Imunon, Inc. Q2 FY2025 earnings call

• Clinical Progress: OVATION 2 trial showed median overall survival increase of 13 months with IMNN-001 plus standard chemo, PARP inhibitors enhanced outcomes. OVATION 3 Phase III trial has 3 sites activated, first patient randomized. - Translational Data: IMNN-001 delivers targeted IL-12 gene therapy with minimal systemic exposure, immunological changes in tumor microenvironment support antitumor activity. - Financing: Introduced 15% stock dividend, bolstered balance sheet with $3 million from warrants and ATM facility, working on NASDAQ compliance. - Cost Control: R&D and G&A expenses reduced, focused on optimizing outcomes while raising capital.

As of June 30, 2025, cash and cash equivalents were $4.7 million. R&D expenses for Q2 2025 were $1.2 million, down from $2.8 million in the same period in 2024. G&A expenses were $1.5 million in Q2 2025, down from $2.2 million in 2024. Net loss for Q2 2025 was $2.7 million or $2.15 per share compared to $4.8 million or $7.64 per share in Q2 2024. There are no distinct product segments as the focus is on a single therapy, IMNN-001.

• OVATION 3 trial has a flexible design with a 250-patient HRD-positive subgroup to reduce cost and enable early efficacy stopping, with potential to expand to 500-patient all-comers. - Aim to have 20 sites open by year-end, monitor enrollment and expenses in real time. - Pursue nondilutive strategies and long-term investors to minimize shareholder dilution.

• Capital Markets: Challenging environment affecting fundraising. - Dilution: Shareholders concerned about dilution with biotech needing capital for Phase III. - Regulatory: Though OS endpoint aids EU approval, potential challenges with trial setup in other regions remain.

Q: Congrats on the progress with the Phase III trial. Any initial demand from the patient side and pace of enrollment in the HRD subset?

A: Douglas V. Faller mentioned high demand due to lack of new frontline treatments in ovarian cancer, HRD subset is 50% of neoadjuvant population, and Foundation Medicine prioritizes assays for quick patient testing.

Q: How are expenses expected to change for the remainder of the year with OVATION 3 enrollment?

A: Stacy R. Lindborg stated controlled costs, investment in start-up for OVATION 3 ahead of enrollment, with expenses expected to be stable.

Q: What's the status on the Avastin trial and next interim look?

A: Stacy R. Lindborg mentioned a call with the study PI soon, and they're in regular contact with sites, with early findings showing potential benefit from the combination.