• A Pfizer focused entirely on developing abuse-deterrent opioid pain medications.
• Like a Moderna or BioNTech dedicated to developing abuse-deterrent opioids.

• PF614: An abuse-deterrent opioid product candidate utilizing TAAP™ technology, designed to prevent abuse and potentially overdose when taken as prescribed.
• PF610: A next-generation opioid prodrug candidate also leveraging TAAP™ technology, aiming for improved safety and abuse deterrence.
• PF300: An overdose protection product candidate designed to inactivate opioids in the event of an overdose.

Ensysce Biosciences (symbol: ENSC) is a clinical-stage pharmaceutical company focused on developing abuse-deterrent and overdose-prevention opioid products. As of its latest financial disclosures, the company has not yet commercialized any products and therefore does not currently generate revenue from product sales. Consequently, it does not have "major customers" in the traditional sense of entities purchasing its drugs.

However, if Ensysce's drug candidates successfully complete clinical trials and receive regulatory approval (e.g., from the FDA), the company's products would be prescription medications. Pharmaceutical manufacturers of prescription drugs typically sell primarily to other companies within the healthcare supply chain, rather than directly to individuals.

Upon potential commercialization, Ensysce's major customers or commercial partners would likely fall into the following categories:

• Pharmaceutical Wholesalers and Distributors: These companies purchase drugs in bulk from manufacturers and then distribute them to pharmacies, hospitals, and clinics. Examples of major public companies in this space include AmerisourceBergen (ABC), Cardinal Health (CAH), and McKesson Corporation (MCK).
• Large Pharmaceutical Companies (Licensing/Commercialization Partners): It is common for clinical-stage biotechnology companies to license their approved drug candidates or entire drug pipelines to larger pharmaceutical companies for further development, manufacturing, and commercialization. Such a partnership would make the larger pharmaceutical company a key "customer" in terms of acquiring rights to the drug.
• Major Hospital Systems and Group Purchasing Organizations (GPOs): Large integrated healthcare networks or GPOs representing many hospitals could enter into direct purchasing agreements for specific approved medications.

Major Suppliers for Ensysce Biosciences (ENSC):

• Cambrex Corporation
• CordenPharma International
• Frontage Laboratories, Inc. (HKEX: 1521.HK)
• Pharmaron Beijing Co., Ltd. (SZSE: 300759.SZ, HKEX: 3759.HK)
• Sharp Packaging Services

Dr. D. Lynn Kirkpatrick, PhD. Chief Executive Officer

Dr. Kirkpatrick has dedicated her career to drug discovery and development. She co-founded two startup companies and successfully advanced three novel cancer drug candidates into human clinical trials. Following the acquisition of her first company, ProlX Pharmaceuticals, by Biomira Inc. (Oncothyreon) in 2006, Dr. Kirkpatrick served as the Chief Scientific Officer of the merged entity. She became President and CEO of Ensysce Biosciences Inc. in January 2009 and guided the company to go public in 2021.

Dave Humphrey. Chief Financial Officer

Mr. Humphrey has served as Chief Financial Officer of Ensysce Biosciences since February 2021. Prior to joining the company, he was the Chief Financial Officer of Senomyx, a publicly-held biotechnology company. He has also held finance and accounting leadership positions and provided consulting services to several life sciences companies, including Active Biosciences, Aurora Biosciences, and Gensia.

Geoff Birkett. Chief Commercial Officer

Mr. Birkett brings over 25 years of pharmaceutical experience, with a focus on CNS, Oncology, Pain, and Addiction. His background includes 18 years at AstraZeneca, where he was the Senior Vice President of Global Development and Marketing for CNS/Oncology products, launching five major market-leading brands such as Nicorette, Prozac, Seroquel, and Zomig. He has also served as CCO/President with multiple biotechnology companies in the pain/addiction sector.

Dr. William Schmidt, PhD. Chief Medical Officer

Dr. Schmidt has more than 25 years of experience in the pharmaceutical industry, specializing in the discovery and development of novel analgesic and narcotic antagonist drugs. He has been involved in 6 successful NDA drug approvals and has expertise in developing opioid-related products.

Linda Pestano, PhD. Chief Development Officer

Dr. Pestano possesses 20 years of experience in the development of vaccines, small molecule drugs, and novel biologics across a diverse range of indications, including pain, cancer, and inflammatory diseases. She has played a crucial role in guiding new therapies from development through to clinical trials.

The key risks to Ensysce Biosciences (ENSC) are primarily centered around its financial viability, the successful progression of its clinical pipeline, and the eventual commercialization of its product candidates.

1. Financial Health and Ability to Continue as a Going Concern

Ensysce Biosciences is a clinical-stage company that consistently operates at a loss, with its revenue predominantly derived from federal grants. The company has demonstrated negative cash flow and struggles to achieve profitability. As of September 30, 2025, its cash and cash equivalents were significantly low at $1.7 million. This reliance on external funding, which often involves dilutive stock issuances, highlights a precarious financial position. Macroaxis, a financial analysis platform, indicates an 88% probability of bankruptcy for Ensysce Biosciences, which is considerably higher than the biotechnology sector and healthcare industry averages.

2. Clinical Development Success and Regulatory Approval

As a clinical-stage pharmaceutical company, Ensysce Biosciences' future is contingent upon the successful completion of its preclinical studies and clinical trials, followed by regulatory approvals for its product candidates. There is no guarantee that its clinical programs will effectively demonstrate the safety and efficacy of its product candidates. The company faces inherent risks of encountering problems or delays in clinical development, and there is no assurance that any of its product candidates will ever receive the necessary regulatory approval or be successfully commercialized.

3. Commercialization and Market Acceptance

Even if Ensysce Biosciences' product candidates achieve regulatory approval, there is no guarantee regarding their commercial potential or market acceptance. The company operates within a competitive market, which could hinder the successful commercialization and adoption of its products. Therefore, the ability to translate regulatory success into meaningful market presence and revenue generation remains a significant risk.

Ensysce Biosciences (ENSC) focuses on developing safer prescription drugs using its proprietary Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms, primarily targeting severe pain relief and opioid use disorder.

• PF614 (TAAP opioid painkiller): This is Ensysce's lead product for severe and/or chronic pain, designed with abuse protection. The addressable market for products designed for chronic and severe pain in the U.S. alone is approximately $3.5 billion. The broader U.S. pain management market was valued at approximately $31.80 billion in 2024 and is projected to reach around $43.58 billion by 2033. The global pain management therapeutics market is estimated at $85.2153 billion in 2024 and is expected to reach $130.8279 billion by 2033.
• PF614-MPAR (TAAP opioid with MPAR overdose protection): This product combines abuse deterrence with overdose protection. The global market for abuse-deterrent formulations (ADFs) is estimated to grow from $25.7 million in 2024 to reach $54.8 million by 2030, representing a CAGR of 6.6%. Another estimate places the global ADF market at $6.0 billion in 2024, projected to reach $16.0 billion by 2034. North America is the largest regional market for ADFs. The global opioids market, which PF614-MPAR would be a part of, was estimated at $22.8 billion in 2022 and is projected to reach $25.3 billion by 2030.
• PF9001 (Opioid Use Disorder (OUD) therapy): This is an OUD drug candidate. The U.S. opioid use disorder market size is evaluated at $3.04 billion in 2024 and is projected to be worth around $8.74 billion by 2034. Globally, the OUD market was valued at $5.87 billion in 2024 and is projected to reach around $16.89 billion by 2034.

• Commercialization of PF614: Ensysce's lead product candidate, PF614, a tamper-resistant oxycodone utilizing the Trypsin Activated Abuse Protection (TAAP™) platform, is a significant driver. With Phase 3 clinical trials initiated in mid-2025 and a New Drug Application (NDA) submission planned for 2026, successful regulatory approval and subsequent market launch would establish the company's first commercial revenue stream.
• Commercialization of PF614-MPAR: This advanced formulation combines PF614 with the Multi-Pill Abuse Resistant (MPAR™) platform, designed to offer overdose protection. Having received FDA Breakthrough Therapy designation and ongoing clinical development supported by federal grants, the successful completion of trials and market introduction of PF614-MPAR are expected to be substantial revenue generators due to its enhanced safety profile addressing the critical need for safer pain relief options.
• Commercialization of PF9001: As the lead drug candidate for opioid use disorder (OUD), PF9001 has secured a U.S. patent and is progressing through preclinical development towards IND-enabling work. Its successful progression through clinical trials and eventual market entry would open a new and significant revenue channel in the opioid use disorder treatment market.
• Strategic Partnerships and Collaborations: Ensysce has already secured a strategic partnership for the development and commercialization of PF614 and PF614-MPAR. Future partnerships, including licensing agreements, milestone payments, and royalties, could provide significant non-product revenue and accelerate market penetration for its pipeline products.
• Expansion into the Chronic Pain Management Market: The company's innovative platforms, TAAP™ and MPAR™, aim to provide safer pain relief by mitigating opioid misuse, abuse, and overdose. Upon commercialization, these products are positioned to address the substantial unmet need in the chronic pain management market, offering a pathway to broader market adoption and revenue growth.

Share Issuance

• In March 2025, Ensysce Biosciences announced a registered direct offering that raised approximately $1.1 million through the issuance and sale of 315,188 shares of common stock at $3.49 per share, coupled with the agreement to issue warrants for an additional 630,376 shares in a concurrent private placement.
• In April 2025, the company secured $2.2 million in gross funding from the exercise of 630,376 warrants, originally issued in March 2025 at $3.24 per share, and in exchange, issued new unregistered warrants for up to 1,260,752 shares at a reduced exercise price of $1.90.
• In August 2024, Ensysce completed a registered direct offering of 3,553,194 shares of common stock, along with private placement warrants to purchase up to 7,106,388 shares, and the cash exercise of certain existing warrants for 7,203,504 shares at a reduced price, while also issuing new warrants to purchase up to 21,610,512 shares.

Inbound Investments

• In December 2024, Ensysce Biosciences entered into a strategic partnership with a specialty drug manufacturer, which included a $10 million commitment and an equity position for the manufacturer, to support the development and commercial launch of PF614 and PF614-MPAR drug products.
• In 2024, the company was awarded a $14 million grant from the National Institute of Health (NIH) for the continued clinical development of PF614-MPAR, with a $5.3 million installment received in the second quarter of 2025 to support its overdose protection program.
• In October 2023, Ensysce Biosciences obtained $1.7 million in financing through a private placement of senior secured convertible notes and warrants with investors.