Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

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It took sev­en months from ex­it­ing “qui­et mode” for Ven­tyx Bio­sciences to land its very own stock tick­er, rais­ing $165 mil­lion in ven­ture funds along the way.

Now, af­ter pric­ing a mas­sive $151.5 mil­lion IPO, the Encini­tas, CA-based biotech is gun­ning for Phase II.

Ven­tyx priced close to 9.5 mil­lion shares at $16 apiece on Wednes­day, the mid­point of its $15 to $17 range. CEO Ra­ju Mo­han filed the S-1 pa­pers at the end of Sep­tem­ber, just over a week af­ter un­veil­ing a $114 mil­lion Se­ries B round. He pen­ciled in the stan­dard fig­ure of $100 mil­lion at first, like­ly know­ing that in the last year, it’s been com­mon for biotechs to raise much more than those ini­tial es­ti­mates.

Mo­han al­so tapped a fa­mil­iar face to chair the com­pa­ny’s board of di­rec­tors last month: Sheila Gu­jrathi, who has been qui­et­ly sup­port­ing Ven­tyx all along. The for­mer Gos­samer Bio CEO made a small in­vest­ment in Ven­tyx’s Se­ries A, which took place be­tween Feb­ru­ary and June 2021, ac­cord­ing to SEC pa­pers.

Sheila Gu­jrathi

Now the com­pa­ny will look to chal­lenge Zeposia, one of the top drugs Gu­jrathi de­vel­oped while at Re­cep­tos. Ven­tyx is hop­ing its S1P1R mod­u­la­tor VTX002 will prove to be a bet­ter op­tion in ul­cer­a­tive col­i­tis, par­tic­u­lar­ly avoid­ing some of Zeposia’s warn­ings around liv­er in­jury and mac­u­lar ede­ma screen­ing. That can­di­date’s head­ed for Phase II by the end of the year, ac­cord­ing to the S-1, and Ven­tyx will use be­tween $45 mil­lion and $55 mil­lion of the IPO funds to get it done.

Al­so head­ed for Phase II is Ven­tyx’s oral TYK2 in­hibitor VTX958 — the com­pa­ny’s lead pro­gram, de­spite the fact that it ap­pears to be slight­ly be­hind VTX002 on the de­vel­op­ment time­line. It’s de­signed to tar­get au­toim­mune dis­eases, with pso­ri­a­sis be­ing the first tar­get. Rough­ly $75 mil­lion to $85 mil­lion of the IPO funds are tagged to bring the can­di­date through Phase II in that in­di­ca­tion.

The re­designed pipeline com­bines pro­grams from three com­pa­nies all found­ed by Mo­han and New Sci­ence Ven­tures. VTX958 was plucked straight from the orig­i­nal Ven­tyx formed in 2019.

A third can­di­date tar­get­ing the NL­RP3 in­flam­ma­some will en­ter the clin­ic by the end of the year, the S-1 states. The NL­RP3 in­flam­ma­some is a key sig­nal­ing pro­tein com­plex in the in­nate im­mune sys­tem, and Ven­tyx thinks in­hibit­ing it could treat a range of sys­temic in­flam­ma­to­ry con­di­tions, such as car­dio­vas­cu­lar, he­pat­ic, re­nal and rheuma­to­log­ic dis­eases.

The idea re­ceived a big boost back in 2017, when No­var­tis pub­lished da­ta show­ing that in­hibit­ing IL-1ß, a cy­tokine re­leased by NL­RP3, re­duced the risk of heart dis­ease and stroke.

When all is said and done, Mo­han will hold just over 4% of shares, while New Sci­ence Ven­tures will have a 37.73% stake. ven­Bio Part­ners, which par­tic­i­pat­ed in the Se­ries B round, takes a 9.98% piece of the cake.

Ven­tyx will list un­der the tick­er $VTYX.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms.

“While no clear trend in the adverse reactions or new safety signal has been identified by Gilead at this time, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine (Vidaza) combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA,” the big biotech said in a statement.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Brian Thomas, Metagenomi CEO

Gen 2: Berke­ley spin­out lands $175M megaround to keep it on the cut­ting edge of the boom­ing gene-edit­ing field

The big bucks keep pumping into the gene-editing field.

This morning Metagenomi, allied with one of the biggest names in the mRNA field with a company DNA that includes the ubiquitous Jennifer Doudna, is showing off a $175 million B round that will pay for a rapid swelling of its staff in pursuit of some of the cutting-edge tech that keeps this field in the spotlight. And they’re aligning themselves with some major industry players with an eye on the clinic while getting behind some startups to help expand the work into new fields.

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Michael Egholm, Standard BioTools president and CEO (IsoPlexis)

Eli Cas­din co-leads $250M in­fu­sion in­to mi­croflu­idics play­er that land­ed NIH fund­ing for Covid-19 test­ing

In about 17 months, Fluidigm has gone from working with sharks to Vikings.

The South San Francisco-based company, which landed NIH money in a Shark Tank-style program for Covid-19 testing, announced that it will take on an investment worth $250 million from Casdin Capital and Viking Global Investors. It will also rebrand, and call itself Standard BioTools. The investment will help the company focus on the highest growth areas of discovery and development and expand its CRO and CMO service providers. Right now, the company’s customer reach is limited to basic research, it said.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.