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Ensysce Biosciences Reports Second Quarter 2026 Financial Results and Recent Business Highlights

(Positive)
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Ensysce Biosciences (NASDAQ: ENSC) reported second quarter 2026 results and completed the stock‑for‑stock acquisition of Cy Biopharma on August 6, 2026, adding lead asset CY200, an FDA Orphan Drug‑designated candidate for Complex Regional Pain Syndrome (CRPS) Type 1.

The transaction, together with concurrent private placement financings, provides up to $77.2 million in funding: $17.1 million cash from Cy Biopharma’s pre‑acquisition notes and approximately $21.5 million in gross proceeds from Series C preferred stock, plus a second tranche of up to $38.6 million tied to clinical milestones. According to Ensysce, this extends cash runway into late 2027, with potential to reach 2028 if the second tranche is triggered.

Q2 2026 federal grant revenue was $1.16 million, R&D expenses $2.47 million, G&A $1.27 million, and net loss attributable to common stockholders $2.57 million (vs. $1.73 million in Q2 2025). Cash at June 30, 2026 was $0.68 million, increasing by about $31 million after quarter‑end from the Cy Biopharma deal and related financings. Ensysce also advanced PF614 and PF614‑MPAR programs, secured the third year of a $15.1 million NIDA grant, retained $5.3 million in remaining grant funds, and gained new MPAR patent protection in Taiwan through 2042.

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Positive

  • Cy Biopharma acquisition adds Orphan Drug CY200 and up to $77.2 million funding
  • Post‑closing cash increased by about $31 million net of transaction expenses
  • Second financing tranche of up to $38.6 million contingent on clinical milestones
  • NIDA grant third‑year funding under $15.1 million award, with $5.3 million remaining
  • MPAR patent protection extended in Taiwan through 2042
  • Federal grant funding of $1.16 million in Q2 2026 supports R&D programs

Negative

  • Q2 2026 net loss attributable to stockholders of $2.57 million, up from $1.73 million
  • Six‑month 2026 operating cash use of $5.46 million, higher than prior year
  • Cash at June 30, 2026 only $0.68 million before post‑quarter financings
  • Federal grant revenue declined by $0.21 million year over year in Q2 2026
  • Stockholders’ equity at June 30, 2026 was negative $1.11 million

News Explained

The acquisition is complete, but its $21.5 million tranche is a definitive agreement to sell Series C non-voting convertible preferred stock; conversion could change common ownership, yet the release gives no conversion price, share count, or ownership percentage to size that effect.

Market Reaction – ENSC

+3.33% $0.36 7.3x vol
15m delay
+3.33% Vs previous close
+9.9% Peak in 1 min
$0.36 Last Price
$0.33 $0.41 Day Range
$5.53M Market Cap
7.3x Rel. Volume

Following this news, ENSC has gained 3.33%, reflecting a moderate positive market reaction. Argus tracked a peak move of +9.9% during the session. Our momentum scanner has triggered 40 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $0.36. Trading volume is exceptionally heavy at 7.3x the average, suggesting very strong buying interest.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Market Context

The earnings-specific history recorded an average move of 4.1% across five events. That record frame...
Analysis

The earnings-specific history recorded an average move of 4.1% across five events. That record frames the acquisition, financing, and pipeline update alongside reported losses; the active S-3 resale registration and moderate short positioning were additional risks to monitor.

Key Figures

Private placement financing: $38.6 million Second financing tranche: up to $38.6 million Cash runway: late 2027 +5 more
8 metrics
Private placement financing $38.6 million Completed with Cy Biopharma acquisition
Second financing tranche up to $38.6 million Triggered by certain clinical milestones
Cash runway late 2027 Current runway following acquisition and financing
Cy Biopharma cash contribution $17.1 million Cash from pre-acquisition convertible note financing
Series C proceeds $21.5 million Gross proceeds before transaction expenses
NIDA grant $15.1 million Third year of funding completed
Cash and cash equivalents $0.7 million As of June 30, 2026
Net loss attributable to common stockholders $2.6 million Second quarter of 2026

Previous Earnings Reports

5 past events · Latest: May 15 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
May 15 Q1 earnings report Positive +13.2% Q1 results, clinical progress, and financing followed a reported net loss.
Mar 30 Full-year earnings Positive +4.8% Full-year results included Phase 3 initiation, patent progress, and reported annual losses.
Nov 14 Q3 earnings report Positive -4.8% Phase 3 initiation and Breakthrough Therapy support accompanied financing and reported losses.
Aug 13 Q2 earnings report Positive -4.2% Operational opioid-program progress and grant funding accompanied a reported quarterly loss.
May 13 Q1 earnings report Positive +11.6% Patent issuance and study progress accompanied improved loss and increased R&D expenses.

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

Pattern Detected

Tag-specific earnings reactions were positive in three of five comparable events, while two positive operational updates diverged with declines.

Key Terms

crps, orphan drug designation, convertible preferred stock, phase 2 trial, +1 more
5 terms
crps medical
"Complex Regional Pain Syndrome (CRPS), to be our lead pipeline asset."
Complex Regional Pain Syndrome (CRPS) is a long-lasting pain disorder in which the body’s pain signaling becomes exaggerated after an injury or without clear cause, like a home alarm that keeps blaring even after the danger is gone. It matters to investors because treatments, diagnostics, and devices for CRPS are a focus of clinical trials and regulatory review, creating potential market opportunities, revenue streams, and regulatory or liability risks for healthcare companies.
orphan drug designation regulatory
"has received U.S. 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.
convertible preferred stock financial
"sale of Series C non-voting convertible preferred stock"
Convertible preferred stock is a special class of company shares that pays priority, usually fixed, payments to holders and can be exchanged later for a set number of common shares. It matters to investors because it combines steady income and added protection with the chance to share in a company’s upside; think of it as a hybrid between a bond that pays regularly and an option to convert into growth-oriented stock, where the conversion rules influence both potential gains and how much common shareholders’ ownership may be reduced.
phase 2 trial medical
"through a randomized Phase 2 trial evaluating efficacy, safety and tolerability"
A phase 2 trial is an intermediate-stage clinical study that tests whether a new treatment works and is reasonably safe in a group of patients who have the condition it targets. Think of it as a field test of a prototype product: it checks real-world effectiveness and side effects on a modest number of users to decide whether the treatment should move to larger, definitive testing. Investors watch phase 2 results because positive outcomes can sharply increase the likelihood of regulatory approval and future sales, while failures often halt development.
breakthrough therapy designation regulatory
"has received FDA's 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.

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

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Acquisition of Cy Biopharma Completed, Adding CY200 for Complex Regional Pain Syndrome
Up to $77 million in new funding with the acquisition of Cy Biopharma
Company to host a Corporate Update Call on Tuesday, August 18, 2026, at 11:00 a.m. ET

SAN DIEGO, CA / ACCESS Newswire / August 13, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage biotechnology company developing novel neuroplastogenic therapies beyond mood disorders, with an initial focus on complex pain, today reported financial and operational results for the second quarter ended June 30, 2026.

On August 6, 2026, we completed the acquisition of Cy Biopharma, Inc. ("Cy Biopharma") with private placement financings of $38.6 million, adding CY200, an Orphan Drug-designated candidate for Complex Regional Pain Syndrome (CRPS), to be our lead pipeline asset. We now have cash runway into late 2027, and a second financing tranche of up to $38.6 million, triggered upon achievement of certain clinical milestones, would carry the company into 2028.

The acquisition was a stock-for-stock merger that brought in $17.1 million in cash from Cy Biopharma's pre-acquisition convertible note financing. Concurrent with the acquisition, Ensysce entered into a definitive agreement for the sale of Series C non-voting convertible preferred stock in a private placement financing with gross proceeds to the Company of approximately $21.5 million before deducting transaction expenses. The private placement financing was led by Ally Bridge Group and included participation from Perceptive Advisors, Dellora Investments, Ikarian Capital and Adage Capital Partners, L.P.

Complex Regional Pain Syndrome (CRPS) Program Update

With the acquisition of Cy Biopharma, the Company added CY200, a clinical-stage neuroplastogenic candidate for the treatment of CRPS Type 1, which has received U.S. FDA Orphan Drug Designation. CRPS is among the most severe chronic pain disorders, with few effective treatment options and significant physical, psychological, and socioeconomic burden, and there is currently no approved therapy for the condition. Rather than managing symptoms alone, CY200 is designed to address the underlying neurobiology of CRPS. The Company intends to apply proceeds from the private placement financings primarily to advance CY200 through a randomized Phase 2 trial evaluating efficacy, safety and tolerability for symptom alleviation in participants with CRPS Type 1, and to prepare for registrational development.

"Cy Biopharma's neuroplastogenic approach to complex pain was the most compelling strategic opportunity we explored, and we believe this acquisition represents a significant value creation opportunity for Ensysce stockholders. The concurrent private placement financing was intentionally sized to support our immediate strategic objectives while maintaining financial discipline and allow us to progress our lead candidate in a pain market valued over $1 billion for which there is currently no approved therapy," said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. "During the second quarter of 2026 we also advanced the clinical development of PF614-MPAR, the first opioid engineered with built-in overdose protection. To support this clinical development, we were awarded the third year of funding under a $15.1 million grant from the National Institute on Drug Abuse (NIDA), completing the award, a powerful vote of confidence from a leading federal agency that has backed this program with two major awards totaling over $26 million over six years."

TAAPTM and MPAR® (Opioid Abuse Deterrent and Overdose Protection Programs) Update

Trypsin‑Activated Abuse Protection (TAAP™) PF614 represents what we believe could 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, providing what we believe is improved safety. Development of PF614 continues with the pivotal PF614-301 Phase 3 clinical trial, a multicenter, randomized, double-blind, placebo-controlled study evaluating PF614 for the treatment of moderate to severe pain following abdominoplasty.

PF614-MPAR is a combination product that integrates both the TAAP and MPAR® (Multi-Pill Abuse Resistance) technologies to deliver effective opioid analgesia with the added benefit of built-in oral overdose protection, and has received FDA's Breakthrough Therapy designation. Ensysce has continued to enroll subjects in the PF614-MPAR-102 study, supported by the NIDA grant, reflecting ongoing external validation of the program's potential impact. As of June 30, 2026, $5.3 million of funding remained available through May 2027 under the grant.

Ensysce also strengthened its intellectual property position for MPAR® during the quarter. In May 2026, the Taiwan Intellectual Property Office issued a patent titled "Compositions Comprising Enzyme-Cleavable Prodrugs and Controlled Release Nafamostat and Methods of Use Thereof," extending MPAR® patent protection through 2042 in that jurisdiction and expanding on U.S. Patent No. 12,599,578, which issued April 14, 2026.

Q2 2026 Financial Results

Cash - Cash and cash equivalents were $0.7 million as of June 30, 2026, compared to $4.3 million as of December 31, 2025. The decrease reflects $5.5 million of cash used in operating activities during the first six months of 2026, partially offset by $1.8 million of net proceeds from a preferred stock financing. Following quarter-end, the acquisition of Cy Biopharma and related financings provided cash of approximately $31 million, net of transaction expenses.

Federal Grants - Funding under federal grants totaled $1.2 million for the second quarter of 2026 compared to $1.4 million in the comparable year ago quarter. This $0.2 million decrease is primarily due to the timing of research activities eligible for funding under the MPAR grant.

Research & Development Expenses - R&D expenses were $2.5 million for the second quarter of 2026 compared to $1.9 million for the same period in 2025, representing an increase of $0.5 million. The increase was primarily the result of external research and development costs related to increased clinical activity for PF614.

General & Administrative Expenses - G&A expenses were $1.3 million in the second quarter of 2026 and $1.2 million for the second quarter of 2025, representing an increase of $0.1 million.

Other Income (Expense) - Total other income (expense) was income of $5,514 for the second quarter of 2026 compared to income of $16,998 in the same period of 2025. Total other income (expense) for the quarters ended June 30, 2026 and June 30, 2025, consisted primarily of interest income from cash and cash equivalents.

Net Income (Loss) - Net loss attributable to common stockholders for the second quarter of 2026 was $2.6 million compared to a net loss of $1.7 million for the second quarter of 2025. As a clinical stage biotech company, our continued research and development efforts toward regulatory approvals for our product candidates are expected to result in losses for the foreseeable future. Results for periods after June 30, 2026, will reflect the acquisition of Cy Biopharma and related transaction expenses, and are therefore not comparable to the periods presented.

Corporate Update Conference Call

CEO, Dr. Lynn Kirkpatrick, President, James Morrison, and Cy Biopharma CMO, Professor Richard Langford, will host a conference call on Tuesday, August 18, 2026, at 11:00 a.m. ET to provide a corporate update, including the recently completed acquisition of Cy Biopharma.

Date: Tuesday, August 18, 2026

Time: 11:00 a.m. ET

U.S. Dial-in: 1-877-407-9716

International Dial-in: 1-201-493-6779

Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1772527&tp_key=742e115fc1

Please dial in at least 10 minutes before the start of the call to ensure timely participation. A playback of the call will be available through Friday, September 18, 2026. To listen, call 1-844-512-2921 within the United States and Canada or 1-412-317-6671 when calling internationally. Please use the replay access ID 13762262.

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," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, possible NASDAQ delisting, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; continuation of government funding; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, available free of charge at the SEC's website 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, whether as a result of new information, future events or otherwise, 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
June 30,
Six Months Ended
June 30,

2026

2025

2026

2025

Federal grants

$

1,164,315

$

1,371,438

$

2,125,313

$

2,691,210

Operating expenses:
Research and development

2,471,752

1,923,430

5,818,633

3,808,957

General and administrative

1,268,952

1,198,523

2,445,299

2,600,279

Total operating expenses

3,740,704

3,121,953

8,263,932

6,409,236

Loss from operations

(2,576,389

)

(1,750,515

)

(6,138,619

)

(3,718,026

)

Total other income (expense), net

5,514

16,998

11,329

38,936

Net loss

$

(2,570,875

)

$

(1,733,517

)

$

(6,127,290

)

$

(3,679,090

)

Adjustments to net loss

166

166

166

166

Net loss attributable to common stockholders

$

(2,570,709

)

$

(1,733,351

)

$

(6,127,124

)

$

(3,678,924

)

Net loss per share attributable to common stockholders, basic and diluted

$

(0.20

)

$

(0.79

)

$

(0.62

)

$

(2.04

)

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

Six Months Ended June 30,

2026

2025

Net cash used in operating activities

$

(5,463,383

)

$

(4,414,280

)

Net cash provided by financing activities

1,829,733

3,123,778

Change in cash and cash equivalents

(3,633,650

)

(1,290,502

)

Cash and cash equivalents at beginning of period

4,310,354

3,502,077

Cash and cash equivalents at end of period

$

676,704

$

2,211,575

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

June 30,

December 31,

2026

2025

Assets
Current assets:
Cash and cash equivalents

$

676,704

$

4,310,354

Prepaid expenses and other current assets

2,169,506

2,934,664

Total current assets

2,846,210

7,245,018

Other assets

111,063

207,461

Total assets

$

2,957,273

$

7,452,479


Liabilities and stockholders' equity (deficit)
Current liabilities:
Accounts payable

$

1,977,629

$

3,267,610

Accrued expenses and other liabilities

1,893,635

993,411

Notes payable and accrued interest

196,842

306,708

Total current liabilities

4,068,106

4,567,729

Long-term liabilities

-

-

Total liabilities

4,068,106

4,567,729

Stockholders' equity (deficit)

(1,110,833

)

2,884,750

Total liabilities and stockholders' equity (deficit)

$

2,957,273

$

7,452,479

SOURCE: Ensysce Biosciences, Inc.



View the original press release on ACCESS Newswire

FAQ

What did Ensysce Biosciences (ENSC) acquire with the Cy Biopharma deal in August 2026?

Ensysce acquired Cy Biopharma in a stock‑for‑stock merger, gaining CY200, an Orphan Drug‑designated candidate for Complex Regional Pain Syndrome Type 1. According to Ensysce, CY200 becomes the lead pipeline asset focused on underlying neurobiology of CRPS, not just symptom management.

How much new funding does Ensysce Biosciences (ENSC) expect from the Cy Biopharma acquisition and related financings?

Ensysce expects up to $77.2 million in funding from Cy Biopharma’s pre‑acquisition notes and two private placement tranches. According to Ensysce, approximately $31 million net closed post‑quarter, with an additional tranche of up to $38.6 million contingent on clinical milestones.

What is the cash runway for Ensysce Biosciences (ENSC) after the Q2 2026 transactions?

According to Ensysce, completed Cy Biopharma financing and private placements extend cash runway into late 2027. A second tranche of up to $38.6 million, if triggered by clinical milestones, is expected to carry the company into 2028 based on current plans.

How did Ensysce Biosciences (ENSC) perform financially in Q2 2026?

Ensysce reported a Q2 2026 net loss attributable to common stockholders of $2.57 million on federal grant revenue of $1.16 million. R&D expenses were $2.47 million and G&A expenses $1.27 million, with cash of $0.68 million at quarter‑end before later financings.

What progress did Ensysce Biosciences (ENSC) report on PF614 and PF614-MPAR in Q2 2026?

Ensysce continued the pivotal PF614-301 Phase 3 trial and enrollment in PF614‑MPAR‑102. According to Ensysce, PF614-MPAR has FDA Breakthrough Therapy designation, is supported by a $15.1 million NIDA grant, and had $5.3 million remaining funding as of June 30, 2026.

What new intellectual property did Ensysce Biosciences (ENSC) secure for MPAR technology in 2026?

In May 2026, Taiwan’s Intellectual Property Office issued an MPAR‑related patent extending protection in that jurisdiction through 2042. According to Ensysce, this patent expands on a U.S. patent issued in April 2026 covering enzyme‑cleavable prodrugs and controlled release nafamostat compositions.

When is the Ensysce Biosciences (ENSC) August 2026 corporate update conference call?

The corporate update call is scheduled for Tuesday, August 18, 2026, at 11:00 a.m. ET. According to Ensysce, investors can join via U.S. dial‑in 1-877-407-9716, international 1-201-493-6779, or a webcast link provided by the company.