- Curran Simpson, Chief
Operating Officer, Appointed as President and CEO
- Co-Founder Kenneth T. Mills to Step Down as President
and CEO; Named Chairman of the Board
ROCKVILLE, Md., June 12,
2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX)
today announced that Curran Simpson,
Chief Operating Officer, has been appointed as President, Chief
Executive Officer and a member of the Board of Directors, effective
July 1, 2024. Co-Founder Kenneth T. Mills will step down as President and
Chief Executive Officer following 15 years of leadership at the
Company, and he is taking on an expanded role on the Board as
Chairman. In connection with these changes, Board member Daniel
Tassé has been appointed as REGENXBIO's Lead Independent Director,
a role previously held by Jerry
Karabelas, Ph.D. Dr. Karabelas and Co-Founder Allan Fox, who has served as Chairman since
2020, will remain on the Board.
Mr. Simpson is a seasoned biopharmaceuticals leader with over 35
years of industry experience. As the Chief Operating Officer (COO)
at REGENXBIO since January 2023, he
has been directly responsible for key business functions including
Research & Clinical Development, Corporate Strategy,
Manufacturing & Quality, Regulatory, and Commercial Operations.
Mr. Simpson joined REGENXBIO in 2015 and served as the Company's
Chief Technology and Operations Officer before becoming COO. Prior
to joining REGENXBIO, he was the Regional Supply Chain Head for
North America and Interim Chief
Operating Officer at GlaxoSmithKline (GSK). Mr. Simpson earlier
served as interim CEO at Human Genome Sciences (HGS), where he led
the integration of HGS into GSK.
"I am honored to serve as REGENXBIO's next President and CEO,"
said Mr. Simpson. "I have been a part of shaping and leading our
programs from preclinical to pivotal stages with Ken, and today,
our AAV Therapeutics platform is well-positioned to make a
meaningful impact. I look forward to our exciting next chapter as I
continue to work with Ken and the rest of REGENXBIO's seasoned
management team and Board to further advance our pipeline, drive
the commercialization and scale of our business and deliver value
for patients, shareholders and our other stakeholders."
"Leading REGENXBIO since our founding in 2009 has been a
privilege," said Mr. Mills. "We have built the Company into a
leader in gene therapy medicines with exciting products progressing
through late-stage developments. As we advance our pivotal stage
clinical trials, approach commercialization and prepare for our
next chapter, now is the right time to transition leadership.
Curran and I have worked closely together over the last nine years,
and I am confident he brings the R&D, operational, and industry
expertise to build on our momentum. I am enthusiastic about the
future of REGENXBIO and excited to continue partnering with Curran
and working alongside the Board in my role as Chairman."
"Curran has held various leadership roles since joining the
Company in 2015 and consistently demonstrated strategic, commercial
and operational expertise and acumen," said Mr. Fox. "The Board is
confident he is the right leader to advance our strategy and
oversee our next phase of meaningful value creation as we
capitalize on our significant commercial opportunities. The Board
and the entire Company would like to thank Ken for his tremendous
contributions to REGENXBIO over the past 15 years. Ken pioneered
the development of our leading AAV Therapeutics platform, enhancing
the landscape of gene therapies, with programs that remain on track
to meet our goals. We look forward to continuing to benefit from
his deep knowledge of this field, REGENXBIO and our therapeutics
pipeline."
REGENXBIO MAINTAINS FINANCIAL & OPERATIONAL
GUIDANCE
The Company today also reiterated its financial guidance
previously provided on May 8, 2024:
REGENXBIO expects its balance in cash, cash equivalents and
marketable securities of $380.5
million as of March 31, 2024
to fund its operations into 2026. This cash runway guidance is
based on the Company's current operational plans and excludes the
impact of any payments that may be received from AbbVie upon the
achievement of development or commercial milestones under our
ABBV-RGX-314 collaboration (including a potential, one-time
$200.0 million milestone for
achievement of first patient dosed in the first pivotal trial for
suprachoroidal delivery for treatment of DR) and the potential
monetization of a priority review voucher that may be received for
RGX-121.
ABOUT CURRAN SIMPSON
Mr. Simpson has served as the Chief Operating Officer at
REGENXBIO since January 2023. In that
role, he has been leading key business functions including Research
& Clinical Development, Corporate Strategy, Manufacturing &
Quality, Regulatory, and Commercial Operations. Mr. Simpson joined
REGENXBIO in 2015 with extensive leadership experience across
biopharmaceutical operations and served as the Company's Chief
Technology and Operations Officer before becoming COO. Prior to
joining REGENXBIO, he was the Regional Supply Chain Head for
North America and Interim Chief
Operating Officer at GlaxoSmithKline (GSK). Mr. Simpson earlier
served as interim CEO of Human Genome Sciences (HGS), where he led
the integration of HGS into GSK, and as Senior Vice President of
Operations and Vice President of Manufacturing Operations at HGS.
Prior to HGS, Mr. Simpson was Director of Manufacturing Sciences at
Biogen. Earlier in his career, Mr. Simpson served in an overseas
assignment at Novo-Nordisk Biochem in Denmark and in various senior development and
engineer roles at Genentech, working on Herceptin® and
Avastin®, among other roles. Mr. Simpson has an M.S. in
surface and colloid science from Clarkson
University and a B.S. in chemical engineering and chemistry
from the Clarkson College of
Technology.
ABOUT REGENXBIO Inc.
REGENXBIO is a leading clinical-stage biotechnology company
seeking to improve lives through the curative potential of gene
therapy. Since its founding in 2009, REGENXBIO has pioneered the
development of AAV Therapeutics, an innovative class of gene
therapy medicines. REGENXBIO is advancing a pipeline of AAV
Therapeutics for retinal and rare diseases, including ABBV-RGX-314
for the treatment of wet AMD and diabetic retinopathy, being
developed in collaboration with AbbVie, RGX-202 for the treatment
of Duchenne and RGX-121 for the treatment of MPS II. Thousands of
patients have been treated with REGENXBIO's AAV Therapeutic
platform, including Novartis' ZOLGENSMA for children with spinal
muscular atrophy. Designed to be one-time treatments, AAV
Therapeutics have the potential to change the way healthcare is
delivered for millions of people. For more information, please
visit WWW.REGENXBIO.COM.
FORWARD-LOOKING STATEMENTS
This press release includes "forward-looking statements," within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These statements express a belief, expectation or
intention and are generally accompanied by words that convey
projected future events or outcomes such as "believe," "may,"
"will," "estimate," "continue," "anticipate," "assume," "design,"
"intend," "expect," "could," "plan," "potential," "predict,"
"seek," "should," "would" or by variations of such words or by
similar expressions. The forward-looking statements include
statements relating to, among other things, REGENXBIO's
expectations and evaluations of its leadership and management team,
future operations, clinical trials, costs and cash flow. REGENXBIO
has based these forward-looking statements on its current
expectations and assumptions and analyses made by REGENXBIO in
light of its experience and its perception of historical trends,
current conditions and expected future developments, as well as
other factors REGENXBIO believes are appropriate under the
circumstances. However, whether actual results and developments
will conform with REGENXBIO's expectations and predictions is
subject to a number of risks and uncertainties, including the
timing of enrollment, commencement and completion and the success
of clinical trials conducted by REGENXBIO, its licensees and its
partners, the timing of commencement and completion and the success
of preclinical studies conducted by REGENXBIO and its development
partners, the timing or likelihood of payments from AbbVie, the
monetization of any priority review voucher, the timely development
and launch of new products, the ability to obtain and maintain
regulatory approval of product candidates, trends and challenges in
the business and markets in which REGENXBIO operates, the size and
growth of potential markets for product candidates and the ability
to serve those markets, the rate and degree of acceptance of
product candidates, and other factors, many of which are beyond the
control of REGENXBIO. Refer to the "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" sections of REGENXBIO's Annual Report on Form 10-K for
the year ended December 31, 2023, and
comparable "risk factors" sections of REGENXBIO's Quarterly Reports
on Form 10-Q and other filings, which have been filed with the U.S.
Securities and Exchange Commission (SEC) and are available on the
SEC's website at WWW.SEC.GOV. All of the forward-looking
statements made in this press release are expressly qualified by
the cautionary statements contained or referred to herein. The
actual results or developments anticipated may not be realized or,
even if substantially realized, they may not have the expected
consequences to or effects on REGENXBIO or its businesses or
operations. Such statements are not guarantees of future
performance and actual results or developments may differ
materially from those projected in the forward-looking statements.
Readers are cautioned not to rely too heavily on the
forward-looking statements contained in this press release. These
forward-looking statements speak only as of the date of this press
release. Except as required by law, REGENXBIO does not undertake
any obligation, and specifically declines any obligation, to update
or revise any forward-looking statements, whether as a result of
new information, future events or otherwise.
Contacts:
Dana
Cormack
Corporate Communications
dcormack@regenxbio.com
Investors:
Chris Brinzey
ICR Westwicke
339-970-2843
chris.brinzey@westwicke.com
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SOURCE REGENXBIO Inc.