Cytarabine

蛇年启新程，双喜临门。安必生制药产品“左乙拉西坦缓释颗粒”（商标名：安而和®）和“注射用阿糖胞苷”（商标名：舒凯宁®）获得国家药品监督管理局颁发的上市批件，实现新年开门红。 图：两个产品获得批准 安而和®左乙拉西坦缓释颗粒，是上海安必生制药持有的一个2.2类改良型新药，适用于12岁及以上的癫痫患者部分性发作的加用治疗。安而和®的成功获批为医药领域增添新动力，也给广大癫痫患者带来了新的治疗选择。 舒凯宁®注射用阿糖胞苷，是江苏安必生制药第五个自主持有的产品，适用于成人和儿童急性非淋巴细胞性白血病的诱导缓解和维持治疗。这也是继孟鲁司特钠片、雷贝拉唑钠肠溶片、西格列汀二甲双胍缓释片、乙酰半胱氨酸泡腾片、美沙拉秦缓释胶囊颗粒、阿戈美拉汀片第八个商业化生产的产品。 这两个产品均由安必生制药自主研发，研发人员秉承“质量源于设计”的理念，成功解决了多项技术难题。两大产品的获批，是安必生制药在研发和生产领域的重要里程碑。安必生人将继续秉承公司的使命和质量承诺：研发生产高质量的仿制药以及创新型制剂药品，让中外患者用得好，用得起，用得放心！我们坚信药品质量源于设计和生产，通过产品和工艺开发、知识管理、人员培训的持续改进，为国内外患者提供安全、有效、优质、可负担的药品！

HOUSTON, Feb. 13, 2025 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has entered into agreements with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 5,828,570 shares of common stock of the Company originally issued in December 2023 and August 2024 all at a reduced exercise price of $1.00 per share. The shares of common stock issuable upon exercise of the outstanding warrants are registered pursuant to effective registration statements on Form S-1 (File No. 333-280951) and on Form S-1 (File No. 333-276851). The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $5.8 million, before deducting financial advisory fees. Roth Capital Partners is acting as the Company's financial advisor for this transaction. In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered warrants to purchase shares of common stock. The new warrants will be exercisable for an aggregate of up to 11,657,140 shares of common stock, at an exercise price of $0.75 per share and will be immediately exercisable upon issuance and for a term of five years from the issuance date. The transaction is expected to close on or about February 14, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the Securities Act of 1933, as amended (the "1933 Act") and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. 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 shall not constitute an offer to sell or a solicitation of an offer to buy 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. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company's lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. The Company is initiating the MIRACLE ( Molecul in R/R AML AnnAraC Clinical Evaluation) Trial (MB-108), a pivotal, adaptive design Phase 3 trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia. Following a successful Phase 1B/2 study (MB-106), with input from the FDA, the Company believes it has substantially de-risked the development pathway towards a potential approval for Annamycin for the treatment of AML. This study is subject to appropriate future filings with potential additional feedback from the FDA and their foreign equivalents. Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of pathogenic viruses, as well as certain cancer indications. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the closing of the offering and the use of the proceeds thereof. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward looking statements by terminology including 'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'projects,' 'intends,' 'potential,' 'may,' 'could,' 'might,' 'will,' 'should,' 'approximately' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Investor Contact: JTC Team, LLC Jenene Thomas (908) 824-0775 [email protected] SOURCE Moleculin Biotech, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED