A uni­corn joins this week’s stam­pede of biotechs in­to the red-hot Nas­daq casi­no

Now that the Ju­ly 4 hol­i­day week is well be­hind us, Nas­daq is get­ting crack­ing again with new of­fer­ings, and biotech com­pa­nies — in­clud­ing a Flag­ship-built uni­corn — are once again dom­i­nat­ing the lat­est round of IPOs lin­ing up for their Nas­daq close­up this week.

The 5 lined up for their IPO runs this week are hunt­ing more than $500 mil­lion and proof that they share a mar­ket val­ue of about $4 bil­lion. Rough­ly half of that is laid out in Ru­bius’ S-1 as that biotech hunts up $200 mil­lion.

The roundup will add an­oth­er batch of IPOs that are all falling on top of a record-set­ting pace in June. The ques­tion now is how long the win­dow will re­main wide open — and ul­ti­mate­ly who wins and who im­plodes. For now, the in­dus­try is on pace to ri­val the go-go times of 2014 — but the smart mon­ey ex­pects a slow­down.

Of course, the smart mon­ey was al­so sur­prised by the burst of biotech IPOs we’ve been see­ing. And Fri­day’s Urovant fil­ing for $150 mil­lion in­di­cates that Vivek Ra­maswamy thinks the IPO run still has legs to go much fur­ther.

Here’s a snap­shot of this week’s ac­tion at the casi­no, er, mar­ket.

Al­lakos

$AL­LK
Based: San Car­los, CA
Seek­ing: $96 mil­lion
Mar­ket cap: $738 mil­lion

Robert Alexan­der

The scoop: The lead drug tar­gets the in­hibito­ry re­cep­tor Siglec-8, found on the sur­face of mast cells and eosinophils. And Al­lakos be­lieves it has re­al po­ten­tial in a broad range of in­di­ca­tions, in­clud­ing eosinophilic gas­tri­tis, in­do­lent sys­temic mas­to­cy­to­sis, ur­ticaria and se­vere al­ler­gic con­junc­tivi­tis. Last sum­mer the biotech re­cruit­ed a pair of ZS Phar­ma vets — Robert Alexan­der and Adam Tomasi — to take over as CEO and COO/CFO. As­traZeneca ac­quired ZS for $2.7 bil­lion.


Con­stel­la­tion Phar­ma

$CNST
Based: Cam­bridge, MA
Seek­ing: $80 mil­lion
Mar­ket cap: $430 mil­lion

Ji­gar Raythatha

The scoop: In this case we have one of the old­est biotechs of the year go­ing pub­lic af­ter wind­ing in and out of an op­tion deal with Genen­tech — which the S-1 tells us walked from their $40 mil­lion up­front. Kei­th Dionne, then CEO, fa­mous­ly cel­e­brat­ed the end of the Genen­tech op­tion, but was gone soon af­ter and re­placed by Ji­gar Raythatha. The com­pa­ny re­or­ga­nized, and went back at the epi­ge­net­ics draw­ing board. The biotech start­ed a Phase Ib/II study of CPI-1205, an EZH2 in­hibitor com­bined with Yer­voy, that they hope will high­light their po­ten­tial in di­al­ing down gene ex­pres­sion in can­cer path­ways to en­hance im­muno-on­col­o­gy drugs.


Cri­net­ics Phar­ma­ceu­ti­cals

$CRNX
Based: San Diego
Seek­ing: $80 mil­lion
Mar­ket cap: $380 mil­lion

The scoop: The team at Cri­net­ics have been work­ing on new drugs af­ter de­vel­op­ing some nov­el thoughts about the way GPCRs work. The lead pro­gram is fo­cused on acromegaly, a rare dis­ease trig­gered when the pi­tu­itary gland pro­duces ex­cess growth hor­mone, caus­ing en­larged bones that can lead to gi­gan­tism, which caused An­dre the Gi­ant to swell in size. It al­so ul­ti­mate­ly killed him. So­mato­statin can rein that in, but syn­thet­ic so­mato­statin analogs don’t al­ways work. That leaves the biotech in the hunt for a small mol­e­cule that can.


Replimune

$RE­PL
Based: Woburn, MA
Seek­ing: $101 mil­lion
Mar­ket cap: $500 mil­lion

The scoop: The team that orig­i­nal­ly in­vent­ed T-Vec , the pi­o­neer­ing on­colyt­ic virus treat­ment that Am­gen bought and pushed to an ap­proval af­ter ac­quir­ing BioVex, are still play­ing in the same field. On­ly now they feel that they’re lead­ing the next-gen crowd of de­vel­op­ers — which is huge. The com­pa­ny is work­ing close­ly with Re­gen­eron on a com­bo us­ing their PD-1 — slat­ed to soon be­come the sixth check­point to hit the mar­ket with big, big plans of its own.


Ru­bius Ther­a­peu­tics

$RU­BY
Based: Cam­bridge, MA
Seek­ing: $200 mil­lion
Mar­ket cap: $1.8 bil­lion

The scoop: They have a ton of mon­ey, in­clud­ing a re­cent megaround, to re­as­sure in­vestors. And the plan is to con­quer the world with a brand new ap­proach: tak­ing red blood cells — de­signed by na­ture to trans­port oxy­gen — hi­jack them through ge­net­ic en­gi­neer­ing tech and get them to car­ry pro­teins need­ed to fight var­i­ous dis­eases. It’s an off-the-shelf ap­proach, rather than one per­son­al­ized for each pa­tient.

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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Novavax site in Gaithersburg, MD. Novavax

Beef­ing up its new gene ther­a­py unit, Catal­ent inks $18M deal to snap up No­vavax fa­cil­i­ties

Catal­ent’s hunt for rapid growth on the gene ther­a­py front — ce­ment­ed with a $1.2 bil­lion ac­qui­si­tion of Paragon Bio­sciences two months ago — has led them to the vac­cine mak­ers at No­vavax.

With an $18 mil­lion pay­ment, Paragon is tak­ing over two No­vavax sites in Gaithers­burg, MD, in­clud­ing more than 100 of the em­ploy­ees al­ready work­ing there. That’s in ad­di­tion to a sig­nif­i­cant re­duc­tion in op­er­at­ing costs, says the com­pa­ny, as No­vavax shifts to re­ly on Paragon for GMP ma­te­ri­als in clin­i­cal tri­als and, even­tu­al­ly, com­mer­cial sup­ply of their prod­ucts.

Zo­genix plans quick re­turn to the FDA with their spurned ap­pli­ca­tion on Dravet syn­drome drug — shares spike

Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

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.