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]).

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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.

On August 29, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that management will present virtually at the H.C. Wainwright 26th Annual Global Investment Conference (Press release, Compugen, AUG 29, 2024, https://www.prnewswire.com/news-releases/compugen-to-present-at-the-hc-wainwright-26th-annual-global-investment-conference-302233882.html [SID1234646216]). The presentation will be available on demand on the Investor Relations section of Compugen’s website at www.cgen.com from Monday, September 9, 2024, 7:00 AM ET for 30 days.

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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

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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]).

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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

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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.

On August 29, 2024 Transcenta Holding Limited ("Company"; stock code: 6628.HK) reported the unaudited consolidated results of the Company and its subsidiaries (collectively, the "Group") for the six months ended June 30, 2024 (the "Reporting Period") (Press release, Transcenta, AUG 29, 2024, View Source [SID1234646217]).

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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

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In the first half of 2024, the Company continued to accelerate clinical progress across both the oncology and non-oncology pipelines.

For company’s lead oncology asset, the Claudin18.2-targeting antibody osemitamab (TST001, A Humanized ADCC Enhanced Claudin18.2 mAb for Solid Tumors), reached key milestones for the treatment of gastric or gastroesophageal junction (G/GEJ) cancer. Company published the encouraging Phase II data of osemitamab (TST001) in combination with checkpoint inhibitor and standard chemotherapy as first-line treatment of G/GEJ cancer at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (ASCO) (Free ASCO Whitepaper), showing that high/medium Claudin18.2 expression is associated with a median PFS of 12.6 months. At the same period, Company published the safety and PK data of TranStar101 study at the 2024 AACR (Free AACR Whitepaper) annual meeting. The safety and pharmacokinetic profile of osemitamab (TST001) in the U.S. patients, is consistent with the profile reported in Chinese patients from TranStar102 study.

Worked with Agilent Technologies, Inc. (Agilent), a world leader in CDx development, and developed a Claudin18.2 companion diagnostic test that can fully support the global pivotal trial of osemitamab (TST001). Successfully received regulatory clearances from the U.S. Food and Drug Administration (FDA), China Center for Drug Evaluation (CDE) and South Korea Ministry of Food and Drug Safety (MFDS). All the achievements validate and further support strategy for the Global Phase III trial (TranStar301). Osemitamab (TST001) is on track to become the first global therapy that delivers the next wave of innovation in the first-line treatment of patients with Claudin18.2 expressing locally advanced or metastatic G/GEJ cancer. Company also plans to explore several Claudin18.2 expressing advanced solid tumors other than G/GEJ cancer.

For lead non-oncology asset, the anti-sclerostin antibody blosozumab (TST002, A Humanized Sclerostin mAb for Osteoporosis), published Single Ascending Dose (SAD) study result in the 2024 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO Congress) in April. After a single dose of blosozumab (TST002) up to 1,200 mg, the average increase of lumbar spine BMD at day 85 (D85) ranged from 3.52% to 6.20% and total hip BMD from 1.30% to 2.24% across dose cohorts. The lumbar spine BMD increase exceeded the least significant difference level (2.77%) and was clinically meaningful.

In addition, Company has completed the enrolment of patients in the dose-escalation part for the First-in-Human (FIH) trial of first-in-class anti-GREMLIN-1 antibody TST003 and the trial is ongoing at multiple clinical centers in the U.S. and China. Have presented one Trial in Progress (TiP) poster of TST003-1001 study at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April.

Furthermore, progress had been made in improving the continuous bioprocessing platform technology HiCB (Highly Intensified Continuous Bioprocessing) and the technology was successfully implemented in the GMP manufacturing of osemitamab (TST001).

Research/Early Development Update:

TST013 (An ADC Candidate Targeting a Validated Tumor Antigen)- TST013 displayed significantly improved anti-tumor activity relative to benchmark ADC and improved tolerability profile which warrants further development
TST808 (A Humanized Antibody Neutralizing One of the Validated Key Targets Regulating B/Plasma Cell Proliferation and Survival) – TST808 has the potential to treat multiple autoimmune renal disorders including IgA nephropathy. Company has obtained the lead molecules and initiated the IND-enabling studies
Business Development Achievements:

Company has continued the collaboration with Agilent for the Claudin18.2 specific IHC CDx Assay to support TranStar301 global Phase III pivotal trial of osemitamab (TST001) in combination with checkpoint inhibitor and chemotherapy
Company has continued the clinical trial collaboration with BMS, and completed the enrolment with osemitamab (TST001),checkpoint inhibitor and chemotherapy combination in TranStar102 in China and in TranStar101 in the U.S.
Technology Partnership & Advancement:

Company has formed a strategic alliance with a company specialized in siRNA drug substance synthesis, to provide CDMO services in siRNA formulation development and F&F
Company’s in-house cell culture media ExcelPro CHO are being evaluated for its performance against market standards for fed-batch, intensified fed-batch and perfusion processes by several external partners including a global leading company of media. This is part of potential collaboration for global commercialization of ExcelPro CHO

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.

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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.