Ensysce Biosciences Reports Third Quarter 2024 Financial Results
Rhea-AI Summary
Ensysce Biosciences (NASDAQ:ENSC) reported Q3 2024 financial results, highlighting a $14 million NIH grant for PF614-MPAR development and the initiation of its second clinical trial. The company submitted a pivotal Phase 3 protocol for PF614 to FDA review. Cash position improved to $4.2 million from $1.1 million at 2023-end. Q3 showed net income of $0.7 million, compared to a $2.7 million loss year-over-year, primarily due to increased federal grant funding of $3.4 million. R&D expenses decreased to $1.7 million from $1.9 million, while G&A expenses slightly declined to $1.1 million.
Positive
- Secured $14 million multi-year NIH grant for PF614-MPAR development
- Cash position increased to $4.2 million from $1.1 million at year-end 2023
- Achieved net income of $0.7 million vs $2.7 million loss in Q3 2023
- Federal grant funding increased to $3.4 million from $0.4 million YoY
- Stockholders' equity of $6.6 million meets Nasdaq compliance requirement
Negative
- Net income in Q3 is expected to be a one-time event due to grant timing
- Federal grant funding expected to decline in coming quarters
- R&D expenses expected to increase in coming quarters
- Company anticipates continued losses for foreseeable future
News Market Reaction – ENSC
In the trading session that priced this news, ENSC gained 5.10%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
AI-generated analysis. How Rhea-AI works. Not financial advice.
Awarded
Submitted Pivotal PF614 Phase 3 Protocol to the FDA for Review
SAN DIEGO, CA / ACCESSWIRE / November 12, 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 third quarter ended September 30, 2024.
Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Our team has made significant progress in the third quarter, and we have line of sight to meaningful clinical initiatives to close out the year. The highlight of the third quarter was NIH's recognition of the potential value provided by our overdose protection technology MPAR®, by awarding Ensysce with a
Dr. Kirkpatrick continued, "We also built on FDA feedback from our End of Phase 2 meeting in February to complete our Phase 3 protocol and have submitted it to the FDA. We expect FDA feedback by the end of November to allow us to complete plans to execute the study over the coming year. Our August financing transaction that raised
TAAPTM (Opioid Abuse Deterrent Program) Update
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 and exposed to the body's own trypsin in the small intestine to activate or "switch on" to release oxycodone.
During the third quarter, the Company submitted to the FDA for regulatory review the protocol and statistical analysis plan for its anticipated final Phase 3 study, PF614-301. The study is entitled "A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty".
MPAR® (Opioid Abuse Deterrent and Overdose Protection Program) Update
PF614-MPAR, designed to treat severe pain with added oral overdose protection, is a combination product of the TAAPTM prodrug PF614 with a trypsin inhibitor. MPAR® (Multi-Pill Abuse Resistance) reduces or "switches off" the release of the opioid only in an overdose situation, providing an additional layer of protection to Ensysce's TAAP™ medications. The clinical data from the first clinical trial, PF614-101, demonstrated that the MPAR® technology reduces release and absorption of oxycodone from PF614 when consumed in more than a prescribed dose, leading to the FDA's Breakthrough Therapy designation in January of this year.
During the third quarter, the Company received approval from the Investigational Review Board ("IRB") of the PF614-MPAR-102 protocol, ‘A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co‑Administered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects.' The Site Initiation Visit has been undertaken and the study is on track to initiate subject dosing this quarter. To execute this study, Ensysce has continued its collaboration with Quotient Sciences to use their Translational Pharmaceutics® platform to perfect the drug product. As reported in August, the Company received a
Opioid Use Disorder (OUD) Program Update
The Company recently announced the selection of its lead OUD drug candidate PF9001 that has been designed using Ensysce's TAAPTM platform. The intent of the program is to reduce both the abuse profile and the cardiovascular side effects associated with traditional methadone OUD treatments. The program is finalizing required studies supported by a multi-year Helping to End Addiction Long-Term (HEAL) award of up to
Q3 2024 Financial Results
Cash - Cash and cash equivalents were
Stockholders' Equity - Stockholders' equity was
Federal Grants - Funding under federal grants totaled
Research & Development Expenses - R&D expenses were
General & Administrative Expenses - G&A expenses were
Other Income (Expense) - Total other income (expense), net, was consistent with income of
Net Income (Loss) - Net income attributable to common stockholders for the third 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 quarterly report on Form 10-Q 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 September 30, |
|
| Nine Months Ended September 30, |
| |||||||||||
| 2024 |
|
| 2023 |
|
| 2024 |
|
| 2023 |
| |||||
Federal grants |
| $ | 3,418,853 |
|
| $ | 435,380 |
|
| $ | 3,906,372 |
|
| $ | 1,715,488 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
| 1,690,674 |
|
|
| 1,914,970 |
|
|
| 3,416,807 |
|
|
| 5,354,713 |
|
General and administrative |
|
| 1,083,433 |
|
|
| 1,227,724 |
|
|
| 3,643,223 |
|
|
| 3,923,277 |
|
Total operating expenses |
|
| 2,774,107 |
|
|
| 3,142,694 |
|
|
| 7,060,030 |
|
|
| 9,277,990 |
|
Income (loss) from operations |
|
| 644,746 |
|
|
| (2,707,314 | ) |
|
| (3,153,658 | ) |
|
| (7,562,502 | ) |
Total other income (expense), net |
|
| 17,023 |
|
|
| 16,508 |
|
|
| (1,268,929 | ) |
|
| 440,588 |
|
Net income (loss) |
| $ | 661,769 |
|
| $ | (2,690,806 | ) |
| $ | (4,422,587 | ) |
| $ | (7,121,914 | ) |
Adjustments to net income (loss) |
|
| - |
|
|
| 1,235 |
|
|
| (216 | ) |
|
| 198 |
|
Net income (loss) attributable to common stockholders |
| $ | 661,769 |
|
| $ | (2,689,571 | ) |
| $ | (4,422,803 | ) |
| $ | (7,121,716 | ) |
Net income (loss) per share attributable to common stockholders, basic and diluted |
| $ | 0.07 |
|
| $ | (0.87 | ) |
| $ | (0.57 | ) |
| $ | (3.32 | ) |
Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
| Nine Months Ended September 30, |
| ||||||
| 2024 |
|
| 2023 |
| |||
Net cash used in operating activities |
| $ | (6,738,610 | ) |
| $ | (8,978,107 | ) |
Net cash provided by financing activities |
|
| 9,768,598 |
|
|
| 7,294,786 |
|
Change in cash and cash equivalents |
|
| 3,029,988 |
|
|
| (1,683,321 | ) |
Cash and cash equivalents at beginning of period |
|
| 1,123,604 |
|
|
| 3,147,702 |
|
Cash and cash equivalents at end of period |
| $ | 4,153,592 |
|
| $ | 1,464,381 |
|
Ensysce Biosciences, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
| September 30, |
|
| December 31, |
| |||
| 2024 |
|
| 2023 |
| |||
Assets |
|
|
|
|
|
| ||
Current assets: |
|
|
|
|
|
| ||
Cash and cash equivalents |
| $ | 4,153,592 |
|
| $ | 1,123,604 |
|
Prepaid expenses and other current assets |
|
| 4,936,915 |
|
|
| 1,165,264 |
|
Total current assets |
|
| 9,090,507 |
|
|
| 2,288,868 |
|
Other assets |
|
| 294,217 |
|
|
| 419,217 |
|
Total assets |
| $ | 9,384,724 |
|
| $ | 2,708,085 |
|
|
|
|
|
|
|
|
| |
Liabilities and stockholders' equity (deficit) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
| $ | 1,967,573 |
|
| $ | 1,936,007 |
|
Accrued expenses and other liabilities |
|
| 447,035 |
|
|
| 542,260 |
|
Notes payable and accrued interest |
|
| 387,176 |
|
|
| 854,697 |
|
Total current liabilities |
|
| 2,801,784 |
|
|
| 3,332,964 |
|
Long-term liabilities |
|
| 3,213 |
|
|
| 26,388 |
|
Total liabilities |
|
| 2,804,997 |
|
|
| 3,359,352 |
|
Stockholders' equity (deficit) |
|
| 6,579,727 |
|
|
| (651,267 | ) |
Total liabilities and stockholders' equity (deficit) |
| $ | 9,384,724 |
|
| $ | 2,708,085 |
|
SOURCE: Ensysce Biosciences, Inc.
View the original press release on accesswire.com