Karl Whitney
About Karl Whitney
Karl Whitney, Ph.D., RAC, is Senior Vice President, Global Regulatory Affairs at Passage Bio (joined February 2024). He leads regulatory strategy and interactions for gene therapy programs, bringing 25 years of regulatory and integrated product development experience, with prior leadership at Precision BioSciences and a decade at CRO Rho, Inc.; education includes a B.A. from Yale and a Ph.D. in Pharmacology from Duke, and he serves as co‑President of the International FOXP1 Foundation and advisor to UNC Eshelman’s Regulatory Science MPS program . Company performance context during his tenure: PASG is pre‑revenue with net loss of $7.75M in Q3 2025 and $32.54M YTD; Q3 2024 net loss was $19.34M, and management guides cash runway into Q1 2027 . The company undertook a reverse stock split process to maintain Nasdaq listing compliance and disclosed related minimum bid price risks .
Past Roles
| Organization | Role | Years | Strategic impact |
|---|---|---|---|
| Precision BioSciences | Vice President & Head of Regulatory Affairs | 2020–2024 | Led regulatory strategy and operations across oncology cell therapy and in vivo genome editing programs . |
| Rho, Inc. (full‑service CRO) | Senior leadership in regulatory and clinical operations | ~2009–2019 | Managed submissions, clinical trial projects, and built regulatory strategy training for Ph.D. scientists . |
| RTI International | Regulatory Program Director | Prior to Rho | Directed regulatory submissions and agency communications . |
External Roles
| Organization | Role | Years | Strategic impact |
|---|---|---|---|
| International FOXP1 Foundation | Co‑President | Current | Governance and advocacy for an ultra‑rare neurodevelopmental disorder . |
| UNC Eshelman School of Pharmacy | Advisor, MPS in Regulatory Science | Current | Advises curriculum and training for regulatory professionals . |
Fixed Compensation
- Salary and bonus details for Karl Whitney are not disclosed. As a smaller reporting and emerging growth company, Passage Bio has reduced executive compensation disclosure requirements; Karl is not a named executive officer in the 2025 proxy (NEOs are CEO, CFO, General Counsel) .
- 2024 NEO target bonuses (indicative of company incentive structure): CEO 55%; CFO 40%; General Counsel 40%; payouts at ~95–99% of target based on corporate/personal goals .
Performance Compensation
- Company structure: Annual cash bonus tied to goals in R&D, regulatory, financial, and general corporate objectives, with Compensation Committee oversight and independent consultant (Pearl Meyer) benchmarking peer groups .
- Equity awards: Company grants stock options and RSUs; options generally vest over four years and RSUs over service periods; Black‑Scholes used for option valuation .
- Company‑level vesting examples and inventory:
- Options outstanding at 9/30/2025: 669,558 shares (WAVG exercise $50.58; 8.0 years remaining); exercisable 341,557 shares (WAVG $84.77) .
- RSUs unvested balance at 9/30/2025: 52,500 shares (WAVG grant‑date fair value $11.44) .
- Clawback policy: Adopted Oct 12, 2023 to recover incentive compensation for Covered Employees (executive officers and Section 16 officers) in the event of financial restatements over prior 3 years .
Equity Ownership & Alignment
- Beneficial ownership table does not list Karl Whitney (NEOs listed are CEO, CFO, General Counsel; directors listed separately). No individual ownership data for Karl is disclosed; thus vested/unvested, options in/out‑of‑the‑money, and ownership % are not available .
- Anti‑hedging/anti‑pledging: Insider Trading Policy prohibits hedging/offsetting transactions and sets timing controls for grants, promoting alignment with shareholders .
- Company equity plans and availability:
- 2020 Equity Incentive Plan reserve and automatic annual increases; 423,039 shares available for future grants under Incentive Plan as of 9/30/2025 .
- 2021 Inducement Plan authorized 125,000 shares; 87,166 available at 9/30/2025 .
- ESPP authorizes purchases at 85% of lower of first/last day price; 60,703 shares available as of 9/30/2025 .
Employment Terms
- Company‑wide employment agreements for certain key personnel provide, in specified circumstances, up to 18 months of salary continuation, up to 150% of target annual bonus, and acceleration of stock‑based award vesting (single/double‑trigger specifics vary by agreement). Karl‑specific severance terms are not disclosed .
- Named executive agreement examples (context for severance structure):
- CEO: 12 months salary + 100% target bonus; change‑in‑control (CIC) 18 months salary + 150% target bonus + equity vesting (subject to conditions) .
- CFO: 12 months salary; CIC 12 months salary + 100% target bonus + equity vesting (subject to conditions) .
- General Counsel: 12 months salary; CIC 12 months salary + 100% target bonus + equity vesting (subject to conditions) .
- Non‑compete/non‑solicit/garden leave specifics for Karl are not disclosed; NEO agreements include non‑competition and non‑solicitation covenants tied to severance eligibility .
Performance & Track Record
- Regulatory leadership: PBFT02 program achieved FDA Fast Track and Orphan Drug Designation; active IND/CTAs and ongoing Phase 1/2 upliFT‑D trial in FTD‑GRN, with positive biomarker signals and evolving safety profile; program planning underway for FTD‑C9orf72 and ALS cohorts .
- Corporate execution milestones:
- Reported robust increases in CSF PGRN and signs of reduced plasma NfL trajectory vs natural history; protocol amendments implemented to address venous sinus thrombosis (VST) risk and immunosuppression regimen .
- Manufacturing progress: suspension‑based process at 200L scale, potency assay alignment with FDA; supports late‑stage development .
- Financial discipline: Q3 2025 net loss $7.75M (vs $19.34M prior‑year quarter) with cash runway guided into Q1 2027 .
Board Governance
- Compensation Committee uses independent consultant (Pearl Meyer) for executive and director compensation benchmarking; reduced disclosure applies as a smaller reporting/emerging growth company .
- Anti‑hedging/insider trading controls and grant‑timing policies in place to reduce misalignment and timing risks .
Compensation Structure Analysis
- Shift toward equity and long‑term incentives persists: options with four‑year service‑based vesting and RSUs service‑based; RSU expense recognition straight‑line over vesting period .
- Discretion in bonus payouts tied to multi‑factor corporate goals (R&D/regulatory/financial); 2024 payouts near target for NEOs, signaling alignment with operational progress (PBFT02 biomarker and safety updates, portfolio focus) .
- Clawback policy strengthens pay‑for‑performance discipline by mandating recovery on restatements .
Risk Indicators & Red Flags
- Listing risk addressed via reverse split authority; continued sensitivity to minimum bid price and potential delisting if not in compliance—implies shareholder value volatility during Whitney’s tenure .
- Emerging growth/smaller reporting status reduces compensation disclosure; transparency constraints on non‑NEO executives like Whitney .
- Safety events (VST, hepatotoxicity) in PBFT02 Dose 1 mitigated via protocol amendments; ongoing monitoring remains a development risk .
Investment Implications
- Retention risk appears moderated by company‑wide severance and CIC acceleration constructs; however, Whitney’s specific terms are not disclosed—monitor Form 8‑Ks for any executive agreements or amendments .
- Alignment: Anti‑hedging/anti‑pledging policy and standard four‑year vesting promote long‑term focus; lack of disclosed personal ownership/transactions for Whitney limits assessment of near‑term selling pressure .
- Regulatory execution is central to PASG’s value creation; Whitney’s prior regulatory leadership and current role align with milestones (IND/CTA management, potency assay alignment, registrational pathway planning), supporting the PBFT02 late‑stage trajectory—consider program safety refinements and biomarker durability as leading indicators .
Data availability note: Karl Whitney is not a named executive officer in the 2025 proxy; compensation, equity holdings, and contract specifics for him are not disclosed publicly. Company‑level policies and program disclosures are used to infer structure and alignment, with explicit caveats above .