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

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

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.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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.

SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

Endpoints Premium

Premium subscription required

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

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

A T-cell play­er with back­ing from Roche takes next big step for BiTE drugs with 'on-of­f' switch to avoid tox­i­c­i­ty

The bispecific T cell engager field is absolutely packed with big-name players who have crowded in despite some high-profile failures in the class. Now, a Bay Area biotech thinks it may have the key to tackling BiTE toxicity, using an old “on-off switch” idea to give doctors more control of the drugs’ effect on patients.

San Francisco-based Soteria Biotherapeutics uncloaked Monday with a $42 million Series A co-led by Roche Venture Fund and 5AM Ventures with participation from the Novartis Venture Fund to advance its bispecific T cell engagers with an “on-off” switch the founders think can avoid some of the dire safety flags endemic to the class.

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.