Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical
company advancing new treatments for patients suffering from
serious diseases but underserved by current therapies, today
announced financial results for the first quarter of 2021 and
provided corporate updates.
“The first quarter saw significant milestones both for our TED
programs and for our corporate growth,” said Jonathan Violin,
Ph.D., President and Chief Executive Officer of Viridian.
“Following the addition of Dr. Barrett Katz as our Chief Medical
Officer earlier this quarter, we have assembled our development and
clinical operations team and are prepared to rapidly advance the
clinical development of VRDN-001 and VRDN-002.”
First Quarter 2021 and Recent Operational
Highlights
VRDN-001: Viridian’s most advanced product
candidate is VRDN-001, a monoclonal antibody targeting the
insulin-like growth factor-1 receptor (IGF-1R), a clinically and
commercially validated target for the treatment of Thyroid Eye
Disease (TED). This antibody had previously been developed in
oncology as AVE-1642 and studied in over 100 patients. The
pharmacokinetics, pharmacodynamics, safety, and tolerability data
from that clinical program has informed the Company’s plans to
evaluate VRDN-001 in TED. IND-enabling activities remain on track
and the Company plans to file an IND in the fourth quarter of 2021,
with initial proof of concept data in patients expected in the
second quarter of 2022, followed by dose exploration to inform
potential intravenous and subcutaneous dosing paradigms.
VRDN-002: Viridian’s second product candidate,
VRDN-002, is a distinct anti-IGF-1R antibody that incorporates
half-life extension technology and is designed to support
administration as a convenient, low volume, subcutaneous injection.
IND-enabling activities remain on track and the Company plans to
file an IND by the end of 2021. The Company expects to initiate
clinical development with a Phase 1 single ascending dose trial to
explore safety, tolerability, pharmacokinetics, and target
engagement of VRDN-002 in healthy volunteers. Data from this trial
is expected in mid-year 2022; the Company also expects to initiate
the dosing of patients in 2022.
Discovery Pipeline: Viridian’s development
strategy includes expanding its discovery pipeline beyond IGF-1R
and TED, with a focus on opportunities that will leverage validated
mechanisms, technologies, and modalities to bring new therapeutic
options to patients underserved by today’s options. The most
advanced of these programs is VRDN-004, a therapeutic antibody
program currently in discovery stage.
First Quarter 2021 Financial Results
Cash Position: Cash, cash equivalents and
short-term investments were $117.1 million as of
March 31, 2021, compared to $127.6 million as of
December 31, 2020. The Company believes that its current cash,
cash equivalents and short-term investments will be sufficient to
fund its operations into 2024.
R&D Expenses: Research and development
expenses increased by $7.7 million to $13.8 million
during the first quarter of 2021, compared to $6.1 million
during the first quarter of 2020. The increase in research and
development expenses was primarily driven by the advancement of the
Company’s lead programs, including expenses related to
manufacturing and IND enabling studies. This increase was partially
offset by a decrease in clinical trial expenses in the first
quarter of 2021.
G&A Expenses: General and administrative
expenses increased by $3.4 million to $6.2 million during
the first quarter of 2021, compared to $2.7 million during the
first quarter of 2020. The increase in general and administrative
expenses was driven by increases in personnel related costs,
including severance, share-based compensation charges, and
consulting expenses.
Net Loss: The Company’s net loss was
$18.5 million for the first quarter of 2021, compared to
$8.0 million for the first quarter of 2020.
Shares Outstanding: As of May 4, 2021,
Viridian had approximately 31,291,175 shares of common stock
outstanding on an as-converted basis, which included 8,429,644
shares of common stock and approximately 22,861,531 shares of
common stock issuable upon the conversion of 342,906 shares of
preferred stock.
About Viridian Therapeutics, Inc.
Viridian Therapeutics is a biotechnology company advancing new
treatments for patients suffering from serious diseases but
underserved by today’s therapies. Viridian’s most advanced program,
VRDN-001, is an anti-IGF-1R monoclonal antibody in development for
TED, a debilitating auto-immune disease that causes inflammation
and fibrosis within the orbit of the eye which can cause double
vision, pain, and potential blindness. Patients with severe disease
often require multiple remedial surgeries to the orbit, eye
muscles, and eyelids. Viridian is based in Boulder, Colorado, and
Waltham, Massachusetts. Learn more about Viridian and its programs
at www.viridiantherapeutics.com.
Follow us on Twitter @ViridianThera and on LinkedIn.
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 the
Company’s expectations, strategies, plans and intentions.
Forward-looking statements include, without limitation, statements
regarding the Company’s expectations and guidance regarding its
business plans and objectives for its product candidates and
pipeline, including the therapeutic potential and clinical benefits
thereof, its projected cash runway, the timing, progress and plans
for the Company’s ongoing and future research and clinical
development programs, future regulatory interactions, expectations
regarding the timing for data, and the timing of the Company’s IND
filings for VRDN-001 and VRDN-002. Forward-looking statements are
neither historical facts nor assurances of future performance.
Instead, they are based on our current beliefs, expectations and
assumptions regarding the future of our business, future plans and
strategies, our clinical results and other future conditions. 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. We may not actually achieve
the forecasts disclosed in our forward-looking statements, and you
should not place undue reliance on our forward-looking statements.
Such forward-looking statements are subject to a number of material
risks and uncertainties including but not limited to: uncertainty
and potential delays related to clinical drug development; the
duration and impact of regulatory delays in our clinical programs;
manufacturing risks; 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; the
company’s future operating results and financial performance; the
timing of pre-clinical and clinical trial activities and reporting
results from same; the effects from the COVID-19 pandemic on the
company’s research, development and business activities and
operating results; and those risks set forth under the caption
“Risk Factors” in the Company’s Annual Report on Form 10-K filed
with the Securities and Exchange Commission (SEC) on March 26, 2021
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 we, nor our 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 our views as of any date subsequent to the date
hereof.
Viridian
Contacts:Investors:Dan FerryLifeSci
Advisors617-430-7576IR@viridiantherapeutics.com
Media:Darby PearsonVerge Scientific
Communications703-587-0831PR@viridiantherapeutics.com
Viridian Therapeutics,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive Loss(in thousands,
except share and per share
data)(unaudited)
|
|
Three Months EndedMarch 31, |
|
|
2021 |
|
2020 |
Revenue: |
|
|
|
|
Collaboration revenue - related party |
|
$ |
1,451 |
|
|
|
$ |
— |
|
|
Collaboration revenue |
|
— |
|
|
|
681 |
|
|
Grant revenue |
|
— |
|
|
|
147 |
|
|
Total revenue |
|
1,451 |
|
|
|
828 |
|
|
Operating expenses: |
|
|
|
|
Research and development |
|
13,806 |
|
|
|
6,103 |
|
|
General and administrative |
|
6,160 |
|
|
|
2,723 |
|
|
Total operating expenses |
|
19,966 |
|
|
|
8,826 |
|
|
Loss from operations |
|
(18,515 |
) |
|
|
(7,998 |
) |
|
Other income (expense): |
|
|
|
|
Interest and other income |
|
55 |
|
|
|
95 |
|
|
Interest and other expense |
|
— |
|
|
|
(141 |
) |
|
Net loss |
|
(18,460 |
) |
|
|
(8,044 |
) |
|
Change in unrealized loss on
investments |
|
(13 |
) |
|
|
— |
|
|
Comprehensive loss |
|
$ |
(18,473 |
) |
|
|
$ |
(8,044 |
) |
|
|
|
|
|
|
Net loss |
|
$ |
(18,460 |
) |
|
|
$ |
(8,044 |
) |
|
Net loss per share, basic and diluted |
|
$ |
(2.91 |
) |
|
|
$ |
(2.65 |
) |
|
Weighted-average shares used to compute basic and diluted net loss
per share |
|
6,336,347 |
|
|
|
3,031,756 |
|
|
|
|
|
|
|
|
|
|
|
Viridian Therapeutics,
Inc.Selected Financial
InformationCondensed Consolidated Balance Sheet
Data(amounts in
thousands)(unaudited)
|
March 31,2021 |
|
December 31,2020 |
|
|
|
|
Cash and cash equivalents |
$ |
46,489 |
|
|
$ |
45,897 |
|
Short-term investments |
$ |
70,611 |
|
|
$ |
81,742 |
|
Total
assets |
$ |
122,832 |
|
|
$ |
131,255 |
|
Total
liabilities |
$ |
16,834 |
|
|
$ |
11,218 |
|
Total stockholders’
equity |
$ |
105,998 |
|
|
$ |
120,037 |
|
Viridian Therapeutics (NASDAQ:VRDN)
過去 株価チャート
から 6 2024 まで 7 2024
Viridian Therapeutics (NASDAQ:VRDN)
過去 株価チャート
から 7 2023 まで 7 2024