Imunon (NASDAQ:IMNN) said it is enrolling patients in its pivotal ovarian cancer trial in line with its plan, but will need additional capital to complete the study and activate all planned sites. The company reported a third-quarter net loss of $3.8 million and said there is substantial doubt about its ability to continue as a going concern.
On its third-quarter 2026 earnings call, President and CEO Dr. Stacy Lindborg said the company is targeting 50% enrollment in the Phase 3 OVATION 3 study in the first quarter of 2028 and full enrollment in the first quarter of 2029. The first planned interim analysis is currently estimated for the first quarter of 2030.
Phase 3 trial and earlier data
OVATION 3 is designed to enroll approximately 500 patients with newly diagnosed advanced epithelial ovarian cancer. It is evaluating IMNN-001 given into the abdominal cavity alongside standard chemotherapy, with overall survival as its primary endpoint. Two planned, event-driven interim analyses could support an earlier submission for full approval if the study meets prespecified statistical thresholds, Executive Vice President and Chief Medical Officer Dr. Douglas Faller said.
Enrollment across active sites has averaged approximately 0.4 patients per site per month, above the company’s planning assumption of approximately 0.3, Lindborg said. The first interim analysis will examine the full intent-to-treat population at 60% of the target overall survival events, rather than focusing on the HRD-positive subgroup.
Faller said independent monitoring reviews identified no new safety concerns in OVATION 3. He also said the company had prepared a regulatory submission to Health Canada and was meeting with potential Canadian sites.
The Phase 3 study follows the smaller Phase 2 OVATION 2 trial, in which median overall survival was 45.1 months for patients receiving IMNN-001 versus 30.4 months in the comparison arm. Faller noted that OVATION 2 was not powered to establish an overall survival benefit. The 95% confidence interval for the 14.7-month difference ranged from negative 3.8 months to 33.3 months, and the one-sided p-value was 0.06.
In a separate Phase 2 minimal residual disease study, median recurrence-free survival was 26.1 months in the IMNN-001 arm versus 11.4 months in the control arm among the 26-patient intent-to-treat population. Faller characterized the findings as hypothesis-generating rather than confirmatory, noting a log-rank p-value of 0.17. He said the study’s independent monitoring committee recommended continuing without modification after finding no new safety signals.
Cash position and funding needs
Interim Chief Financial Officer Josh Blacher said Imunon had $4.0 million in cash and cash equivalents at Sept. 30, along with $5.0 million in restricted cash associated with its June financing. Cash used in operating activities was $3.2 million for the third quarter and $10.2 million for the first nine months of 2026.
Research and development expenses were $1.8 million for the quarter, compared with $1.9 million a year earlier. General and administrative expenses were $1.7 million, up from $1.6 million. Net loss available to common shareholders widened to $3.8 million, or $0.64 per share, from $3.4 million, or $1.16 per share, in the prior-year quarter.
Blacher said the company’s independent registered public accounting firm included a going-concern explanatory paragraph in its report. Lindborg said Imunon had filed a registration statement for a proposed securities offering but declined to discuss its terms beyond the filing.
Asked how many sites the company could activate with its current resources, Lindborg did not provide a number. She said additional capital would be required both to complete the trial and to activate 50 sites.
NCI collaboration and ThermoDox agreement
During the quarter, Imunon entered a cooperative research and development agreement with the National Cancer Institute’s Cancer Therapy Evaluation Program. Under the agreement, NCI investigators are expected to evaluate IMNN-001 in additional solid tumors and combinations, with the NCI assuming regulatory sponsorship and operational responsibility. Additional studies remain subject to the institute’s resource allocation and priorities, Lindborg said.
Imunon also agreed to sell its rights to ThermoDox, a heat-activated formulation of doxorubicin, to VoxelDox Therapeutics, which plans to develop it for glioblastoma. The transaction is contingent on VoxelDox completing a planned $2.5 million financing. At closing, Imunon would receive an approximately 4.76% equity interest, along with potential development and sales milestones of up to $16.5 million and royalties of 3.5% to 6% on net sales of approved ThermoDox-related products.
Lindborg said there is no deadline for VoxelDox to raise the financing and close the transaction. She also said Imunon exchanged $1.2 million of debt plus accrued interest for non-convertible preferred stock in September, reducing the note balance by approximately 43% without issuing common stock or warrants.
About Imunon (NASDAQ:IMNN)
Imunon, Inc. (NASDAQ: IMNN) is a clinical-stage biotechnology company focused on developing treatments for cancer and other serious diseases. The company uses proprietary nucleic acid delivery technologies to develop therapeutic candidates designed to stimulate the immune system or deliver genetic instructions directly to target cells. Imunon’s lead program is GEN-1, an investigational interleukin-12 gene-mediated immunotherapy intended to treat ovarian cancer. The company has evaluated GEN-1 in combination with chemotherapy and other treatments in clinical studies.
