurements will also be obtained during the trial. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: approval by the FDA of the sNDA and expanded label for IGALMI, IGALMI’s ability to make a transformative impact on the lives of a large patient population, ability to advance a strategic option to maximize shareholder value and advance the commercial and development plans for IGALMI. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. 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: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; 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 Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI®; 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; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at and the Investors section of the Company’s website at. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contact Information: Corporate/Investors Russo Partners Nic Johnson [email protected] 1.303.482.6405 Media Russo Partners David Schull [email protected] 1.858.717.2310 Source: BioXcel Therapeutics, Inc.

CorMedix (CRMD) came out with quarterly earnings of $0.43 per share, beating the Zacks Consensus Estimate of $0.35 per share. This compares to earnings of $0.3 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +24.64%. A quarter ago, it was expected that this pharmaceutical and medical device company would post earnings of $0.86 per share when it actually produced earnings of $0.61, delivering a surprise of -29.07%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. CorMedix, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $127.43 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 16.00%. This compares to year-ago revenues of $39.08 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. CorMedix shares have lost about 35.5% since the beginning of the year versus the S&P 500's gain of 8.8%. While CorMedix has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for CorMedix was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.23 on $93.65 million in revenues for the coming quarter and $0.44 on $299.95 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 41% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, BioXcel Therapeutics, Inc. (BTAI), is yet to report results for the quarter ended March 2026. This company is expected to post quarterly loss of $0.59 per share in its upcoming report, which represents a year-over-year change of +60.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. BioXcel Therapeutics, Inc.'s revenues are expected to be $0.29 million, up 70.6% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report CorMedix Inc (CRMD) : Free Stock Analysis Report BioXcel Therapeutics, Inc. (BTAI) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

BioXcel Therapeutics, Inc. (BTAI) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.59 per share in its upcoming report, which represents a year-over-year change of +60.7%. Revenues are expected to be $0.29 million, up 70.6% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 10.26% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For BioXcel Therapeutics, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +18.64%. On the other hand, the stock currently carries a Zacks Rank of #2. So, this combination indicates that BioXcel Therapeutics will most likely beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that BioXcel Therapeutics would post a loss of$0.34 per share when it actually produced a loss of -$0.58, delivering a surprise of -70.59%. Over the last four quarters, the company has beaten consensus EPS estimates just once. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. BioXcel Therapeutics appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. ANI Pharmaceuticals (ANIP), another stock in the Zacks Medical - Biomedical and Genetics industry, is expected to report earnings per share of $1.28 for the quarter ended March 2026. This estimate points to a year-over-year change of -24.7%. Revenues for the quarter are expected to be $205.41 million, up 4.2% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for ANI has been revised 0.1% up to the current level. Nevertheless, the company now has an Earnings ESP of +7.81%, reflecting a higher Most Accurate Estimate. When combined with a Zacks Rank of #3 (Hold), this Earnings ESP indicates that ANI will most likely beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report BioXcel Therapeutics, Inc. (BTAI) : Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

sNDA submitted seeking approval of IGALMI® in the at-home (outpatient) setting for the treatment of acute agitation associated with bipolar disorders or schizophrenia sNDA submission timeline supports potential approval as early as year-end 2026 Advancing commercial and launch plans based on third-party market assessment NEW HAVEN, Conn., March 27, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today reported financial results for the fourth quarter and full-year 2025 and provided an update on its late-stage pipeline and commercial launch readiness plans. The Company submitted a supplemental New Drug Application (sNDA) in January to the U.S. Food and Drug Administration (FDA) seeking label expansion of IGALMI for the acute treatment of agitation associated with bipolar disorders and schizophrenia in the at-home setting. The Company is also developing commercial strategy and launch plans for IGALMI in the at-home setting, following completion of a comprehensive market assessment. “2025 was a successful year for our Company, setting the stage for the potential label expansion of IGALMI in the at-home setting and continuing progress with commercial plans for the potential launch of IGALMI,” said Vimal Mehta, Ph.D., Chief Executive Officer of BioXcel Therapeutics. “Our confidence in the substantial market opportunity in the at-home setting, where there are no FDA-approved options available, is reiterated by our recent market opportunity assessment. We also remain focused on advancing our Alzheimer’s dementia program, which is another large market opportunity.” BXCL501 Late-Stage Clinical Programs SERENITY Program IGALMI At-Home sNDA Submission: The Company submitted an sNDA in January to the FDA seeking to expand the IGALMI label for the at-home treatment of acute agitation in bipolar disorder and schizophrenia. The filing is supported by the SERENITY At-Home pivotal Phase 3 trial. Advancing Commercial Preparations: As part of the commercial preparation efforts, the Company appointed Mark Pavao as Interim Chief Commercial Officer to lead the development and execution of the launch plans for IGALMI in the at-home setting. Market Opportunity Assessment: BioXcel Therapeutics is progressing commercial preparation efforts, supported by completion of a third-party market assessment and building on insights to guide a launch plan. The third-party commercial assessment shows the large potential total addressable market for IGALMI in the at-home setting. Analysis of market research revealed up to 86 million addressable annual episodes that may require treatment. Growing Awareness for Self-Administered Treatments at Home: To support commercial preparations through building awareness ahead of potential launch, the Company hosted a virtual roundtable on December 8 featuring leading medical experts discussing advancements in treating acute agitation related to neuropsychiatric conditions, including the potential role of IGALMI outside of the hospital setting. TRANQUILITY PROGRAM TRANQUILITY In-Care Phase 3 Trial: designed as a double-blind, placebo-controlled study to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for acute treatment of agitation associated with Alzheimer’s dementia in the care setting. The program remains part of the Company’s broader development strategy. FDA has provided feedback on the clinical protocol. The Company has selected a CRO to prepare for trial initiation. Increasing Awareness of Treating Acute Agitation in Alzheimer’s Dementia: The Company sponsored a virtual KOL roundtable on February 27 focused on acute agitation in Alzheimer’s dementia and the unmet need for an FDA-approved treatment option. The event featured leading medical experts and included discussions on the latest developments in the treatment of acute agitation in Alzheimer’s dementia and the potential role of BXCL501. The event reinforced the significant, differentiated, unmet medical need for an approved treatment in this indication. Investigator-Sponsored Trial (IST) Positive Phase 2 Topline Results from Columbia University-Led Study of BXCL501 for Treatment of Opioid Withdrawal, Funded by NIDA: The IST study evaluating BXCL501 for the treatment of opioid withdrawal symptoms in adults with opioid use disorder (OUD) undergoing a methadone taper demonstrated clinical benefits and favorable tolerability profile. These results strengthen the growing body of evidence supporting BXCL501’s clinical benefit across multiple potential indications, reinforcing its potential as a pipeline within a product. Fourth Quarter and Full Year 2025 Financial Results Net revenue from IGALMI® was $256,000 for the fourth quarter of 2025, compared to $366,000 for the same period in 2024. Net revenue from IGALMI® was $642,000 for the full year of 2025, compared to $2.3 million for the same period in 2024. The Company is focused on preparing for IGALMI’s launch in the at-home setting and maintaining IGALMI’s brand awareness with minimal commercial resources. Cost of Goods Sold for the fourth quarter of 2025 was $32,000, compared to $832,000, and for the full-year was $164,000, compared to $2.1 million, for the same period in 2024, respectively. The decrease in Cost of Goods Sold for the fourth quarter and full-year ended December 31, 2025 is primarily the result of lower charges for reserves for excess or obsolete inventory compared to the same respective periods in 2024. Research and Development (R&D) expenses were $6.7 million for the fourth quarter of 2025, compared to $5.9 million for the same period in 2024. The increased expenses for the fourth quarter of 2025 were primarily due to the increase in clinical trial expense due to the execution of the SERENITY At-Home pivotal Phase 3 safety trial. R&D expenses were $30.3 million for the full year of 2025, compared to $30.4 million for the full year of 2024. Selling, General and Administrative (SG&A) expenses were $3.8 million for the fourth quarter of 2025, compared to $4.1 million for the same period in 2024. SG&A expenses were $20.5 million for the full year of 2025, compared to $34.5 million for the full year of 2024. The decreased costs for the fourth quarter and the full year 2025 were primarily attributable to a decrease in personnel and related costs, lower legal and professional fees, and lower commercial and marketing costs resulting from the Clinical Reprioritization. Net Loss: BioXcel Therapeutics reported an operating loss of $10.3 million and a net loss of $12.5 million for the fourth quarter of 2025, compared to an operating loss of $10.5 million and net loss of $10.9 million for the same period in 2024. For the full year of 2025, BioXcel Therapeutics reported an operating loss of $50.5 million and a net loss of $69.9 million, compared to an operating loss of $67.2 million and a net loss of $59.6 million for the full year of 2024. Total cash used in operating activities for 2025 totaled approximately $57.6 million, down $14.4 million from 2024 cash used in operating activities of approximately $72.0 million. Cash and cash equivalents and restricted cash totaled $28.8 million as of December 31, 2025. The Company remains in compliance with the covenants in its Credit Agreement. About BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. About BXCL501 Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. About IGALMI® (dexmedetomidine) sublingual film IGALMI® (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children. IMPORTANT SAFETY INFORMATION IGALMI can cause serious side effects, including: Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint. Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations. Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI. Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours. The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing. These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects. Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids. Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or [email protected]. Please see full prescribing information at Igalmi.com. About the SERENITY At-Home Phase 3 Trial The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120-mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The trial is designed to evaluate 200 patients with a history of agitation episodes residing at home either alone or with caregivers/informants. Patients are self-administering 120-mcg of BXCL501 or placebo when agitation episodes occur over the 12-week trial period, with safety data (adverse events) collected during the trial. In addition, patients or caregivers/informants will complete a modified global impression of severity (mCGIs) and a clinical global impression of change (mCGI-C) two hours after dosing as an exploratory endpoint to evaluate use in the outpatient setting. About the TRANQUILITY In-Care Phase 3 Trial The TRANQUILITY In-Care trial is designed as a double-blind, placebo-controlled study to evaluate the efficacy and safety of a 60-mcg dose of BXCL501 over a 12-week period for agitation associated with Alzheimer’s dementia in the care setting. The trial is expected to enroll approximately 150 patients 55 years and older who have mild, moderate, or severe dementia with mini-mental state examination scores of 0 to 25 and who reside in skilled nursing facilities, memory care units, or assisted living facilities. Patients will self-administer 60-mcg of BXCL501 or placebo when episodic agitation episodes occur over the trial period. The primary endpoint is expected to be a change from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at two hours post-first dose. Additional PEC and Clinical Global Impressions – Improvement Scale measurements will also be obtained during the trial. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: acceptance by the FDA of our sNDA, approval by the FDA of the sNDA and expanded label for IGALMI, advancing the clinical evaluation of the broader use of BXCL501 in Alzheimer’s dementia, and BXCL501’s potential to be a pipeline within a product. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. 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: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; 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 Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI®; 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; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at and the Investors section of the Company’s website at. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contact Information: Corporate/Investors Russo Partners Nic Johnson [email protected] 1.303.482.6405 Media Russo Partners David Schull [email protected] 1.858.717.2310 Source: BioXcel Therapeutics, Inc.

NEW HAVEN, Conn., March 05, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today 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. The study suggested that BXCL501 may be as effective as or superior to lofexidine (Lucemyra®) for reducing the symptoms of opioid withdrawal during methadone taper, while having a more convenient dosing regimen and demonstrating a favorable tolerability profile. In this study, BXCL501 had similar or lower overall rates of cardiovascular (CV) effects than lofexidine. Specifically, the most common CV adverse event for Lucemyra, orthostatic hypotension, was significantly lower for the 180 µg twice daily (BID) BXCL501 dose group (18% vs 50% lofexidine, p<0.05) and remained lower in the highest 240 µg BID BXCL501 dose group (37%) over the seven-day dosing period. There were no reports of sedation or somnolence in the BXCL501 treatment arms (5% reported sedation in the lofexidine arm). These results support potential future development of BXCL501 in opioid withdrawal. These findings build on the earlier Company-sponsored Phase 1b/2 study, RELEASE,1 which established the tolerability profile of selected BXCL501 doses in opioid-dependent patients and extend those results into a clinically distinct setting that included a methadone taper and an active comparator. The results are consistent with the mechanism of action of BXCL501 (alpha 2-adrenergic receptor agonism), as locus coeruleus drives various opioid withdrawal symptoms.2 These results strengthen the growing body of evidence supporting BXCL501 across multiple potential indications, reinforcing its potential as a “pipeline within a product.” These findings build on positive results from Phase 3 pivotal studies evaluating BXCL501 for the treatment of acute agitation associated with bipolar disorder and schizophrenia, as well as Alzheimer’s disease. For this National Institute on Drug Abuse (NIDA)-funded study, BioXcel Therapeutics supplied BXCL501. This study was planned as a 4-arm trial: BXCL501 180 µg BID or 240 µg BID, placebo, and lofexidine 0.54 mg QID as a positive control. It enrolled participants who were predominantly exposed to fentanyl and included a high proportion of participants exposed to fentanyl adulterated or associated with xylazine (FAAX), which has been designated as an emerging threat by the White House Office of National Drug Control Policy.3 The trial was completed after 80 patients were enrolled. Key takeaways from the study include: BXCL501 240 µg BID reduced opioid withdrawal symptoms compared to placebo during a seven-day methadone taper, as measured by the Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop). After receiving BXCL501 240 µg, patients experienced a greater than 30% reduction in SOWS-Gossop scores, with peak symptom improvement observed on days 3 and 4. The reduction in withdrawal symptoms with BXCL501 numerically exceeded that observed with lofexidine 0.54 mg administered four times daily. BXCL501 demonstrated a favorable tolerability profile, with rates of key adverse events (including dizziness, orthostatic hypotension, bradycardia and insomnia) comparable to or lower than those reported for lofexidine in the Lucemyra® (lofexidine) FDA label. “As we continue to face a worldwide crisis encompassing a large patient population suffering from opioid use disorder, these results showcase an encouraging therapeutic milestone demonstrating the significant potential of BXCL501 as a therapy for meaningfully reducing opioid withdrawal symptoms,” said Dr. Sandra Comer, Principal Investigator of the study and Professor of Neurobiology in the Department of Psychiatry at Columbia University. “Opioid withdrawal remains a significant burden on the healthcare system and patients, and despite available therapies, there is still a substantial unmet need for safe and more effective treatment options that can help patients successfully transition to other medications such as buprenorphine or naltrexone for long-term benefits.” Notably, OUD remains a critical global health crisis, with an estimated 36 to 61 million people worldwide living with opioid dependence.4 Approximately 85% of chronic opioid users experience at least one withdrawal episode every six months, suggesting that 30 to 50 million individuals globally may require withdrawal management each year. In the United States alone, approximately 5.9 million people have diagnosed OUD, and about 8.9 million report annual opioid misuse.5 Despite this substantial need, only about 25% of individuals with a substance use disorder receive specialized treatment, highlighting a significant treatment gap.6 Currently approved options for opioid withdrawal management are limited, and tolerability challenges may affect adherence, underscoring the potential importance of BXCL501’s differentiated profile as a non-opioid, orally dissolving thin film formulation of dexmedetomidine administered twice daily. Another potential advantage of BXCL501 is that it may be particularly well-suited for treating withdrawal from opioids adulterated with xylazine. About BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. About BXCL501 Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: potential future development of BXCL501 in opioid withdrawal; BXCL501’s potential as a “pipeline within a product”; the potential of BXCL501 to serve as a safe and effective treatment option that can help patients successfully transition to other medications. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. 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: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; 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 Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI®; 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; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at and the Investors section of the Company’s website at. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contact Information: Corporate/Investors Russo Partners Nic Johnson [email protected] 1.303.482.6405 Media Russo Partners David Schull [email protected] 1.858.717.2310 Source: BioXcel Therapeutics, Inc. References

sNDA submission expected in early Q1 2026 for expanded usage of IGALMI® in home setting based on positive data from the SERENITY At-Home trial NEW HAVEN, Conn., Nov. 12, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today reported financial results for the third quarter of 2025 and provided an update on its late-stage agitation clinical development programs. As part of this update, the Company said it plans to submit early in the first quarter of 2026 a supplemental New Drug Application (sNDA) seeking FDA approval for the at-home use of IGALMI® for the acute treatment of agitation associated with bipolar disorders or schizophrenia. In addition, the company has taken additional steps toward the initiation of the TRANQUILITY In-Care Phase 3 Trial evaluating BXCL501 in agitation associated with Alzheimer’s dementia. “We are focused on the next phase of our journey, preparing for an sNDA submission and advancing pre-launch and commercial readiness activities,” said Vimal Mehta, Ph.D., the Company’s CEO. “BXCL501 has the potential to redefine the treatment of agitation, addressing an at-home market opportunity of 57 to 77 million annual episodes in the U.S. alone. This momentum lays the foundation for meaningful, long-term growth and value creation as we work to make BXCL501 accessible to patients at home, where they need it most.” BioXcel Therapeutics continues to maintain a disciplined approach to manage its cash runway in support of the planned sNDA submission and achieving key corporate milestones. BXCL501 Late-Stage Clinical Programs SERENITY Program SERENITY At-Home Phase 3 Safety Trial: Double-blind, placebo-controlled study to evaluate the safety of a 120 mcg dose of BXCL501 in patients for acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. A total of 246 patients were randomized, and data was collected on 2,628 agitation episodes in 215 patients. No discontinuations due to tolerability in the BXCL501 arm. Adverse event profile consistent with approved IGALMI® label and multiple clinical trials in the institutional setting. No drug-related serious adverse events (SAEs), syncopes or falls reported. No new or unexpected treatment emergent adverse events (TEAEs). No severe TEAEs associated with BXCL501 treatment and most TEAEs were mild. No trend of more frequent AEs over time or with repeat dosing. Tolerability remained consistent throughout the repeat dosing in the trial. BXCL501 demonstrated a mean reduction in mCGI-S score from baseline compared to placebo at 2 hours, and demonstrated continued effects and consistent benefit with repeat dosing. SERENITY At-Home Supporting Correlation Study: High correlation between validated clinician assessments and the mCGI-S scale used in SERENITY At-Home Phase 3 Trial provides strong support for mCGI-S as a measurement of exploratory efficacy outcomes. TRANQUILITY Program TRANQUILITY In-Care Phase 3 Trial: designed as a double-blind, placebo-controlled study to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for acute treatment of agitation associated with Alzheimer’s dementia in the care setting. The program remains part of the Company’s broader development strategy. FDA has provided feedback on the clinical protocol. The Company is evaluating proposals from CROs to prepare for trial initiation. Conferences and Publications Data from the SERENITY At-Home Phase 3 trial were presented on November 7 at the 2025 Neuroscience Education Institute Fall Congress by Dr. Leslie Citrome. Research published in the journal Frontiers in Pharmacology showed that BXCL501 caused a significant reduction in behaviors induced by stress in translatable behavioral models related to psychiatric disorders, providing further support for the drug’s mechanism of action and potential suitability for broadly addressing stress-related disorders in addition to agitation. Corporate Updates At-Home Agitation Market Insights The Company believes the total addressable market is significantly higher (57-77M agitation episodes annually) than previously anticipated (23M agitation episodes annually). The previous estimate of 23M annual episodes was based on historic claims data, reflecting approximately 1.2 episode per patient per month. The claims data likely underestimate the actual episode frequency due to the lack of approved treatment options. The Company believes the total addressable market is significantly higher than previously reported. IGALMI® Market Presence The Company is continuing to supply IGALMI® to patients and providers, and build brand awareness, with minimal commercial resources. Third Quarter 2025 Financial Results Net revenue from IGALMI® was $98 thousand for the third quarter of 2025, compared to $214 thousand for the same period in 2024. Cost of Goods Sold for the third quarter of 2025 was $11 thousand, compared to $1.17 million for the same period in 2024. Cost of goods sold is related to the costs to produce, package, and deliver IGALMI® to customers, as well as costs related to excess or obsolete inventory. There were no charges for reserves for excess or obsolete inventory in the three months ended September 30, 2025, compared to charges of $1.15 million for excess and obsolete inventory for the three months ended September 30, 2024. Research and Development (R&D) expenses were $8.7 million for the third quarter of 2025, compared to $5.1 million for the same period in 2024. The increase in expenses was primarily attributable to an increase in clinical trial activity associated with the SERENITY at-home Phase 3 studies and offset by a decrease in personnel related to the company’s reprioritization. Selling, General and Administrative (SG&A) expenses were $5.4 million for the third quarter of 2025, compared to $7.7 million for the same period in 2024. The decreased expenses were attributable to a decrease in personnel and related costs, lower professional fees, and lower commercial and marketing costs resulting from reprioritization actions taken in 2024. Net Loss: BioXcel Therapeutics reported an operating loss of $14.2 million and a net loss of $30.9 million for the third quarter of 2025**, compared to an operating loss of $15.3 million and net loss of $13.7 million for the same period in 2024**. The Company used $18.8 million in operating cash during the third quarter of 2025. Cash and cash equivalents and restricted cash totaled $37.3 million as of September 30, 2025. The Company raised an additional $4.9 million subsequent to quarter-end pursuant to sales under the Company’s at-the-market (ATM) program. **In the third quarter of 2025, the loss from operations of $14.2 million was increased by unrealized losses of $12.5 million related to derivative liabilities and in the third quarter of 2024, the loss from operations of $15.3 million was offset by unrealized gains of $4.8 million related to derivative liabilities. About BXCL501 Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. About the SERENITY At-Home Phase 3 Trial The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The trial is designed to evaluate 200 patients with a history of agitation episodes residing at home either alone or with caregivers/informants. Patients are self-administering 120 mcg of BXCL501 or placebo when agitation episodes occur over the 12-week trial period, with safety data (adverse events) collected during the trial. In addition, patients or caregivers/informants will complete a modified global impression of severity (mCGIs) and a clinical global impression of change (mCGI-C) two hours after dosing as an exploratory endpoint to evaluate use in the outpatient setting. About the TRANQUILITY In-Care Phase 3 Trial The TRANQUILITY In-Care trial is designed as a double-blind, placebo-controlled study to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 over a 12-week period for agitation associated with Alzheimer’s dementia in the care setting. The trial is expected to enroll approximately 150 patients 55 years and older who have mild, moderate, or severe dementia with mini-mental state examination scores of 0 to 25 and who reside in skilled nursing facilities, memory care units, or assisted living facilities. Patients will self-administer 60 mcg of BXCL501 or placebo when episodic agitation episodes occur over the trial period. The primary endpoint is expected to be a change from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at two hours post-first dose. Additional PEC and Clinical Global Impressions – Improvement Scale measurements will also be obtained during the trial. About IGALMI® (dexmedetomidine) sublingual film INDICATION IGALMI® (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children. IMPORTANT SAFETY INFORMATION IGALMI can cause serious side effects, including: Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint. Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations. Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI. Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours. The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing. These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects. Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids. Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or [email protected]. Please see full prescribing information at Igalmi.com. About BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company built on artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the Company’s planned advancement of its SERENITY and TRANQUILITY programs; redefining how agitation is managed; bringing IGALMI® directly to patients in the at-home setting; transforming neuroscience through the strategic use of AI-driven drug discovery and human insight; reimagining existing medicines and accelerating the development of innovative therapies; transforming the standard of care in neuropsychiatry and improve lives around the world. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. 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: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; 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 Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI®; 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; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at and the Investors section of the Company’s website at . These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contact Information Corporate/Investors Russo Partners Nic Johnson [email protected] 1.303.482.6405 Media Russo Partners David Schull [email protected] 1.858.717.2310 Source: BioXcel Therapeutics, Inc. IGALMI® is a registered trademark of BioXcel Therapeutics, Inc.

Completes clinical trials required by FDA for sNDA submission planned for the first quarter of 2026 NEW HAVEN, Conn., Oct. 14, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced positive results from the correlation study related to exploratory efficacy outcomes from the SERENITY At-Home trial. The results, along with the data from the SERENITY At-Home trial, will be included in the supplemental New Drug Application (sNDA) submission that is planned for the first quarter of 2026. The standard method for measuring acute agitation associated with schizophrenia and bipolar disorder is the Positive and Negative Syndrome Scale – Excited Component (PEC) administered by a trained clinician, which was used in the Serenity I & II Pivotal Trials. In order to evaluate BXCL501 for continued clinical effect with repeat dosing in the at-home setting using an exploratory efficacy measurement, the Company, in consultation with FDA, developed the modified CGI-S (mCGI-S) scale, which can be scored by patients and/or caregivers. The study assessed the correlation between PEC and mCGI-S in this prospective, open label, in-clinic trial in 33 patients. The results demonstrated a strong correlation between the clinician assessments and the patient or caregiver (informant) rated outcomes, providing support for using mCGI-S to assess efficacy in the outpatient setting. A statistically significant and strong correlation between the PEC and mCGI-S with a correlation of ρ=0.89; p<0.0001 for patients and ρ=0.88; p<0.0001 for informants was observed. “We are pleased with the strong and significant correlation observed with clinician assessment for both patients and informants, providing support for our exploratory efficacy outcomes in the SERENITY At-Home study.” said Dusan Kostic, Ph. D. Senior Vice President Medical Affairs and Clinical Development. “We plan to include these findings as a part of our upcoming sNDA package.” There were no serious adverse events reported and the safety profile remains consistent with the IGALMI® label. Additional data and results will be presented at upcoming medical meetings and conferences. About Modified Clinical Global Impression – Severity Scale (mCGI-S) The original clinician rated CGI-S scale describes an 8-point rating of agitation symptoms where zero means there was no assessment performed and scores of 1-7 rate increasing severities of the symptoms being assessed. For ease of implementation by the patient and informant in the home setting this scale was modified in consultation with FDA. The modified CGI-S is a 4-point scale where 0 is no agitation, and scores of 1-3 describe increasing severities of agitation (mild, moderate, or severe). About the Positive and Negative Syndrome Scale - Excited Component (PEC) The PEC is a 5-item assessment for rating acute psychomotor agitation within the following domains: excitement, hostility, tension, uncooperativeness, and poor impulse control (Montoya et al. 2011). Each item utilizes a 7-point scale, with domain-specific descriptions of the signs the rater may observe for each severity rating: 1 = Absent, 2 = Minimal, 3 = Mild, 4 = Moderate, 5 = Moderate Severe, 6 = Severe, and 7 = Extreme. The total PEC score is the sum of the five domain scores, ranging from 5 to 35. A PEC score of 14 is the threshold needed to treat an acute agitation episode. About BXCL501 Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. About BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the Company’s planned advancement of its SERENITY program; potential market opportunity for BXCL501; release of data from the SERENITY At-Home trial; the submission of an sNDA to the FDA; the supply of IGALMI® through existing distribution channels; the potential for the results from the Company’s completed, ongoing and proposed clinical trials to support regulatory approvals for its product candidates and change the treatment paradigm for agitation. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. 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: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; 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 Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI®; 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; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors section of the Company’s website at www.bioxceltherapeutics.com. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contact Information Corporate/Investors Russo Partners Nic Johnson [email protected] 1.303.482.6405 Media Russo Partners David Schull [email protected] 1.858.717.2310 Source: BioXcel Therapeutics, Inc. IGALMI® is a registered trademark of BioXcel Therapeutics, Inc.

Company to host conference call at 8 a.m. ET, August 27, 2025 NEW HAVEN, Conn., Aug. 26, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it will host an investor call and live webcast at 8 a.m. ET, August 27, 2025 to review topline data from the SERENITY At-Home Pivotal Phase 3 trial evaluating the safety of BXCL501, the Company’s proprietary, sublingual film formulation of dexmedetomidine, as an acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting. The data will be disseminated in a morning press release and presented during the investor call/webcast. To access the webcast, please use the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=S598spob, or dial in at 877-407-5795 / +1 201-689-8722. A link to the webcast and accompanying presentation materials will also be available on the Investors section of the corporate website, bioxceltherapeutics.com, and a replay will be available through November 26, 2025. About the SERENITY At-Home Phase 3 Trial The trial was designed to study 200 patients with a history of agitation episodes despite being on stable treatment for their underlying bipolar or schizophrenia residing at home either alone or with caregivers/informants. Patients were required to self-administer 120 mcg of BXCL501 (the approved dose under medical supervision) or placebo when they experienced agitation episodes over the 12-week trial period, and their safety data (adverse events) was collected during the trial. In addition, patients or caregivers/informants completed a modified global impression of severity (mCGIs) two hours after dosing as an exploratory endpoint to assess their experience in the outpatient setting. About BXCL501 Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. About IGALMI® (dexmedetomidine) sublingual film INDICATION IGALMI® (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children. IMPORTANT SAFETY INFORMATION IGALMI can cause serious side effects, including: Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint. Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations. Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI. Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours. The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing. These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects. Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids. Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201- 1088 or [email protected]. Please see full prescribing information at Igalmi.com. About BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the Company’s planned advancement of its TRANQUILITY and SERENITY trials and the trial designs thereof; potential market opportunity for BXCL501; release of topline data from the ongoing SERENITY trial; the submission of an sNDA to the FDA; the supply of IGALMI through existing distribution channels; the potential for the results from the Company’s completed, ongoing and proposed clinical trials to support regulatory approvals for its product candidates. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. 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: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; 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 Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI; 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; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors section of the Company’s website at www.bioxceltherapeutics.com. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contact Information Corporate/Investors Russo Partners Nic Johnson [email protected] 1.303.482.6405 Media Russo Partners David Schull [email protected] 1.858.717.2310 Source: BioXcel Therapeutics, Inc. IGALMI® is a registered trademark of BioXcel Therapeutics, Inc.

Topline data from SERENITY At-Home Phase 3 trial for acute treatment of agitation associated with bipolar disorders or schizophrenia expected in August FDA meeting scheduled in August and is intended to support potential sNDA submission for label expansion of IGALMI® in the at-home setting Publication of non-clinical data in Frontiers in Pharmacology suggests potential applications of BXCL501 in chronic conditions BioXcel Therapeutics strengthens cash position NEW HAVEN, Conn., Aug. 12, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today reported its financial results for the second quarter of 2025 and announced that its SERENITY At-Home pivotal Phase 3 safety trial for acute treatment of agitation associated with bipolar disorders or schizophrenia was complete. Topline results from the study are expected in August. "We are incredibly excited about the upcoming top-line data readout for our SERENITY At-Home Phase 3 trial – our primary market research and preliminary results regarding the frequency of agitation episodes during the trial suggest a target addressable market meaningfully larger than our original estimate of 23 million agitation episodes in the at-home setting annually,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “This expanded opportunity estimate presents a significant prospect to help many bipolar disorder and schizophrenia patients, fulfilling our core mission." BXCL501 Late-Stage Clinical Programs SERENITY Program SERENITY At-Home Phase 3 Trial: The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting: The trial enrolled more than 200 patients across 22 sites nationwide, with no single site enrolling more than 11% of the total patient population. The vast majority of patients dosed completed the full 12-week study. Data from more than 2,200 agitation episodes was collected. The distribution of enrolled patients was balanced between the two patient populations, bipolar disorders and schizophrenia. The trial received two favorable recommendations from the Data Safety Monitoring Board (DSMB). TRANQUILITY Program TRANQUILITY In-Care Phase 3 Trial: designed as a double-blind, placebo-controlled study to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 for acute treatment of agitation associated with Alzheimer’s dementia in the care setting. The program remains part of the Company’s broader development strategy. The Company is evaluating CROs for trial initiation. BXCL501 in Chronic Conditions Research published in the journal Frontiers in Pharmacology showed that BXCL501 caused a significant reduction in behaviors induced by stress in translatable behavioral models related to psychiatric disorders, providing further support for the drug’s mechanism of action and potential suitability for broadly addressing stress-related disorders in addition to agitation. Corporate Updates IGALMI® Market Presence The Company is continuing to supply IGALMI® to patients and providers in the institutional setting, and build brand awareness, with minimal commercial resources. Second Quarter 2025 Financial Results Net revenue from IGALMI® was $120 thousand for the second quarter of 2025, compared to $1.1 million for the same period in 2024. Cost of Goods Sold for the second quarter of 2025 was $107 thousand, compared to $62 thousand for the same period in 2024. Cost of goods sold is related to the costs to produce, package, and deliver IGALMI® to customers, as well as costs related to excess or obsolete inventory. There was $95 thousand for charges for reserves for excess or obsolete inventory in the three months ended June 30, 2025, compared to none for the same period in 2024. Research and Development (R&D) expenses were $10.3 million for the second quarter of 2025, compared to $8.0 million for the same period in 2024. The increase in expenses was primarily attributable to an increase in clinical trial activity associated with the SERENITY at-home Phase 3 studies and offset by a decrease in personnel related to the company’s reprioritization. Selling, General and Administrative (SG&A) expenses were $5.6 million for the second quarter of 2025, compared to $9.5 million for the same period in 2024. The decreased expenses were attributable to a decrease in personnel and related costs, lower professional fees, and lower commercial and marketing costs resulting from reprioritization actions taken in 2024. Net Loss: BioXcel Therapeutics an operating loss of $15.9 million and a net loss of $19.2 million for the second quarter of 2025, compared to an operating loss of $17.3 million and net loss of $8.3 million for the same period in 2024**. The Company used $12.6 million in operating cash during the second quarter of 2025. Cash and cash equivalents and restricted cash totaled $18.6 million as of June 30, 2025. This does not include an additional $11.5 million of gross proceeds from sales pursuant to the company at-the-market program and $3.6 million received in connection with the exercise of outstanding warrants subsequent to quarter-end. **In the second quarter of 2024, the loss from operations of $17.3 million was offset by unrealized gains of $12 million related to derivative liabilities. About BXCL501 Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. About the SERENITY At-Home Phase 3 Trial The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The trial is designed to evaluate 200 patients with a history of agitation episodes residing at home either alone or with caregivers/informants. Patients are self-administering 120 mcg of BXCL501 or placebo when agitation episodes occur over the 12-week trial period, with safety data (adverse events) collected during the trial. In addition, patients or caregivers/informants will complete a modified global impression of severity (mCGIs) and a clinical global impression of change (mCGI-C) two hours after dosing as an exploratory endpoint to evaluate use in the outpatient setting. About the TRANQUILITY In-Care Phase 3 Trial The TRANQUILITY In-Care trial is designed as a double-blind, placebo-controlled study to evaluate the efficacy and safety of a 60 mcg dose of BXCL501 over a 12-week period for agitation associated with Alzheimer’s dementia in the care setting. The trial is expected to enroll approximately 150 patients 55 years and older who have mild, moderate, or severe dementia with mini-mental state examination scores of 0 to 25 and who reside in skilled nursing facilities, memory care units, or assisted living facilities. Patients will self-administer 60 mcg of BXCL501 or placebo when episodic agitation episodes occur over the trial period. The primary endpoint is expected to be a change from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at two hours post-first dose. Additional PEC and Clinical Global Impressions – Improvement Scale measurements will also be obtained during the trial. About IGALMI® (dexmedetomidine) sublingual film INDICATION IGALMI® (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children. IMPORTANT SAFETY INFORMATION IGALMI can cause serious side effects, including: Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint. Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations. Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI. Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours. The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing. These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects. Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids. Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201-1088 or [email protected]. Please see full prescribing information at Igalmi.com. About BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the Company’s planned advancement of its TRANQUILITY and SERENITY trials and the trial designs thereof; potential market opportunity for BXCL501; release of topline data from the ongoing SERENITY trial; the submission of an sNDA to the FDA; the supply of IGALMI through existing distribution channels; the potential for the results from the Company’s completed, ongoing and proposed clinical trials to support regulatory approvals for its product candidates. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. 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: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY program; its dependence on the success and commercialization of IGALMI®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; 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 Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI; 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; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors section of the Company’s website at www.bioxceltherapeutics.com. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contact Information Corporate/Investors Russo Partners Nic Johnson [email protected] 1.303.482.6405 Media Russo Partners David Schull [email protected] 1.858.717.2310 Source: BioXcel Therapeutics, Inc. IGALMI® is a registered trademark of BioXcel Therapeutics, Inc.