Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company
advancing new treatments for patients suffering from serious
diseases underserved by current therapies, today announced
financial results for the first quarter ending March 31, 2022 and
provided corporate updates, including interim results for the
healthy volunteer portion of the Company’s ongoing proof of concept
trial of VRDN-001 in Thyroid Eye Disease (TED).
“Our ongoing VRDN-001 and VRDN-002 clinical trials are poised to
deliver data in the coming months that we believe will transform
Viridian and significantly advance our goal of improving patient
care in Thyroid Eye Disease,” said Jonathan Violin, Ph.D.,
President and CEO of Viridian Therapeutics. “Our first clinical
results are highly encouraging. The VRDN-001 healthy volunteer
interim data show saturation of IGF-1 response at all doses tested,
confirming robust IGF-1R inhibition as seen in our preclinical
data, with an excellent safety and tolerability profile. We look
forward to seeing the first efficacy data from TED patients
soon.”
First Quarter 2022 and Recent Highlights
VRDN-001: Viridian’s most advanced product
candidate VRDN-001 is a differentiated humanized monoclonal
antibody that binds and blocks the insulin-like growth factor-1
receptor (IGF-1R) with sub-nanomolar affinity. This mechanism of
action is clinically and commercially validated for the treatment
of TED. The Company’s ongoing first clinical trial for VRDN-001 is
a Phase 1/2 proof of concept study that includes multiple
randomized, placebo-controlled cohorts of TED patients. The trial
is designed to assess the potential for VRDN-001 to provide rapid
improvement of signs and symptoms of TED at six weeks, after two
intravenous (IV) infusions of VRDN-001. The Company expects to
announce top line proof of concept clinical data from two patient
cohorts in the third quarter of 2022.
Dose escalation and healthy volunteer enrollment is complete,
and the Company continues to enroll TED patients at sites in the
U.S. and Canada. Each TED cohort includes eight patients randomized
in a 3:1 ratio to receive VRDN-001 or placebo. The first cohort is
evaluating two infusions of 10 mg/kg VRDN-001; the second cohort is
evaluating two infusions of 20 mg/kg VRDN-001.
The healthy volunteer portion of the trial includes doses of 3
mg/kg, 10 mg/kg and 20 mg/kg in 13 subjects. No drug related
adverse events associated with hyperglycemia, hearing loss or
muscle spasms have been reported to date. Other adverse events have
been generally comparable to placebo; to date, there have been no
infusion reactions or serious adverse events. Interim data for
plasma levels of IGF-1, a biomarker for target engagement, show a
rapid increase that saturated after the first infusion at levels
that were similar for all doses tested, including 3 mg/kg. Based on
these results the Company now plans to enroll a cohort of TED
patients at a dose of 3 mg/kg following the completion of the 10
mg/kg and 20 mg/kg cohorts in this trial. The Company expects to
report top-line data from the 3 mg/kg cohort in the fourth quarter
of 2022.
“The interim healthy volunteer data suggests robust activity of
VRDN-001 at doses from 3 mg/kg to 20 mg/kg, with excellent safety
and tolerability based on our observations to date. In TED patients
we are assessing safety and tolerability as well as multiple
efficacy endpoints and expect to report top line data on proptosis,
clinical activity score and diplopia,” said Dr. Barrett Katz, M.D.,
M.B.A., Chief Medical Officer of Viridian Therapeutics. “These
efficacy measurements will be assessed at six weeks, after two
infusions of VRDN-001. We will report the same endpoints used to
evaluate teprotumumab, focusing on mean change from baseline in
proptosis reduction, but will also report proptosis responder rate,
clinical activity score, and diplopia.”
VRDN-002: Viridian’s second product candidate,
VRDN-002, is a distinct, next-generation IGF-1R antibody
incorporating half-life extension technology, designed to support
administration as a convenient, low-volume, subcutaneous injection
for the treatment of TED. In March 2022, Viridian announced dosing
of the first subject in a first-in-human, healthy volunteer Phase 1
clinical trial evaluating VRDN-002. This is a single ascending dose
trial to explore safety, tolerability, pharmacokinetics and
pharmacodynamics of intravenously administered VRDN-002 at doses of
3 mg/kg, 10 mg/kg, and 20 mg/kg in up to 16 healthy volunteers. The
Company has completed dose escalation and expects to announce top
line data from this Phase 1 trial in the third quarter of 2022.
Results from this trial will confirm the feasibility of a
low-volume subcutaneous dosing paradigm for TED patients; the
company is planning a SC proof of concept trial in TED patients as
the next step in VRDN-002 development. The Company believes a
low-volume subcutaneous injection would improve convenience for
patients and physicians, mitigate treatment burdens, and expand the
settings of care for TED therapies.
Discovery Pipeline: Viridian’s pipeline
expansion is focused on additional opportunities that leverage
validated mechanisms and technologies in therapeutic areas
underserved by today’s available medicines. The most advanced of
these programs is VRDN-004, a therapeutic monoclonal antibody
program currently in discovery stage for an undisclosed rare
disease. VRDN-005 is a second discovery-stage program for another
undisclosed indication in which the Company believes patient care
can be advanced with a novel therapeutic monoclonal antibody.
First Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents and
short-term investments were $175 million as of March 31, 2022,
compared with $197 million as of December 31, 2021.
After the first quarter ended, the Company entered into a debt
financing agreement with Hercules Capital, Inc. for up to $75
million. Under the terms of the agreement, Viridian drew an initial
$5 million at closing.
An additional $20 million is available at the Company’s request
through June 15, 2023, with an additional $25 million available
upon the Company’s achievement of certain milestones, and the
remaining $25 million available subject to final lender approval.
The Company is under no obligation to draw funds in the future.
Excluding this $75 million credit facility, 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 were $17.7 million during the first quarter of 2022,
compared with $13.8 million for the same period last year. The
increase in research and development expenses was primarily driven
by personnel related costs, license fees and clinical trial costs
for VRDN-001 and VRDN-002. These increases were offset by expenses
related to manufacturing and IND-enabling studies for VRDN-001 and
VRDN-002 that were incurred in the first quarter of 2021.
G&A Expenses: General and administrative
expenses were $8.4 million during the first quarter of 2022,
compared with $6.2 million for the same period last year. 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
$25.7 million for the first quarter of 2022, compared with
$18.5 million for the same period last year. The increase in
net loss was driven by increased operating costs, as described
above, as well as lower revenue from our collaboration with Zenas
in the first quarter of 2022 compared to 2021.
Shares Outstanding: As of March 31, 2022,
Viridian had approximately 42,883,007 shares of common stock
outstanding on an as-converted basis, which included 27,169,422
shares of common stock outstanding and an aggregate of
approximately 15,713,585 shares of common stock issuable upon the
conversion of 212,566 and 23,126 shares of Series A and Series B
preferred stock, respectively.
First Quarter 2022 Financial Results Conference
Call
Viridian’s management will host a conference call today at 4:30
p.m. ET to discuss the financial results and recent corporate
developments. The dial-in number for the conference call is
1-877-270-2148 for domestic participants and 1-412-902-6510 for
international participants. A live webcast of the conference call
can be accessed through the “Events” page in the Investors section
of the Viridian Therapeutics website. Following the live webcast,
an archived version of the call will also be available on the
website.
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 a differentiated humanized monoclonal antibody
targeting insulin-like growth factor-1 receptor (IGF-1R), a
clinically and commercially validated target for the treatment of
thyroid eye disease (TED). 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.
TED is a debilitating autoimmune disease that causes inflammation
and fibrosis within the orbit and behind 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 Waltham,
Massachusetts.
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 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, the
sufficiency of the Company’s financial position and its projected
cash runway, the timing, progress and plans for the Company’s
ongoing and future research and clinical development programs,
trial design and protocols for ongoing clinical trials, and
expectations regarding the timing of top line data for the VRDN-001
and VRDN-002 programs, the safety and efficacy of the Company’s
product candidates, and the unpredictable relationship between
preclinical study results and clinical study results.
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: 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, including those risks set forth under the
caption “Risk Factors” in our Annual Report on Form 10-K filed with
the Securities and Exchange Commission (SEC) on March 11, 2022 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 THERAPEUTICS,
INC.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS(amounts in
thousands, except share and per share
data)(unaudited)
|
Three Months Ended March 31, |
|
|
2022 |
|
|
|
2021 |
|
Revenue: |
|
|
|
Collaboration Revenue - related party |
$ |
216 |
|
|
$ |
1,451 |
|
Total revenue |
|
216 |
|
|
|
1,451 |
|
Operating
Expenses: |
|
|
|
Research and development |
|
17,746 |
|
|
|
13,806 |
|
General and administrative |
|
8,359 |
|
|
|
6,160 |
|
Total operating expenses |
|
26,105 |
|
|
|
19,966 |
|
Loss from operations |
|
(25,889 |
) |
|
|
(18,515 |
) |
Other
income |
|
|
|
Interest and other income |
|
196 |
|
|
|
55 |
|
Net
loss |
|
(25,693 |
) |
|
|
(18,460 |
) |
|
|
|
|
Change in
unrealized loss on investments |
|
(778 |
) |
|
|
(13 |
) |
Comprehensive loss |
$ |
(26,471 |
) |
|
$ |
(18,473 |
) |
|
|
|
|
Net loss |
$ |
(25,693 |
) |
|
$ |
(18,460 |
) |
Net loss per share, basic and diluted |
$ |
(0.98 |
) |
|
$ |
(2.91 |
) |
Weighted-average shares used to compute basic and diluted loss per
share |
|
26,126,092 |
|
|
|
6,336,347 |
|
|
|
|
|
VIRIDIAN THERAPEUTICS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(amounts in
thousands)(unaudited)
|
|
|
|
|
March 31, |
December 31, |
|
|
2022 |
|
|
2021 |
Cash and
cash equivalents |
$ |
30,858 |
|
$ |
42,299 |
Short-term
investments |
$ |
144,570 |
|
$ |
154,666 |
Total
assets |
$ |
183,165 |
|
$ |
203,709 |
Total
liabilities |
$ |
16,523 |
|
$ |
15,993 |
Total
stockholders’ equity |
$ |
166,642 |
|
$ |
187,716 |
Total
liabilities and stockholders’ equity |
$ |
183,165 |
|
$ |
203,709 |
|
|
|
|
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