Manchester, UK-based F2G has patched together another $100 million in funding a little over a year after receiving a CRL for its experimental fungal infection drug known as olorofim, it said Thursday morning.
The biotech has met with the FDA multiple times since that June 2023 no-go, and the company plans to ask the US regulator for approval again “toward the end” of 2025, with the goal of securing a green light by mid-2026, CEO Francesco Maria Lavino told Endpoints News.
The new financing is tranched, with $62.5 million coming in at first and another $37.5 million that is dependent on milestones, the company told Endpoints.
Francesco Maria LavinoAs a Series H, the new financing represents a rare private funding round. Many biotechs will go public or get acquired after netting a handful or less of private rounds from VC firms and other investors. The Series H is also somewhat of an outlier in the current financing environment because it’s an up round, Lavino said, meaning it values the company higher than its last disclosed round of $70 million in August 2022.
It’s been a long time coming for the biotech: F2G was founded in 1998 and was one of the original tenants in the University of Manchester’s incubator facility.
But investments for antifungals and anti-infectives have historically paled in comparison to other areas of drug development.
Lavino, though, is positioning F2G as a rare disease company.
“The way we are developing the drug is more like a rare disease product. We are really focusing on infection that had limited or, in many cases, no option,” Lavino said. “Clearly, that’s a very different value proposition than a more general anti-infective or antibiotic, where you are dealing with a lot of generics.”
He said most of the patients are immunocompromised, including those with leukemia. If they don’t get treated, they’ll die, he said. The company also has a compassionate use program that has “daily requests.”
Second shot at approval
After last year’s CRL, F2G met with the FDA last October, March and again in August, thanks in part to the benefit of having breakthrough therapy designation, Lavino said. He described the rejection as “relatively speaking, benign,” and noted the company and regulator have “aligned” on a resubmission plan.
“The FDA is still open. We are basically packaging the data in a different way,” Lavino said.
F2G will resubmit olorofim for approval based on an open-label Phase 2b and “slightly different historical control data,” Lavino said. F2G will give the FDA data on about 200 patients from the Phase 2b this time around versus the approximately 100 that it delivered the first time, Lavino said.
The Phase 2b tested olorofim, formerly F901318, in patients with invasive fungal infections who had limited treatment options. Included were rare mold infections like azole-resistant aspergillosis, scedosporiosis and lomentosporiosis, among others.
A Phase 3 study is testing olorofim against liposomal amphotericin B followed by standard of care. Dubbed OASIS, the study is enrolling about 225 patients and is slated to have a primary completion 12 months from now, according to the federal clinical trials database.
Shionogi, F2G’s European and Asia licensing partner, will likely wait for that Phase 3 data before submitting for approval in Europe, Lavino said. That could change, though, as more results come in from the Phase 2 study, but “a conditional approval in Europe” is “not part of our baseline,” he added.
After securing FDA approval, F2G could consider further dealmaking to expand olorofim’s potential in other regions, including Latin America, Lavino said.
For now, it has the money to get on the market in the US thanks to new investors AMR Action Fund and ICG. Existing backers also contributed to the new round, including Novo Holdings, Advent Life Sciences, Sofinnova Partners, Forbion and others.