Four biotechs haul in $303M+ from a fresh burst of IPOs

De­spite the longest-ever US gov­ern­ment shut­down sub­du­ing IPO ac­tiv­i­ty in the first-quar­ter — health­care IPOs dom­i­nat­ed, ac­count­ing for 70% of the 20 IPOs in the re­gion, ac­cord­ing to ac­count­ing firm Ernst & Young. In­ter­est in the sec­tor has far from cooled — with four drug de­vel­op­ers fo­cus­ing on a range of con­di­tions from the ever-pop­u­lar im­muno-on­col­o­gy to fail­ure-friend­ly Alzheimer’s — set to make their pub­lic de­buts on Thurs­day.

Lieping Chen

In March, Yale spin­out NextCure laid out the blue­print for its im­muno-on­col­o­gy re­search in Na­ture Med­i­cine, af­ter se­cur­ing $40 mil­lion up­front in an R&D col­lab­o­ra­tion with Lil­ly and bring­ing its cash haul to a cool $180 mil­lion. The com­pa­ny — found­ed in 2015 by Lieping Chen, a not­ed I/O re­searcher be­hind Am­plim­mune, a com­pa­ny bought out by As­traZeneca five years ago — has now raised $75 mil­lion in an IPO. The com­pa­ny, which is poised to trade un­der the sym­bol $NXTC, of­fered 5 mil­lion shares at $15 — the mid­point of its range of $14 to $16. The Beltsville, Mary­land-based drug de­vel­op­er is fo­cus­ing on PD-L1-neg­a­tive tu­mors to help the scores of pa­tients for whom check­point in­hibitors don’t work. Its lead ex­per­i­men­tal drug — NC318 — tar­gets an im­munomod­u­la­to­ry re­cep­tor called Siglec-15 and is cur­rent­ly be­ing test­ed in a Phase I/II tri­al in pa­tients with ad­vanced or metasta­t­ic sol­id tu­mors.

Steve Dominy

With the field of Alzheimer’s drug de­vel­op­ment lit­tered with fail­ure and the amy­loid-be­ta hy­poth­e­sis all but dead, a fresh ap­proach to treat­ing the mem­o­ry-wast­ing dis­ease has gar­nered in­ter­est in Cor­texyme. The South San Fran­cis­co-based biotech is bet­ting that Por­phy­romonas gin­gi­valis — a bac­te­r­i­al pathogen as­so­ci­at­ed with chron­ic pe­ri­odon­ti­tis — could be vi­tal to com­bat­ing Alzheimer’s-re­lat­ed neu­rode­gen­er­a­tion, based on the find­ings of  UCSF psy­chi­a­trist Steve Dominy. Cor­texyme’s lead ex­per­i­men­tal drug is de­signed to in­hib­it gingi­pains — the tox­ic pro­tease se­cret­ed by P. gin­gi­valis — and is be­ing eval­u­at­ed in Phase II/III study. Backed by Pfiz­er (14.71%) and Take­da (12.32%), the com­pa­ny has now raised $75 mil­lion in an IPO. The com­pa­ny, which is set to trade un­der the sym­bol $CRTX, of­fered 4.4 mil­lion shares at $17 — the mid­point of its range of $16 to $18.

With car­dio­vas­cu­lar dis­eases im­pli­cat­ed in an es­ti­mat­ed third of all deaths, drug­mak­ers (and in­vestors) are al­ways on the hunt for new treat­ments. Cana­di­an biotech Mile­stone Phar­ma­ceu­ti­cals’ sole as­set is a nasal spray for­mu­la­tion of a cal­ci­um chan­nel block­er, which has been craft­ed to treat a rapid heart rate con­di­tion that is usu­al­ly treat­ed with in­tra­venous in­fu­sions in the ER. The hope is the rapid-on­set drug (cur­rent­ly in late-stage de­vel­op­ment) can help pa­tients re­solve sud­den episodes of parox­ys­mal supraven­tric­u­lar tachy­car­dia — which are of­ten ac­com­pa­nied by pal­pi­ta­tions, chest pres­sure, pain, short­ness of breath and faint­ing — on their own. The drug, etri­pamil, is al­so be­ing eval­u­at­ed for atri­al fib­ril­la­tion and angi­na. Ven­ture in­vestors col­lec­tive­ly claim more than 80% of the com­pa­ny, which raised $82.5 mil­lion in an up­sized IPO. The drug de­vel­op­er, set to trade as $MIST, of­fered 5.5 mil­lion shares at $15, sell­ing an ad­di­tion­al 500,000 shares at the mid­point of the range of $14 to $16.

Bill Hin­shaw

About a year af­ter en­tic­ing No­var­tis ex­ec­u­tive Bill Hin­shaw to run its op­er­a­tions, Flag­ship Pi­o­neer­ing-backed Ax­cel­la Health is tak­ing its pre­clin­i­cal pipeline of meta­bol­ic mod­u­la­tors — based on sci­ence that sug­gests amino acids can re­store health across a net­work of dys­reg­u­lat­ed path­ways — on to the pub­lic mar­ket. The com­pa­ny’s lead ex­per­i­men­tal drug is be­ing de­vel­oped for he­pat­ic en­cephalopa­thy, which are neu­ropsy­chi­atric ab­nor­mal­i­ties as­so­ci­at­ed with pa­tients suf­fer­ing from liv­er dys­func­tion, typ­i­cal­ly chron­ic liv­er dis­ease. The Cam­bridge, Mass­a­chu­setts-based biotech — set to trade un­der the sym­bol $AXLA — raised $71 mil­lion by of­fer­ing 3.6 mil­lion shares at $20, the low end of the range of $20 to $22.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Sanjiv Patel, Relay CEO

Re­lay reaps $400M IPO wind­fall af­ter draw­ing the cur­tain on mo­tion-based drug de­sign pipeline

A red-hot venture market back in 2018 propelled Relay Therapeutics to a whopping $400 million crossover round. And now, the biotech is riding on a red-hot IPO market to a public debut that brought in the same exact amount.

The $400 million raise breaks down to 20 million shares sold at $20 each — above even the amended proposed range of $16 to $18.

It’s also double what Relay had penciled in with the initial S-1 filing, in yet another illustration that those figures are often nothing more than a placeholder these days.

Donald Trump and Anthony Fauci (AP Images)

Covid-19 roundup: Fau­ci fires back at White House cam­paign to un­der­mine him

Anthony Fauci has called the White House campaign to discredit him “a bit bizarre” and said he stands by his previous statements, even if he has since changed his views.

The NIAID chief — who has received an outpouring of support following reports that the Trump administration has sent a document akin to opposition research to multiple news outlets — spoke with his usual candor in interviews with The Atlantic.

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De­spite safe­ty, ef­fi­ca­cy con­cerns, FDA Ad­Com nar­row­ly rec­om­mends Mallinck­rodt drug

A day after the FDA detailed significant concerns about just how effective or safe an experimental Mallinckrodt liver drug was, an advisory committee decided by a single vote to recommend it for approval.

“I voted yes to approve, but I also wrote in, ‘but barely,’” Paul Ridker, a cardiologist at Brigham and Women’s Hospital and one of the panelists, said at the meeting, according to FierceBiotech. The vote was 8-7.

John Furey, Imvax CEO

A neu­ro­sur­geon spent the past 30 years de­vel­op­ing a neoanti­gen tu­mor vac­cine. Now he has $112M to put it to piv­otal test

As a neurosurgeon, David Andrews knew there wasn’t much he could do for his glioma patients after resecting — rarely fully — their tumor. Even with the best treatment and care available, median overall survival is just somewhere between 14 and 16 months.

Then in the 1990s, his mentor at Thomas Jefferson University introduced him to Renato Baserga, a pathologist who had been studying the effect of using antisense oligonucleotide to knock out the insulin-like growth factor type 1 receptor in cancers. As IGF-R1 drives tumor growth and metastasis, the preclinical reasoning went, implanting a molecule targeting the receptor together with the tumor material near lymph nodes can slow down the spread of the cancer.

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BioAt­la rakes in $72.5M Se­ries D, ad­vanc­ing re­search for pH-de­tect­ing can­cer treat­ments

A little over a year after agreeing to a worldwide collaboration with hefty Chinese biotech BeiGene worth up to $270 million, BioAtla is ready for another haul.

The San Diego-based biotech pulled in a $72.5 million haul for their Series D financing, which the company announced Wednesday. Funds will go toward their four main clinical programs developing cancer treatments, two of which are currently in Phase II, BioAtla president and former Celgene COO Scott Smith said.

Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

A day af­ter Mod­er­na vac­cine re­sults, ru­mors swirl of pend­ing As­traZeneca da­ta

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet. 

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.