– Stephen Mahoney appointed President and Chief
Executive Officer –
– Potential best-in-class subcutaneous and
intravenous thyroid eye disease (TED) programs targeting
insulin-like growth factor 1 receptor (IGF-1R) remain on track;
subcutaneous program selection expected by year-end 2023 and
VRDN-001 THRIVE Phase 3 topline results in active TED expected in
mid-2024 –
– Company discloses novel portfolio of
preclinical neonatal Fc receptor (FcRn) inhibitors with broad
potential to treat autoimmune diseases; first Investigational New
Drug (IND) submission planned by year end 2024 –
– Private placement with participation from new
and existing investors to fund portfolio strategy and extend
operating runway into 2026 –
Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology
company focused on discovering and developing potential
best-in-class medicines for serious and rare diseases, today
announced that Stephen Mahoney has been appointed the company’s
President and Chief Executive Officer, and a member of the Board of
Directors, effective immediately. Viridian also disclosed a
preclinical portfolio of FcRn inhibitors designed to deliver next
generation treatments for patients suffering from antibody-mediated
autoimmune diseases. To advance its expanded strategic priorities,
the company also announced that it has entered into an agreement to
sell shares of its common and Series B preferred stock to certain
institutional investors in a private placement transaction and will
receive aggregate gross proceeds of $185 million, before deducting
estimated offering expenses.
New Chief Executive Officer to Drive
Expanded Strategic Priorities
Stephen Mahoney’s appointment as President and Chief Executive
Officer combines his leadership and track record of operational
execution with the company’s strategy of delivering potentially
best-in-class next generation molecules in commercially established
disease areas. Viridian’s pipeline is composed of intravenous and
subcutaneous IGF-1R inhibitors for patients with TED and, as of
today’s announcement, next generation FcRn inhibitors for the
treatment of autoimmune diseases. Scott Myers’s departure as
President and CEO of the company was effective as of October 29,
2023.
“We are grateful for Scott’s contributions and the operational
progress Viridian was able to achieve during his tenure,” said
Tomas Kiselak, Chairman of Viridian’s Board of Directors. “The
Board believes that the transition to Steve’s leadership with his
strong track record of driving execution and his alignment with our
corporate strategy can enable Viridian to build a potentially
best-in-class IGF-1R inhibition franchise in TED and advance our
efforts to deliver next generation FcRn inhibitors for the
treatment of autoimmune diseases.”
Mr. Mahoney brings more than two decades of experience in the
biopharmaceutical industry where he has held a number of strategic,
operational, financial, business development and legal roles with
regional and global responsibilities. He most recently served as
President, Chief Financial and Operating Officer of Magenta
Therapeutics. Prior to Magenta, Mr. Mahoney served as President and
Chief Operating Officer of Kiniksa Pharmaceuticals. He also served
as Chief Commercial Officer, among other executive titles of
increasing responsibility, at Synageva Biopharma Corp. and was a
business and transactional attorney at Genzyme Corporation. Mr.
Mahoney holds an M.B.A. and J.D. from Boston College and a B.A.
from Colorado College.
“I am excited to join the Viridian team at this critical time
and help deliver on the promise of the company’s broad pipeline,”
said Mr. Mahoney. “As we seek to optimize our future commercial
position with the TED franchise, we have a dual focus of delivering
the results from our two THRIVE Phase 3 clinical trials of VRDN-001
in both active and chronic TED while also prioritizing and
accelerating the development of a potentially best-in-class
subcutaneous delivery option for patients. As announced today, we
are also thrilled about the potential of our novel portfolio of
FcRn inhibitors, and we look forward to moving these programs to
the clinic as quickly as possible.”
Viridian also announced that Thomas Beetham will be joining the
company as Chief Operating Officer, and Shan Wu, Ph.D., will be
joining as Chief Business Officer, each of whom have worked with
Mr. Mahoney in prior companies and will strengthen Viridian’s
management team.
TED Clinical Development Remains On
Track with Selection of Subcutaneous Program by Year End 2023 and
VRDN-001 THRIVE Topline Results in Active TED Expected in
Mid-2024
Viridian continues to advance its differentiated and improved
product candidates for TED patients and is simultaneously focused
on developing both its subcutaneous and intravenous IGF-1R
inhibitor programs. The company has designed the subcutaneous
program to be a potentially best-in-class, self-administered,
infrequent, and low-volume injection for patients. The intravenous
VRDN-001 program, which features a shorter infusion time and fewer
infusions compared to the currently marketed IGF-1R inhibitor, is
on track for its Phase 3 data readouts. The company expects that
its intravenous VRDN-001 has the potential to establish a strong
foothold in the multi-billion-dollar TED commercial market and will
help facilitate the future introduction of its subcutaneous
program.
Viridian is on track to select its lead subcutaneous IGF-1R
program by the end of 2023 and expects such program to enter a
pivotal Phase 2/3 trial in mid-2024. The company expects topline
results from the first THRIVE Phase 3 clinical trial for
intravenous VRDN-001 for active TED to be available in mid-2024.
The THRIVE-2 clinical trial in chronic TED patients is recruiting
patients, and the company expects topline clinical results by year
end 2024.
Next Generation FcRn Inhibitor
Portfolio Unveiled; First IND Filing Planned by Year End
2024
Consistent with Viridian’s vision to develop the next generation
of best-in-class products for severe autoimmune and rare diseases,
the company disclosed that it is developing a portfolio of
engineered FcRn inhibitors, VRDN-006 and VRDN-008. FcRn inhibitors
have the potential to treat a broad array of autoimmune diseases,
representing a significant commercial market opportunity.
Viridian’s multi-pronged engineering approach has resulted in a
portfolio of FcRn-targeting molecules that leverage the clinically
and commercially validated mechanism of FcRn inhibition while
potentially addressing the limitations of current agents such as
incomplete IgG suppression and needed improvements in safety.
VRDN-006 is a FcRn-targeting Fc fragment, and in non-human
primate studies, demonstrated specificity for blocking FcRn-IgG
interactions while showing no increases in albumin or low-density
lipoprotein (LDL) levels. In head-to-head non-human primate
studies, VRDN-006 demonstrated comparable potency and IgG lowering
to efgartigimod, the current standard of care in FcRn inhibition,
as well as a similar safety profile. Viridian plans to file an IND
for VRDN-006 by year end 2024 and expects healthy volunteer data
for VRDN-006 in the second half of 2025. VRDN-008 is a novel,
first-in-class FcRn inhibitor that aims to pair IgG suppression
with extended half-life technology, potentially enabling deeper and
more durable suppression than existing anti-FcRn therapies. Both
molecules are designed to be convenient, self-administered,
subcutaneous products. The company plans to share additional
details about its FcRn portfolio in 2024.
$185 Million Financing to Fund Expanded Pipeline and Extend Cash
Runway
Viridian announced it has entered into agreements for a private
placement financing that is expected to close by November 1, 2023,
and result in anticipated gross proceeds of approximately $185
million, before deducting estimated offering expenses. The
financing was led by Fairmount Funds with participation from both
existing investors, including Braidwell LP, Commodore Capital, Deep
Track Capital, Venrock, Paradigm BioCapital and Perceptive
Advisors, as well as new investors, including entities managed by
RTW Investments, LP and Surveyor Capital (a Citadel company). In
the private placement, Viridian is selling an aggregate of
8,789,022 shares of its common stock at a price of $12.38 per share
and an aggregate of 92,312 shares of its Series B preferred stock
at a price of $825.3746 per share, which are convertible into
approximately 6,154,441 shares of common stock, subject to
beneficial ownership conversion limits. Proceeds will be used to
fund pipeline programs, including the FcRn portfolio, and for
general corporate purposes and working capital. The company also
expects that the proceeds will extend its cash runway to fund its
operating plan into 2026.
Jefferies, Evercore ISI, and Stifel are acting as lead placement
agents for the private placement financing. LifeSci Capital LLC and
Wedbush PacGrow are also acting as co-placement agents for the
private placement financing.
The securities being sold in the private placement have not been
registered under the Securities Act of 1933, as amended (the
Securities Act), or any states' securities laws, and may not be
offered or sold in the United States, except pursuant to an
effective registration statement or an applicable exemption from
the registration requirements of the Securities Act. Viridian has
agreed to file a registration statement with the Securities and
Exchange Commission registering the resale of the shares issued in
the private placement.
This press release shall not constitute an offer to sell, or the
solicitation of an offer to buy, nor shall there be any sale of
these securities in any state or jurisdiction in which such offer,
solicitation, or sale would be unlawful prior to registration or
qualification under the securities laws of any such state or
jurisdiction.
Notice of Issuance of Inducement
Grants
Viridian also announced the grant of an inducement award to Mr.
Mahoney, as well as to Mr. Beetham and to two other new employees,
including Dr. Wu, in each case as an inducement material to such
executive officer or employee’s employment pursuant to Rule
5635(c)(4) of the Nasdaq Listing Rules. Mr. Mahoney was granted an
option to purchase 1,259,400 shares of Viridian’s common stock, Mr.
Beetham was granted an option to purchase 474,400 shares of
Viridian’s common stock, and the other new employees were granted
options to purchase an aggregate of 268,200 shares of Viridian’s
common stock. In each case, the shares underlying the options vest
become exercisable as follows: one quarter of the underlying shares
on the first anniversary of October 30, 2023 and then in equal
monthly installments thereafter over the following 36 months,
subject to the grantee’s continued service to the company. The
exercise price of the stock options will equal the closing price of
the company's common stock on October 30, 2023, the date of the
grant. The inducement awards were granted outside of the company’s
Amended and Restated 2016 Equity Incentive Plan but remain subject
to the terms and conditions of such plan.
About Viridian Therapeutics
Viridian is a biopharmaceutical company focused on engineering
and developing potential best-in-class medicines for patients with
serious and rare diseases. Viridian’s expertise in antibody
discovery and engineering enables it to develop differentiated
therapeutic candidates for previously validated drug targets in
commercially established disease areas.
Viridian is advancing multiple candidates in the clinic for the
treatment of patients with TED. The company is conducting two
global Phase 3 studies (THRIVE and THRIVE-2) to evaluate the safety
and efficacy of VRDN-001 in patients with active and chronic TED.
Simultaneously, the company is developing its subcutaneous program
strategy with the goal of providing a potentially more conveniently
administered therapy to patients with TED. In addition to its TED
portfolio, Viridian is advancing a novel portfolio of FcRn
inhibitors with the potential to be developed in multiple
autoimmune diseases. Viridian is also developing additional
preclinical assets in autoimmune and rare diseases.
Viridian is based in Waltham, Massachusetts. For more
information, please visit www.viridiantherapeutics.com. Follow
Viridian on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These statements may be identified by the use of words such
as, but not limited to, "anticipate," "believe," "continue,"
"could," "estimate," "expect," "intend," "may," "might," "plan,"
"potential," "predict," "project," "should," "target," "will," or
"would" or other similar terms or expressions that concern our
expectations, plans and intentions. Forward-looking statements
include, without limitation, statements regarding our expectations,
strategies, plans and intentions. Forward-looking statements are
neither historical facts nor assurances of future performance.
Instead, they are based on our current beliefs, expectations, and
assumptions. New risks and uncertainties may emerge from time to
time, and it
is not possible to predict all risks and uncertainties. No
representations or warranties (expressed or implied) are made about
the accuracy of any such forward-looking statements. Such
forward-looking statements are subject to a number of material
risks and uncertainties including but not limited to: the potential
efficacy and safety of VRDN-001 for the treatment of TED, the
relationship between the results from the positive data from the
ongoing Phase 1/2 clinical trial of VRDN-001 in patients with
chronic TED and the results of ongoing or future clinical trials;
the timing, progress and plans for our ongoing or future research,
pre-clinical and clinical development programs; expectations
regarding the timing for data; uncertainty and potential delays
related to clinical drug development; the duration and impact of
regulatory delays in our clinical programs; the timing of and our
ability to obtain and maintain regulatory approvals for our
therapeutic candidates; manufacturing risks; our ability to develop
a subcutaneous formulation (SC); our plan regarding a lead SC
program candidate; expectations regarding use of proceeds from the
private placement financing; expectations regarding our FcRn
portfolio; other matters that could affect the sufficiency of
existing cash, cash equivalents and short-term investments to fund
operations; our financial position and its projected cash runway;
our future operating results and financial performance; the
clinical utility of our therapeutic candidates and our intellectual
property position; the timing of pre-clinical and clinical trial
activities and reporting results from same, including those risks
set forth under the caption "Risk Factors" in our Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission
(SEC) on August 8, 2023 and other subsequent disclosure documents
filed with the SEC. Any forward-looking statement speaks only as of
the date on which it was made. Neither the Company, nor its
affiliates, advisors, or representatives, undertake any obligation
to publicly update or revise any forward-looking statement, whether
as a result of new information, future events or otherwise, except
as required by law. These forward-looking statements should not be
relied upon as representing the Company’s views as of any date
subsequent to the date hereof.
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