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Bioxcel Therapeutics Inc (BTAI)
NASDAQ:BTAI

Bioxcel Therapeutics (BTAI) AI Stock Analysis

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BTAI

Bioxcel Therapeutics

(NASDAQ:BTAI)

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Neutral 47 (OpenAI - 5.2)
Rating:47Neutral
Price Target:
$1.50
▼(-5.66% Downside)
The score is held down primarily by very weak financial performance (ongoing large losses, heavy cash burn, negative equity and high debt). Technical indicators are mixed and do not confirm a strong uptrend, while valuation lacks support due to negative earnings and no dividend. Offsetting factors include constructive corporate catalysts around IGALMI’s potential at-home label expansion and supportive clinical data.
Positive Factors
FDA‑approved lead product (IGALMI)
An FDA‑approved commercial product provides a durable revenue stream and regulatory validation. IGALMI establishes manufacturing, distribution and payer relationships, enabling further label expansions and commercial learning that support longer‑term revenue generation and partnership opportunities.
sNDA submission supported by Phase 3 data
Seeking at‑home approval backed by Phase 3 safety/efficacy data is a structural change that expands the addressable market and care settings. If approved, it shifts treatment from institutional to outpatient settings, altering long‑term prescribing patterns, payer coverage dynamics, and commercial potential.
Strengthening commercial leadership
Installing experienced commercial leadership and active launch planning improves execution capacity over months. Building a commercial organization and go‑to‑market strategy is a durable prerequisite for scaling prescriptions, payer engagement, and distribution needed to convert regulatory gains into sustainable sales.
Negative Factors
Negative equity and high leverage
A negative equity position combined with sizable debt versus a small asset base is a structural constraint on financial flexibility. It raises refinancing and covenant risk, increases likelihood of dilutive capital raises, and can limit ability to fund R&D or scale commercial operations without costly external financing.
Persistent heavy cash burn
Sustained negative operating and free cash flow requires continual capital raises, which can dilute shareholders and divert management focus. Ongoing cash burn constrains reinvestment in commercialization and clinical programs and creates execution risk if funding conditions tighten over the medium term.
Minimal, volatile revenue and negative margins
Small, volatile revenue with negative gross profit and large losses indicates limited commercial traction and weak operating leverage. Without sustained revenue scale or margin improvement, the company cannot self‑fund growth, keeping profitability distant and increasing dependence on external capital.

Bioxcel Therapeutics (BTAI) vs. SPDR S&P 500 ETF (SPY)

Bioxcel Therapeutics Business Overview & Revenue Model

Company DescriptionBioXcel Therapeutics, Inc. is a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and 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 indices. Its commercial product, IGALMI (developed as BXCL501) is a proprietary, sublingual film formulation of dexmedetomidine for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The company also continues to conduct clinical trials evaluating BXCL501 for the treatment of agitation in Alzheimer's disease patients, and for adjunctive treatment of patients with major depressive disorder, as well as in the community for agitation associated with bipolar disorders and schizophrenia. In addition, it is developing BXCL502 as a potential therapy for chronic agitation in dementia; and BXCL701, an investigational, orally administered, systemic innate immunity activator for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors. The company was incorporated in 2017 and is headquartered in New Haven, Connecticut.
How the Company Makes MoneyBioxcel Therapeutics generates revenue primarily through the commercialization of its drug candidates, once they receive regulatory approval. The company's revenue streams include direct sales of approved therapies and potential milestone payments and royalties from licensing agreements or partnerships with other pharmaceutical companies. Their revenue model is heavily reliant on the successful development and commercialization of their drug pipeline, and they may also engage in collaborations that provide funding for research and development in exchange for potential future revenue sharing. Additionally, strategic partnerships with larger pharmaceutical firms can provide upfront payments or cost-sharing arrangements that contribute to their earnings, although specific details of such partnerships are not publicly detailed.

Bioxcel Therapeutics Earnings Call Summary

Earnings Call Date:Nov 14, 2024
(Q3-2024)
|
% Change Since: |
Next Earnings Date:Mar 05, 2026
Earnings Call Sentiment Neutral
The earnings call highlighted progress in clinical trials and significant financial improvements, such as reduced net loss and increased revenue over the nine-month period. However, challenges remain with decreased quarterly revenue, increased costs, and uncertainties regarding cash runway and financing.
Q3-2024 Updates
Positive Updates
Phase III Trials Progress
BioXcel announced milestones with two pivotal Phase III trials for BXCL501, targeting agitation in bipolar disorder, schizophrenia, and Alzheimer's dementia.
Significant Reduction in Net Loss
Net loss decreased to $13.7 million in Q3 2024 from $50.5 million in Q3 2023, indicating improved financial management.
Substantial Increase in Net Revenue Over Nine Months
Net revenue for the first nine months of 2024 was $1.9 million, an 89% increase from $1 million in the same period in 2023.
Reduction in Operating Expenses
Research and development expenses decreased from $19.6 million in Q3 2023 to $5.1 million in Q3 2024, while selling, general, and administrative expenses decreased from $24.3 million to $7.7 million.
Department of Defense Grant
A Phase IIa efficacy and safety study of BXCL501 for acute stress disorder received funding from a Department of Defense grant.
Negative Updates
Decrease in Quarterly Revenue
Net revenue from IGALMI decreased to $214,000 in Q3 2024 from $341,000 in Q3 2023, primarily due to the timing of reorders.
Increased Cost of Goods Sold
Cost of goods sold increased to $1.2 million in Q3 2024 from $512,000 in Q3 2023, due to higher noncash charges for excess or obsolete inventory.
Cash Runway and Financing Uncertainty
There is ongoing concern about the sufficiency of current cash reserves and the need for strategic financing alternatives to reach trial completion.
Company Guidance
During the recent BioXcel Therapeutics Q3 2024 earnings call, the company provided guidance on its ongoing clinical trials and financial performance. Vimal Mehta, CEO, highlighted the advancement of two pivotal Phase III trials for BXCL501, targeting agitation associated with bipolar disorder, schizophrenia in the home setting, and Alzheimer's dementia. The SERENITY At-Home trial aims for a 9 to 12-month duration with 26 active sites enrolling 200 patients. Financially, the company reported $214,000 in net revenue from IGALMI, marking a decline from $341,000 in Q3 2023, but a 89% year-over-year increase in net revenue for the nine months ended September 30, 2024. Operating expenses saw a reduction, with research and development expenses at $5.1 million, down from $19.6 million the previous year, and selling, general, and administrative expenses reduced to $7.7 million from $24.3 million. The company recorded a net loss of $13.7 million, significantly improved from $50.5 million in Q3 2023, and ended the quarter with $40.4 million in cash and cash equivalents. BioXcel is focused on strengthening its balance sheet and exploring strategic financing alternatives to support its trials through to data readout.

Bioxcel Therapeutics Financial Statement Overview

Summary
Very weak fundamentals: minimal and volatile revenue (TTM down ~13%), negative gross profit, and deeply negative margins. Cash burn remains heavy (TTM operating/free cash flow about -$58M) and the balance sheet is stressed with negative equity and high debt (~$109M) versus a small asset base (~$45M), despite some improvement versus 2022–2023.
Income Statement
8
Very Negative
Revenue remains very small and volatile, with TTM (Trailing-Twelve-Months) revenue down ~13% versus the prior period, despite growth in earlier years off a low base. Profitability is weak: TTM (Trailing-Twelve-Months) gross profit is negative and losses remain extremely large (deeply negative operating and net margins), indicating the business is still far from break-even. A positive is that losses have narrowed meaningfully versus 2022–2023, but the earnings profile is still heavily loss-making.
Balance Sheet
12
Very Negative
The balance sheet shows elevated financial risk: stockholders’ equity is negative in 2023–2025 and total debt is high (~$109M in TTM (Trailing-Twelve-Months)) relative to the company’s asset base (~$45M). The negative equity position limits financial flexibility and can pressure funding options. A modest positive is that total debt has not surged dramatically year-over-year, but leverage remains structurally challenging given the capital structure.
Cash Flow
15
Very Negative
Cash burn remains heavy, with TTM (Trailing-Twelve-Months) operating cash flow and free cash flow both around -$58M, implying ongoing dependence on external financing. The pace of cash burn has improved versus 2023–2024 (less negative cash flow), which is constructive. However, free cash flow is still solidly negative and provides limited self-funding capacity.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue752.00K2.27M1.38M375.00K0.000.00
Gross Profit-287.00K123.00K120.00K355.00K-297.00K0.00
EBITDA-51.29M-44.16M-165.42M-157.22M-107.00M-82.11M
Net Income-68.21M-59.60M-179.05M-165.76M-106.93M-82.17M
Balance Sheet
Total Assets44.79M38.34M73.70M205.85M239.44M219.94M
Cash, Cash Equivalents and Short-Term Investments37.32M29.85M65.22M193.72M232.97M213.12M
Total Debt109.29M102.95M101.38M94.16M1.40M1.64M
Total Liabilities133.71M131.44M130.21M129.08M17.77M13.24M
Stockholders Equity-88.92M-93.10M-56.51M76.78M221.67M206.70M
Cash Flow
Free Cash Flow-58.21M-72.03M-155.03M-135.48M-82.60M-66.67M
Operating Cash Flow-58.21M-72.03M-155.01M-135.34M-82.15M-66.35M
Investing Cash Flow0.000.00-20.00K-139.00K-445.00K-316.00K
Financing Cash Flow55.15M36.66M26.52M96.24M102.45M247.36M

Bioxcel Therapeutics Technical Analysis

Technical Analysis Sentiment
Negative
Last Price1.59
Price Trends
50DMA
1.87
Negative
100DMA
2.16
Negative
200DMA
2.28
Negative
Market Momentum
MACD
-0.06
Positive
RSI
34.88
Neutral
STOCH
6.37
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BTAI, the sentiment is Negative. The current price of 1.59 is below the 20-day moving average (MA) of 1.84, below the 50-day MA of 1.87, and below the 200-day MA of 2.28, indicating a bearish trend. The MACD of -0.06 indicates Positive momentum. The RSI at 34.88 is Neutral, neither overbought nor oversold. The STOCH value of 6.37 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for BTAI.

Bioxcel Therapeutics Risk Analysis

Bioxcel Therapeutics disclosed 85 risk factors in its most recent earnings report. Bioxcel Therapeutics reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Bioxcel Therapeutics Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
54
Neutral
$166.07M-6.11-14.23%4121.12%83.30%
52
Neutral
$44.45M-0.72-56.86%35.80%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
47
Neutral
$34.77M-0.16-66.96%71.83%
46
Neutral
$71.56M-1.82-246.14%62.84%
45
Neutral
$36.19M-1.05-133.09%11.11%20.65%
44
Neutral
$17.23M-0.23-100.00%32.37%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BTAI
Bioxcel Therapeutics
1.59
-3.33
-67.68%
ATNM
Actinium Pharmaceuticals
1.16
-0.02
-1.69%
KZR
Kezar Life Sciences
6.07
-0.15
-2.41%
ANVS
Annovis Bio
2.70
-0.54
-16.67%
BCAB
BioAtla
0.27
-0.19
-40.75%
IPSC
Century Therapeutics
1.90
1.12
143.59%

Bioxcel Therapeutics Corporate Events

Business Operations and StrategyProduct-Related AnnouncementsRegulatory Filings and Compliance
BioXcel seeks FDA approval for at-home IGALMI use
Positive
Jan 20, 2026

On January 20, 2026, BioXcel Therapeutics announced that it had submitted a supplemental New Drug Application on January 14, 2026 to the U.S. Food and Drug Administration seeking approval for IGALMI’s use in the at-home setting for the acute treatment of agitation associated with bipolar disorders or schizophrenia. The proposed label expansion would extend IGALMI beyond supervised healthcare settings to a broader at-home patient population, addressing a segment where there are currently no FDA‑approved treatment options and potentially strengthening the company’s positioning in the neuropsychiatric agitation market.

The most recent analyst rating on (BTAI) stock is a Hold with a $2.00 price target. To see the full list of analyst forecasts on Bioxcel Therapeutics stock, see the BTAI Stock Forecast page.

Business Operations and StrategyExecutive/Board ChangesProduct-Related Announcements
BioXcel Therapeutics names interim CCO amid IGALMI expansion
Positive
Jan 12, 2026

On January 12, 2026, BioXcel Therapeutics announced the appointment of Mark Pavao as Interim Chief Commercial Officer to support the potential launch of its drug IGALMI for at-home use. The company plans to submit a supplemental New Drug Application this month seeking FDA approval to expand IGALMI’s indication to at-home treatment of acute agitation in patients with bipolar disorders or schizophrenia, a move that could significantly broaden its commercial reach and influence treatment practices for managing psychiatric agitation outside institutional settings.

The most recent analyst rating on (BTAI) stock is a Hold with a $2.00 price target. To see the full list of analyst forecasts on Bioxcel Therapeutics stock, see the BTAI Stock Forecast page.

Executive/Board ChangesShareholder MeetingsStock Split
BioXcel Therapeutics Holds Annual Stockholders Meeting
Neutral
Dec 15, 2025

On December 12, 2025, BioXcel Therapeutics held its annual stockholders meeting where 44.68% of the company’s outstanding common stock was represented. During the meeting, three Class I directors were elected, and several proposals were approved, including the appointment of Ernst & Young LLP as the independent auditor, executive compensation, a potential reverse stock split, and authorization for meeting adjournments if necessary.

The most recent analyst rating on (BTAI) stock is a Buy with a $10.00 price target. To see the full list of analyst forecasts on Bioxcel Therapeutics stock, see the BTAI Stock Forecast page.

Product-Related Announcements
BioXcel Presents Phase 3 Study on BXCL501
Positive
Nov 10, 2025

On November 10, 2025, BioXcel Therapeutics announced the presentation of their Phase 3 study on BXCL501 at the Neuroscience Education Institute Conference. The study, conducted in a home setting, demonstrated that BXCL501 is safe and effective for treating agitation in patients with bipolar disorder or schizophrenia. The trial showed that the drug was well-tolerated with no increase in adverse events over repeated doses, and significantly more patients experienced full resolution of agitation symptoms compared to placebo.

The most recent analyst rating on (BTAI) stock is a Buy with a $10.00 price target. To see the full list of analyst forecasts on Bioxcel Therapeutics stock, see the BTAI Stock Forecast page.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Jan 20, 2026