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II

Imunon, Inc. (IMNN)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 GAAP loss narrowed meaningfully: net loss was $2.7M vs $4.8M YoY on a 45% reduction in operating expenses; cash was $4.7M at quarter-end, with ~$3.1M raised post-quarter and runway extended into Q4 2025 .
  • Phase 3 OVATION 3 launched ahead of industry timelines; three sites activated and first patient treated, with management highlighting 15 weeks from protocol approval to enrollment vs ~28-week benchmark .
  • Corporate actions: announced a 15% stock dividend, effected a 15-for-1 reverse split, and received a Nasdaq listing extension to complete the compliance plan—key near-term trading catalysts .
  • Against Wall Street consensus, IMNN delivered a significant EPS beat for Q2 2025 (actual -1.87 vs -4.14 consensus), while the company remains pre-revenue; focus shifts to funding and execution in OVATION 3 to sustain momentum*.

What Went Well and What Went Wrong

What Went Well

  • Cost discipline and improved loss: OpEx fell to $2.8M (-45% YoY), driving net loss improvement to $2.7M from $4.8M; R&D fell to $1.2M and G&A to $1.5M .
  • Rapid Phase 3 start and investigator enthusiasm: “Industry benchmarks show an average of 28 weeks from protocol approval to enrollment opening, but we accomplished this in 15 weeks for OVATION 3” .
  • Strengthened clinical narrative: ASCO oral presentation and Gynecologic Oncology publication reinforced unprecedented overall survival outcomes in OVATION 2 and mechanistic translational data validating IL‑12 local immune activation .

What Went Wrong

  • Lower investment income due to smaller cash balances ($27k vs $225k YoY) highlights funding constraints despite post-quarter inflows .
  • Listing/compliance pressure remains a watch item despite an extension; minimum bid price compliance was still pending broader execution at call time .
  • Discrepancy in “first patient” timing (press release cites July 30; call cites July 25) could raise communications scrutiny; operationally immaterial but worth noting .

Financial Results

GAAP Operating Metrics

Metric ($USD)Q2 2024Q1 2025Q2 2025
Net Loss$4.8M $4.1M $2.7M
Operating Expenses$5.0M $4.1M $2.8M
R&D Expense$2.8M $2.2M $1.2M
G&A Expense$2.2M $2.0M $1.5M
Investment Income$225k $43k $27k
Cash & Equivalents (end of period)$5.9M (FY24 YE table) $2.9M $4.7M

Notes: Post-quarter inflows ~$3.1M via warrants and ATM; runway extended into Q4 2025 .

EPS and EBITDA (S&P Global)

MetricQ2 2024Q1 2025Q2 2025
Primary EPS Actual ($)-6.65*-3.65*-1.87*
EBITDA Actual ($)-4,945,019*-4,078,618*-2,692,855*

Values retrieved from S&P Global.

Revenue

MetricQ2 2024Q1 2025Q2 2025
Revenue Consensus Mean ($)0.00*0.00*0.00*

Values retrieved from S&P Global.

KPIs and Corporate Actions

KPIQ2 2024Q1 2025Q2 2025
First Phase 3 Site Initiated—May 8, 2025 —
First Patient Treated (OVATION 3)——Jul 30, 2025 (press release) ; Jul 25, 2025 (call)
Sites Activated (OVATION 3)——3 sites; goal 20 by YE 2025
Private Placement——$3.25M gross; warrants potential $6.5M
ATM/Warrants Post-Q——~$3.1M net; ~50/50 split per CFO
Stock Dividend——15% stock dividend announced Jul 28, 2025
Reverse Split——15-for-1 effective Jul 25, 2025
Nasdaq Extension——Listing extension granted Jul 15, 2025

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCompany ops“Into late Q2 2025” (as of Mar 31) “Into Q4 2025” (post July inflows) Raised runway
Phase 3 Sites Activated2025First site initiated (no count) 3 activated; corporate goal 20 by YE 2025 New explicit target
Nasdaq Bid Price ComplianceNear-termNot statedExpect ≥$1 for 10 consecutive days “as early as this Friday” (at call) New expectation
MRD Avastin Combo Enrollment2025Corporate goal: 35 patients in 2025 “Observing and working closely… optimistic to get to 35 by year-end” Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’24 and Q1’25)Current Period (Q2’25)Trend
Phase 3 initiation & designFDA-engaged EoP2; dual-primary OS endpoints; ~95%+ power; interim looks; HRD and ITT strategies Launched rapidly; 3 sites active; first patient treated; HRD-first strategy to reduce cost 40% with potential expansion to all-comers Acceleration; operational execution improving
R&D execution (OVATION 2)Unprecedented OS benefit (13-month median in ITT), HR fell to 0.69; PARP subgroup HR 0.38; favorable safety ASCO oral and journal publication; translational ESMO data confirming local immune activation Narrative strengthening
Financing strategyCash constrained; exploring partnerships; sell/license PlaCCine; ATM optionality Post-Q inflows ~$3.1M; 15% stock dividend; active non-dilutive pursuits; NASDAQ plan support Incremental runway; broader toolkit
HRD biomarker focusHRD/ITT dual endpoints; consider HRD-first if capital-limited HRD-first start with central biomarker testing; no treatment delays (Foundation Medicine prioritization) Clearer biomarker-driven approach
Avastin combo MRD studyTarget 50 total; corporate goal 35 in 2025; safety encouraging Continued enrollment; safety confirmed; sites expanding; translational outputs contemplated Progressing
Nasdaq complianceRisk acknowledged; timeline to regain complianceExtension granted; bid-price plan underway Improving footing
PlaCCine DNA vaccineEarly human POC; durability and stability advantages; partnership route 6-month NAb durability in Phase 1; program deprioritized and partner-seeking Partner-driven optionality

Management Commentary

  • “Industry benchmarks show an average of 28 weeks from protocol approval to enrollment opening, but we accomplished this in 15 weeks for OVATION 3” — Stacy Lindborg, CEO .
  • “We are fully committed to minimizing shareholder dilution… we have introduced a one-time stock dividend designed to enhance shareholder value… 15% dividend in common stock” — Stacy Lindborg, CEO .
  • “We enrolled our first patient in OVATION III on 07/25/2025… investigators around the country and internationally asking if they could participate” — Douglas Faller, CMO .
  • “As of 06/30/2025, cash and cash equivalents were $4,700,000… received approximately $3,000,000 of net proceeds from the exercise of warrants and sales under its ATM facility” — Kim Graper, CFO .

Q&A Highlights

  • Enrollment and HRD screening: Investigators have patient demand; HRD testing is SoC and prioritized by Foundation Medicine to avoid treatment delays .
  • OpEx trajectory: Costs expected to remain controlled; OVATION III manufacturing staged ahead of enrollment to smooth expense cadence .
  • Funding mix: ~$3.0M post-Q raised split roughly 50/50 between ATM and warrant exercises; ATM carries nominal 3% fee .
  • EU approval and sites: OS as primary endpoint should support EU approval without EU patient enrollment; EU sites under consideration to accelerate trial .
  • Avastin combo: Combination appears safe; early second-look laparoscopy suggests benefit in IMNN‑001 recipients; push to reach 35 patients in 2025 .

Estimates Context

MetricQ2 2024Q1 2025Q2 2025
Primary EPS Consensus Mean ($)-7.17*-4.79*-4.14*
Primary EPS Actual ($)-6.65*-3.65*-1.87*
Surprise ($)+0.52*+1.14*+2.27*
Revenue Consensus Mean ($)0.00*0.00*0.00*
Primary EPS – # of Estimates3*4*4*

Values retrieved from S&P Global.

Implication: IMNN produced a large EPS beat in Q2 2025 driven by aggressive OpEx control and post-quarter financing support; with no revenue, estimate changes will largely track expected OpEx and financing runway.

Key Takeaways for Investors

  • Execution momentum: Phase 3 launched quickly with sites activating and first patient treated—key for de-risking timelines and attracting partners .
  • Cost discipline is working: Material OpEx cuts drove a large EPS beat vs consensus; monitor continuity of lean spend as site count ramps* .
  • Funding path: Extended runway into Q4 2025 with multiple levers (ATM, warrants, stock dividend, partnerships); further capital likely tied to OVATION 3 enrollment cadence and ASCO/ESMO follow-through .
  • Clinical differentiation: OVATION 2 OS benefit and mechanistic data position IMNN‑001 distinct from checkpoint inhibitors in a “cold” tumor; HRD-first strategy may accelerate path and reduce cost .
  • Corporate actions as catalysts: Reverse split, dividend, and Nasdaq plan could broaden investor base and support near-term trading dynamics .
  • Watch for data updates: Avastin combo MRD progress and additional translational disclosures may reinforce the platform and partnership prospects .
  • Risk lens: Pre-revenue biotech with capital market dependence; listing compliance plan and financing execution remain critical near-term variables .

Values retrieved from S&P Global.