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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:
$2.00
▼(-0.99% Downside)
The score is held down primarily by weak financial performance (minimal revenue, large losses, heavy cash burn) and elevated balance sheet risk (negative equity and high debt relative to assets). Technicals show only modest near-term improvement within a broader downtrend, while valuation is hard to support due to negative earnings and no dividend. Positive clinical and regulatory-related corporate updates provide some offsetting upside.
Positive Factors
Commercial FDA-approved product
Owning an FDA-approved branded product gives BioXcel a durable commercial revenue stream and shifts the company from pure R&D risk toward execution risk. Over months, prescription demand, payer coverage, and distribution execution will drive recurring sales potential and strategic partnerships.
sNDA and positive Phase 3 supporting at-home use
A successful sNDA backed by positive Phase 3/At-Home data structurally expands the addressable market from institutional settings to outpatient/home treatment. That broadens prescribing contexts, increases potential prescription volume, and can materially change long-term revenue trajectory if approved and adopted.
Strengthened commercial leadership
Adding an experienced interim CCO ahead of a potential new indication strengthens commercial execution capability. Durable benefits include improved payer engagement, distribution setup, and launch planning—critical for converting regulatory approvals into sustained market uptake over months.
Negative Factors
Heavy cash burn
Sustained negative operating and free cash flow around -$58M TTM implies continued dependence on external financing. Over the medium term this heightens dilution and refinancing risk, limiting the company’s ability to self-fund commercialization, additional trials, or strategic investments without raising capital.
Negative equity and elevated leverage
A negative equity position combined with high debt relative to a small asset base constrains financial flexibility and raises refinancing risk. Structurally, this can increase borrowing costs, limit strategic options, and pressure management to prioritize short-term liquidity over long-term commercial investment.
Minimal, volatile revenue and negative gross profit
Low and volatile product revenue with negative gross profit indicates the business remains far from break-even and reliant on improving pricing, volume, or cost structure. Over months this undermines internal cash generation and makes sustained commercial scaling contingent on successful market adoption and payer coverage.

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
Development-stage financials remain weak: very small/volatile revenue with TTM down ~13%, negative gross profit, and still very large operating/net losses despite improvement vs. 2022–2023. Balance sheet risk is high with negative equity (2023–2025) and sizable debt (~$109M TTM) versus a smaller asset base (~$45M). Cash burn remains heavy (TTM operating cash flow and free cash flow ~-$58M), implying continued reliance on external financing.
Income Statement
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
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
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
Positive
Last Price2.02
Price Trends
50DMA
1.88
Positive
100DMA
2.49
Negative
200DMA
2.28
Negative
Market Momentum
MACD
>-0.01
Negative
RSI
57.52
Neutral
STOCH
82.26
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BTAI, the sentiment is Positive. The current price of 2.02 is above the 20-day moving average (MA) of 1.80, above the 50-day MA of 1.88, and below the 200-day MA of 2.28, indicating a neutral trend. The MACD of >-0.01 indicates Negative momentum. The RSI at 57.52 is Neutral, neither overbought nor oversold. The STOCH value of 82.26 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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
52
Neutral
$45.40M-0.73-56.86%35.80%
52
Neutral
$169.57M-6.56-14.23%4121.12%83.30%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
47
Neutral
$43.96M-0.21-66.96%71.83%
46
Neutral
$97.27M-2.33-246.14%62.84%
45
Neutral
$43.36M-1.17-133.09%11.11%20.65%
45
Neutral
$21.26M-0.27-100.00%32.37%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
BTAI
Bioxcel Therapeutics
2.02
-4.12
-67.10%
ATNM
Actinium Pharmaceuticals
1.30
0.04
3.17%
KZR
Kezar Life Sciences
6.14
-0.16
-2.54%
ANVS
Annovis Bio
3.45
-1.32
-27.67%
BCAB
BioAtla
0.31
-0.19
-37.07%
IPSC
Century Therapeutics
2.04
1.07
110.31%

Bioxcel Therapeutics Corporate Events

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.

Business Operations and StrategyProduct-Related Announcements
BioXcel Therapeutics Updates sNDA Timeline for IGALMI®
Neutral
Oct 30, 2025

On October 30, 2025, BioXcel Therapeutics announced an update on the timeline for submitting a Supplemental New Drug Application (sNDA) for IGALMI® to expand its label for at-home use. Following the completion of the SERENITY At-Home Pivotal Phase 3 Safety Trial and a supporting correlation study in 2025, the company anticipates submitting the sNDA in early 2026, potentially impacting its market positioning and offering new treatment options for patients.

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 AnnouncementsRegulatory Filings and Compliance
BioXcel Announces Positive SERENITY At Home Study Results
Positive
Oct 14, 2025

On October 14, 2025, BioXcel Therapeutics announced positive results from a correlation study related to the SERENITY At Home trial, which will be included in a supplemental New Drug Application submission planned for early 2026. The study demonstrated a strong correlation between clinician assessments and patient or caregiver-rated outcomes using the modified CGI-S scale, supporting its use for evaluating BXCL501 in outpatient settings, with no serious adverse events reported.

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 12, 2026