Bio­phar­ma IPO boom yields buoy­ant biotech pub­lic de­buts

The past week has seen a smor­gas­bord of big­ger-than-ex­pect­ed bio­phar­ma IPO de­buts led by Chi­nese biotech Leg­end, as in­vestors put their chips on the in­dus­try that is ex­pect­ed to be the tick­et out of the pro­tract­ed Covid-19 cri­sis — amid a broad­er mar­ket that is com­ing back to life with US busi­ness­es grad­u­al­ly re­open­ing.

The J&J-part­nered com­pa­ny not on­ly emerged with one of the largest pub­lic rais­es in biotech his­to­ry clock­ing in meaty $424 mil­lion, but saw its shares $LEGN soar more than 60% on its first day of trad­ing.

Leg­end — which si­lenced skep­tics such as ri­val Blue­bird bio’s Nick Leschly by earn­ing the part­ner­ship with J&J in an $350-mil­lion up­front deal for its CAR-T ther­a­py — had orig­i­nal­ly filed for a healthy $350 mil­lion IPO, based on a range of $18-$20. But they man­aged to rake in $23 per share, set­ting the stage for a wind­fall that eclipsed mam­moth rais­es from peers in­clud­ing Juno and Gala­pa­gos, but short of Mod­er­na’s record-set­ting $600 mil­lion in 2018.

Leg­end’s lead ex­per­i­men­tal drug, pur­posed as the last line of de­fense for pa­tients with re­lapsed and re­frac­to­ry mul­ti­ple myelo­ma, is ex­pect­ed to be put un­der reg­u­la­to­ry re­view in the sec­ond half of 2020.

Oth­er biotech per­for­mances were al­so buoy­ant, ei­ther by pric­ing above the range or thanks to up­sized of­fer­ings.

No­var­tis-backed Pli­ant Ther­a­peu­tics, for in­stance, had pen­ciled in a $86 mil­lion raise back in May. But that ini­tial es­ti­mate, much like a clutch of oth­ers in re­cent weeks, was over­shad­owed with its ac­tu­al haul: $144 mil­lion. It priced at the high end of its range at $16, but sized up the to­tal shares of­fered to 9 mil­lion.

The South San Fran­cis­co biotech, which is al­lied with the Swiss drug­mak­er on an in­te­grin in­hibitor de­signed to tack­le fi­bro­sis as­so­ci­at­ed with NASH on the ba­sis of re­search con­duct­ed by sci­en­tif­ic co-founder Dean Shep­pard, raised $100 mil­lion ahead of the IPO in a round led by No­var­tis. The com­pa­ny’s tech­nol­o­gy, which al­so holds promise in fields such as on­col­o­gy and mus­cu­lar dy­s­tro­phy, is fo­cused on TGF-β ac­ti­va­tion. Flaunt­ing a $577 mil­lion mar­ket cap, Pli­ant $PLRX fin­ished its first day of trad­ing up a healthy 39%.

Neigh­bor­ing biotech Ap­plied Mol­e­c­u­lar Trans­port al­so up­sized its of­fer­ing gen­er­at­ing a $154 mil­lion yield, well above its ini­tial $100 mil­lion es­ti­mate. The com­pa­ny, which jumped on the IPO band­wag­on per­haps more out of ne­ces­si­ty than am­bi­tion af­ter de­clar­ing sub­stan­tial doubts about its abil­i­ty to con­tin­ue as a go­ing con­cern at the end of the first quar­ter, has an in­flam­ma­to­ry-dis­ease fo­cused pipeline.

Its lead drug, AMT-101, is an IL-10 ag­o­nist en­gi­neered to tamp down in­flam­ma­tion in au­toim­mune dis­or­ders such as ul­cer­a­tive col­i­tis and rheuma­toid arthri­tis. Shares of the ear­ly-stage drug de­vel­op­er, found­ed and led by life sci­ences con­sul­tant Tahir Mah­mood, rose $AMTI 28% on its first day, grant­i­ng it a re­spectable half a bil­lion dol­lar mar­ket cap.

Fi­nal­ly, the de­but for the first Swedish com­pa­ny to list on Nas­daq in 15 years al­so reaped gains ahead of the topline read­out of its Phase III drug ex­pect­ed by the end of this year. The com­pa­ny, Cal­lid­i­tas Ther­a­peu­tics, was ini­tial­ly eye­ing a $75 mil­lion raise but up­sized its deal to raise $90 mil­lion.

The com­pa­ny’s lead drug, Ne­fe­con, is an oral for­mu­la­tion of the cor­ti­cos­teroid budes­onide li­censed from Up­p­sala Uni­ver­si­ty. The biotech has been de­vel­op­ing the drug for use in an or­phan au­toim­mune re­nal dis­ease known as IgA nephropa­thy (IgAN). En­gi­neered as an im­muno­sup­pres­sant, the drug is de­signed to keep pa­tients from pro­gress­ing to end-stage re­nal dis­ease. Shares of the com­pa­ny $CALT ticked up about 1% on its first day, mark­ing a $476 mil­lion mar­ket cap.

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.

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.”

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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JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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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.

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.