Rezafungin acetate

SAN DIEGO, May 15, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today reported financial results for the first quarter ended March 31, 2024, and provided an update on its corporate activities and product pipeline. “Our reacquisition of our CD388 program, which we have developed to date in collaboration with Janssen Pharmaceuticals, Inc., a Johnson & Johnson Company, (Janssen) as a once-per-flu season universal preventative of influenza A and B, along with the divestiture of the rezafungin program to our former partner Mundipharma, enables us to focus all of our development efforts on our Cloudbreak DFC platform,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Our priority now is to evaluate the efficacy and safety of CD388 in providing season-long, universal protection from influenza in a Phase 2b study, which we intend to initiate during the upcoming Northern Hemisphere influenza season.” Dr. Stein continued, “Concurrent with the reacquisition of CD388, we closed a $240.0 million private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund (BVF), and Canaan Partners. We are thrilled with the substantial investment by this top-tier syndicate of new and existing investors and believe it is indicative of the significant potential of CD388 as a universal preventative of seasonal and pandemic influenza. We believe that CD388 may have significant advantages beyond and in addition to flu vaccines, with the potential for universal protection even in the absence of a robust immune system, and without the requirement for seasonal influenza strain prediction.” Recent Corporate Highlights Reacquired exclusive global development and commercial rights to CD388: In April 2024, Cidara entered into a definitive agreement with Janssen, to reacquire the exclusive global development and commercial rights to CD388, which is in development for the prevention of all strains of influenza A and B. Cidara is finalizing the protocol for a Phase 2b clinical trial, which the Company intends to initiate during the upcoming Northern Hemisphere influenza season. Closed $240.0 million private placement: In April 2024 and in conjunction with the reacquisition of CD388, Cidara closed a definitive agreement for the sale of preferred stock in a $240.0 million private placement led by RA Capital Management, with significant participation from Bain Capital Life Sciences, BVF, and Canaan Partners. The proceeds from the private placement were used to fund the upfront payment of $85.0 million under the agreement with Janssen and the remainder of the gross proceeds of $155.0 million are expected to provide runway beyond topline data from CD388’s planned Phase 2b trial. Divested rezafungin to its former licensee, Mundipharma: In April 2024, Cidara entered into an asset purchase agreement with Napp Pharmaceutical Group Limited, a member of the international network of Mundipharma independent associated companies, for the divestiture of rezafungin. Cidara estimates that it will achieve approximately $128.0 million in cost savings over the patent life of rezafungin. Appointed Laura Tadvalkar, Ph.D., Ryan Spencer, and James Merson, Ph.D., to Board of Directors: In April 2024 and in connection with the private placement, appointed Dr. Tadvalkar, Managing Director at RA Capital Management, Mr. Spencer, Chief Executive Officer and a director of Dynavax Technologies, and Dr. Merson, former Global Therapeutic Area Head for Infectious Diseases at Janssen Research & Development, LLC, to the Company’s Board of Directors, while David Gollaher, Ph.D. and Timothy Franson, M.D., stepped down from the Board. Announced a Reverse Stock Split: On April 12, 2024, Cidara’s Board of Directors approved a 1-for-20 reverse stock split. On April 22, 2024 the Company filed an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of its issued and outstanding common stock, at a ratio of 1-for-20, and a reduction in the number of authorized shares of common stock, at a ratio that is equal to half of the reverse stock split ratio. The Company’s common stock began trading on a split-adjusted basis commencing upon market open on April 24, 2024 under a new CUSIP number, 171757206, and remain listed on the Nasdaq Capital Market under the symbol “CDTX”. Presented at 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) conference: In April 2024, Cidara presented data from the Phase 2a study of CD388, showing the DFC was well tolerated and demonstrated statistically significant antiviral effects when administered as a single subcutaneous dose in healthy volunteers challenged with influenza at the 34th ESCMID conference. The Company also presented data from a Phase 1 single ascending dose study of CD388 which showed the drug has an extended half-life of 6-8 weeks. Presented at AACR Annual Meeting 2024: In April 2024, Cidara presented new data on novel Cloudbreak DFC candidates at the AACR Annual Meeting. The Company delivered four poster presentations highlighting the data on the Company’s multispecific CD73/PD-1 DFC, its CCR5-targeting DFC, and CBO421, its lead oncology DFC candidate targeting CD73. First Quarter 2024 Financial Results Revenue totaled $8.5 million for the three months ended March 31, 2024, compared to $26.1 million for the same period in 2023. Revenue for the three months ended March 31, 2024 related to the achievement of a milestone, ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta, royalty revenue, as well as product revenue related to shipments of REZZAYO naked vials to Mundipharma. Revenue for the three months ended March 31, 2023 related to the achievement of a milestone and ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta. Cash and cash equivalents totaled $29.0 million as of March 31, 2024, compared with $35.8 million as of December 31, 2023. Cost of product revenue was $1.6 million for the three months ended March 31, 2024, and primarily consisted of direct material costs, third-party manufacturing costs and indirect overhead costs associated with the manufacture, quality assessment and delivery of REZZAYO naked vials shipped to Mundipharma. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred. Research and development expenses were $11.6 million for the three months ended March 31, 2024, compared to $18.9 million for the same period in 2023. The decrease in research and development expenses for the three months ended March 31, 2024, compared to the three months ended March 31, 2023 is primarily due to lower clinical expenses associated with the rezafungin clinical trials, lower clinical expenses associated with our Cloudbreak platform and lower personnel costs. Selling, general and administrative (SG&A) expenses were $6.0 million for the three months ended March 31, 2024, compared to $4.5 million for the same period in 2023. The SG&A expenses for all periods primarily relate to consulting, personnel and legal costs. Net loss for the three months ended March 31, 2024 was $10.3 million, compared to a net income of $3.0 million for the same period in 2023. During the three months ended March 31, 2024, Cidara did not sell shares of common stock pursuant to its at-the-market sales agreement. As of March 31, 2024, Cidara had 4,561,696 shares of common stock outstanding and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 1,052,236 shares of common stock. About Cidara Therapeutics Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. Cidara is headquartered in San Diego, California. For more information, please visit Forward-Looking Statements This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether we will start a Phase 2b clinical trial for CD388 in 2024, whether CD388 will be shown to have advantages beyond and in addition to flu vaccines, and whether CD388 will ultimately be approved for commercial sale by regulators in the U.S. or any country or will generate any revenue. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, delays in action by regulatory authorities, and other obstacles on the enrollment of patients or other aspects of CD388, or other DFC development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise. INVESTOR CONTACT: Brian Ritchie LifeSci Advisors (212) 915-2578 britchie@lifesciadvisors.com MEDIA CONTACT: Michael Fitzhugh LifeSci Communications mfitzhugh@lifescicomms.com CIDARA THERAPEUTICS, INC. Condensed Consolidated Statements of Operations (unaudited) Three Months Ended March 31, (In thousands, except share and per share data) 2024 2023 Revenues: Collaboration revenue $ 5,637 $ 26,107 Product revenue 2,826 — Total revenues 8,463 26,107 Operating expenses: Cost of product revenue 1,563 — Research and development 11,593 18,869 Selling, general and administrative 5,998 4,457 Total operating expenses 19,154 23,326 Income (loss) from operations (10,691 ) 2,781 Other income, net: Interest income, net 365 232 Total other income, net 365 232 Net income (loss) and comprehensive income (loss) (10,326 ) 3,013 Allocation of earnings to participating securities — (636 ) Net income (loss) attributable to common stockholders $ (10,326 ) $ 2,377 Basic net earnings (loss) per common share $ (2.28 ) $ 0.60 Diluted net earnings (loss) per common share $ (2.28 ) $ 0.60 Shares used to compute basic net earnings (loss) per common share 4,537,782 3,932,050 Shares used to compute diluted net earnings (loss) per common share 4,537,782 5,059,514 Condensed Consolidated Balance Sheet Data March 31, 2024 December 31, 2023 (In thousands) (unaudited) Cash and cash equivalents $ 29,018 $ 35,778 Total assets 52,716 67,030 Total liabilities 70,496 75,240 Total stockholders’ equity (deficit) (17,780 ) (8,210 )

2023年，FDA的CDER一共批准了55款新分子实体（NME）药物，其中包括6款多肽类药物，占据CDER今年批准新分子实体药物的11%，称得上大获丰收之年。多肽获批新药从治疗领域来看，抗肿瘤（一款用于治疗；一款用于肿瘤诊断）、抗感染和罕见病（Rett综合征、全身性重症肌无力）领域各2款。 · DAYBUE（trofinetide，曲非奈肽）是一种新型的IGF-1氨基末端三肽的类似物，于2023年3月被FDA批准用于治疗2岁及以上儿童的雷特综合征。这是治疗雷特综合症的里程碑式事件，在审批过程中，FDA授予了DAYBUE优先审评、孤儿药和快速通道认定的头衔。 · REZZAYO（rezafungin）是一种新型棘白菌素，通过抑制β-1,3-葡萄糖合成酶从而扰乱真菌细胞壁的完整性来发挥作用，也成为十多年来首个获得FDA批准的新棘白菌素。 · POSLUMA（flotufolastat F 18）于2023年5月25日，得到FDA监管批准，用于疑似转移的前列腺癌男性的PSMA阳性病变的PET。它是第一个获得FDA批准的采用专有放射性杂交技术开发的PSMA靶向成像剂。 · PAXLOVID由于疫情原因在2021年12月22日获得了FDA的紧急使用授权，但正式获批日期是2023年5月25日。PAXLOVID中包含两种活性成分nirmatrelvir和ritonavir，它们都是拟肽类物质，两种拟肽相得益彰，造就了Paxlovid“沧海横流，方显英雄本色”的医药史地位。 · APHEXDA（motixafortide）与非格司亭(G-CSF)联合使用，将造血干细胞动员至外周血，用于多发性骨髓瘤患者的采集和随后的自体移植。这是十年来美国批准的第一个用于治疗多发性骨髓瘤的干细胞动员创新药物。 · ZILBRYSQ（zilucoplan）获FDA批准用于治疗抗乙酰胆碱受体（AChR）抗体阳性的全身型重症肌无力（gMG）成年患者。该药是一种每日一次经皮下给药的新型大环肽类C5补体抑制剂。2019年，其被FDA授予孤儿药资格，2023年12月1日，zilucoplan获得了欧盟委员会针对gMG的批准。 Global多肽药物的优势在于其有较高的靶向性和选择性，以及相对较低的毒副作用。FDA已批准的多肽药物主要分布在7大疾病治疗领域，包括罕见病、肿瘤、糖尿病、胃肠道、免疫、心血管疾病、骨科等。 2022年全球市场销售额排名前十的多肽类药物中前八名均为糖尿病或肥胖症用药，主要以GLP-1受体激动剂为主。其中销售额最高的司美格鲁肽2022年全球销售额达到109.14亿美元，度拉糖肽以74.40亿美元紧随其后。此外，GLP-1类药物（司美格鲁肽）在糖尿病和肥胖相关的心衰（HFpEF）和慢性肾病（CKD）领域均取得优异治疗效果，并在积极拓展阿尔兹海默（AD）和非酒精性脂肪肝（NASH）等适应症。随着司美格鲁肽、度拉糖肽等GLP-1多肽药物销售快速增长，全球肽类药物市场规模有望加速扩容，迎来多肽药物的春天。 目前全球获批的多肽类药物约180种，2022年全球多肽药物市场规模达729亿美元，2023年全球多肽药物市场规模将达到795亿美元，从区域分布来看，目前美国和欧洲是多肽药物最主要的市场，其中，美国占比高达42.43%。而司美格鲁肽作为一种新型多肽药物，以其卓越的疗效和广阔的市场前景，成为了2023年的多肽“爆款”药物。 其作为诺和诺德的明星产品，在2023年共取得了212.01亿美元的销售额，其中注射液Ozempic（2型糖尿病）收入139.17亿美元，同比增长60%；片剂Rybelsus（2型糖尿病）收入27.26亿美元，同比增长66%；注射液Wegovy（肥胖）收入45.57亿美元，同比增长407%。这一成就的背后，是多肽药物行业的飞速发展和技术创新的不断突破。 Domestic中国多肽药物市场的产品结构与国际成熟市场差异显著，国内销售额较大的多肽药物主要是抗肿瘤和免疫调节类产品，与发达国家相比，中国多肽药物其他治疗领域市场份额还相对较少，随着我国鼓励创新药研发和推进仿制药一致性评价工作的政策出台，预计未来将有更多具有显著临床效果的多肽创新药和多肽仿制药获批上市，使得我国多肽药物市场进一步扩容。 我国多肽药物市场由2016年的415.8 亿元增长至2020年的595亿元，期间复合增长率达到9.37%。预计2023年中国多肽类药物市场规模将达到881亿元。 多肽创新药物的研发与生产存在较高壁垒，下游药企倾向于和专业的多肽CDMO或原料药企业合作，实现降本增效。根据弗若斯特沙利文数据，2021-2030年全球多肽CDMO市场规模有望由22亿美元增长至118亿美元，CAGR为21%；中国多肽CDMO市场规模有望从13亿元增长至185亿元，CAGR为34%。国内多肽CDMO虽然起步较晚，但凭借成本优势和技术、产能上的突破，有望赶超海外头部企业。 References参考文献 1、《GLP~1多肽药物固相合成载体和辅助材料行业分析，GLP~1多肽药物成长可期，固相载体和纯化材料有望受益-231110》，野村东方国际证券，2023.11 2、《多功能GLP-1药物引领行业发展，关注上游原料药板块》，平安证券，2023.11 内容来源于网络，如有侵权，请联系删除。