Ensysce Biosciences (ENSC) AI Stock Analysis

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Ensysce Biosciences

(NASDAQ:ENSC)

Rating:32Underperform

Price Target:―

Ensysce Biosciences faces significant financial difficulties, with severe declines in revenue and negative profitability, heavily weighing on its overall stock score. The technical analysis indicates bearish momentum, though some indicators suggest a potential for reversal. Valuation remains unattractive due to negative earnings and lack of dividends. The company must address its financial challenges to improve its stock outlook.

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

Market Cap

$6.20M

Dividend YieldN/A

Average Volume (3M)608.05K

Price to Earnings (P/E)―

Beta (1Y)1.73

Revenue Growth415.58%

EPS Growth90.81%

CountryUS

Employees7

SectorHealthcare

Sector Strength51

IndustryBiotechnology

Share Statistics

EPS (TTM)-0.79

Shares Outstanding2,968,444

10 Day Avg. Volume51,807

30 Day Avg. Volume608,051

Financial Highlights & Ratios

PEG RatioN/A

Price to Book (P/B)N/A

Price to Sales (P/S)N/A

P/FCF RatioN/A

Enterprise Value/Market Cap0.45

Enterprise Value/Revenue0.37

Enterprise Value/Gross Profit5.05

Enterprise Value/Ebitda-0.42

Forecast

1Y Price TargetN/A

Price Target UpsideN/A

Rating ConsensusN/A

Number of Analyst Covering0

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:Aug 13, 2025

(Q4-2023)

% Change Since: |

Next Earnings Date:Nov 17, 2025

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

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

Very Negative

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

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.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	7.41M	5.21M	2.23M	2.52M	3.53M	3.93M
Gross Profit	549.21K	-2.01M	-5.36M	-17.31M	3.53M	3.93M
EBITDA	-6.58M	-6.73M	-10.72M	-24.22M	-19.87M	-1.61M
Net Income	-6.58M	-7.99M	-10.61M	-24.17M	-29.08M	56.77K
Balance Sheet
Total Assets	5.57M	5.60M	2.71M	5.89M	16.42M	351.81K
Cash, Cash Equivalents and Short-Term Investments	2.21M	3.50M	1.12M	3.15M	12.26M	194.21K
Total Debt	424.52K	301.66K	854.70K	4.43M	17.21M	4.27M
Total Liabilities	2.51M	2.22M	3.36M	9.91M	24.58M	7.01M
Stockholders Equity	3.39M	3.71M	-322.86K	-4.03M	-7.88M	-6.44M
Cash Flow
Free Cash Flow	-6.20M	-7.50T	-10.78M	-17.89M	-8.24M	-1.25M
Operating Cash Flow	-6.20M	-7.50T	-10.78M	-17.89M	-8.24M	-1.25M
Investing Cash Flow	0.00	0.00	0.00	4.50K	0.00	183.40M
Financing Cash Flow	7.37M	9.88T	8.76M	8.77M	20.31M	1.10M

Ensysce Biosciences Technical Analysis

Technical Analysis Sentiment

Negative

Last Price2.09

Price Trends

50DMA

2.15

Negative

100DMA

2.23

Negative

200DMA

4.35

Negative

Market Momentum

MACD

-0.02

Negative

RSI

48.42

Neutral

STOCH

70.15

Neutral

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 2.09 is below the 20-day moving average (MA) of 2.10, below the 50-day MA of 2.15, and below the 200-day MA of 4.35, indicating a bearish trend. The MACD of -0.02 indicates Negative momentum. The RSI at 48.42 is Neutral, neither overbought nor oversold. The STOCH value of 70.15 is Neutral, 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
Sector *	51 Neutral	$7.86B	-0.26	-41.41%	2.22%	22.87%	-2.01%
APVO	38 Underperform	$5.39M	―	-437.34%	―	―	98.45%
ENSC	32 Underperform	$6.20M	―	-253.29%	―	415.58%	90.81%
GLMD	28 Underperform	$6.96M	―	-53.99%	―	―	56.31%
REVB	28 Underperform	$4.69M	―	-340.81%	―	―	94.99%
ENVB	24 Underperform	$3.67M	―	-261.96%	―	―	80.53%
TAOX	―	$20.30M	―	-154.62%	―	―	―

* Healthcare Sector Average

Performance Comparison

ENSC

Ensysce Biosciences

2.09

-3.39

-61.86%

GLMD

Galmed Pharmaceuticals

1.27

-1.86

-59.42%

APVO

Aptevo Therapeutics

1.64

-255.51

-99.36%

ENVB

Enveric Biosciences

1.13

-6.52

-85.23%

REVB

Revelation Biosciences

2.76

-48.12

-94.58%

TAOX

Tao Synergies

5.82

2.13

57.72%

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: Apr 24, 2025