IMUNON Advances Phase 3 Ovarian Cancer Trial With Strong Clinical Momentum While Streamlining Operations

IMUNON’s lead candidate IMNN-001 marks major milestone as first patient dosed in pivotal Phase 3 OVATION 3 Study for advanced ovarian cancer treatment. The clinical-stage biotech company also announced a 15% stock dividend and completed a reverse stock split as it repositions for long-term growth.

Phase 3 Trial Launch Signals Confidence in Gene Therapy Approach

On July 30, 2025, the company announced that the first patient received treatment in the OVATION 3 Study, marking a critical turning point for IMNN-001, its proprietary DNA-based immunotherapy. The Phase 3 trial will evaluate IMNN-001 combined with standard neoadjuvant and adjuvant chemotherapy against chemotherapy alone in women with newly diagnosed stage IIIC or IV ovarian cancer.

Three clinical sites are currently enrolling patients, with the company targeting 20 activated sites by year-end 2025. The randomized, controlled study will enroll patients in both the broader population and a subgroup with homologous recombination deficiency (HRD), including those carrying BRCA1 or BRCA2 mutations. The primary endpoint measures overall survival (OS), with secondary endpoints tracking surgical response, chemotherapy effectiveness, clinical response and time to next treatment.

Strong Phase 2 Data Provides Clinical Validation

The Phase 3 launch follows positive Phase 2 OVATION 2 data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in June. Results demonstrated that patients receiving IMNN-001 plus standard therapy achieved a median 13-month increase in overall survival compared to standard therapy alone (46 months versus 33 months), representing a hazard ratio of 0.69.

For patients also receiving PARP inhibitor maintenance therapy, the survival benefit expanded further, with median OS not yet reached in the IMNN-001 treatment arm after more than five years of follow-up, compared to 37 months in the control group (hazard ratio 0.38). The treatment showed a favorable safety profile with no elevation in immune-related adverse events.

The mechanism of action research presented at the European Society of Medical Oncology (ESMO) Gynaecological Cancers Congress revealed that IMNN-001 creates an anti-tumor environment by recruiting CD8+ T cells, macrophages and dendritic cells to the tumor site while reducing immunosuppressive regulatory T cells. This translational data validates the immunotherapy’s selective activation at cancer locations.

DNA Vaccine Platform Shows Durability Promise

Beyond its lead oncology program, IMUNON’s PlaCCine DNA vaccine technology demonstrated encouraging results in a Phase 1 COVID-19 booster trial. Six-month data showed that a single dose targeting Omicron XBB1.5 induced up to a 3-fold median increase in neutralizing antibody titers, with stronger responses at higher doses (1.0-2.0 mg versus 0.5 mg). Individual responses reached 8-fold increases in some participants.

The vaccine demonstrated superior stability compared to mRNA platforms—maintaining potency for up to one year at refrigerated temperatures and one month at room temperature. Given the company’s strategic reprioritization, IMUNON plans to seek partners for further IMNN-101 development.

Financial Results Reflect Strategic Cost Management

For the second quarter 2025, IMUNON reported a net loss of $2.7 million, or $2.15 per share, compared to a $4.8 million loss ($7.64 per share) in Q2 2024. Operating expenses declined 45% year-over-year to $2.8 million from $5.0 million, driven by lower costs across research and development, general and administrative functions.

Research and development expenses fell 43% to $1.2 million from $2.8 million, primarily due to completion of the Phase 2 OVATION 2 study and cost reductions in the PlaCCine vaccine program. General and administrative expenses decreased to $1.5 million from $2.2 million, reflecting lower employee-related and legal costs.

For the first half of 2025, the company reported a net loss of $6.8 million ($6.08 per share) versus $9.7 million ($15.51 per share) in the same 2024 period. Operating expenses totaled $6.9 million, down 31% from $10.0 million year-over-year. Net cash used in operations was $5.8 million compared to $10.4 million in the prior year period.

As of June 30, 2025, cash and cash equivalents totaled $4.7 million. The company raised $3.1 million in net proceeds during July 2025 through warrant exercises and its at-the-market offering, extending its runway into the fourth quarter of 2025.

Capital Raises and Corporate Actions Support Development

In May 2025, IMUNON completed a private placement raising approximately $3.25 million from the sale of common stock and short-term warrants at $0.45 per share. Additional gross proceeds of approximately $6.50 million are potentially available if warrant holders fully exercise their positions on a cash basis. The net proceeds support the Phase 3 OVATION 3 Study and general corporate operations.

Reflecting management confidence in the clinical programs and long-term strategy, the company announced a 15% stock dividend on July 28, 2025, distributing 0.15 shares per existing share to holders of record on August 7, 2025, with distribution expected August 21, 2025.

The company also executed a 15-for-1 reverse stock split effective July 25, 2025, consolidating 31.8 million shares outstanding into approximately 2.1 million shares. The action helps support compliance with Nasdaq listing standards. Notably, the Nasdaq Hearing Panel granted IMUNON an exception to maintain its listing, affirming that the company has achieved compliance with the equity rule through recent fundraising activities.

Forward Strategy Balances Innovation With Financial Discipline

IMUNON’s leadership believes the company possesses sufficient capital resources to fund planned operations through the fourth quarter of 2025. CEO Stacy Lindborg emphasized that advancing the Phase 3 OVATION 3 trial represents the priority, with the company taking strategic steps to conserve cash while securing resources for this “potentially transformative therapy.”

The clinical validation from Phase 2 data, combined with operational cost reductions and selective financing, positions IMUNON to advance its gene therapy platform targeting an area of significant unmet patient need in women with advanced ovarian cancer.