- Reported positive topline data from
proof-of-concept study of VRDN-001 in patients with chronic thyroid
eye disease (TED) -
- THRIVE Phase 3 trial in patients with active
TED amended to reflect Viridian’s confidence in 5-infusion
treatment regimen and key stakeholder feedback on evolving TED
treatment paradigm –
- THRIVE-2 Phase 3 trial in patients with
chronic TED expected to start in the third quarter of 2023 –
- Selection of lead subcutaneous (SC) program
in TED planned for year-end 2023 -
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 financial results and provided a corporate update for the
second quarter ended June 30, 2023.
“Last month, we established proof-of-concept for VRDN-001 in
patients with chronic TED, marking an exciting milestone for the
Company and building on the compelling data we previously reported
in active TED. VRDN-001 demonstrated profound clinical activity in
chronic TED patients after only two infusions, confirming this
candidate’s ability to potentially be an effective therapy in
active and chronic TED,” said Scott Myers, President and CEO of
Viridian Therapeutics. “We are also quickly advancing our potential
first-in-class subcutaneous TED program and are proud to announce
that our Phase 1 trial for VRDN-001 SC in healthy volunteers is
fully enrolled. In addition, our Phase 1 trial for VRDN-003 SC has
been initiated and is now enrolling healthy volunteers.”
Added Mr. Myers: “The significant strides we have made with our
TED program this quarter lay the foundation for us to execute on
all upcoming key milestones. We remain committed to initiating our
Phase 3 THRIVE-2 trial of VRDN-001 in chronic TED patients during
the third quarter – our second pivotal trial for this candidate –
and selecting our lead subcutaneous program by year-end.”
Program highlights
Thyroid eye disease (TED)
Intravenous (IV) program:
VRDN-001
Viridian’s lead product candidate, VRDN-001, is a monoclonal
antibody which acts as a full antagonist of insulin-like growth
factor-1 receptor (IGF-1R). VRDN-001 is being evaluated in clinical
trials for the treatment of active and chronic TED.
- Preliminary data from the ongoing Phase 1/2 trial of VRDN-001
demonstrated clinically meaningful and rapid improvement in signs
and symptoms of chronic TED at week 6 after receiving two infusions
of VRDN-001 10 mg/kg or 3 mg/kg. VRDN-001 was generally well
tolerated in both dose cohorts.
- The THRIVE Phase 3 trial evaluating the efficacy and safety of
VRDN-001 in patients with active TED was amended to include the
VRDN-001 5-infusion treatment regimen and placebo arms only with
the primary endpoint assessment at week 15. Topline results from
the THRIVE Phase 3 trial are expected in the middle of 2024.
- Initiation of the THRIVE-2 Phase 3 trial evaluating the
efficacy and safety of VRDN-001 in patients with chronic TED is
planned for the third quarter of 2023, with topline results
expected by year-end 2024.
Subcutaneous (SC) programs: VRDN-001,
VRDN-002, and VRDN-003
The Company is advancing VRDN-001, VRDN-002, and VRDN-003 as SC
program candidates, each with the potential to be developed into a
convenient, SC, self-administered pen device.
- The VRDN-001 SC Phase 1 trial in healthy volunteers was
initiated and is fully enrolled.
- Viridian recently initiated the Phase 1 trial in healthy
volunteers evaluating IV and SC cohorts of VRDN-003.
- Viridian expects the initiation of a SC pen device supply
agreement with an experienced drug delivery device manufacturer in
the second half of 2023.
- The Company expects topline results from its Phase 1 trials,
evaluating VRDN-001 and VRDN-003 SC in healthy volunteers, in the
fourth quarter of 2023.
- Viridian plans to select its lead SC program based on the
preclinical and clinical data available across all three programs
by year-end 2023, and plans to advance the selected SC program into
a pivotal trial in the middle of 2024.
Preclinical programs in autoimmune and rare disease
VRDN-004, VRDN-005, and
VRDN-006
- Viridian is developing multiple preclinical assets in rare and
autoimmune diseases. The Company plans to announce additional
information on at least one of these programs in 2023.
Financial results
- Cash Position: Cash, cash equivalents, and short-term
investments were $334.3 million as of June 30, 2023, compared with
$373.9 million as of March 31, 2023. The Company believes that its
current cash, cash equivalents, and short-term investments will be
sufficient to fund its operations into the second half of
2025.
- R&D Expenses: Research and development expenses were
$40.1 million during the second quarter of 2023, compared with
$21.7 million for the same period last year. Research and
development expenses for the second quarter of 2023 include costs
related to manufacturing costs for various programs as well as
costs related to ongoing clinical trials. Other drivers for the
increase in research and development expenses include:
personnel-related costs (including share-based compensation) and
license costs.
- G&A Expenses: General and administrative expenses
were $19.3 million during the second quarter of 2023, compared with
$8.1 million for the same period last year. The increase in general
and administrative expenses was driven by personnel-related costs
including share-based compensation, as well as market research,
accounting and other professional fees.
- Net Loss: The Company’s net loss was $55.1 million for
the second quarter of 2023, compared with $29.5 million for the
same period last year. The increase in net loss was driven by the
increase in operating expenses described above.
- Shares outstanding: As of August 1, 2023, Viridian had
approximately 43,631,098 shares of common stock outstanding on an
as-converted basis, which included 58,541,509 shares of common
stock and an aggregate of approximately 14,910,411 shares of common
stock issuable upon the conversion of 172,435 and 51,210 shares of
Series A and Series B preferred stock, respectively.
Conference call and webcast
As noted on the Company’s VRDN-001 Phase 1/2 data call in July,
the Company will not be hosting a conference call to discuss its
second quarter financial results. The Company will resume hosting a
regular quarterly earnings call in November for its third quarter
2023 financial results.
About Viridian Therapeutics
Viridian Therapeutics 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 thyroid eye disease (TED). The Company
is conducting its first global Phase 3 trial called ‘THRIVE’ to
evaluate the safety and efficacy of VRDN-001 in patients with
active TED. Viridian is also planning a second Phase 3 trial,
called THRIVE-2, to evaluate the safety and efficacy of VRDN-001 in
patients with chronic TED. In addition to its program for
intravenously administered VRDN-001, the Company is advancing three
candidates for its subcutaneous strategy with the goal of providing
a more conveniently administered therapy to patients with TED.
Viridian is also developing multiple 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 Twitter.
Note regarding 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, VRDN-002, and
VRDN-003 for the treatment of Thyroid Eye Disease (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; trial protocols for
ongoing clinical trials; 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,
including VRDN-001, VRDN-002, and VRDN-003; manufacturing risks;
our ability to develop a subcutaneous formulation (SC); our plan
regarding a lead SC program candidate; our expectations regarding a
pen device supply partnership; competition from other therapies or
products; 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 May 10, 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS (amounts in thousands, except share and
per share data) (unaudited) Three
Months Ended June 30, Six Months Ended June 30,
2023
2022
2023
2022
Revenue: Collaboration Revenue - related party
$
72
$
256
$
170
$
472
Total revenue
72
256
170
472
Operating Expenses: Research and development
40,083
21,712
90,823
39,458
General and administrative
19,264
8,108
41,095
16,467
Total operating expenses
59,347
29,820
131,918
55,925
Loss from operations
(59,275
)
(29,564
)
(131,748
)
(55,453
)
Other income Interest and other income
4,378
227
8,865
423
Interest expense
(166
)
(154
)
(331
)
(154
)
Net loss
(55,063
)
(29,491
)
(123,214
)
(55,184
)
Change in unrealized loss on investments
1
(142
)
217
(920
)
Comprehensive loss
$
(55,062
)
$
(29,633
)
$
(122,997
)
$
(56,104
)
Net loss
$
(55,063
)
$
(29,491
)
$
(123,214
)
$
(55,184
)
Net loss per share, basic and diluted
$
(1.27
)
$
(1.06
)
$
(2.88
)
$
(2.05
)
Weighted-average shares used to compute basic and diluted loss per
share
43,253,457
27,762,257
42,753,476
26,948,692
Viridian Therapeutics, Inc. Selected Financial
Information Condensed Consolidated Balance Sheets
(amounts in thousands) (unaudited) June
30, December 31,
2023
2022
Cash, cash equivalents and short-term investments
$
334,291
$
424,550
Other assets
17,176
10,541
Total assets
$
351,467
$
435,091
Total liabilities
35,610
40,027
Total stockholders’ equity
315,857
395,064
Total liabilities and stockholders’ equity
$
351,467
$
435,091
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version on businesswire.com: https://www.businesswire.com/news/home/20230808571508/en/
Investors: Louisa Stone, 617-272-4604 Manager, Investor
Relations IR@viridiantherapeutics.com
Todd James, 617-272-4691 Senior Vice President, Corporate
Affairs and Investor Relations IR@viridiantherapeutics.com
Media: Matt Fearer, 617-272-4605 Vice President, Corporate
Communications Media@viridiantherapeutics.com
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