A pair of biotechs pre pares to hit Nas daq, as to tal 2021 IPO raise quick ly ap proach es $3B

两家生物技术公司准备冲击Nas daq,为tal 2021年IPO快速融资30亿美元

2021-02-13 05:00:11 ENDPOINTS NEWS

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Af­ter a busy week last week when 10 biotechs went pub­lic, the in­dus­try con­tin­ues to see a steady stream of com­pa­nies mak­ing their de­buts. With Ada­gene pric­ing ear­li­er this week and two more biotechs join­ing them late Thurs­day in­to ear­ly Fri­day, there have now been 16 com­pa­nies to IPO so far in 2021. The to­tal com­bined raise is rapid­ly ris­ing and ap­proach­ing $3 bil­lion al­ready — biotechs have pulled in rough­ly $2.86 bil­lion thus far. That growth has large­ly been dri­ven by Sana’s mega IPO, which ac­counts for about one-fourth of the over­all sum. But five oth­er biotechs have al­so raised more than $200 mil­lion each: Gra­cell, Cul­li­nan, Bolt, Im­muno­core and Vor. Here’s a run­down of the two com­pa­nies that priced af­ter mar­ket close Thurs­day af­ter­noon, as well as an­oth­er biotech that filed its S-1 on Thurs­day night. Spun out of Johns Hop­kins back in 2018, Nex­Im­mune is look­ing to cap­i­tal­ize on strong ASH da­ta from its lead pro­gram. The biotech priced at $17, the high end of its range, rais­ing $110 mil­lion in the process. It plans to trade on the tick­er $NEXI. Orig­i­nal­ly plan­ning to sell 4.7 mil­lion shares, Nex­Im­mune ul­ti­mate­ly sold 6.5 mil­lion, help­ing it achieve that high end. Nex­Im­mune cen­ters around the con­cept of spe­cial­ized nanopar­ti­cles that act as anti­gen-pre­sent­ing cells to in­cite a T cell at­tack on tu­mors. Re­searchers pre­sent­ed ini­tial re­sults from a Phase I/II study last De­cem­ber for NEXI-001, show­ing it in­duced a re­turn to base­line lev­els of ab­solute lym­pho­cyte counts with­in three to 35 days among the first five pa­tients dosed. The pro­gram is still in its ear­ly days, though, and Nex­Im­mune is look­ing to en­roll some­where be­tween 22 and 28 to­tal pa­tients. With­in its S-1, Nex­Im­mune said it plans to steer IPO funds to­ward both this pro­gram and NEXI-002, first dosed in a hu­man last Oc­to­ber in a mul­ti­ple myelo­ma tri­al. If the com­pa­ny’s tech ends up work­ing, re­searchers say it could spark a more durable at­tack that would in­volve more tar­gets and less like­li­hood of a set­back for pa­tients — par­tic­u­lar­ly if they can make an im­pact on naïve and mem­o­ry T cells to keep the hu­man im­mune sys­tem on alert. Deci­bel Ther­a­peu­tics is mov­ing fast af­ter a Se­ries D just three months ago. Back in No­vem­ber, the com­pa­ny raised $82 mil­lion in the round, and Thurs­day evening they priced their up­sized IPO. Deci­bel priced at $18 per share, the high end of its range, and pulled in $127 mil­lion. They sold 7.1 mil­lion shares af­ter an­nounc­ing plans to sell 5.9 mil­lion. When it hits Nas­daq on Fri­day, Deci­bel will trade on the tick­er $DBTX. Deci­bel had spent years fo­cused on pre­vent­ing hear­ing loss, but they piv­ot­ed last win­ter to gene ther­a­pies that can re­store lost hear­ing. The move came af­ter fail­ing to find a bio­mark­er that could let them run a pre­ven­ta­tive tri­al, as well as what they char­ac­ter­ized as sur­pris­ing ad­vance­ments in ge­nom­ic and re­gen­er­a­tive tech­nol­o­gy. It’s now one of three ma­jor Boston-area biotechs chas­ing these types of cures, next to the gene ther­a­py out­fit Ak­ou­os and the stem cell re­gen­er­a­tion de­vel­op­ers at Fre­quen­cy Ther­a­peu­tics. Deci­bel’s first gene ther­a­py was de­vel­oped in col­lab­o­ra­tion with Re­gen­eron, but isn’t sched­uled to hit the clin­ic un­til at least 2022. Re­searchers are start­ing with fix­ing a sin­gle gene in peo­ple with the OTOF mu­ta­tions, but the long-term goal is to build cures for more gen­er­al hear­ing loss and bal­ance dis­or­ders. On the small­er side of things, neu­ro dis­or­der biotech Pro­ta­genic Ther­a­peu­tics filed for an $18 mil­lion IPO on Thurs­day. The NY-based biotech is work­ing on neu­ropep­tides de­rived from the TCAP fam­i­ly. Pro­ta­genic’s lead pro­gram, PT00114, is be­ing de­vel­oped to treat stress-re­lat­ed dis­or­ders such as PTSD and drug and al­co­hol ad­dic­tions with­out in­ter­fer­ing with brain func­tion. The com­pound is ex­pect­ed to com­plete IND-en­abling stud­ies in ear­ly 2021, and sub­se­quent­ly en­ter Phase I/II tri­als. Pro­ta­genic said in its S-1 it plans to fun­nel mon­ey to­ward en­rolling this “bas­ket” tri­al, with the goal of sign­ing up 42 pa­tients. Ul­ti­mate­ly, Pro­ta­genic’s goal is to im­prove men­tal health by coun­ter­bal­anc­ing stress over­drive and restor­ing the health of neu­ronal cells. Pro­ta­genic is al­ready list­ed on the OTC­QB mar­ket, with se­cu­ri­ties list­ed at $4.14 as of Feb. 2. Avance Clinical is the leading Australian CRO for biotechs, and a Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner. Avance Clinical is a full-service CRO with 24-years of experience, led by CEO Yvonne Lungershausen who is recognised as co-founder of Australia’s clinical research industry. The company has deep expertise, as well as extensive partnerships with technology leaders including Medidata, Oracle, and Medrio to deliver the region’s best clinical trial services to its biotech clients. Avance Clinical grew more than 57% in 2020 and has more than doubled staff numbers. Astellas and Seagen made a big splash with their Nectin-4 targeting therapy Padcev in late 2019, scoring a conditional FDA approval to target urothelial cancer. Now, the results are in for the confirmatory study for that indication, and it looks like a resounding win for Padcev. Astellas and Seagen’s Padcev extended patients’ lives to an average 12.9 months compared with nine months for a chemo control, according to full data from the Phase III EV-301 study presented Friday at the virtual ASCO GU meeting. Eli Lilly let go of former CFO Josh Smiley earlier this week, and it apparently had good reason to do so after the veteran finance chief reportedly sent inappropriate messages to employees. But the firing came with a special poke in the eye for Smiley, who will be forced to forfeit $24 million in compensation as he walks out the door. According to an SEC filing, Lilly required Smiley to forgo $1 million of his 2020 cash bonus, around $3 million of his due shareholder value awards the past three years, and all other current and future equity incentive awards as part of his severance deal— which in aggregate total more than $24 million in future payouts wiped away. In a coda to a six-year legal fight on the PCSK9 terrain, the US Federal Court of Appeals has ruled that Amgen’s patent claims for PCSK9 antibodies as a class are invalid, handing a win to Sanofi and Regeneron. The implications, though, may reverberate far beyond Amgen. The Thousand Oaks, CA-based company, whose Repatha was approved a month after Praluent in 2015, may take comfort in the fact that its sales have consistently eclipsed Sanofi or Regeneron’s, although neither has climbed anywhere near the blockbuster expectations developers and analysts had. As the obesity epidemic in America worsened throughout the years, many biotechs cropped up hoping to develop weight-loss drugs that would help stem this tide. But now, Novo Nordisk’s diabetes cash cow semaglutide is showing such startlingly effective results in obesity that it may have a head start in cornering the market. In nearly a 2,000-person trial, participants injected themselves with either semaglutide or placebo for 68 weeks. Patients in the drug arm saw an average 15% weight loss, compared with just 2.4% on placebo, and almost a third lost more than 20% of their weight. Researchers published the data Wednesday in the New England Journal of Medicine, and all p-values came out to p<0.001. Over the last decade, Hans-Peter Kiem, the Fred Hutch stem cell biologist, and 5AM Ventures chief Kush Parmar founded a slate of prominent biotechs, including Vor and Homology Medicines. But whenever the two spoke, there was one idea Kiem couldn’t stop pitching. Kiem wanted to build a gene therapy biotech that would try to edit a patient’s stem cells with a single injection, rather than by the arduous and now three-decades-old process of removing, modifying and re-implanting them. If he could pull it off, he could take the curative results bluebird bio saw in sickle cell and instantly make it safer and far more scalable. Cancer-clearing CAR-T drugs could be given by IV at the local clinic. Amicus stock got hammered Thursday afternoon after the biotech put out word that the crown jewel in the pipeline just failed the primary endpoint in a head-to-head study with the standard of care for Pompe disease. CEO John Crowley, though, has a long track record at spotlighting the positive, which was on full display in its statement on the failed study. Researchers for the company highlighted some marginally positive secondary data with an improvement in respiratory function from a post hoc analysis that they plan to roll ahead to the FDA. Gilead’s battle-scarred alliance with Galapagos just suffered another grievous wound. The biotech partners reported Wednesday morning that they are abandoning their late-stage pivotal program for ziritaxestat (GLPG1690) — along with everything else in the clinic — after the drug failed a futility analysis, the latest in a series of big setbacks to afflict these players. This drug was at the heart of Dan O’Day’s revised alliance with Galapagos back in the summer of 2019, as the then newly-named Gilead CEO looked to diversify the pipeline and satisfy analysts’ demands for a broader product portfolio with what he called a “transformative” pact. Gilead paid close to $5 billion in an upfront and equity investment for that deal, which now largely lies in ruin. Maribavir, once a trial dud and multiple-time castoff, received new life from the FDA right before Takeda picked up Shire in 2019. Now, Takeda is posting winning late-stage data from the drug that could help it succeed where so many others have failed. In a 352-person trial comparing maribavir to physician’s choice antivirals, more than twice as many patients on maribavir achieved CMV viremia clearance at eight weeks — the study’s primary endpoint, according to Takeda. Of the 235 patients who received maribavir, 131 (or 55.7%) achieved clearance versus 28 of 117 (or 23.9%) of those on conventional antiviral therapies (p<0.001). Viremia is the isolation of CMV by culture.
在上周忙碌的一周里,10家生物技术公司去了酒吧,顾客们试着去看看源源不断的公司在做他们的生意。 随着Ada Gene本周的上市和两家biotechs周四晚些时候到周五的上市,2021年迄今已有16家公司IPO。到目前为止,生物技术公司已经获得了2.86美元的利润。 这一增长很大程度上得益于萨那的大规模IPO,这一规模约占整个IPO总额的四分之一。但也有五家生物技术公司分别筹集了2亿美元以上的资金:Gracell、Culli Nan、Bolt、IM-Munocore和VOR。 这是两家周四中午收盘时定价的公司,以及一家周四晚上提交S-1的生物技术公司。 早在2018年从Johns Hopkins剥离出来的NexingMune正期待着从其主导产品中摄取浓烈的ASH Da。 这种生物技术的售价为17美元,是其产品系列中的高端产品,但在这一过程中却带来了1.1亿美元的收益。它计划以nexi美元的价格进行交易。Orig公司计划出售470万股股票,而Nex公司出售了650万股,帮助它实现了这一高端。 免疫细胞围绕着特定的纳米粒子的概念,这些纳米粒子作为抗原细胞,在肿瘤上诱导T细胞。研究人员在上次对NEXI-001进行的一次I/II期研究中预先发送了初步结果,表明在前五次给药的3-35天内,该研究使细胞数量重新回到了基线水平。 这个项目还在酝酿中,不过,国家正在考虑在22岁和28岁之间推出一些项目。NEXIMMUNE表示,它计划引导IPO资金同时投向这一项目和NEXI-002项目。NEXI-002项目首次在一个男人的最后一个项目上投入,是在一个多项目的Myelo-Ma三个项目上投入的。 研究人员说,如果公司的技术最终奏效,它可能会激发出一种更持久的方法,这将为人们带来更多的焦油,而不像是一种挫折--如果他们能在幼稚和成熟的T细胞上建立一个免疫系统,使人类免疫系统保持警惕,那么就会产生更多的问题。 就在三个月前Deci'bel Ther'a'peu'tics正在快速移动。 回到过去,这家公司一轮融资8200万美元,周四晚间,他们为自己的IPO定价。Deciébel的股价为每股18美元,是其股价区间的高端,盈利1.27亿美元。他们出售了710万股股票,而另一个计划是出售590万股。 当它在周五触及NAS DAQ时,Deci'bel将以$DBTX为记号进行交易。 Deci'bel已经花了很多年的时间来预测失去的听力,但他们没有找到上一次的胜利,他们创造了一个可以重新储存失去的听力的馅饼。这一举措是因为他们找不到一个生物标志物,可以让他们经营一个预开发的三家公司,以及他们在通用和再通用的技术产品中的销售广告。 它现在是波士顿地区三家主要的生物技术公司之一,与基因疗法和干细胞疗法紧挨着。 Decibel的第一个基因疗法是在与Regeneron合作的实验室中进行的,但至少要到2022年才能进入临床。研究人员正在着手修复与耳鼻喉疾病有关的缺陷基因,但长期目标是为更多的遗传性听力损失和缺陷建立治疗方法。 从小的方面来看,新生物技术公司周四提交了1800万美元的IPO申请。 这家位于纽约的生物技术公司正致力于从TCAP技术中分离出来的新产品。ProtaGenic公司的主导产品PT00114正致力于治疗压力性疾病,如PTSD和药物,并与大脑功能无关。 该项目是为2021年完成的,并为第一阶段和第二阶段的三个阶段。ProtaGenic在其S-1中表示,它计划为推出这款“Bas'ket”三元机提供乐趣,目标是签约42名用户。 最后,Prota-genic的目标是通过消除压力而不是动力和恢复新细胞的健康来改善男性的健康。在OTC-QB市场上,Prota-genic已经准备好了,截至2月2日,Se-cu-ri-ties的价格为4.14美元。 Avance Clinical是澳大利亚领先的生物技术CRO公司,也是Frost&Sullivan亚太地区CRO市场领导奖获得者。Avance Clinical是一家提供全方位服务的CRO,拥有24年的经验,由首席执行官Yvonne Lungershausen领导,他是澳大利亚临床研究行业的共同创始人。该公司拥有深厚的专业知识,并与包括Medidata、Oracle和Medrio在内的技术领先者建立了广泛的合作伙伴关系,为其生物技术客户提供该地区最好的临床试验服务。Avance Clinical在2020年增长超过57%,员工人数增加了一倍多。 Astellas和Seagen在2019年末推出了Nectin-4靶向疗法Padcev,获得FDA有条件批准,用于靶向尿路上皮癌。现在,该研究的结果正在进行验证性研究,这对帕德切夫来说似乎是一个巨大的胜利。 根据Astellas和Seagen的Padcev将患者的平均寿命延长到12.9个月,而化疗控制的患者平均寿命为9个月,这是周五在虚拟ASCO GU会议上公布的第三阶段EV-301研究的完整数据。 本周早些时候,礼来公司解雇了前首席财务官乔希•斯迈利,在这位资深财务主管据报道向员工发送不当信息后,礼来公司显然有充分的理由这么做。但这次解雇对斯迈利来说是一个特别的打击,他将被迫在走出房门时被没收2400万美元的赔偿金。 根据SEC的一份文件,礼来要求斯迈利放弃其2020年的100万美元现金奖金、过去三年到期的约300万美元股东价值奖励,以及作为其离职协议的一部分的所有其他当前和未来股权激励奖励--这些奖金总计超过2400万美元的未来支付被抹掉。 在PCSK9领域长达六年的法律斗争中,美国联邦上诉法院裁定安进公司将PCSK9抗体作为一类的专利主张无效,赛诺菲和再生龙赢得了胜利。 然而,其影响可能远远超出了安进的范围。 这家总部位于加利福尼亚州千橡市的公司,其Repatha在2015年比Praluent晚一个月获得批准,或许会感到欣慰的是,该公司的销售额一直超过赛诺菲或Regeneron公司,尽管这两家公司的销售额都没有达到开发商和分析师的预期。 随着肥胖症在美国的蔓延,多年来不断恶化,许多生物技术公司突然出现,希望能开发出减肥药来帮助遏制这一趋势。但现在,诺和诺德的糖尿病摇钱树semaglutide在肥胖方面显示出惊人的有效效果,它可能在市场上占了先机。 在一项近2000人的试验中,参与者给自己注射semaglutide或安慰剂,持续68周。服用药物的患者平均体重减轻了15%,而服用安慰剂的患者仅为2.4%,几乎三分之一的患者体重减轻了20%以上。研究人员在周三的《新英格兰医学杂志》上发表了这一数据,所有的P值均为P<0.001。 在过去的十年里,弗雷德·哈奇的干细胞生物学家汉斯-彼得·基姆和5AM Ventures的首席执行官库什·帕尔马创立了一系列著名的生物技术,包括Vor和同源药品。但每当两人说话的时候,有一个想法是基姆无法停止投球。 Kiem想要建立一种基因治疗生物技术,通过一次注射就可以编辑病人的干细胞,而不是通过取出、修改和重新植入这些干细胞的艰苦过程。如果他能成功,他就能取得蓝鸟生物在镰刀细胞中看到的治疗效果,并立即使它更安全,更可扩展。可在当地诊所静脉注射清除癌症的CAR-T药物。 Amicus公司周四下午遭到重创,此前该生物技术公司发布消息称,在庞贝病护理标准的一项面对面研究中,这颗正在酝酿中的皇冠上的明珠刚刚未能达到主要终点。 然而,首席执行官约翰•克劳利在强调积极方面有着悠久的历史记录,这一点在其关于失败研究的声明中得到了充分展示。该公司的研究人员从一项事后分析中强调了一些轻微积极的辅助数据,即呼吸功能的改善,他们计划将这些数据提交给FDA。 基列与加拉帕戈斯的战斗伤痕累累的联盟刚刚遭受了另一个严重的创伤。 这两家生物技术合作伙伴周三早间报告说,他们将放弃锆英司他酯(GLPG1690)的后期关键项目--以及诊所里的其他所有项目--因为该药物没有通过无效性分析,这是困扰这些公司的一系列重大挫折中的最新一例。 这种药物是丹·奥戴(Dan O'Day)在2019年夏天与加拉帕戈斯修订后的联盟的核心,当时这位刚上任的Gilead首席执行官希望通过一项他称之为“变革性”的协议,使管道多样化,并满足分析师对更广泛产品组合的需求。Gilead为这笔交易支付了近50亿美元的前期投资和股权投资,现在这笔交易基本上已经破产。 马里巴韦,曾经是一个试验哑弹和多次丢弃,在2019年竹田接手夏尔之前,从FDA获得了新生。现在,武田公布了从药物中获得的后期数据,这些数据可以帮助它在许多其他药物失败的地方取得成功。 根据Takeda的说法,在一项352人的试验中,比较了maribavir和医生选择的抗病毒药物,使用maribavir的患者在8周时达到CMV病毒血症清除率的两倍多,这是该研究的主要终点。在接受马里巴韦治疗的235例患者中,131例(55.7%)获得清除,而在接受常规抗病毒治疗的117例患者中,28例(23.9%)获得清除(P<0.001)。病毒血症是通过培养分离CMV。

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