Ensysce Biosciences Narrows Loss in Q2

Key Points

• GAAP EPS loss was narrower than expected at $(0.79) per share for Q2 2025, compared to the estimate of $(1.01).

• Federal grant income totaled $1.37 million in Q2 2025, with no commercial sales reported.

• Ensysce Biosciences advanced its PF614 opioid program into Phase 3 in Q3 2025 and achieved major milestones in its overdose-protection study.

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Ensysce Biosciences (NASDAQ:ENSC), a biotechnology company developing abuse-deterrent opioid therapies, reported its second-quarter results on August 13, 2025. The quarter’s biggest news included the launch of a pivotal Phase 3 clinical trial for its lead program, PF614, and full enrollment in a key study of its PF614-MPAR overdose-protection candidate. Financially, the quarter fell short of expectations. The company reported a GAAP loss per share of $(0.79), beating analysts’ estimates of $(1.01). Revenue, all from federal grants, was $1.37 million, more than double the year-ago period. Despite research progress, the net loss and continued absence of commercial revenue signal ongoing financial pressure for the company.

Source: Analyst estimates for the quarter provided by FactSet.

Ensysce Biosciences: Business Model and Strategic Focus

Ensysce Biosciences is a biotech company focused on developing safer opioid painkillers. Its main goal is to address the opioid misuse crisis through advanced drug formulations that deter abuse while retaining pain-relief effectiveness. The company’s lead candidates are built on two platforms: Trypsin-Activated Abuse Protection (TAAP), which only releases the opioid drug when swallowed and exposed to digestive enzymes, and the Multi-Pill Abuse Resistant (MPAR) system, designed to reduce overdose risks.

Recently, the company’s efforts have centered on progressing its lead candidate, PF614, a TAAP-formulated opioid aimed at providing both pain relief and resistance to various forms of abuse. Another core focus is the PF614-MPAR combination, which includes a mechanism to “switch off” opioid effects at high doses. Success depends on clinical progress, securing regulatory approvals such as Breakthrough Therapy status, and expanding intellectual property protection for its proprietary technologies.

Second Quarter Highlights: Research Milestones and Financial Performance

The company made notable progress on its product pipeline during the period. It started the pivotal Phase 3 clinical trial for PF614, targeting post-surgical pain and built on TAAP formulation technology, with initiation announced in July 2025. This clinical program aims to demonstrate pain control with abuse deterrence, particularly for at-risk patients. In parallel, the PF614-MPAR overdose-protection therapy reached a new milestone with full enrollment in its Part 2 study during Q2 2025, which investigates how food affects the drug’s performance. Federal grants—especially a second $5.3 million installment from the National Institute on Drug Abuse (NIDA) during Q2 2025—played a key role in funding these developments.

Financial metrics reflect these R&D efforts. Revenue (GAAP) was $1.37 million, supported exclusively by federal grants rather than commercial sales. There was a sharp rise in research and development spending: up to $1.92 million from $0.95 million a year earlier (GAAP). This leap underscores intensified clinical trial activities. General and administrative costs, which cover daily operations and personnel, were flat compared to the prior year at $1.20 million.

The company’s reported net loss attributable to common stockholders (GAAP) narrowed to $1.73 million, a slight improvement from the $1.97 million loss in Q2 2024. The loss per share of $(0.79) (GAAP) was narrower than what analysts expected, pointing to ongoing cash use and the absence of any commercial revenue. Cash and equivalents stood at $2.21 million as of June 30, 2025, down from $3.50 million as of December 31, 2024.

Operationally, the company advanced its broader opioid use disorder (OUD) pipeline, naming PF9001 as its chief OUD candidate and attaining a new patent allowance related to the composition and use of this drug. These moves strengthen the company's intellectual property position. No product revenue was reported or expected, as Ensysce remains pre-commercial and focused entirely on R&D. There were no one-time gains, losses, or dividends declared or changed during this quarter.

Products and Pipeline Milestones

The company’s pipeline is led by PF614, a TAAP opioid painkiller now in pivotal Phase 3 testing for acute pain. MPAR is the Multi-Pill Abuse Resistant adjunct designed to prevent overdose by shutting off opioid release in high-risk situations. PF9001 is an opioid use disorder therapy still in preclinical development, supported by recent grant awards.

Each platform targets a specific need in opioid safety: TAAP reduces the potential for tampering or non-oral abuse by requiring digestive enzyme activation, while MPAR counters overdose by limiting bioavailability of the opioid at excessive intake levels. The company’s progress in securing patent rights for PF9001 demonstrates ongoing effort in safeguarding its technology as it moves future programs toward investigational new drug (IND) applications.

Looking Ahead: Outlook and Key Watch Areas

The company did not provide explicit financial guidance for the next quarter or full fiscal 2025. Management highlighted clinical progress and continued commitment to advancing PF614 and PF614-MPAR programs. With the current cash balance and increasing R&D investment, the need for future financing or partnerships is likely to remain a key focus.

Ensysce Biosciences does not currently pay a dividend. Investors should monitor upcoming clinical data, new regulatory developments, and any updates on funding or strategic partnerships as the company approaches critical phases in its product development and approval process.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.

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