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.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,700+ biopharma pros reading Endpoints daily — and it's free.

Credit: Shutterstock

Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

UP­DAT­ED: Ac­celeron res­ur­rects block­buster hopes for so­tater­cept with pos­i­tive PhII — and shares rock­et up

Acceleron $XLRN says that its first major trial readout of 2020 is a success.

In a Phase II study of 106 patients with pulmonary arterial hypertension (PAH), Acceleron’s experimental drug sotatercept hit its primary endpoint: a significant reduction in pulmonary vascular resistance. The drug also met three different secondary endpoints, including the 6-minute walking test.

“We’re thrilled to report such positive topline results from the PULSAR trial,” Acceleron CEO Habib Dable said in a statement. The company said in a conference call they plan on discussing a Phase III trial design with regulators.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,700+ biopharma pros reading Endpoints daily — and it's free.

Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”

Pfiz­er ax­es 6 ear­ly to late-stage can­cer stud­ies from the pipeline — with one oth­er cut for sick­le cell dis­ease

Pfizer trimmed a group of 3 R&D programs using their PD-L1 Bavencio — partnered with Merck KGaA — in their latest pipeline cull.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,700+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: In­cyte scores much need­ed PhI­II suc­cess — and of course it’s de­liv­ered by rux­oli­tinib

Incyte’s efforts to breathe a second life into ruxolitinib — its JAK inhibitor sold in pill form as Jakafi — has been greeted with clear, if preliminary and unsurprising, Phase III success.

Topline data from the TRuE-AD2 cements ruxolitinib’s foundational importance for Incyte, and gives analysts hope that there might yet be room for growth in a pipeline that’s suffered multiple R&D setbacks.

Stephen Hahn, AP

The FDA un­veils a new reg­u­la­to­ry frame­work to speed along gene ther­a­pies, re­ward­ing the lead­ing play­ers

Bioregnum Opinion Column by John Carroll

The emphasis at the FDA over the past 5 years or so has been on assisting drug developers as much as they can to speed up regulatory reviews and push more drugs into the market. And they are now crafting a final set of regulations aimed at flagging through a whole new generation of gene therapies in clinical testing at a rapid clip.

In a set of 6 prospective guidances posted on the FDA web site Tuesday morning, FDA commissioner Stephen Hahn committed the agency to staying flexible in handing out designations that are critical to gaining early approvals for drugs that claim to be once-and-done but don’t have anything close to the data needed to prove it.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.