An­oth­er 4 phar­mas make the fa­bled Nas­daq leap, with com­bined raise rapid­ly ap­proach­ing $4.5B

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The IPO train is once again full-steam ahead with four new pric­ings an­nounced af­ter mar­ket close Thurs­day.

De­sign Ther­a­peu­tics, Edge­wise Ther­a­peu­tics, Ike­na On­col­o­gy and Uni­verse Phar­ma­ceu­ti­cals are all hit­ting Nas­daq on Fri­day. The for­mer three each hauled in more than $100 mil­lion, with De­sign rais­ing $240 mil­lion, Edge­wise net­ting $176 mil­lion and Ike­na pulling off a $125 mil­lion raise. Uni­verse clocked in at $25 mil­lion.

With Fri­day’s pric­ings, the com­bined in­dus­try IPO raise now sits at al­most $4.5 bil­lion and is rough­ly on pace to eclipse 2020’s record sum of $16.5 bil­lion, ac­cord­ing to fig­ures kept by Nas­daq.

The rais­es al­so come short­ly af­ter La­va went pub­lic ear­li­er this week, and the last two weeks have now seen a com­bined nine IPO pric­ings. It sug­gests that biotech de­buts are back in full swing af­ter a brief cool down pe­ri­od at the end of Feb­ru­ary, which it­self fol­lowed a week where 10 com­pa­nies priced their IPOs.

From launch to IPO in a lit­tle over a year

De­sign se­cured its launch round just over a year ago, and is now tak­ing its Gene­TAC plat­form pub­lic with a $20 per share pric­ing.

The San Diego-based biotech fo­cus­es on de­gen­er­a­tive dis­eases linked to nu­cleotide re­peat ex­pan­sions, and is co-found­ed and chaired by Pratik Shah, who pre­vi­ous­ly helped en­gi­neer two mul­ti-bil­lion M&A deals. Shah was CEO of Aus­pex for 2 years be­fore Te­va scooped it up for $3.5 bil­lion in 2015, and he was al­so chair­man at Syn­thorx, which Sanofi bought out for $2.5 bil­lion at the end of 2019.

Gene­TAC, short for gene tar­get­ed chimeras, helps De­sign go af­ter what it says are more than 40 de­gen­er­a­tive dis­eases caused by nu­cleotide re­peat ex­pan­sions. The biotech has two pipeline pro­grams thus far, one in Friedre­ich’s atax­ia and one in my­oton­ic dy­s­tro­phy type-1.

IPO funds are slat­ed to go to­ward both of these pro­grams, De­sign wrote in its S-1. It es­ti­mates $30 mil­lion is need­ed to take the Friedre­ich’s atax­ia can­di­date through a Phase I tri­al and $35 mil­lion to take the DM1 pro­gram through Phase I.

An­oth­er $35 mil­lion will fund a cur­rent­ly undis­closed pro­gram, with the re­main­der of the cash go­ing to­ward gen­er­al R&D and cor­po­rate pur­pos­es.

De­sign will list un­der the tick­er $DS­GN.

Edge­wise takes its mus­cle ther­a­pies pub­lic

Edge­wise hits Nas­daq on Fri­day with $176 mil­lion in new cash and a $16 per share pric­ing.

The biotech is fo­cus­ing on rare mus­cle dis­or­ders, with am­bi­tions in Duchenne mus­cu­lar dy­s­tro­phy, Beck­er mus­cu­lar dy­s­tro­phy, and limb-gir­dle mus­cu­lar dy­s­tro­phy. Its lead pro­gram is al­ready in the clin­ic. Edge­wise says that EDG-5506 is a small mol­e­cule in­hibitor for fast my­ofiber (type II) myosin de­signed to ad­dress the root cause of dy­s­trophinopathies.

It’s cur­rent­ly in a Phase I tri­al for DMD, Beck­er and LGMD and Edge­wise hopes it can lim­it the hy­per­con­trac­tion stress caused by the lack of dy­s­trophin in these dis­eases. About $80 mil­lion of the IPO funds will be fun­neled to­ward this pro­gram to get it through the Phase I study and through the in­ter­im read­out of a Phase II/III study.

An ad­di­tion­al $55 mil­lion is ear­marked for the re­search and de­vel­op­ment of three pre­clin­i­cal pro­grams, EDG-6289, EDG-002 and EDG-003. EDG-6289 is list­ed as a mus­cle sta­bi­liz­er, while the oth­er two are billed as mus­cle de­sen­si­tiz­ers.

Edge­wise will list un­der the tick­er $EWTX.

BMS-part­nered Ike­na plow­ing for­ward 

For­mer­ly known as Kyn Ther­a­peu­tics, Ike­na is al­so pric­ing at $16 per share.

The Bris­tol My­ers Squibb part­ner aims to lever­age meta­bol­ic path­ways and the bro­ken-down mol­e­cules that re­sult from the body’s me­tab­o­lism in­to sup­press­ing the body’s im­mune sys­tem. BMS’ stake orig­i­nal­ly came from Cel­gene pri­or to its buy­out, and the S-1 in­di­cat­ed a few weeks ago that the com­pa­ny’s stake in Ike­na is about 8%, good for 14,545,450 to­tal shares.

Cel­gene bought those shares at $1 a piece back in Jan­u­ary 2019, ac­cord­ing to the S-1. With Ike­na pric­ing at $16, that eq­ui­ty is now worth more than $232.7 mil­lion for BMS.

Ike­na’s lead in-house pro­gram is IK-930, an oral small mol­e­cule in­hibitor of a tran­scrip­tion fac­tor known as TEAD. It hasn’t yet reached the clin­ic, but Ike­na is work­ing with BMS and Mer­ck on a few tu­mor mi­croen­vi­ron­ment pro­grams that have al­ready hit Phase I.

About $35 mil­lion to $40 mil­lion of the IPO funds are slat­ed to go to­ward IK-930 to en­able com­ple­tion of IND stud­ies and a Phase I launch. And $25 mil­lion to $30 mil­lion is pen­ciled in for Ike­na’s ERK5 pro­gram to nom­i­nate a can­di­date and get a Phase I start­ed.

The biotech has $55 mil­lion to $60 mil­lion set for the two BMS-part­nered pro­grams, an­oth­er $10 mil­lion to $15 mil­lion for the Mer­ck-part­nered pro­gram, and $25 mil­lion to $30 mil­lion slat­ed for pre­clin­i­cal pro­grams.

Ike­na will list un­der the tick­er $IK­NA.

East­ern med­i­cine com­pa­ny Uni­verse en­ters IPO par­ty

Uni­verse pulls up the rear this week, pric­ing at $5 per share and rais­ing a mod­est $25 mil­lion sum.

The Ji’an, Jiangxi, Chi­na-based com­pa­ny mar­kets its pro­grams to­ward the el­der­ly in Chi­na with its tra­di­tion­al Chi­nese med­i­cine de­riv­a­tives, with the goal of ad­dress­ing phys­i­cal con­di­tions re­lat­ed to ag­ing as well as their gen­er­al well-be­ing. Uni­verse boasts 26 reg­is­tra­tions and ap­provals with Chi­nese reg­u­la­tors and sells 13 prod­ucts as of ear­ly March.

With­in its F-1, Uni­verse says it’s split­ting the IPO raise in­to four rough­ly equal parts. There is 28% list­ed for up­grad­ing and ex­pand­ing man­u­fac­tur­ing fa­cil­i­ties, 27% for R&D, 24% for mar­ket­ing and 21% for cor­po­rate up­keep.

Uni­verse list­ed un­der the tick­er $UPC.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Covant acting CEO Matt Maisak (L) and CSO Iván Cornella

With Boehringer In­gel­heim’s help, Roivant churns out an­oth­er Vant to go up against En­deav­or, Im­pact founders

Roivant Sciences has added another branch to its family tree, unveiling Covant Therapeutics with a $10 million upfront commitment from Boehringer Ingelheim to turn up the heat in cancer.

The Boston-based drug discovery startup will jointly create a new small molecule immunotherapy with the private German pharma giant. The deal, made public Tuesday morning, includes up to $471 million in future payments and tiered royalties, should the product make it to market.

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Richard Murray, Jounce Therapeutics CEO

Jounce nix­es Redx of­fer as I/O biotech in­stead goes with Con­cen­tra Bio­sciences’ takeover bid

A minority shareholder has won out in the Jounce Therapeutics takeover battle, with the once-ambitious immunotherapy biotech now choosing to be acquired by Kevin Tang’s Concentra Biosciences rather than follow through with an already-announced deal that would have brought the UK’s Redx onto Nasdaq.

Via its new merger partner, Jounce is expected to get $1.85 per share from Concentra, which was formed by Tang Capital Partners, the owner of about 10% of Jounce shares. Two weeks ago, Concentra laid out a $1.80 per share proposal plus more for the ability to swoop up 80% of proceeds from licenses of legacy programs out of Jounce’s pipeline.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Max Colao, OncoVerity CEO

Tiny mul­ti­omics biotech se­cures for­mer J&J drug, new ex­ecs and new fi­nanc­ing

A new spinout from Belgium’s argenx seeks to give new life to a candidate once in-licensed to J&J.

OncoVerity announced Monday afternoon that it had in-licensed cusatuzumab from argenx. The biotech also appointed two new C-suite executives and secured a $30 million Series A round.

CEO Max Colao joins OncoVerity after working as Aurinia’s commercial chief, and stints at Alexion and Amgen. New CMO Clay Smith has been associate chief of the University of Colorado’s hematology division.

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Kevin Lee, Bicycle Therapeutics CEO

No­var­tis rides with Bi­cy­cle for new pact on tar­get­ed ra­dio­ther­a­pies

Novartis has inked a three-year deal with Bicycle Therapeutics to develop new targeted radiotherapies for cancer.

Novartis will pay Bicycle $50 million upfront, with downstream milestones adding up to a potential $1.7 billion. In exchange, Bicycle will use its virus-based platform to discover new bicyclic peptides, which it calls bicycles, that would be used for radiotherapies. Those bicycles would act as a homing beacon for radioactive isotopes, delivering them to cancer cells to kill the cells while limiting radiation to healthy tissue.

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