Casdozokitug

– Remaining $60 Million of outstanding convertible notes to be repurchased post-close of pending UDENYCA divestiture – REDWOOD CITY, Calif., April 01, 2025 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus” or the “Company,” NASDAQ: CHRS) announced today that it has entered into privately negotiated transactions (the “Repurchases”) with certain holders (the “Holders”) of its 1.500% Convertible Senior Subordinated Notes due 2026 (the “Convertible Notes”), pursuant to which the Company agreed to repurchase approximately $170 million aggregate principal amount of the Convertible Notes from such holders at a cash repurchase price equal to 100% of their principal amount, together with the accrued and unpaid interest to, but excluding, the date of repurchase. The Repurchases are conditioned upon, among other things, the closing of the previously announced divestiture of the UDENYCA (pegfilgrastim-cbqv) franchise pursuant to that certain asset purchase agreement (the “Agreement”), dated as of December 2, 2024 between the Company and Intas Pharmaceuticals Ltd. (“Intas”), a limited company incorporated in India (the “Transaction”). Following the closing of the Repurchases, approximately $60 million aggregate principal amount of Convertible Notes will remain outstanding. Following the closing of the Transaction, Coherus intends to conduct a repurchase offer for such remaining Convertible Notes pursuant to the Fundamental Change Repurchase Right (as defined in the indenture, dated as of April 17, 2020 (the “Indenture”), between the Company and U.S. Bank Trust Company, National Association, as trustee (the “Trustee”)) at a cash repurchase price equal to 100% of their principal amount, together with the accrued and unpaid interest to, but excluding, the date of repurchase. Coherus also announced today that the Holders party to the Repurchases, which constitute a majority of the aggregate principal amount of the outstanding Convertible Notes, have agreed to provide their consent (the “Requisite Consents”) to adopt certain proposed amendments (the “Amendments”) to the Indenture. In connection with the Requisite Consents, the Company and the Trustee will execute a supplemental indenture (the “Supplemental Indenture”) to the Indenture effecting the Amendments. The Amendments will modify the Indenture to permit the proposed transaction for the divestiture of UDENYCA. About Coherus BioSciences Coherus is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI® (toripalimab-tpzi), with growing revenues and a promising pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, and other cancers. Our strategy is to grow sales of LOQTORZI in nasopharyngeal carcinoma and advance the development of new indications for toripalimab in combination with both our pipeline candidates as well as our partners’, driving multiple development and sales synergies from proprietary combinations. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in three ongoing clinical studies: a Phase 1/2 study in advanced solid tumors including combination with toripalimab in NSCLC, a Phase 2 study in HCC, and a randomized Phase 2 study in HCC evaluating casdozokitug in combination with toripalimab and bevacizumab. CHS-114 is a highly selective, competitively positioned, cytolytic anti-CCR8 antibody currently in a Phase 1 study in patients with advanced solid tumors, including HNSCC and gastric cancer. Coherus markets LOQTORZI, a novel next-generation PD-1 inhibitor, and UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta. In December 2024, Coherus announced the planned divestiture of its UDENYCA franchise. The transaction is expected to close early in the second quarter of 2025. Neulasta® is a registered trademark of Amgen, Inc. Forward-Looking Statements The statements in this press release include express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Repurchases, the Requisite Consents, the Supplemental Indenture and the proposed transaction between the Company and Intas that involve risks and uncertainties relating to future events and the future performance of the Company. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity,” “likely,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. You can also identify forward-looking statements by discussions of strategy, plans or intentions. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding: Coherus’ business, the Agreement and related matters, including, but not limited to, the consummation of the Repurchases, the Requisite Consents and the Supplemental Indenture, the ability to satisfy the closing conditions to consummate the proposed transaction at all or in the estimated time frame; prospective performance and opportunities with respect to the Company and its pipeline; statements about revenue or sales growth; statements about development and sales synergies; the ability of the Company’s product candidates to enhance outcomes for cancer patients; statements about the potential uses of proceeds from the proposed divestiture transaction including with respect to the repurchase offer for remaining Convertible Notes following the closing of the divestiture transaction; statements about the Company’s ability to repay its indebtedness in the future and the assumptions underlying or relating to such statements. These forward-looking statements are based on the Company’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, assumptions and changes in circumstances, many of which are beyond the control of the Company. A number of important factors, including those described in this press release, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: uncertainties as to the timing for completion of the proposed transaction, including the Repurchases, the Requisite Consents and the Supplemental Indenture; uncertainties as to the Company’s ability to satisfy the conditions necessary to consummate the proposed UDENYCA divestiture; the possibility that competing offers will be made by third parties; the occurrence of any event, change or other circumstance that may give rise to a right of one or both of Intas and the Company to terminate the Agreement; the possibility that the proposed transaction may not be completed in the time frame expected by the Company or at all; the risk that the proposed transaction disrupts the Company’s current plans and operations or diverts the attention of the Company’s management or employees from ongoing business operations; the effects of the proposed transaction on relationships with the Company’s employees, suppliers, business or collaboration partners or governmental entities, or other third parties as a result of the proposed transaction; the ability to retain and hire key personnel; significant or unexpected costs, charges or expenses resulting from the proposed transaction; the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the Company after the consummation of the proposed transaction; potential negative effects related to this announcement or the consummation of the proposed transaction on the market price of the Company’s common stock and/or the Company’s operating or financial results; and the nature, cost and outcome of any litigation and other legal proceedings, including any legal proceedings related to the proposed UDENYCA divestiture transaction. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. There can be no assurance that the transaction described above will in fact be consummated in the manner described or at all. For a further discussion of these and other factors that could cause the Company’s future results to differ materially from any forward-looking statements see the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2025, as updated by the Company’s subsequent periodic reports filed with the SEC and in other documents the Company files with the SEC, including the definitive proxy statement of the Company relating to the proposed transaction for the divestiture of UDENYCA filed with the SEC on January 28, 2025. Any forward-looking statements speak only as of the date of this press release and are made based on the current good faith beliefs and judgments of the Company’s management, and the reader is cautioned not to rely on any forward-looking statements made by the Company. Unless required by law, the Company is not under any duty and undertakes no obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, of new information, data or methods, future events or other changes UDENYCA® and LOQTORZI®, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners. No Offer or Solicitation This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended. Additional Information and Where to Find It In connection with the proposed divestiture of UDENYCA, the Company filed with the SEC a definitive proxy statement on Schedule 14A on January 28, 2025, and it may also file other documents regarding the proposed transaction with the SEC. Promptly after filing its definitive proxy statement with the SEC, the Company started the process of mailing the definitive proxy statement and a proxy card to each stockholder entitled to vote at the special meeting relating to the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ CAREFULLY THE PROXY STATEMENT AND OTHER RELEVANT DOCUMENTS FILED OR TO BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS THERETO AND ANY DOCUMENTS INCORPORATED BY REFERENCE THEREIN, IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION, RELATED MATTERS AND THE PARTIES TO THE PROPOSED TRANSACTION. You may obtain a free copy of the proxy statement and other relevant documents (if and when they become available) that are or will be filed with the SEC for free at the SEC’s website at www.sec.gov. Copies of the documents filed with the SEC by the Company will be available free of charge on the Company’s website at https://investors.coherus.com/sec-filings or by contacting the Company’s Investor Relations Department at IR@coherus.com. Coherus BioSciences Contact Information: For investors:Jodi SieversVP, Investor Relations & Corporate CommunicationsIR@coherus.com

1. 国内首个！恒瑞医药长效胰岛素申报上市 1月23日，恒瑞医药宣布舒地胰岛素注射液（INS068）的药品上市许可申请获国家药监局受理。该产品为国内首个自主研发的长效胰岛素类似物。此次上市申请主要是基于两项关键III期临床试验（301研究和302研究）的积极结果。这两项研究在基础胰岛素治疗血糖控制不佳以及口服降糖药治疗血糖控制不佳的成人2型糖尿病（T2DM）中评价了舒地胰岛素注射液和甘精胰岛素的有效性和安全性，其中301研究共随机入组423例受试者，302研究共随机入组513例受试者。这两项研究均已于2024年12月顺利完成。研究结果表明，在联合或不联合口服降糖药条件下，舒地胰岛素治疗26周后糖化血红蛋白（HbA1c）相对基线变化非劣于甘精胰岛素，舒地胰岛素组在T2DM患者中安全性、耐受性良好，其不良事件性质与甘精胰岛素相似，低血糖事件和夜间低血糖事件略低于甘精胰岛素组，两项研究均达到了主要研究终点。 2. 新型双重机制止痛药III期临床成功 1月22日，Tris Pharma宣布其用于治疗急性疼痛的首创口服双NMR激动剂Cebranopadol的关键性III期临床试验ALLEVIATE-1取得积极结果。Cebranopadol 是一种 FIC 的试验性疗法，通过靶向 NOP（伤害感受肽/孤啡肽FQ）和 MOP（µ-阿片肽）两种关键受体（双 NMR 激动剂），治疗中度至重度疼痛以及阿片类药物使用障碍 (OUD)。ALLEVIATE-1 临床试验 (NCT06545097) 是一项多中心、随机、双盲、安慰剂对照的 III 期研究。该研究旨在评估 Cebranopadol 与安慰剂相比对全腹部整形术后中度至重度急性疼痛的疗效和安全性。研究的主要终点是根据数字评价量表（NRS）评估的镇痛效果。临床研究结果表明，与安慰剂相比，使用 400 µg（每天一次、连续两天）Cebranopadol 治疗可显著降低疼痛强度（最小二乘均值差异为 59.2）。此外，Cebranopadol 的耐受性通常良好，安全性与安慰剂相当，没有与 Cebranopadol 相关的严重不良事件。最常见的不良事件是恶心。 3. 潜在First-in-Class IL-27单抗临床结果积极，针对肝细胞癌 1月23日，Coherus BioSciences公布其白细胞介素-27（IL-27）靶向抗体casdozokitug（casdozo）与PD-L1靶向抗体atezolizumab（atezo）和VEGF靶向抗体bevacizumab（bev）联合，治疗无法切除的局部晚期或转移性肝细胞癌（HCC）初治患者的2期试验最新数据。分析显示，患者的疾病控制率（DCR）达58.6%，其中有部分患者的肿瘤在接受治疗后完全消退。详细数据将公布于2025年美国临床肿瘤学会（ASCO）胃肠癌症研讨会当中。根据新闻稿，casdozokitug是首款进入临床研究的IL-27抗体。 4. 信达PD-1/IL-2在国内启动头对头K药II期临床，治疗黑色素瘤 1月23日，药物临床试验登记与信息公示平台官网显示，信达生物在 1 月 22 日登记了一项评估 IBI363 单药头对头帕博利珠单抗（K 药）治疗晚期黑色素瘤受试者的 II 期临床试验（CTR20250280）。IBI363 是信达生物自主研发的全球首创 PD-1/IL-2 双特异性融合蛋白，同时具有阻断 PD-1/PD-L1 通路和激活 IL-2 通路两项功能。IBI363 的 IL-2 臂经过了设计改造，保留了其对 IL-2 Rα 的亲和力，但削弱了对 IL-2Rβ 和 IL-2Rγ 的结合能力，以此降低毒性。本次启动的是一项随机、开放、多中心的 II 期研究，旨在评估 IBI363 单药治疗对比帕博利珠单抗在既往未经过系统性治疗的不可切除局部晚期或转移性黏膜型及肢端型黑色素瘤受试者中的有效性和安全性，计划入组 180 名受试者。 5. GSK启动BCMA ADC头对头达雷妥尤单抗III期临床，一线治疗多发性骨髓瘤 1 月 22 日，GSK 在药物临床试验登记与信息公示平台登记了一项 Belantamab mafodotin（玛贝兰妥单抗）联合来那度胺和地塞米松（BRd）头对头达雷妥尤单抗联合来那度胺和地塞米松（DRd）一线治疗多发性骨髓瘤的 III 期 DREAMM-10 研究。DREAMM-10 研究是一项随机、平行分组、开放的国际多中心 III 期临床试验，旨在评估 BRd 对比 DRd 在不适合自体干细胞移植的新诊断多发性骨髓瘤（ TI-NDMM ）受试者中的有效性和安全性。全球 165 家机构共同参与，国内计划入组 80 名受试者，国际入组 520 名受试者。主要终点是无进展生存期（PFS）、MRD 阴性状态。 1. 诺和诺德引进口服小分子BACH1抑制剂全球权益，用于血液疾病 1月22日，IMMvention Therapeutix宣布，公司与诺和诺德达成战略合作和许可协议，共同开发用于镰状细胞病 (SCD) 和其他慢性疾病的口服疗法。根据协议，诺和诺德获得临床前BACH1 抑制剂的全球独家许可，并接管所有进一步开发、监管提交和全球商业化工作；此外，IMMvention 还保留了将某些脑渗透性 BACH1 抑制剂开发用于治疗帕金森病、阿尔茨海默病等疾病的权利。 2. 复宏汉霖私有化终止 1月22日，复星医药发布公告，宣布复宏汉霖私有化终止。上海复星医药董事会于2024年6月24日及2024年8月23日分别作出决议，批准对控股子公司复宏汉霖的私有化方案及其修订。中国国家发展和改革委员会于2024年11月21日已就本次交易出具备案批准。2025年1月22日，吸收合并作为特别决议案于复宏汉霖临时股东大会上获出席会议的三分之二以上（含本数）有表决权股东的批准，但于仅由独立H股股东享有表决权的复宏汉霖H股类别股东大会上未获通过，因此，本次交易协议的生效条件未获达成，吸收合并将不予实施，复宏汉霖将保留H股上市地位。截至2025年1月22日，复星医药（通过控股子公司）合计持有复宏汉霖59.56%的股权，本次交易虽未达成，但不会影响复星医药对复宏汉霖的控股地位，复宏汉霖仍将是复星医药集团重要的抗体技术平台。 内容来源于网络，如有侵权，请联系删除。