Patricia Hirano
SOLENO THERAPEUTICSAbout Patricia Hirano
Patricia Hirano, age 58, is Senior Vice President, Regulatory Affairs at Soleno Therapeutics, with over 20 years in biopharma regulatory roles; she joined Soleno as Vice President in January 2019 after consulting as Head of Regulatory Affairs and Quality from April 2017 to December 2018 . Her background spans pharmaceuticals, biologics, and drug‑device combinations across oncology, cardiovascular, neurology, pulmonary/allergy, and endocrine/metabolic diseases, with prior roles at Titan Pharmaceuticals, PRTM (now PwC), CV Therapeutics (acquired by Gilead), and Matrix Pharmaceutical (acquired by Chiron) . Under Soleno’s 2024–2025 regulatory cadence, the company submitted the NDA for VYKAT XR in June 2024, received FDA Priority Review in August 2024, and achieved FDA approval on March 26, 2025—milestones aligned to PSUs—while TSR rose to $679 on a $100 base by year‑end 2024 and net income remained negative as the company transitioned to commercialization . Revenue ramped with launch: $32.657 million in Q2 2025 and $66.018 million in Q3 2025, with EBITDA improving from negative to positive as commercialization progressed .*
Past Roles
| Organization | Role | Years | Strategic Impact |
|---|---|---|---|
| Soleno Therapeutics | Head of Regulatory Affairs & Quality (consulting) | Apr 2017–Dec 2018 | Built regulatory framework toward NDA submission and approval |
| Soleno Therapeutics | Vice President, Regulatory Affairs → Senior Vice President | Jan 2019–present | Led regulatory strategy culminating in FDA approval of VYKAT XR |
| Titan Pharmaceuticals, Inc. | Various regulatory/operations roles | Pre‑2010 (years not disclosed) | Advanced programs across multiple therapeutic areas |
| PRTM (now PwC) | Consultant/operations roles | Pre‑2010 (years not disclosed) | Project management and regulatory consulting |
| CV Therapeutics, Inc. (acquired by Gilead) | Various roles | Pre‑2010 (years not disclosed) | Contributed to development programs prior to acquisition |
| Matrix Pharmaceutical, Inc. (acquired by Chiron) | Various roles | Pre‑2010 (years not disclosed) | Supported development in oncology prior to acquisition |
External Roles
| Organization | Role | Years | Notes |
|---|---|---|---|
| Bay Area Compliance Discussion Group | Coordinator | Since 1998 | Longstanding industry compliance leadership |
| The Big C Society | Director | Since Apr 2014 | Non‑profit directorship |
Fixed Compensation
| Metric | 2023 | 2024 |
|---|---|---|
| Base Salary ($) | $340,000 | $375,000 |
| Target Bonus (%) | 30% | 35% |
| Actual Bonus Paid ($) | $153,000 | $137,812 |
Additional update:
- 2025 annual base salary set at $432,000; 2024 cash bonus paid $137,812; new 2025 grants: 13,800 options and 6,400 RSUs with specified vesting (see Performance Compensation) .
Performance Compensation
Annual cash incentive (2024)
| Metric | Weighting | Target | Actual | Payout | Vesting |
|---|---|---|---|---|---|
| Corporate goals (R&D/operations milestones) | 100% | Board‑approved milestones | Achieved above target | 105% of target | Paid per annual program |
Goals centered on NDA submission/acceptance, priority review, commercial readiness, and financing; deemed significant by independent directors .
Equity awards (2024)
| Type | Grant Date | Shares | Grant Date Fair Value ($) | Vesting | Performance Metric |
|---|---|---|---|---|---|
| Stock Options | Jan 4, 2024 | 16,000 | $516,997 | 50% on Jan 1, 2025; remaining monthly over 24 months | Time‑based |
| RSUs | Jan 4, 2024 | 24,000 | $880,800 | Quarterly in 2024 (Mar 31, Jun 30, Sep 30, Dec 31) | Time‑based |
| PSUs | Jul 17, 2024 | 85,000 | $4,137,800 | 25% on Aug 1, 2024; 25% on NDA acceptance (Aug 27, 2024); 50% on FDA approval (Mar 26, 2025) | Regulatory milestones (NDA acceptance, FDA approval) |
2025 awards (new approvals)
| Type | Grant Date | Shares | Vesting |
|---|---|---|---|
| Stock Options | Jan 1, 2025 | 13,800 | Monthly over 48 months, starting first anniversary of Jan 1, 2025 |
| RSUs | Dec 15, 2024 (annual cycle) | 6,400 | 25% annually each Dec 15 |
Key option award details (as of Dec 31, 2024)
| Grant Date | Exercisable | Unexercisable | Strike ($) | Expiration | Vesting Notes |
|---|---|---|---|---|---|
| Jan 4, 2024 | — | 16,000 | 36.70 | Jan 4, 2034 | 50% at 1‑yr; monthly thereafter |
| May 26, 2023 | 44,569 | 39,879 | 5.25 | May 26, 2033 | 1/36 monthly over 3 years |
| Jan 25, 2023 | 9,583 | 10,417 | 2.41 | Jan 25, 2033 | 1/48 monthly over 4 years |
| Jul 27, 2022 | 13,333 | — | 2.60 | Jul 27, 2032 | Fully vested |
| Jan 8, 2021 | 18,504 | 3,029 | 33.60 | Jan 23, 2031 | Milestone tranches + monthly vest |
Equity Ownership & Alignment
| Component | Amount |
|---|---|
| Shares owned (outstanding) | 10,638 |
| Warrants | 1,333 |
| Options exercisable within 60 days | 54,899 |
| Total beneficial ownership | 66,871 (less than 1%) |
- Hedging and pledging prohibited for employees and directors under Soleno’s insider trading policy; pre‑clearance required, blackout periods apply .
- No executive stock ownership guidelines were disclosed; the proxy reports beneficial ownership by named executive officers .
Employment Terms
| Term | Detail |
|---|---|
| Current Role & Pay | Senior Vice President, Regulatory Affairs; 2025 base salary $432,000; 2025 equity grants as above |
| Target Bonus | 35% of base salary (2024); 30% (2023) |
| Severance (no CIC) | 6 months base salary + 6 months COBRA reimbursement upon termination without Cause or resignation for Good Reason, subject to release |
| Change‑of‑Control (double trigger) | If termination within 3 months prior to or 6 months after a CIC: 6 months base salary + 6 months COBRA + 50% of annual target bonus + 100% acceleration of unvested equity, subject to release |
| Clawback | SEC/Nasdaq‑compliant compensation recovery policy adopted; incentive‑based comp subject to recovery upon restatement |
| Governance Practices | No excise tax or other gross‑ups; no single‑trigger CIC; no hedging/pledging by executives/directors |
Company Performance Context
| Metric | Q4 2024 | Q1 2025 | Q2 2025 | Q3 2025 |
|---|---|---|---|---|
| Revenue ($) | — | — | 32,657,000 | 66,018,000 |
| EBITDA ($) | -58,286,000* | -42,272,000* | -4,922,000* | 23,221,000* |
Values retrieved from S&P Global.*
Pay‑versus‑Performance snapshot:
- Value of initial $100 investment based on Company TSR: $29.91 (2022), $608.08 (2023), $679.10 (2024); Net income: $(24,067,000) (2022), $(38,988,000) (2023), $(175,489,000) (2024) .
Investment Implications
-
Alignment: Hirano’s equity mix is heavily performance‑linked (85,000 PSUs tied to NDA acceptance/approval and significant milestone‑weighted vesting), indicating strong pay‑for‑regulatory‑execution alignment .
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Vesting and supply overhang: Major PSU vesting occurred March 26, 2025 (FDA approval); additional RSUs vest annually on Dec 15 and options vest monthly—monitor potential selling pressure windows and any Form 10b5‑1 activity, noting blackout and pre‑clearance constraints .
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Retention risk: Severance provides modest cash protection (6 months) but full equity acceleration only on double‑trigger CIC; time‑based RSUs/options and milestone PSUs aid retention through ongoing vesting .
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Trading signals: Continued commercialization ramp (Q2→Q3 revenue acceleration) and positive EBITDA in Q3 2025 strengthen fundamentals post‑approval; watch for future equity award cadence and any additional milestone‑linked grants as signals of regulatory/commercial priorities .*
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Governance: No hedging/pledging and no single‑trigger CIC reduce misalignment risks; clawback policy adds discipline .
Overall: Hirano’s incentives are tightly coupled to regulatory milestones and commercialization, with vesting schedules that could create episodic liquidity overhangs; retention appears supported by ongoing vesting rather than large cash severance, while governance policies limit misalignment through hedging/pledging prohibitions and clawbacks .