REGENXBIO Inc
For the period ended May 31, 2024. Filed Apr 4, 2024.
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May 31, 2024 · Filed Apr 4, 2024
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 Kenneth T. Mills, our President and CEO, and Allan M. Fox, the Chairman of the Board.
Ratification of Appointment of Independent Registered Public Accounting Firm: Please vote “For” (page 21)
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 24)
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.
About REGENXBIO
We are a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. Our investigational gene therapies are designed to deliver functional genes to address genetic defects in cells, enabling the production of therapeutic proteins or antibodies that are intended to impact disease. Through a single administration, gene therapy could potentially alter the course of disease significantly and deliver improved patient outcomes with long-lasting effects.
Our investigational gene therapies use adeno-associated virus ("AAV") vectors from our proprietary gene delivery platform, which we call our NAV® Technology Platform. AAV vectors are non-replicating viral delivery vehicles that are not known to cause disease. Our NAV Technology Platform consists of exclusive rights to a large portfolio of AAV ("NAV Vectors") vectors, including commonly used AAV8, and AAV9 vectors. We believe this platform forms a strong foundation for our current clinical-stage programs and with our ongoing research and development, we expect to continue to expand our platform and pipeline of potential AAV vector-based gene therapies. We refer to commercial and investigational AAV vector-based gene therapies as AAV Therapeutics.
Business Highlights
In 2023, 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 announced the global expansion of the ongoing 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. 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. |
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| RGX-202 for the Treatment of Duchenne Muscular Dystrophy (“Duchenne”) | We met our enrollment goals for the first-in-human study of RGX-202 to support dose escalation, reported positive interim data from dose level 1, and initiated enrollment for dose level 2. |
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| RGX-121 for the Treatment of Mucopolysaccharidosis Type II (“MPS II”) | We completed enrollment in the CAMPSIITE® pivotal trial of RGX-121 for the treatment of patients up to 5 years old diagnosed with MPS II, and received RMAT designation. Milestones achieved support plans to file a BLA in 2024 using the accelerated approval pathway. A second Phase I/II trial of RGX-121 for the treatment of pediatric patients with MPS II over the age of 5 years old is ongoing. |
| Pipeline Prioritization and Corporate Restructuring | We announced that our high priority programs are ABBV-RGX-314, RGX-202 and RGX-121. As part of our pipeline prioritization, we also announced that we are pursuing strategic alternatives, including potential partnering, for our other rare neurodegenerative disease clinical stage programs: RGX-111 for the treatment of severe Mucopolysaccharidosis Type I, RGX-181 for the treatment of late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, a form of Batten disease and RGX-381 for the treatment of the ocular manifestations of CLN2 disease. |
| Financial Strength | We ended 2023 with over $300 million in cash, cash equivalents and marketable securities. In the first quarter of 2024, the Company conducted an equity offering in which we received approximately $131 million of net proceeds. |
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 reduce waste.
In recognition of the Company’s waste reduction efforts, in June of 2023 the Company was awarded the Outstanding Efforts in Waste Reduction and Recycling Award in Montgomery County, Maryland.
We are committed to providing equal opportunity in all aspects of employment and have established a DEI Champion Group to further our diversity, equity and inclusion initiatives.
Our Board believes that gender diversity and 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 four most recent additions.
Investor Engagement in 2023
Following our 2023 annual meeting, as part of our off-season stockholder engagement efforts, our leadership team reached out to engage with 18 stockholders representing approximately 74% 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 governance. We also provided these stockholders with an overview of the overall state of the AAV 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.