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.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joel Dudley, new partner at Innovation Endeavors (Tempus Labs)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs from 2020.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.