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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Time for round 2: Il­lu­mi­na-backed VC snags $325M for its next fund

Illumina Ventures closed off its second investment fund with a total commitment of $325 million, offering fresh fuel to back a slate of startups that have already included a smorgasbord of companies, covering everything from diagnostics to biotech drug development and genomics.

Fund II brings the total investment under Illumina Ventures’ oversight to $560 million, which has been focused on early-stage companies. And it has a transatlantic portfolio that includes SQZ, Twist and Encoded Therapeutics.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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