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.

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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UP­DAT­ED: Have a new drug that promis­es to fight Covid-19? The FDA promis­es fast ac­tion but some de­vel­op­ers aren't hap­py

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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The race to de­vel­op Covid-19 drugs and vac­cines is on — here’s what’s hap­pen­ing in the UK

Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.

On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 — an inhaled formulation of interferon-beta-1a — that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.

‘There was a grow­ing weari­ness’: Rush­ing against a pan­dem­ic clock, As­pen Neu­ro­sciences se­cures $70M Se­ries A

Just before Christmastime, Howard Federoff got a tip from Washington: There was a new virus in China. And this one could be bad.

News report of the virus had not yet appeared. Federoff, a neuroscientist, was briefed because years before, he was vetted as part of a group — he didn’t give a name for the group — to consult for the US government on emerging scientific issues. His day job, though, was CEO of Aspen Neurosciences, a Parkinson’s cell therapy startup that days before had come out of stealth mode and gave word to investors they were hoping to raise $70 million. That, Federoff realized, would be difficult if a pandemic shut down the global economy.

FDA puts pe­di­atric aGVHD drug on pri­or­i­ty re­view lane — will they go vir­tu­al with the ad­comm?

Despite worries about regulatory delays due to new work arrangements under Covid-19, the FDA appears intent to go full speed ahead with its everyday work, not only granting priority review to a stem cell therapy for acute graft versus host disease but also plotting an advisory committee meeting for it.

With a PDUFA date of September 30, the journey of the drug — remestemcel-L, or Ryoncil — could shed light on the agency’s capacity to facilitate drug development unrelated to Covid-19.

Covid-19 roundup: Trump push­es his new fa­vorite, untest­ed drug; CRISPR out­lines crip­pling im­pact of Covid-19

President Trump has a new favorite Covid-19 drug.

After a conversation with Japanese Prime Minister Shinzo Abe, Politico reports, the president is pressuring the FDA to issue emergency use authorization for favipiravir, a flu drug that showed glimpses of success in China but remains unproven and carries a list of worrying side effects. The push comes after a week-plus in which the White House touted a potentially effective but unproven malaria medication despite the concerns of scientific advisors such as NIAID director Anthony Fauci. And Trump ally Rudy Giuliani has been talking up unproven cell therapy efforts on Twitter.

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ITeos nabs $125M as they prep Keytru­da com­bi­na­tion tri­al — if Covid-19 will let them

For iTeos, it turned out, $75 million could only last so long.

Two years after announcing their eye-catching Series B raise, the Belgian biotech is back with an even larger Series B-2: $125 million.

The now $175 million financing – $25 million of the first B round is considered part of the second – illustrates the vast capital available for those with promising new immuno-oncology compounds, particularly those that might be used in combination with existing therapies. In December, iTeos announced a collaboration with Merck to test its lead compound with Keytruda this year. The proceeds will push forward that trial and help fund the ongoing Phase I/II trials for that compound, EOS-850, and a second one, EOS-448.

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