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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.