Flagship's AI-focused Generate Biomedicines files IPO

Generate Biomedicines has filed for an IPO on the Nasdaq, seeking to raise upwards of $100 million for its AI-powered drug discovery operations.

Incubated by Flagship Pioneering, Generate applies AI to teasing out the three-dimensional structure of human proteins, including how they are folded, to determine function and design drugs that can change their activity.

In December, it started two phase 3 trials of its lead AI-designed drug candidate, long-acting anti-TSLP antibody GB-0895, in patients with severe asthma whose symptoms are inadequately controlled using current therapies. AI was used in the design of the antibody to achieve ultra-high-affinity TSLP binding, extended half-life, and high specificity for its target, reducing the risk of side effects.

The SOLAIRIA‑1 and SOLAIRIA‑2 studies have a target enrolment of 1,600 adult and adolescent patients and will see how GB-0895 compares to placebo in reducing clinically significant asthma exacerbations over 52 weeks when added to current therapies.

The drug is being administered just twice a year in the two studies, which could differentiate it from other biologic therapies for severe uncontrolled asthma, such as Amgen's TSLP-directed Tezspire (tezepelumab), Sanofi/Regeneron's IL-4 and IL-13 inhibitor Dupixent (dupilumab), and IL-5 blockers like GSK's Nucala (mepolizumab), which are dosed once a month.

If it makes it through to market, GB-0895 could provide an alternative to GSK's recently approved, twice-yearly IL-5 inhibitor Exdensur (depemokimab), which is approved specifically for severe asthma with type 2 inflammation.

Generate's pipeline also includes two other clinical trial-ready candidates for oncology indications, namely MMAE-directed antibody GB-4362 – intended to reduce toxicity with MMAE-carrying antibody-drug conjugates – and GB-5267, a cell therapy that targets MUC16 and is being developed for ovarian cancer.

According to the prospectus for the IPO, the proceeds will go towards its phase 3 programme, starting a phase 1b trial of GB-0895 in chronic obstructive pulmonary disease (COPD), and taking its cancer candidates through phase 1 testing.

Generate has proved very successful in raising venture capital, closing a $273 million third-round in 2023 and a $370 million second round two years earlier. It has also forged two R&D alliances, with Novartis and Amgen, worth up to $1 billion-plus and $1.9 billion, respectively. Pricing plans for the IPO have not yet been disclosed.

The filing with the US Securities & Exchange Commission (SEC) comes shortly after two other biotech IPOs, for Eikon Therapeutics and Veradermics, closed this week, overshooting their original fundraising targets by a comfortable margin.

Two other companies – AgomAb Therapeutics and Spyglass Pharma – are also on course to complete listings this week, already setting up 2026 as a potentially bumper year for biotech IPOs.

Generate is seeking to list on the Nasdaq under the GEMB symbol.