James Kelly
ORAGENICSAbout James Kelly
Dr. James “Jim” Kelly serves as Chief Medical Officer (CMO) of Oragenics (OGEN), focused on the company’s intranasal neurosteroid program ONP‑002 for concussion. Prior to OGEN, he was Executive Director of the Marcus Institute for Brain Health and Professor of Neurology at the University of Colorado Anschutz; he previously founded and directed the National Intrepid Center of Excellence (NICoE) at Walter Reed, leading integrated care for TBI and psychological comorbidities. His remit at OGEN includes overseeing Phase II development and engagement with clinical and regulatory stakeholders; public disclosures confirm his CMO role as of 2025. Performance metrics specific to his tenure (TSR, revenue, EBITDA) are not disclosed.
Past Roles
| Organization | Role | Years | Strategic Impact |
|---|---|---|---|
| Marcus Institute for Brain Health (University of Colorado Anschutz) | Executive Director; Professor of Neurology | Not disclosed | Led specialized treatment programs for veterans with persistent TBI symptoms; oversaw integrated clinical care and program leadership. |
| Avalon Action Alliance | National Director of TBI Programs | Not disclosed | Coordinated national programs for TBI care; clinical coordinating center at MIBH. |
| National Intrepid Center of Excellence (NICoE), Walter Reed | Founding Director | Not disclosed | Built interdisciplinary, high‑tech integrative model for complex TBI with psychological conditions; frequent engagement with Military Health System, VA, Congress. |
| FDA and Brain Injury Trials (various) | Clinical/regulatory engagement | Not disclosed | Interacted with FDA and clinical trials for brain injury; advocate for acute‑phase treatments to improve outcomes. |
External Roles
| Organization | Role | Year | Strategic Impact |
|---|---|---|---|
| Leigh Steinberg Foundation for Concussion, TBI & Brain Health | Medical Board Member | 2025 | Contributes to advancing brain health research and awareness; aligns OGEN’s concussion program with external medical leadership. |
| Emergencies in Medicine Conference | Presenter (ONP‑002, Trigger‑to‑Treat) | 2025 | Showcased ONP‑002 clinical protocols integrating BRAINBox biomarker platform; supports clinical adoption narrative. |
| 3rd Nasal Formulation & Delivery Summit | Panelist | 2025 | Shared intranasal CNS therapeutic insights; reinforces OGEN’s delivery science positioning. |
Fixed Compensation
- James Kelly is not listed among OGEN’s Named Executive Officers (NEOs) in 2024 or 2025 proxy statements; detailed base salary, target bonus, and actual bonus paid are not disclosed.
Performance Compensation
- Stock/option awards, performance metrics (e.g., revenue growth, EBITDA, TSR percentile), and vesting schedules specific to James Kelly are not disclosed in the 2024 or 2025 DEF 14A filings.
Equity Ownership & Alignment
- James Kelly is not included in the Security Ownership of Certain Beneficial Owners and Management tables; total beneficial ownership, vested/unvested breakdown, options in‑the‑money value, and any pledging are not disclosed.
- Any equity granted to executives under OGEN’s 2021 Equity Incentive Plan would be governed by plan features including no repricing without shareholder approval, clawback applicability, and no accelerated vesting of assumed awards on change‑of‑control—enhancing pay‑for‑performance alignment and governance.
Employment Terms
- No employment agreement, severance, or change‑of‑control terms for James Kelly are disclosed via proxy or 8‑K appointments; Item 5.02 filings and DEF 14A executive contract sections address other NEOs (Murphy, Huffman, Redmond) but not Kelly.
Performance & Track Record
- Clinical program leadership: As CMO, Kelly oversees ONP‑002 Phase IIa development; OGEN selected Southern Star Research as CRO with HREC approval, moving to site initiation and enrollment—reflecting execution progress.
- Clinical strategy: Promotes “Trigger‑to‑Treat” paradigm and integration of BRAINBox multimodal biomarker platform to improve acute concussion diagnostics and stratification in ONP‑002 trials.
- Thought leadership: Active dissemination at nasal delivery and emergency medicine venues, reinforcing OGEN’s scientific narrative in non‑invasive CNS therapeutics.
Investment Implications
- Alignment/retention: Absence of disclosed compensation and ownership for Kelly limits visibility into his pay mix and equity alignment; however, governance features of the 2021 Plan (clawbacks, no repricing, performance awards) provide structural guardrails if equity is granted.
- Execution signal: Kelly’s role in advancing ONP‑002 through CRO selection and biomarker‑integrated trial design signals operational readiness in concussion development; near‑term trial milestones (Phase IIa enrollment and interim readouts) are key catalysts.
- Disclosure gap risk: Lack of executive‑specific pay/ownership detail raises uncertainty on compensation alignment and potential insider‑selling pressure assessments; monitor future proxies and 8‑Ks for CMO‑specific awards or agreements.