Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia tees up an IPO for its AI drug dis­cov­ery plat­form, like­ly not will­ing to set­tle for just $100M

The biotech IPO mar­ket awoke from its sum­mer hi­ber­na­tion on Fri­day morn­ing with a small AD­HD drug de­vel­op­er seek­ing a mod­est raise, but late Fri­day night saw an­oth­er com­pa­ny file its SEC pa­per­work, one that will like­ly shoot for the stars.

Ex­sci­en­tia, the UK-based AI out­fit with bold claims about its plat­form, sub­mit­ted its F-1 on Fri­day, pen­cil­ing in an ini­tial $100 mil­lion raise es­ti­mate. That fig­ure will al­most cer­tain­ly end up much high­er, as Ex­sci­en­tia has spent most of 2021 rack­ing up huge fundrais­ing sums thanks to a Se­ries C ex­ten­sion head­ed by Black­Rock, and an up to $525 mil­lion Se­ries D that in­clud­ed a $300 mil­lion eq­ui­ty in­vest­ment from Soft­Bank.

AI biotechs have proven large­ly suc­cess­ful at drum­ming up hype around their tech­nol­o­gy, and Ex­sci­en­tia is no dif­fer­ent. Promis­ing to cut down on the lengthy process that is drug de­vel­op­ment by months, if not years, Ex­sci­en­tia will seek to join one of its main com­peti­tors in Re­cur­sion on Nas­daq.

Both com­pa­nies claimed to be the first to put an AI-de­vel­oped drug in­to the clin­ic. Re­cur­sion did so in Ju­ly 2019, even though CEO Chris Gib­son read­i­ly con­ced­ed the pro­gram orig­i­nal­ly came out of Dean Li’s lab at Mer­ck.

Ex­sci­en­tia fol­lowed up with its an­nounce­ment in Jan­u­ary 2020, though its can­di­date — de­vel­oped in part­ner­ship with Sum­it­o­mo Dainip­pon — emerged af­ter the pair syn­the­sized 350 com­pounds and test­ed them in a lab be­fore de­cid­ing on one to move for­ward. Whether ei­ther pro­gram tru­ly came from AI is large­ly be­side the point, how­ev­er, as both biotechs con­tin­ue to en­list ma­jor part­ners and sig­nif­i­cant in­vest­ment.

In par­tic­u­lar, Ex­sci­en­tia ex­pand­ed a Cel­gene-era deal with Bris­tol My­ers Squibb in May, one that could see more than $1.2 bil­lion paid out when all is said and done. The biotech fol­lowed that up with a small ac­qui­si­tion for the mol­e­cule-screen­ing biotech All­cyte in June, and less than two weeks lat­er joined forces with EQRx.

Fol­low­ing its own mas­sive fundrais­ing rounds, Re­cur­sion went pub­lic in April to the tune of a $436.4 mil­lion raise, a fig­ure that could prove a use­ful barom­e­ter for Ex­sci­en­tia’s Nas­daq am­bi­tions. There’s al­so the ma­chine learn­ing biotech in­sitro, which hasn’t an­nounced plans to go pub­lic just yet but raked in $400 mil­lion in a Se­ries C this past March.

Though it helped Sum­it­o­mo ad­vance two ad­di­tion­al pro­grams in­to Phase I, one of which brought about Ex­sci­en­tia’s “first AI” claims, the biotech has just one in-house can­di­date in hu­man stud­ies: an A2a re­cep­tor an­tag­o­nist co-de­vel­oped with Evotec. This can­di­date en­tered the clin­ic in April, and Ex­sci­en­tia plans to fun­nel a good chunk of its IPO raise to­ward the pro­gram.

The biotech hasn’t spec­i­fied how it plans to divvy up its new cash, on­ly list­ing the “de­vel­op­ment” of its plat­form and the in-house com­pound as the main ben­e­fi­cia­ries. There will al­so be $70 mil­lion set aside for Ex­sci­en­tia’s Gates Foun­da­tion-part­nered pan­dem­ic pre­pared­ness pro­gram.

As the cal­en­dar ap­proach­es the fourth quar­ter, the biotech IPO mar­ket re­mains on pace to eclipse last year’s record raise of $16.5 bil­lion. Through near­ly nine months, the sec­tor has com­bined to raise near­ly $13 bil­lion per the End­points News tal­ly, and two more biotechs in DiCE Ther­a­peu­tics and Tyra Bio­sciences are ex­pect­ed to land nine-fig­ure rais­es lat­er this week.

Pass­ing 2020’s fig­ure may ul­ti­mate­ly re­quire an end-of-year boost, giv­en the slow­down of pric­ings over the sum­mer. If Ex­sci­en­tia comes any­where close to Re­cur­sion’s to­tal, the in­dus­try may be well on its way to an­oth­er phe­nom­e­nal IPO year.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Af­ter sell­ing to Genen­tech, the old Je­cure team is back at an RNA-fo­cused start­up — and more en­thu­si­as­tic than ever

When Genentech swooped in to buy NASH-focused Jecure Therapeutics back in 2018, a handful of the startup’s executives weren’t quite ready to disperse.

It had been just three years since Jecure launched with a preclinical portfolio of NLRP3 inhibitors — and the takeover came sooner than anyone, including CEO Jeff Stafford, had expected. So he got talking with James Veal and Gretchen Bain, two serial entrepreneurs in charge of Jecure’s R&D.

Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.