On 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, reported financial results for the fourth quarter and full year of 2022 (Press release, Ensysce Biosciences, MAR 30, 2023, View Source [SID1234629602]).

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Dr. 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."

TAAPTM (Opioid Abuse Deterrent Program) Updates

Our 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.

On February 28, 2023, the Company announced the database lock for the oral Human Abuse Potential (HAP) study of PF614. With the database lock, no further change to the trial data is permissible.
On January 4, 2023, the Company announced that it had successfully completed the clinical portion of study PF614-104, ‘A Randomized, Double-Blind, Placebo- and Active-Controlled, Crossover Study to Evaluate the Oral Abuse Potential of PF614 Compared with Oxycodone Immediate-Release Tablets, and Placebo in Non-Dependent Recreational Opioid Users’ (ClinicalTrials.gov: NCT05571345) conducted by Dr. Vince Clinical Research.
On November 14, 2022, the Company announced that it received written guidance from the FDA that an acute pain indication may be appropriate for the Company’s lead Trypsin Activated Abuse Protection (TAAPTM) product, PF614.
On October 31, 2022, the Company announced positive topline results from an intranasal human abuse potential (HAP) study for PF614 showing inhalation of PF614 did not produce the ‘drug liking’ effects of crushed oxycodone. Ensysce’s TAAPTM technology is designed to limit activation to oral administration, be highly resistant to tampering to reduce abuse.
MPARTM (Opioid Abuse Deterrent and Overdose Protection Program) Updates

PF614-MPAR 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.

On March 22, 2023, the Company announced the completion of enrollment in the final stage of the Phase 1 study, PF614-MPAR-101. This study was conducted by Dr. Maria Bermudez MD, at Quotient Sciences, Miami, Florida.
On December 19, 2022, the Company announced data from the initial stage of PF614-MPAR-101 successfully demonstrating the overdose protection qualities of its drug product, PF614-MPAR.
On December 5, 2022, the Company announced that it had completed the clinical portion of the initial stage of PF614-MPAR-101, entitled ‘Single-Dose Study to Evaluate the Pharmacokinetics of oxycodone and PF614, when PF614 Solution is Co-Administered with Nafamostat, as an Immediate-Release Solution and/or Extended-Release (ER) Capsule Formulations in Healthy Subjects’, conducted by Dr. Maria Bermudez MD, at Quotient Sciences, Miami, Florida.
Financial Results

Cash – Cash and cash equivalents were $3.1 million as of December 31, 2022, as compared to $4.5 million as of September 30, 2022, and $12.3 million as of December 31, 2021. Subsequent to year-end, the Company completed a $3.0 million registered direct offering for the sale of 3,571,431 shares of the Company’s common stock at a purchase price of $0.84 per share.
Federal Grants – Funding under federal grants was $1.4 million for the fourth quarter of 2022 compared to $1.6 million in the comparable year ago quarter. For the full year 2022, funding from federal grants was $2.5 million compared to $3.5 million for full year 2021. The differences are primarily related to both pre-clinical and clinical activities for the MPARTM program.
Research & Development Expenses – R&D expenses were $6.4 million for the fourth quarter of 2022 compared to $2.2 million for the same period in 2021 and $19.8 million for the full year of 2022 compared to $4.7 million for the full year of 2021. The increases were primarily the result of increased external research and development costs related to the clinical programs for PF614 and PF614-MPAR.
General & Administrative Expenses – G&A expenses were $1.2 million for the fourth quarter of 2022 compared to $1.5 million for the same period of 2021 and $6.9 million for the full year of 2022 compared to $18.7 million for the full year of 2021. The decrease for the full year period was primarily driven by a one-time $11.6 million non-cash expense related to warrants issued under a share subscription facility.
Other Income (Expense) – Total other income (expense), net was income of $0.7 million for the fourth quarter of 2022 compared to expense of $8.0 million for the same period of 2021. For the full year periods, total other income (expense), net was income of $0.0 million in 2022 compared to expense of $9.3 million in 2021. The change in other expenses is primarily due to non-cash fair value adjustments for convertible notes and warrants.
Net Loss – Net loss for the fourth quarter of 2022 was $5.5 million compared to $10.0 million for the fourth quarter of 2021. For the full year of 2022, net loss was $24.2 million compared to $29.1 million for the full year of 2021. 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.
Corporate Update Conference Call

As 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.

Date: Tuesday, April 11, 2023
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 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.

Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Operations

2021 2020 2021 2020
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 )
Ensysce Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows

2021 2020
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
Ensysce Biosciences, Inc.
Condensed 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