IMUNON Q1 2024 Financial Results and Business Update

IMUNON, Inc. (NASDAQ: IMNN), based in Lawrenceville, New Jersey, has announced its financial results for the first quarter that ended on March 31, 2024, while also sharing updates on its clinical development programs. IMUNON specializes in DNA-mediated immuno-oncology therapies and the development of next-generation vaccines.

IMUNON is currently working on IMNN-001, a DNA-based interleukin-12 (IL-12) immunotherapy targeted at the first-line treatment of locally advanced ovarian cancer. The therapy is undergoing Phase 2 clinical trials. Another significant area of focus for IMUNON is its PlaCCine modality, which involves a proprietary DNA plasmid and synthetic DNA delivery technology for the expression of pathogen antigens, aimed at developing next-generation vaccines.

Michael H. Tardugno, IMUNON’s Executive Chairman, highlighted that the company is anticipating a productive summer as they aim to enhance treatments for late-stage ovarian cancer and offer an innovative vaccine platform. IMUNON is on track to deliver topline results for their OVATION 2 Study in mid-2024. Preliminary data from this study indicated an approximate 30% delay in disease progression or death in the treatment group, compared to the control group. Additionally, subgroup analyses suggested longer progression-free survival (PFS) and overall survival (OS) in patients treated with a PARP inhibitor and IMNN-001.

IMUNON has also initiated a Phase 1 proof-of-concept study for its seasonal COVID-19 booster vaccine, IMNN-101, after securing an Investigational New Drug (IND) application approval from the U.S. Food and Drug Administration (FDA). The goal is to confirm the safety and effectiveness of this DNA-based vaccine as an annual booster. Early preclinical data has shown promising immunological responses and viral clearance in non-human primates, and superior results in mice compared to mRNA vaccines.

In a significant corporate development, IMUNON has appointed Stacy R. Lindborg, Ph.D., as President and Chief Executive Officer, effective May 13, 2024. Dr. Lindborg, who has been with IMUNON’s board since 2021, previously served as Co-Chief Executive Officer of BrainStorm Cell Therapeutics. She brings nearly 30 years of pharmaceutical and biotech industry experience, particularly in R&D, regulatory affairs, and strategy development.

Recent developments include interim PFS and OS data from the OVATION 2 Study, showing a delay in disease progression and improved survival trends in the treatment arm. The study aims to evaluate the safety and biological activity of intraperitoneal IMNN-001 combined with chemotherapy before tumor reduction surgery in patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

IMUNON has also started a Phase 1/2 clinical trial to evaluate IMNN-001 in combination with Bevacizumab (Avastin®) for advanced ovarian cancer, with patient enrollment underway at the University of Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center. The primary endpoint of this trial is the detection of minimal residual disease (MRD), with secondary endpoints focusing on PFS.

In April 2024, the FDA cleared IMUNON's IND application to commence human testing of IMNN-101, a seasonal COVID-19 booster vaccine based on the PlaCCine platform. The Phase 1 study aims to evaluate safety, tolerability, neutralizing antibody response, and durability in healthy adults.

Financially, for the three months ended March 31, 2024, IMUNON reported a net loss of $4.9 million, or $0.52 per share, compared to a net loss of $5.6 million, or $0.68 per share, for the same period last year. Operating expenses decreased by 12% to $5.0 million. Research and development (R&D) expenses increased to $3.3 million, while general and administrative expenses decreased to $1.7 million.

IMUNON concluded the first quarter with $9.8 million in cash, investments, and accrued interest receivable, which is expected to fund its operations through the end of 2024. The company has also secured $1.3 million in non-dilutive funding from the sale of New Jersey Net Operating Losses.