Andrew Cheng, Akero Therapeutics CEO

With pos­i­tive PhII NASH da­ta in tow, Akero opens $175M pub­lic of­fer­ing

It didn’t take long for Akero Ther­a­peu­tics to open up a pub­lic of­fer­ing af­ter un­veil­ing mid-stage clin­i­cal da­ta that sent its stock soar­ing to its high­est price in over a year.

De­tails are scant, but with Akero’s mar­ket cap now at more than $1 bil­lion, we know that Akero is seek­ing $175 mil­lion via an un­der­writ­ten pub­lic of­fer­ing of shares of its com­mon stock, trad­ing un­der the tick­er $AKRO. Un­der­writ­ers get 30 days to snatch up an­oth­er $26.25 mil­lion in shares.

Akero’s pub­lic of­fer­ing an­nounce­ment comes not even 12 hours af­ter un­veil­ing promis­ing da­ta in NASH — where a study met both its pri­ma­ry end­point and mul­ti­ple sec­ondary end­points in more than 100 pa­tients.

In short, Akero’s topline da­ta showed that 41% of pa­tients in the 50 mg arm and 39% of pa­tients in the 28 mg arm of lead drug can­di­date EFX showed at least one stage of im­prove­ment in fi­bro­sis with­out wors­en­ing of NASH, es­sen­tial­ly dou­ble the place­bo rate at 20% and meet­ing the pri­ma­ry end­point of the study.

Two oth­er mea­sures Akero looked at in­clud­ed NASH re­solv­ing with­out wors­en­ing fi­bro­sis — which was seen in 76% of the 50 mg group and 47% of the 28 mg group, com­pared to the place­bo group at 15%. The fi­nal mea­sure ex­am­ined both fi­bro­sis im­prove­ment and NASH res­o­lu­tion, which was re­port­ed in 41% of the 50 mg group and 29% of the 28 mg group. Place­bo rate in that group was 5%, again a sta­tis­ti­cal­ly sig­nif­i­cant dif­fer­ence.

An­a­lysts and in­vestors cheered the re­sults in a field that has been rife with fail­ures and mis­steps for years on end, yet cer­tain safe­ty ques­tions re­main amid pa­tients dis­con­tin­u­ing mid-tri­al due to ad­min rea­sons and AEs, as the biotech looks at go­ing in­to Phase III.

In the mean­time, here’s what an­a­lysts with Jef­feries not­ed be­fore the of­fer­ing was an­nounced:

Fo­cus mov­ing for­ward will be on cash run­way and how mgmt will con­sid­er fund­ing for a Phase III; we es­ti­mate they will have ~$120M of cash YE:22 and a burn of ~$30M/q. In ad­di­tion­al to pos­si­bil­i­ty of a cap­i­tal raise, AKRO has an ad­di­tion­al $90M avail­able from the Her­cules debt fa­cil­i­ty and per­haps the ear­li­er PFE $25M eq­ui­ty in­vest­ment could sig­nal some strate­gic in­ter­est. We con­tin­ue to like it, as it’s clear that AKRO has an ac­tive drug.

Akero’s near-im­me­di­ate piv­ot to a pub­lic of­fer­ing af­ter pos­i­tive da­ta is hard­ly a new or un­com­mon trend. Re­lay Ther­a­peu­tics sought $300 mil­lion af­ter spot­light­ing its bile duct can­cer ther­a­py da­ta at ES­MO this month, and when Virid­i­an’s eye dis­ease ther­a­py da­ta in one of three treat­ment arms al­so saw pos­i­tive re­sults, the biotech then an­nounced its pub­lic of­fer­ing plans for $175 mil­lion.

And Karuna Ther­a­peu­tics, rid­ing high on pos­i­tive da­ta in schiz­o­phre­nia, an­nounced its plans to take the pub­lic of­fer­ing route in ear­ly Au­gust — of­fer­ing an eye-pop­ping $600 mil­lion with a po­ten­tial max of $690 mil­lion.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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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.

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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.

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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.

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.

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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.”

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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.

John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.