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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Nashville-based CD­MO nets a $65M Se­ries B to ex­pand fa­cil­i­ty and ca­pa­bil­i­ties

Another $65 million is music to the ears of the team at August Bioservices, a contract manufacturer in Nashville.

The company announced the Series B round last week, which will fund equipment in a new building expected to open in 2023, according to CEO Jenn Adams. It was led by Oak HC/FT, the same firm that led August’s Series A round in July 2020.

August Bioservices, a producer of materials such as prefilled syringes, IV bags and vials, was formed back in 2020 after the acquisition of PMI BioPharma Solutions, also based in Nashville. Adams said the goal was to build a business that could “address the scarcity of supply relative to sterile injectable manufacturing based in the US” and provide a broad range of manufacturing services.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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