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.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Tasly Bio­phar­ma pitch­es long-await­ed IPO — will it trig­ger an­oth­er $1B gold rush on HKEX?

In the run up to the Hong Kong stock ex­change’s an­tic­i­pat­ed rule change — open­ing the door for Chi­nese pre-rev­enue biotechs to go pub­lic clos­er to home — more than a year ago, Tasly Bio­phar­ma was one of the big play­ers whose ru­mored in­ter­est helped stoke en­thu­si­asm for the new list­ing venue. The com­pa­ny has since kept the drum­roll rum­bling in the back­ground, rais­ing a pre-IPO round and con­vinc­ing part­ner Trans­gene to swap own­er­ship in a joint ven­ture for eq­ui­ty. Now the oth­er shoe has fi­nal­ly dropped as ex­ecs out­line plans for a pipeline dom­i­nat­ed by car­dio­vas­cu­lar drugs.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.