IMUNON Q2 2024 Financial Results and Business Update

IMUNON, Inc., a clinical-stage company focused on DNA-mediated immuno-oncology therapy, recently announced its financial results for the three and six months ending June 30, 2024. The company also shared updates on its clinical development programs, notably highlighting positive topline results from the Phase 2 OVATION 2 Study for advanced ovarian cancer and discussing the progress of its seasonal COVID-19 booster candidate, IMNN-101.

Dr. Stacy Lindborg, President and CEO of IMUNON, expressed excitement over the recent advancements, stating that the positive results of the OVATION 2 Study marked a significant milestone for the company. The study showed an increase in overall survival rates for patients treated with IMNN-001, compared to those receiving standard care. The company plans to meet with the FDA to discuss the path towards initiating a Phase 3 pivotal study in early 2025.

Key Developments:

IMNN-001 Immunotherapy:

The Phase 2 OVATION 2 Study for advanced ovarian cancer revealed promising results. On June 24, 2024, IMUNON announced that the study's database was locked and median overall survival (OS) and progression-free survival (PFS) were reached. Positive topline results were shared on July 30, 2024. Highlights include:
- An 11.1 month increase in median OS compared with standard care.
- A hazard ratio of 0.74 in the intent-to-treat population, indicating a 35% improvement in survival.
- Among the 90% of trial participants who received at least 20% of specified treatments per protocol, those in the IMNN-001 arm had a 15.7 month increase in median OS with a hazard ratio of 0.64, indicating a 56% survival improvement.
- For the 40% of trial participants treated with a poly ADP-ribose polymerase (PARP) inhibitor, the hazard ratio decreased to 0.41, with the median OS in the IMNN-001 treatment arm not yet reached, compared to 37.1 months in the standard care arm.

The PFS results also supported the OS outcomes with:
- A three-month improvement in PFS over standard care.
- A hazard ratio of 0.79, indicating a 27% improvement in delaying disease progression for the IMNN-001 treatment arm.

IMUNON plans to present the full OVATION 2 Study results at an upcoming medical conference and submit them for publication in a peer-reviewed journal.

MRD Study:

The Phase 1/2 study of IMNN-001 in combination with bevacizumab is progressing. This study, involving several top cancer research centers, aims to enroll 50 patients with Stage III/IV advanced ovarian cancer. The primary endpoint is the detection of minimal residual disease (MRD) by second-look laparoscopy, with secondary endpoints including overall survival and progression-free survival. As of June 30, 2024, seven patients were enrolled and treated in the Phase 1 portion of this study.

PlaCCine Vaccine:

IMUNON received FDA clearance to begin a Phase 1 clinical trial with IMNN-101, a seasonal COVID-19 booster vaccine. The study aims to evaluate the safety, tolerability, neutralizing antibody response, and durability of the vaccine in healthy adults. The trial, which will enroll 24 subjects, commenced patient recruitment at DM Clinical Research in Philadelphia. Topline data are expected by the end of 2024.

Corporate Developments:

On July 30, 2024, IMUNON entered into a Securities Purchase Agreement, raising $10 million through the sale of 5 million shares of common stock. This funding will support the company's operations and forthcoming clinical trials.

Financial Results:

IMUNON reported a net loss of $4.8 million for Q2 2024, an improvement from the $5.6 million net loss in Q2 2023. Operating expenses for Q2 2024 were $5 million, down 8% from $5.5 million in Q2 2023. Research and development expenses decreased to $2.8 million from $3.1 million the previous year, while general and administrative expenses slightly decreased to $2.2 million. The company had $5.3 million in cash and investments as of June 30, 2024, and expects its capital resources to fund operations into Q3 2025.

IMUNON continues to develop its technologies and advance its clinical programs, aiming to provide new treatment options for patients with challenging medical conditions.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!