Ensysce Biosciences Reports First Quarter 2024 Financial Results
Ensysce Biosciences reported their first quarter 2024 financial results, highlighting progress in their clinical programs with FDA breakthrough therapy designations for their lead opioid products, PF614 and PF614-MPAR. The company received positive feedback and guidance from the FDA, affirming their path to regulatory approval and commercialization. Ensysce is set to begin Phase 3 clinical trials in the second half of 2024, showcasing their innovative TAAP and MPAR opioids for severe pain relief with reduced abuse potential.
Received FDA breakthrough therapy designations for PF614 and PF614-MPAR, expediting clinical programs and affirming innovative opioid development.
Guidance from the FDA to reduce regulatory risks and advance commercialization plans for TAAP and MPAR opioids.
Cash and cash equivalents increased to $3.4 million as of March 31, 2024, with additional proceeds from warrant exercises.
Successful management of research and development expenses, leading to reduced costs for the first quarter of 2024.
Net loss attributable to common stockholders for the first quarter of 2024 was $3.1 million, reflecting continued investment in research and development efforts.
Reduction in federal grants funding compared to the previous year's first quarter, impacting overall financial performance.
Total other income (expense) was an expense of $1.3 million for the first quarter of 2024, highlighting financial challenges.
Insights
The financial health of Ensysce Biosciences suggests an uptick in liquidity from
However, investors should note the increase in net loss year-on-year from
PF614's progression to Phase 3 clinical trial initiation in the second half of 2024 is a critical step for Ensysce, representing an advanced stage of clinical development. The FDA's Breakthrough Therapy designation for PF614-MPAR is indicative of the drug's potential to offer clinical advantages over existing therapies. Such designations can expedite development timelines and may enhance investor confidence in the drug's prospects.
However, while the market typically reacts favorably to positive regulatory milestones, it is important for investors to remain cautious until the approval is actually granted and the company successfully navigates the complex landscape of drug commercialization. To that end, the dual TAAP and MPAR technologies present a unique proposition in the effort to mitigate opioid abuse. The Phase 1 study data providing the ground for the FDA's recognition suggest a strong scientific foundation, which if continued through Phase 3, can significantly increase the likelihood of commercial success.
The opioid market has been under considerable scrutiny due to abuse potential and Ensysce's TAAP and MPAR technologies address this pressing issue, potentially carving out a significant niche in pain management therapeutics. The FDA's acknowledgment through Breakthrough Therapy designation not only boosts the credibility of PF614-MPAR but also signals to stakeholders that the drug candidate may have a differentiated and competitive profile in the market.
From an investor's perspective, the balance between innovation and risk is pivotal. Ensysce's approach in seeking regulatory approvals for products with inherent abuse-deterrent properties aligns with current regulatory and social imperatives, potentially leading to market adoption driven by both prescriber and regulatory preference for safer opioid options. Nonetheless, the ultimate commercial viability will hinge on the successful completion of Phase 3 trials, NDA approval and market acceptance of the TAAP and MPAR-based products.
PF614's Phase 3 Clinical Plans Affirm the Path to Regulatory Approval
FDA Breakthrough Therapy Designation of PF614-MPAR Expedites Clinical Program
SAN DIEGO, CA / ACCESSWIRE / May 13, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today reported financial and operational results for the first quarter ended March 31, 2024.
Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "In the first quarter of 2024, we continued to accelerate the progress of our clinical programs toward regulatory approvals. Early in the quarter, a constructive end of Phase 2 meeting was held with the U.S. Food & Drug Administration (FDA) for our lead opioid product, PF614, providing solid guidance for a Phase 3 clinical trial expected to initiate in the second half of 2024. The FDA also provided guidelines to reduce the regulatory risks for our commercialization plan.
Additionally, in January, the FDA's grant of Breakthrough Therapy designation for PF614-MPAR affirms belief in our novel approach to providing the ‘Next Generation' of opioid products. This exclusive designation, granted to fewer than 300 drugs since its introduction in 2012, was based on data generated in our Phase 1 study, PF614-MPAR-101, which demonstrated that the unique combination can add oral overdose protection to our prescription TAAP (Trypsin-Activated Abuse Protection) products. This designation is intended to accelerate product development and provide guidance to aid the design of our PF614-MPAR programs to efficiently move toward a new drug application (NDA) submission and approval of this innovative opioid. Coupled with the previously granted Fast Track designation for PF614, Breakthrough Therapy designation for PF614-MPAR demonstrates the FDA's recognition of these transformational pain medications."
Dr. Kirkpatrick added, "We look forward to beginning our Phase 3 clinical trials in the second half of 2024. We believe the data we have generated to date from multiple clinical studies de-risk our path to commercialization. These studies have verified PF614 delivers oxycodone in an equivalent manner to commercially available opioids and provides pain relief with reduced abuse potential. We believe our TAAP and MPAR (Multi-Pill Abuse Resistance) opioids have a proven safety profile that surpasses the current slate of extended-release opioid analgesics, and we look forward to providing additional milestones and updates in the months ahead," concluded Dr. Kirkpatrick.
TAAP TM (Opioid Abuse Deterrent Program) Update
Our lead product, PF614, is a Trypsin-Activated Abuse Protection (TAAP TM ) extended-release oxycodone and a potential "next generation" analgesic for severe pain. The Company's TAAP TM technology is designed to control release, be highly resistant to tampering, and reduce abuse through a unique chemical modification. PF614's TAAP TM modification makes it inactive until it is swallowed, following which it is activated or "turned on" to release oxycodone by the body's own trypsin, an enzyme in the small intestine. As mentioned, Ensysce recently received FDA guidance on the strategy and design of its Phase 3 clinical program and expects to commence enrollment for the Phase 3 clinical trial in the second half of 2024.
MPAR® (Opioid Abuse Deterrent and Overdose Protection Program) Update
PF614-MPAR is a combination product of the TAAP prodrug PF614 with a trypsin inhibitor, designed to treat severe pain while providing overdose protection. MPAR® (Multi-Pill Abuse Resistance) reduces or "turns off" the release of the opioid to prevent an overdose, providing an additional layer of protection to Ensysce's TAAP™ medications. Over the past year, clinical data demonstrated that the MPAR® technology reduces release and absorption of oxycodone from PF614 when consumed in more than a prescribed dose.
Ensysce received notice from the FDA that it had granted Breakthrough Therapy designation for PF614-MPAR, specifically acknowledging the potential impact of the innovative MPAR® overdose protection technology. Breakthrough Therapy is an elite designation that expedites the development and review of drugs that are intended to treat a serious condition where the drug may demonstrate substantial improvement over available therapies.
In February, the Company received additional productive guidance from the FDA to aid the execution of our PF614-MPAR programs to efficiently move toward a new drug application (NDA) submission and approval to bring this innovative drug to market.
Q1 2024 Financial Results
Cash - Cash and cash equivalents were
Federal Grants - Funding under federal grants totaled to
Research & Development Expenses - R&D expenses were
General & Administrative Expenses - G&A expenses were
Other Income (Expense) - Total other income (expense), net was an expense of
Net Loss - Net loss attributable to common stockholders for the first quarter of 2024 was
About Ensysce Biosciences
Ensysce Biosciences is a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. Leveraging its Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. For more information, please visit www.ensysce.com.
Definitions
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; 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 annual report on Form 10-K and current reports on Form 8-K, which are 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 March 31, | ||||||||
| 2024 | 2023 | |||||||
Federal grants | $ | 305,722 | $ | 789,635 | ||||
Operating expenses: | ||||||||
Research and development | 778,904 | 1,796,015 | ||||||
General and administrative | 1,369,782 | 1,554,855 | ||||||
Total operating expenses | 2,148,686 | 3,350,870 | ||||||
Loss from operations | (1,842,964 | ) | (2,561,235 | ) | ||||
Total other income (expense), net | (1,273,599 | ) | 369,429 | |||||
Net loss | $ | (3,116,563 | ) | $ | (2,191,806 | ) | ||
Adjustments to net loss | (216 | ) | (4,368 | ) | ||||
Net loss attributable to common stockholders | $ | (3,116,779 | ) | $ | (2,196,174 | ) | ||
Net loss per share attributable to common stockholders, basic and diluted | $ | (0.55 | ) | $ | (2.08 | ) | ||
Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
Net cash used in operating activities | $ | (3,408,403 | ) | $ | (3,606,919 | ) | ||
Net cash provided by financing activities | 5,689,148 | 1,874,982 | ||||||
Change in cash and cash equivalents | 2,280,745 | (1,731,937 | ) | |||||
Cash and cash equivalents at beginning of period | 1,123,604 | 3,147,702 | ||||||
Cash and cash equivalents at end of period | $ | 3,404,349 | $ | 1,415,765 | ||||
Ensysce Biosciences, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 3,404,349 | $ | 1,123,604 | ||||
Prepaid expenses and other current assets | 1,292,291 | 1,165,264 | ||||||
Total current assets | 4,696,640 | 2,288,868 | ||||||
Other assets | 377,550 | 419,217 | ||||||
Total assets | $ | 5,074,190 | $ | 2,708,085 | ||||
Liabilities and stockholders' equity (deficit) | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 981,720 | $ | 1,936,007 | ||||
Accrued expenses and other liabilities | 408,435 | 542,260 | ||||||
Notes payable and accrued interest | 245,973 | 854,697 | ||||||
Total current liabilities | 1,636,128 | 3,332,964 | ||||||
Long-term liabilities | 17,433 | 26,388 | ||||||
Total liabilities | 1,653,561 | 3,359,352 | ||||||
Stockholders' equity (deficit) | 3,420,629 | (651,267 | ) | |||||
Total liabilities and stockholders' equity (deficit) | $ | 5,074,190 | $ | 2,708,085 | ||||
SOURCE: Ensysce Biosciences, Inc.
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FAQ
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