Ensysce Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results
- Significant progress made by Ensysce in 2023 operationally and clinically for lead pain therapeutic PF614 and overdose protection product PF614-MPAR.
- FDA grant of Breakthrough Therapy designation to PF614-MPAR in January 2024.
- Completion of successful End of Phase 2 meeting with FDA regarding PF614.
- Publication of clinical evaluation results for PF614 in Clinical and Translational Science journal.
- Reduction in abuse potential of PF614 compared to OxyContin demonstrated in clinical studies.
- Ensysce's financial results show a decrease in cash and cash equivalents, federal grants, R&D and G&A expenses, and net loss compared to the previous year.
- Corporate update conference call scheduled for March 21, 2024, to discuss recent milestones and financial results.
- None.
Insights
The financial results announced by Ensysce Biosciences indicate a significant reduction in net loss from $25.1 million in the full year of 2022 to $10.6 million in 2023. This improvement in net loss is primarily attributed to a decrease in research and development expenses, which dropped from $19.8 million to $7.6 million year-over-year. The reduction in R&D expenses could signal a transition from early to later stages of clinical trials, which often involve higher initial costs associated with setup and recruitment. However, the company's cash position decreased from $3.1 million at the end of 2022 to $1.1 million at the end of 2023, raising concerns about its ability to fund ongoing and future operations without securing additional financing.
From an investor's perspective, the exercise of warrants contributing to cash proceeds of $6.8 million in early 2024 is a positive development, providing the company with a necessary cash infusion. Nonetheless, the low cash reserves relative to the company's burn rate may necessitate further capital raising efforts, which could result in dilution for existing shareholders. The company's financial performance suggests a need for careful monitoring of its cash flow management and potential future funding requirements.
Ensysce's announcement of the FDA Breakthrough Therapy designation for PF614-MPAR is a pivotal milestone for the company. Breakthrough Therapy status is granted to drugs that may offer substantial benefits over existing therapies for serious or life-threatening conditions. This designation can lead to expedited development and review processes, potentially shortening the time to market. For stakeholders, this could mean a faster path to revenue generation from this product, assuming successful completion of clinical trials and regulatory approval.
Furthermore, the PF614 product's bioequivalence to existing opioids, coupled with reduced abuse potential, positions it as a compelling candidate in the fight against the opioid epidemic. The use of TAAP technology to deter abuse is a novel approach that could differentiate PF614 in the competitive pain management market. If the Phase 3 clinical trials, set to commence in the second half of 2024, yield positive results, Ensysce could capture a significant share of the opioid market with a safer alternative, subject to FDA approval. However, the long-term impact will depend on the drug's clinical efficacy, safety profile and market acceptance post-launch.
The opioid epidemic in the United States represents a substantial market for safer pain management solutions. Ensysce's advancement of PF614 and PF614-MPAR through clinical trials addresses a critical need for opioids with reduced risk of abuse and overdose. The market potential for these products is significant, given the high demand for effective pain relief that also mitigates the risks associated with opioid use.
The company's strategic positioning with TAAP and MPAR technologies could disrupt the opioid market by offering a unique value proposition. However, market penetration will hinge on successful Phase 3 trial outcomes, regulatory approval and effective commercialization strategies. It is essential to consider the competitive landscape, including other pharmaceutical companies that may be developing similar abuse-deterrent formulations. The breakthrough designation by the FDA certainly boosts the company's prospects, but actual market impact will be determined by the product's performance in clinical trials and subsequent adoption by healthcare providers and patients.
Corporate Update Call to be Held Thursday, March 21, 2024 at 11:00am ET to Discuss Recent FDA Breakthrough Therapy Designation and Phase 3 Clinical Plans
SAN DIEGO, CA / ACCESSWIRE / March 15, 2024 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today reported financial results for the fourth quarter and full year of 2023.
Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "We are proud of the significant progress Ensysce has made in 2023 both operationally and clinically for our lead pain therapeutic, PF614, and our overdose protection product, PF614-MPAR. Our advancements were particularly instrumental in providing a foundation for our constructive end of Phase 2 meeting with the U.S. Food & Drug Administration (FDA) for PF614. We believe the FDA's guidance positioned Ensysce favorably and solidified the PF614 Phase 3 clinical study designs to initiate enrollment in the second half of 2024, ultimately reducing regulatory risks that could impede our commercialization plan. Especially encouraging was the FDA grant of Breakthrough Therapy designation to PF614-MPAR in January 2024, acknowledging its unique advantage over current opioids. Breakthrough Therapy, an exclusive designation applied to less than 300 drugs historically, offers Ensysce the opportunity to accelerate our clinical programs and go-to market plans."
"Importantly, the collective empirical data we've received from four completed clinical studies verify PF614's bioequivalence to commercially available opioids but with reduced abuse potential, and reaffirms our belief that Ensysce's PF614 will provide a "next generation" opioid family with the added value proposition of safer products with overdose protection. We have many reasons to remain optimistic on our path to regulatory approval as we advance through our Phase 3 clinical trials beginning in the second half of 2024. Progress in 2023 and early 2024 has provided further evidence that our innovative analgesics will provide prescribers and patients in severe pain with an alternative, effective option with safety advantages to address the opioid epidemic in the United States," concluded Dr. Kirkpatrick.
TAAPTM (Opioid Abuse Deterrent Program) Updates
Our lead product, PF614, is a Trypsin-Activated Abuse Protection (TAAPTM) extended-release oxycodone and a potential "next generation" analgesic for severe pain. The Company's TAAPTM technology is designed to control release, be highly resistant to tampering, and reduce abuse through a unique chemical modification. PF614's TAAPTM 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. Ensysce recently completed a Phase 2 clinical trial for PF614, 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. Ensysce believes it has a body of evidence showing that PF614 works as designed, has a good safety profile and is bioequivalent to OxyContin providing strong efficacy, yet reduced abuse potential.
As a reaffirmation of the Company's belief in the efficacy of PF614, on February 15, 2024, the Company announced the online publication of its manuscript entitled, "Clinical evaluation of PF614, a novel TAAPTM prodrug of oxycodone, versus OxyContin® in a multi-ascending dose study with a bioequivalence arm in healthy volunteers" by the open-access medical journal Clinical and Translational Science (CTS) sponsored by the American Society of Clinical Pharmacology and Therapeutics (ASCPT). The results from the two-part PF614‑102 study demonstrate a clear dose relationship between PF614 and oxycodone, which is the foundation for the FDA submission.
As previously mentioned, on January 31, 2024, the Company completed a successful End of Phase 2 meeting with the FDA regarding PF614 and received guidance on its non-clinical development approach and clinical development plans.
Instrumental to the meeting was the PF614-201 study, "A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects" that concluded in December 2023. This study measured the time-of-onset of pain-relief in healthy volunteers and showed that Ensysce's TAAPTM chemical approach delivers effective analgesia. This study was a meaningful component of the Company's Phase 3 clinical protocol design and a driver of the positive outcome with the FDA.
MPAR® (Opioid Abuse Deterrent and Overdose Protection Program) Updates
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.
Importantly, in January 2024, Ensysce received notice from the FDA that it had granted Breakthrough Therapy designation for PF614-MPAR, 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 design of our PF614-MPAR programs to efficiently move toward a new drug application (NDA) submission and approval to bring this innovative drug to market.
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 fourth quarter of 2023 was
Corporate Update Conference Call
Ensysce CEO, Dr. Lynn Kirkpatrick, CFO, Dave Humphrey, and CMO, Dr. William Schmidt, will host a conference call on Thursday, March 21, 2024, at 11:00am ET to provide a corporate update and review recent company milestones. The call will conclude with Q&A from participants. An accompanying updated presentation will be posted prior to the call to the Company's investor relations website.
Date: Thursday, March 21, 2024
Time: 11:00am ET
U.S/ Dial-in: 1-877-407-0792
International Dial-in: 1-201-689-8263
Webcast: ENSC Corporate Update Call
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 Thursday, April 4, 2024. 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 pin number 13744594.
Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Operations
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
Federal grants | $ | 515,032 | $ | 1,433,463 | $ | 2,230,520 | $ | 2,523,383 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 2,232,760 | 6,441,927 | 7,587,473 | 19,835,875 | ||||||||||||
General and administrative | 1,437,957 | 1,192,322 | 5,361,234 | 6,909,603 | ||||||||||||
Total operating expenses | 3,670,717 | 7,634,249 | 12,948,707 | 26,745,478 | ||||||||||||
Loss from operations | (3,155,685 | ) | (6,200,786 | ) | (10,718,187 | ) | (24,222,095 | ) | ||||||||
Total other income (expense), net | (348,676 | ) | 722,710 | 91,912 | 14,410 | |||||||||||
Net loss | $ | (3,504,361 | ) | $ | (5,478,076 | ) | $ | (10,626,275 | ) | $ | (24,207,685 | ) | ||||
Adjustments to net loss | 66 | (43,832 | ) | 264 | (877,811 | ) | ||||||||||
Net loss attributable to common stockholders | $ | (3,504,295 | ) | $ | (5,521,908 | ) | $ | (10,626,011 | ) | $ | (25,085,496 | ) | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | (1.13 | ) | $ | (18.30 | ) | $ | (4.69 | ) | $ | (139.42 | ) | ||||
Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows
| Year Ended December 31, | ||||||||
| 2023 | 2022 | |||||||
Net cash used in operating activities | $ | (10,779,982 | ) | $ | (17,887,439 | ) | ||
Net cash provided by investing activities | - | 4,500 | ||||||
Net cash provided by financing activities | 8,755,884 | 8,765,905 | ||||||
Change in cash and cash equivalents | (2,024,098 | ) | (9,117,034 | ) | ||||
Cash and cash equivalents at beginning of period | 3,147,702 | 12,264,736 | ||||||
Cash and cash equivalents at end of period | $ | 1,123,604 | $ | 3,147,702 | ||||
Ensysce Biosciences, Inc.
Condensed Consolidated Balance Sheets
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 1,123,604 | $ | 3,147,702 | ||||
Prepaid expenses and other current assets | 1,165,264 | 2,151,467 | ||||||
Total current assets | 2,288,868 | 5,299,169 | ||||||
Other assets | 419,217 | 585,883 | ||||||
Total assets | $ | 2,708,085 | $ | 5,885,052 | ||||
Liabilities and stockholders' deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,936,007 | $ | 2,943,791 | ||||
Accrued expenses and other liabilities | 542,260 | 2,253,809 | ||||||
Notes payable and accrued interest | 854,697 | 4,266,610 | ||||||
Total current liabilities | 3,332,964 | 9,464,210 | ||||||
Long-term liabilities | 26,388 | 450,494 | ||||||
Total liabilities | 3,359,352 | 9,914,704 | ||||||
Stockholders' deficit | (651,267 | ) | (4,029,652 | ) | ||||
Total liabilities and stockholders' equity | $ | 2,708,085 | $ | 5,885,052 | ||||
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, 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
SOURCE: Ensysce Biosciences, Inc.
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FAQ
What is Ensysce Biosciences, Inc. reporting in the press release?
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What designation did the FDA grant to PF614-MPAR in January 2024?
When did Ensysce complete a successful meeting with the FDA regarding PF614?
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