Pe­ter Thiel-backed ATAI is prepar­ing to go to Nas­daq, as in­ter­est in psy­che­delics reach­es fever pitch

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The team be­hind ATAI Life Sci­ences has ratch­eted up mo­men­tum over the last few months, and now they’re look­ing to cap­i­tal­ize with an IPO.

Backed by bil­lion­aire Pe­ter Thiel, ATAI filed its SEC pa­per­work late Tues­day and out­lined its plans to take its port­fo­lio of ex­per­i­men­tal psy­che­del­ic med­i­cines to Nas­daq. They’ve list­ed a $100 mil­lion raise for now, though that fig­ure has com­mon­ly proved to be a mere place­hold­er dur­ing the biotech boom and the com­pa­ny could end up rais­ing much more.

Take, for ex­am­ple, an­oth­er biotech that just went pub­lic last week in Re­cur­sion. The AI drug de­vel­op­ers al­so pen­ciled in $100 mil­lion but end­ed up rais­ing $436 mil­lion once their IPO closed, good for the sec­ond-biggest IPO raise of 2021 be­hind on­ly Sana.

Flo­ri­an Brand

The in­dus­try will have to wait and see just how much ATAI ends up rais­ing, but they’ll cer­tain­ly add to the hefty to­tal among biotech so far this year. In 2021, there have now been 46 biotechs to ei­ther file or price their IPOs notch­ing a com­bined $5.46 bil­lion tal­ly across the de­buts, per an End­points News tal­ly.

If ATAI’s pre­vi­ous two fundrais­es are any in­di­ca­tion, their fi­nal IPO to­tal could be sig­nif­i­cant. Last No­vem­ber, ATAI raised $125 mil­lion in a Se­ries C that was co-led by Thiel’s firm, scor­ing the com­pa­ny a $1 bil­lion post-mon­ey val­u­a­tion. Then in March, ATAI “dou­bled down” on their strat­e­gy, as CEO Flo­ri­an Brand told End­points at the time, scor­ing a $157 mil­lion Se­ries D.

That marked a four-month span in which the com­pa­ny saw near­ly $300 mil­lion of cap­i­tal flow in­to its cof­fers, book­end­ing the ad­di­tion of Recog­ni­fy Life Sci­ences and its schiz­o­phre­nia pro­grams in­to the ATAI fam­i­ly of com­pa­nies.

ATAI’s busi­ness mod­el for de­vel­op­ing ther­a­peu­tics cov­er­ing a range of men­tal health dis­or­ders in­volves bring­ing port­fo­lio com­pa­nies un­der one um­brel­la, some­thing that Brand told End­points last month had been dri­ving the heavy in­ter­est with the con­sec­u­tive nine-fig­ure rais­es. Brand re­cent­ly brought in the 14th such port­fo­lio firm a few weeks ago with Psy­ber, which looks to im­prove men­tal health dis­or­ders and in­duce be­hav­ioral changes through “brain com­put­er in­ter­face” tech­nol­o­gy.

With the funds from the IPO, ATAI has iden­ti­fied pro­grams from six of its com­pa­nies that will be the pri­ma­ry fo­cus. The S-1 lists the com­pa­nies as Per­cep­tion, Recog­ni­fy, De­meRx, GA­BA, Neu­ronasal and Viridia, with ATAI look­ing to launch ei­ther Phase I or Phase II stud­ies for their drug can­di­dates.

The dis­or­ders in­volved in­clude treat­ment re­sis­tant de­pres­sion, schiz­o­phre­nia, opi­oid use dis­or­der, gen­er­al­ized anx­i­ety dis­or­der and mild trau­mat­ic brain in­jury.

Psy­che­delics are see­ing a come­back and in­vestors have flocked to­ward the field, as ev­i­denced by ATAI’s pre­vi­ous rais­es and the $146.6 mil­lion IPO last Sep­tem­ber for Com­pass Path­ways. The promi­nent in­vestor firm RA Cap­i­tal Man­age­ment, which par­tic­i­pates in a pletho­ra of biotech crossover rounds, al­so re­cent­ly led a $125 mil­lion Se­ries B for GH Re­search, an Irish com­pa­ny look­ing at re­pur­pos­ing the drug known as “toad ven­om” for ther­a­peu­tic pur­pos­es.

So­cial: Pe­ter Thiel, AP Im­ages

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Raju Mohan, Ventyx Biosciences CEO

Ven­tyx sprints to Wall Street less than a year af­ter emerg­ing from stealth

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It took seven months from exiting “quiet mode” for Ventyx Biosciences to land its very own stock ticker, raising $165 million in venture funds along the way.

Now, after pricing a massive $151.5 million IPO, the Encinitas, CA-based biotech is gunning for Phase II.

Ventyx priced close to 9.5 million shares at $16 apiece on Wednesday, the midpoint of its $15 to $17 range. CEO Raju Mohan filed the S-1 papers at the end of September, just over a week after unveiling a $114 million Series B round. He penciled in the standard figure of $100 million at first, likely knowing that in the last year, it’s been common for biotechs to raise much more than those initial estimates.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Ep­i­darex, Sofinno­va dou­ble down on a par­al­lel take on 3rd-gen CAR-T — aim­ing straight at ovar­i­an can­cer

When John Maher treated the first head and neck cancer patient at Guy’s Hospital in London with his pan-ErbB CAR-T back in 2015, he was among a small club of researchers convinced they had an answer to the challenges that had kept those engineered T cells — wildly successful in hematological cancers — either too dangerous or out of reach for patients with solid tumors.

The field has blossomed since then, with a proliferation of technologies that promise to address any number of challenges identified as unique to solid tumors. And Maher himself has rethought his approach and come up with a new CAR-T platform to generate the next slate of candidates.