Evan Fein­berg could have picked a bet­ter time to launch his AI biotech, Gen­e­sis. He an­nounced a $4.1 mil­lion round last No­vem­ber; by March, South San Fran­cis­co, Cal­i­for­nia was un­der lock­down.

Still, a year lat­er, he can look back at his ear­ly tenure with a cer­tain de­gree of sat­is­fac­tion.

“To see the things we’ve ac­com­plished, all from my couch?” Fein­berg told End­points News. “It’s re­al­ly bizarre.”

As with most ear­ly-stage biotechs, it’s dif­fi­cult to ver­i­fy pre­cise­ly what they’ve ac­com­plished, but Gen­e­sis Ther­a­peu­tics has man­aged to check some key box­es: They’ve ex­pand­ed the team from 5 mem­bers to 12. In Oc­to­ber, James Sabry and Aviv Regev at Genen­tech tapped them to help dis­cov­er new mol­e­cules. And with some in­ter­nal proof-of-con­cept da­ta to show in­vestors, they an­nounced to­day a $52 mil­lion Se­ries A round to help them land more big-name part­ners and ad­vance an in­ter­nal pipeline of small mol­e­cule drugs.

The round was led by Rock Springs, with old pals at An­dreessen Horowitz and Fe­li­cis Ven­tures, among oth­ers, chip­ping in.

Gen­e­sis be­longs to a raft of biotechs now try­ing to use ma­chine learn­ing and neur­al net­works to sift through bil­lions of small mol­e­cules and find the best ones to hit a giv­en tar­get. The $52 mil­lion raise is a size­able start­ing round, al­though not out of step with the cash that has re­cent­ly be­gun to flow in­to the space; Atom­wise, ar­guably the flashiest name in the field, re­cent­ly raised a $123 mil­lion Se­ries B.

Atom­wise and oth­ers have al­so no­tably at­tract­ed crit­i­cism for over-hyp­ing what their al­go­rithms can do and how quick­ly they can speed up drug de­vel­op­ment.

Vi­jay Pande

Fein­berg and a16z’s Vi­jay Pande, who men­tored Fein­berg when he was a grad­u­ate stu­dent at Pande’s Stan­ford lab, have sought to dis­tin­guish them­selves by point­ing to the team that has been as­sem­bled. It’s not just soft­ware en­gi­neers, Fein­berg said, but al­so dyed-in-the-wool med­i­c­i­nal chemists — the tra­di­tion­al hu­man al­go­rithms of drug dis­cov­ery — such as CSO Pep­pi Pr­a­sit, a Ver­sant ad­vi­sor and vet­er­an of Mer­ck and Ami­ra Phar­ma­ceu­ti­cals, and VP Nick Scott, an­oth­er Ami­ra vet­er­an.

“They don’t re­al­ly have pa­tience for the sort of neb­u­lous claims that of­ten pro­lif­er­ate in the com­pu­ta­tion­al space,” Fein­berg said. “They want to see da­ta, they want to see ex­per­i­ments in the lab­o­ra­to­ry ver­i­fy­ing com­pu­ta­tion­al pre­dic­tions be­ing use­ful for re­al drug tar­gets, oth­er­wise it’s just not in­ter­est­ing to them.”

Fein­berg al­so points to their al­go­rithms, the ba­sis of which has been pub­lished in promi­nent chem­istry jour­nals, and which he says has im­proved sub­stan­tial­ly over the past years.

The com­pa­ny is one of just a hand­ful in the AI small mol­e­cule space look­ing to build an in­ter­nal pipeline. For now, what those can­di­dates are and what they will tar­get re­main en­tire­ly un­der wraps.

As Congress considers whether to adopt sweeping new legislation to lower prescription drug prices across the board, the Kaiser Family Foundation is out with a new report on Monday showing how a more targeted approach on a subset of drugs might be a more efficient way to save government funds.

“This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors,” wrote Juliette Cubanski, deputy director of the program on Medicare policy at KFF, and Tricia Neuman, SVP of KFF. “Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources, though it would also leave some potential savings on the table.”

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

It was another busy week in the biotech IPO market as the second quarter continues to churn out significant investment into the sector.

Recursion led the way with a $436 million raise on Friday, pricing its IPO at $18, the high end of its range. Our own John Carroll went in depth on that raise over the weekend. Also on Friday, preclinical cancer biotech Biomea Fusion debuted with a $153 million raise priced at its own high end of $17 per share. The two companies helped push the combined IPO raise for 2021 to nearly $5.5 billion.

It’s always a surprise when a court has to step in to tell the FDA that it erred in performing one of its main duties: classifying whether a medical product is drug or a device.

But that’s what the US Court of Appeals for the District of Columbia did on Friday, making clear to the world’s top drug regulator that Genus Medical Technologies’ contrast agent barium sulfate (also known as Vanilla SilQ) should not be considered a drug, as the FDA had said, but a medical device.

Seagen is riding the wave of two new priority reviews straight to the FDA.

The Bothell, WA-based biotech and their partners at Astellas announced Monday that two supplemental BLAs for Padcev had been accepted by US regulators. FDA has set Aug. 17 as the PDUFA date for the reviews.

“With our recent regulatory submissions, we intend to provide the highest level of clinical evidence supporting Padcev use — overall survival data from a randomized Phase III trial — and expand availability in multiple countries where there is unmet medical need,” said Astellas oncology chief Andrew Krivoshik.