Melina Cioffi
About Melina Cioffi
Senior Vice President – Regulatory Affairs at Aquestive Therapeutics (AQST). Age 42, Pharm.D. from University of the Sciences in Philadelphia with a post-doctoral industry fellowship at Rutgers University (Ernest Mario School of Pharmacy). Joined AQST in August 2020 to lead Regulatory Affairs after leadership roles at Axsome Therapeutics (Head of Regulatory Affairs), Forest Laboratories/Allergan (Director, Regulatory Affairs), and earlier roles at Sunovion (Sumitomo Pharma) and Novartis . AQST shareholder performance improved over her tenure with pay-versus-performance TSR rising from $23.19 to $51.93 to $91.52 per $100 invested (2022→2024), while net income remained negative, moving from $(54.4)mm to $(7.9)mm to $(44.1)mm (all $ thousands) .
Performance snapshot (company-level, fiscal years)
| Metric | FY 2022 | FY 2023 | FY 2024 |
|---|---|---|---|
| TSR ($ value of initial $100) | $23.19 | $51.93 | $91.52 |
| Net Income ($000s) | $(54,410) | $(7,870) | $(44,137) |
Past Roles
| Organization | Role | Years | Strategic impact |
|---|---|---|---|
| Axsome Therapeutics | Head of Regulatory Affairs | — | Led regulatory strategy and agency interactions |
| Forest Laboratories (now Allergan) | Director, Regulatory Affairs | — | Directed regulatory programs across multiple therapeutic areas |
| Sunovion (now Sumitomo Pharma) | Regulatory roles | — | Advanced filings and regulatory engagement |
| Novartis | Regulatory roles | — | Supported development/regulatory activities |
External Roles
| Organization | Role | Years | Notes |
|---|---|---|---|
| Not disclosed | — | — | No public company directorships or external board roles disclosed in filings reviewed |
Fixed Compensation
- Individual compensation for Dr. Cioffi is not separately disclosed (not a Named Executive Officer). AQST is a Smaller Reporting Company; NEO disclosures for 2024 covered CEO, Chief Legal Officer, and Chief Innovation & Technology Officer (retired) .
- Company program (context): Base salary plus annual cash incentive opportunity for executives; 2024 NEO target bonus percentages: CEO 60%, CLO 50%; bonuses capped at 200% of target .
Performance Compensation
- Individual incentive metrics/weighting for Dr. Cioffi are not disclosed. Company-wide framework used by the Compensation Committee: annual corporate financial/strategic/operational goals (basis for annual cash bonuses) and long-term equity (time-based RSUs, stock options; 2023 also included performance/market-condition RSUs for executives) .
Company equity incentive structures and vesting
| Award type | Typical vesting/terms | Award timing | Notes |
|---|---|---|---|
| Time-based RSUs | 25%, 25%, 50% on 1st, 2nd, 3rd anniversaries | 2023 and 2024 executive grants | RSU grants: 3/9/2023 and 3/7/2024 followed this schedule |
| Stock options | 25%, 25%, 50% over 3 years (various grant cohorts) | Annual cycle and off-cycle | 2024 options granted 3/7/2024 with same 25/25/50 vesting |
| Market-condition RSUs (executive PSU program) | Vest based on 3-year stock price performance (through 5/5/2026), with “Performance Price” test | Tranche #1 (5/5/2023), Tranche #2 (8/9/2023) | Designed to promote stock price growth; target sizes disclosed for NEOs |
Equity Ownership & Alignment
- Beneficial ownership: Dr. Cioffi filed a Form 3 on April 25, 2025, reporting 182,261 shares of AQST common stock (direct) .
- Options reported on Form 3 include, among others: 15,000 options at $7.86 (exp. 08/31/2030) and 12,500 options at $6.62 (exp. 11/24/2030) (direct) .
- Ownership as % of S/O: ≈0.18% using 182,261 shares vs. 99,317,153 shares outstanding (3/21/2025) .
- Hedging/pledging: Company prohibits hedging, short sales, and pledging/margin accounts for directors, officers and employees (strong alignment policy) .
Ownership and derivatives (as disclosed)
| Security | Amount | Form | Terms |
|---|---|---|---|
| Common stock | 182,261 | Direct | As of Form 3 (event 04/25/2025) |
| Stock option | 15,000 | Direct | Exercisable 08/31/2021; exp. 08/31/2030; $7.86 strike |
| Stock option | 12,500 | Direct | Exercisable 11/24/2021; exp. 11/24/2030; $6.62 strike |
Notes on insider trading plans and activity
- No 10b5‑1 plan or Form 4 trading history for Dr. Cioffi was identified in filings reviewed; AQST disclosed a 10b5‑1 plan for another executive in December 2023 (illustrative of company practice) .
- Company Insider Trading Policy imposes pre-clearance and blackout windows for designated insiders .
Employment Terms
- Dr. Cioffi’s individual employment agreement or severance terms are not disclosed in the proxy/10‑K sections reviewed.
- NEO framework (for context): if terminated without cause or for good reason (outside a change-in-control), severance equal to 12 months of salary+target bonus paid monthly, pro‑rata bonus for year of termination, continuation of health/life benefits during severance period, and immediate vesting of unvested equity (performance awards at target) subject to release and restrictive covenants; during a CIC period, severance is a lump sum 1.0x salary+target bonus, benefits for 12 months, and accelerated vesting; 280G best‑net treatment applies to NEOs .
- Non‑compete/non‑solicit: NEO agreements include restrictive covenants during employment and for the severance period .
- Clawback: Equity awards are subject to the company’s clawback policy and exchange/law requirements .
Compensation Structure Analysis
- Shift toward equity that mixes time‑based RSUs and options, with added market‑condition RSUs in 2023 for executives (raising at‑risk, stock‑price‑linked pay) .
- Vesting schedules (25/25/50) support multi‑year retention; options remain performance‑sensitive given strike prices .
- Strong alignment safeguards (anti‑hedging/pledging) lower misalignment risk .
- Use of independent consultant (Aon) and formal equity grant policy suggest governance discipline (grant timing tied to open windows/earnings) .
Risk Indicators & Red Flags
- No pledging permitted; hedging prohibited (mitigates alignment concerns) .
- Company-level litigation risk around Libervant approval (unrelated to individual compensation), but material to overall performance/stock drivers .
- Clawback language embedded in plan documentation (recoupment ready) .
Expertise & Qualifications
- Pharm.D.; ~20 years in regulatory affairs across psychiatry, neurology, allergy/immunology; led numerous FDA interactions; elevates execution credibility for Anaphylm and Libervant regulatory paths .
- Current AQST executive roster shows her as SVP, Regulatory Affairs (leadership-level accountability) .
Investment Implications
- Alignment/retention: Meaningful direct ownership (≈0.18% of S/O) and multiple option grants align interests and create retention hooks through multi‑year vesting; hedging/pledging prohibitions further align incentives .
- Potential selling pressure: Watch standard vesting cycles (25/25/50) for time‑based RSUs/options, which can trigger tax‑related sales around anniversaries; no 10b5‑1 plan identified for Dr. Cioffi, so monitor future Form 4s .
- Performance linkage: Company has layered in market‑condition RSUs for executives (price‑based), indicating a focus on stock performance; as Regulatory lead, Dr. Cioffi’s execution on FDA milestones (Anaphylm NDA, Libervant matters) remains a key stock catalyst .
- Governance quality: Use of independent consultant, equity grant policy, and clawback language reduce governance risk around pay .
Disclosures gaps: As Dr. Cioffi is not a Named Executive Officer, AQST does not provide her specific base salary, target bonus, or individualized equity grant details in the proxy; ownership and options are visible via her Form 3. Future Form 4s will be critical for tracking transactions and potential selling pressure .
Citations:
Background/age/role . Compensation framework . Anti‑hedging/pledging . Clawback . Ownership table share count . Form 3 holdings/options . TSR/net income (Pay vs. Performance) . Anaphylm/Libervant regulatory context . 10b5‑1 example (other exec) .
