Ex-con Sam Wak­sal's start­up prices IPO, join­ing pa­rade of biotechs with Nas­daq news

Biotechs are com­ing out of the wood­work this morn­ing to set terms for their IPOs. So far, we’ve tracked five com­pa­nies rais­ing rough­ly $486 mil­lion com­bined, in­clud­ing an IPO from ex-con Sam Wak­sal’s Kad­mon spin­off MeiraGTx $MGTX.

MeriaGTx — $75 mil­lion

Sam Wak­sal

The com­pa­ny’s founder, Wak­sal, is a biotech ex­ec once sen­tenced to prison for his in­sid­er trad­ing con­vic­tion in­volv­ing Martha Stew­art. He was al­so the founder of Kad­mon, a com­pa­ny he had to bail from be­fore it could file its own IPO back in 2016. And now his brain­child — un­der the di­rec­tion of for­mer Kad­mon com­mer­cial chief Alexan­dria Forbes — has filed to raise $75 mil­lion.

Alexan­dria Forbes

The gene ther­a­py com­pa­ny said it’s priced its IPO at $15 per share, in­tend­ing to use the new cash to push five of its prod­uct can­di­dates in­to Phase I/II tri­als. The com­pa­ny has been build­ing out gene ther­a­py man­u­fac­tur­ing op­er­a­tions to sup­port its work, which is ini­tial­ly fo­cused on oph­thal­mol­o­gy, or eye dis­eases, where the first gen­er­a­tion of de­vel­op­ers found some ear­ly suc­cess­es. MeiraGTx said much of the new IPO mon­ey will go to­ward four oph­thal­mol­o­gy pro­grams and one sali­vary gland pro­gram.

Ma­gen­ta Ther­a­peu­tics — $100M

Join­ing MeiraGTx in pric­ing this morn­ing is Ma­gen­ta Ther­a­peu­tics $MG­TA, which plans to sell at $14 to $16 per share. We cov­ered Ma­gen­ta’s IPO plans late last month, when the com­pa­ny had pen­ciled in a $100 mil­lion pub­lic of­fer­ing. At the range Ma­gen­ta an­nounced to­day, the com­pa­ny should raise right around that mark.

Ac­cord­ing to a state­ment filed with the SEC, the cash will be used to push for­ward Ma­gen­ta’s most ad­vanced clin­i­cal pro­gram: a cell ther­a­py called MG­TA-456. The drug, cur­rent­ly in Phase II tri­als, is be­ing test­ed in pa­tients with in­her­it­ed meta­bol­ic dis­or­ders. Ma­gen­ta says new IPO mon­ey would ad­vance the treat­ment through a piv­otal tri­al, pay for some com­mer­cial­iza­tion ac­tiv­i­ties, and al­so fund re­search in­to ad­di­tion­al in­di­ca­tions for the ther­a­py, such as sick­le cell dis­ease and blood can­cers. Be­yond that, Ma­gen­ta might use the new funds to back MG­TA-145, a nov­el stem cell mo­bi­liza­tion prod­uct can­di­date.

Kezar Life Sci­enes — $86M

Next up is Kezar Life Sci­ences, which ex­pects to sell be­tween $14 and $16 per share. This one al­so isn’t brand new to us, as we cov­ered their ini­tial S-1 fil­ing in late May.  The com­pa­ny’s amend­ed S-1 notes the max cap­i­tal raised could be $85.9 mil­lion.

Kezar $KZR has plans to use the IPO mon­ey to push for­ward its pipeline of au­toim­mune drugs. Spun out of Am­gen with small mol­e­cules from the plate of the for­mer Onyx Phar­ma­ceu­ti­cals, Kezar’s lead prod­uct is KZR-616. The drug is a se­lec­tive im­muno­pro­tea­some in­hibitor that’s about to be test­ed in a Phase Ib/II tri­al in lu­pus and lu­pus nephri­tis. The IPO might al­so fu­el KZR-616 for the treat­ment of id­io­path­ic in­flam­ma­to­ry my­opathies and up to three ad­di­tion­al au­toim­mune in­di­ca­tions in­to Phase Ib or Phase II clin­i­cal tri­als.

Au­to­lus Ther­a­peu­tics — $125M

Then there’s Lon­don-based Au­to­lus Ther­a­peu­tics, which is de­vel­op­ing can­cer ther­a­pies based on CAR-T cell tech­nol­o­gy. The com­pa­ny plans to raise $125 mil­lion by of­fer­ing 7.8 mil­lion shares be­tween $15 and $17 per share.

The com­pa­ny, found­ed in 2014, will use a big chunk of the pro­ceeds to get proof-of-con­cept in Phase I/II clin­i­cal tri­als of AU­TO2 in mul­ti­ple myelo­ma, AU­TO3 in pe­di­atric ALL and DL­B­CL, and AU­TO4 in pe­riph­er­al T-cell lym­phoma. It hopes to ad­vance three prod­uct can­di­dates through lat­er phas­es of clin­i­cal de­vel­op­ment and, po­ten­tial­ly, reg­is­tra­tion, ac­cord­ing to its F-1.

Ei­dos Ther­a­peu­tics — $100M

Neil Ku­mar

Last up is San Fran­cis­co-based Ei­dos Ther­a­peu­tics, Bridge­Bio’s start­up fo­cused on TTR amy­loi­do­sis. The biotech is out of the IPO chute look­ing at $100 mil­lion by of­fer­ing 6.3 mil­lion shares at $15 to $17 per share. In­sid­ers are buy­ing up half.

Bridge­Bio chief Neil Ku­mar has been bull­ish about this par­tic­u­lar sub­sidiary in the group, even though it’s up against some heavy­weight play­ers in drug de­vel­op­ment, in­clud­ing Al­ny­lam, Io­n­is and even Pfiz­er.

Their drug was ini­tial­ly ad­vanced by Is­abel­la Graef at Stan­ford and Mamoun Al­hamad­sheh, the com­pa­ny sci­en­tif­ic co-founders, who nailed down pre­clin­i­cal ev­i­dence that the drug can sta­bi­lize TTR and pre­vent the cas­cade of events that caus­es the dis­ease — a dis­ease mod­i­fy­ing ap­proach that will now head to the clin­ic.

Ei­dos says most of the pro­ceeds will fund the clin­i­cal de­vel­op­ment of AG10 for the treat­ment of AT­TR-CM and AT­TR-PN, in­clud­ing its on­go­ing Phase II AT­TR-CM and planned Phase III AT­TR-PN clin­i­cal tri­als.

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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HHS Secretary Xavier Becerra (Jacquelyn Martin/AP Images)

HHS fin­ish­es off Trump-era rule that would've erased ba­sic FDA regs with­out fre­quent re­views

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.