The pan­dem­ic IPOs keep rolling, as Gen­er­a­tion, Avid­i­ty, Vax­cyte each claim 200M+

If it wasn’t al­ready, biotech’s pan­dem­ic IPO boom is in full swing.

Af­ter a week that saw the largest Chi­nese biotech IPO in his­to­ry and an­oth­er $154 mil­lion for a com­pa­ny that emerged on­ly last Sep­tem­ber, four dif­fer­ent biotechs raised over $200 mil­lion. Each of them up­sized their of­fer­ings or priced at the top end — or more — of their orig­i­nal range.

Col­lec­tive­ly, they raised $926 mil­lion, or an av­er­age of $231 mil­lion per com­pa­ny.

The new rais­es are part of a broad­er trend, as in­vestors have flocked to biotech stocks as is­lands of sta­bil­i­ty in an in­creas­ing­ly rocky and pan­dem­ic-strick­en stock mar­ket. Large­ly, that’s meant bal­loon­ing val­u­a­tions for pub­lic com­pa­nies, such as Mod­er­na and Vir, who are mak­ing treat­ments or vac­cines for Covid-19.

But the com­pa­nies go­ing pub­lic this week don’t have large Covid-19 pro­grams. They con­sist of a Chi­nese can­cer de­tec­tion com­pa­ny and three com­pa­nies that are still pre­clin­i­cal, a stage when it used to be rare for com­pa­nies to go pub­lic, let alone raise vast cap­i­tal. The new rounds are a con­tin­u­a­tion of that trend, glimpses of which were seen be­fore the out­break hit the US, as the mar­ket showed an ap­petite for such ear­ly-stage ven­tures.

Six pre­clin­i­cal biotechs have now raised over $150 mil­lion in 2020, com­pared with just two over the pre­vi­ous three years, ac­cord­ing to num­bers from Re­nais­sance Cap­i­tal. That in­cludes David Liu’s Beam Ther­a­peu­tics, which raised $180 mil­lion on a base pair edit­ing plat­form in Feb­ru­ary, Jim Wil­son’s Pas­sage Bio, and Ver­sant’s Black Di­a­mond Ther­a­peu­tics.

Ge­off Mc­Do­nough Gen­er­a­tion

Gen­er­a­tion Bio was the first com­pa­ny to go pub­lic this week, grab­bing $200 mil­lion in a twice-up­sized of­fer­ing. Run by Gen­zyme vet Ge­off Mc­Do­nough, it’s de­vel­op­ing gene ther­a­pies that can be de­liv­ered by lipid nanopar­ti­cles in­stead of vi­ral vec­tors. The idea is that the nanopar­ti­cles can last as long as the now-com­mon ade­no-as­so­ci­at­ed virus­es, while be­ing eas­i­er to scale and sell for less than the cur­rent mul­ti-mil­lion dol­lar price tags for gene ther­a­pies.

In Jan­u­ary, the com­pa­ny raised $110 mil­lion, bring­ing their to­tal to $235 mil­lion. At the time, Mc­Do­nough told End­points News they might look for an IPO in 12 to 18 months to fund their clin­i­cal work.

Avid­i­ty Bio­sciences, an Eli Lil­ly-backed an­ti­sense biotech, priced at $14 to $16, up­sized the range to $17 to $18, and then priced at the high end of that, earn­ing $259 mil­lion in the end. The com­pa­ny works on mus­cle dis­or­ders, par­tic­u­lar­ly my­oton­ic mus­cu­lar dy­s­tro­phy. They com­bine an­ti­sense oligonu­cleotides — an old way of drug­ging RNA — with hom­ing an­ti­bod­ies to cre­ate what they call an­ti­body oligonu­cleotides con­ju­gates. The idea is that the an­ti­body will guide the an­ti­sense to se­quences that were pre­vi­ous­ly dif­fi­cult to tar­get. Their last round was in No­vem­ber, for $100 mil­lion.

Vax­cyte filed for its IPO ex­act­ly two months af­ter it raised $110 mil­lion in a Se­ries D, and end­ed up rais­ing $249 mil­lion. At the time of the last raise, it was known as SutroVax — a holdover from its days as a spin­out of Sutro Bio­phar­ma — but they changed their name and lo­go in ad­vance of fil­ing for what was orig­i­nal­ly sten­ciled as a $100 mil­lion IPO.

There may be no bet­ter time to go pub­lic as a vac­cine com­pa­ny, and the re­turn of vac­cines to the cen­ter of pub­lic at­ten­tion may have boost­ed their over­all raise, but Vax­cyte is work­ing on a far dif­fer­ent mar­ket and type of in­oc­u­la­tion than coro­n­avirus. The com­pa­ny is try­ing to cre­ate a fol­low-up to Pre­vnar13, the Pfiz­er pneu­mo­nia vac­cine that’s earned over $30 bil­lion in one of the few block­buster vac­cine mar­kets. Vax­cyte’s lead prod­uct is meant to guard against 24 strains of bac­te­ria, in­stead of Pre­vnar’s 13, and is com­pet­ing against ex­per­i­men­tal in­oc­u­la­tions at Pfiz­er and else­where.

In the fi­nal large raise, Il­lu­mi­na-part­nered Burn­ing Rock Biotech, a DNA-se­quenc­ing based can­cer de­tec­tion com­pa­ny, earned $223 mil­lion, pric­ing a dol­lar above their orig­i­nal $13.50 to $15.50 range. They got to ring the open­ing bell to­day at the Nas­daq.

And on a small­er note, AI-fo­cused Chi­nese biotech, Lantern Phar­ma had an ever-so-slight­ly up­sized IPO. They filed for $25 mil­lion and raised $26 mil­lion.

The Price of Re­lief: Ex­plor­ing So­lu­tions to the Ris­ing Costs of On­col­o­gy Drugs

In 2020, The National Cancer Institute estimated about 1.8 million new cases of cancer diagnosed in the United States, while the costs associated with treatment therapies continued to escalate. Given the current legislative climate on drug pricing, it’s never been more important to look at the evolution of drug pricing globally and control concerns of sustainable and affordable treatments in oncology.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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