Dovitinib

众所周知，二级市场是资本创新要素流动的重要部分，而IPO则一度成为未获盈利Biotech的康庄大道。 公司上市以后，更容易筹集资金投入新药开发，通过产品商业化创造收益，反哺股市投资者——这个正向循环构，构成过去生物制药行业发展的主线之一，尤其在资本市场活跃时期，似乎只要获得入场券，一家Biotech日后便大概率平步青云。 以美股为代表的IPO窗口，在2024年率先重新洞开，20多家Biotech由此进入二级市场。但是，它们很快发现，另一边的形势也不容乐观。许多新上市的公司，很快跌破发行价。 尽管美股Biotech股价与临床阶段缺乏强关联，可大体上，一家公司股价暴跌，背后一定是出现不小的问题，无论临床开发的失败，抑或战略布局的踏空。 下文，将结合GEN收录数据，对从2024年股价跌幅排名前五的Biotech进行梳理，尝试为行业勾勒出“2025年避坑指南”。 正如在上一篇文章里提到的，反向股票分割常作为公司股价低迷时期的自救之举，Exicure似乎凭借这种操作，在2024年底将股价拉升了近500%。不过，我们也要看到更大的背景。五家跌幅超99%的Biotech案例中，反向股票分割都被提上日程，结果于事无补，甚至有的下跌反而是在实施该措施之后发生。 大健康领域一度被视为蓝海，事实却证明，要讲好一个由生物技术驱动、横跨消费与严肃医疗的故事并不容易。生物技术的高回报建立在高风险上，如果不能找到技术落地与市场需求的平衡，被时代甩下便并非杞人忧天。 股价涨幅有情绪的影响，问题是，如果负面情绪不能得到很好地管理，连锁反应很可能会伤及根本，比如2024年，TFF Pharmaceuticals就宣布破产清算。 1 Aditxt 2024年跌幅：99.90% 2023年12月，Aditxt曾宣布以1亿美元收购Evofem Biosciences，当日收获高达83.95%的股价涨幅。2024年，这家Biotech陷入低迷之际，再次祭出并购的法宝。 但很可惜，“故技重施”并非万金油。 自从2024年4月签署跟Appili Therapeutics的最终协议以来，Aditxt股价不升反降，一度被纳斯达克警告退市。这大概离不开交易进展缓慢的影响。事实上，就连Evofem的并购案进度，也超出Aditxt本来的预期，继续延至2025年1月。 为阻止股价下滑，并重新符合纳斯达克的最低出价规则，Aditxt从去年10月2日起实施“1比40”反向股票分割。如今，Aditxt还在悬崖边上。 2017年设立的Aditxt开发了一种免疫重编程技术，旨在重新训练免疫系统以诱导耐受性，解决移植器官排斥、自身免疫性疾病和过敏问题。作为关联资产，Aditxt还发明出一套提供检测免疫系统概况的工具。 目前，上述想法仍未变成现实。根据最新计划，自免候选药物ADI-100会在近期向FDA递交IND申请，用于治疗1型糖尿病、牛皮癣、僵人综合征等。如果一切顺利，首次人体试验最早也要在2025年下半年才能完成。 钱是绕不开的话题，尤其考虑到两笔尚未完成的收购。基于低迷的股价表现，Aditxt已暂停股权融资，将其融资策略转向债务融资，为其收购计划提供资金。 Aditxt一些手牌看起来不错。例如，FDA对Appili旗下的ATI-1801开发战略给予了积极反馈，这款外用抗寄生虫产品符合NDA提交的要求。不确定在于，尚缺乏有关NDA提交的具体要求或时间表的重要细节。 尽管这看起来像是“拆东墙补西墙”，Aditxt将新一年的现金流，希望寄托在两家要被收购的公司上。 2024年上半年，Evofem的收入为780万美元。而现阶段，Appili已从美国国防部获得约600万美元资助。这项资助的总额在1400万美元，旨在开发一种传染病疫苗ATI-1701。 2 CNS Pharmaceuticals 2024年跌幅：99.81% CNS Pharmaceuticals的惨痛，是从2024开年就开始的。去年年初，该Biotech股价迅速从约每股60美元的高位，一路“跌跌不休”。 这背后，似乎有财务上的阴霾影响。2023年第三季度报告显示，CNS Pharmaceuticals净亏损进一步扩大，同比下降37.93%，对投资者的信心不得不说是个打击。随后进入2024年，生物技术板块整体下行的情况，无疑更加放大了对某些个股的担忧。 2017年成立以来，CNS Pharmaceuticals专注于开发治疗大脑和中枢神经系统肿瘤的药物。贝柔比星（Berubicin）是其主要候选管线，具备穿过血脑屏障潜力，但最快的一项研究仍在II期临床。 至于另一项资产微管抑制剂TPI 287，则来自Cortice Biosciences授权。2024年7月，Cortice跟CNS Pharmaceuticals签署协议，允许后者在四个国家/地区对TPI 287进行开发。吊诡的是，这次合作并不被二级市场看好，相反，声明引发该股的又一次下跌。 关键问题是，CNS Pharmaceuticals如何支付对价？答案是用股票。为该笔交易，它增发60多万股股票，大大稀释了现有股东的股权。 早前，“1比50”的反向股票分割曾帮助CNS Pharmaceuticals拉升了股价，但效果并不持久。2024年9月，纳斯达克再度发出退市警告。 CNS Pharmaceuticals的苦苦挣扎，凸显了制药行业一些Biotech面临的持续资金挑战。而众所周知，神经系统疾病方面，长期充斥着临床失败的消息，包括辉瑞、渤健等巨头都先后受挫。想要开启变革，Biotech显然需要更大的勇气和实打实的准备。 根据资产负债表，CNS Pharmaceuticals持有的现金暂且多于债务。但该公司还在迅速消耗现金储备，如果趋势持续下去，可能会加剧与纳斯达克的合规问题。 此外，该股的相对强弱指数（RSI）表明其处于超卖区域，这或许会引起反向投资者或那些寻求潜在扭转局面的投资者的兴趣，包括MNC的并购。 I期临床数据显示，44%的患者在贝柔比星治疗后获得了临床反应。CNS Pharmaceuticals预计，2025年上半年，II期临床结果的主要分析数据会对外公布，公司“准备在短期内为所有利益相关者释放价值”。 3 Allarity Therapeutics 2024年跌幅：99.66% 区别于其他Biotech，Allarity虽然同样没有盈利，却至少保证现金流眼下无虞。根据2024年第三季度报告，它的流动资产总额为2036.6万美元，相对应的总负债只有741.4万美元。 然而，投资者明显对这家2012年成立的药企有更高的期待。否则我们无法解释，为何Allarity会出现在跌幅最大的Biotech名单上。 纵观管线布局，Allarity可以说是围绕MNC的资产展开。早前，Allarity从卫材引进PARP/tankyrase双重抑制剂Stenoparib。在2018年，Allarity又通过交易，从诺华获得小分子泛酪氨酸激酶抑制剂Dovitinib的许可。 很可惜，这种“反向策略”，并没有将新药开发的概率提高多少。随之而来的，是接二连三的麻烦。 2021年12月，Allarity提交了Dovitinib的NDA申请，希望将转移性肾细胞癌（mRCC）三线治疗作为商业化的突破口。可在2022年2月，FDA发出CRL，表示申请“不够完整，无法进行实质性审查”。同年晚些时候，FDA对Dovitinib的申报提出新的研究要求。 单药不行，那就联用——Allarity的对策是，调转方向，把Dovitinib和Stenoparib等其他潜在疗法组合在一起。结果，因为没有如约支付费用，2024年1月，诺华终止Stenoparib的授权。 失去Dovitinib之后，Allarity只好重新回到仅有的Stenoparib上面，但负面影响却并未终止。 2024年7月，SEC发出“韦尔斯通知”（Wells Notice），建议对Allarity涉嫌违反《美国联邦证券法》的行为采取执法行动。报道显示，“韦尔斯通知”与Allarity开发Dovitinib期间在FDA会议上的某些“披露”有关。 Allarity认为自己的行为适当。事实上，此事后续也暂无后文，但投资者却进一步投出不信任票。 在运营和财务方面，Allarity去年实施战略变革，不仅扩大与Ascendiant Capital Markets的场外交易协议，还任命新的CFO Alexander Epshinsky。Allarity也做了“1比30”的反向股票分割。 资金的灵活性给Allarity一定的腾挪空间。2024年9月，Allarity表示，在Stenoparib治疗晚期卵巢癌的II期试验中，两名患者已接受治疗超过一年。这一结果凸显了持久的临床益处和成药潜力。 然而，2025年会如何，Allarity还需要拿出更多的结果来说服投资者。 4 Elevai Labs 2024年跌幅：99.37% 2023年11月，Elevai顶着“外泌体抗衰第一股”的光环在纳斯达克上市。但这次风光登场，已经是仅有的高光时刻，随后该公司股价一路跳水。 大健康领域通常被视为“奶与蜜之地”，因为消费医疗的属性，让其有更多溢价空间。事实上，Elevai确实推出一系列主打促进胶原蛋白再生的护肤产品，销售至美国、加拿大和其他国际市场的皮肤科、整形外科和专业医疗中心。 除了功能护肤，Elevai也布局了生物制药，开发针对肥胖症和增肌的候选药物EL-22和EL-32。 众所周知，市场上已获批用于减肥的GLP-1药物，如诺和诺德的Ozempic、Wegovy，礼来的 Zepbound、Mounjaro，已经改变了肥胖治疗领域。然而，高达40%的体重减轻是由于肌肉损失造成的。 Elevai认为，当前肥胖领域未满足的关键需求之一，是避免在减肥治疗期间出现肌肉流失。EL-22正是一种含有肌肉生长抑制素抗原的工程益生菌，通过引发免疫反应，帮助人们在保持肌肉质量的同时实现大幅减脂。 实际上，这条道路并不宽敞。肌肉生长抑制素与肌细胞膜上的ActRIIB结合导致肌肉退化，已并非什么冷门洞见，包括礼来在内，都在围绕阻断该过程进行下一代药物开发。 在其他药企高举高打的同时，Elevai却只有一项在韩国开展的小规模I期临床，来表明EL-22良好安全性和耐受性，投资者的担忧也就不难理解。 据透露，Elevai正与KCRN Research合作，为预计在2025年第一季度与FDA进行pre-IND会议做准备，希望打通EL-22这种工程益生菌的临床开发制定监管途径。换言之，EL-22能否进入美国市场仍面临巨大的未知。 Elevai的案例，凸显了一家志在多元化发展的Biotech的艰难。反观近几年，辉瑞、GSK、强生等巨头，都已开启消费健康部门等拆分计划，暗示着战略聚焦的重要性。 2024年前三季度，Elevai的净亏损进一步扩大至431万美元。同年11月，Elevai试图通过“1拆200”的反向股票分割来阻止投资者抛售股票。 Elevai还2024年底更名为PMGC Holdings，并将注册地从特拉华州迁至内华达州。至于市场是否有耐心等待它的重组变革，或许就另说了。 5 TFF Pharmaceuticals 2024年跌幅：99.07% 对于TFF Pharmaceuticals来说，2024年是历史性的一年——12月12日，这家Biotech结束了最后一个交易日，收盘价为每股6.5美分。第二天，纳斯达克暂停了该股票交易。 去年11月，TFF宣布解散。而在该消息发布的两个月前，TFF Pharmaceuticals还宣布，与埃默里大学和生物医学高级研究与发展局建立新的伙伴关系。 此次合作志向远大，双方希望测试将mRNA药物转化为干粉吸入制剂的可行性，而无需冷链储存。TFF Pharmaceuticals将为此提供技术支持，实验室数据表明，该工艺生产的吸入型干粉制剂的空气动力学特性，可以将多达75%的剂量输送到肺部深处。 从原理上说，TFF Pharmaceuticals平台不会引入高温、剪切应力等可能损坏治疗成分完整性的因素，而是将这些材料重新配制成易于储存且常温稳定储存的干粉剂型，使治疗药物和疫苗更容易覆盖全球。 与口服药物相比，这种新剂型能够将治疗药物直接输送到目标器官（如肺）中，以较低的剂量给药，从而减少不必要的毒性和副作用。 2024年11月，一项采用甲型流感病毒血凝素（HA）mRNA疫苗作为样本进行的研究证明，TFF Pharmaceuticals专有的薄膜冷冻干燥技术（TFFD）可用于制备HA mRNA-LNP干粉制剂，但需要足够量的赋形剂，来最大限度减少HA mRNA-LNP疫苗受到冷冻干燥过程中复杂应力引起的物理性质、结构和免疫原性的变化。 这或许是挑战之处。尽管存在突破可能，TFF Pharmaceuticals仍需讲好一个商业化闭环的故事，而市场认为，它的财务状况已不允许。 TFF Pharmaceuticals自2018年成立，迅速受到多方关注。2019年，该公司在纳斯达克IPO。而IPO后的6轮融资中，它筹集到超过6000万美元资金，投资者包括美国国家过敏和传染病研究所、Leidos和Liquid Venture Partners。 人员方面，2023年诺贝尔生理学或医学奖得主Drew Weissman，一度是TFF Pharmaceuticals的科学顾问。 而在药物市场端，根据早前研究，约40%的上市药物和约90%的在研药物由难溶性分子组成。这意味着，诸如TFF Pharmaceuticals开发的粉末制剂，有望利用自身更强的稳定性、适用性和便携性脱颖而出。 可一副好牌最终还是打烂了。宣布解散前，TFF Pharmaceuticals董事会批准了一项清算计划，并任命会计师事务所Verdolino & Lowey负责人Craig Jalbert身兼数职，负责监督公司的清算工作。 参考资料： 1.StockWatch: Wall Street’s Leaders and Laggards of 2024 同写意媒体矩阵，欢迎关注↓↓↓

NEW YORK, Nov. 10, 2024 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR) and certain officers. The class action, filed in the United States District Court for the Southern District of New York, and docketed under 24-cv-06952, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Allarity securities between May 17, 2022 and July 19, 2024, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials. If you are a shareholder who purchased or otherwise acquired Allarity securities during the Class Period, you have until November 12, 2024 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at . To discuss this action, contact Danielle Peyton at [email protected] or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased. [Click here for information about joining the class action] Allarity is a clinical-stage biopharmaceutical company that develops oncology therapeutics using drug-specific companion diagnostics generated by its Drug Response Predictor technology. Allarity's drug candidates include, inter alia, Dovitinib, a pan-tyrosine kinase inhibitor for the treatment of renal cell carcinoma ("RCC"). The Company's companion diagnostic technology for Dovitinib is referred to as "DRP®-Dovitinib" or "Dovitinib-DRP." On April 2, 2021, Allarity's predecessor parent corporation, Allarity Therapeutics A/S, announced that it had submitted a premarket approval application ("PMA") to the U.S. Food and Drug Administration ("FDA") for Dovitinib-DRP (the "Dovitinib-DRP PMA"). On December 22, 2021, Allarity issued a press release announcing that it had submitted a new drug application ("NDA") to the FDA seeking marketing approval for Dovitinib for the third-line treatment of RCC patients (the "Dovitinib NDA"). On February 18, 2022, Allarity issued a press release announcing that it had received Refusal to File ("RTF") letters from the FDA for the Dovitinib NDA and the Dovitinib-DRP PMA because "the NDA . . . and the PMA application . . . were not sufficiently complete to permit substantive reviews," noting that "the FDA's cited reasons for the RTF decision primarily include[d], but [we]re not limited to, that submitted clinical trial data do not enable a conclusion of efficacy based on non-inferiority data set" and that, because "the PMA and NDA were filed as related applications, the RTFs also apply to the DRP®-Dovitinib companion diagnostic." Following these developments, Allarity continued to represent to investors and the market that it remained committed to pursuing the Dovitinib NDA and would work with the FDA to determine a clear regulatory path forward for resubmitting that application. The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Defendants had overstated the Dovitinib NDA's continued regulatory prospects; (ii) Allarity and three of its former officers had engaged in illegal, illicit, and/or otherwise improper conduct in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA; (iii) the foregoing misconduct subjected the Company to an increased risk of regulatory and/or governmental scrutiny and enforcement action, as well as significant legal, monetary, and reputational harm; (iv) following Allarity's announcement that it was, in fact, being investigated for wrongdoing in connection with the Dovitinib NDA and/or the Dovitinib-DRP PMA, the Company downplayed the substantial likelihood that an enforcement action would result from such investigation; and (v) as a result, the Company's public statements were materially false and misleading at all relevant times. On June 29, 2022, Allarity issued a press release announcing that, "[e]ffective immediately," it had appointed Defendant James G. Cullem ("Cullem"), the Company's then-current Chief Business Officer, as its interim Chief Executive Officer ("CEO"), and Defendant Joan Y. Brown ("Brown"), the Company's then-current Director of Financial Reporting, as its interim Chief Financial Officer ("CFO"), and that its former CEO Defendant Steve R. Carchedi ("Carchedi") and former CFO Defendant Jens Knudsen ("Knudsen") had both purportedly "stepped down from those roles to pursue other opportunities." The next day, Allarity disclosed in an U.S. Securities and Exchange Commission ("SEC") filing that Defendants Carchedi and Knudsen had either "resigned" or been "terminat[ed]" from all positions with the Company and its subsidiaries, while indicating that such "resignation" or "termination" may have been for cause, but without clarifying the same. Following these disclosures, Allarity's stock price fell $0.31 per share, or 19.02%, to close at $1.32 per share on June 30, 2022. On August 2, 2022, Allarity issued a press release announcing that "its Board of Directors has mandated a refocus of the Company's oncology pipeline strategy away from development of monotherapies" and, accordingly, "determined that advancing dovitinib as a monotherapy in adults is no longer commercially viable or in the best interests of its shareholders," citing "feedback that the Company recently received from the [FDA] from a Type C advisory meeting held in Q2 2022, regarding a potential Phase 3 clinical development path for dovitinib as a monotherapy third-line treatment for metastatic [RCC]." Accordingly, the Company would no longer pursue the Dovitinib NDA, which sought approval of Dovitinib as a monotherapy. On this news, Allarity's stock price fell $0.045 per share, or 3.688%, to close at $1.175 per share on August 2, 2022. On February 6, 2023, Allarity disclosed in an SEC filing that, "[i]n January 2023, we received a letter to produce documents from the SEC and that stated that the staff of the SEC is conducting an investigation . . . to determine if violations of the federal securities laws have occurred" in connection with "disclosures relating to submissions, communications and meetings with the FDA regarding our NDA for Dovitinib or Dovitinib-DRP." On this news, Allarity's stock price fell $0.009 per share, or 3.8%, to close at $0.228 per share on February 6, 2023. On December 11, 2023, Allarity disclosed in another SEC filing that, "[o]n December 8, 2023, [Defendant] Cullem was terminated as [CEO] of Allarity . . . and all other positions with the Company and its subsidiaries" and that Defendant Thomas Jensen had been appointed as the Company's new CEO on the same date. On this news, Allarity's stock price fell $0.075 per share, or 13.37%, to close at $0.486 per share on December 11, 2023. Then, on July 22, 2024, Allarity disclosed in yet another SEC filing that it had received a Wells Notice from the SEC's staff "relating to the Company's previously disclosed SEC investigation," advising that "[t]he Wells Notice relates to the Company's disclosures regarding meetings with the [FDA] regarding the Company's NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021"; that, per the Company's understanding, "all conduct relating to the SEC Wells Notice occurred during or prior to fiscal year 2022"; and "that three of its former officers"—the same number of Company officers terminated during the Class Period—"received Wells Notices from the SEC relating to the same conduct." On this news, Allarity's stock price fell $0.004 per share, or 2.38%, to close at $0.164 per share on July 22, 2024. Finally, on September 13, 2024, Allarity disclosed in yet another SEC filing that, "[o]n September 12, 2024, the Company received a notice of resignation from [Defendant] Brown, its [CFO], effective September 12, 2024." Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See . Attorney advertising. Prior results do not guarantee similar outcomes. 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