Weath­er­ing the storm: An­oth­er biotech braves Covid-19 in up­sized IPO

Zen­tal­is isn’t the on­ly biotech to de­fy ex­pec­ta­tions as fi­nan­cial mar­kets across the globe roil from the shock of the coro­n­avirus pan­dem­ic. Keros Ther­a­peu­tics has man­aged to ex­e­cute an IPO, hit­ting the top end of its pric­ing range and sell­ing more shares than orig­i­nal­ly en­vi­sioned, as it shep­herds its lead drug in­to mid-stage de­vel­op­ment.

The Lex­ing­ton, Mass­a­chu­setts-based com­pa­ny’s pipeline of drugs tar­get a fam­i­ly of pro­teins called trans­form­ing growth fac­tor-be­ta (TGF-β), sig­nal­ing path­ways that reg­u­late blood cell and platelet pro­duc­tion, and growth, re­pair, and main­te­nance of mus­cle and bone.

The com­pa­ny’s ear­ly-stage lead drug, KER-050, is un­der de­vel­op­ment for the treat­ment of low blood cell counts, or cy­tope­nias, in­clud­ing ane­mia and throm­bo­cy­tope­nia. Phase II tri­als are planned in pa­tients with myelodys­plas­tic syn­dromes (MDS), and those suf­fer­ing from myelofi­bro­sis. Its sec­ond drug, KER-047, is in a Phase I study, and is be­ing de­vel­oped for use in pa­tients suf­fer­ing from ane­mia re­sult­ing from el­e­vat­ed lev­els of a key reg­u­la­tor of iron ab­sorp­tion and re­cy­cling, as well as a rare mus­cu­loskele­tal dis­or­der called FOP. Keros al­so has a pre­clin­i­cal prod­uct be­ing de­vel­oped for bone loss and PAH.

Keros has raised $96 mil­lion, hand­some­ly beat­ing its $80 mil­lion tar­get, hav­ing of­fered 6 mil­lion shares for $16 a pop. Pre­vi­ous­ly, the biotech had planned to of­fer 5 mil­lion shares in the range of $14 to $16 each. The stock KROS made its de­but on Wednes­day.

Keros, which raised $56 mil­lion in a Se­ries C round last month, is one of a hand­ful of biotechs that got their pre-IPO road­show “test of the wa­ters” meet­ings done be­fore the coro­n­avirus out­break hit, so the on­ly thing left was road­shows, which are easy to ex­e­cute vir­tu­al­ly — in­deed road­shows have al­ways had vir­tu­al com­po­nents even be­fore the pan­dem­ic, said Jor­dan Saxe, se­nior man­ag­ing di­rec­tor of list­ing ser­vices at Nas­daq, in an in­ter­view with End­points News.

Saxe has pre­dict­ed 30 to 35 biotech IPOs this year, rais­ing about $3.5 bil­lion, ver­sus last year’s har­vest of $5 bil­lion. How­ev­er, in com­par­i­son to the fi­nan­cial cri­sis of 2008, it is still a big num­ber.

In re­cent days, ven­ture cap­i­tal firms have re­port­ed record fund­ing. Be­tween Flag­ship Pi­o­neer­ing, ARCH Ven­tures, Deer­field and ven­Bio, near­ly $4 bil­lion in fund­ing has been ear­marked for the life sci­ences. In fact, the first quar­ter of 2020 was the sin­gle largest quar­ter ever for bio­phar­ma ven­ture fund­ing in the Unit­ed States, hit­ting $5.5 bil­lion in ag­gre­gate fund­ing across 171 fi­nanc­ing rounds, not­ed At­las Ven­ture’s Bruce Booth in a blog post, cit­ing Pitch­book da­ta.

So what is so ap­peal­ing, so re­deem­ing about biotech? Un­like most oth­er sec­tors, which are de­pen­dent on the sale of prod­ucts and ser­vices, the bio­phar­ma in­dus­try makes med­i­cines, which we all need come rain or come shine. Apart from time­line de­lays to clin­i­cal tri­als and reg­u­la­to­ry sub­mis­sions, fun­da­men­tals re­main strong, and in many ar­eas, the in­dus­try is con­sid­ered key, so lab work is con­tin­u­ing.

“While typ­i­cal in­dus­tries are of­ten af­fect­ed by acute changes in con­sumer de­mand (and spikes in un­em­ploy­ment), this isn’t re­al­ly the case with bio­phar­ma: there are plen­ty of un­met needs of pa­tients where in­no­v­a­tive new ther­a­peu­tics can have a mean­ing­ful im­pact,” Booth said. “Loss-mak­ing bio­phar­ma is where many of these new drugs are dis­cov­ered and/or de­vel­oped to­day: com­pa­nies that get fund­ed, and val­ued, based on da­ta which ac­crues over years, not weeks and months. That dis­con­nect from con­ven­tion­al eco­nom­ic cy­cles is one of the rea­sons why bio­phar­ma tends to out­per­form oth­er sec­tors dur­ing fi­nan­cial re­ces­sions.

Ad­di­tion­al re­port­ing by Am­ber Tong.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Tony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Kid­ney dis­ease drug­mak­er Goldfinch Bio shuts down

Goldfinch Bio, attempting to make treatments for kidney diseases and diabetic nephropathy, is shutting down.

President and CEO Tony Johnson confirmed to Endpoints News Friday afternoon that the biotech shut down after “fundraising challenges in the current macro-environment.” Fierce Biotech first reported the news.

Johnson, who joined in 2017 after a stint as SVP of early clinical development at AstraZeneca, said in a text that the company “entered the ABC process recently,” referring to an assignment for the benefit of the creditors, which provides a different wind-down avenue than a bankruptcy.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.