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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.