IMNN News & Events

Imunon announced final clinical data from the completed Phase 2 OVATION 2 clinical trial evaluating IMNN-001 in combination with standard of care neoadjuvant and adjuvant chemotherapy. The large randomized 112-patient study evaluated IMNN-001 in women with newly diagnosed advanced ovarian cancer. IMNN-001, the company's lead drug candidate, utilizes its proprietary non-viral DNA delivery platform, TheraPlas, the only nucleic acid nanoparticle technology showing promise in treating cancer. This novel immunotherapy is designed to recruit the entirety of the immune system by enabling locoregional secretion of the powerful cancer-fighting cytokine interleukin 12, altering the tumor microenvironment. Based on prior data assessments, IMUNON previously reported a median 11.1-month increase in OS in the IMNN-001 treatment arm compared to SoC chemotherapy alone. Following the most recent data assessment, the company is now reporting a median 14.7-month increase in OS in women in the IMNN-001 treatment arm compared to SoC alone, demonstrating continuous improvement in OS. In addition, the new IMNN-001 data showed that women treated with IMNN-001 and SoC chemotherapy plus poly ADP-ribose polymerase inhibitors as part of maintenance therapy achieved a median increase in OS of 24.2 months compared to SoC chemotherapy alone.

Imunon announced a strategic reorganization that will eliminate headcount not essential to the Phase 3 trial and redefine the job descriptions for additional employees to reduce operating expenses while supporting the company's focused strategy to advance the OVATION 3 Phase 3 clinical trial in women with newly diagnosed advanced ovarian cancer. The company also announced that Khursheed Anwer, Ph.D., MBA, Executive Vice President and Chief Scientific Officer, who has been at IMUNON for nearly 12 years, will retire effective February 20, 2026.

IMUNON entered into a securities purchase agreement with a single healthcare-focused institutional investor for the purchase and sale of 1,939,114 shares of common stock, together with warrants to purchase up to an aggregate of 1,939,114 shares of common stock, in a registered direct offering priced at-the-market under Nasdaq rules. Each share of common stock is being sold together with one warrant to purchase one share of common stock at a combined purchase price of $3.61. The warrants will have an exercise price of $3.482 per share, will be exercisable immediately upon issuance, and will expire five years from the date of issuance. The pre-funded warrants will have an exercise price of $0.0001 per share, will be exercisable immediately upon issuance, and will not expire. Maxim Group is acting as the lead placement agent for the offering. Brookline Capital Markets, a division of Arcadia Securities, is acting as co-placement agent for the offering. The gross proceeds to IMUNON from the offering are expected to be approximately $7M, before deducting placement agents' fees and other estimated offering expenses. The offering is expected to close on or about December 31, subject to satisfaction of customary closing conditions.

CEO Stacy Lindborg said in a shareholder letter, in part, "As we close out 2025, I am excited to reflect on a year marked by significant clinical progress, robust data validation, and strategic execution that has significantly strengthened IMUNON's position. Our focus on harnessing the power to activate the body's immune system against cancer has yielded compelling results, bringing us closer to delivering innovative therapies that could transform patient outcomes and create substantial value for you, our shareholders. Very importantly, we believe that we are well positioned for an equally successful 2026...As we enter 2026, IMUNON is poised for key milestones, including continued enrollment in OVATION 3 with interim analyses potentially enabling early stopping and BLA filing in the HRD+ population. We anticipate additional data presentations at major conferences, further translational insights from OVATION 2 tumor samples, and progress on business development initiatives. With Fast Track and Orphan Drug designations in place, we are dedicated to bringing IMNN-001 to patients in need while driving sustainable shareholder value. On behalf of the IMUNON team, thank you for your unwavering support. Together, we are on the cusp of redefining cancer care.'