BioPharma, Artificial Intelligence

Generate Biomedicines’ IPO Brings In $400M for Pivotal Tests of Severe Asthma Drug

Flagship Pioneering-founded Generate Biomedicines aims to offer less frequent injections compared to a blockbuster asthma drug from partners Amgen and AstraZeneca. Generate’s drug comes from a “programable biology” platform technology that uses AI and machine learning to design proteins with desirable properties.

Despite wide availability of biologic drugs for asthma, use of these injectable medicines remains low — patients just dislike frequent injections. Generate Biomedicine’s lead drug candidate could offer a dosing edge over blockbuster asthma medicines currently available, and the company now has $400 million in IPO cash to support two ongoing pivotal clinical trials.

Late Thursday, Somerville, Massachusetts-based Generate priced its offering of 25 million shares at $16 each, which was the midpoint of the price range the company set earlier in the week. Those shares began trading on the Nasdaq Friday under the stock symbol “GENB.”

In its IPO filing, Generate says an estimated 1.9 million people in the U.S., the five largest economies in Europe, and Japan, have severe asthma that’s eligible for treatment with a biologic. However, industry sources suggest that between 15% and 25% of these patients receive such therapy. Biologics available for asthma include Sanofi’s Dupixent, which is administered by injection every two to four weeks, and GSK’s Nucala, which offers monthly dosing. GSK’s newest asthma drug is Exdensur, which is administered every six months. All three products treat asthma driven by eosinophils, a type of immune cell.

Severe asthma can also stem from TSLP, a signaling protein whose excessive activity can play a role in a range of immunological conditions. The only FDA-approved TSLP-blocking drug is Tezspire, a blockbuster seller marketed by partners Amgen and AstraZeneca. This antibody is administered as a monthly injection. Generate’s drug, GB-0895, is a TSLP-blocking antibody designed for six-month dosing.

GB-0895 came from a Generate platform technology that uses artificial intelligence models to form design hypotheses for potential drugs. Those hypotheses are then verified by hardware systems that run experiments. These analyses and tests run in cycles, each one creating data that improve the next cycle.

“Since inception, the Generate Platform was designed to create differentiated protein therapeutics and unlock the promise of a new method of designing drugs through a concept we call programmable biology,” the company said in the filing. “For biology to be programmable, it means that we must be able to design, write and execute biological functions with pre-specified intent, across therapeutic areas and protein modalities.”

Generate’s technology designed an antibody with greater binding affinity to TSLP and an extended half-life. Those properties are now being put to the test in humans. Generate is conducting two Phase 3 studies enrolling adults and adolescents with severe uncontrolled asthma. Both will evaluate six-month dosing of the injectable drug for one year. The main goal is measuring the annualized asthma exacerbation rate.

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In the filing, Generate said it believes six-month dosing along with the durable suppression of TSLP could differentiate its asthma drug from others. Companies with TSLP-targeting antibodies in the clinic include Upstream Bio, GSK, Apogee Therapeutics, Uniquity Therapeutics, and Windward Bio. Amgen and AstraZeneca also have an inhaled TSLP inhibitor for asthma in mid-stage clinical development.

Generate believes GB-0895 has potential applications in other respiratory conditions and a Phase 1b test is ongoing in moderate-to-severe chronic obstructive pulmonary disease. Data in this indication are expected later this year, according to the filing. The company’s technology has also yielded two cancer drugs, GB-4362 and GB-5267, both in early clinical development.

Generate was founded in 2018 by Flagship Pioneering, a firm that builds startups around platform technologies. Since its inception and prior to the IPO, Generate had raised $805.3 million from selling equity in the company, according to the filing. The most recent financing was a $273 million Series C round in 2023. Flagship holds a 48.76% post-IPO stake in Generate.

Generate does record some revenue from ongoing R&D partnerships with Amgen and Novartis. As of the end of 2025, Generate reported its cash position was $221.5 million. That capital, combined with the IPO proceeds, will finance clinical trials. About $300 million is planned for completing the two Phase 3 tests of GB-0895 in severe asthma. Another $100 million will go toward completing Phase 1b testing of this drug in COPD and to start the next phase of clinical testing in this indication.

Generate plans to spend $75 million on its technology and to bring multiple programs through candidate nomination and the preclinical research that could support a clinical trial application. The company has also budgeted $15 million to bring cancer programs GB-4362 and GB-5267 through the readout of preliminary Phase 1 data.

In the filing, Generate said it does not plan to provide guidance on the timing of milestones, including expected data readouts. But according to clinical trial records, the Phase 3 tests for the asthma drug have estimated completion dates of December 2028 and January 2029. Generate estimates its capital will last into the first half of 2028.

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