IMUNON Shifts Gears: Pulls Public Offering as Breakthrough Ovarian Cancer Data Steals Spotlight at ASCO

DENVER, Colo., May 23, 2025 (247marketnews.com)- In a move that underscores growing confidence in its clinical momentum, IMUNON (NASDAQ:IMNN) withdrew its previously filed Form S-1 registration statement, opting not to proceed with a public offering at this time. The decision comes just as the company prepares to present what may be the most compelling data in its history at the upcoming 2025 ASCO Annual Meeting, where IMUNON appears set to let its data do the talking.

A Bold Clinical Pivot

The Form S-1 was intended to raise capital likely aimed at funding the advancement of IMNN-001, the company’s novel DNA-mediated immunotherapy for ovarian cancer, but without selling securities and the statement never declared effective by the SEC, IMUNON pulled the plug.

This pivot coincides with the public unveiling of Phase 2 OVATION 2 data showing unprecedented survival benefits for patients with newly diagnosed advanced ovarian cancer. Presented in a podium session at ASCO and simultaneously published in Gynecologic Oncology, the results have ignited optimism among clinicians and investors alike.

Stacy Lindborg, Ph.D., IMUNON’s president and CEO, said, “We are very encouraged by these remarkable results and the fact that they are being presented in two of the most prestigious platforms in oncology research – the ASCO Annual Meeting and Gynecologic Oncology. As we continue to evaluate findings from our Phase 2 OVATION 2 Study, the data show consistently strong improvement in overall and progression-free survival, suggesting that IMNN-001 may drive positive outcomes that can truly make a difference in the lives of women with ovarian cancer, even for those with advanced and very difficult to treat stages of disease.”

Landmark Survival Outcomes in Ovarian Cancer

The Phase 2 OVATION 2 study evaluated IMNN-001 in combination with standard neoadjuvant and adjuvant chemotherapy (N/ACT), with or without PARP inhibitors. In a 112-patient, randomized trial, the results speak volumes:

  • Overall Survival (OS): Median OS in the treatment group extended 13 months longer than standard care alone (46 vs. 33 months; HR 0.69).
  • Progression-Free Survival (PFS): Treatment arm showed a 3-month increase over standard care (14.9 vs. 11.9 months; HR 0.79).
  • In patients receiving PARP inhibitors, PFS improvement was even more striking—nearly 12 months (33.8 vs. 22.1 months).
  • In the PARP subgroup, median OS has not yet been reached after more than five years, compared to 37 months in the control arm (HR 0.38).
  • HRD+ patients (those with BRCA1/2 mutations) showed robust responses, with an OS hazard ratio of 0.42.

Crucially, IMNN-001 was well tolerated, with no serious immune-related or systemic toxicities reported—a significant consideration for immunotherapy in oncology.

Phase 3 Launch and What’s Ahead

Armed with FDA alignment, IMUNON has already initiated the pivotal Phase 3 OVATION 3 study, focused on overall survival as the primary endpoint. The randomized trial will enroll patients with newly diagnosed advanced epithelial ovarian cancer, including HRD+ subgroups, to further validate IMNN-001’s potential as a new frontline standard.

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