Ankit Ma­hade­via

Late last week Spero Ther­a­peu­tics threw its S-1 in­to the IPO ring as the biotech queue for jump­ing in­to the pub­lic are­na was grow­ing longer by the day.

Spero got start­ed with some seed fund­ing from At­las Ven­ture and a high-pro­file part­ner­ship with Roche, but that pact end­ed last year with­out near­ly as much fan­fare as it was orig­i­nal­ly an­nounced.

The biotech’s lead an­tibi­ot­ic is SPR994, an oral for­mu­la­tion of the car­bapenum-class an­tibi­ot­ic tebipen­em, which Spero in-li­censed from Mei­ji Sei­ka with a very mod­est up­front of $600,000, with up to $3 mil­lion in mile­stones. The Japan­ese com­pa­ny won an ap­proval for this an­tibi­ot­ic in 2009 and hand­ed over da­ta on 1200 pa­tients. The ther­a­py is sold as Orapen­em.

That fits in­to a new strat­e­gy for flip­ping biotechs in­to the pub­lic mar­kets. By in-li­cens­ing the prod­uct on a re­gion­al ba­sis — the an­nounce­ment came out yes­ter­day — Spero can style it­self as a near-term late-stage biotech com­pa­ny, which is like­ly to be much more ap­pe­tiz­ing the in­vestors.

Two more drugs — SPR741 and SPR206 — are com­ing off Spero’s plat­form tech, which is de­signed to punch up an­tibi­otics so they can pen­e­trate the out­er cell mem­branes of Gram-neg­a­tive bac­te­ria.

The plan now is to tee up a Phase I study of SPR994 and then move straight in­to a piv­otal Phase III for com­mu­ni­ty-ac­quired uri­nary tract in­fec­tions, pro­vid­ed they get the FDA’s bless­ing.

Spero was launched by found­ing CEO Ankit Ma­hade­via, who earned a pay pack­age worth a to­tal of $814,985 last year. Ma­hade­via al­so owns 2.8% of the stock. The biotech gath­ered a $51.7 mil­lion crossover round last spring.

Two of At­las’ funds own around 23% of the eq­ui­ty now, with SR One com­ing in at 17% and the old Google Ven­tures ring­ing up at 13.2%. Oth­er in­vestors in­clude Lund­beck­fond, RA and Os­age Uni­ver­si­ty Part­ners

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.