BioXcel Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Updates

Rhea-AI Summary

BioXcel Therapeutics (Nasdaq: BTAI) reported Q2 2025 financial results and provided key updates on its clinical programs. The company completed its SERENITY At-Home Phase 3 trial for treating agitation in bipolar disorders and schizophrenia patients, with topline results expected in August. The trial enrolled over 200 patients across 22 sites, collecting data from more than 2,200 agitation episodes.

Financial results showed IGALMI® revenue of $120,000 in Q2 2025, down from $1.1M in Q2 2024. The company reported an operating loss of $15.9M and a net loss of $19.2M. Cash position stood at $18.6M as of June 30, 2025, with additional post-quarter funding of $15.1M through ATM sales and warrant exercises.

Positive

• Completed SERENITY At-Home Phase 3 trial with over 2,200 agitation episodes data collected
• FDA meeting scheduled in August for potential IGALMI® label expansion
• Secured additional $15.1M in funding post-quarter end
• Reduced SG&A expenses by 41% year-over-year to $5.6M

Negative

• IGALMI® revenue declined 89% to $120,000 in Q2 2025 from $1.1M in Q2 2024
• Net loss increased to $19.2M from $8.3M year-over-year
• R&D expenses increased 29% to $10.3M year-over-year
• Recorded $95,000 in charges for excess/obsolete inventory reserves

Insights

Biotech Financial Analyst

BTAI completed a pivotal trial for at-home agitation treatment with topline data imminent; financials show declining revenue amid cash burn concerns.

BioXcel's completion of its SERENITY At-Home Phase 3 trial represents a critical inflection point for the company's growth strategy. The trial, which collected data from over 2,200 agitation episodes across more than 200 patients, aims to expand IGALMI's label into the at-home setting—a market management now believes is substantially larger than their initial estimate of 23 million annual agitation episodes. Two favorable DSMB recommendations suggest a reasonable safety profile thus far.

The financial picture shows concerning trends. Q2 IGALMI revenue plummeted to just $120,000 compared to $1.1 million in Q2 2024, signaling significant commercial challenges despite the company's stated continued supply with "minimal commercial resources." R&D expenses increased to $10.3 million (vs. $8.0 million in Q2 2024) due to SERENITY trial costs, while SG&A decreased to $5.6 million from $9.5 million following 2024's reprioritization actions.

Cash position remains precarious with $18.6 million as of June 30, supplemented by post-quarter financing of $15.1 million (ATM proceeds plus warrant exercises). With a quarterly cash burn of $12.6 million and net loss of $19.2 million, runway appears limited to roughly 2-3 quarters, suggesting additional financing will likely be needed regardless of the SERENITY results.

The upcoming August data readout and FDA meeting represent binary events that could dramatically alter BioXcel's trajectory. Success could unlock substantial market opportunity and partnership potential, while failure would severely limit growth prospects given IGALMI's current commercial underperformance.

Psychiatric Treatment Specialist

BXCL501's at-home trial completion with 2,200+ agitation episodes and favorable safety monitoring suggests potential paradigm shift in psychiatric care delivery.

The completion of BioXcel's SERENITY At-Home Phase 3 safety trial represents a potentially transformative milestone in psychiatric care. The trial's scope—capturing data from over 2,200 agitation episodes across both bipolar disorder and schizophrenia patients—provides an unprecedented dataset on agitation management outside institutional settings. The favorable Data Safety Monitoring Board recommendations suggest the sublingual dexmedetomidine formulation maintains its established safety profile in less controlled environments.

Particularly noteworthy is the trial's balanced enrollment between schizophrenia and bipolar disorder populations, allowing for robust subgroup analyses of safety profiles across these distinct conditions. The high trial completion rate further strengthens the dataset's integrity and suggests acceptable tolerability in the at-home setting. Should the upcoming data support label expansion, IGALMI would become the first FDA-approved at-home treatment specifically targeting agitation in these patient populations.

Beyond acute agitation, the publication in Frontiers in Pharmacology highlighting BXCL501's effects in stress-induced behavioral models opens intriguing potential applications for chronic stress-related conditions. This pharmacological profile could eventually position the medication for broader psychiatric applications beyond episodic agitation management.

The company's parallel pursuit of the TRANQUILITY program for Alzheimer's-related agitation, though currently in CRO evaluation phase, demonstrates a comprehensive approach to addressing agitation across multiple neuropsychiatric conditions. If successful across these programs, BXCL501 could establish a new paradigm in treating acute symptoms across the neuropsychiatric spectrum, potentially reducing emergency department visits and hospitalizations while improving quality of life for patients and caregivers.

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 medinfo@bioxceltherapeutics.com. 

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
nic.johnson@russopartnersllc.com 
1.303.482.6405

Media
Russo Partners
David Schull
david.schull@russopartnersllc.com 
1.858.717.2310

Source: BioXcel Therapeutics, Inc.
IGALMI^® is a registered trademark of BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc.
Statements of Operations
(Unaudited, in thousands, except per share amounts)
		Three months ended June 30,								Six months ended June 30,
		2025				2024				2025				2024
Revenues
Product revenues		$	120			$	1,104			$	288			$	1,686
Operating expenses
Cost of goods sold			107				62				121				141
Research and development			10,256				8,032				14,810				19,433
Selling, general and administrative			5,609				9,450				11,308				22,715
Restructuring costs			-				856				-				856
Total operating expenses			15,972				18,400				26,239				43,145
Loss from operations			(15,852	)			(17,296	)			(25,951	)			(41,459	)
Other (income) expense
Interest expense, net			4,222				3,700				8,215				7,307
Interest income			(230	)			(671	)			(509	)			(1,618	)
Other (income) expense, net			(657	)			(12,026	)			(7,216	)			(12,058	)
Net loss and comprehensive loss		$	(19,187	)		$	(8,299	)		$	(26,441	)		$	(35,090	)
Net loss per share - basic and diluted		$	(2.45	)		$	(3.30	)		$	(4.17	)		$	(15.78	)
Weighted average shares outstanding - basic and diluted			7,843				2,516				6,347				2,223
Condensed Balance Sheets
(Unaudited, in thousands)
		June 30,				December 31,
		2025				2024
Cash and cash equivalents and restricted cash		$	18,575			$	29,854
Total assets		$	25,789			$	38,338
Total liabilities		$	133,456			$	131,439
Total stockholders' equity (deficit)		$	(107,667	)		$	(93,101	)

FAQ

What were BioXcel Therapeutics (BTAI) Q2 2025 earnings results?

BTAI reported Q2 2025 revenue of $120,000, an operating loss of $15.9M, and a net loss of $19.2M. The company ended the quarter with $18.6M in cash and cash equivalents.

What are the key findings from BTAI's SERENITY At-Home Phase 3 trial?

The trial enrolled over 200 patients across 22 sites, collected data from more than 2,200 agitation episodes, and received two favorable recommendations from the Data Safety Monitoring Board. Topline results are expected in August 2025.

How much additional funding did BTAI secure after Q2 2025?

BTAI secured $15.1M in additional funding post-quarter end, consisting of $11.5M from ATM program sales and $3.6M from warrant exercises.

What is the market opportunity for BTAI's IGALMI in the at-home setting?

Based on preliminary results, BTAI estimates a target addressable market larger than the original estimate of 23 million agitation episodes annually in the at-home setting for bipolar disorder and schizophrenia patients.

How did BTAI's operating expenses change in Q2 2025?

R&D expenses increased to $10.3M due to clinical trial activity, while SG&A expenses decreased to $5.6M from $9.5M due to lower personnel costs and reduced commercial activities.