Men­tal health-fo­cused atai chops 30% of staff to 'fur­ther fo­cus' on loom­ing read­outs

Chop­ping the pipeline and dis­con­tin­u­ing fund­ing for cer­tain pro­grams were not enough to keep atai Life Sci­ences’ fi­nances in check af­ter all.

More than half a year af­ter an­nounc­ing those changes, the com­pa­ny has tak­en an­oth­er long look at its pipeline of drugs for men­tal health dis­or­ders and laid off 30% of its staffers. The lay­offs will main­ly im­pact those in gen­er­al and ad­min­is­tra­tion and non-clin­i­cal de­vel­op­ment roles, atai added.

A spokesper­son told End­points News that “be­cause the de­ci­sion was geared to en­sure we are equipped with the right team to hit our clin­i­cal pro­gram mile­stones (some ac­cel­er­at­ed) and gen­er­ate mean­ing­ful da­ta, the 30% of em­ploy­ees who were af­fect­ed came pri­mar­i­ly from gen­er­al and ad­min­is­tra­tive ar­eas rather than clin­i­cal de­vel­op­ment.

Flo­ri­an Brand

CEO and co-founder Flo­ri­an Brand called the de­ci­sion part of an ef­fort to “fur­ther fo­cus our cap­i­tal al­lo­ca­tion to­wards gen­er­at­ing mean­ing­ful clin­i­cal read­outs in the near-term” and op­er­ate more ef­fi­cient­ly.

Many biotechs have cit­ed sim­i­lar rea­sons in shrink­ing their work­force in re­cent months, as pub­lic and pri­vate com­pa­nies alike find them­selves hav­ing to go longer with less mon­ey — un­til they hit good enough da­ta to en­tice in­vestors.

Atai re­vealed in Au­gust that it’s im­ple­ment­ing a “com­pa­ny-wide cost op­ti­miza­tion” to save mon­ey, with fund­ing dis­con­tin­ued for cer­tain dis­cov­ery pro­grams be­ing de­vel­oped at its sub­sidiaries and oth­ers de­pri­or­i­tized. But its shares $ATAI kept go­ing down and are now trad­ing at $1.58.

It is now bank­ing on sev­er­al key pro­grams, in­clud­ing RL-007, with which it’s re­cent­ly dosed the first pa­tient in a Phase IIb study in cog­ni­tive im­pair­ment as­so­ci­at­ed with schiz­o­phre­nia; and GRX-917, for which a Phase II study in anx­i­ety dis­or­der is planned.

Then there are the two can­di­dates for treat­ment-re­sis­tant de­pres­sion. PCN-101, an iso­mer of ke­t­a­mine, re­cent­ly flopped in a Phase IIa tri­al but atai is still con­sid­er­ing next steps; COMP360 is a psilo­cy­bin ther­a­py that is now in Phase III, and the com­pa­ny is speed­ing up the tri­al so that topline da­ta are now ex­pect­ed in the sum­mer of 2024.

The com­pa­ny now ex­tends its cash on hand to fund op­er­a­tions in­to the first half of 2026.

Ed­i­tor’s note: This sto­ry has been cor­rect­ed to clar­i­fy that atai did not drop out of part­ner­ships, but rather stopped fund­ing pro­grams it was de­vel­op­ing in part­ner­ship with sub­sidiaries.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

Endpoints Premium

Premium subscription required

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

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.

Lay­offs hit pri­vate gene ther­a­py star­tups, mi­graine biotech Sat­suma as in­dus­try squeeze doesn’t let up

Two small gene therapy makers and a biotech working on an investigational migraine drug have let employees go. The moves add to a broader year-long wave of layoffs that have sidelined thousands of workers in the industry.

Satsuma Pharmaceuticals said after Tuesday’s market close that it will lay off 36% of its workers, effective this Friday. The South San Francisco and Durham, NC biotech submitted its approval request to the FDA this month for a migraine drug, but Satsuma won’t be building a commercial team as it seeks an “established pharmaceutical company” to deliver STS101 to patients, should it get the green light. The company had 25 employees at the end of 2022.

FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,900+ biopharma pros reading Endpoints daily — and it's free.