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.

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.

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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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Yao-Chang Xu, Abbisko Therapeutics founder and CEO

Qim­ing-backed Ab­bisko makes $200M+ Hong Kong de­but, as a SPAC and Agenus spin­out al­so price on Nas­daq

Three new entities priced their public debuts late Thursday and early Friday, including a SPAC, a traditional Nasdaq IPO and a Chinese biotech joining the Hong Kong Index.

Shanghai-based Abbisko Therapeutics raised the most money of the triumvirate, garnering $226 million in its Hong Kong debut and pricing at HK$12.46, or roughly $1.60 in US dollars. The blank check company followed up with a $150 million raise, while MiNK Therapeutics priced on Nasdaq at $12 per share and a $40 million raise.

FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

FDA ad­comm to de­cide on mol­nupi­ravir EUA; Can­cer at­las un­veils new po­ten­tial drug tar­get

The FDA has another adcomm coming down the pipeline — this time on Covid-19 oral antiviral molnupiravir.

The federal agency’s advisory committee will meet on November 30th to go over Merck and Ridgeback’s EUA request for their investigational antiviral drug, and discuss the available data supporting its use in Covid-19 patients.

This comes two weeks after Merck claimed that their antiviral pill reduced the chance that newly diagnosed Covid-19 patients would be hospitalized or die by 50%. The pharma made the announcement after interim data on 775 patients in their clinical trial showed the antiviral’s potential.