IMNNNasdaqPharmaceutical PreparationsUS GAAP · USD

Imunon, Inc.

Imunon, Inc. is a clinical-stage biotechnology company developing non-viral DNA-based therapies and vaccines. Its lead platform, TheraPlas®, is being advanced for solid tumors such as advanced ovarian cancer, while PlaCCine® is designed for vaccine applications in infectious diseases.

Kysy yhtiöstä
Liikevoitto (EBIT)−14,7milj. USD
+23,4 %v/v
Nettotulos−14,5milj. USD
+22,2 %v/v
Vapaa kassavirta−14,2milj. USD
+24,9 %v/v

Tilikausi 2025 · muutos edellisvuodesta

Kehitys 2020–2025

−30−20−10010milj. USD2020: 0,50 milj. USD2020: EBIT −18 milj. USD20202021: 0,50 milj. USD2021: EBIT −21 milj. USD20212022: 0,50 milj. USD2022: EBIT −25 milj. USD20222023: 0,50 milj. USD2023: EBIT −21 milj. USD20232024: EBIT −19 milj. USD20242025: EBIT −15 milj. USD2025−15
LiikevaihtoLiikevoitto (EBIT)

Liiketoiminta

Osuus liikevaihdosta
Oncology therapeutics70 %

Includes IMNN-001 and related development work for solid tumors, especially advanced ovarian cancer.

Vaccine platform15 %

Includes PlaCCine® programs that code viral antigens for infectious disease vaccines.

Clinical development and regulatory10 %

Includes preclinical, clinical, FDA interaction, and trial advancement activities.

Manufacturing and CMC5 %

Includes process development, potency assay work, and cGMP manufacturing readiness.

Asiakkaat

Imunon does not yet commercialize products, so its near-term 'customers' are primarily clinical trial sites, investigators, regulators, and future licensing or collaboration partners rather than end-market buyers. If approved, its therapies would be used by oncology specialists and hospitals treating patients with advanced ovarian cancer, and potentially by public health or commercial vaccine channels for PlaCCine® programs.

Regulators and clinical trial stakeholders

The company works with the FDA, trial investigators, and manufacturing reviewers to advance IMNN-001 through development and align on CMC requirements.

Future biopharma collaboration partners

Potential partners may fund, run, or commercialize programs in exchange for rights or shared economics.

Oncology treatment providers

If approved, hospitals and oncology specialists would use IMNN-001 for advanced ovarian cancer patients.

Vaccine development partners

PlaCCine® could be licensed or partnered for infectious disease vaccine development and commercialization.

Strategia

Imunon’s strategy is to advance IMNN-001 into a Phase 3 pivotal study, secure FDA alignment on clinical and CMC requirements, and preserve optionality through collaborations. Because the company has not commercialized products and has limited cash, financing, partnership, and grant execution are as important as clinical progress.

Advance IMNN-001 into Phase 3Lyhyt aikaväli

Clinical proof-of-concept and pivotal data are the main value drivers for a pre-revenue biotech.

Secure financing and non-dilutive supportLyhyt aikaväli

The company has limited cash and substantial going-concern risk, so funding determines operating continuity.

Build partnership optionalityKeskipitkä aikaväli

Collaborations can reduce capital needs and accelerate development or commercialization.

Maantiede

Imunon is headquartered in the United States and its disclosed operating footprint centers on U.S.-based development and manufacturing. The company specifically referenced manufacturing at its Huntsville, Alabama facility and FDA interactions in the U.S., which makes domestic regulatory execution central to the business.

Riskit

Imunon is a pre-revenue clinical-stage biotech, so its main risks are clinical failure, regulatory delay, and financing shortfalls. The company also faces going-concern risk, dilution from equity issuance, and Nasdaq listing risk if it cannot maintain compliance or raise capital on acceptable terms.

Järjestetty vakavuuden mukaan
MatalaKohtalainenKorkeaMatalaKohtalainenKorkeaVaikutus →Todennäköisyys →Going-concern and liquidity shortfall1Clinical development failure2Financing dilution and unfavorable terms3Regulatory and CMC execution risk4Nasdaq listing compliance5
Vaikutus on riskin vakavuus ja todennäköisyys sen toteutumisen todennäköisyys lähivuosina, molemmat arvioitu yhtiön raporttien perusteella. Numerot vastaavat listaa.
  1. Going-concern and liquidity shortfallVaikutus: KriittinenTodennäköisyys: Korkea

    The company disclosed substantial doubt about its ability to continue without additional capital.

    Kohdistuu: Cash runway and ability to fund trials

  2. Clinical development failureVaikutus: KorkeaTodennäköisyys: Korkea

    Drug research and development is inherently uncertain and pivotal studies can fail at any stage.

    Kohdistuu: IMNN-001 and future pipeline programs

  3. Financing dilution and unfavorable termsVaikutus: KorkeaTodennäköisyys: Korkea

    The company relies on equity, partnerships, and grants, which may be unavailable or dilutive.

    Kohdistuu: ATM program and future capital raises

  4. Regulatory and CMC execution riskVaikutus: KorkeaTodennäköisyys: Matala

    FDA alignment on manufacturing, potency assays, and comparability is required for Phase 3 and BLA readiness.

    Kohdistuu: IMNN-001 manufacturing and approval path

  5. Nasdaq listing complianceVaikutus: KeskitasoTodennäköisyys: Korkea

    Failure to meet continued listing standards could lead to delisting and reduced liquidity.

    Kohdistuu: Common stock trading on Nasdaq

Kirjanpito

Harkinnanvaraiset erät
Going-concern assessment

Management disclosed substantial doubt about continuing operations, which affects financial statement presentation and investor interpretation.

Vaikutus: May require additional disclosures and highlights liquidity risk

Equity issuance and dilution

ATM and other stock sales are a primary funding source and affect share count and per-share metrics.

Vaikutus: Increases dilution and can pressure valuation

Collaboration and licensing accounting

Future partner arrangements could involve upfront fees, milestones, or cost-sharing that require judgment on timing and classification.

Vaikutus: Could shift reported revenue and deferred income

Grant and subsidy recognition

Government funding, if obtained, may offset development costs and change the reported burn rate.

Vaikutus: Could reduce net loss in periods received

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Päivitetty: 24.9.2026