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 second quarter ending June 30, 2022 and
provided corporate updates.
Earlier today in a separate news release, the Company announced
positive initial clinical data from the first cohort of the ongoing
Phase 1/2 clinical trial of VRDN-001, an IGF-1R antibody, in
patients with thyroid eye disease (TED). In addition, Viridian
announced positive topline data from a first-in-human Phase 1
clinical trial of intravenously administered VRDN-002 in healthy
volunteers.
“We believe today’s positive initial VRDN-001 data for the
treatment of Thyroid Eye Disease is transformative for Viridian and
significantly advances our goal of improving patient care in TED.
VRDN-001 delivered a rapid, compelling and clinically meaningful
improvement at week 6 across all efficacy measures of TED:
proptosis, clinical activity score, and diplopia, exceeding results
from any prior TED trials,” said Jonathan Violin, Ph.D., President
and CEO of Viridian Therapeutics. “We look forward to quickly
advancing VRDN-001, which we believe can be a best-in-class IV
therapy for patients, to Phase 3. In addition, promising initial
VRDN-002 data, together with the unveiling of VRDN-003, an extended
half-life version of VRDN-001, significantly advances our
subcutaneous (SC) strategy. We expect to advance either VRDN-002 or
VRDN-003 into registrational trials by year end 2023 based on
clinical data from the two programs and expect to initiate our SC
Phase 3 program in early 2024.”
Clinical plan and future milestones for Viridian TED
programs
Additional VRDN-001 Phase 1/2 Cohorts
- VRDN-001 20mg/kg cohort data presentation planned for a medical
meeting in the fourth quarter of 2022. VRDN-001 3mg/kg cohort is
expected to deliver data in the fourth quarter of 2022
- Additional VRDN-001 chronic TED proof-of-concept cohorts now
planned to launch in the fourth quarter of 2022, with data expected
in the first half of 2023
Global VRDN-001 Phase 3
Program in Active and Chronic TED
- First VRDN-001 double-blind, placebo-controlled Phase 3 trial
(THRIVE), in active TED patients, expected to initiate by the end
of 2022, with topline data expected in mid-year 2024. The planned
trial will evaluate the 10mg/kg dose, with a rapid 30-minute
infusion time, in two treatment regimens:
- a standard 8-infusion Q3W regimen matching Tepezza dosing
regimen
- an accelerated 12-week, 5-infusion Q3W regimen, offering a 43%
shorter, highly differentiated dosing regimen
- Second VRDN-001 double-blind, placebo-controlled Phase 3 trial
(THRIVE-2), in chronic TED patients, expected to initiate in the
first half of 2023 with topline data by the end of 2024
- THRIVE and THRIVE-2 trial results are expected to form the
basis of both a biologics license application (BLA) in the US as
well as a marketing authorization application (MAA) in the EU
SC Program: VRDN-002 and VRDN-003
- VRDN-002 will advance to a proof-of-concept trial in TED,
evaluating 300mg SC injection, dosed Q2W or Q4W, with data expected
in the second half of 2023
- Viridian is unveiling VRDN-003, an extended half-life version
of VRDN-001. VRDN-003 builds upon the clinical performance of
VRDN-001 by incorporating the same technology that enabled VRDN-002
to achieve its substantially extended half-life. VRDN-003 has
similar non-human primate half-life to VRDN-002 and is expected to
match the VRDN-002 human half-life. IND filing for VRDN-003 is
planned for the second quarter of 2023 with proof-of-concept data
expected in the fourth quarter of 2023.
- By the end of 2023, the Company expects to select to advance
either VRDN-002 or VRDN-003 into registrational trials based on
clinical data from the two programs and plans to initiate a global
Phase 3 program of a potentially best-in-class SC therapy for TED
in early 2024.
Conference call and webcastThe Company will
host a conference call today at 8:00 a.m. ET to discuss the topline
data for VRDN-001 and VRDN-002. The Viridian management team will
be joined by Raymond Douglas, M.D., Ph.D., Director of the Thyroid
Eye Disease Program at Cedars-Sinai Medical Center. The dial-in
number for the conference call is 1-877-407-0789 for domestic
participants and 1-201-689-8562 for international participants. The
conference ID is 13730501. 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.
Second Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents and
short-term investments were $161.2 million as of June 30, 2022,
compared with $197 million as of December 31, 2021. The Company
believes that its current cash, cash equivalents and short-term
investments, in addition to its $75M credit facility, will be
sufficient to fund its operations into 2024.
During the second quarter 2022, 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.
R&D Expenses: Research and development
expenses were $21.7 million during the second quarter of 2022,
compared with $12.6 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, as well as costs related to our
preclinical programs. These increases were offset by expenses
related to manufacturing costs for VRDN-001 and VRDN-002 that were
incurred in the second quarter of 2021. Research and development
expenses were $39.5 million during the six months ended June 30,
2022, compared with $26.4 million for the same period last year.
The increase in research and development expenses was primarily
driven by personnel related costs, license fees, clinical trial
costs for VRDN-001 and VRDN-002, as well as costs related to our
preclinical programs. These increases were offset by expenses
related to manufacturing and IND-enabling studies for VRDN-001 and
VRDN-002 that were incurred in the same period last year.
G&A Expenses: General and administrative
expenses were $8.1 million during the second quarter of 2022,
compared with $6.5 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.General
and administrative expenses were $16.5 million during the six
months ended June 30, 2022, compared with $12.7 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 $29.5
million for the second quarter of 2022, compared with $18.0 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 June 30, 2022,
Viridian had approximately 42,909,027 shares of common stock
outstanding on an as-converted basis, which included 28,463,980
shares of common stock outstanding and an aggregate of
approximately 14,445,047 shares of common stock issuable upon the
conversion of 193,539 and 23,126 shares of Series A and Series B
preferred stock, respectively.
About Viridian TherapeuticsViridian
Therapeutics is a biotechnology company advancing new
treatments for patients suffering from serious diseases underserved
by current therapies. Viridian’s most advanced program, VRDN-001,
is a differentiated 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).
VRDN-002 is a distinct anti-IGF-1R antibody and incorporates
half-life extension technology. VRDN-003 is an extended half-life
version of VRDN-001. Both VRDN-002 and VRDN-003 are designed for
administration as convenient, low-volume, subcutaneous
injections. TED is a debilitating autoimmune disease that
causes inflammation and fibrosis within the orbit of the eye which
can cause double vision, pain, and potential blindness. Viridian is
based in Waltham, Massachusetts.
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 and VRDN-002 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 and the first-in-human
Phase 1 clinical trial of VRDN-002 and results of ongoing and
future clinical trials; the timing, progress and plans for the
Company’s ongoing and future research and clinical development
programs; trial protocols for ongoing clinical trials, including
the clinical trials for VRDN-001 and VRDN 002; expectations
regarding the timing for data, including the expected timing of
additional data from the ongoing Phase 1/2 clinical trial of
VRDN-001 and the first-in-human Phase 1 clinical trial of VRDN-002;
uncertainty and potential delays related to clinical drug
development; the duration and impact of regulatory delays in the
Company’s 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 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.
VIRIDIAN THERAPEUTICS,
INC.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, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
Collaboration Revenue - related party |
$ |
256 |
|
|
$ |
1,090 |
|
|
$ |
472 |
|
|
$ |
2,541 |
|
Operating
Expenses: |
|
|
|
|
|
|
|
Research and development |
|
21,712 |
|
|
|
12,565 |
|
|
|
39,458 |
|
|
|
26,371 |
|
General and administrative |
|
8,108 |
|
|
|
6,523 |
|
|
|
16,467 |
|
|
|
12,683 |
|
Total operating expenses |
|
29,820 |
|
|
|
19,088 |
|
|
|
55,925 |
|
|
|
39,054 |
|
Loss from operations |
|
(29,564 |
) |
|
|
(17,998 |
) |
|
|
(55,453 |
) |
|
|
(36,513 |
) |
Other
income |
|
|
|
|
|
|
|
Interest and other income |
|
227 |
|
|
|
34 |
|
|
|
423 |
|
|
|
89 |
|
Interest expense |
|
(154 |
) |
|
|
— |
|
|
|
(154 |
) |
|
|
— |
|
Net
loss |
|
(29,491 |
) |
|
|
(17,964 |
) |
|
|
(55,184 |
) |
|
|
(36,424 |
) |
|
|
|
|
|
|
|
|
Change in
unrealized loss on investments |
|
(142 |
) |
|
|
9 |
|
|
|
(920 |
) |
|
|
(4 |
) |
Comprehensive loss |
$ |
(29,633 |
) |
|
$ |
(17,955 |
) |
|
$ |
(56,104 |
) |
|
$ |
(36,428 |
) |
|
|
|
|
|
|
|
|
Net loss |
$ |
(29,491 |
) |
|
$ |
(17,964 |
) |
|
$ |
(55,184 |
) |
|
$ |
(36,424 |
) |
Net loss per share, basic and diluted |
$ |
(1.06 |
) |
|
$ |
(2.21 |
) |
|
$ |
(2.05 |
) |
|
$ |
(5.04 |
) |
Weighted-average shares used to compute basic and diluted loss per
share |
|
27,762,257 |
|
|
|
8,106,765 |
|
|
|
26,948,692 |
|
|
|
7,226,447 |
|
VIRIDIAN THERAPEUTICS,
INC.CONDENSED CONSOLIDATED BALANCE SHEET
DATA(amounts in
thousands)(unaudited)
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2022 |
|
2021 |
|
Cash and cash equivalents |
$ |
161,207 |
|
$ |
196,965 |
|
Other
assets |
|
8,607 |
|
|
6,744 |
|
Total assets |
$ |
169,814 |
|
$ |
203,709 |
|
Total
liabilities |
|
27,916 |
|
|
15,993 |
|
Total
stockholders’ equity |
|
141,898 |
|
|
187,716 |
|
Total liabilities and stockholders’ equity |
$ |
169,814 |
|
$ |
203,709 |
|
Investor and Media ContactJohn JordanViridian
TherapeuticsVice President, Investor Relations& Corporate
Communications617-272-4691IR@viridiantherapeutics.com
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