Biotech's IPO raise ap­proach­es $5.5B as Nas­daq con­tin­ues to prove fruit­ful with 2 de­buts and three new fil­ings

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It was an­oth­er busy week in the biotech IPO mar­ket as the sec­ond quar­ter con­tin­ues to churn out sig­nif­i­cant in­vest­ment in­to the sec­tor.

Re­cur­sion led the way with a $436 mil­lion raise on Fri­day, pric­ing its IPO at $18, the high end of its range. Our own John Car­roll went in depth on that raise over the week­end. Al­so on Fri­day, pre­clin­i­cal can­cer biotech Bio­mea Fu­sion de­buted with a $153 mil­lion raise priced at its own high end of $17 per share. The two com­pa­nies helped push the com­bined IPO raise for 2021 to near­ly $5.5 bil­lion.

There were al­so sev­er­al new SEC fil­ings at the end of last week, with Gy­ro­scope Ther­a­peu­tics, Ta­laris Ther­a­peu­tics and Sagimet Bio­sciences all sub­mit­ting their rel­e­vant pa­per­work. Gy­ro­scope and Ta­laris each pen­ciled in the $100 mil­lion that’s be­come a com­mon place­hold­er through­out the IPO boom, while Sagimet put down $75 mil­lion.

And lat­er this week, biotech is ex­pect­ing an­oth­er huge IPO af­ter Zymer­gen set its terms, ex­pect­ing at least $400 mil­lion in its raise.

A hearty raise for Bio­mea gets its pre­clin­i­cal R&D to Nas­daq

Bio­mea is work­ing on small mol­e­cules for ge­net­i­cal­ly de­fined can­cers, but with a twist — they want their drugs to be ir­re­versible.

As the com­pa­ny lays out in its S-1, an ir­re­versible small mol­e­cule is a syn­thet­ic com­pound that forms a per­ma­nent bond to its tar­get pro­tein. The idea here is to in­duce greater tar­get se­lec­tiv­i­ty, low­er drug ex­po­sure and pro­vide a much more durable re­sponse than typ­i­cal small mol­e­cules.

Bio­mea is fo­cus­ing sole­ly on its lead pro­gram, known as BMF-219. The can­di­date comes from the biotech’s ir­re­versible small mol­e­cule plat­form and is aimed at in­hibit­ing menin in menin-de­pen­dent can­cers. BMF-219 hasn’t hit the clin­ic yet, but Bio­mea is hop­ing to file an IND at some point in the sec­ond half of 2021.

The S-1 ex­pands on how Bio­mea plans to get there. About $80 mil­lion to $90 mil­lion of the raise will go to­ward the BMF-219 pro­gram, in­clud­ing the IND-en­abling stud­ies as well as a planned Phase I/II tri­al. An­oth­er $40 mil­lion to $45 mil­lion is slat­ed for R&D for two ad­di­tion­al undis­closed pro­grams.

Bio­mea is trad­ing on the tick­er $BMEA.

All signs point to­ward big IPO for Gy­ro­scope

Fil­ing its F-1 on Fri­day, Gy­ro­scope is look­ing to cap­i­tal­ize on its sig­nif­i­cant mo­men­tum from the first quar­ter.

Back in Feb­ru­ary, the UK-based biotech post­ed an ear­ly win for its AMD gene ther­a­py, not­ing pa­tients who re­spond­ed to their GT005 can­di­date in a Phase I/II tri­al saw a 146% in­crease in an im­por­tant bio­mark­er and a de­crease in fur­ther down­stream bio­mark­ers. Then in March, Gy­ro­scope took that win to the bank in clos­ing a $148 mil­lion Se­ries C.

Less than a month lat­er, Gy­ro­scope is push­ing for­ward to Nas­daq. The $100 mil­lion writ­ten out in their F-1 is like­ly a mod­est place­hold­er, giv­en the na­ture of their Se­ries C just a few weeks ago. The com­pa­ny plans to use a sig­nif­i­cant por­tion of its pro­ceeds to ad­vance GT005 in three stud­ies, as well as fund re­search in an­oth­er prod­uct known as GT011.

GT005 is cur­rent­ly in two Phase II stud­ies for pa­tients with ge­o­graph­ic at­ro­phy, an ir­re­versible de­gen­er­a­tion of reti­nal cells caused by dry-AMD. The can­di­date is in­ject­ed un­der the reti­na to in­crease pro­duc­tion of the Com­ple­ment Fac­tor I pro­tein, which Gy­ro­scope be­lieves could damp­en an over­ac­tive com­ple­ment sys­tem that’s been tied to wors­en­ing at­ro­phy in AMD pa­tients.

Once it de­buts, Gy­ro­scope plans to trade on the tick­er $VISN.

Ta­laris seeks to trans­plant it­self to the pub­lic do­main

Ta­laris, too, re­cent­ly saw a nine-fig­ure raise, com­ing in the form of a $115 mil­lion Se­ries B back in Oc­to­ber.

The mis­sion here is to make or­gan trans­plants safer — and po­ten­tial­ly elim­i­nate the need for im­muno­sup­pres­sive drugs — by way of al­lo­gene­ic stem cell ther­a­py. At the time of the Se­ries B, CEO Scott Re­quadt said he saw “dra­mat­ic progress” over the pre­vi­ous 18 months, not­ing Ta­laris had its first Phase III tri­al for the lead FCR001 pro­gram in liv­ing donor kid­ney trans­plant re­cip­i­ents.

FCR001 it­self is com­posed of stem and im­mune cells that are pro­cured from a healthy donor, who is al­so the or­gan trans­plant donor. Ta­laris does all its man­u­fac­tur­ing it­self and is then ad­min­is­tered to the pa­tient af­ter “non­mye­loab­la­tive con­di­tion­ing,” ac­cord­ing to the biotech’s S-1.

Some of the IPO cash will be fun­neled to­ward the reg­is­tra­tional Phase III for FCR001, while ad­di­tion­al funds will help fur­ther R&D and oth­er tri­als for the pro­gram. There will al­so be some mon­ey ear­marked for the ex­pan­sion of CMC op­er­a­tions to sup­port even­tu­al com­mer­cial­iza­tion of the ap­proved prod­uct, should it get there.

Af­ter pric­ing, Ta­laris plans to trade on the tick­er $TALS.

Sagimet rides Feb­ru­ary crossover to IPO fil­ing

For­mer­ly known as 3-V Bio­sciences, Sagimet brings up the rear among Fri­day’s fil­ings.

The biotech fo­cus­es on de­vel­op­ing se­lec­tive FASN in­hibitors for liv­er dis­eases and can­cers in­clud­ing NASH, for which they re­leased pos­i­tive Phase II da­ta for the pro­gram TVB-2640 in June 2020. Sagimet said the can­di­date’s high dose had a 61% re­sponse rate across 30 pa­tients and led to a mean liv­er fat re­duc­tion of 28.2%.

And this Feb­ru­ary, Sagimet pulled in an $80 mil­lion Se­ries F crossover to help launch a Phase IIb study for that pro­gram. The FASN en­zyme is in­volved in lipid syn­the­sis. In­hibit­ing it, in the­o­ry, could re­duce fat pro­duc­tion and al­le­vi­ate these tar­get dis­eases.

Sagimet’s S-1 laid out a fair­ly vague plan for its IPO raise, not­ing on­ly that some funds will help the stud­ies and man­u­fac­tur­ing for TVB-2640, as well as launch­ing a first in-hu­man tri­al for an­oth­er pro­gram.

The biotech plans to trade un­der the tick­er $SGMT.

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.

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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.

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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.

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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.

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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.