Faraz Ali, Tenaya Therapeutics CEO

Six more biotechs price pub­lic de­buts just be­fore the start of the week­end

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An­oth­er six biotechs priced IPOs on Thurs­day and Fri­day, join­ing this week’s big rush to Wall Street. Biotech com­pa­nies have raised more than $11.7 bil­lion so far this year, clos­ing in on last year’s record $16.5 bil­lion raise.

Scroll down for every­thing you need to know about the lat­est com­pa­nies hit­ting Nas­daq.

Tenaya Ther­a­peu­tics catch­es IPO win­dow months af­ter crossover round

Up­on pulling in a $106 mil­lion crossover round back in March, Tenaya Ther­a­peu­tics CEO Faraz Ali told End­points News that the com­pa­ny wasn’t plan­ning on “op­por­tunis­ti­cal­ly try­ing to catch an IPO win­dow” — that they’d wait un­til the sci­ence was ready.

On Thurs­day, the com­pa­ny priced a $180 mil­lion IPO, of­fer­ing an up­sized 12 mil­lion shares at $15 apiece (the mid­point of a $14 to $16 range).

Tenaya had ini­tial­ly filed for a $100 mil­lion ear­li­er this month, though many com­pa­nies in the last year and a half have gone on to raise much more than those ini­tial es­ti­mates. The Cal­i­for­nia-based biotech’s over­all mis­sion is to ex­am­ine how fresh sources of re­gen­er­a­tive cells could po­ten­tial­ly re­pair a dam­aged heart. It’s al­so fo­cused on gene ther­a­pies and pre­ci­sion med­i­cines as well.

A good chunk of the IPO fund­ing ($35 mil­lion to $40 mil­lion) will go straight in­to Tenaya’s lead gene ther­a­py can­di­date, which tar­gets ge­net­ic hy­per­trophic car­diomy­opa­thy due to mu­ta­tions in the MYBPC3 gene. That can­di­date’s head­ed for the clin­ic in 2022, ac­cord­ing to the S-1/A. 

An­oth­er $10 mil­lion to $15 mil­lion is tagged for the com­pa­ny’s lead can­di­date from its pre­ci­sion med­i­cine plat­form: a small mol­e­cule in­hibitor of HDAC6i, which Tenaya says is al­so head­ed for the clin­ic next year. The com­pa­ny be­lieves that can­di­date has po­ten­tial in heart fail­ure with pre­served ejec­tion frac­tion, and ge­net­ic di­lat­ed car­diomy­opa­thy.

The Col­umn Group, a re­turn­ing in­vestor in Tenaya, holds 25.19% of the com­pa­ny’s shares, ac­cord­ing to the S-1/A, while Ali con­trols a 1.34% piece.

Tenaya will list un­der the tick­er $TNYA.

Af­ter years of fly­ing un­der the radar, Im­muneer­ing makes the jump to Wall Street

Im­muneer­ing has kept a fair­ly low pro­file since launch­ing with $17 mil­lion back in 2019. That is, un­til it land­ed an­oth­er $62 mil­lion and re­cruit­ed Jef­feries an­a­lyst Biren Amin as CFO ear­li­er this year. Now, the Cam­bridge, MA-based biotech is hop­ping on­to Nas­daq with a $112.5 mil­lion IPO.

Biren Amin

Af­ter pen­cil­ing in a $100 mil­lion raise at the be­gin­ning of this month, Im­muneer­ing of­fered 7.5 mil­lion shares at $15 apiece, the mid­point of a $14 to $16 range. The com­pa­ny’s on­col­o­gy pro­grams tar­get mu­ta­tions of the MAPK and mTOR path­ways, which run par­al­lel to each oth­er and get ac­ti­vat­ed in more than half of can­cers.

Be­tween $33 mil­lion and $38 mil­lion will be used to bring Im­muneer­ing’s lead can­di­date, a dual-MEK in­hibitor dubbed IMM-1-104, in­to the clin­ic for the treat­ment of ad­vanced sol­id tu­mors in pa­tients har­bor­ing RAS mu­ta­tions, ac­cord­ing to the S-1/A. Im­muneer­ing plans on sub­mit­ting an IND for that can­di­date in the first quar­ter of 2022.

An­oth­er $38 mil­lion to $43 mil­lion will fund the de­vel­op­ment of oth­er can­di­dates in on­col­o­gy and neu­ro­science, the com­pa­ny said.

Har­vard MBA Ben Ze­skind, who helms the com­pa­ny, now owns 13.7% of shares, ac­cord­ing to the S-1/A. Citadel and Cor­morant As­set Man­age­ment each have a 7% piece of the pie.

Im­muneer­ing will list un­der the tick­er $IM­RX.

Rani Ther­a­peu­tics brings ro­bot­ic pill to Nas­daq in dis­ap­point­ing launch

For­mer Rani Ther­a­peu­tics CEO Mir Im­ran said back in Jan­u­ary 2020 that an IPO was a “dis­tinct pos­si­bil­i­ty” rough­ly a year from then. Af­ter a year and a half, and a $69 mil­lion Se­ries E round, the com­pa­ny has fi­nal­ly priced a $73.3 mil­lion pub­lic de­but.

Mir Im­ran

The biotech, which is work­ing on a ro­bot­ic pill to re­place in­jectable drugs, ini­tial­ly pen­ciled in a $100 mil­lion raise ear­li­er this month. But it end­ed up bring­ing in slight­ly less, of­fer­ing about 6.66 mil­lion shares at $11 apiece — much low­er than the an­tic­i­pat­ed $14 to $16 range.

While the idea of turn­ing in­jectable drugs in­to pills isn’t new, Rani’s ap­proach makes use of an en­teric coat­ing that pro­tects the pill from the acidic am­bi­ence of the stom­ach, then dis­solves as the pill moves in­to the in­tes­tine and pH lev­els rise. A chem­i­cal re­ac­tion in­flates a bal­loon, and the pres­sure push­es a dis­solv­able mi­cronee­dle in­to the in­testi­nal wall.

The in­jec­tion is pain-free, a Rani spokesper­son said. And be­cause the tech­nol­o­gy is ag­nos­tic to the pay­load, Rani be­lieves it could be used to de­liv­er pep­tides, pro­teins and an­ti­bod­ies.

About $45 mil­lion to $55 mil­lion from the IPO pro­ceeds will be used to ad­vance Rani’s in­ter­nal pipeline, which in­cludes its lead pro­gram with oc­treotide, an off-patent bi­o­log­ic that treats the hor­mon­al dis­or­der acromegaly. The in­jectable drug is cur­rent­ly ap­proved by both the FDA and EMA, and Rani said it got the Phase I re­sults it was look­ing for back in Jan­u­ary 2020, when the 58-per­son study in healthy vol­un­teers demon­strat­ed a 65% “bioavail­abil­i­ty” for the pill rel­a­tive to the in­jectable.

An­oth­er $25 mil­lion to $35 mil­lion will be used to ad­vance Rani’s man­u­fac­tur­ing scale-up and au­toma­tion, ac­cord­ing to the S-1/A. Im­ran owns 53.5% of shares, the doc­u­ment states.

Rani will list un­der the tick­er $RANI.

Af­ter putting off plans to go pub­lic, IN8bio prices IPO months lat­er

Af­ter de­lay­ing plans for a pub­lic de­but back in No­vem­ber, IN8bio has of­fi­cial­ly priced a $40 mil­lion IPO, rais­ing slight­ly less than it pen­ciled in while set­ting the terms last week.

IN8bio of­fered 4 mil­lion shares at $10 apiece, the low end of a $10 to $12 range. The com­pa­ny had ini­tial­ly filed in Oc­to­ber for an $86 mil­lion raise, with plans to of­fer 4.7 mil­lion shares at a range of $15 to $17 apiece. But it lat­er backed out, of­fer­ing no ex­pla­na­tion for the hold-up.

The team is work­ing on ge­net­i­cal­ly mod­i­fied gam­ma delta T cell ther­a­pies, with two Phase I can­di­dates for glioblas­toma and leukemia, re­spec­tive­ly. Be­tween $8 mil­lion and $13 mil­lion will go to­ward INB-200, the glioblas­toma can­di­date, which is ex­pect­ed to pro­duce topline re­sults from a sec­ond co­hort lat­er this year. An­oth­er $1 and $2 mil­lion is set aside for INB-100, the leukemia can­di­date, which is set for a topline read­out from all Phase I co­horts in 2023, ac­cord­ing to the S-1/A.

Bios Eq­ui­ty Part­ners holds 35.3% of IN8bio’s shares, while CEO William Ho has an­oth­er 13.6%.

IN8bio al­so says it plans on fil­ing three INDs be­tween the first half of 2022 and 2023. It will list un­der the tick­er $INAB.

Omega goes pub­lic on the mo­men­tum of a mas­sive crossover round

On the heels of a $126 mil­lion crossover round in March, Flag­ship-backed Omega Ther­a­peu­tics has priced a $125.8 mil­lion IPO to take its “epige­nom­ic con­trollers” in­to the clin­ic.

Omega — which had ini­tial­ly pen­ciled in a $100 mil­lion raise ear­li­er this month — of­fered 7.4 mil­lion shares at $17 a piece, the mid­point of a $16 to $18 range.

The com­pa­ny is us­ing its dis­cov­ery plat­form to tar­get what it calls in­su­lat­ed ge­nom­ic do­mains (IGDs), paired DNA sites with a pro­tein binder that up- or down-reg­u­late gene ex­pres­sion in lo­cal­ized “zip codes.” By tar­get­ing epige­nomics, Omega be­lieves it can mod­u­late gene ex­pres­sion in a hy­per-tar­get­ed way with­out hav­ing to add or delete nu­cleotides in pa­tients’ ge­net­ic code.

About $39 mil­lion will go to­ward the R&D of these “epige­nom­ic con­trollers,” while an­oth­er $78 mil­lion is set aside for IND-en­abling stud­ies and get­ting cur­rent pro­grams in­to the clin­ic, ac­cord­ing to the S-1/A.  

The lead can­di­date, OTX-2002, is head­ed for a Phase I proof-of-con­cept study against c-myc, a “mas­ter” onco­gene that crops up in a high per­cent­age of tu­mor types. The com­pa­ny ex­pects to file an IND for that can­di­date in he­pa­to­cel­lu­lar car­ci­no­ma in the first half of 2022. And two to three more in­ves­ti­ga­tion­al epige­nom­ic con­trollers will be de­clared by mid-2022, the S-1/A states.

Flag­ship, which launched Omega back in 2019, holds 52.9% of the com­pa­ny’s shares.

Omega will list un­der the tick­er $OM­GA.

Lon­don-list­ed com­pa­ny makes its way to Wall Street 

Max­Cyte is al­ready trad­ing on Lon­don’s AIM — but now, it’s about to have it’s very own spot on Nas­daq.

The com­pa­ny priced a $176 mil­lion IPO on Fri­day, of­fer­ing 13.5 mil­lion shares at $13 apiece, on the high­er end of an $11.50 to $13.50 range.

Max­Cyte’s tech­nol­o­gy us­es elec­tro­po­ra­tion, which ap­plies an elec­tric field to tem­porar­i­ly in­crease the per­me­abil­i­ty of the cell mem­brane and al­low in­tra­cel­lu­lar de­liv­ery of mol­e­cules, such as ge­net­ic ma­te­r­i­al and pro­teins.

The com­pa­ny tagged be­tween $20 mil­lion to $30 mil­lion for R&D ac­tiv­i­ties, and an­oth­er $20 mil­lion to $30 mil­lion to ex­pand its man­u­fac­tur­ing ca­pa­bil­i­ties and in­vest in au­toma­tion, ac­cord­ing to the S-1/A.

It will list un­der the tick­er $MX­CT.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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