REGENXBIO Inc
For the period ended May 30, 2025. Filed Apr 8, 2025.
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What shareholders are asked to vote on at a company's meeting. It is where to find what directors and top executives are paid, and who owns the most shares.
May 30, 2025 · Filed Apr 8, 2025
Contents
PROXY STATEMENT SUMMARY
PROXY STATEMENT EXECUTIVE SUMMARY
This summary highlights information contained elsewhere in this Proxy Statement. This summary does not contain all of the information you should consider. Please read the entire Proxy Statement carefully before voting.
Voting Overview and Vote Recommendations of the Board - Items of Business
Election of Directors: Please vote “For” each nominee(page 6)
Director nominees have the right mix of experience, qualifications and skills and represent a mix of diverse experience, background and thought to contribute to our strategy and to the Board’s ability to perform its duties.
All of our directors are independent, except for Curran Simpson, our President and CEO, Kenneth T. Mills, the Chairman of the Board, and Allan M. Fox.
Ratification of Appointment of Independent Registered Public Accounting Firm: Please vote “For” (page 20)
PricewaterhouseCoopers LLP (“PwC”) is an independent accounting firm with the breadth of expertise and knowledge necessary to effectively audit our business.
PwC has served as our independent registered public accounting firm since 2015.
Advisory Vote on Executive Compensation: Please vote “For” (page 23)
Independent oversight by the Compensation Committee with the assistance of an independent external consultant.
Executive compensation targets are determined based on an annual peer group review and annual analysis of all elements of executive compensation for each executive.
Advisory Vote on the Frequency of Executive Compensation: Please vote “One Year” (page 50)
On an advisory basis, to determine how often stockholders prefer to have an advisory vote on the compensation of executives (every year, every two years, or every three years).
An annual vote offers direct and immediate feedback on the Company’s compensation programs.
We have held advisory votes on executive officer compensation on an annual basis since 2019 based on our stockholders’ expressed preference for an annual say on pay at the 2019 annual meeting.
Approve the REGENXBIO Inc. 2025 Equity Incentive Plan: Please vote “For”(page 51)
The Company has put forth an appropriately balanced equity incentive plan designed to attract and retain top talent and align their interests with the Company's long-term goals.
The proposed equity incentive plan was crafted to align with current executive compensation trends and recommended best practices.
About REGENXBIO
We are a biotechnology company on a mission to improve lives through the curative potential of gene therapy. Since its founding in 2009, REGENXBIO has pioneered the field of AAV gene therapy. REGENXBIO is advancing a late-stage pipeline of one-time treatments for rare and retinal diseases, including RGX-202 for the treatment of Duchenne; clemidsogene lanparvovec (RGX-121) for the treatment of MPS II and RGX-111 for the treatment of MPS I, both in partnership with Nippon Shinyaku; and surabgene lomparvovec (ABBV-RGX-314) for the treatment of wet AMD and diabetic retinopathy, in collaboration with AbbVie. REGENXBIO's investigational gene therapies have the potential to change the way healthcare is delivered for millions of people.
Business Highlights
In 2024, we made significant progress toward our clinical development and business objectives, including the following achievements:
| ABBV-RGX-314 for the Treatment of wet AMD and DR under the eyecare collaboration with AbbVie | We achieved key enrollment milestones with ABBV-RGX-314 ATMOSPHERE® and ASCENT™ pivotal clinical trials evaluating the efficacy and safety of ABBV-RGX-314 in patients with wet AMD using the subretinal delivery approach. We announced positive new data from multiple trials in the ABBV-RGX-314 program, including from the Phase II bridging study evaluating the clinical performance using the NAVXpress™ manufacturing platform process and the phase II AAVIATE® trial for the treatment of wet AMD using suprachoroidal delivery and the phase II ALTITUDE® trial using in-office suprachoroidal delivery for the treatment of DR without center-involved diabetic macular edema (DME). We completed a successful End-of-Phase II meeting with the FDA for our Phase II ALTITUDE trial and expanded enrollment into a new cohort of patients with center-involved DME. |
|---|---|
| RGX-202 for the Treatment of Duchenne Muscular Dystrophy (“Duchenne”) | We delivered on RGX-202 milestones, including a successful End-of-Phase II meeting with the FDA, initiating a pivotal (Phase III) trial of AFFINITY DUCHENNE®, approval for trial initiation in Canada, and announcing first strength and functional assessment data for both dose levels. |
| RGX-121 for the Treatment of Mucopolysaccharidosis Type II (“MPS II”) | We announced that the pivotal phase of the CAMPSIITE® trial of RGX-121 for the treatment of patients up to 5 years old diagnosed with MPS II achieved its primary endpoint in addition to reporting positive long-term safety and tolerability data.We also announced a successful pre-Biologics License Application (BLA) meeting for RGX-121, where we finalized details of our BLA with the FDA. Then in alignment with the FDA we completed filing of the first two sections of the rolling BLA for RGX-121. |
| Pipeline Prioritization and Corporate Restructuring | We successfully implemented and completed our strategic pipeline prioritization and corporate restructuring announced in late 2023, which was designed to prioritize the development of ABBV-RGX-314, RGX-202 and RGX-121, while seeking strategic alternatives for our other clinical stage programs.We achieved our stated goal of strategic alternatives for our other clinical stage product candidates. We completed out-licensing agreements for RGX-181 for the treatment of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, and RGX-381 for the treatment of the ocular manifestations of CLN2 disease. In January 2025, we announced a strategic partnership to develop and commercialize RGX-121 and RGX-111 for the treatment of MPS II and MPS I, respectively, in the United States and Asia.We achieved our corporate objective of targeted cost reductions in excess of $50.0 million in 2024 stemming from the corporate restructuring plan implemented in late 2023. |
| Corporate Development and Pipeline Advancement | We successfully transitioned senior leadership roles with the internal elevation of a newly appointed CEO and a new external hire of a CFO. Looking towards early portfolio plans, we continued to invest in our pre-clinical pipeline. |
| Financial Strength | We ended 2024 with $244.9 million in cash, cash equivalents and marketable securities. In the first quarter of 2025, the Company announced a strategic partnership with Nippon Shinyaku to develop and commercialize RGX-121 and RGX-111, with a $110.0 million upfront payment received under the collaboration in March 2025. |
Corporate Governance Highlights
Our commitment to effective corporate governance is illustrated by the following practices:
Our Board actively oversees and approves our corporate strategy.
Our Board and board committee agendas are structured to engage our directors in informed reviews of strategic and forward-looking issues.
Our Board reviews our enterprise-level risks and risk management practices.
The charters of the Board committees clearly establish the committees’ respective roles and responsibilities.
Our Board committees are fully independent.
We have a strong, independent, clearly defined lead independent director role with meaningful governance duties.
Our independent directors actively engage in board meetings, have direct access to management, and have discretion to hire independent advisors at the Company’s expense.
Sustainability Highlights
Our Board has a long-standing commitment to corporate responsibility.
We are committed to remaining cognizant of our impact on the wider environment in which we operate including Company initiatives designed to improve manufacturing yields and measuring baseline emissions to identify opportunities reduce waste.
We are committed to providing equal opportunity in all aspects of employment.
Our Board believes that gender, racial and ethnic diversity are important in providing diverse viewpoints. Our commitment to that belief is reflected in the composition of our Board, which includes three women among its five most recent additions.
Investor Engagement in 2024
Throughout 2024, including following our 2024 annual meeting, our leadership team consistently engaged with our top 25 shareholders representing approximately 68% of our outstanding common stock to discuss the progress of our clinical trials, our business strategy, our financial performance and strategic initiatives and our corporate guidance. We also provided stockholders an overview of the overall state of the gene therapy industry.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.