Rain Ther­a­peu­tics head­lines newest slate of IPO-bound biotechs with $100M pen­ciled in for lead on­col­o­gy pro­gram

Ed­i­tor’s note: In­ter­est­ed in fol­low­ing bio­phar­ma’s fast-paced IPO mar­ket? You can book­mark our IPO Track­er here.

A fresh slate of biotech IPOs has filed to go pub­lic as the cal­en­dar turns to­ward the sec­ond quar­ter.

Three com­pa­nies filed their reg­is­tra­tional pa­per­work over the hol­i­day week­end, with Rain Ther­a­peu­tics and Im­pel Neu­roPhar­ma sub­mit­ting S-1s on Fri­day and Aneb­u­lo Phar­ma­ceu­ti­cals do­ing so last Thurs­day. Rain leads the es­ti­mat­ed rais­es of the group with a $100 mil­lion tranche pen­ciled in, fol­lowed by Im­pel at $75 mil­lion and Aneb­u­lo at a mod­est $15 mil­lion.

The moves come af­ter a huge haul for the sec­tor in the first quar­ter, which saw 32 biotechs file or price their IPOs. Among the com­pa­nies that went pub­lic, the in­dus­try raised more than $4.6 bil­lion in the first three months of the year.

Should biotechs con­tin­ue at this pace, 2021 will eclipse 2020’s record raise by more than $2 bil­lion, ac­cord­ing to fig­ures from Nas­daq.

Rain cap­i­tal­izes on Dai­ichi Sankyo pro­gram li­censed last year

Rain Ther­a­peu­tics saw a show­er of good for­tune in 2020.

Around La­bor Day last year, the biotech tripled its pipeline in the span of a week, li­cens­ing a re­search pro­gram from Drex­el Uni­ver­si­ty and nab­bing a Phase II-ready drug from Dai­ichi Sankyo. Rain fol­lowed that up with a $63 mil­lion fundraise short­ly af­ter to push for­ward all three of its pro­grams.

The new­er can­di­dates pair up with the com­pa­ny’s orig­i­nal mis­sion, one which helped it launch with an $18 mil­lion Se­ries A back in 2018. Rain’s first ex­per­i­men­tal drug was tar­lox­o­tinib, a small mol­e­cule in­hibitor de­signed to tar­get low oxy­gen lev­els in tu­mors and there­by spar­ing healthy tis­sues.

Now, though, the Dai­ichi pro­gram has be­come Rain’s lead. Dubbed RAIN-32, the can­di­date will see the bulk of Rain’s IPO funds fun­neled to­ward it. Per the S-1, Rain plans to launch three stud­ies for RAIN-32, in­clud­ing a piv­otal Phase III study in an MDM2-am­pli­fied sub­type of li­posar­co­ma.

The raise will al­so help fund a Phase II tu­mor-ag­nos­tic bas­ket tri­al in cer­tain sol­id tu­mors and a Phase 2 tri­al in in­ti­mal sar­co­ma for the pro­gram, as well as help man­u­fac­tur­ing costs and fund fur­ther trans­la­tion­al stud­ies.

Rain plans to trade un­der the tick­er $RAIN.

Im­pel tak­ing its in­haled drugs pub­lic ahead of mi­graine PDU­FA

More than two years af­ter its crossover raise, Im­pel Neu­roPhar­ma is fi­nal­ly head­ing to Nas­daq.

The Seat­tle-based biotech has a unique ap­proach for get­ting CNS drugs de­liv­ered to the brain — through the nose. Im­pel’s tech is cen­tered around a de­liv­ery sys­tem of nasal dos­es of old and thor­ough­ly un­der­stood drugs, with re­search go­ing to­ward mi­graines, Parkin­son’s and ag­i­ta­tion re­lat­ed to autism.

Led by CEO Adri­an Adams, Im­pel hopes an en­hanced nasal de­liv­ery ap­proach can im­prove a drug’s per­for­mance, of­fer­ing an open­ing for an im­proved ther­a­peu­tic ef­fect with a liq­uid or dry for­mu­la­tion of an old drug. Their mi­graine pro­gram has com­plet­ed its piv­otal study, with an ex­pect­ed PDU­FA date of Sept. 6 lat­er this year.

As such, the ma­jor­i­ty of the planned IPO cash will go to­ward fund­ing the po­ten­tial com­mer­cial launch of the mi­graine treat­ment, which Im­pel plans to mar­ket as Trud­he­sa. The drug is an up­per nasal for­mu­la­tion of di­hy­droer­go­t­a­mine to treat acute mi­graines.

The re­main­der of the IPO funds will help the INP105 pro­gram, de­signed for acute treat­ment of ag­i­ta­tion and ag­gres­sion as­so­ci­at­ed with autism spec­trum dis­or­der. This can­di­date is a nasal re­for­mu­la­tion of olan­za­p­ine.

Im­pel plans to list un­der the tick­er $IM­PL.

Cannabi­noid over­dose biotech Aneb­u­lo looks to fund new stud­ies

Aneb­u­lo Phar­ma­ceu­ti­cals brings up the rear this week, pen­cil­ing in just $15 mil­lion for its IPO raise.

The Lake­way, TX-based com­pa­ny, found­ed just last year, is fo­cused on de­vel­op­ing treat­ment for cannabi­noid over­dose and sub­stance ad­dic­tion. Aneb­u­lo’s lead can­di­date, ANEB-001, is de­signed to re­verse the neg­a­tive ef­fects of cannabi­noid over­dose with­in one hour of ad­min­is­tra­tion.

Aneb­u­lo is hop­ing to ful­ly fi­nance a Phase II proof-of-con­cept study for the pro­gram with its IPO mon­ey. But this won’t be the last time Aneb­u­lo is look­ing to raise mon­ey — in their S-1, they not­ed that they’ll have more cap­i­tal in about 18 months to run the piv­otal safe­ty tri­als, launch the drug com­mer­cial­ly and make mile­stone pay­ments to Ver­nalis, from whom Aneb­u­lo li­censed its pro­gram.

The biotech plans to trade un­der the tick­er $ANEB.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

Endpoints Premium

Premium subscription required

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

Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

When Ginkgo went comparison shopping for a financial market to list their now $15 billion company, the New York Stock Exchange had a back-pocket sweetener the Nasdaq couldn’t offer: The most sought-after ticker in biotech, $DNA.

DNA — the most famous three letters in biology and the ticker for the world’s first biotech, Genentech, from 1999 until it was bought out by Roche for $48 billion in 2009 — will now be the ticker for Ginkgo, a 12-year-old synthetic biology startup with grand ambitions to change not only how drugs, but also everyday products like meat and perfumes, are made.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another day, another SPAC vying for a spot on Nasdaq.

On Wednesday, OncoSec Medical CEO Daniel O’Connor filed the S-1 paperwork for a new blank-check company he’s leading called Larkspur Health Acquisition. The former Advaxis chief penciled in a $75 million raise, with plans to offer 7.5 million shares at $10 apiece.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.