IMUNON Releases Q3 2024 Financial Results and Business Updates

IMUNON, Inc., a clinical-stage company focusing on DNA-mediated immunotherapy, has announced its financial results for the third quarter ending September 30, 2024. The company also provided updates on its clinical developments, particularly regarding IMNN-001 and IMNN-101. The third quarter of 2024 was marked by significant progress, notably the presentation of positive results from the OVATION 2 Study of IMNN-001 in treating advanced ovarian cancer.

Stacy Lindborg, Ph.D., the President and CEO of IMUNON, highlighted that the OVATION 2 Study showcased an 11.1-month improvement in overall survival for patients treated with IMNN-001 compared to the standard care. The data was even more promising for patients who also received PARP inhibitors. The company has been in discussions with the U.S. Food and Drug Administration (FDA) to finalize the design of their planned registrational study and is preparing for an End-of-Phase 2 meeting with the FDA. IMUNON aims to commence a pivotal Phase 3 study involving 500 patients in the first quarter of 2025.

On October 30, 2024, IMUNON announced that new clinical data from the Phase 2 OVATION 2 Study of IMNN-001 would be presented at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting. The late-breaking abstract was accepted due to its compelling results. The presentation will be made by Dr. Jennifer Scalici from Emory University School of Medicine, who is a principal investigator in the trial.

During the Ovarian Cancer R&D Day held on September 18, 2024, several distinguished leaders in research and patient care presented, including Dr. Sid Kerkar, Dr. William Bradley, Dr. L.J. Wei, Dr. Amir Jazaeri, and Dr. Premal Thaker. These experts discussed various aspects of IMNN-001's development, including its safety, efficacy, and the potential for combining progression-free survival and overall survival to evaluate the treatment's impact.

The topline results from the OVATION 2 Study announced on July 30, 2024, confirmed the safety and efficacy of IMNN-001 in treating advanced ovarian cancer. Highlights included an 11.1-month increase in median overall survival (OS) compared to standard care, with a 35% improvement in survival. In patients who received at least 20% of specified treatments per-protocol, there was a 15.7-month increase in median OS, representing a 56% improvement. For those treated with a PARP inhibitor, the hazard ratio for survival decreased further to 0.41, indicating significant survival benefits.

Furthermore, the progression-free survival (PFS) results supported these findings, showing a three-month improvement compared to standard care, with a 27% improvement in delaying disease progression for the IMNN-001 treatment arm.

In terms of corporate developments, IMUNON raised $10 million through a registered direct financing on July 30, 2024. They also made strategic additions to their leadership team, with Susan Eylward joining as General Counsel and Corporate Secretary, and Kristin Longobardi appointed Senior Vice President of Operations. These appointments aim to ensure operational excellence and support the company’s future growth plans.

Financially, IMUNON reported having $10.3 million in cash and investments as of September 30, 2024, which is projected to fund operations into the third quarter of 2025. Research and development expenses for the third quarter were $3.3 million, up from $2.0 million in the same period of 2023. General and administrative expenses decreased slightly to $1.7 million from $1.9 million in the previous year. The net loss for the third quarter was $4.9 million or $0.34 per share, compared to a net loss of $3.5 million or $0.37 per share in the third quarter of 2023.

For the nine months ending September 30, 2024, research and development expenses were $9.4 million, compared to $7.7 million for the same period in 2023. General and administrative expenses were $5.6 million, down from $7.3 million the previous year. The year-to-date net loss remained at $14.6 million, with a slight improvement in loss per share to $1.39 from $1.64 in 2023.

IMUNON remains committed to advancing its innovative treatments and is enthusiastic about its prospects for both patients and shareholders moving forward.