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.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

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Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.

Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.