CAMBRIDGE, Mass., May 6, 2026, 15:04 EDT
- Ernexa reported that its ERNA-101, when combined with PD-1 blockade, eliminated all measurable tumors in a preclinical ovarian cancer model.
- ERNA jumped roughly 60% following the announcement, with shares swinging across a broad range during the session.
- Still at the preclinical stage, the company just wrapped up a 1-for-25 reverse stock split to maintain its place on the Nasdaq.
Ernexa Therapeutics Inc. reported Wednesday that its lead cell therapy, ERNA-101, paired with PD-1 blockade, wiped out tumors completely and delivered 100% long-term survival in preclinical ovarian cancer studies. “Complete tumor eradication and durable survival,” is how Chief Scientific Officer Robert H. Pierce summed up the results. Chief Executive Sanjeev Luther called the data “beyond expectations.” GlobeNewswire
Traders latched onto the latest readout, pushing Ernexa shares up roughly 60% to $6.38 in afternoon trade. The stock swung between $7.66 and $3.70, with around 58.9 million shares changing hands.
The timing came right after Ernexa’s common shares started trading on a split-adjusted basis, reflecting the 1-for-25 reverse stock split detailed in a filing. Ernexa said the move aimed to restore compliance with Nasdaq’s $1 minimum bid price rule. Back in March, the company laid out plans to submit an investigational new drug application for ERNA-101 in the third quarter, targeting a Phase 1 first-in-human study for the fourth quarter.
ERNA-101, an allogeneic induced mesenchymal stem cell therapy, is built as an off-the-shelf option from reprogrammed adult cells. Its job: home in on tumors and secrete cytokines—proteins meant to direct immune function. The goal? Flip immune-cold tumors into targets for T cells, and then combine that with a PD-1 blocker, a drug that lifts restraints on immune cells.
The company reported that the combination surpassed the efficacy of either standalone therapy, cutting both tumor burden and ascites—fluid accumulation commonly seen with advanced cancer. Ernexa intends to incorporate these results into its development plans as it pushes ERNA-101 toward human trials for advanced ovarian cancer.
Platinum-resistant ovarian cancer hasn’t been an easy target for drugmakers. The American Cancer Society puts the 2026 estimate at 21,010 U.S. women diagnosed, with roughly 12,450 expected deaths. The FDA, in a recent trial summary, defined platinum-resistant cases as those that worsen within six months of platinum chemo.
The competitive landscape keeps shifting. Back in February, the FDA cleared Merck’s Keytruda and Keytruda Qlex, each given with paclitaxel—with or without bevacizumab—for select PD-L1-positive, platinum-resistant cases of ovarian, fallopian tube, or primary peritoneal cancer. Then in March, Corcept Therapeutics picked up approval for relacorilant plus nab-paclitaxel in certain adults who’d already been treated for platinum-resistant disease.
This is still an early-stage signal. Ernexa’s results are preclinical—not from patients yet—and the path ahead includes hurdles in manufacturing, regulation, and safety. Only then can the company launch a Phase 1 trial to gauge dosing, tolerability, and get an initial read on activity in people.
Financing hangs over Ernexa. The company reported $1.9 million in cash and an accumulated deficit of $245.6 million as of Dec. 31, 2025. Its annual report flagged recurring losses and its need for additional working capital, casting substantial doubt on whether Ernexa can keep operating as a going concern.
For Ernexa, the news sharpens its narrative on ERNA-101 just as questions swirl about its stock and listing status. Up next: a quieter, but crucial, hurdle—moving the program into clinical trials and proving the mouse data weren’t just noise.
