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 for the fourth quarter and full year
ended December 31, 2022.
“2022 was a productive year for Viridian, as we made significant
progress and reached multiple important milestones in our TED
program with VRDN-001, our lead product candidate. Building on this
positive momentum, we are strategically positioned to continue the
advancement of our pipeline of TED programs in 2023,” said Scott
Myers, President and CEO of Viridian Therapeutics. “As part of my
recent appointment as CEO, I look forward to advancing our recently
initiated THRIVE Phase 3 trial of VRDN-001 in patients with active
TED, generating data in patients with chronic TED, continuing the
development of our subcutaneous programs, and beginning to
establish our commercial capabilities. These activities support our
overall goal to build a fully integrated biopharmaceutical
company.”
Added Mr. Myers: “We also look forward to providing additional
details on one of our preclinical programs later this year. Our
preclinical programs have the potential to expand our current
pipeline beyond TED and build on our strategy of developing
best-in-class medicines that address known limitations of current
therapies.”
Program highlights
Thyroid eye disease (TED)
Intravenous (IV) program: VRDN-001Viridian’s
lead product candidate, VRDN-001, is a monoclonal antibody believed
to act 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.
- In January 2023, the Company announced positive data from the
third, low-dose cohort in its ongoing Phase 1/2 clinical trial of
VRDN-001 in patients with active TED.
- In December 2022,
the Company announced that the first patient was enrolled in its
THRIVE Phase 3 trial evaluating the efficacy and safety of VRDN-001
in patients with active TED, with topline results expected in the
middle of 2024.
- Clinical and
non-clinical presentations of VRDN-001 are expected at the 49th
Annual Meeting of the North American Neuro-Ophthalmology Society
(NANOS) from March 11th to 16th, 2023, in Orlando, Florida.
- Initial results from the proof-of-concept study of VRDN-001 in
patients with chronic TED are expected in the second quarter of
2023.
- 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 middle of 2023, with topline results expected by
year-end 2024.
Subcutaneous (SC) programs: VRDN-001, VRDN-002, and
VRDN-003The Company is advancing VRDN-001, VRDN-002, and
VRDN-003 as SC program candidates. All three candidates have the
potential to be developed into a convenient, SC, self-administered
pen device. VRDN-001 IV’s low-dose data support its potential as a
SC candidate. VRDN-002 is a novel anti-IGF-1R monoclonal antibody
incorporating half-life extension technology. VRDN-003 is an
anti-IGF-1R monoclonal antibody with the same amino acid sequence
as VRDN-001, except for the addition of the half-life extension
technology that is incorporated in VRDN-002.
- In January 2023, the Company announced that updated
pharmacokinetic (PK) modeling support feasibility of ongoing
development of a self-administered pen for SC administration, and a
planned dosing interval of up to once monthly for its SC program
candidates.
- A clinical poster presentation of VRDN-002 Phase 1 data in
healthy volunteers is expected at the 49th Annual Meeting of NANOS
from March 11th to 16th, 2023 in Orlando, Florida.
- The filing of the investigational new drug application (IND)
for VRDN-003 with the US Food and Drug
Administration (FDA) is planned for the second quarter of
2023.
- The Company plans to initiate Phase 1 trials in healthy
volunteers for both VRDN-003 and VRDN-001 SC, with topline results
expected in the fourth quarter of 2023.
- VRDN-002 proof-of-concept trial results in patients with active
TED are expected by year-end 2023.
- The Company expects to select its lead SC program by year-end
2023 and 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.
Corporate highlights
- In February 2023, the Company appointed Scott Myers as
President and Chief Executive Officer and a member of the Board of
Directors. Mr. Myers has more than 30 years of biopharmaceutical
and medical technology experience and has held global executive
leadership and director roles at numerous commercial- and
development-stage biopharmaceutical companies.
- In November 2022, Viridian promoted and hired the following
senior executives:
- Deepa Rajagopalan, M.D., was promoted to Chief Product and
Strategy Officer after joining the Company in 2021 to lead new
product and portfolio development. Dr. Rajagopalan is focused on
advancing the Company’s pre-approval commercialization planning
efforts for TED and market development activities for its
discovery-stage pipeline.
- Rob Henderson, Ph.D., was promoted to Chief Scientific Officer
after joining the Company in 2021 as Senior Vice President of
Research. As Chief Scientific Officer, Dr. Henderson leads all
nonclinical science and research at Viridian.
- Todd James joined Viridian as Senior Vice President, Corporate
Affairs and Investor Relations. Mr. James served in a similar
position at Acceleron Pharma from 2015 until its acquisition by
Merck in 2021.
Financial results
- Cash Position: Cash, cash equivalents, and
short-term investments were $424.6 million as
of December 31, 2022, compared with $431.3
million as of September 30, 2022. 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 $39.3 million during the fourth
quarter of 2022, compared with $22.4 million for the same
period last year. The increase in research and development expenses
was primarily driven by an increase in chemistry, manufacturing,
and controls (CMC) expenses, preclinical costs, expenses related to
milestones and upfront payments, as well as personnel costs.
Research and development expenses were $100.9
million during the 12 months ended December 31, 2022, compared
with $56.9 million for the same period last year. The
increase in research and development expenses was primarily driven
by clinical trial and preclinical costs, expenses related to
milestones and upfront payments, and CMC expenses.
- G&A Expenses: General and
administrative expenses were $9.9 million during the
fourth quarter of 2022, compared with $6.9 million for
the same period last year. The increase in general and
administrative expenses was driven by increases in
personnel-related costs and consulting expenses. General and
administrative expenses were $35.2 million during the 12
months ended December 31, 2022, compared with $25.8
million for the same period last year.
- Net Loss: The Company’s net loss
was $45.8 million for the fourth quarter of 2022,
compared with $28.9 million for the same period last
year. The increase in net loss was driven by increased operating
costs, as described above.
- Shares outstanding: As of March 1,
2023, Viridian had approximately 57,748,362 shares of common stock
outstanding on an as-converted basis, which included 42,837,951
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
The Company will host a webcast and conference call to discuss
its fourth quarter and full year 2022 financial results today,
Wednesday, March 8 at 8:00 a.m. ET.
The webcast can be accessed under “Events and Presentations” on
the Investors section of the Viridian website at
viridiantherapeutics.com. To participate in the conference call,
please dial 1-877-407-0789 (domestic) or 1-201-689-8562
(international) and reference code 13736278. A replay of the
webcast will be available following the completion of the
event.
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
recently initiated 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 evaluating VRDN-001 in a Phase 2
proof-of-concept trial in patients with chronic TED. In addition to
its intravenously administered VRDN-001 program, the Company is
advancing two candidates for its subcutaneous strategy with the
goal of providing a more conveniently administered therapy to
patients with TED. Viridian is 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.
Note regarding forward-looking statementsThis
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, plans and intentions. Forward-looking
statements include, without limitation, statements regarding the
Company’s expectations, strategies, plans and intentions.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based on the
Company’s 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
TED; the relationship between the results from the positive data
from the Phase 1/2 clinical trial of VRDN-001 and the results of
ongoing or future clinical trials; the timing, progress and plans
for the Company’s ongoing and future research 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 the
Company’s clinical programs; manufacturing risks; the Company’s
ability to develop a subcutaneous formulation; the Company’s
ability to build a fully integrated biopharmaceutical company;
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 financial
position and its projected cash runway; 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 the Company’s 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 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 |
|
Twelve Months Ended |
|
December 31, |
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
Collaboration Revenue - related party |
$ |
105 |
|
|
$ |
214 |
|
|
$ |
1,772 |
|
|
$ |
2,963 |
|
Total revenue |
|
105 |
|
|
|
214 |
|
|
|
1,772 |
|
|
|
2,963 |
|
Operating Expenses: |
|
|
|
|
|
|
|
Research and development |
|
39,317 |
|
|
|
22,394 |
|
|
|
100,894 |
|
|
|
56,886 |
|
General and administrative |
|
9,854 |
|
|
|
6,901 |
|
|
|
35,182 |
|
|
|
25,805 |
|
Total operating expenses |
|
49,171 |
|
|
|
29,295 |
|
|
|
136,076 |
|
|
|
82,691 |
|
Loss from operations |
|
(49,066 |
) |
|
|
(29,081 |
) |
|
|
(134,304 |
) |
|
|
(79,728 |
) |
Other income |
|
|
|
|
|
|
|
Interest and other income |
|
3,449 |
|
|
|
138 |
|
|
|
4,916 |
|
|
|
318 |
|
Interest expense |
|
(168 |
) |
|
|
(3 |
) |
|
|
(486 |
) |
|
|
(3 |
) |
Net loss |
|
(45,785 |
) |
|
|
(28,946 |
) |
|
|
(129,874 |
) |
|
|
(79,413 |
) |
|
|
|
|
|
|
|
|
Change in unrealized loss on investments |
|
300 |
|
|
|
(154 |
) |
|
|
(233 |
) |
|
|
(149 |
) |
Comprehensive loss |
$ |
(45,485 |
) |
|
$ |
(29,100 |
) |
|
$ |
(130,107 |
) |
|
$ |
(79,562 |
) |
|
|
|
|
|
|
|
|
Net loss |
$ |
(45,785 |
) |
|
$ |
(28,946 |
) |
|
$ |
(129,874 |
) |
|
$ |
(79,413 |
) |
Net loss per share, basic and diluted |
$ |
(1.13 |
) |
|
$ |
(1.31 |
) |
|
$ |
(4.05 |
) |
|
$ |
(6.66 |
) |
Weighted-average shares used to compute basic and diluted loss per
share |
|
40,541,507 |
|
|
|
22,109,530 |
|
|
|
32,087,293 |
|
|
|
11,918,712 |
|
Viridian Therapeutics, Inc. |
|
Selected Financial Information |
|
Condensed Consolidated Balance Sheets |
|
(amounts in thousands) |
|
(unaudited) |
|
|
|
|
|
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
Cash, cash equivalents, and short-term investments |
$ |
424,550 |
|
$ |
196,965 |
|
Other assets |
|
10,541 |
|
|
6,744 |
|
Total assets |
$ |
435,091 |
|
$ |
203,709 |
|
Total liabilities |
|
40,027 |
|
|
15,993 |
|
Total stockholders’ equity |
|
395,064 |
|
|
187,716 |
|
Total liabilities and stockholders’ equity |
$ |
435,091 |
|
$ |
203,709 |
|
ContactsSource: Viridian Therapeutics,
Inc.
Investors:Louisa Stone, 617-272-4604Manager, Investor
RelationsIR@viridiantherapeutics.com
Todd James, 617-272-4691Senior Vice President, Corporate Affairs
and Investor RelationsIR@viridiantherapeutics.com
Media:Matt Fearer, 617-272-4605Vice President, Corporate
CommunicationsMedia@viridiantherapeutics.com
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