Duyuru • May 25
Ensysce Biosciences Inc. Receives Notice of Nasdaq Non-Compliance and Potential Delisting Due to Equity Requirements On May 21, 2026, Ensysce Biosciences Inc. received notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“ Nasdaq”) stating that due to the Company’s non-compliance with the $2.5 million stockholders’ equity requirement set forth in Nasdaq Listing Rule 5550(b)(1) as of March 31, 2026, the Company is subject to delisting unless it submits a plan within 45 days (by July 6, 2026) to regain compliance. If the plan is accepted, the Company may be granted an extension of up to 180 days from May 21, 2026, to regain compliance. If the plan is not accepted, the Company may appeal to the Nasdaq Hearings Panel (the “Panel”). The Company plans to submit timely a plan to Nasdaq. The Company intends to actively explore options to regain compliance with Nasdaq listing requirements; however, there can be no assurance that Nasdaq will accept the Company’s plan to regain compliance or that, if the plan is not accepted and the Company appeals, the Panel will accept the plan or that the Company will be able to evidence compliance prior to the expiration of any extension that may be granted to the Company. Reported Earnings • May 18
First quarter 2026 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2026 results: US$0.52 loss per share. Revenue: US$961.0k (down 27% from 1Q 2025). Net loss: US$3.56m (loss widened 83% from 1Q 2025). Revenue missed analyst estimates by 49%. Earnings per share (EPS) exceeded analyst estimates by 29%. Revenue is expected to decline by 30% p.a. on average during the next 2 years, while revenues in the Biotechs industry in the US are expected to grow by 22%. Major Estimate Revision • Apr 07
Consensus revenue estimates increase by 208%, EPS downgraded The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast increased from US$2.50m to US$7.70m. EPS estimate fell from -US$0.29 to -US$3.54 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$16.45 unchanged from last update. Share price rose 7.0% to US$0.58 over the past week. Reported Earnings • Mar 31
Full year 2025 earnings: EPS and revenues exceed analyst expectations Full year 2025 results: US$3.98 loss per share. Revenue: US$5.07m (down 2.8% from FY 2024). Net loss: US$10.2m (loss widened 27% from FY 2024). Revenue exceeded analyst estimates by 37%. Earnings per share (EPS) also surpassed analyst estimates by 16%. Duyuru • Mar 01
Ensysce Biosciences Inc. Receives Notice of Non-Compliance with Nasdaq Minimum Bid Price Listing Requirement On February 25, 2026, Ensysce Biosciences Inc. (the “Company”) received a notice (the “Deficiency Letter”) from the listing qualifications department staff of The Nasdaq Stock Market (“Nasdaq”) stating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2) because the bid price for the Company’s common stock had closed below $1.00 per share for the previous 30 consecutive business days. Nasdaq requires that Ensysce common stock have a minimum bid price of at least $1 per share (the “Minimum Bid Price”). In accordance with Nasdaq listing rule 5810(c)(3)(A), the Company has 180 calendar days, or until August 24, 2026, to regain compliance. The Deficiency Letter states that to regain compliance, the bid price for the Company’s common stock must close at the Minimum Bid Price for a minimum of ten consecutive business days during the compliance period ending August 24, 2026. The Deficiency Letter states that the Nasdaq staff may require a longer period for compliance with the Minimum Bid Price in some circumstances, but generally not more than 20 consecutive business days. With respect to the Minimum Bid Price, if the Company does not regain compliance by August 24, 2026, the Deficiency Letter states that the Company may be granted additional time by Nasdaq staff if the Company satisfies all other initial listing standards and continuing listing standards and provides written notice of its intention to cure the deficiency during a second compliance period of up to 180 days. If Nasdaq staff determines that the Company will not be able to cure the deficiency or is otherwise ineligible, Nasdaq staff will provide written notice to the Company that its securities are subject to delisting. At that time, the Company may appeal any such delisting determination to a Nasdaq hearings panel. There can be no assurance that additional time will be granted or that an appeal would be successful. Also, there can be no assurance that any steps the Company takes to regain compliance will not negatively impact the market value of our common stock. The Company intends to actively monitor the closing bid price for the Company’s common stock between now and August 24, 2026 and may, if appropriate, evaluate available options to resolve the deficiency and regain compliance with the Minimum Bid Price requirement. The Deficiency Letter has no immediate effect on the listing of the Company’s common stock, and the Company’s common stock continues to trade on the Nasdaq Capital Market under the symbol “ENSC.” While the Company is exercising diligent efforts to maintain the listing of its common stock on Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with all of Nasdaq’s listing requirements and standards. If we do not meet those obligations, Nasdaq could delist our common stock. If delisting occurs, it could be more difficult to buy or sell our securities and to obtain accurate quotations, and the price of our common stock could suffer a material decline. In addition, a delisting would impair our ability to raise capital through the public markets, could deter broker-dealers from making a market in or otherwise seeking or generating interest in our securities and might deter certain institutions and persons from investing in our securities. Any of these could negatively impact our financial condition or our ability to operate our business and maintain adequate capital. New Risk • Feb 11
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 18% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (18% average weekly change). Shareholders have been substantially diluted in the past year (178% increase in shares outstanding). Market cap is less than US$10m (US$2.21m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$3.0m net loss next year). Revenue is less than US$5m (US$4.5m revenue). Price Target Changed • Feb 09
Price target decreased by 19% to US$16.45 Down from US$20.23, the current price target is provided by 1 analyst. New target price is 3,465% above last closing price of US$0.46. Stock is down 92% over the past year. The company is forecast to post a net loss per share of US$4.73 next year compared to a net loss per share of US$11.45 last year. New Risk • Dec 31
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (178% increase in shares outstanding). Market cap is less than US$10m (US$3.36m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$2.6m net loss in 2 years). Share price has been volatile over the past 3 months (11% average weekly change). Revenue is less than US$5m (US$4.5m revenue). Duyuru • Nov 24
Ensysce Biosciences, Inc., Annual General Meeting, Dec 23, 2025 Ensysce Biosciences, Inc., Annual General Meeting, Dec 23, 2025. Major Estimate Revision • Nov 21
Consensus revenue estimates fall by 33% The consensus outlook for revenues in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from US$5.50m to US$3.70m. Forecast losses increased from -US$3.68 to -US$4.73 per share. Biotechs industry in the US expected to see average net income decline 7.5% next year. Consensus price target down from US$20.23 to US$19.23. Share price fell 22% to US$1.61 over the past week. Duyuru • Nov 19
Ensysce Biosciences, Inc. announced that it has received $2.487 million in funding On November 17, 2025, Ensysce Biosciences, Inc closed the transaction. Reported Earnings • Nov 17
Third quarter 2025 earnings: EPS and revenues miss analyst expectations Third quarter 2025 results: US$1.29 loss per share (down from US$1.00 profit in 3Q 2024). Revenue: US$493.1k (down 86% from 3Q 2024). Net loss: US$3.73m (down US$4.39m from profit in 3Q 2024). Revenue missed analyst estimates by 65%. Earnings per share (EPS) also missed analyst estimates by 70%. Revenue is expected to decline by 118% p.a. on average during the next 2 years, while revenues in the Biotechs industry in the US are expected to grow by 22%. Board Change • Oct 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. Chairman of Clinical Advisory Board & Chief Medical Officer Bill Schmidt was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Reported Earnings • Aug 14
Second quarter 2025 earnings: EPS and revenues exceed analyst expectations Second quarter 2025 results: US$0.79 loss per share (improved from US$3.35 loss in 2Q 2024). Revenue: US$1.37m (up US$1.19m from 2Q 2024). Net loss: US$1.73m (loss narrowed 12% from 2Q 2024). Revenue exceeded analyst estimates by 104%. Earnings per share (EPS) also surpassed analyst estimates by 22%. Revenue is forecast to grow 64% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Breakeven Date Change • May 15 The 2 analysts covering Ensysce Biosciences previously expected the company to break even in 2026. New consensus forecast suggests the company will make a profit of US$22.2m in 2026. Average annual earnings growth of 75% is required to achieve expected profit on schedule.
Reported Earnings • May 15
First quarter 2025 earnings released: US$1.39 loss per share (vs US$8.21 loss in 1Q 2024) First quarter 2025 results: US$1.39 loss per share (improved from US$8.21 loss in 1Q 2024). Revenue: US$1.32m (up 332% from 1Q 2024). Net loss: US$1.95m (loss narrowed 38% from 1Q 2024). Revenue is forecast to grow 75% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Duyuru • Apr 01
Ensysce Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $1.021209 million. Ensysce Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $1.021209 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 315,188
Price\Range: $3.24
Transaction Features: Registered Direct Offering Reported Earnings • Mar 12
Full year 2024 earnings: EPS and revenues exceed analyst expectations Full year 2024 results: US$11.45 loss per share (improved from US$70.40 loss in FY 2023). Revenue: US$5.21m (up 134% from FY 2023). Net loss: US$7.99m (loss narrowed 25% from FY 2023). Revenue exceeded analyst estimates by 26%. Earnings per share (EPS) also surpassed analyst estimates by 8.0%. Revenue is forecast to grow 120% p.a. on average during the next 2 years, compared to a 20% growth forecast for the Biotechs industry in the US. Breakeven Date Change • Jan 23
No longer forecast to breakeven The 2 analysts covering Ensysce Biosciences no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$32.4m in 2026. New consensus forecast suggests the company will make a loss of US$11.7m in 2026. Price Target Changed • Dec 09
Price target increased by 515% to US$627 Up from US$102, the current price target is an average from 2 analysts. New target price is 8,596% above last closing price of US$7.21. Stock is down 56% over the past year. The company is forecast to post a net loss per share of US$12.45 next year compared to a net loss per share of US$70.40 last year. Duyuru • Dec 04
Ensysce Biosciences Announces 1-for-15 Reverse Stock Split to Regain Compliance with Bid Price Requirement Ensysce Biosciences, Inc. announced that on December 6, 2024, effective at 12:01 a.m. Eastern Time, it will implement a 1-for-15 reverse split of its common stock. The Company's common stock will begin trading on a split-adjusted basis when the market opens on December 6, 2024, under its current trading symbol "ENSC". The new CUSIP number of the Company's common stock following the reverse stock split will be 293602 504. The reverse stock split is intended, among other things, primarily to increase the bid price of the Company's common stock to enable the Company to regain compliance with the minimum bid price requirement of $1.00 per share for continued listing on The Nasdaq Capital Market. Reported Earnings • Nov 14
Third quarter 2024 earnings: EPS and revenues exceed analyst expectations Third quarter 2024 results: EPS: US$0.067 (up from US$0.87 loss in 3Q 2023). Revenue: US$3.42m (up US$2.98m from 3Q 2023). Net income: US$661.8k (up US$3.35m from 3Q 2023). Profit margin: 19% (up from net loss in 3Q 2023). The move to profitability was primarily driven by higher revenue. Revenue exceeded analyst estimates significantly. Earnings per share (EPS) also surpassed analyst estimates. Revenue is forecast to grow 148% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Duyuru • Nov 07
Ensysce Biosciences Receives Positive Nasdaq Listing Determination Ensysce Biosciences, Inc. announced that it has received notice from The Nasdaq Stock Market (‘Nasdaq’) as described in a decision dated November 5, 2024, that the Company may continue its listing on The Nasdaq Capital Market tier with an extension to November 14, 2024, to demonstrate compliance with the equity requirement in Listing Rule 5550(b)(1) as of September 30, 2024, with filing of its Form 10-Q. Additionally, the Company received an extension to December 19, 2024, to evidence compliance with the Minimum Bid Price in Listing Rule 5550(a)(2), all other applicable requirements and the Company's satisfaction of certain other interim conditions. Duyuru • Oct 08
Ensysce Biosciences, Inc., Annual General Meeting, Nov 21, 2024 Ensysce Biosciences, Inc., Annual General Meeting, Nov 21, 2024. Duyuru • Sep 20
Ensysce Biosciences, Inc. Submits Phase 3 Protocol to the FDA Ensysce Biosciences, Inc. announced it has submitted to the FDA its PF614-301 protocol of the study, "A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty". Included in the Phase 3 study is the Company's statistical analysis plan for review and input by the FDA. The study, once finalized with the FDA, will be conducted through four to six clinical sites in the United States, and is designed to assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate-to-severe pain following abdominoplasty. Additionally, Ensysce will evaluate PF614 versus an active comparator, the use of rescue medication and the safety and tolerability of PF614. Price Target Changed • Sep 01
Price target decreased by 32% to US$9.05 Down from US$13.38, the current price target is an average from 2 analysts. New target price is 2,191% above last closing price of US$0.40. Stock is down 78% over the past year. The company is forecast to post a net loss per share of US$1.11 next year compared to a net loss per share of US$4.69 last year. Duyuru • Aug 30
Ensysce Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $1.669895 million. Ensysce Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $1.669895 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,490,798
Price\Range: $0.47
Discount Per Security: $0.033
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,062,396
Price\Range: $0.4699
Discount Per Security: $0.033
Transaction Features: Registered Direct Offering Duyuru • Aug 28
Ensysce Biosciences, Inc. Announces IRB Approval for Key MPAR Study Ensysce Biosciences, Inc. announced that it has received Investigational Review Board ("IRB") approval of the PF614-MPAR-102 protocol, 'A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co-Administered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects.' Ensysce has continued its collaboration with Quotient Sciences to conduct this second clinical study of MPAR using their Translational Pharmaceutics®? platform. Ensysce has continued its collaborate with Quotient Sciences to conducted this second clinical study ofMPAR using their Translational Pharmaceuticalaceutics®? platform. The approval of this study protocol represents another key milestone towards completing the clinical development of first-in-class opioid with both abuse and overdose protection. Clinical data from initial study demonstrated the unique overdose protection built into PF614-MPAR, which led to the FDA designation of Breakthrough Therapy. PF614-MPAR is the only opioid to receive such recognition and one of only 300 drugs ever approved for this designation. Major Estimate Revision • Aug 21
Consensus revenue estimates decrease by 25%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$1.20m to US$900.0k. EPS estimate increased from -US$1.52 to -US$1.21 per share. Biotechs industry in the US expected to see average net income decline 14% next year. Consensus price target of US$13.38 unchanged from last update. Share price was steady at US$0.41 over the past week. Reported Earnings • Aug 16
Second quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2024 results: US$0.22 loss per share (improved from US$0.98 loss in 2Q 2023). Revenue: US$181.8k (down 63% from 2Q 2023). Net loss: US$1.97m (loss narrowed 12% from 2Q 2023). Revenue missed analyst estimates by 39%. Earnings per share (EPS) exceeded analyst estimates by 33%. Revenue is forecast to grow 122% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in the US. Major Estimate Revision • May 20
Consensus revenue estimates decrease by 26%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$1.63m to US$1.20m. EPS estimate increased from -US$3.03 to -US$1.52 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target broadly unchanged at US$13.38. Share price rose 6.7% to US$0.62 over the past week. Breakeven Date Change • May 15
No longer forecast to breakeven The 2 analysts covering Ensysce Biosciences no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$29.0m in 2026. New consensus forecast suggests the company will make a loss of US$4.28m in 2026. Reported Earnings • May 13
First quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2024 results: US$0.55 loss per share. Revenue: US$305.7k (down 61% from 1Q 2023). Net loss: US$3.12m (loss widened 42% from 1Q 2023). Revenue missed analyst estimates by 24%. Earnings per share (EPS) exceeded analyst estimates by 39%. Revenue is forecast to grow 107% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Price Target Changed • Apr 09
Price target increased by 16% to US$13.50 Up from US$11.65, the current price target is an average from 2 analysts. New target price is 1,631% above last closing price of US$0.78. Stock is down 78% over the past year. The company is forecast to post a net loss per share of US$3.03 next year compared to a net loss per share of US$4.69 last year. Duyuru • Mar 30
Ensysce Biosciences Receives Notice from The Nasdaq Stock Market Regarding Non-Compliance with Nasdaq Listing Rule 5550(a)(2) On March 27, 2024, Ensysce Biosciences Inc. (the ‘Company’) received a notice (the ‘Deficiency Letter’) from the listing qualifications department staff of The Nasdaq Stock Market (‘Nasdaq’) stating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2) because the bid price for the Company’s common stock had closed below $1.00 per share for the previous 30 consecutive business days. Nasdaq requires that Ensysce common stock have a minimum bid price of at least $1 per share (the ‘Minimum Bid Price’). In accordance with Nasdaq listing rule 5810(c)(3)(A), the Company has 180 calendar days, or until September 23, 2024, to regain compliance. The Deficiency Letter states that to regain compliance, the bid price for the Company’s common stock must close at the Minimum Bid Price for a minimum of ten consecutive business days during the compliance period ending September 23, 2024. The Deficiency Letter does not explicitly address that the Nasdaq staff may require a longer period for compliance with the Minimum Bid Price in some circumstances, but generally not more than 20 consecutive business days. With respect to the Minimum Bid Price, if the Company does not regain compliance by September 23, 2024, Nasdaq staff will provide written notice to the Company that its securities are subject to delisting. At that time, the Company may appeal any such delisting determination to a Nasdaq hearings panel. There can be no assurance that an appeal would be successful. The Company intends to actively monitor the closing bid price for the Company’s common stock between now and September 23, 2024 and may, if appropriate, evaluate available options to resolve the deficiency and regain compliance with the Minimum Bid Price requirement. The Deficiency Letter has no immediate effect on the listing of the Company’s common stock, and the Company’s common stock continues to trade on the Nasdaq Capital Market under the symbol ‘ENSC.’ However, as previously reported, on November 13, 2023, the company received notice from the Listing Qualifications department of Nasdaq stating that, due to the company’s non-compliance with the $2.5 million stockholders’ equity requirement set forth in Nasdaq Listing Rule 5550(b)(1) as of September 30, 2023, the company was subject to delisting unless it timely request a hearing before the Nasdaq Hearings Panel (the ‘Panel’), which the company did, resulting in a hearing that was held before the Panel in early February 2024. The Panel granted the company’s request for continued listing until May 13, 2024. The company intends to actively explore options to regain compliance with Nasdaq listing requirements; however, there can be no assurance that the Panel will grant the company’s request for continued listing or that the company will be able to evidence compliance prior to the expiration of any extension that may be granted to the company by the Panel. While the Company is exercising diligent efforts to maintain the listing of its common stock on Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with all of Nasdaq’s listing requirements and standards. If the company do not meet those obligations, Nasdaq could delist the company’s common stock. If delisting occurs, it could be more difficult to buy or sell its securities and to obtain accurate quotations, and the price of the company’s common stock could suffer a material decline. In addition, a delisting would impair the company’s ability to raise capital through the public markets, could deter broker-dealers from making a market in or otherwise seeking or generating interest in the company’s securities and might deter certain institutions and persons from investing in the company’s securities. Any of these could negatively impact the company’s financial condition or the company’s ability to operate the company’s business and maintain adequate capital. Major Estimate Revision • Mar 22
Consensus EPS estimates fall by 32% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -US$2.30 to -US$3.03 per share. Revenue forecast of US$1.63m unchanged since last update. Biotechs industry in the US expected to see average net income decline 8.3% next year. Consensus price target down from US$11.65 to US$11.33. Share price was steady at US$0.80 over the past week. Price Target Changed • Mar 21
Price target decreased by 16% to US$11.33 Down from US$13.43, the current price target is an average from 3 analysts. New target price is 1,351% above last closing price of US$0.78. Stock is down 86% over the past year. The company is forecast to post a net loss per share of US$3.03 next year compared to a net loss per share of US$4.69 last year. Breakeven Date Change • Mar 18
Forecast to breakeven in 2026 The 3 analysts covering Ensysce Biosciences expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$62.3m in 2026. Average annual earnings growth of 63% is required to achieve expected profit on schedule. Reported Earnings • Mar 15
Full year 2023 earnings released Full year 2023 results: Net income: (up US$25.1m from FY 2022). Price Target Changed • Feb 20
Price target decreased by 13% to US$11.65 Down from US$13.43, the current price target is an average from 2 analysts. New target price is 1,127% above last closing price of US$0.95. Stock is down 86% over the past year. The company is forecast to post a net loss per share of US$4.74 next year compared to a net loss per share of US$139 last year. Duyuru • Feb 15
Ensysce Biosciences Announces Publication of Clinical Bioequivalence Manuscript Ensysce Biosciences, Inc. announced online publication of its manuscript entitled, "Clinical evaluation of PF614, a novel TAAP(TM) prodrug of oxycodone, versus OxyContin® in a multi-ascending dose study with a bioequivalence arm in healthy volunteers" published online by the open-access medical journal Clinical and Translational Science (CTS) sponsored by the American Society of Clinical Pharmacology and Therapeutics (ASCPT). The article is authored by members of the Ensysce team plus external experts; D. Lynn Kirkpatrick PhD, Cari Evans RN, Linda A. Pestano PhD, Jeffrey Millard PhD, Matthew Johnston MD, Emily Mick PharmD, and William K. Schmidt PhD. The results from the two-part PF614-102 study are very significant as believe they demonstrate a clear dose relationship between PF614 and oxycodone, which is the foundation for the FDA submission. The BE arm showed that plasma oxycodone bioequivalence was successfully achieved between 100 mg PF614 and 40 mg OxyContin. PF614 provided similar oxycodone exposures in both fasted and fed states, showing that it can be taken either on an empty stomach or with food, these data highlight PF614's potential advantage compared to other marketed abuse deterrent formulation (ADF) opioids. PF614 also showed a longer (12 hour) half-life, a major patient benefit in severe pain treatment. This manuscript provides a report of the safety and pharmacokinetics (PK) profile of PF614, a Trypsin-Activated Abuse Protection (TAAP™) oxycodone prodrug designed to reduce recreational drug abuse. PF614 was compared to OxyContin® in healthy subjects in the initial multi-ascending dose arm of the study. Additionally, the manuscript details the second arm which evaluated oxycodone release from PF614 and OxyContin administered to 60 subjects in both a fasted and fed state in order to assess whether PF614 is bioequivalent (BE) to OxyContin. The notable distinction identified in this study between PF614 and OxyContin was the longer half-life of PF614, which provides a benefit to the patient as this is a true twice daily pain treatment. believe this differentiating feature is critically important as steady blood levels can deliver sustained analgesia throughout the day to prevent breakthrough pain and the need for additional therapeutics. CTS is a peer-reviewed open-access medical journal that highlights original research and helps to bridge laboratory discoveries with the diagnosis and treatment of human disease. New Risk • Feb 14
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: US$13m Forecast net loss in 2 years: US$9.7m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (21% average weekly change). Shareholders have been substantially diluted in the past year (151% increase in shares outstanding). Market cap is less than US$10m (US$2.71m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$9.7m net loss in 2 years). Revenue is less than US$5m (US$3.1m revenue). Price Target Changed • Feb 14
Price target decreased by 13% to US$11.65 Down from US$13.43, the current price target is an average from 2 analysts. New target price is 1,255% above last closing price of US$0.86. Stock is down 88% over the past year. The company is forecast to post a net loss per share of US$4.74 next year compared to a net loss per share of US$139 last year. Duyuru • Feb 01
Ensysce Biosciences Announces Positive End of Phase 2 Meeting with FDA for PF614 to Treat Severe Pain Ensysce Biosciences, Inc. announced the completion of a constructive End of Phase 2 meeting with the Food and Drug Administration (FDA) regarding its lead ‘Next Generation' analgesic, PF614. The meeting facilitated an affirmation of the Company's non-clinical program and enabled an exchange of constructive ideas regarding Ensysce's Phase 3 clinical trial designs for PF614. As previously announced, the Company has performed five clinical studies to evaluate the safety, abuse potential and efficacy of PF614 for the treatment of severe pain. The clinical data has demonstrated that PF614 was bioequivalent to OxyContin for delivering oxycodone, meaning one could easily substitute PF614 for OxyContin in patients with pain. However, PF614 was found to have a longer half-life than OxyContin. Ensysce believes that the longer twelve-hour half-life could improve the pain-relieving qualities of PF614, reduce opioid-related adverse events, and provide true twice daily dosing. Evaluation of both nasal (insufflation) and oral abuse-potential studies met key endpoints that showed PF614 had significantly lower scores for "Overall Drug Liking" and willingness to "Take Drug Again" than the oxycodone comparator. Additionally, PF614 showed significant analgesic activity in a recent study that measured the time-of-onset of pain-relief in healthy volunteers. The study confirmed the prior clinical pharmacokinetic studies that measured oxycodone blood levels following oral administration of PF614 and showed that Ensysce's TAAP chemical approach delivers strong analgesia. This study was key to the design of the Company's Phase 3 clinical protocols and positive discussions with the FDA. Duyuru • Jan 17
Ensysce Biosciences, Inc. has filed a Follow-on Equity Offering. Ensysce Biosciences, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Series B-1 Warrants
Security Type: Equity Warrant
Security Name: Series B-2 Warrants
Security Type: Equity Warrant
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Duyuru • Dec 15
Ensysce Biosciences, Inc. Announces Key Efficacy Data for Lead Analgesic Ensysce Biosciences, Inc. announced that its most recent study has demonstrated crucially important data for PF614 on pain intensity efficacy and speed of onset. The PF614-201 study, 'A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy male Subjects', which completed enrollment in November 2023, demonstrated time-to-efficacy onset for the analgesia effect and significant decrease of pain intensity versus placebo of PF614 at two different dose levels, the first ever measured for this TAAP opioid. The study endpoints matched all previous clinical studies, demonstrating that Ensysce's TAAP chemical approach delivers strong analgesia safely and effectively. This 'time of onset' study data supports the key elements of Phase 3 study designs that will allow the Company to affirm its Phase 3 plans and launch strategy for PF614 with the FDA during its End of Phase 2 meeting scheduled in late January 2024. New Risk • Dec 01
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 19% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (over 12x increase in shares outstanding). Market cap is less than US$10m (US$2.56m market cap). Minor Risk Revenue is less than US$5m (US$3.1m revenue). Duyuru • Nov 29
Ensysce Biosciences, Inc. announced that it has received $1.7 million in funding On November 28, 2023, Ensysce Biosciences, Inc. closed the transaction. The company announced that it has issued senior secured convertible promissory notes in the aggregate principal amount of $1,224,000 for an aggregate purchase price of $1,133,333 in its second and final tranche closing. The company issued warrants to purchase 2,511,394 shares. Duyuru • Nov 18
Ensysce Biosciences Receives Non-Compliance Notice from Nasdaq On November 13, 2023, Ensysce Biosciences, Inc. (the “Company”) received notice from the Listing Qualifications department of The Nasdaq Stock Market LLC (“Nasdaq”) stating that, due to the Company’s non-compliance with the $2.5 million stockholders’ equity requirement set in Nasdaq Listing Rule 5550(b)(1) as of September 30, 2023, the Company was subject to delisting unless it timely requests a hearing before the Nasdaq Hearings Panel (the “Panel”). The Company plans to timely request a hearing before the Panel, which request will stay any further action by Nasdaq pending the conclusion of the hearing process. The Company intends to actively explore options to regain compliance with Nasdaq listing requirements; however, there can be no assurance that the Panel will grant the Company’s request for continued listing or that the Company will be able to evidence compliance prior to the expiration of any extension that may be granted to the Company by the Panel. Duyuru • Nov 17
Ensysce Biosciences, Inc. Announces Enrollment Completion for PF614-201 Clinical Study Ensysce Biosciences, Inc. announced that the PF614-201 study, 'A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy male Subjects' has completed enrollment. The goal of this exploratory Phase 2 PF614-201 study is to confirm the approximate time of onset for PF614 analgesic effects prior to initiation of Phase 3 efficacy evaluations. Major Estimate Revision • Nov 16
Consensus revenue estimates decrease by 21%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$2.66m to US$2.11m. EPS estimate increased from -US$5.05 to -US$4.80 per share. Biotechs industry in the US expected to see average net income growth of 5.7% next year. Consensus price target of US$12.25 unchanged from last update. Share price rose 3.8% to US$0.88 over the past week. Reported Earnings • Nov 11
Third quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2023 results: US$0.87 loss per share (improved from US$61.58 loss in 3Q 2022). Revenue: US$435.4k (up 56% from 3Q 2022). Net loss: US$2.69m (loss narrowed 73% from 3Q 2022). Revenue missed analyst estimates by 27%. Earnings per share (EPS) exceeded analyst estimates by 18%. Revenue is forecast to grow 62% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Duyuru • Oct 25
Ensysce Biosciences, Inc. announced that it expects to receive $1.7 million in funding Ensysce Biosciences, Inc. entered into a Securities Purchase Agreement with investors for an aggregate gross proceeds of $1.7 million on October 23, 2023. The Company will issue to the investors (i) senior secured convertible promissory notes in the aggregate principal amount of $612,000 for an aggregate purchase price of $566,667 (collectively, the “Notes”) and (ii) warrants (collectively, the “Warrants”) to purchase 1,255,697 shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”) in the aggregate with first closing on October 26, 2023.The company will issue (i) Notes in the aggregate principal amount of $1,224,000 for an aggregate purchase price of $1,133,333 and (i) Warrants to purchase 2,511,394 shares of the Common Stock in the aggregate on second closing. The Notes, subject to an original issue discount of eight percent (8%), have a term of six months from their respective date of issuance and bear a interest rate of 6% per annum. The Notes are convertible into the Common Stock, at a per share conversion price equal to $1.5675. Beginning ninety days following issuance of the respective Notes, the Company is obligated to redeem monthly one third (1/3 rd ) of the original principal amount under the applicable Note, plus accrued but unpaid interest, liquidated damages and any other amounts then owing to the holder of such Note.The Warrants will have an exercise price of $1.5675, the same as the conversion price, and are exercisable for five years following issuance, issuance to occur on each of the first and second closing dates under the agreement. The closing is expected to occur on October 26, 2023. Duyuru • Sep 27
Ensysce Biosciences, Inc. Announces Completion of Site Initiation Visit for PF614-201 Clinical Study Ensysce Biosciences, Inc. announced the Site Initiation Visit (SIV) was completed for the PF614-201 study, 'A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy male Subjects' to evaluate time of onset for PF614. The study is being conducted by Dr. George Atiee at Dr. Vince Clinical Research (DVCR) in Overland, KS. Each study serves a critical purpose and this new study's importance is grounded in the ability to best determine optimal prescribing options for surgical patients, while also key in preparing for full Phase 3 evaluation of PF614. PF614 is a chemically modified opioid product that requires initial metabolic transformation by trypsin in the small intestine for activation to be able to relieve severe pain in patients who require an opioid-level analgesic. The company believe PF614 will be a game changer for the treatment of severe pain and represents a new generation of pain products. Duyuru • Sep 15
Ensysce Biosciences Completes Scale Up Manufacture of PF614 to Support Phase 3 Studies Ensysce Biosciences, Inc. announced that two scale up manufactures have been completed for the Company's lead drug candidate PF614, a next generation pain medicine to treat severe pain. The success of the scaled manufacturing work has positioned the Company to begin its commercialization strategy consistent with timeline expectations. As a result of the positive progress on its clinical milestones, Ensysce has commenced the next phase of development, including planning its phase 3 studies and increasing its manufacturing capacity in line with commercial readiness. The previous clinical milestones met for PF614 over the past year include PF614 delivered oxycodone in an equivalent manner to Oxycodin to treat severe pain (defined as 'bioequivalence'), yet notably PF614 had significantly lower scores of "Drug Liking" and 'Take Drug Again' than its oxycodone comparator in two different recreational drug abuse studies indicating that it was less likely to be abuse by drug users. Using two different Contract Manufacturing Organizations, Veranova and Purisys LLC, Ensysce has completed the manufacture of over 10 kilograms of the active pharmaceutical ingredient that will be used for the final stages of non-clinical studies, the final clinical trials that will lead to filing its New Drug Application and drug product manufacture. It is intended that Purisys LLC will continue to support the Company's larger scale commercial manufacture going forward. PF614 is a Trypsin Activated Abuse Protected (TAAPTM) product designed as a delayed onset extended-release oxycodone prodrug. TAPTM chemical modification inactivates the active ingredient in Ensysce's products including PF614 until they are swallowed. This provides abuse deterrence, resistance to manipulation and other forms of recreational drug abuse, while providing a high degree of pain relief for those who require opioid analgesics for 24/7 round-the-clock severe pain. Reported Earnings • Aug 13
Second quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2023 results: US$0.98 loss per share (improved from US$56.48 loss in 2Q 2022). Revenue: US$490.5k (up 136% from 2Q 2022). Net loss: US$2.24m (loss narrowed 72% from 2Q 2022). Revenue missed analyst estimates by 41%. Earnings per share (EPS) exceeded analyst estimates by 64%. Revenue is forecast to grow 58% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Duyuru • Aug 09
Ensysce Biosciences, Inc. Announces Investigational Review Board Approval of Key Study Protocol Ensysce Biosciences, Inc. announced the Investigational Review Board (IRB) approval of PF614-201 protocol, 'A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy male Subjects.' The study will be conducted at Dr. Vince Clinical Research (DVCR) in Overland Park, Kansas, and is designed to confirm time of onset for pain relief by PF614. Duyuru • Jul 15
Ensysce Biosciences, Inc., Annual General Meeting, Aug 24, 2023 Ensysce Biosciences, Inc., Annual General Meeting, Aug 24, 2023, at 09:00 Pacific Standard Time. Agenda: To elect the two Class II directors named in our Proxy Statement to hold office until the annual meeting of stockholders for the calendar year ended December 31, 2025 and until their respective successors have been duly elected and qualified; to approve the amendment of the Ensysce Biosciences, Inc. Amended and Restated 2021 Omnibus Incentive Plan to increase the aggregate number of shares of the Company’s common stock that may be issued under the plan from 31,296 shares to 617,092 shares; to ratify the appointment Moss Adams LLP as company's independent registered public accounting firm for the fiscal year ending December 31, 2023; and to transact such other business as may properly come before the meeting or any adjournments or postponements thereof. Duyuru • Jun 14
Ensysce Biosciences Regains Compliance with the Equity Requirement in Nasdaq Listing Rule 5550(b)(1) On June 13, 2023, Ensysce Biosciences, Inc. announced that it has received notice from The Nasdaq Stock Market LLC ('Nasdaq') that the company has demonstrated compliance with the equity requirement in Listing Rule 5550(b)(1), as described in the Hearing Panel's (‘Panel’) decision dated February 14, 2023, as amended. As a result, Ensysce common stock will continue trading on Nasdaq's Capital Market tier. Major Estimate Revision • May 22
Consensus EPS estimates upgraded to US$9.75 loss, revenue downgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$3.70m to US$3.60m. 2023 losses expected to reduce from -US$37.37 to -US$9.75 per share. Biotechs industry in the US expected to see average net income decline 81% next year. Consensus price target down from US$29.40 to US$16.43. Share price fell 12% to US$2.72 over the past week. Reported Earnings • May 17
First quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2023 results: US$2.08 loss per share. Revenue: US$789.6k (up 31% from 1Q 2022). Net loss: US$2.20m (loss widened 32% from 1Q 2022). Revenue missed analyst estimates by 17%. Earnings per share (EPS) exceeded analyst estimates by 59%. Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Duyuru • May 11
Ensysce Biosciences, Inc. has completed a Follow-on Equity Offering. Ensysce Biosciences, Inc. has completed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,800,876
Price\Range: $3.887
Security Name: Series A-1 Warrants
Security Type: Equity Warrant
Securities Offered: 1,800,876
Security Name: Series A-1 Warrants
Security Type: Equity Warrant
Securities Offered: 1,800,876
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Major Estimate Revision • Apr 13
Consensus revenue estimates increase by 14% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$3.23m to US$3.70m. Forecast losses expected to reduce from -US$48.87 to -US$37.37 per share. Biotechs industry in the US expected to see average net income decline 51% next year. Consensus price target down from US$69.90 to US$29.40. Share price rose 8.2% to US$3.83 over the past week. Price Target Changed • Apr 12
Price target decreased by 58% to US$29.40 Down from US$69.90, the current price target is an average from 2 analysts. New target price is 686% above last closing price of US$3.74. Stock is down 99% over the past year. The company is forecast to post a net loss per share of US$37.37 next year compared to a net loss per share of US$139 last year. Reported Earnings • Apr 02
Full year 2022 earnings: EPS and revenues miss analyst expectations Full year 2022 results: US$11.62 loss per share (improved from US$356 loss in FY 2021). Revenue: US$2.52m (down 28% from FY 2021). Net loss: US$25.1m (loss narrowed 16% from FY 2021). Revenue missed analyst estimates by 4.3%. Earnings per share (EPS) also missed analyst estimates by 16%. Revenue is forecast to grow 63% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in the US. Recent Insider Transactions • Mar 03
Independent Chairman of the Board recently bought US$182k worth of stock On the 1st of March, Robert Gower bought around 379k shares on-market at roughly US$0.48 per share. This transaction amounted to 50% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Robert's only on-market trade for the last 12 months. Duyuru • Feb 08
Ensysce Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $3.000002 million. Ensysce Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $3.000002 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,571,431
Price\Range: $0.84
Discount Per Security: $0.0588
Transaction Features: Registered Direct Offering Duyuru • Feb 01
Ensysce Biosciences Receives Non-Compliance Notice from Nasdaq On January 27, 2023, Ensysce Biosciences Inc. (the “Company”) received a notice in the form of a letter (the “Deficiency Letter”) from the listing qualifications department staff of The Nasdaq Stock Market (“Nasdaq”) stating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2) because the bid price for the Company’s common stock had closed below $1.00 per share for the previous 30 consecutive business days. In accordance with Nasdaq listing rule 5810(c)(3)(A), the Company has 180 calendar days, or until July 26, 2023, to regain compliance. The Deficiency Letter states that to regain compliance, the bid price for the Company’s common stock must close at $1.00 per share or more (the “Minimum Bid Price”) for a minimum of 10 consecutive business days during the compliance period ending July 26, 2023. The Deficiency Letter does not explicitly address that the Nasdaq staff may require a longer period of time for compliance with the Minimum Bid Price in some circumstances, but generally not more than 20 consecutive business days. The Deficiency Letter has no immediate effect on the listing of the Company’s common stock, and the Company’s common stock continues to trade on the Nasdaq Capital Market. If the Company does not regain compliance by July 26, 2023, Nasdaq staff will provide written notice to the Company that its securities are subject to delisting. At that time, the Company may appeal any such delisting determination to a Nasdaq hearings panel. The Company intends to actively monitor the closing bid price for the Company’s common stock between now and July 26, 2023 and may, if appropriate, evaluate available options to resolve the deficiency and regain compliance with the Minimum Bid Price requirement. While the Company is exercising diligent efforts to maintain the listing of its common stock on Nasdaq, there can be no assurance that the Company will be able to regain or maintain compliance with Nasdaq listing standards. On June 17, 2022, 11, 2022, received written notice from Nasdaq that had regained compliance with the Minimum Bid Price requirement. However, on December 14, 2022, received a notice of a determination (the “Notice”) from Nasdaq, which referenced the Nasdaq letter sent to the Company, dated June 16, 2022 (the “June 16th Notice”), that the Company’s Minimum Value of Listed Securities (“MVLS”) was below the minimum of $35 million required for continued listing. Because did not regain compliance by the deadline set forth in the June 16th Notice requested a hearing before a Nasdaq Hearings Panel (the “Panel”). That hearing was held on January 26, 2023 and await the decision of the Panel. In connection with the hearing, any suspension or delisting action has been stayed pending the determination of the Panel following the hearing. In that regard, the Panel has the authority to grant an additional extension period not to exceed past June 12, 2023. There can be no assurance that the Company will be granted more time to attempt to comply with the MVLS requirement or be able to regain or maintain compliance with Nasdaq listing standards, including the Minimum Bid Price requirement. Duyuru • Jan 26
Ensysce Biosciences, Inc. Announces Initiation of Final Stage of Groundbreaking Opioid Overdose Protection Phase 1 Study Ensysce Biosciences, Inc. announced the initiation of the final stage of the Phase 1 study of PF614-MPAR. PF614-MPAR is the overdose protectionversion of its lead product, PF614, and this keystudy is being conducted in healthy subjects by Dr. Maria Bermudez MD, at Quotient Sciences, Miami, Florida. PF614, a TAAP prodrug of oxycodone, has a number of safety features designed to reduce abuse, including its extended-release profile that has been shown to reduce ‘drug liking' in recreational drug users. Additionally, its requirement for exposure to the enzyme trypsin to release oxycodone reduces the ability of recreational users to chew, crush and snort, or manipulate and inject to change the opioid release profile. The combination product PF614-MPAR has another layer of safety, with an added trypsin inhibitor to prevent overdose. PF614-MPAR is designed to provide optimal pain relief at prescribed doses. Accidental or intentional overdose is designed to be limited by the overdose protection built into each capsule with the addition of Ensysce's formulated trypsin inhibitor, nafamostat. With MPAR (Multi-Pill Abuse Resistance) technology, the target dose of one or two prescribed PF614-MPAR capsules will release the expected concentration of oxycodone required to provide pain relief as intended. However, when three or more capsules are taken, exceeding the target dose, the increased exposure to nafamostat progressively inhibits the release of oxycodone from the excess PF614 ingested. This allows the inactive drug to pass through the body, thus averting an overdose. The recently completed initial stage of the trial sought to optimize PF614-MPAR (the PF614/nafamostat combination) for both release rate and ratio of the combination. Data from the trialdemonstrated that PF614-MPAR could deliver oxycodone similarly toPF614, which was the goal of the study. In line with expectations, the results of the study demonstrated that an overdose of PF614-MPAR would result in diminished oxycodone release and uptake as compared to an equivalent amount of PF614. In the final stage of the study, the selected PF614-MPAR formulation will be evaluated by measuring oxycodone release from increasing dose units delivered to a group of healthy subjects. Duyuru • Jan 05
Ensysce Biosciences, Inc. Announces Successful Completion of Clinical Portion of Oral Human Abuse Potential Trial Ensysce Biosciences, Inc. announced that it has successfully completed the clinical portion of study PF614-104, ‘A Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Oral Abuse Potential of PF614 Compared with Oxycodone Immediate-Release Tablets, and Placebo in Non-Dependent Recreational Opioid Users' (ClinicalTrials.gov: NCT05571345) being conducted by Dr. Vince Clinical Research. This is the second human abuse potential (HAP) study completed for PF614, a controlled-release oxycodone TAAPä prodrug, following completion of an intranasal HAP study in August 2022. HAP studies are critical for gaining abuse-deterrent labeling as outlined by the FDA. The trial was designed to evaluate abuse potential in non-dependent, recreational drug users, including measures of "drug liking" and whether study participants would "take drug again." Orally administered PF614 was compared to immediate-release oxycodone HCl. The global opioid epidemic is primarily driven by individuals abusing opioids through manipulation of currently marketed products. PF614 is designed to maintain its extended-release (ER) profile even after being subjected to common methods of manipulation, including chewing and crushing the product prior to oral administration. The PF614-104 study examined the ‘Drug Liking' as well as pharmacokinetic release of oxycodone from each test agent, including PF614 (50, 100 and 200 mg doses), oxycodone HCl (40 mg), and placebo, all administered orally in a blinded rotation among 32 recreational drug users. The primary outcome measure is the maximum effect (Emax) for ‘Drug Liking.' Data from the clinical trial is expected to be released in March 2023. Duyuru • Dec 21
Ensysce Biosciences Announces Data from PF614-MPAR-101-Part A Successfully Demonstrating Opioid Overdose Protection Ensysce Biosciences, Inc. announced data demonstrating the overdose protection of its drug product, PF614-MPAR from the clinical study being conducted in Healthy Subjects by Dr. Maria Bermudez MD, at Quotient Sciences, Miami, Florida. PF614-MPAR is designed to provide optimal pain relief at prescribed doses. Accidental or intentional overdose is limited by the overdose protection built into each capsule with the addition of Ensysce's formulated nafamostat ingredient. With MPAR technology, one or two PF614-MPAR capsules taken as prescribed will release the expected concentration of oxycodone required to provide pain relief as intended. However, when three or more capsules are taken, the increased exposure to nafamostat inhibits the trypsin-mediated release of oxycodone from the excess PF614 ingested, allowing the inactive parent drug to pass through the body unmodified. The recently completed Part A of the trial allowed the optimization of the nafamostat formulation by evaluating the PF614/nafamostat combination for both release rate and ratio of the combination. Data from the trial was able to show that in healthy subjects we could deliver oxycodone similarly with PF614 and PF614-MPAR, which was the goal of the study. Additionally, and as anticipated, the results of the study demonstrated that a large overdose of PF614-MPAR would result in diminished oxycodone release and uptake as compared to an equivalent amount of an unprotected opioid. In early 2023, the final formulation selected from this study will be evaluated as increasing dose units of PF614-MPAR in a group of healthy subjects in Part B of the study. MPARTM (Multi-Pill Abuse Resistance) is designed to prevent drug overdose by inhibiting the activation and release of opioid when more than prescribed doses are taken. PF614 is a TAAPTM (Trypsin Activated Abuse Protection) prodrug of oxycodone designed to reduce abuse of this opioid pain medication. TAAPTM chemical modification inactivates the active ingredient in Ensysce's products until they are swallowed and exposed to a digestive enzyme, trypsin. PF614 requires exposure to trypsin, which safely turns ‘on' the release of oxycodone. The PF614-MPAR has additional protection of an added trypsin inhibitor, nafamostat, to turn ‘off' the release of oxycodone in an overdose situation. The MPARTM combination technology of a TAAP prodrug and a trypsin inhibitor is the first platform that the Company expects may prevent all four common methods of opioid abuse - chewing, inhaling, injecting and oral overdose. Duyuru • Dec 17
Ensysce Biosciences Receives Non-Compliance Notice from Nasdaq On December 14, 2022, Ensysce Biosciences, Inc. (Company) received a notice of a determination (the “ Notice”) by the staff of the Nasdaq Listing Qualifications Department within The Nasdaq Stock Market LLC (“ Nasdaq”). The Notice references the Nasdaq letter sent to the Company, dated June 16, 2022 (the “ June 16th Notice”). The June 16th Notice stated that the Company’s Minimum Value of Listed Securities (“ MVLS”) for the preceding 30 consecutive business days was below the minimum of $35 million required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq listing rule 5550(b)(2) and that the Company had until December 13, 2022, to regain compliance. The Notice states that the Company has not regained compliance with the MVLS requirement within the period provided and that the securities of the Company would be subject to delisting unless the Company timely requests a hearing before a Nasdaq Hearings Panel (the “Panel”). Accordingly, the Company intends to timely request a hearing before the Panel. The hearing request will automatically stay any suspension or delisting action pending the hearing and the expiration of any additional extension period granted by the Panel following the hearing. In that regard, the Panel has the authority to grant an additional extension period not to exceed June 12, 2023. Notwithstanding the foregoing, there can be no assurance that the Company will be granted more time to attempt to comply with the MVLS requirement or be able to regain or maintain compliance with Nasdaq listing standards. Major Estimate Revision • Dec 10
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 losses forecast to reduce from -US$126 to -US$54.07 per share. Revenue forecast unchanged from US$2.35m at last update. Biotechs industry in the US expected to see average net income decline 93% next year. Consensus price target down from US$244 to US$57.00. Share price fell 44% to US$1.20 over the past week. Duyuru • Dec 09
Ensysce Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $4.06 million. Ensysce Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $4.06 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,900,000
Price\Range: $1.4
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 5,800,000 Duyuru • Dec 06
Ensysce Biosciences Inc. Announces Completion of Clinical Portion of Overdose Protection Trial PF614-MPAR-101-Part A Ensysce Biosciences, Inc. announced that it has successfully completed the clinical portion of study PF614-MPAR-101 Part A, entitled ‘Single-Dose Study to Evaluate the Pharmacokinetics of oxycodone and PF614, when PF614 Solution is Co-Administered with Nafamostat, as an Immediate-Release Solution and/or Extended-Release Capsule Formulations in Healthy Subjects', being conducted by Dr. Maria Bermudez MD, at Quotient Sciences, Miami Florida. MPARTM is designed to prevent drug overdose by inhibiting the activation and release of opioid when more than prescribed doses are taken. PF614 is a TAAPTM prodrug of oxycodone designed to reduce abuse of this opioid pain medication. TAAPTM chemical modification inactivates the active ingredient in Ensysce's products until they are swallowed and exposed to a digestive enzyme, trypsin. PF614 requires exposure to trypsin, which safely turns ‘on' the release of oxycodone. The PF614-MPAR has additional protection of an added trypsin inhibitor, nafamostat, to turn ‘off' the release of oxycodone in an overdose situation. The MPARTM combination technology of a TAAP prodrug and a trypsin inhibitor is the first platform that the Company expects may prevent all four common methods of opioid abuse - chewing, inhaling, injecting and oral overdose. Major Estimate Revision • Nov 21
Consensus revenue estimates fall by 33% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$3.15m to US$2.10m. Forecast losses increased from -US$12.40 to -US$12.95 per share. Biotechs industry in the US expected to see average net income decline 94% next year. Consensus price target down from US$160 to US$124. Share price rose 2.1% to US$2.42 over the past week. Reported Earnings • Nov 18
Third quarter 2022 earnings: EPS and revenues miss analyst expectations Third quarter 2022 results: US$5.13 loss per share (improved from US$14.15 loss in 3Q 2021). Revenue: US$279.4k (down 77% from 3Q 2021). Net loss: US$9.90m (loss narrowed 42% from 3Q 2021). Revenue missed analyst estimates by 72%. Earnings per share (EPS) also missed analyst estimates by 60%. Revenue is forecast to grow 129% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 13 percentage points per year, which is a significant difference in performance. Price Target Changed • Nov 17
Price target increased to US$240 Up from US$150, the current price target is an average from 2 analysts. New target price is 9,349% above last closing price of US$2.54. Stock is down 92% over the past year. The company is forecast to post a net loss per share of US$12.40 next year compared to a net loss per share of US$29.64 last year. Board Change • Nov 16
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Chief Medical Officer Bill Schmidt was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Duyuru • Nov 01
Ensysce Biosciences Announces Positive Topline Results of Clinical Study Evaluating Human Abuse Potential of Intranasal Administration of PF614, A TAAP Abuse-Deterrent Oxycodone Extended-Release Product Ensysce Biosciences Inc. announced positive topline results from a human abuse potential (HAP) study for PF614. PF614 is a new class of analgesia, a Trypsin Activated Abuse-Protected oxycodone product. Ensysce's TAAPTM technology is designed to be highly resistant to tampering and abuse as compared to traditional Abuse Deterrent Formulations (ADFs) of oxycodone. The product's abuse-deterrent characteristics are being evaluated in laboratory and clinical studies, consistent with the 2015 FDA Guidance for labeling. The HAP study was designed to test if known recreational drug users "liked" the product and is critical for new drugs in this class. The primary measure in this study, "drug liking," is recommended by the FDA in their Guidance on "Assessment of Abuse Potential of Drugs." This measure is known to correlate with a drug's potential for abuse. Intranasal administration of PF614 powder from capsule was compared with intranasal administration of crushed oxycodone immediate-release (IR) tablets in non-dependent, recreational opioid users (n=26). The primary endpoint for the study was "drug liking at this moment," measured up to 24 hours after dosing using a visual analogue scale (VAS). In the study, PF614 powder produced significantly lower peak "drug liking" (Emax) when compared with intranasal crushed IR oxycodone (p = 0.0133) using the full modified completer population in a 3-period crossover of PF614 vs. crushed oxycodone and placebo. Furthermore, in a first period analysis of initial impressions of each drug, a similarly strong difference was noted between PF614 (n=8) and crushed IR oxycodone (n=10) (p = 0.0175), even with this smaller cohort of subjects. Statistically significant differences in peak effects (Emax) between PF614 and crushed IR oxycodone intranasal were also demonstrated for the secondary endpoint of "take drug again," also using a first period analysis, where PF614 produced only 27% as high an Emax score as crushed oxycodone among recreational drug users (p < 0.0001). Prescription opioids are critical in the management of moderate-to-severe chronic pain. PF614 has a true 12-hour half-life designed chemically to maintain its analgesic effects over a prolonged dosing interval. In contrast, extended-release (ER) ADFs in this category contain high doses of active drug in an extended-release formulation and abusers frequently tamper with these formulations in an attempt to subvert the time-release mechanism and access the entire drug load at once. Many conventional ER formulations are susceptible to tampering techniques such as crushing, chewing, or dissolving the active drug in various solvents. Crushed ER formulations can be used intranasally to achieve high plasma concentrations and maximum euphoric effects. PF614 has been developed using novel trypsin-activated chemistry (not an ER formulation) that occurs only in the gastrointestinal tract. This is expected to provide clinicians and patients with a novel approach to abuse-deterrence that does not alter its release of active drug even if chewed, crushed or dissolved in water. Duyuru • Oct 29
Ensysce Biosciences, Inc. Announces First Subjects Dosed in Second Human Abuse Potential Study Ensysce Biosciences, Inc. announced the first subjects dosed in the PF614-104 study, ‘A Randomized, Double-blind, Placebo and Active-Controlled, Crossover Study to Evaluate the Oral Abuse Potential of PF614 Compared with Oxycodone Immediate-Release Tablets, and Placebo in Non-Dependent Recreational Opioid Users' (ClinicalTrials.gov Identifier: NCT05571345). The study is being conducted by Drs. Brad Vince and Steven Hull at Dr. Vince Clinical Research (DVCR) in Overland, KS. This study is designed to test and confirm that oral PF614 will have less potential for ‘Drug Liking' by recreational drug users versus immediate release oxycodone at equivalent drug dosages. The PF614-104 study will examine the desirability of three doses of PF614 versus a currently marketed dose of oxycodone HCl and versus placebo in recreational drug users. Eligible subjects will receive five treatments (one per treatment period) in a randomized, double-blind, crossover manner. The primary outcome measure will be ‘Drug Liking' and the key secondary endpoint will be ‘Take Drug Again'. Duyuru • Sep 23
Ensysce Biosciences Announces Initiation of Second Human Abuse Potential Study, Being Conducted by DVCR Ensysce Biosciences, Inc. announced the initiation of PF614-104, ‘A Randomized, Double-blind, Placebo and Active-Controlled, Crossover Study to Evaluate the Oral Abuse Potential of PF614 Compared with Oxycodone Immediate-Release Tablets, and Placebo in Non-Dependent Recreational Opioid Users.' The study is being conducted by Dr. Brad Vince, from Dr. Vince Clinical Research (DVCR), at one of the most innovative and technologically advanced clinical pharmacology units, newly constructed and recently opened in Overland Park, Kansas. This study is designed to test and confirm that PF614 will have less potential for drug liking versus immediate release oxycodone at equivalent drug dosages. The PF614-104 study will examine the desirability of three doses of PF614 versus a current marketed equivalent and placebo in recreational drug users. Eligible subjects will receive five treatments (one per treatment period) in a randomized, double-blind, crossover manner. The primary outcome measure will be ‘Drug Liking' and the key secondary endpoint will be ‘Take Drug Again'. Duyuru • Sep 17
Ensysce Biosciences, Inc. Announces Chief Medical Officer Changes Ensysce Biosciences, Inc. announced that it is in receipt of the tender of resignation from its Chief Medical Officer, Dr. Nily Osman, such resignation effective as of September 15, 2022. The Company has appointed Dr. William K. Schmidt, Ph.D. as the Company’s interim Chief Medical Officer, effective as of September 15, 2022. Dr. Schmidt, who also serves as the Company’s Senior Vice President of Clinical Development. Dr. Schmidt, age 72, served as Ensysce’s Chief Medical Officer between January 1, 2016 and April 18, 2022. Between April 18, 2022 and September 15, 2022 he served as the Company’s Senior Vice President of Clinical Development. He is also the Head of NorthStar Consulting, the Parliamentarian and a former president of the Eastern Pain Association, the largest regional affiliate of the American Pain Society. He has over 25 years of pharmaceutical industry experience with a special emphasis on the discovery and development of novel analgesic and narcotic antagonist drugs. He was previously Vice President of Clinical Development for CrystalGenomics (Seoul, South Korea) and its United States subsidiary, CG Pharmaceuticals (Emeryville, CA); Senior Vice President of Development at Limerick BioPharma; Vice President, Clinical Research, for Renovis, Inc.; and Vice President, Scientific Affairs and acting Vice President, Clinical Research and Development, at Adolor Corporation. At Adolor Corporation, Dr. Schmidt was a key member of the team leading to the clinical development, NDA filing, and FDA approval of Entereg® (alvimopan), a peripherally-acting opioid antagonist. Currently Dr. Schmidt serves as an expert on pain medicine pharmaceutical development with pharmaceutical and biotech companies throughout North America, Europe, Asia, Latin America, and Australia. Dr. Schmidt received a Bachelor of Arts degree from the University of California Berkeley and his Ph.D. University of California-San Francisco. Duyuru • Sep 01
Ensysce Biosciences and Quotient Sciences Announce A Partnership on the Development and Clinical Testing of Ensysce's PF614-MPAR, A Novel Opioid Designed to Prevent Abuse and Overdose Ensysce Biosciences, Inc. announced a partnership to support the development and clinical testing of PF614-MPAR. PF614-MPAR is a novel opioid combination product for the potential treatment of chronic pain that is designed to prevent both abuse and overdose. Quotient Sciences is currently using its integrated Translational Pharmaceutics® platform to identify a PF614-MPAR formulation that allows conversion into oxycodone within the prescribed dose range but reduces conversion to oxycodone at higher than prescribed dose levels in an overdose scenario. The formulation will be an optimized composition that balances dose and release rate, with the candidate formulations being tested in the clinic having been selected from emerging clinical data in order to achieve the desired exposure profile, allowing formulation optimization in man rather than preclinical species. Major Estimate Revision • Aug 19
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$3.65m to US$3.15m. EPS estimate reaffirmed at -US$0.62 per share. Biotechs industry in the US expected to see average net income decline 57% next year. Consensus price target up from US$7.50 to US$8.00. Share price fell 14% to US$0.42 over the past week.