Eiger Group International, Inc.

According to official documents released by the U.S. Securities and Exchange Commission (SEC), the pharmaceutical company Amylyx, headquartered in Cambridge, Massachusetts, successfully completed a transaction with Eiger last Friday. Under the signed agreement, Amylyx will fully take over the development, manufacturing, and commercialization rights related to the GLP-1 antagonist Avexitide. The positive impact of this transaction news has led to a 5% increase in the company's stock price, reaching a market capitalization of $126 million as of the time of writing. According to the company's latest financial report, Amylyx had $373.3 million in cash, equivalents, and short-term investments as of the first quarter of this year.   According to the Eiger company's official website, Avexitide is currently in Phase 2 clinical trials, primarily used to treat neonatal hypoglycemia and congenital hyperinsulinism. However, it is worth noting that this biotechnology company headquartered in Palo Alto, California, applied for bankruptcy protection in April of this year.   The mechanism of action of Avexitide is to antagonize the GLP-1 receptor, in order to counteract the effects of excessive GLP-1 secretion, which is different from the current mainstream strategies for weight loss and diabetes treatment. Amylyx has not yet disclosed the specific development plans for the indications of Avexitide.   Amylyx has already established a presence in the field of insulin-related diseases, with a Phase 2 candidate drug in development for the treatment of Wolfram syndrome. Wolfram syndrome is a genetic disease involving insulin-dependent diabetes mellitus that typically manifests in childhood and affects approximately 3,000 people in the United States. Apart from this, Amylyx's other clinical-stage projects are primarily focused on neurological or neurodegenerative diseases, including progressive supranuclear palsy, ALS (amyotrophic lateral sclerosis), and Alzheimer's disease.   At the same time, Amylyx stated that it will continue to pursue further research and development of the previously withdrawn ALS treatment drug Relyvrio and actively explore candidate drugs for other nervous system indications. On April 4th of this year, due to unsatisfactory results from the Phase III clinical trial, Amylyx announced that its drug Relyvrio will be withdrawn from the US and Canadian markets and that it plans to lay off 70% of its workforce.   In a large-scale Phase III clinical trial published earlier this year, Relyvrio did not show superior effects compared to placebo in improving participants' ALS Functional Rating Scale (a measure of respiratory, swallowing, and speech capabilities at 48 weeks). The drug also failed to significantly improve patients' reported quality of life, overall survival rate, and respiratory function. Prior to this, Relyvrio was priced at $158,000 per year. According to financial data, the drug's first-year sales reached $380 million. Regarding the upcoming withdrawal, Amylyx stated that if patients wish to continue treatment, they can contact their doctors to access the free drug program.

Phase 3 HDV D-LIVR (lonafarnib/ritonavir) Study: Pre-NDA Meeting Planned by End of Q2 Phase 3 HDV LIMT-2 (peginterferon lambda) Study: On Track to Complete Randomization by End of Q2 Phase 3 HI AVANT (avexitide) Program: Startup Activities Initiated Cash Position: $98.9 million in Cash, Cash Equivalents, and Short-Term Debt Securities as of December 31, 2022 PALO ALTO, Calif., March 16, 2023 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases, today reported financial results for fourth quarter and full year 2022 and provided a business update. "In December, we announced that both our lonafarnib-based treatments met the primary endpoint in our pivotal Phase 3 D-LIVR trial in hepatitis delta virus (HDV), and we look forward to the pre-NDA meeting with the FDA, which we expect by end of Q2," said David Apelian, MD, PhD, Interim CEO, Eiger. "In addition, we have completed screening in our Phase 3 LIMT-2 study and expect to complete enrollment by the end of Q2. We continue to execute on our unwavering mission to develop innovative therapies for patients with rare diseases, with a focus on maintaining a position of readiness and being thoughtful about how best to employ our resources." Dr. Apelian continued, "On the corporate front, using both internal and external advisors, we continue our program prioritization analyses to assess the most promising drivers for shareholder value. Given the robust nature of this process, we anticipate providing an update in Q2. In addition, we remain focused on preparing for a planned pre-NDA meeting and guidance from FDA on the D-LIVR program in mid-2023." Business Highlights Hepatitis Delta Virus Platform Lonafarnib-Based Regimens for HDV First-in-class, oral prenylation inhibitor In December, announced Phase 3 D-LIVR study topline Week 48 data met the primary endpoint Lonafarnib/ritonavir response rate of 10.1% (p=0.0044) Lonafarnib/ritonavir in combination with peginterferon alfa response rate of 19.2% (p<0.0001) Key secondary endpoint of proportion of patients with improvement in histological response rate demonstrated with statistical significance in combination arm vs placebo Pre-NDA meeting planned by end of Q2 D-LIVR Week 72 data expected to be presented in mid-2023 Peginterferon Lambda for HDV Potential first-in-class, well-tolerated interferon Potential to be interferon of choice in HDV combination therapies Phase 3 LIMT-2 study of peginterferon lambda monotherapy Anticipate complete randomization by end of Q2 (N=150) Combination of Peginterferon Lambda and Lonafarnib/Ritonavir for HDV Combination of Eiger's two proprietary HDV therapies in development Phase 2 LIFT-2 study in collaboration with National Institutes of Health initiating in 2023 Single arm study (N=30), 48 weeks of treatment with 24 weeks of follow-up Zokinvy ® (lonafarnib) for Progeria and Processing-Deficient Progeroid Laminopathies Granted marketing authorization approval in EU and U.K. Avexitide for Rare Metabolic Disorders Phase 3 startup activities initiated in AVANT congenital hyperinsulinism (HI) program Optimizing product-related impurities in the finished drug product to support Phase 3 dosing Rare Pediatric Disease designation for HI – Priority Review Voucher eligible Financial Guidance $98.9 million in cash, cash equivalents, and short-term debt securities as of December 31, 2022 Fourth Quarter and Full Year 2022 Financial Results Net revenue was $2.7 million and $13.5 million in fourth quarter and full year 2022, respectively, as compared to $3.4 million and $12.1 million for the same periods in 2021. The decrease in fourth quarter was primarily driven by a decrease in units shipped during the quarter and the increase in full year 2022 was primarily driven by the upfront payment received from AnGes, Inc. pursuant to the Marketing and Distribution Agreement, which was executed in May 2022. Cost of sales was $0.3 million and $1.8 million for fourth quarter and full year 2022, respectively, as compared to $0.1 million and $0.7 million for the same periods in 2021. The increase in fourth quarter was primarily driven by a minimum purchase commitment by our contract manufacturer. The increase in full year was primarily driven by a one-time write-off of a non-conforming batch of inventory. Research and Development expenses were $18.5 million and $75.3 million for fourth quarter and full year 2022, respectively, as compared to $18.2 million and $64.4 million for the same periods in 2021. Net change in the fourth quarter was relatively flat. The increase in full year was primarily driven by an increase in headcount related expenses, including stock-based compensation expense and travel expenses related to participation in scientific conferences, an increase in clinical and manufacturing expenditures related to avexitide Phase 3 readiness, and a milestone related to the Phase 3 LIMT-2 study of peginterferon lambda. This increase was primarily offset by a decrease in contract manufacturing expenditures on lonafarnib. Selling, General and Administrative expenses were $8.3 million and $29.1 million for fourth quarter and full year 2022, respectively, as compared to $6.0 million and $23.9 million for the same periods in 2021. The increase in fourth quarter and full year primarily relate to outside services, including consulting and advisory services to support the Company's growth. Total operating expenses include non-cash expenses of $2.4 million and $13.3 million for fourth quarter and full year 2022, respectively, as compared to $2.8 million and $10.7 million for the same periods in 2021. The Company reported a net loss of $25.1 million, or $0.57 per share basis and $96.8 million, or $2.32 per share basis for fourth quarter and full year 2022, respectively. This compares to a net loss of $21.8 million, or $0.64 per share basis and $33.9 million, or $1.00 per share basis for the same periods in 2021. Cash, cash equivalents, and short-term debt securities as of December 31, 2022 totaled $98.9 million compared to $106.1 million as of December 31, 2021. As of December 31, 2022, the Company had 44,074,284 common shares outstanding. About Eiger Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious rare diseases. The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication. All five Eiger rare disease programs have been granted FDA breakthrough therapy designation. For additional information about Eiger and its clinical programs, please visit . Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, prospective products, preclinical and clinical pipelines, regulatory objectives, business strategy and plans and objectives for future operations, are forward-looking statements. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the timing of our ongoing and planned clinical development; the sufficiency of our cash, cash equivalents and short-term debt securities to fund our operations; expectations regarding the timing and availability of topline data from our Phase 3 D-LIVR study in HDV; the timing of interactions with the FDA; the ability to fully enroll the Phase 3 LIMT-2 study and Phase 3 AVANT study; our capability to provide sufficient quantities of any of our products or product candidates, including peginterferon lambda, for studies or to meet anticipated full-scale commercial demands; our ability to finance, independently or through collaborations, the continued advancement of our development pipeline; and the potential for success of any of our products or product candidates. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including additional applicable risks and uncertainties described in the "Risk Factors" sections in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 and Eiger's subsequent filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only as of the date on which they are made. Eiger does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise. Investors: Sylvia Wheeler Wheelhouse Life Science Advisors [email protected] Media: Aljanae Reynolds Wheelhouse Life Science Advisors [email protected] SOURCE Eiger BioPharmaceuticals, Inc.

关注并星标CPHI制药在线经历资本寒冬后，全球biotech的日子可谓艰辛。2023年，海外biotech的裁员潮还在继续，且愈演愈烈。截至3月10日，今年有超过45家biotech正在裁员。这一数字透露出的信息不言而喻，生物科技行业的苦日子还没结束。而正当biotech们勒紧裤腰带过日子的节点下，黑天鹅悄然而至。3月11日，美国前20大银行之一的硅谷银行轰然倒塌，宣布破产。由于硅谷银行是最支持科技行业的银行之一，因此其倒闭给整个生物技术行业也带来了超强冲击波。根据第四季度财报，硅谷银行存款中，有12%属于医疗保健和生物技术行业。硅谷银行服务的不少企业为初创企业。对于这些企业来说，一旦后续资金出现问题，融资也无法跟上，打击便有可能是致命的。看上去，与硅谷银行有往来的biotech们似乎处在了风暴中央。/ 01 /轰然倒塌的硅谷银行硅谷银行事件简单来说，是一次因利率上升而导致的银行流动性危机：SVB为满足客户提取资金的需求，选择折价出售资产，但这一行为也引发市场对该银行偿付能力的质疑，最终加剧挤兑。这一消息，对于全球生物科技行业来说，无疑是一个重磅炸弹。一直以来，硅谷银行都是医疗健康初创公司金融服务的深度参与方。根据财报，硅谷银行的第一大服务行业，就是生命科学行业。硅谷银行的服务，贯穿这些公司整个生命周期，从发展早期到壮大的后期。下面这个数字或许更能说明其在生命科学领域的重要地位：美国近一半风险投资支持的医疗健康公司，都与该银行有业务往来。去年，硅谷银行更是参与了去年美国医疗健康及科技板块44%的IPO项目。据外媒报道，生命科学企业客户，在SVB银行的存款资金总额为342亿美元，贷款总额为74亿美元。很显然，硅谷银行是生物科技领域极为关键的支柱金融服务机构之一。也正是因为其地位过于显著，导致市场对受硅谷银行波及的biotech充满担忧。一方面，SVB服务的众多对象为初创公司；另一方面，据Forbes报道，在SVB的1610亿的存款中，超过93%没有存款保险。这意味着，不少初创公司或需要待接管清理工作完成后，按照比例进行赔付。对于这些初创企业来说，能否及时获得现金，将成为公司能否走下去的关键。/ 02 /逐步扩大的受害者名单随着硅谷银行事件的发酵，生物科技行业“受害者”名单逐步浮出水面。比如，在二级市场备受关注的Axsome Therapeutics。Axsome是一家专注于精神疾病创新药研发的biotech。其核心管线包括用于戒烟和治疗阿尔兹海默症躁动症的AXS-05、治疗偏头痛的AXS-07等等。其中，AXS-07已经递交上市申请，AXS-05、AXS-12、AXS-14三条管线已进入3期临床阶段。得益于颇具看点的管线，2022年Axsome股价涨幅超过1倍，目前最新市值高达25亿美金。不过，在硅谷银行风波中，Axsome不幸中招了。3月10日，其发布公告表示，在硅谷银行中存有“实质影响的现金”。受该消息影响，Axsome股价大跳水，最终收跌近6%。受到影响的不只是Axsome，3月10日，发布相关公告的上市biotech不在少数。比如，Protagonist Therapeutics同样发布公告表示，其大约有1300万美金存放于硅谷银行。不过，Protagonist表示，公司还有另外2.18亿美金存放于其它机构。相比于Protagonist ，部分biotech显得没有那么幸运。Eiger Biopharma公告表示，大约有830万美元现金存放于硅谷银行。虽然总金额数值不大，但占比并不低，约占公司现金和现金等价物的6.9%。受该消息影响，Eiger股价下跌了11.11%。不过，大部分公司受到的影响或许相对有限。已经有多位投行分析师在对上市公司进行调查后，发现大多数人对SVB的依赖很小。硅谷银行冲击波对海外biotech的影响有多大，还有待时间给出答案。/ 03 /会影响国内Biotech吗？那么，硅谷银行时间会对国内biotech造成冲击吗？答案或许是肯定的。就目前来看，影响主要涉及两类企业。一类是在硅谷银行有直接存款的企业；另一类则是以客户主要为海外biotech的CXO企业。当然，总体来说，硅谷银行对国内公司的影响更为有限。目前来看，包括亚盛医药、和誉、亚虹医药、百诚医药、诺辉健康、九洲药业、绿叶制药、康方生物、金斯瑞生物科技、康宁杰瑞、诺诚健华、康诺亚、君实生物、信达生物、和黄医药等诸多医药公司纷纷表示，和硅谷银行没有业务往来。而存在业务往来的公司，涉及金额总的也并不多。比如云顶新耀表示，其在硅谷银行的存款远低于公司现金总量的1%。圣诺医药也表示，硅谷银行只是来往银行，只是用来发工资及支付费用，所以存款量不多。对公司没有太大影响。CXO方面，康龙化成表示，目前在硅谷银行的存款少于总现金的10%。并且，康龙化成表示，大约有50个左右客户使用硅谷银行账户。药石科技则表示，目前并未在硅谷银行存款，影响的客户也不超过20家，总体影响可控。或许，也真如这些企业所说，硅谷银行时间的冲击并不会太大。根本上，此次事件是由于资产负债端期限错配问题带来的挤兑危机。疫情大放水期间，硅谷银行采取了激进的投资策略。负债端，由于硅谷银行66%的存款均为活期存款，而资产新增规模的70%用于购买可供出售金融资产和持有至到期投资，仅24%用于发放贷款，导致了期限错配问题。在美联储加息的政策下，进一步放大了资产负债端期限错配的问题，最终导致了这一次危机的出现。如果拥有足够的处理时间，硅谷银行事件相信依然能够得到化解，那么硅谷银行事件的影响相对可控。接下来，事态会如何发展呢？让我们继续看下去。文／黄恺智药研习社近期研习会报名来源：氨基观察声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~