Imunon, Inc. (IMNN)·Q1 2025 Earnings Summary

Executive Summary

• Q1 2025 delivered disciplined cost control and clinical execution: net loss of $4.1M and basic/diluted EPS of $(0.28), with operating expenses down 18% year over year to $4.1M and cash used in operations of $2.8M . Cash and equivalents were $2.9M at March 31, 2025, implying funding into late Q2 2025 per company commentary .
• Phase III OVATION 3 for IMNN-001 initiated its first clinical site on May 8; ASCO accepted OVATION 2 data for an oral presentation, with full Phase 1/2 data scheduled for publication in Gynecologic Oncology on June 3, strengthening scientific validation .
• Management emphasized near‑term financing and partnerships to extend runway and fund OVATION 3; dilution “top of mind,” with an update expected by the end of this quarter .
• S&P Global consensus EPS for Q1 2025 was −4.79; S&P’s normalized actual EPS registered −3.65, a beat versus expectations. Revenue consensus was $0, in line for a pre‑revenue biotech (values marked with *; Values retrieved from S&P Global).

What Went Well and What Went Wrong

What Went Well

• First Phase III site initiated for OVATION 3; investigators from prior studies re‑engaging, signaling strong clinical enthusiasm .
• Scientific momentum: ASCO oral presentation acceptance and peer‑reviewed publication of OVATION 2 data deepen external validation of IMNN‑001 .
• Operating discipline: R&D down to $2.2M from $3.3M YoY and total OpEx down 18%, narrowing net loss YoY to $4.1M from $4.9M .

Management quotes:

• “We have initiated the first clinical site in our Phase III pivotal study of IMNN‑001.”
• “We are actively working on value‑added financing and partnerships… Dilution is top of mind.”
• “Product… has passed all of the release specifications and has been ready to ship for weeks.”

What Went Wrong

• Cash is tight: $2.9M at quarter‑end with runway only into late Q2 2025; financing remains a near‑term imperative .
• G&A increased to $2.0M from $1.7M YoY, reflecting higher employee‑related expenses despite overall OpEx reductions .
• Continued net losses typical of pre‑revenue biotech; sequential liquidity reduced from $5.9M at 12/31/24 to $2.9M at 3/31/25, heightening financing urgency .

Financial Results

YoY Comparison (Q1 2024 → Q1 2025)

Notes: YoY OpEx decline driven primarily by lower costs from the PlaCCine DNA vaccine proof‑of‑concept and IMNN‑001 development tied to OVATION 2 .

Sequential Comparison (Q4 2024 → Q1 2025)

Values marked with *; Values retrieved from S&P Global.

Estimates vs Actual (S&P Global)

Values marked with *; Values retrieved from S&P Global.

KPIs

• Net cash used in operating activities: $2.8M (Q1 2025) .
• Cash runway: into late Q2 2025 per company disclosure .

Segment breakdown: Not applicable; company is pre‑revenue biotechnology.

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• Strategic focus on ovarian cancer and unlocking IL‑12: “We may be close… to unlocking the power of interleukin‑12 to effectively treat… ovarian cancer.”
• Trial strategy and endpoints: “The primary endpoint of the study is overall survival… Secondary endpoints include surgical and chemotherapy response scores…”
• Financing stance: “Dilution is top of mind… working on value‑added financing and partnerships… goal is to cover OVATION 3 trial costs through corporate partnerships and equity.”
• Manufacturing readiness: “We have pulled the manufacturing of the core active pharmaceutical ingredients in‑house… product… has been ready to ship for weeks.”

Q&A Highlights

• ASCO content embargo: Management confirmed new information will be presented but details are restricted until ASCO; signaling confidence in dataset .
• Phase III design: Readouts prioritize HRD subgroup with two interims; ~45 sites projected; OS is the single primary across populations, not dual .
• MRD collaboration: Additional site (University of Oklahoma) initiated; Johns Hopkins re‑staffed; preliminary data expected by year‑end .
• Financing timing: Update expected by end of the quarter; ongoing pursuit of corporate partnering and equity .

Estimates Context

• EPS beat: S&P normalized Q1 2025 EPS actual −3.65 vs consensus −4.79 indicates a better‑than‑expected loss profile, while company‑reported EPS was $(0.28) basic/diluted. Values marked with *; Values retrieved from S&P Global. [Company EPS reference: 8‑K press release]
• Revenue in line: Consensus $0 and actual $0 consistent with pre‑revenue status. Values marked with *; Values retrieved from S&P Global.
• Implications: Street models may need to reflect lower near‑term OpEx and disciplined cash burn, contingent on financing outcomes and Phase III scale‑up .

Key Takeaways for Investors

• Clinical execution is de‑risking: First Phase III site initiation and ASCO oral presentation elevate the probability of success and potential regulatory dialogue on accelerated pathways (OS primary, HRD focus) .
• Cost discipline supports runway: YoY OpEx down 18% and R&D down by $1.1M; cash burn improved vs prior year quarter; runway into late Q2 2025 but financing is imminent .
• Financing is the near‑term swing factor: Expect an update by quarter‑end; partnering for PlaCCine and geographic dealmaking could be non‑dilutive offsets; equity likely part of the mix .
• Manufacturing readiness reduces execution risk: In‑house API and released product ready to ship should support enrollment pace and COGS positioning long‑term .
• Trial design offers optionality: HRD‑focused early readout and two interims provide multiple shots‑on‑goal; OS primary endpoint could support EU and US approvals if positive .
• Trading implications (near term): Potential positive sentiment around ASCO oral and Gynecologic Oncology publication; watch for financing headline risk and equity dilution .
• Medium‑term thesis: If Phase III replicates OVATION 2 survival benefits, IMNN‑001 could redefine frontline ovarian cancer therapy and create a high‑value asset with partnering or commercialization pathways .