Ensysce Biosciences Reports Third Quarter 2026 Financial Results and Business Highlights

Rhea-AI Summary

Ensysce Biosciences (NASDAQ:ENSC) reported a third-quarter 2026 net loss attributable to common stockholders of $82.3 million following its Cy Biopharma acquisition. The year-earlier loss was $3.7 million. Results included a $79.9 million non-cash charge for acquired research programs. Cash ended September at $29.7 million, versus $4.3 million at December 31, 2025; third-quarter federal grants rose to $2.2 million from $0.5 million.

The August acquisition added CY200 for complex regional pain syndrome. Ensysce submitted its Phase 2a protocol in September; UK regulators and the ethics committee requested additional information on November 6, and a response is being prepared. Enrollment awaits clearance. Ensysce completed enrollment in the final stage of PF614-MPAR-102, its overdose-protection study, while PF614 development continues in a pivotal Phase 3 trial. Recent financing proceeds are intended primarily for CY200 development.

14 points · 3 major

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Rhea-AI Sentiment measures something else, the tone of the wording.

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1 major · 13 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointCash of $29,670,793 at September 30, 2026, increased from $4,310,354 at December 31, 2025.
• Major pointCy Biopharma acquisition completed in August, adding clinical-stage CY200 and $11.4 million in net cash.
• Major pointSeries C private placement provided $19.6 million in net proceeds during the first nine months of 2026. 2.8× market cap
• Moderate pointThird-quarter federal grants of $2,181,632 increased from $493,104 in 2025.
• Moderate pointNIDA funding of $2.7 million remained available at September 30 for study completion and long-term non-clinical studies. 39% of market cap
• Moderate pointStockholders' equity increased to $27,111,778 from $2,884,750 at December 31, 2025.

8 minor points

• Minor pointNine-month federal grants of $4,306,945 increased from $3,184,314 in 2025.
• Minor pointPF614-MPAR-102 final-stage enrollment completed in August 2026.
• Minor pointCY200 Phase 2a protocol submitted in September for UK regulatory and ethics review.
• Minor point. Forward-looking: it has not happened yet and may not happen.CY200 development funding is the intended primary use of recent private placements, including preparation for registrational development.
• Minor pointPF614 development continues in the pivotal PF614-301 Phase 3 trial for pain following abdominoplasty.
• Minor pointThird-quarter other income of $382,578 increased from $11,967 in 2025.
• Minor pointNine-month other income of $393,907 increased from $50,903 in 2025.
• Minor pointNotes payable and accrued interest declined to $154,874 from $306,708 at December 31, 2025.

Negative

• Major pointThird-quarter common-stockholder net loss widened to $82,318,122 from $3,729,128 in 2025.
• Moderate pointCY200 UK trial clearance remains pending following November 6 requests for additional information from regulators and the ethics committee.
• Moderate pointNine-month research and development expense increased to $8,994,480 from $6,763,866 in 2025.
• Minor pointThird-quarter loss per share widened to $4.52 from $1.29 in 2025, basic and diluted.
• Minor pointNine-month common-stockholder net loss widened to $88,445,246 from $7,408,052 in 2025.

8 minor points

• Minor pointNine-month loss per share widened to $6.95 from $3.42 in 2025, basic and diluted.
• Minor pointAcquired research programs generated a one-time non-cash charge of $79,907,223, primarily related to CY200.
• Minor pointThird-quarter research and development expense increased to $3,175,848 from $2,954,909 in 2025.
• Minor pointThird-quarter general and administrative expense increased to $1,594,722 from $1,279,290 in 2025.
• Minor pointNine-month general and administrative expense increased to $4,040,022 from $3,879,569 in 2025.
• Minor pointNine-month operating cash use increased to $6,859,977 from $6,280,459 in 2025.
• Minor pointSeries B Preferred Stock retirement resulted in a $0.2 million deemed dividend in the third quarter.
• Minor point. Forward-looking: it has not happened yet and may not happen.Continued losses are expected for the foreseeable future as Ensysce pursues product approvals.

Key Figures

Cash and cash equivalents: $29.7 million Net loss attributable to common stockholders: $82.3 million Acquired in-process R&D charge: Approximately $79.9 million +3 more

Cash and cash equivalents

$29.7 million

As of September 30, 2026; compared with $4.3 million at December 31, 2025

Net loss attributable to common stockholders

$82.3 million

Q3 2026; compared with $3.7 million in Q3 2025

Acquired in-process R&D charge

Approximately $79.9 million

One-time, non-cash charge from the Cy Biopharma acquisition, primarily related to CY200

Series C private placement net proceeds

$19.6 million

Net proceeds included in financing activities during the first nine months of 2026

Cash used in operating activities

$6.9 million

First nine months of 2026

NIDA award funds remaining

$2.7 million

As of September 30, 2026, under the $15.1 million multi-year award supporting PF614-MPAR-102 and related studies

Previous Earnings Reports

2 past events · Latest: Aug 13

Same Type 2 events

1. Aug 13

   Q2 earnings

   24h Move

   +14.8%

   Acquisition and financings added CY200 and reported up to $77.2 million funding capacity.

2. Nov 14

   Q3 earnings

   24h Move

   -4.8%

   Reported Q3 net loss of $3.7 million and cash of $1.7 million alongside PF614 milestones.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

orphan drug designation, breakthrough therapy designation, double-blind, placebo-controlled, +1 more

5 terms

orphan drug designation regulatory

"active ingredient has received FDA Orphan Drug Designation"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

breakthrough therapy designation regulatory

"has received FDA Breakthrough Therapy designation"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

double-blind medical

"multicenter, randomized, double-blind, placebo-controlled"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

placebo-controlled medical

"randomized, double-blind, placebo-controlled, parallel-group"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

new drug application regulatory

"required for an eventual New Drug Application"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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SAN DIEGO, CA / ACCESS Newswire / November 12, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage biotechnology company developing innovative neuroplastogenic therapies beyond mood disorders, with an initial focus on Complex Regional Pain Syndrome ("CRPS"), today reported financial and operational results for the third quarter ended September 30, 2026.

The third quarter of 2026 was a transformational period for Ensysce. In August, the Company completed the acquisition of Cy Biopharma, Inc. ("Cy Biopharma"), adding CY200, a clinical-stage neuroplastogenic candidate for CRPS whose active ingredient has received FDA Orphan Drug Designation, as its lead pipeline asset, and in September submitted the protocol for a Phase 2a study of CY200 to the UK Medicines and Healthcare products Regulatory Agency (MHRA). Ensysce also completed enrollment in the final stage of the PF614-MPAR-102 study of its Breakthrough Therapy-designated, overdose-protected opioid. The Company ended the quarter with $29.7 million in cash and cash equivalents.

"Ensysce is a fundamentally different company today than it was at the start of the year," said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. "With CY200, we now lead with a potentially first-in-class approach to CRPS, a devastating condition for which there is currently no FDA-approved therapy. At the same time, completing enrollment in PF614-MPAR-102 brings us closer to the clinical evidence needed to advance what we believe is the first opioid engineered with built-in overdose protection. With a strengthened balance sheet and two differentiated pain programs, our focus now is on initiating the CY200 Phase 2a study and delivering on the milestones ahead."

CY200 and Complex Regional Pain Syndrome (CRPS) Program Update

CY200 is a psilocybin-predominant botanical extract being developed for CRPS. Its development follows an observational pilot study of psilocybin in patients with CRPS and other chronic pain conditions that was funded by Cy Biopharma. CRPS is among the most severe chronic pain disorders, with significant physical, psychological and socioeconomic burden, and no FDA-approved therapy. CY200 is designed to address the underlying neurobiology of the condition rather than simply manage symptoms.

In September 2026, the Company submitted a Phase 2a protocol (CYBIO 001) in the UK for combined MHRA and research ethics committee reviews. CYBIO 001 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, proof-of-concept study that will evaluate the efficacy, safety and tolerability of CY200 compared to placebo in adult participants with CRPS Type 1 and will be conducted in the UK.

On November 6, 2026, the MHRA and the research ethics committee reviewing the CY200 Phase 2a clinical trial protocol requested additional information to support the Company's clinical trial application. The Company is preparing its response for the MHRA's consideration.

"Our priority since the acquisition has been to advance CY200 efficiently, and submitting the CYBIO 001 protocol to the MHRA in September was a significant first step," said James Morrison, President of Ensysce. "Patients with CRPS have very few treatment options. Our focus now is on preparing our sites and clinical team so we are ready to commence enrollment as soon as practicable once we receive regulatory clearance in the UK."

The Company intends to apply proceeds from recent private placement financings primarily to advance CY200 through this study and to prepare for registrational development. Also in September 2026, the Company hosted a clinical symposium on severe pain and CRPS at PainWeek 2026. Additionally, Professor Richard Langford, Chief Medical Officer of Cy Biopharma, was selected to present comments at the FDA's public hearing, "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs."

TAAP™ and MPAR^® (Opioid Abuse Deterrent and Overdose Protection Programs) Update

Trypsin-Activated Abuse Protection (TAAP™) PF614 is designed to be a next-generation extended-release oxycodone with built-in abuse protection. PF614 remains inactive until it is swallowed and exposed to trypsin in the small intestine, where it "switches on" to release oxycodone in a controlled manner, designed to reduce the potential for abuse through non-oral routes such as injection and snorting. Development of PF614 continues in the pivotal PF614-301 Phase 3 trial, a multicenter, randomized, double-blind, placebo-controlled study evaluating PF614 for the treatment of moderate to severe pain following abdominoplasty.

PF614-MPAR, which combines the active analgesic, TAAP™ PF614, with the Company's MPAR^® (Multi-Pill Abuse Resistance) technology and has received FDA Breakthrough Therapy designation, is designed to deliver effective opioid analgesia with built-in protection against oral overdose. In August 2026, Ensysce completed enrollment in Part 3, the final stage of the PF614-MPAR-102 study. Part 3 was designed to further characterize PF614-MPAR's protective profile across a full range of dosing scenarios and to evaluate the effect of food on the delivery of analgesia and overdose protection. The study is funded through the Company's $15.1 million multi-year NIDA award, under which $2.7 million remained available as of September 30, 2026, to support completion of the study and the long-term non-clinical studies required for an eventual New Drug Application.

Q3 2026 Financial Results

Cash - Cash and cash equivalents were $29.7 million as of September 30, 2026, compared to $4.3 million as of December 31, 2025. The increase reflects $21.1 million of net cash provided by financing activities, primarily $19.6 million of net proceeds from the Series C private placement. Also contributing to the increase was $11.4 million of net cash acquired from Cy Biopharma, partially offset by operating activities which used $6.9 million of cash during the first nine months of 2026.

Federal Grants - Funding under federal grants totaled $2.2 million for the third quarter of 2026 compared to $0.5 million in the comparable year-ago quarter. This $1.7 million increase is primarily due to the timing of research activities eligible for funding under the MPAR grant, including the PF614-MPAR-102 study.

Research & Development Expenses - R&D expenses were $3.2 million for the third quarter of 2026 compared to $3.0 million for the same period in 2025, representing an increase of $0.2 million. The increase was driven by incremental expenses from the Cy Biopharma acquisition.

General & Administrative Expenses - G&A expenses were $1.6 million in the third quarter of 2026 and $1.3 million for the third quarter of 2025, representing an increase of $0.3 million, primarily due to incremental expenses from the Cy Biopharma acquisition.

Acquired In-Process Research and Development - The acquisition of Cy Biopharma in August 2026 resulted in a one-time non-cash charge of approximately $79.9 million for acquired in-process research and development ("IPR&D") related to the value of research programs under development, primarily CY200.

Other Income (Expense) - Total other income (expense) was income of $0.4 million for the third quarter of 2026 compared to income of less than $0.1 million in the same period of 2025. Total other income (expense) for the quarter ended September 30, 2026, consisted primarily of foreign exchange gains at the Company's foreign subsidiaries acquired in the Cy Biopharma acquisition.

Net Income (Loss) - Net loss attributable to common stockholders for the third quarter of 2026 was $82.3 million compared to a net loss of $3.7 million for the third quarter of 2025. Net loss attributable to common stockholders for the third quarter of 2026 includes the non-cash acquired IPR&D charge of approximately $79.9 million and a $0.2 million deemed dividend related to the retirement of the Series B Preferred Stock. As a clinical-stage biotech company, Ensysce expects its continued research and development efforts toward regulatory approval of its product candidates to result in losses for the foreseeable future.

About Ensysce Biosciences

Ensysce Biosciences is a clinical-stage biotechnology company developing novel neuroplastogenic therapies using psychedelics that go beyond mood disorders and address the root cause of chronic pain through central nervous system modulation. The Company is also developing a new class of highly novel opioids for the treatment of severe pain while minimizing the risk of both drug abuse and overdose. For more information, please visit www.ensysce.com.

Definitions

CRPS: complex regional pain syndrome - a severe chronic pain disorder for which there is currently no approved therapy.

TAAP™: trypsin activated abuse protection - designed to protect against prescription drug abuse.

MPAR^®: multi-pill abuse resistance - designed to protect against abuse and accidental overdose.

Forward-Looking Statements

Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. All forward-looking statements are based upon management's estimates and forecasts and reflect the current views, assumptions, expectations and opinions of the Company as of the date hereof. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expected, including (i) possible Nasdaq delisting; (ii) failure to obtain stockholder approval for the conversion of the Series C non-voting convertible preferred stock into shares of common stock of the combined company; (iii) risks related to the combined company's ability to manage its operating expenses and its expenses associated with the acquisition; (iv) unexpected costs, charges or expenses resulting from the acquisition; (v) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the acquisition; (vi) the uncertainties associated with the combined company's product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement and completion of clinical trials, studies and evaluations (including in connection with the MHRA's request for additional information on the CY200 Phase 2a clinical trial application); (vii) risks related to the inability of the combined company to obtain sufficient additional capital, including the continuation of government funding, to continue to advance these or other product candidates; (viii) failure to achieve the clinical trial milestone for the milestone closing of the Series C private placement; (ix) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (x) risks related to the failure to realize any value from product candidates currently being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; and (xi) risks associated with the possible failure to realize certain anticipated benefits of the acquisition, including with respect to future financial and operating results. These statements are also subject to risks and uncertainties described in Ensysce's most recent annual report on Form 10-K and quarterly report on Form 10-Q and in other filings that it makes with the U.S. Securities and Exchange Commission (the "SEC"), available at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, except as required under applicable law.

Ensysce Biosciences Company Contact:

Lynn Kirkpatrick, Ph.D.
Chief Executive Officer
(858) 263-4196

Ensysce Biosciences Investor Relations Contact:

Shannon Devine
MZ North America
Main: 203-741-8811
ENSC@mzgroup.us

Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)

		Three Months Ended September 30,								Nine Months Ended September 30,
		2026				2025				2026				2025
Federal grants		$	2,181,632			$	493,104			$	4,306,945			$	3,184,314
Operating expenses:
Research and development			3,175,848				2,954,909				8,994,480				6,763,866
General and administrative			1,594,722				1,279,290				4,040,022				3,879,569
Acquired in-process research and development			79,907,223				-				79,907,223				-
Total operating expenses			84,677,793				4,234,199				92,941,725				10,643,435
Loss from operations			(82,496,161	)			(3,741,095	)			(88,634,780	)			(7,459,121	)
Total other income (expense), net			382,578				11,967				393,907				50,903
Net loss		$	(82,113,583	)		$	(3,729,128	)		$	(88,240,873	)		$	(7,408,218	)
Adjustments to net loss			(204,539	)			-				(204,373	)			166
Net loss attributable to common stockholders		$	(82,318,122	)		$	(3,729,128	)		$	(88,445,246	)		$	(7,408,052	)
Net loss per share attributable to common stockholders, basic and diluted		$	(4.52	)		$	(1.29	)		$	(6.95	)		$	(3.42	)

Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)

		Nine Months Ended September 30,
		2026				2025
Net cash used in operating activities		$	(6,859,977	)		$	(6,280,459	)
Net cash provided by (used in) investing activities			11,392,335				(123,643	)
Net cash provided by financing activities			21,065,072				4,575,243
Effect of exchange rate changes on cash and cash equivalents			(236,991	)			-
Change in cash and cash equivalents			25,360,439				(1,828,859	)
Cash and cash equivalents at beginning of period			4,310,354				3,502,077
Cash and cash equivalents at end of period		$	29,670,793			$	1,673,218

Ensysce Biosciences, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)

		September 30,				December 31,
		2026				2025
Assets
Current assets:
Cash and cash equivalents		$	29,670,793			$	4,310,354
Prepaid expenses and other current assets			1,126,309				2,934,664
Total current assets			30,797,102				7,245,018
Other assets			156,279				207,461
Total assets		$	30,953,381			$	7,452,479
Liabilities and stockholders' equity
Current liabilities:
Accounts payable		$	2,033,669			$	3,267,610
Accrued expenses and other liabilities			1,653,060				993,411
Notes payable and accrued interest			154,874				306,708
Total current liabilities			3,841,603				4,567,729
Long-term liabilities			-				-
Total liabilities			3,841,603				4,567,729
Stockholders' equity			27,111,778				2,884,750
Total liabilities and stockholders' equity		$	30,953,381			$	7,452,479

SOURCE: Ensysce Biosciences

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Ensysce Biosciences' third-quarter 2026 financial results?

Ensysce reported a $82,318,122 net loss attributable to common stockholders, compared with $3,729,128 a year earlier. Basic and diluted loss per share was $4.52 versus $1.29. Results included a one-time non-cash acquired research charge of $79,907,223.

What is the status of Ensysce's CY200 Phase 2a trial?

UK regulatory clearance remains pending after the MHRA and research ethics committee requested additional information on November 6, 2026. Ensysce is preparing its response and intends to begin enrollment as soon as practicable after clearance.

What will Ensysce's CY200 Phase 2a study evaluate?

CYBIO 001 will evaluate efficacy, safety and tolerability of CY200 versus placebo in adults with complex regional pain syndrome Type 1. The UK study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group proof-of-concept trial.

What does the final stage of Ensysce's PF614-MPAR-102 study examine?

Part 3 examines PF614-MPAR's protective profile across a full range of dosing scenarios and the effect of food on delivery of pain relief and overdose protection. The study is funded through Ensysce's $15.1 million multi-year NIDA award.