Ensysce Biosciences, Inc. Announces $5 Million Concurrent Registered Direct Offering and Exercise of Warrants

On August 29, 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, reported that it has entered into definitive agreements, providing the Company with aggregate gross proceeds of $5 million, for the issuance and sale of an aggregate of 3,553,194 of its shares of common stock (or common stock equivalents in lieu thereof) at a purchase price of $0.47 per share (or common stock equivalent in lieu thereof) in a registered direct offering (Press release, Ensysce Biosciences, AUG 29, 2024, View Source [SID1234646201]). The Company also entered into definitive agreements to exercise certain outstanding warrants to purchase up to an aggregate of 7,203,504 shares of common stock of the Company originally issued in February 2024, having an exercise price of $1.06 per share, at a reduced exercise price of $0.47 per share. The shares of common stock issuable upon exercise of such outstanding warrants are registered pursuant to an effective registration statement on Form S-1 (No. 333-276537). In a concurrent private placement, the Company has also agreed to issue and sell unregistered Series A-3 warrants to purchase up to an aggregate of 14,358,450 shares of common stock and unregistered Series A-4 warrants to purchase up to an aggregate of 14,358,450 shares of common stock. The Series A-3 warrants and the Series A-4 warrants will have an exercise price of $0.47 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock issuable upon exercise of the warrants. The Series A-3 warrants have a term of eighteen months from the date of stockholder approval and the Series A-4 warrants have a term of five years from the date of stockholder approval. The offerings are expected to close on or about August 29, 2024, subject to the satisfaction of customary closing conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offerings.

The gross proceeds to the Company from the concurrent offerings are expected to be approximately $5 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offerings for continued development of its TAAPTM and MPAR programs and for working capital. The net proceeds from the offerings will supplement the recently announced $14 million grant award from the National Institutes of Health supporting clinical development of PF614-MPAR, an abuse-deterrent opioid with overdose protection that has received Breakthrough Therapy designation from the FDA.

The securities offered in the registered direct offering (but excluding the unregistered warrants offered in the concurrent private placement and the shares of common stock underlying such unregistered warrants) are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-269157), including a base prospectus, previously filed with the Securities and Exchange Commission (SEC) on January 9, 2023 and declared effective by the SEC on January 17, 2023. The offering of the securities to be issued in the registered direct offering are being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The offer and sale of the unregistered warrants described above are being made in a transaction not involving a public offering and have not been registered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Rule 506(b) of Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

The Company also has agreed to amend certain existing warrants to purchase up to an aggregate of 2,000,000 shares of common stock that were previously issued in November 2023 and have an exercise price of $1.5675 per share such that the amended warrants will have a reduced exercise price of $0.47 per share effective upon the closing of the offering, and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

Crinetics Pharmaceuticals to Participate in Two Upcoming Investor Conferences

On August 29, 2024 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported that company management will participate in fireside chats at the Morgan Stanley 22nd Annual Global Healthcare Conference and the Cantor Global Healthcare Conference both being held in New York, NY in September (Press release, Crinetics Pharmaceuticals, AUG 29, 2024, View Source [SID1234646200]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Morgan Stanley 22nd Annual Global Healthcare Conference

Fireside chat on Wednesday, September 4, 2024 at 5:35 p.m. Eastern Time

Cantor Global Healthcare Conference

Fireside chat on Wednesday, September 18, 2024 at 8:35 a.m. Eastern Time

The live and archived webcasts will be accessible on the Events & Presentations page in the Investors section of the Crinetics’ website at www.crinetics.com/events.

C4 Therapeutics to Participate in Upcoming September Investor Conferences

On August 29, 2024 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, reported that C4T management will participate in fireside chats at two September investor conferences (Press release, C4 Therapeutics, AUG 29, 2024, View Source [SID1234646199]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Fireside Chat Details:

Event: Wells Fargo Healthcare Conference taking place in Boston, MA
Date/Time: September 5, 2024 at 8:45 AM ET

Event: 2024 Cantor Global Healthcare Conference taking place in New York, New York
Date/Time: September 18, 2024 at 8:35 AM ET

Live webcasts will be available on the Investors section of the company’s website at www.c4therapeutics.com. Archived replays of the webcasts will be available for approximately 30 days following the live events.

Arvinas to Participate in Upcoming Investor Conferences

On August 29, 2024 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that management will participate in two upcoming investor conferences (Press release, Arvinas, AUG 29, 2024, View Source [SID1234646198]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Wells Fargo Healthcare Conference on Thursday, September 5, 2024.

Ian Taylor, Ph.D., President, R&D, and Randy Teel, Ph.D., Chief Business Officer, will participate in a fireside chat. A live audio webcast of the presentation will be available here and on the Events + Presentations section of the Company’s website.

Cantor Global Healthcare Conference on Thursday, September 19, 2024.

Noah Berkowitz, MD, Ph.D. Chief Medical Officer, and Andrew Saik, Chief Financial Officer, will participate in a fireside chat. A live audio webcast of the presentation will be available here and on the Events + Presentations section of the Company’s website.

Artiva Biotherapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights

On August 29, 2024 Artiva Biotherapeutics, Inc. (Nasdaq: ARTV), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, reported financial results for the second quarter ended June 30, 2024, and highlighted recent progress (Press release, Artiva Biotherapeutics, AUG 29, 2024, View Source [SID1234646197]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Artiva is at an inflection point as we advance AlloNK in clinical development across multiple autoimmune indications and transition to a publicly traded company," said Fred Aslan, M.D., Artiva’s Chief Executive Officer. "With two trials in autoimmunity underway, we are focused on the potential of AlloNK in delivering effective, safe, and accessible cell therapies for patients with devastating autoimmune disease."

Recent Business Highlights

AlloNK


Treatment initiated in the first patient in an investigator-initiated basket trial (IIT) exploring AlloNK in combination with rituximab in patients with rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis/microscopic polyangiitis, and SLE. The trial is being conducted by Integral Rheumatology & Immunology Specialists (IRIS), a community rheumatology clinic, demonstrating the potential to bring AlloNK to patients in a community setting in addition to academic and transplant centers. The study is assessing the safety, tolerability, and clinical activity of AlloNK (also known as AB-101).


Announced treatment of the first LN patient in Artiva sponsored Phase 1/1b trial in April 2024. To Artiva’s knowledge, this marks the first patient to receive an allogeneic, off-the-shelf NK cell therapy in a U.S. clinical trial for treatment of an autoimmune disease. In the Phase 1/1b trial, AlloNK will be administered in combination with rituximab or obinutuzumab. The trial was expanded to include patients with SLE without kidney involvement.


Expect to report initial data on autoimmune indications from at least one of the Phase 1/1b trial or the basket IIT in the first half of 2025.

Corporate and Financial Updates


Significantly extended cash runway through the completion of Artiva’s initial public offering (IPO). Strengthened balance sheet with approximately $179.0 million in gross proceeds from the IPO in July 2024, which extends cash runway at least through the end of 2026 and through key clinical data milestones.

Second Quarter 2024 Financial Results


Cash, Cash Equivalents and Short-Term Investments. As of June 30, 2024, Artiva had cash, cash equivalents, and short-term investments of $46.6 million. In addition, Artiva completed its IPO in July 2024 in which it sold 14,920,000 shares of its common stock, including partial exercise of the overallotment option, for gross proceeds of $179.0 million.


Collaboration Revenue. Collaboration revenue was $0 for the three months ended June 30, 2024, compared to $3.5 million for the three months ended June 30, 2023. Revenues in 2023 were related to the Merck Sharpe & Dohme Corp. collaboration which was terminated in October 2023.


Research and Development Expenses. Research and development expenses were $12.3 million for the three months ended June 30, 2024, compared to $11.3 million for the three months ended June 30, 2023.


General and Administrative Expenses. General and administrative expenses were $3.9 million for the three months ended June 30, 2024, compared to $4.1 million for the three months ended June 30, 2023.


Other Income (Expense), net. Other expense, net, was $1.7 million for the three months ended June 30, 2024, compared to other income, net, of $0.5 million for the three months ended June 30, 2023. Other expense, net, for the three months ended June 30, 2024, includes a loss on change in fair value of simple agreements for future equity (SAFEs) of $2.4 million.


Net Loss. Net loss totaled $17.8 million for the three months ending June 30, 2024, as compared to $11.3 million for the three months ending June 30, 2023, with non-cash stock-based compensation expense of $1.5 million and $2.5 million for the three months ended June 30, 2024 and 2023, respectively.