Full Press Release Details
Biosciences Reports Fourth Quarter and Full Year 2022 Financial Results
Corporate Update Call to be Held Tuesday, April 11, 2023 ~
DIEGO, CA, March 30, 2023 - Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC),
a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety, today reported financial results
for the fourth quarter and full year of 2022.
Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Our focus remains on execution and advancing clinical development
plans for our programs that provide strong pain relief using our PF614 and PF614-MPAR drug products. This has been evident in the recently
released news regarding completion of enrollment of our first PF614-MPAR study and completion of the clinical stage of two human abuse
potential studies for PF614. These studies add to the clinical support demonstrating that Ensysce has a novel approach for delivering
effective pain management and safely alleviating severe pain in patients requiring an opioid analgesic. These recent accomplishments
move us closer to our Phase 3 plans and toward bringing what we believe is the Next Generation of Analgesia' for severe
pain to commercialization."
(Opioid Abuse Deterrent Program) Updates
lead program, PF614 is a "Trypsin-Activated Abuse Protection" (TAAPTM) extended-release oxycodone. The Company's
TAAPTM technology is designed to control release, be highly resistant to tampering, and reduce abuse through a unique chemical
modification that is activated by trypsin. The achievements highlighted below advance the company toward Phase 3 clinical evaluation.
(Opioid Abuse Deterrent and Overdose Protection Program) Updates
is a combination abuse-protected product designed to overcome prescription drug overdose. MPAR (Multi-Pill Abuse Resistance) reduces
the release of the opioid in an overdose situation, providing the additional layer of protection to Ensysce's TAAP pain
medications. The select achievements outlined below demonstrate how Ensysce has progressed, what we believe is the first prescription
drug overdose protection technology to be developed.
Update Conference Call
previously announced, CEO, Dr. Lynn Kirkpatrick, CFO, Dave Humphrey, and CMO, Dr. William Schmidt, will host a conference call on Tuesday,
April 11, 2023, at 11:00am ET to provide a corporate update and review the recently released results from the oral HAP study of PF614.
The call will conclude with Q&A from participants. An accompanying presentation will be posted prior to the call to the Company's
investor relations website.
Tuesday, April 11, 2023
U.S. Dial-in: 1-877-407-0792
International Dial-in: 1-201-689-8263
Webcast: 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
Tuesday, May 9, 2023. 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 13737179.
Consolidated Statements of Operations
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Federal grants | $ | 1,433,463 | $ | 1,635,292 | $ | 2,523,383 | $ | 3,531,199 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 6,441,927 | 2,187,850 | 19,835,875 | 4,690,082 | ||||||||||||
| General and administrative | 1,192,322 | 1,454,187 | 6,909,603 | 18,711,548 | ||||||||||||
| Total operating expenses | 7,634,249 | 3,642,037 | 26,745,478 | 23,401,630 | ||||||||||||
| Loss from operations | (6,200,786 | ) | (2,006,745 | ) | (24,222,095 | ) | (19,870,431 | ) | ||||||||
| Total other income (expense), net | 722,710 | (8,030,379 | ) | 14,410 | (9,275,470 | ) | ||||||||||
| Net income (loss) | $ | (5,478,076 | ) | $ | (10,037,124 | ) | $ | (24,207,685 | ) | $ | (29,145,901 | ) | ||||
| Adjustments to net income (loss) | (43,832 | ) | (802,926 | ) | (877,811 | ) | (740,950 | ) | ||||||||
| Net income (loss) attributable to common stockholders | $ | (5,521,908 | ) | $ | (10,840,050 | ) | $ | (25,085,496 | ) | $ | (29,886,851 | ) | ||||
| Net income (loss) per share attributable to common stockholders, basic and diluted | $ | (1.52 | ) | $ | (8.93 | ) | $ | (11.62 | ) | $ | (29.64 | ) |
Consolidated Statements of Cash Flows
| Year Ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| Net cash used in operating activities | $ | (17,887,439 | ) | $ | (8,242,177 | ) | ||
| Net cash provided by investing activities | 4,500 | - | ||||||
| Net cash provided by financing activities | 8,765,905 | 20,312,699 | ||||||
| Change in cash and cash equivalents | (9,117,034 | ) | 12,070,522 | |||||
| Cash and cash equivalents at beginning of period | 12,264,736 | 194,214 | ||||||
| Cash and cash equivalents at end of period | $ | 3,147,702 | $ | 12,264,736 |
Consolidated Balance Sheets
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 3,147,702 | $ | 12,264,736 | ||||
| Prepaid expenses and other current assets | 2,151,467 | 3,397,857 | ||||||
| Total current assets | 5,299,169 | 15,662,593 | ||||||
| Other assets | 585,883 | 754,756 | ||||||
| Total assets | $ | 5,885,052 | $ | 16,417,349 | ||||
| Liabilities and stockholders' deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,943,791 | $ | 301,104 | ||||
| Accrued expenses and other liabilities | 2,253,809 | 3,432,407 | ||||||
| Notes payable and accrued interest | 4,266,610 | 12,748,155 | ||||||
| Total current liabilities | 9,464,210 | 16,481,666 | ||||||
| Long-term liabilities | 450,494 | 8,093,741 | ||||||
| Total liabilities | 9,914,704 | 24,575,407 | ||||||
| Stockholders' deficit | (4,029,652 | ) | (8,158,058 | ) | ||||
| Total liabilities and stockholders' equity | $ | 5,885,052 | $ | 16,417,349 |
Biosciences is a clinical-stage biotech company using its proprietary technology platforms to develop safer prescription drugs. Leveraging
TAAPTM and MPAR , the Company is in the process of developing a unique, tamper-proof treatment option for pain that
minimizes the risk of both drug abuse and overdoses. 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.
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.
Biosciences Company Contact:
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Ensysce Biosciences Inc.