Raj S. Pruthi
About Raj S. Pruthi
Chief Medical Officer–Urology appointed June 17, 2025; physician–scientist with 25+ years in urologic oncology across industry (enGene CMO; J&J Global Medical Affairs—Bladder/Oncology) and academia (Chair of Urology at UCSF and UNC). MD (Duke), Urologic Surgery residency at Stanford, MHA (UNC), with guideline leadership for NMIBC at AUA and ICUD, positioning him to drive RLMD’s NDV‑01 registrational path . Operationally, NDV‑01 has shown high complete response rates in Phase 2 follow‑ups (e.g., 91–92% “anytime” CR at 6–9 months) and secured FDA alignment on two Phase 3 paths targeted for 1H’26 start under his CMO role . Company context: pre‑revenue with continuing net losses, though quarterly net loss and operating cash burn trended lower through Q3’25 (table below; values from S&P Global).*
Past Roles
| Organization | Role | Years | Strategic Impact |
|---|---|---|---|
| enGene Holdings Inc. | Chief Medical Officer | Prior to 2025 | Led global registrational therapeutic trial design in bladder cancer |
| Johnson & Johnson Innovative Medicine | Global Medical Affairs Leader, Bladder Cancer; Sr. Medical Director, Oncology (Global – Prostate/Bladder) | Prior to enGene | Guided global medical affairs across bladder/prostate oncology |
| University of California, San Francisco (UCSF) | Professor and Chair, Department of Urology | Prior tenure | Led academic urology department; clinical trials and guideline development |
| University of North Carolina, Chapel Hill | Professor and Chair, Department of Urology | Prior tenure | Department leadership; guideline committee contributions |
External Roles
| Organization | Role | Years | Strategic Impact |
|---|---|---|---|
| American College of Surgeons | Chair, Advisory Council for Urology; Board of Governors | Current | Professional standards; national urology governance |
| Hofstra/Northwell Zucker School of Medicine | Adjunct Professor, Department of Urology | Current | Academic collaboration; training and research |
| Belmont Univ., Thomas F. Frist, Jr. College of Medicine | Professor, Dept. of Health System Sciences | Current | Health systems expertise applied to clinical development |
| American Board of Urology/AUA Examination Committee | Former Member | Past | Credentialing; exam content leadership |
| Society of Academic Urology | Past-President | Past | Academic urology leadership network |
| AUA Guidelines Committee (NMIBC); ICUD Bladder Cancer Guidelines | Member/Contributor | Past | Authored NMIBC management guidelines |
Fixed Compensation
No employment agreement or compensation terms (base salary, target bonus, equity grant) for Raj S. Pruthi have been disclosed in SEC filings to date; appointment was furnished under Reg FD via press release (Item 7.01) without comp details . Company‑wide compensation framework highlights for NEOs: emphasis on pay‑for‑performance with discretion to reduce cash payouts; after a negative Say‑on‑Pay in 2024, Board determined no salary increases for 2025 and no 2024 cash bonuses or LTIs until strategic initiatives increase shareholder value .
Performance Compensation
Not disclosed for Raj S. Pruthi (no PSU/RSU metrics, weightings, targets, payout formulas, or vesting schedules filed). Company plans allow for stock options, SARs, restricted stock/units, performance share awards and cash awards under the 2014/2021 Equity Incentive Plans .
Equity Ownership & Alignment
| Item | Detail |
|---|---|
| Open‑Market Purchase | Purchased 55,000 RLMD shares on August 29, 2025 (reported via Item 7.01 8‑K) |
| Beneficial Ownership Level | Not disclosed for Raj in the 2025 proxy’s principal stockholders table (covers directors/NEOs only) |
| Hedging/Pledging Policy | Company does not have a policy prohibiting hedging by employees/officers/directors (no explicit pledging prohibition disclosed) |
| Clawback Policy | Company adopted a clawback policy in Nov 2023 compliant with Rule 10D‑1; covers erroneously‑awarded incentive‑based compensation over prior three fiscal years |
| Ownership Guidelines | Not disclosed for executives/directors in proxy |
Employment Terms
| Term | Raj S. Pruthi |
|---|---|
| Role/Start Date | Chief Medical Officer–Urology; appointment announced June 17, 2025 |
| Contract Term/Expiration | Not disclosed |
| Severance | Not disclosed for Raj; company‑level NEO agreements feature double‑trigger change‑in‑control severance; plan documents provide single‑trigger award acceleration on change‑in‑control unless award agreements specify otherwise |
| Non‑compete/Non‑solicit | Not disclosed for Raj |
| Garden Leave/Consulting | Not disclosed |
| Clawback/Insider Trading Windows | Clawback policy (Rule 10D‑1) and insider trading policy with window restrictions disclosed at company level |
NDV‑01 Clinical Performance Under His Remit
| Metric | 3 months | 6 months | Anytime |
|---|---|---|---|
| Complete Response (% of evaluable) – Phase 2 follow‑up | 83% (19/23) | 90% (19/21) | 91% (21/23) |
| Metric | 3 months | 6 months | 9 months | Anytime |
|---|---|---|---|---|
| Complete Response (% of evaluable) – updated Phase 2 follow‑up | 84% (21/25) | 87% (20/23)* | 85% (17/20)* | 92% (23/25) |
| Notes | Includes CR after re‑induction (60% CR rate) | Includes CR after re‑induction (60% CR rate) |
| Subpopulation (BCG‑Unresponsive) | 3 months | 6 months | 9 months | Anytime |
|---|---|---|---|---|
| Complete Response (%) | 82% (9/11) | 78% (7/9) | 88% (7/8) | 91% (10/11) |
Key regulatory progress: FDA Type B pre‑IND minutes support two Phase 3 paths—single‑arm in high‑grade refractory BCG‑unresponsive NMIBC and randomized adjuvant study in intermediate risk NMIBC—with no additional non‑clinical studies required; initiation targeted for 1H’26 . Company reaffirmed upcoming NDV‑01 Phase 2 12‑month data and Phase 3 starts in 1H’26, with Raj leading medical strategy .
Company Financial Context (latest 4 quarters)
| Metric (USD) | Q4 2024 | Q1 2025 | Q2 2025 | Q3 2025 |
|---|---|---|---|---|
| Revenues | —* | —* | —* | —* |
| Net Income (Loss) | (18,657,136)* | (17,559,465)* | (9,866,442)* | (10,091,496)* |
| Cash from Operations | (8,799,634)* | (18,067,033)* | (6,401,876)* | (6,721,856)* |
*Values retrieved from S&P Global.
Investment Implications
- Strong alignment and near‑term trading signal: open‑market purchase of 55,000 shares is a positive insider‑buying datapoint (non‑derivative, cash outlay) and suggests confidence ahead of NDV‑01 Phase 3 program initiation .
- Execution credibility: prior CMO and guideline leadership plus FDA alignment on two registrational paths reduces development pathway uncertainty; NDV‑01 Phase 2 efficacy signals across overall and BCG‑unresponsive cohorts support potential best‑in‑class profile .
- Compensation/retention risk: absence of disclosed employment terms (salary, bonus, equity grants, severance) creates opacity on pay‑for‑performance alignment and retention economics; company clawback is a positive, while lack of an anti‑hedging prohibition is a governance red flag for alignment purity .
- Dilution/plan mechanics: equity plan features broad award types and change‑in‑control accelerations; shareholders approved large plan capacity historically and sought +2.0M shares in 2025, implying reliance on equity for talent retention and potential dilution as programs advance .