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Ensysce Biosciences (ENSC)
NASDAQ:ENSC
US Market

Ensysce Biosciences (ENSC) AI Stock Analysis

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ENSC

Ensysce Biosciences

(NASDAQ:ENSC)

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Neutral 42 (OpenAI - 5.2)
Rating:42Neutral
Price Target:
$0.86
▼(-14.46% Downside)
The score is driven primarily by weak financial performance (sharp TTM revenue decline, heavy losses, and ongoing cash burn) and bearish technicals (price below key moving averages with negative MACD). Valuation is constrained by negative earnings and no dividend, partially offset by supportive financing and governance-related corporate actions.
Positive Factors
Patent protection for MPAR
A granted USPTO allowance for MPAR (composition and method claims) secures long-duration IP around Ensysce’s overdose-protection platform. Durable patent coverage supports exclusivity, licensing leverage, and higher barriers to competition across opioid and other CNS indications.
Regulatory alignment on PF614 manufacturing
Explicit FDA agreement on CMC approach materially de-risks scale-up and commercial manufacturing pathways for PF614. This regulatory validation shortens time-to-market risk, lowers likelihood of CMC-related delays, and strengthens the case for eventual commercial readiness.
Pivotal Phase 3 progress
Initiation and active enrollment in a pivotal Phase 3 trial is a structural milestone that advances clinical validation of PF614’s abuse-protection concept. Successful pivotal data would enable regulatory filings and create a pathway to commercial revenue long term.
Negative Factors
Sustained cash burn
Significant and persistent negative operating and free cash flow erodes runway absent material funding or revenue, forcing recurring capital raises. Chronic cash burn limits strategic flexibility, increases financing risk, and can pressure clinical program timelines if funding gaps emerge.
Sharp revenue decline and losses
A steep TTM revenue decline coupled with deeply negative margins demonstrates the business remains far from self-sustaining. Persistent operating losses weaken equity stability, heighten dilution risk, and mean successful commercialization of clinical-stage assets is required to alter the structural financial trajectory.
Reliance on dilutive financing and equity actions
Repeated dependence on convertible financings, warrants and recent share-offering filings indicates the company must turn to equity-linked capital to fund development. While extending runway, these instruments are dilutive and can materially dilute shareholders and constrain long-term per-share value if commercialization is delayed.

Ensysce Biosciences (ENSC) vs. SPDR S&P 500 ETF (SPY)

Ensysce Biosciences Business Overview & Revenue Model

Company DescriptionEnsysce Biosciences, Inc., a clinical-stage pharmaceutical company, engages in developing various prescription drugs for severe pain relief in opioid addiction, misuse, abuse, and overdose in the United States. It develops products using Trypsin Activated Abuse Protection platform, an abuse-resistant opioid prodrug technology; and Multi-Pill Abuse Resistance platform, an over-dose protection opioid prodrug technology. The company is developing PF614, a TAAP prodrug candidate of oxycodone, which is in Phase II clinical trial for the treatment of acute or chronic pain; and PF614-MPAR, a combination product of PF614 and nafamostat that is in Phase I clinical trial for overdose protection against excessive oral ingestion, as well as an oral and inhalation drug product of nafamostat for use against coronaviral infections and other pulmonary diseases, such as cystic fibrosis. It is also developing PF329, an extended-release prodrug of hydromorphone that is similar to PF614; PF8001 and PF8026 are extended and immediate-release prodrugs of amphetamine for ADHD medication abuse; and PF26810, an extended-release prodrug of methadone for opioid use disorder. The company is based in La Jolla, California.
How the Company Makes MoneyEnsysce Biosciences makes money primarily through the development and commercialization of its proprietary drug formulations and technologies. The company's revenue model includes licensing agreements and partnerships with pharmaceutical companies interested in incorporating Ensysce's abuse-deterrent technologies into their own products. Additionally, Ensysce seeks to generate revenue through the direct sale of its developed pharmaceutical products once they receive regulatory approval. Significant partnerships with other biotech and pharmaceutical firms, as well as potential government funding or grants for addressing public health crises like the opioid epidemic, also play a role in the company's earnings strategy.

Ensysce Biosciences Earnings Call Summary

Earnings Call Date:Mar 15, 2024
(Q4-2023)
|
% Change Since: |
Next Earnings Date:Mar 26, 2026
Earnings Call Sentiment Neutral
The earnings call highlighted significant clinical achievements, including FDA breakthrough designations and successful trial completions, against a backdrop of financial challenges and reduced funding. The company is making progress toward its goals but needs additional funding to maintain momentum.
Q4-2023 Updates
Positive Updates
Significant Clinical Progress
2023 marked a year of exceptional clinical progress for Ensysce's next-generation analgesics, moving programs closer to commercialization.
FDA Breakthrough Therapy Designation
PF614-MPAR received breakthrough therapy designation from the FDA in January 2024, an exclusive classification that has been granted to less than 300 drugs.
Positive Phase II Studies
Completed Phase II trials for PF614 demonstrated efficacy in pain relief and provided data supporting Phase III study designs.
Strong Intellectual Property Portfolio
Ensysce has a global intellectual property portfolio of over 100 patents issued in 25 countries, ensuring protection and growth opportunities.
Financial Improvements
The company reduced its net loss from $25.1 million in 2022 to $10.6 million in 2023, indicating better financial management.
Negative Updates
Limited Cash Reserves
The company ended 2023 with $1.1 million in cash and cash equivalents, highlighting the need for additional funding to initiate Phase III trials.
Decreased Government Funding
Federal grants decreased from $2.5 million in 2022 to $2.2 million in 2023 due to the timing of research activities.
R&D Expense Reduction
Research and development expenses declined significantly, potentially impacting the pace of clinical development.
Company Guidance
During Ensysce Biosciences' Q4 2023 earnings call, the company provided detailed guidance on its advancements and future plans. Ensysce reported significant clinical progress with its next-generation opioid analgesics, focusing on the PF614 and PF614-MPAR products. The company completed five clinical trials for PF614, including a human abuse potential study and an analgesic efficacy study. Ensysce plans to initiate Phase III trials for PF614 in the second half of 2024, following FDA feedback. They also received breakthrough therapy designation for PF614-MPAR, highlighting its potential to prevent opioid overdose. Financially, Ensysce ended 2023 with $1.1 million in cash, supplemented by early 2024 warrant exercises and plans to raise additional funds before starting Phase III trials. The company’s R&D expenses decreased in 2023, totaling $7.6 million, with a focus on optimizing manufacturing and preparing for pivotal clinical trials.

Ensysce Biosciences Financial Statement Overview

Summary
Overall, Ensysce Biosciences is facing severe financial challenges with declining revenues, negative profitability margins, and a heavily leveraged balance sheet. The company is reliant on external financing to sustain its operations, which poses a significant risk to long-term viability. Immediate strategic financial restructuring is recommended to stabilize the company's finances.
Income Statement
18
Very Negative
Ensysce Biosciences has shown a significant decline in its revenue, with Total Revenue dropping to zero in the most recent fiscal year. The company is experiencing negative EBIT and EBITDA margins, indicating operational losses. The net profit margin is also negative, reflecting substantial losses. Revenue growth has been negative, showing a concerning trend for the business.
Balance Sheet
42
Neutral
The balance sheet reveals high financial leverage with a negative stockholders' equity, suggesting potential insolvency risks. The Debt-to-Equity ratio is unfavorable due to negative equity. However, the company retains a notable amount of cash and short-term investments, providing some liquidity. The equity ratio is negative, showing liabilities exceeding assets.
Cash Flow
14
Very Negative
Cash flow from operations is deeply negative, indicating significant cash outflows are not being covered by operational activities. The Free Cash Flow is also negative, yet the company has managed to maintain positive financing cash flow, suggesting reliance on external funding. There is no visible growth in free cash flow, which is a concern for sustainability.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue4.49M5.21M2.23M2.52M3.53M3.93M
Gross Profit-4.19M-2.01M-5.36M-17.31M3.53M3.93M
EBITDA-1.92M-6.73M-10.72M-24.22M-25.93M834.82K
Net Income-10.97M-7.99M-10.61M-24.17M-29.08M56.77K
Balance Sheet
Total Assets3.18M5.60M2.71M5.89M16.42M351.81K
Cash, Cash Equivalents and Short-Term Investments1.67M3.50M1.12M3.15M12.26M194.21K
Total Debt364.07K301.66K854.70K4.43M17.21M4.27M
Total Liabilities2.30M2.22M3.36M9.91M24.58M7.01M
Stockholders Equity1.20M3.71M-322.86K-3.71M-7.88M-6.44M
Cash Flow
Free Cash Flow-7.17M-7.50T-10.78M-17.89M-8.24M-1.25M
Operating Cash Flow-7.04M-7.50T-10.78M-17.89M-8.24M-1.25M
Investing Cash Flow-123.64K0.000.004.50K0.00183.40M
Financing Cash Flow4.69M9.88T8.76M8.77M20.31M1.10M

Ensysce Biosciences Technical Analysis

Technical Analysis Sentiment
Negative
Last Price1.01
Price Trends
50DMA
1.46
Negative
100DMA
1.84
Negative
200DMA
2.04
Negative
Market Momentum
MACD
-0.15
Negative
RSI
30.39
Neutral
STOCH
12.92
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ENSC, the sentiment is Negative. The current price of 1.01 is below the 20-day moving average (MA) of 1.03, below the 50-day MA of 1.46, and below the 200-day MA of 2.04, indicating a bearish trend. The MACD of -0.15 indicates Negative momentum. The RSI at 30.39 is Neutral, neither overbought nor oversold. The STOCH value of 12.92 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for ENSC.

Ensysce Biosciences Risk Analysis

Ensysce Biosciences disclosed 48 risk factors in its most recent earnings report. Ensysce Biosciences 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

Ensysce Biosciences 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
$1.60B-9.94-587.58%-74.73%95.81%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
47
Neutral
$5.34M-1.79-24.80%1371.65%64.13%
44
Neutral
$4.29M-0.22-46.34%70.71%
42
Neutral
$3.27M-0.14-270.54%1.51%77.64%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ENSC
Ensysce Biosciences
0.90
-6.87
-88.42%
NBY
NovaBay Pharma
12.69
12.21
2521.90%
GLMD
Galmed Pharmaceuticals
0.78
-2.12
-73.00%
CYCN
Cyclerion Therapeutics
1.36
-1.63
-54.52%
SILO
Silo Pharma
0.38
-1.58
-80.56%
ALZN
Alzamend Neuro
2.25
-8.19
-78.45%

Ensysce Biosciences Corporate Events

Business Operations and StrategyExecutive/Board ChangesRegulatory Filings and ComplianceShareholder Meetings
Ensysce Biosciences Shareholders Approve Key Corporate Actions
Positive
Jan 8, 2026

At its annual meeting of stockholders held on January 7, 2026, Ensysce Biosciences, Inc. secured shareholder approval for several key corporate actions that collectively strengthen its capital structure, governance continuity and financial oversight. Investors approved the full issuance of common stock and the exercise of warrants previously issued to an investor to comply with Nasdaq Listing Rule 5635(d), authorized a substantial increase in shares available under the company’s 2021 Omnibus Incentive Plan from 121,457 to 721,457 to expand its capacity for equity-based compensation, elected two Class I directors, William Chang and Lee Rauch, to serve terms expiring at the 2028 annual meeting, and ratified Baker Tilly US, LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2025, while a proposed adjournment authority was not brought to a vote.

The most recent analyst rating on (ENSC) stock is a Hold with a $0.98 price target. To see the full list of analyst forecasts on Ensysce Biosciences stock, see the ENSC Stock Forecast page.

Private Placements and Financing
Ensysce Biosciences Secures $4M Financing for PF614
Positive
Nov 17, 2025

On November 14, 2025, Ensysce Biosciences closed a $4 million convertible preferred stock financing, with the potential for an additional $16 million over the next 24 months. This funding will accelerate the Phase 3 clinical program for PF614, a flagship analgesic candidate, and support general corporate initiatives. The financing reflects strong investor confidence in Ensysce’s mission to innovate pain management solutions with built-in abuse and overdose protection.

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 09, 2026