Pe ter Thiel-backed psy che delics play er ATAI pulls in an oth er nine-fig ure raise. But they're not ready to talk IPO — ...

泰尔后背的psy che delics玩er ATAI拉在一个oth er 9 fig升高。但他们还没准备好谈IPO...

2021-03-04 10:33:14 ENDPOINTS NEWS

本文共3193个字,阅读需8分钟

Rough­ly three and a half months since its last fundrais­ing round, the Pe­ter Thiel-backed ATAI Life Sci­ences has pulled in its lat­est ven­ture haul. The com­pa­ny closed a $157 mil­lion Se­ries D round ear­ly Wednes­day as it press­es the gas on its psy­che­delics-based strat­e­gy. Though the short time be­tween the two rais­es will like­ly fu­el spec­u­la­tion about a po­ten­tial jump to Nas­daq, ATAI isn’t ready to talk about that just yet, pre­emp­tive­ly de­clin­ing com­ment on all IPO-re­lat­ed ques­tions. Nev­er­the­less, it marks a four-month span in which the com­pa­ny has seen near­ly $300 mil­lion of cap­i­tal flow in­to its cof­fers, as well as Thiel join­ing its cadre of in­vestors. ATAI’s busi­ness mod­el for de­vel­op­ing ther­a­peu­tics cov­er­ing a range of men­tal health dis­or­ders — bring­ing port­fo­lio com­pa­nies un­der one um­brel­la — is dri­ving the heavy in­vestor in­ter­est, CEO Flo­ri­an Brand told End­points News. With the new raise com­ing al­most im­me­di­ate­ly af­ter the Se­ries C, ATAI can now “dou­ble down” on its strat­e­gy, Brand said. “A lot of aware­ness is in­creas­ing that the men­tal health cri­sis is a se­vere is­sue, which has on­ly been am­pli­fied by Covid,” Brand said. “The way we’ve po­si­tioned our­selves gives us a very good op­por­tu­ni­ty to bring more ef­fec­tive treat­ments to the mar­ket and cre­ate in­ter­est among the in­vestor com­mu­ni­ty on more projects.” Right now, ATAI has 13 pro­grams de­vel­op­ing drugs, and has dis­closed two plat­form-based com­pa­nies they’ve wel­comed in­to their port­fo­lio. On top of that, the mar­ket has seem­ing­ly val­i­dat­ed ATAI’s fo­cus on psy­che­delics. Brand point­ed to Com­pass Path­ways’ $146.6 mil­lion IPO last Sep­tem­ber as a key de­vel­op­ment for le­git­imiz­ing what ATAI is al­so try­ing to ac­com­plish. Com­pass’s most re­cent da­ta come from De­cem­ber 2019 in a Phase Ib tri­al, show­ing their man-made ver­sion of the chem­i­cal psilo­cy­bin — a psy­choac­tive in­gre­di­ent found in some species of “mag­ic mush­rooms” — had been well-tol­er­at­ed in 89 healthy vol­un­teers. Co­in­ci­den­tal­ly or not, Com­pass al­so brought in in­vest­ments from Thiel to re­search psilo­cy­bin with psy­cho­log­i­cal sup­port as a treat­ment for men­tal ill­ness­es such as de­pres­sion, anx­i­ety and ad­dic­tion. Though the cash has been flow­ing in for ATAI, the M&A land­scape has been qui­et since their Jan­u­ary deal to ac­quire schiz­o­phre­nia-fo­cused com­pa­ny Recog­ni­fy Life Sci­ences. Brand said he’s hop­ing that ATAI’s ac­qui­si­tion ap­petite will kick back in­to gear with the new Se­ries D. But ATAI’s big­ger goal over the next few years, now that they have some more cash to ex­pand their port­fo­lio, is to push the psy­che­delics space to re­sem­ble pre­ci­sion med­i­cine. ATAI is ul­ti­mate­ly work­ing to­ward dig­i­tal ther­a­peu­tics that can ide­al­ly pre­dict what treat­ments might work best for spe­cif­ic pa­tients, CMO Srini­vas Rao told End­points. It’s still too ear­ly for the com­pa­ny to di­vulge too much of its ef­forts on this front, Rao said, but once they get the ball rolling they hope to push for­ward an “ag­gres­sive” time­line. The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights. Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates. In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders? Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday. CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means. Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society. One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies. The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.” They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management. GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan. The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday. A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement. The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance. It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though. “I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.” Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic. Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one. Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms. Janux Therapeutics had kept a relatively low profile since being founded back in 2017 but burst onto the scene late last year when Merck plunked down more than $1 billion in promised milestones for its T cell engagers. Now, less than three months later, the small biotech has clinched its first round of private funding led by some prominent backers. As it prepares its first programs for INDs, Janux completed a $56 million Series A on Wednesday morning, with Jay Lichter’s Avalon Ventures joining forces with new investors OrbiMed and RA Capital Management to fund the company. Janux will use the cash to primarily advance its T cell engagers targeting PSMA and TROP2, which are expected to hit the clinic in the first and second quarters of 2022, respectively.
从上一轮融资开始算起,经过了三个半月的时间,这家由PeterThiel支持的ATAI Life Sciences已经收获了最新的收益。 这家公司周三在其基于PSY-CHE-DELICS的State-Gy上加气时,收盘价为1.57亿美元。虽然这两家公司之间的短时间内将会喜欢关于向NAS DAQ的初步跃升的FuelSpecution,但ATAI目前还没有准备好谈论这个问题,在所有IPO相关的问题上都要先进行讨论。 更重要的是,这标志着在四个月的时间里,该公司看到了近3亿美元的资本流入其客户,同时也看到了泰尔加入其客户队伍。 Atai公司的业务模式是为一系列男性健康疾病提供服务--带来一个更好的服务--是为重磅产品提供服务,首席执行官Flo-rianBrand告诉End-points News。布兰德说,随着新的加薪,阿泰现在可以“降低”其战略。 布兰德说:“很多人都意识到男性健康问题是一个问题,这一点已经被Covid所证实。”“我们自我介绍的方式为我们提供了一个很好的机会,为市场带来更多的优惠,并在更多的项目中为客户提供更多的优惠。” 现在,阿泰有13个生产药物的项目,并关闭了两个基于平台的公司,它们已经进入了自己的港口。 最重要的是,这个标记似乎已经在psyche-delics上对阿泰伊的特征进行了评价。Brand公司将去年9月PATH WAYS公司146.6百万美元的IPO作为一项关键举措,以此来说明ATAI公司的现状,因此要努力去实现这一目标。 康帕斯最有价值的数据来自2019年的一个第三阶段,展示了他们的人造化学物质--在某些种类的“杂物杂物室”中发现的物质--在89个健康的实验中得到了很好的应用。不管有没有合作,公司都是从泰尔引进的,用PSY_CHO_LOG_I_PORT来研究PSY_CHO_LOG_I_SUP_PORT来治疗男性的疾病,如压力、焦虑和压力。 尽管现金一直在为阿泰流入,但自从他们今年1月与Acquire Schiz?o?phrenia-fcused com?pa?ny recogn?nify Life Sciences达成交易以来,并购地景就一直在被抢走。布兰德说,他希望阿泰的Acqui-Sitionappetite将重新投入到新的SE D中来。 但阿泰在未来几年的大目标,现在他们有更多的现金和他们的港口,是推动PSY公司的空间,以恢复前期医疗。CMO Srini-vas Rao告诉End-Points说:“我们正在努力挖掘能够预测哪种治疗最适合消费者的疗法。” Rao说,对公司来说,在这方面过于吹嘘自己的优势还太早,但一旦他们开始行动,他们希望推动一个“统一的”时间表。 这场全球大流行可能扰乱了经济,夺走了数十万人的生命,扼杀了整个行业,但它对生物制药风险投资的唯一影响是帮助该领域达到令人眩晕的新高度。 根据DealForma首席执行官Chris Dokomajilar的记录,以下是业内前100名风险投资家的排名,根据他们公开参与的交易数量排名。然后,数字大师计算出他们投入每笔交易的估计金额--按玩家人数分配现金--以表明他们是如何管理自己的辛迪加的。 去年年底,FDA命令百时美施贵宝放弃Opdivo在SCLC的审批,这可能是对那些利用验证性研究来支持加速审批的制药商的一次早期打击。现在,默克是下一个上火线的--我们看到FDA对上市后违法者的严厉打击了吗? 默克公司周一表示,该公司已经撤回了对转移性小细胞肺癌的PD-(L)1抑制剂Keytruda的上市批准,作为FDA对不符合上市后检查点的药物进行“全行业评估”的一部分。 CRLS.483s.CBER、CDER和RWE。对于生物制药专业人员来说,这些首字母缩略词之所以引起注意,是因为FDA在药物开发中起着重要作用。现在Endpoints正在加倍扩大监管覆盖范围,并推出一份关注White Oak公司发展的周报,并对这一切意味着什么进行分析和洞察。 报道将由我们新的高级编辑Zachary Brennan领导。他加入了POLITICO的端点,在那里他报道了制药。在此之前,他是管理事务专业人士协会的新闻刊物《管理焦点》的执行编辑。 欧洲最受瞩目的生物制药投资者之一将获得5.4亿美元,投资于新的跨界交易,为处于后期阶段的公司投资。 这家总部位于巴黎的风投公司表示,新的Sofinnova跨界基金融资使他们成为“欧洲最大的跨界投资者,致力于后期生物制药和医疗技术投资”。 他们在法国获得了法国政府颁发的“Tibi”特许权,从而获得了60亿欧元的资金池,帮助他们在机构投资者中获得了优势。自50年前成立以来,这家风险集团已经支持了500多家公司,目前管理着超过20亿欧元的资金。 葛兰素史克公司和Vir Biotechnology公司在接到NIH一项针对住院Covid-19患者的重大研究的邀请后,希望他们合作的抗体之一能够赢得胜利。但就像礼来一样,这对组合的药物不能击中目标,现在他们将被留在认真看比赛计划。 合作伙伴周三表示,NIH已经停止了GSK和Vir的抗体VIR-7831在其晚期Active-3试验中的注册,因为该药物在实现住院的Covid-19患者的持续康复方面显示出可忽略不计的效果。 一周多一点后,BrainStorm公司承认FDA的监管机构已经通知他们,该生物技术公司需要更多的数据才能获得ALS治疗NurOwn的批准--同时仍在吹捧疗效的“明确信号”,并不排除申请--该机构决定在一份最不寻常的声明中澄清记录。 FDA的声明完全是对自己的一记耳光,它提供的药效数据与该公司去年11月的公开声明不同,并且排除了任何统计意义的可能性。 Paul Sekhri偶尔会想到,如果他们成功了,他的公司将登上《纽约时报》的头版,并成为地球上几乎所有主要新闻媒体的头版报道。不过,他尽量不去想这件事。 “我只想把注意力集中到这一点上,”塞赫里说,然后承认,“是的,我绝对想过了。” 塞克里是一名长期从事生物制药的高管,曾在赛诺菲和诺华任职。如今,他担任eGenesis首席执行官已进入第三年。eGenesis是乔治•丘奇的门生杨露汉创建的生物技术公司,旨在对猪进行基因改造,使它们能够用于器官移植。他带领他们通过了一个megaround,刚刚关闭了另一个,从17个不同的投资者那里筹集了1.25亿美元,将有史以来第一个(人化的)猪移植到人类的诊所。 过去十年,制药商已经证明JAK抑制剂可以治疗从类风湿性关节炎到COVID-19等一小部分免疫相关疾病。现在礼来又拿出了一个新的。 礼来及其生物技术合作伙伴Incyte周三宣布,他们的JAK抑制剂baricitinib在一项针对斑秃的III期试验中有效地修复了患者的头发。斑秃是一种会导致突然、严重和斑片状脱发的自身免疫性疾病。礼来没有对546名患者的试验结果进行分析,但主要终点是脱发症状标准评分的改善。 Janux Therapeutics自2017年成立以来一直保持着相对低调的姿态,但去年年底,默克公司斥资逾10亿美元,承诺为其T细胞参与器提供一系列里程碑项目,这让Janux Therapeutics突然崭露头角。现在,不到三个月后,这家小型生物技术公司已经获得了由一些知名支持者牵头的第一轮私人融资。 Janux在为INDs准备第一个项目的同时,于周三上午完成了5600万美元的a轮融资,由Jay Lichter的Avalon Ventures联合新的投资者OrbiMed和RA Capital Management为该公司提供资金。Janux公司将利用这笔资金主要推进针对PSMA和TROP2的T细胞接合器,预计将分别于2022年第一季度和第二季度投入临床应用。

以上中文文本为机器翻译,存在不同程度偏差和错误;偶尔因源网页结构局限,内容无法一次完整呈现。请理解并参考原站原文阅读。

阅读原文