Ensysce Biosciences(ENSC)
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Ensysce Biosciences, Inc. (ENSC) CEO Dr. Lynn Kirkpatrick on Corporate Update Call (Transcript)
2022-04-06 17:57
Ensysce Biosciences, Inc. Corporate Update Conference Call Summary Company Overview - **Company**: Ensysce Biosciences, Inc. (NASDAQ: ENSC) - **Industry**: Biotech, focusing on opioid drug development - **Key Technologies**: - **TAAP** (Trypsin-Activated Abuse Protection): Aims to reduce abuse and overdose of opioids - **MPAR** (Multi-Pill Abuse Resistance): Designed to prevent overdose when more than the prescribed dose is taken - **Investment**: Over $100 million since inception, with more than 100 patents issued in 25 countries [5][6] Core Points and Arguments - **Focus on Opioid Crisis**: Ensysce aims to address the opioid crisis through innovative drug safety technologies [5] - **FDA Approval**: Received FDA allowance for Investigational New Drug Application (IND) for PF614-MPAR, a combination product for abuse deterrence and overdose protection [8] - **Funding**: Received $2.8 million from the National Institute on Drug Abuse (NIDA) for Phase 1 study of PF614-MPAR, totaling $8 million in support from NIDA [9] - **Public Market Debut**: Listing on NASDAQ has provided opportunities for clinical program progression [10] - **Management Team Expansion**: Appointment of Dr. Linda Pestano as Chief Development Officer to enhance drug development efforts [11] Clinical Program Updates - **Phase 1 Study Enrollment**: First patients enrolled in the Phase 1 study of PF614-MPAR, which combines abuse and overdose protection [12] - **Multi-Ascending Dose Study**: Completed first part of clinical study PF614-102, with data expected by the end of Q2 2022 [14] - **Bioequivalence Study**: Initiated in January 2022, comparing PF614 to OxyContin, with data expected by the end of Q2 2022 [14] - **Human Abuse Liability Studies**: Two studies planned to evaluate abuse deterrent labeling, with data expected in Q3 2022 and Q1 2023 [15][24] Financial Highlights - **Revenue Growth**: Federal grant funding increased to $1.6 million in Q4 2021 from $0.4 million in Q4 2020; total funding for 2021 was $3.5 million [17] - **Operating Expenses**: R&D expenses rose to $2.2 million in Q4 2021 from $1.3 million in Q4 2020; G&A expenses increased significantly due to public company costs [18] - **Net Loss**: Total net loss for 2021 was $29.1 million, with significant non-cash expenses related to fair value adjustments [20] - **Cash Position**: Ended 2021 with $12.3 million in cash, up from $0.2 million at the end of 2020 [21] Future Outlook - **Upcoming Milestones**: Anticipated reporting on three major data milestones by the end of 2022, including clinical study results and safety data [24] - **Market Positioning**: Ensysce believes it is well-positioned to create long-term shareholder value by addressing prescription drug abuse and expanding its technology platforms [23] Additional Considerations - **Supply Chain Issues**: Acknowledgment of prevalent supply chain issues affecting drug development timelines [25] - **Regulatory Pathway**: Ongoing discussions with the FDA regarding the 505(b)(2) regulatory pathway for PF614 [33] This summary encapsulates the key points from the Ensysce Biosciences conference call, highlighting the company's focus on innovative opioid solutions, financial performance, and future milestones.
Ensysce Biosciences(ENSC) - 2021 Q4 - Annual Report
2022-03-31 20:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended: December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-38306 ENSYSCE BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) | --- | --- | |----------------------------------------- ...
Ensysce Biosciences(ENSC) - 2021 Q3 - Quarterly Report
2021-11-15 22:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 par value per share Warrants to purchase one share of Common Stock ENSC ENSCW The Nasdaq Stock Market LLC The Nasdaq Stock Market LLC Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SEC ...
Ensysce Biosciences(ENSC) - 2021 Q2 - Quarterly Report
2021-08-16 12:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Delaware 82-2755287 ( State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 7946 Ivanhoe Avenue, Suite 201 La Jolla, California 92037 (Address of principal executive offices) (Zip Code) Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 par value per share Warrants to purchase one share of Common Stock ENSC ENSCW The Nasdaq Stock Market LLC The ...
Ensysce Biosciences(ENSC) - 2021 Q1 - Quarterly Report
2021-06-08 01:56
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38306 LEISURE ACQUISITION CORP. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorpo ...
Ensysce Biosciences(ENSC) - 2020 Q4 - Annual Report
2021-03-15 19:36
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission file number: 001-38306 LEISURE ACQUISITION CORP. (Exact name of registrant as specified in its charter) | --- | --- | |-------------------------------- ...
Ensysce Biosciences(ENSC) - 2020 Q3 - Quarterly Report
2020-11-09 21:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38306 LEISURE ACQUISITION CORP. (Exact name of registrant as specified in its charter) | --- | --- | |---------------------------- ...
Ensysce Biosciences(ENSC) - 2020 Q2 - Quarterly Report
2020-08-07 20:46
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38306 LEISURE ACQUISITION CORP. (Exact name of registrant as specified in its charter) | --- | --- | |--------------------------------- ...
Ensysce Biosciences(ENSC) - 2020 Q1 - Quarterly Report
2020-05-07 20:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-38306 LEISURE ACQUISITION CORP. (Exact name of registrant as specified in its charter) | --- | --- | |-------------------------------- ...
Ensysce Biosciences(ENSC) - 2019 Q4 - Annual Report
2020-03-10 20:21
Merger and Acquisition Strategy - The company entered into a Merger Agreement with GTWY Holdings, which is the parent of Gateway Casinos & Entertainment Limited, one of Canada's largest gaming companies, involving a proposed business combination[21]. - The company intends to focus on the location-based leisure sector for potential acquisitions, leveraging the management team's expertise[41]. - The acquisition strategy includes identifying and building a company in the leisure sector, with plans for additional mergers and acquisitions post-Business Combination[42]. - The company plans to utilize its management team's networks to identify acquisition opportunities and conduct thorough due diligence on prospective target businesses[43][44]. - The Business Combination must involve target businesses with an aggregate fair market value of at least 80% of the assets held in the Trust Account[51]. - The company may structure the Business Combination to acquire less than 100% of the target business, provided it maintains a controlling interest of 50% or more of the voting securities[52]. - The company anticipates that target business candidates will be sourced from various unaffiliated entities, including investment banking firms and private equity groups[66]. - The company may continue to seek a Business Combination with a different target if the initial proposed Business Combination is not completed[111]. - The company is considering a Business Combination with an operating company in the leisure sector but is not limited to any specific industry[216]. - The company will not pursue a Business Combination with another blank check company or a business directly competitive with Inspired due to non-competition agreements[217]. Financial Overview - The Initial Public Offering (IPO) generated total gross proceeds of $200 million from the sale of 20 million units at $10.00 per unit, with an additional $6.825 million raised from a private placement of warrants[25]. - As of the IPO closing date, $200 million was deposited into a Trust Account, invested in U.S. government treasury bills or money market funds[26]. - The company has approximately $188,312,000 available for a Business Combination as of December 31, 2019, after accounting for $7,000,000 in deferred underwriting fees[59]. - A strategic investor has entered into a Contingent Forward Purchase Contract for gross proceeds of approximately $62,500,000, involving the purchase of 6,250,000 units at $10.00 per unit[60]. - The initial amount held in the Trust Account was $10.00 per public share, expected to increase with accrued interest[93]. - The company has $1,061,151 of proceeds held outside the Trust Account as of December 31, 2019, which may be used for costs associated with dissolution[115]. - The company has received working capital loans of $1,000,000 in January 2020[188]. - The company must maintain a minimum stockholders' equity of $2,500,000 to continue listing on Nasdaq[175]. Business Combination Process - The company has until April 5, 2020, to complete a Business Combination, with the possibility of extending this deadline upon stockholder approval[27]. - Stockholder approval is required if shares issued equal or exceed 20% of the outstanding common stock[84]. - The company may conduct redemptions without stockholder votes under SEC tender offer rules[80]. - Redemptions will be conducted for at least 20 business days if following tender offer rules[97]. - The company will not complete the Business Combination if public stockholders tender more shares than offered[97]. - The company anticipates that the per-share redemption price will be based on the aggregate amount in the Trust Account divided by outstanding public shares[93]. - If stockholder approval is required, redemptions will be conducted in conjunction with a proxy solicitation[98]. - The company may seek to recruit additional managers post-Business Combination[79]. - The management team intends to devote necessary time to the Business Combination process, although no specific hours are mandated[53]. - The company may seek to raise additional funds through private offerings of debt or equity securities in connection with the Business Combination[64]. Risks and Challenges - The company has not engaged in any operations or generated revenue to date, classifying it as a "shell company" under the Securities Exchange Act of 1934[40]. - The lack of business diversification may expose the company to significant risks in a single industry[76]. - The company may face intense competition from other entities in identifying and acquiring target businesses, which could limit its ability to acquire larger targets[133]. - Risks associated with combining with financially unstable businesses may adversely impact the company[218]. - Stockholders may experience a reduction in the value of their shares post-Business Combination, with limited remedies available[218]. - If the Business Combination is not completed, public stockholders who elected to redeem their shares will not be entitled to redeem for the pro rata share of the Trust Account[110]. - If too many public stockholders exercise their redemption rights, the company may not meet closing conditions for a Business Combination[155]. - The ability of public stockholders to redeem shares may make the company's financial condition unattractive to potential Business Combination targets[154]. - If the funds outside the Trust Account are insufficient, the company may need to borrow funds or liquidate[188]. - If the Business Combination is not completed, public stockholders may receive less than $10.35 per share upon liquidation[188]. Compliance and Regulatory Issues - The company is classified as an "emerging growth company" and will remain so until it meets certain revenue or market value thresholds[58]. - The company is exempt from certain SEC rules protecting stockholders in blank check companies due to having net tangible assets exceeding $5,000,000[179]. - If the company is deemed an investment company, it may face burdensome compliance requirements that could hinder its ability to complete a Business Combination[202]. - The Trust Account is intended to hold funds pending the completion of a Business Combination or the return of funds to public stockholders[206]. - The company does not plan to comply with certain procedures under Delaware law, which may increase stockholder liability[209]. - If bankruptcy occurs, the Trust Account proceeds may be subject to claims from third parties, potentially affecting stockholder distributions[128]. - The company has not secured third-party financing for the Business Combination, and there is no assurance that such financing will be available[59]. - The company has the ability to register a significant number of securities, which may adversely affect the market price of its common stock[215]. - The grant of registration rights to initial stockholders may complicate the completion of a Business Combination and affect the market price of common stock[214].