Tegafur/Gimeracil/Oteracil Potassium

CHARLOTTESVILLE, Va., March 01, 2024 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 1,150,000 shares of common stock of the Company originally issued in October 2023, having an exercise price of $2.82 per share and eighteen months term. The shares of common stock issuable upon exercise of the warrants are registered pursuant to an effective registration statement on Form S-1 (No. 333-275397). The gross proceeds to the Company from the exercise of the warrants are expected to be $3,530,500, prior to deducting placement agent fees and estimated offering expenses. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. In consideration for the immediate exercise of the warrants for cash and the payment of $0.125 per new warrant, the Company will issue new unregistered warrants to purchase up to 2,300,000 shares of common stock. The new warrants will have an exercise price of $2.82 per share, will be immediately exercisable upon issuance and will have a term of eighteen months from the issuance date. The offering is expected to close on or about March 6, 2024, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds for general corporate purposes, including general and administrative expenses, working capital and to support regulatory and clinical activities related to AD04, its lead investigational drug product for the treatment of Alcohol Use Disorder (AUD). The new warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the new warrants issued in the private placement and the shares of common stock underlying the new warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants. This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. About Adial Pharmaceuticals, Inc. Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company's lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients and was recently investigated in the Company's ONWARD™ pivotal Phase 3 clinical trial for the potential treatment of AUD in subjects with certain target genotypes (estimated to be approximately one-third of the AUD population) identified using the Company's companion diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, and no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com. Forward-Looking Statements This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include without limitation, statements regarding the closing of the private placement, the satisfaction of the closing conditions of the private placement, and the use of net proceeds from the private placement as well as the potential of AD04 to treat other addictive disorders such as opioid use disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, market and other conditions, our ability to pursue our regulatory strategy, our ability to maintain our Nasdaq listing, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to retain our key employees or maintain our Nasdaq listing, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2022, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law. Investor Contact Crescendo Communications, LLCDavid Waldman / Alexandra SchiltTel: 212-671-1020Email: adil@crescendo-ir.com

SHANGHAI, Sept. 21, 2023 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced the publication of two cases of the treatment of metastatic pancreatic cancer with CARsgen's CT041, an innovative Claudin (CLDN) 18.2 CAR T-cell Therapy, in Journal of Hematology & Oncology (IF 23.186), titled "CT041 CAR T cell therapy for Claudin18.2–positive metastatic pancreatic cancer" ()[1] (NCT04581473 and NCT03874897). For case 1, a 58-year-old woman was diagnosed with pancreatic cancer with lung and lymph nodes metastasis. First-line nab-paclitaxel plus gemcitabine and second-line irinotecan-liposome plus 5-flurouracil were failed before she was enrolled in CT041 clinical trial, after confirming CLDN18.2 expression as 2+/70%. After lymphodepletion consisting of fludarabine, cyclophosphamide, and nab-paclitaxel, a CT041 dose of 250 × 106 cells was administered to the patient in September 2021. Grade 2 cytokine release syndrome (CRS) occurred, which was later controlled by tocilizumab. Partial response (PR) was achieved according to RECIST v1.1, with great shrinkage of lung metastasis. For case 2, a 75-year-old woman was diagnosed as pT2N0 pancreatic cancer after she underwent surgery in May 2019. Lung metastasis was found after 5 months during routine post-surgery follow-up. S-1 monotherapy was given as the first-line chemotherapy starting from December 2019. During the surgical area palliative radiation, tumor progression was observed in the lung. Since the CLDN18.2 expression was determined as 3+/60%, the patient was enrolled in CT041 clinical trial. After receiving lymphodepletion consisting of fludarabine, cyclophosphamide and nab-paclitaxel, the patient was infused with a CT041 dose of 250 × 106 cells in July 2021. Patient experienced grade 2 CRS, which was further controlled with tocilizumab. PR was reached since the first evaluation 4 weeks after infusion. Target lesions of lung metastasis subsequently disappeared and achieved complete response. The tumor was still under well control until the last follow-up in July 2023. The peripheral blood CLDN18.2 CAR copy number in both patients exhibited a rapid post-infusion increase, peaking within 2 weeks. Concurrently, fluorescence-activated cell sorting results indicated an increase in peripheral blood CD8+ T cells and Treg cells, alongside a reduction in CD4+ T cells and B cells. These shifts in immune cell phenotypes demonstrated greater persistence compared to alterations in cytokine levels. Raffaele Baffa, MD, PhD, Chief Medical Officer of CARsgen Therapeutics, remarked that, "I am delighted to see the publication of two cases on our CT041's treatment of metastatic pancreatic cancer cases in the Journal of Hematology & Oncology. The fact that both patients achieved partial response after receiving CT041 infusion is truly encouraging. Pancreatic cancer remains one of the most challenging malignancies in the field of oncology, with extremely poor prognosis and limited treatment options. Therefore, the development of innovative therapy is crucial in providing hope to pancreatic cancer patients. Our preliminary data from the treatment of pancreatic cancer with CAR T-cell therapy indicate its potential in achieving significant anti-tumor responses, even in patients who have failed multiple previous treatment regimens. We believe that CT041 has the potential to transform the treatment landscape of pancreatic cancer and other solid tumors, offering new hope to patients and their families." About CT041 CT041 is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. CT041 targets the treatment of Claudin18.2 positive solid tumors with a primary focus on GC/GEJ and PC. Trials in CARsgen include investigator-initiated trials (NCT03874897), a Phase Ib clinical trial for advanced GC/GEJ and PC and a confirmatory Phase II clinical trial for advanced GC/GEJ in China (CT041-ST-01, NCT04581473), a Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). CT041 was granted Regenerative Medicine Advanced Therapy (RMAT) Designation by U.S. FDA for the treatment of advanced GC/GEJ with Claudin18.2-positive tumors in January 2022 and was granted PRIME eligibility by the EMA for the treatment of advanced gastric cancer in November 2021. CT041 received Orphan Drug designation from the U.S. FDA in 2020 for the treatment of GC/GEJ and Orphan Medicinal Product designation from the EMA in 2021 for the treatment of advanced gastric cancer. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform, encompassing target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable. Forward-Looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading "Principal Risks and Uncertainties" in our most recent annual report and interim report and other announcements and reports made available on our corporate website, . No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Reference 1. Qi, C., Xie, T., Zhou, J. et al. CT041 CAR T cell therapy for Claudin18.2-positive metastatic pancreatic cancer. J Hematol Oncol 16, 102 (2023). Contact CARsgen For more information, please visit Public Relations: [email protected] Investor Relations: [email protected] SOURCE CARsgen Therapeutics