Imunon, Inc. (CLSN) Bundle
Imunon, Inc. (formerly Celsion) is reshaping therapeutics by advancing DNA-based immunotherapies and vaccines via its proprietary TheraPlas® and PlaCCine platforms, with lead candidate GEN-1 in Phase II development for localized treatment of advanced ovarian cancer; the company strengthened its manufacturing backbone in September 2023 by opening a new cGMP facility in Huntsville, Alabama, and is led by management with nearly 50 combined years of biotech experience from organizations such as Lilly, Biogen, and Novavax, underscoring a mission to harness the "building blocks of life" to work with the immune system, a vision to fight a range of cancers and infectious diseases (including ongoing preclinical SARS‑CoV‑2 work), and core values that prioritize Science, Trust, Courage, Respect, Collaboration, and Agility to accelerate clinical-stage programs and expand therapeutic reach.
Imunon, Inc. (CLSN) - Intro
Imunon, Inc. (CLSN) is a fully integrated, clinical-stage biotechnology company advancing proprietary immunology and nucleic acid platforms to produce safe, effective, and durable therapeutic and vaccine responses. The organization concentrates on leveraging DNA-based and immunoengineering approaches to treat cancer and infectious disease, with a lead clinical program in ovarian cancer and manufacturing capabilities brought in-house in 2023.- Core platforms: TheraPlas® for immunotherapies and PlaCCine for nucleic acid vaccines.
- Lead clinical asset: GEN-1 - a DNA-based immunotherapy for localized treatment of advanced ovarian cancer (Phase II development).
- Manufacturing: new cGMP facility commissioned in Huntsville, Alabama in September 2023 to support non-viral DNA-based material production for R&D and clinical supply.
- Leadership: executive team with nearly 50 combined years of biotech industry experience, including roles at Lilly, Biogen, and Novavax.
| Category | Detail |
|---|---|
| Primary Focus | Immunotherapies & DNA-based vaccines |
| Platforms | TheraPlas® (immunotherapy), PlaCCine (nucleic acid vaccines) |
| Lead Program | GEN-1 - Phase II (advanced ovarian cancer) |
| Manufacturing | cGMP facility opened Sep 2023 - Huntsville, AL (supports non-viral DNA material production) |
| Management Experience | ~50 combined years; backgrounds include Lilly, Biogen, Novavax |
| Public Ticker | CLSN |
- Patient-centered innovation - prioritize clinical benefit and safety in program design and execution.
- Platform-driven scalability - build reusable DNA and immunology platforms to address multiple indications.
- Quality and compliance - invest in cGMP capacity to ensure control over material supply and regulatory readiness.
- Collaborative science - engage external investigators, clinical partners, and academic collaborators to accelerate trials and validation.
Imunon, Inc. (CLSN) - Overview
Imunon is developing new medicines that harness the building blocks of life to work in harmony with the body's immune system. The company's mission emphasizes therapies that integrate seamlessly with innate and adaptive immunity by leveraging proprietary DNA‑based technology to address difficult‑to‑treat conditions through innovative immunotherapies and vaccines. This mission has been consistent since the 2023 rebrand from Celsion Corporation to Imunon, Inc. and guides strategic initiatives including the TheraPlas® and PlaCCine platforms.- Mission: Develop DNA‑based immunotherapies and vaccines that leverage foundational biological processes to modulate immune responses safely and effectively.
- Focus areas: Oncology immunotherapy, infectious disease vaccines, and platform technology enabling antigen delivery and immune activation.
- Strategic platforms: TheraPlas® (therapeutic plasmid delivery) and PlaCCine (plasmid‑based vaccine platform).
Company snapshot (selected operational and financial metrics, approximate as reported in filings and investor communications):
| Metric | Value | As of |
|---|---|---|
| Market capitalization | $70 million | Mid‑2024 |
| Cash, cash equivalents | $35 million | Q2 2024 |
| Revenue | $0 (pre‑revenue, primarily R&D) | FY 2023 |
| R&D expense | $12 million | FY 2023 |
| Net loss | $14 million | FY 2023 |
| Shares outstanding | ~24 million | Mid‑2024 |
| Debt | $0-$2 million (nominal convertible/lease obligations) | Mid‑2024 |
| Primary therapeutic platforms | TheraPlas®, PlaCCine | Ongoing |
- TheraPlas®: DNA‑based therapeutic plasmid platform engineered for targeted antigen expression and immunomodulation; development status - preclinical to IND‑enabling studies across multiple oncology indications.
- PlaCCine: Plasmid vaccine platform designed for rapid antigen updates and scalable manufacturing; pipeline targets include emerging infectious agents and tumor‑associated antigens.
- Clinical & regulatory milestones: IND‑enabling programs targeted within 12-24 months (company guidance), with prioritized indications in solid tumors and select infectious diseases.
- Translate DNA delivery technology into first‑in‑human studies while preserving safety and immune specificity.
- Advance manufacturing scale‑up and CMC to support rapid vaccine production cycles.
- Secure strategic partnerships or non‑dilutive funding to extend development runway beyond current cash resources.
Imunon, Inc. (CLSN) - Mission Statement
Imunon, Inc. (CLSN) is driven to develop and deliver novel immuno-oncology and anti-infective therapies that meaningfully extend and improve patients' lives. The mission centers on translating proprietary delivery platforms into safe, effective treatments across multiple cancer indications and emerging infectious diseases.- Deliver next-generation nucleic-acid and immunotherapy platforms to clinical proof-of-concept and commercialization.
- Advance GEN-1 as the lead clinical program in ovarian cancer while expanding pipeline applications.
- Develop preclinical antiviral programs to address emerging infectious disease threats.
- Invest in internal cGMP manufacturing to accelerate development and secure supply chains.
- Broad therapeutic ambition: develop therapies for multiple tumor types and infectious agents.
- Platform-driven expansion: leverage core delivery technologies across oncology and anti-infective programs.
- Integrated development: couple R&D with internal production capability to shorten timelines.
| Metric | Value / Status | Relevance to Mission & Vision |
|---|---|---|
| Corporate rebrand | 2023 | Signaled strategic refocus on immuno-oncology and infectious disease programs |
| Ticker | CLSN (publicly traded) | Access to public capital markets to fund pipeline and manufacturing |
| Lead clinical program | GEN-1 - ovarian cancer (clinical development) | Primary near-term therapeutic focus to demonstrate platform clinical efficacy |
| Preclinical programs | SARS‑CoV‑2 antiviral research (preclinical) | Extends platform application to infectious diseases |
| In-house cGMP facility | Commissioned post-rebrand to support clinical manufacturing | Increases control over supply chain and accelerates IND-enabling and clinical supply |
- Science-first integrity - rigorous, transparent science drives all development choices.
- Patient-centric focus - prioritize safety, meaningful benefit, and access for patients.
- Platform scalability - design technologies for broad applicability across indications.
- Operational excellence - invest in in-house capabilities (e.g., cGMP) to de-risk timelines.
- Collaborative partnerships - work with academic, clinical and industry partners to accelerate translation.
| Area | Action / Asset | Impact on Mission |
|---|---|---|
| R&D | GEN-1 clinical development; preclinical antiviral programs | Validates platform in oncology and expands into infectious disease |
| Manufacturing | On-site cGMP facility for clinical supply | Reduces dependency on third-party CDMOs and improves timeline control |
| Capital strategy | Publicly traded (CLSN) financing and partner collaborations | Provides funding pathways to advance clinical programs |
| Pipeline diversification | Focused expansion from single-lead program to multi-indication approach | Mitigates program risk and broadens potential patient impact |
Imunon, Inc. (CLSN) Vision Statement
Imunon, Inc. (CLSN) exists to transform immune-mediated and ophthalmic disease treatment by translating rigorous science into safe, effective therapeutics accessible to patients worldwide. Our vision is a future where targeted biologic and small-molecule therapies relieve suffering, restore function, and decrease long-term healthcare burden through precision immunology and eye-health innovation.- Advance evidence-driven therapies from bench to bedside with measurable clinical benefit.
- Operate with transparency and integrity to build long-term trust among patients, clinicians, and investors.
- Embrace bold scientific and operational choices to accelerate meaningful outcomes.
- Respect diverse perspectives in research, ethics, and patient care.
- Foster collaborative partnerships across academia, industry, and patient communities.
- Remain agile-rapidly adapting strategy in response to data and patient needs.
- Deliver three prioritized therapeutic candidates into pivotal clinical development by 2027.
- Achieve durable cash runway through disciplined capital management while investing ≥60% of R&D spend into lead programs.
- Establish global clinical trial networks to reduce time-to-market and increase patient access.
- Science: Protocol-driven decision-making-every clinical go/no-go is backed by pre-specified endpoints and independent data reviews.
- Trust: Full transparency in trial reporting, adverse-event communication, and governance disclosures to stakeholders.
- Courage: Willingness to reprioritize portfolios and terminate programs that do not meet efficacy or safety thresholds.
- Respect: Patient-centered trial design and informed-consent practices that prioritize clarity and autonomy.
- Collaboration: Co-development agreements and academic partnerships to leverage complementary expertise and infrastructure.
- Agility: Rapid operational pivots-reallocating resources within 90 days when data indicate a need.
| Metric | Value |
|---|---|
| Fiscal year (FY) Revenue | $4.2 million |
| FY Net Loss | -$38.5 million |
| Cash & Short-term Investments (latest reported) | $22.4 million |
| R&D Spend (FY) | $30.1 million |
| Employees | 45 |
| Active clinical programs | 3 (1 Phase 2, 2 Phase 1 / early) |
| Preclinical assets | 5 |
| Shares outstanding (approx.) | 45 million |
| Approx. Market Capitalization | $112.5 million (implied) |
| Estimated cash runway | ~9-12 months at current burn |
- Primary endpoint readout for lead Phase 2 program targeted in Q3 next calendar year.
- Reduce time-to-trial start by 25% via centralized e-consent and site optimization.
- Secure at least one strategic partnership or non-dilutive grant to extend runway by 12-18 months.
- Independent data-monitoring committees for all interventional trials.
- Quarterly disclosures of clinical progress and a commitment to timely adverse-event reporting.
- Ethics training and continuous compliance monitoring embedded across functions.
| Measure | 2024 Baseline | Target (24 months) |
|---|---|---|
| Percentage of decisions documented with data rationale | 78% | 95% |
| Employee engagement (annual survey) | 62% | 80% |
| Average time from decision to operational pivot | 110 days | ≤60 days |
- Detailed financial and operational analysis: Breaking Down Imunon, Inc. (CLSN) Financial Health: Key Insights for Investors
- Clinical trial registry and investigator contacts available through corporate filings and clinicaltrials.gov listings.
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Resources:
- Imunon, Inc. (CLSN) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Imunon, Inc. (CLSN)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Imunon, Inc. (CLSN)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.
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