Full Press Release Details
Biosciences Reports Fourth Quarter and Full Year 2023 Financial Results
Corporate Update Call to be Held Thursday, March 21, 2024 at 11:00am ET to Discuss Recent FDA Breakthrough Therapy Designation and Phase
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.
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."
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.
(Opioid Abuse Deterrent Program) Updates
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.
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.
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.
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.
(Opioid Abuse Deterrent and Overdose Protection Program) Updates
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
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.
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.
- Cash and cash equivalents were $1.1 million as of December 31, 2023, as compared to $1.5 million as of September 30, 2023.
After year end, the Company received cash proceeds of $2.1 million from the exercise of warrants, originally issued in the fourth quarter
of 2023, to purchase 1.3 million shares of common stock. Additionally, in February 2024, the Company received gross proceeds of $4.7
million, prior to deducting placement agent fees and offering expenses, from the exercise of warrants to purchase 3.6 million shares
of common stock originally issued in May 2023.
Grants - Funding under federal grants totaled to $0.5 million for the fourth quarter of 2023 compared to $1.4 million in the
comparable year ago quarter. For the full year of 2023, funding from federal grants was $2.2 million compared to $2.5 million for the
full year of 2022. The decreases are due to the timing of research activities eligible for funding, particularly relative to the MPAR
& Development Expenses - R&D expenses were $2.2 million for the fourth quarter of 2023 compared to $6.4 million for
the same period in 2022. For the full year of 2023, R&D expenses were $7.6 million compared to $19.8 million for the full year of
2022. The decreases were primarily the result of reduced external research and development costs related to the clinical programs for
PF614 and PF614-MPAR, particularly regarding bioequivalence and human abuse potential studies for PF614.
& Administrative Expenses - G&A expenses were $1.4 million in the fourth quarter of 2023, a slight increase compared
to $1.2 million for the same period of 2022. For the full year of 2023, G&A expenses were $5.4 million, a decrease compared to $6.9
million for the full year of 2022. The quarterly increase from the same prior year period was primarily a result of higher non-cash stock-based
compensation, while the full year decrease resulted from reduced consulting, legal, liability insurance and employee bonus expenses.
Income (Expense) - Total other income (expense), net was an expense of $0.3 million for the fourth quarter of 2023 compared
to income of $0.7 million for the same period of 2022. For the full year, total other income (expense), net was income of $91,912 in
2023 compared to income of $14,410 in 2022. The changes in other expenses were primarily due to non-cash fair value adjustments for convertible
Loss - Net loss attributable to common stockholders for the fourth quarter of 2023 was $3.5 million compared to $5.5 million
for the fourth quarter of 2022. For the full year of 2023, net loss was $10.6 million compared to $25.1 million for the full year of
2022. 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.
Update Conference Call
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.
Thursday, March 21, 2024
Dial-in: 1-877-407-0792
Dial-in: 1-201-689-8263
ENSC Corporate Update Call
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.
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 | ) |
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 |
Consolidated Balance Sheets
| December 31, 2023 | December 31, 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 |
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.
trypsin activated abuse protection - designed to protect against prescription drug abuse.
multi-pill abuse resistance - designed to protect against abuse and accidental overdose.
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