Neurona Therapeutics has circled up $102 million to push its off-the-shelf cell therapy for epilepsy through phase 3 testing.
The oversubscribed financing round was backed by more than 15 investors, including Fidelity Management & Research Company, the Column Group and Alexandria Venture Investments, according to an April 3 news release.
The California biotech will use the cash infusion to support its pipeline of allogeneic cell therapy candidates for chronic neurological disorders, including its lead candidate that takes aim at one of the most common forms of epilepsy.
The asset, dubbed NRTX-1001, is currently being tested in an open-label phase 1/2 trial among patients with drug-resistant mesial temporal lobe epilepsy (MTLE), plus another phase 1/2 study for drug-resistant unilateral MTLE.
In December, Neurona presented data from ten patients in the ongoing unilateral MTLE study, with five patients in a low-dose cohort demonstrating a 92% median reduction in disabling seizures from baseline in the evaluation period, which was seven to 12 months after administration.
The cell therapy has been well-tolerated at both dose levels, with no adverse events attributed to NRTX-1001 to date, according to Neurona.
The biotech plans to launch other trials for NRTX-1001 in neocortical focal epilepsy and other areas in the future.
The lead candidate is comprised of GABAergic interneurons and received a regenerative medicine advanced therapy (RMAT) tag in June 2024.
As part of the RMAT designation, Neurona and the FDA discussed advancing the cell therapy into late-stage testing. The biotech is preparing for a single pivotal phase 3 trial, called Epic, in which adults with drug-resistant MTLE will be randomized in a double-blind design to receive either NRTX-1001 or a sham control. Depending on the results, the data will be used to support regulatory submission for potential drug approval, according to the biotech.
Neurona did not disclose what series the new fundraise is. The round follows a separate undisclosed series financing round in early 2024 of $120 million. A year earlier, Neurona had laid off a quarter of its staff, or 18 of 68 total employees, in light of the funding environment at the time.
More broadly, that funding landscape is no better today. But Neurona was able to raise money last year off the back of an early peek at data from two patients in the phase 1/2 trial that was shared in December 2023, and now again with the more recent data shared at the end of last year.
As general interest shifts away from the entire cell and gene therapy field, layoffs have hit the landscape heavily. In the first quarter of the year, at least 20 layoff rounds were recorded at cell and gene companies during that time, representing about 31% of all biopharma layoffs this past quarter.
A large part of the company cuts has to do with a lack of financing and investor interest, with macrophage cell therapy biotech Carisma Therapeutics announcing plans to wind down and noting a “challenging funding environment" just last week.