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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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Look­ing to push CAR-T in sol­id tu­mors, Bay Area biotech goes pub­lic in SPAC flip — with slight name change

SPACs might be slowly creeping back.

Monday evening, Estrella Biopharma said it was going public via a SPAC deal with TradeUP Acquisition Corp. The deal is set to close in the first half of 2023, and if all goes as planned, the public version of Estrella — dubbed Estrella Immunopharma — will be worth around $398.5 million.

The Bay Area biotech will also get around $45.4 million in cash, and TradeUp stockholders will get around 15% stock in the public biotech.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.

Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

Andrew Crockett, KalVista CEO

KalVista ends a PhII study ear­ly af­ter pa­tients suf­fer se­vere and life-threat­en­ing side ef­fects

KalVista took a beating Tuesday after announcing it would scrap a Phase II trial for one of its experimental drugs.

The biotech said in an early morning press release that it is terminating the study for KVD824 after multiple patients in every treatment group saw unsafe, elevated levels of certain liver enzymes. By ending the trial now, KalVista hopes to save some money and funnel it toward another study for its lead program, CEO Andrew Crockett said in a statement.

Pen­ny stock play­er to re­view all op­tions to try stay­ing afloat af­ter clin­i­cal tri­al fail

Adamis Pharmaceuticals is slowly tumbling down, and the biotech is looking at all its options.

After a Phase II/III trial failure last month that sent the penny stock player down an additional 50% to just 15 cents a share, the company said Monday that it is examining options to get the best value for its investors. A statement from Adamis indicates that alternatives include anything from a partnership to a sale of Adamis’ two commercial products, Zimhi and Symjepi.

Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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