Leen Kawas, Athira CEO

An­oth­er biotech — Seat­tle-based Athi­ra — files for an IPO, hop­ing to fi­nal­ly break through in Alzheimer's

Yet an­oth­er biotech is aim­ing to go pub­lic, as this year’s IPO boom con­tin­ues to show no sign of abat­ing any time soon.

The newest en­trant to the mar­ket is Athi­ra Phar­ma, a small, Seat­tle-based com­pa­ny that pegs a $100 mil­lion tar­get as its raise es­ti­mate. So far in 2020, there have al­ready been 48 biotech IPOs, a num­ber that sur­pass­es the to­tal from all of 2019.

Per­cep­tive is the most promi­nent backer of the com­pa­ny, per the SEC fil­ing, with the Joe Edel­man-run hedge fund own­ing 11.6% of shares. RTW In­vest­ments put in a 10.9% stake, and Athi­ra CEO Leen Kawas checks in at third with 9.4% own­er­ship.

Athi­ra fo­cus­es its ef­forts on neu­rode­gen­er­a­tive dis­eases, main­ly Alzheimer’s, and just a cou­ple months ago closed an $85 mil­lion Se­ries B fi­nanc­ing. Found­ed in 2011, the com­pa­ny has spent the ma­jor­i­ty of its time push­ing the NDX-1017 pro­gram, a small mol­e­cule that tar­gets he­pa­to­cyte growth fac­tor (HGF) and its re­cep­tor, MET.

Hon­ing in on the dam­aged synap­tic net­work in the brain is a fa­mil­iar strat­e­gy in Alzheimer’s re­search, but the HGF tar­get is rel­a­tive­ly un­ex­plored.

The goal of the Se­ries B raise was to fund Phase II/III tri­als for the pro­gram af­ter Athi­ra pre­sent­ed what they said was a pos­i­tive ef­fi­ca­cy pro­file in Phase Ib.

In that study, re­searchers mea­sured pa­tients’ abil­i­ty to count dis­tinct tones in­sert­ed through­out a string of re­peat­ed sounds. For those with de­men­tia, the nor­mal recog­ni­tion falls with­in a 400 to 450 mil­lisec­ond range, Kawas said in June, and the study’s base­line was 390 mil­lisec­onds. In the drug arm of the tri­al, which en­rolled just sev­en pa­tients, that dropped to an av­er­age of 311 mil­lisec­onds. There was no change among four place­bo pa­tients, Kawas not­ed.

The Phase II/III study, ran­dom­ized and dou­ble-blind­ed, is mea­sur­ing two dif­fer­ent dos­es in pa­tients with mild-to-mod­er­ate Alzheimer’s. Athi­ra is plan­ning a sep­a­rate late-stage study that will run in par­al­lel to the cur­rent­ly on­go­ing tri­al.

Alzheimer’s re­search has gen­er­al­ly end­ed poor­ly for those that have come be­fore Athi­ra, with the most promi­nent fail­ures com­ing from mul­ti­ple high-pro­file stud­ies at Bio­gen sur­round­ing the amy­loid be­ta the­o­ry. Back in 2018, con­tro­ver­sy arose about the de­sign of a Phase II tri­al af­ter an­a­lysts not­ed pos­i­tive da­ta were over­shad­owed by the fact that APOe4 car­ri­ers, who are at a high­er risk of the dis­ease, were placed in the low­er-dose arm of the tri­al with­out tak­ing them out of the place­bo. Ul­ti­mate­ly, that dis­crep­an­cy may have al­lowed the da­ta to hit its sta­tis­ti­cal­ly sig­nif­i­cant end­point.

Ac­cord­ing to SVB Leerink’s Ge­of­frey Porges, in­de­pen­dent re­searchers “in­di­cat­ed that they be­lieve most or all of the ap­par­ent dif­fer­ence in the [Phase II] tri­al was at­trib­ut­able to APOe4 dif­fer­ences,” and were “al­so very sus­pi­cious about the ba­sis for Bio­gen’s en­roll­ment ex­pan­sion for their piv­otal tri­als, and thought this was best ex­plained as an at­tempt to achieve sta­tis­ti­cal sig­nif­i­cance from a mar­gin­al sig­nal.”

But as Athi­ra plans for their IPO, they ap­pear un­daunt­ed by the tri­als that have come be­fore.

Janet Woodcock (AP Images)

Janet Wood­cock to be act­ing FDA com­mis­sion­er while Biden team fi­nal­izes nom­i­nee — re­ports

Janet Woodcock is set to be the most powerful person at the FDA in less than a week.

The veteran regulator and longtime director of the Center for Drug Evaluation and Research has been tapped as acting commissioner of the FDA, according to reports by BioCentury’s Steve Usdin and Pink Sheet’s Sarah Karlin-Smith.

The appointment was requested by the incoming Biden team, Karlin-Smith added, as they sort out the nomination of a permanent successor to Stephen Hahn — whose one-year tenure has been defined by Covid-19.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Janet Woodcock (AP Images)

Janet Wood­cock is in the run­ning for FDA com­mis­sion­er — what does that mean for the agen­cy's fu­ture?

Just a day after reports emerged that Janet Woodcock will serve as interim chief of the FDA, word has gotten out that she is also in the running for the permanent job.

The decision, as the initial wave of reactions suggest, could have dramatic implications for where the agency is headed in the next four years — if not beyond.

Woodcock, the longtime CDER director, is being vetted alongside former FDA principal deputy commissioner Joshua Sharfstein, Bloomberg reported. Already tapped as acting head of the agency, she’s set to take over from Stephen Hahn right after Biden’s inauguration next week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

CEO Brett Monia (Ionis)

Can Brett Mo­nia push Io­n­is be­yond Spin­raza?

For 30 years, Brett Monia struggled as one of Ionis’ top scientists to get their antisense technology to work. Now, as CEO, he’s trying to use it to turn Ionis into one of the industry’s biggest biotechs.

Monia, one of the handful of young scientists who in 1989 followed Stanley Crooke across the country from SmithKline (now GSK) in Philadelphia to found Ionis in Northern California, replaced Crooke as CEO last January. By then, they had proven antisense, an RNA-based method for manipulating gene expression, could work dramatically well in at least some instances, transforming spinal muscular atrophy with the Biogen-partnered blockbuster Spinraza.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Steve Harr (L) and Hans Bishop

Paint­ing by the num­bers, Sana founders carve up a gi­ant uni­corn-sized IPO — for a biotech that has­n't quite made it to the clin­ic

Sana Biotechnology is one of those startups that was sketched in on the chalkboard day one in the shape of a unicorn.

A giant unicorn.

And from the numbers the cell therapy 2.0 play spelled out in their S-1 $SANA, it’s clear that the company founders — led by a pair of major VCs aligned with some high-profile industry figures — are hunting a big chunk of that value for themselves.

The raise they penciled in — $150 million — isn’t likely what they actually have in mind, and it doesn’t do justice to the size of their ambitions.

Endpoints Premium

Premium subscription required

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

Terry Rosen, Arcus CEO

Gilead part­ner Ar­cus earns an­a­lyst­s' plau­dits for ear­ly pan­cre­at­ic can­cer da­ta that 'ex­ceed­ed ex­pec­ta­tion­s'

Arcus’ small molecule CD73 inhibitor for pancreatic cancer got a standing ovation from analysts who said preliminary data “exceeded expectations”— making waves in a field that’s seen little progress in several years and proving the candidate could be worth the hundreds of millions Gilead provided upfront in a deal that included more than a billion dollars for opt-in rights and milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Eli Lil­ly re-ups di­ver­si­ty pledge, pitch­ing in $30M to ven­ture fund for mi­nor­i­ty-owned health­care firms

The fight against racial injustice spurred by a series of high-profile shootings of Black men by police earlier this year put Big Pharma and healthcare — industries targeted for their lack of diversity — in the hot seat. Eli Lilly made an early pledge to change its ways and put more back into the community, and now it’s continuing to make good on that commitment.

Lilly will infuse $30 million into the Unseen Capital Health Fund, a venture fund looking to invest in early-stage minority-owned healthcare companies that have been historically “unseen” by the investment community, the pharma said Friday.

Laurie Glimcher, Dana-Farber president and CEO (Getty Images)

UP­DAT­ED: With its rank-and-file churn­ing out star­tups, Dana-Far­ber launch­es ven­ture fund to cap­i­tal­ize on that suc­cess

The pace of innovation at the Dana-Farber Cancer Institute in recent years has seen a wave of startups launch with IP or leadership sourced from the nonprofit’s ranks. Now, looking for its own returns on that success, Dana-Farber has launched a new venture fund to invest in those fledgling businesses.

On Thursday, Dana-Farber unveiled Binney Street Capital — its first-ever venture fund. Roche and Verily veteran Luba Greenwood has been tapped to lead the fund, which was named after the location of the institute’s Boston site.

David Kessler in April 2009 (Eric Risberg/AP Images)

Covid-19 roundup: Hack­ers start re­leas­ing 'ma­nip­u­lat­ed' Covid-19 vac­cine docs; Ex-FDA com­mish David Kessler to re­place Mon­cef Slaoui as Op­er­a­tion Warp Speed chief — re­port

There’s a new twist on the EMA Covid-19 hacking story.

Friday the European agency put out the 5th in a series of statements about the hackers who broke into their system, noting that some of the information on vaccines that was gleaned in the attack is showing up online — altered to raise questions about the Covid-19 vaccines now in use.

This included internal/confidential email correspondence dating from November, relating to evaluation processes for COVID-19 vaccines. Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.

Nadim Ahmed (Bristol Myers Squibb)

Bris­tol My­er­s' top hema­tol­ogy ex­ec is on his way out — right on the heels of a $6B CVR im­plo­sion

Fourteen days after the $6.3 billion CVR tied to the approval of liso-cel went up in smoke, one of the top execs in charge of the work at Bristol Myers Squibb is preparing to step out of his job.

Mizuho analyst Salim Syed, who’s been following every twist and turn in the CVR saga, told investors on Thursday morning that Nadim Ahmed is on his way out. Syed’s note:

Recall, Ahmed is EVP and President of Hematology at BMY (i.e. JCAR017 and bb2121 are both hematological drugs). He’s still listed on the BMY management page. This is true — he’s still technically there. However, I have confirmed w/ BMY that his last day is tomorrow, Friday 1/15. To my best knowledge, Ahmed does not have another job lined up post his departure tomorrow.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,000+ biopharma pros reading Endpoints daily — and it's free.