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II

Imunon, Inc. (IMNN)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 net loss per share was $1.16, materially better than Wall Street consensus of -$1.81, a ~$0.65 EPS beat; the company remains pre-revenue and continues to operate as a single R&D segment. Cash was $5.3M at quarter-end, with runway guided into mid-Q1 2026; monthly burn is ~$1.25–$1.5M . EPS estimate values retrieved from S&P Global.*
  • OVATION 3 Phase 3 enrollment is ahead of plan: four U.S. sites activated (target doubling before year-end) and nine patients randomized by end-October; FDA endorsed OS as a single-study registration endpoint with interim analyses designed to enable full approval within the studied population if thresholds are met .
  • R&D Day and a series of major oncology meetings (ASCO/ESMO/AACR/SITC/IGCS) showcased translational data supporting IMNN-001’s mechanism (turning “cold” tumors “hot”) and strengthening enthusiasm among investigators; MRD study enrollment capped at 30 ITT with H1 2026 completion goal to refocus resources on Phase 3 .
  • Nasdaq compliance regained in August (minimum bid price) and shareholder equity above $2.5M; corporate actions (reverse split and 15% stock dividend) executed in Q3 to stabilize listing and align shareholders ahead of pivotal milestones .

What Went Well and What Went Wrong

What Went Well

  • Phase 3 momentum: “OVATION 3 enrollment is surging ahead of plan,” with four sites activated and expected to double by year-end; first patient treated in July and nine randomized by end-October, underscoring investigator enthusiasm .
  • Strength of clinical/translational data: Management highlighted a 13-month median OS benefit in Phase 2 and mechanistic data showing macrophage uptake and local cytokine induction, reinforcing IMNN-001’s ability to convert immunologically “cold” tumors to “hot” .
  • Financial discipline and listing stability: Monthly cash burn down to ~$1.25–$1.5M; $4.5M raised via warrants/ATM in Q3; Nasdaq bid-price compliance regained; shareholder equity reported at ~$4.1M .

What Went Wrong

  • Runway remains limited despite progress: Cash and equivalents at $5.3M with going-concern disclosure; runway only into mid-Q1 2026—dependency on equity and non-dilutive partnerships persists .
  • Site activation pace reset vs prior aspiration: From a prior corporate goal of 20 sites open by year-end to current expectation of doubling from four to eight in 2025, reflecting cash-constrained activation decisions .
  • Pre-revenue status with continuing operating losses: Q3 net loss $3.4M; no product revenue contribution—operating model reliant on financing and partnerships; investment income fell YoY on lower cash balances .

Financial Results

MetricQ3 2024Q2 2025Q3 2025
EPS (Basic & Diluted, $)$(3.76) $(2.15) $(1.16)
Net Loss ($USD Millions)$(4.85) $(2.74) $(3.43)
Revenue ($USD Millions)— (pre-revenue)— (pre-revenue)— (pre-revenue)
R&D Expense ($USD Millions)$3.29 $1.23 $1.90
G&A Expense ($USD Millions)$1.67 $1.54 $1.58
Total Operating Expenses ($USD Millions)$4.96 $2.77 $3.48

Estimate comparison (Wall Street consensus vs actual):

MetricConsensus (Q3 2025)Actual (Q3 2025)
Primary EPS Consensus Mean ($)$(1.81)*$(1.16)*
Revenue Consensus Mean ($USD Millions)$0.00*— (pre-revenue)*

Values retrieved from S&P Global.*

Observations:

  • EPS beat vs consensus by ~$0.65 driven by lower operating expenses YoY (R&D -42% and G&A -6%) and targeted financing; pre-revenue status persisted .
  • Sequential EPS improvement from Q2 to Q3 reflects controlled OpEx and modest investment income; YoY improvement driven by large R&D downshift post OVATION 2 and PlaCCine PoC completion .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayOperatingInto Q4 2025 Into mid-Q1 2026 Raised
Site Activation (OVATION 3)2025Corporate goal: 20 sites activated in 2025 Expect doubling from 4→8 by year-end; preparing global CRO for surge in 2026 Reset/lowered near-term pace
Full Enrollment (OVATION 3)Program~3 years with potential for 2 years under aggressive plans Late 2028 (all-comers) with possibility to accelerate with financing Clarified timeline
MRD Study Enrollment CapStudyOngoing enrollment paceCap at 30 ITT; reach in H1 2026 Formalized cap
Listing ComplianceNasdaqWorking toward compliance Minimum bid price regained; equity above $2.5M Achieved

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
Trial Design & FDA EndpointOS primary; HRD-first strategy; interim analyses outlined 15-week startup to first patient; 1:1 randomization; HRD subgroup focus FDA endorsed OS single-study registration; interim analyses could deliver full approval in studied group Reinforced, more explicit
Enrollment & SitesFirst site initiated 3 sites activated; first patient dosed 4 activated; expect doubling; 9 patients randomized by end-Oct Accelerating
Translational/MechanismDose-dependent IL-12 increases; local immune activation OVATION 2 translational data; investigator interest Macrophage uptake, TME remodeling; SITC/ESMO/AACR presentations Broadening external validation
MRD StudyTargeting completion; 15 patients by Q2 Sites expanding; data expected end-year Cap at 30 ITT; H1 2026 target; favorable DSMB updates Scoped, focused
Financing & RunwaySeeking partners; ATM use; equity Stock dividend; reverse split; delisting risk mitigation Cash to mid-Q1 2026; $4.5M raised; bid-price compliance regained Stabilizing listing; still capital-dependent
EU Regulatory/AccessGoal to support EU with OS endpoint Considering EU sites; OS critical EMA acceptability; payer focus on OS outcomes Consistent focus

Management Commentary

  • “OVATION 3 enrollment is surging ahead of plan,” with robust early site performance and investigator enthusiasm driving above-estimate per-site enrollment .
  • “IMNN-001’s potential to deliver a 13-month median overall survival benefit…represents a potential paradigm shift,” supported by multiple presentations and translational evidence of turning ‘cold’ tumors ‘hot’ .
  • “Monthly cash burn is now approximately $1.25–$1.5 million,” with financing decisions calibrated to preserve shareholder value while funding pivotal development .
  • “The NASDAQ compliance matter is closed…we are at $4.1 million in the shareholder equity threshold,” improving listing stability .

Q&A Highlights

  • Interim analyses and label: Positive interim efficacy could enable full approval in the tested population (e.g., HRD subgroup if prioritized); broader label would require completion of all-comers cohort .
  • Pain management protocol: Prophylactic analgesia is mandated across sites to ensure patient comfort during intraperitoneal administration; MRD and OVATION 3 have not observed abdominal discomfort issues under protocol .
  • EU pathway: EMA acceptability anchored on OS; payers prioritize OS over PFS, aligning with the chosen endpoint .
  • Acceleration potential: With more funding, full enrollment could compress from ~3 years toward ~2 years via proactive CRO engagement and site activation sequencing .
  • OVATION 2 updates and site overlap: Final OS refresh expected near year-end; substantial overlap planned from high-performing OVATION 2 sites into Phase 3 .

Estimates Context

  • EPS beat: Actual Q3 2025 EPS of $(1.16) vs consensus $(1.81) -> ~$0.65 beat, reflecting OpEx reductions and controlled G&A . EPS estimate and consensus values retrieved from S&P Global.*
  • Revenue: Consensus at $0, consistent with pre-revenue status; actual revenue remains non-applicable [GetEstimates]. Values retrieved from S&P Global.*

Where estimates may adjust:

  • Given sequential EPS improvement and controlled OpEx, near-term estimates may modestly revise upward for EPS, while revenue remains unchanged until partnership/licensing events materialize. Values retrieved from S&P Global.*

KPIs

KPIQ2 2025Q3 2025
Sites Activated (OVATION 3)3 4; expect doubling before year-end
Patients Randomized (OVATION 3)—9 by end-October
Cash & Equivalents ($USD Millions)$4.7 $5.3
Monthly Cash Burn ($USD Millions)—~$1.25–$1.5
Shareholder Equity ($USD Millions)—~$4.08–$4.10

Key Takeaways for Investors

  • Near-term trading: EPS beat and compliance milestones reduce downside tail risk; shares may remain sensitive to financing cadence and partnership news-flow given limited runway .
  • Clinical execution: Early Phase 3 momentum plus strong translational data underpin probability-of-success; interim OS analyses are credible stock catalysts as they could enable full approval in the tested subgroup .
  • Capital strategy: Expect iterative equity plus pursuit of non-dilutive deals; monitoring ATM utilization and warrant exercises is critical for dilution math and runway extensions .
  • Enrollment scalability: CRO readiness and site overlap from OVATION 2 suggest capacity to accelerate with funding; watch for site activation updates and geographic expansion .
  • Regulatory alignment: OS endpoint and EMA acceptability de-risk the path; payer emphasis on OS supports value narrative if interim shows success .
  • MRD data: Cap at 30 ITT and H1 2026 completion could surface additional mechanistic/maintenance insights and aid Phase 3 narrative .
  • Risk management: Going-concern disclosures persist; investors should incorporate dilution scenarios and monitor cash, equity levels, and burn trajectory closely .

Values retrieved from S&P Global.*