Viridian Therapeutics, Inc. (Nasdaq: VRDN) (the “Company” or
“Viridian”), a biopharmaceutical company advancing new treatments
for patients suffering from serious diseases and underserved by
current therapies, today announced financial results for the second
quarter ended June 30, 2021, and provided corporate updates.
“We continue to make rapid progress with our lead TED program,
VRDN-001,” said Jonathan Violin, Ph.D., President and Chief
Executive Officer of Viridian. “Following a highly collaborative
pre-IND dialogue with the FDA for VRDN-001, we remain on track to
submit IND filings for both VRDN-001 and VRDN-002 to the FDA in the
fourth quarter of 2021. This would put us on track to report key
Phase 1/ 2 proof of concept clinical data in TED patients in the
second quarter of 2022 for VRDN-001, quickly followed by Phase 1
first-in-human data in mid-year 2022 for VRDN-002. We are also
progressing our discovery programs as we expand our pipeline beyond
IGF-1R and TED, advancing our strategy to discover and develop
novel and differentiated monoclonal antibodies.”
Second Quarter 2021 and Recent Highlights
VRDN-001: Viridian’s most advanced product
candidate is VRDN-001, 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). This antibody has previously been
studied in over 100 oncology patients as AVE1642, informing plans
for rapid development in TED. The Company recently completed a
successful pre-Investigational New Drug (IND) meeting with the U.S.
Food and Drug Administration (FDA) and gained alignment on initial
development plans and the proposed design for a randomized,
placebo-controlled Phase 1/ 2 clinical proof of concept trial. This
trial will evaluate safety, tolerability, and efficacy with the
potential for clinically meaningful improvement in proptosis, the
defining characteristic of TED, previously shown to be improved by
IGF-1R blockade. The protocol allows for flexibility to
subsequently assess multiple doses and treatment regimens to inform
product profiles that may be superior to currently available
therapies. The Company remains on track to file an IND in the
fourth quarter of 2021, with initial proof of concept clinical data
in TED patients expected in the second quarter of 2022.
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 with 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
intravenous VRDN-002 in healthy volunteers. Data from this trial
are expected by mid-year 2022, and could demonstrate feasibility of
a low-volume and/or low-frequency dosing paradigm. In parallel,
formulation development is on track to support initiation of a
clinical trial evaluating low-volume subcutaneous injection of
VRDN-002 in 2022. The Company believes a low-volume subcutaneous
injection could improve convenience for patients and physicians,
mitigate treatment burdens, and expand the settings of care for TED
therapies.
Discovery Pipeline: Viridian’s corporate
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
available medicines. The most advanced of these programs is
VRDN-004, a therapeutic monoclonal antibody program currently in
discovery stage. The Company continues to evaluate additional
opportunities to expand its product pipeline for rare disease
indications and remains focused on opportunities to leverage
validated mechanisms and technologies to bring new therapeutic
options to patients underserved by current therapies.
Scientific Presentations: The Company announced
that it will present preclinical data on VRDN-001 and VRDN-002 at
the American Thyroid Association (ATA) Annual Meeting, which will
be held virtually from September 30 to October 3, 2021. Details of
the Company’s presentations will be announced in the coming
weeks.
Appointments:
- Kristian Humer appointed Chief
Financial Officer and Chief Business Officer in July 2021. He
brings more than 20 years of life science investment banking,
mergers and acquisitions, and partnering experience to Viridian.
Most recently, Mr. Humer served as Managing Director of Banking,
Capital Markets & Advisory for the Global Healthcare team at
Citigroup, Inc.
- Deepa Rajagopalan, M.D., appointed
Senior Vice President of New Product and Portfolio Development, in
July 2021. Most recently, Dr. Rajagopalan served as Vice President
of New Products at Intercept Pharmaceuticals, and previously held
roles at Alexion Pharmaceuticals and Bain & Company.
- Jennifer Moses, CPA, appointed to
the Company’s Board of Directors and as Chair of the Company’s
Audit Committee in July 2021. Ms. Moses is the Chief Financial
Officer of G1 Therapeutics. Prior to G1 Therapeutics, she was a
partner at Rankin McKenzie, LLC, and previously held roles of
increasing responsibility at Deloitte.
Second Quarter 2021 Financial Results
Cash Position: Cash, cash equivalents and
short-term investments were $109.3 million as of June 30,
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 $8.8 million to $12.6 million
during the second quarter of 2021, compared to $3.8 million
during the second 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 second
quarter of 2021.
G&A Expenses: General and administrative
expenses increased by $3.8 million to $6.5 million during
the second quarter of 2021, compared to $2.7 million during
the second 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
$18.0 million for the second quarter of 2021, compared to
$6.4 million for the second quarter of 2020.
Shares Outstanding: As of August 10, 2021,
Viridian had approximately 31,294,508 shares of common stock
outstanding on an as-converted basis, which included 9,542,087
shares of common stock and approximately 21,752,421 shares of
common stock issuable upon the conversion of 326,270 shares of
preferred stock.
About Viridian Therapeutics, Inc.
Viridian Therapeutics is a biotechnology company advancing new
treatments for patients suffering from serious diseases and
underserved by today’s 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), 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 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, the Company’s other periodic reports 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 EndedJune 30, |
|
Six Months EndedJune 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue - related party |
$ |
1,090 |
|
|
$ |
— |
|
|
$ |
2,541 |
|
|
$ |
— |
|
Collaboration revenue |
— |
|
|
— |
|
|
— |
|
|
681 |
|
Grant revenue |
— |
|
|
168 |
|
|
— |
|
|
315 |
|
Total revenue |
1,090 |
|
|
168 |
|
|
2,541 |
|
|
996 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
12,565 |
|
|
3,836 |
|
|
26,371 |
|
|
9,939 |
|
General and administrative |
6,523 |
|
|
2,706 |
|
|
12,683 |
|
|
5,429 |
|
Total operating expenses |
19,088 |
|
|
6,542 |
|
|
39,054 |
|
|
15,368 |
|
Loss from operations |
(17,998 |
) |
|
(6,374 |
) |
|
(36,513 |
) |
|
(14,372 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest and other income |
34 |
|
|
33 |
|
|
89 |
|
|
128 |
|
Interest and other expense |
— |
|
|
(94 |
) |
|
— |
|
|
(235 |
) |
Net loss |
(17,964 |
) |
|
(6,435 |
) |
|
(36,424 |
) |
|
(14,479 |
) |
Change in unrealized gain
(loss) on investments |
9 |
|
|
— |
|
|
(4 |
) |
|
— |
|
Comprehensive loss |
$ |
(17,955 |
) |
|
$ |
(6,435 |
) |
|
$ |
(36,428 |
) |
|
$ |
(14,479 |
) |
|
|
|
|
|
|
|
|
Net loss |
$ |
(17,964 |
) |
|
$ |
(6,435 |
) |
|
$ |
(36,424 |
) |
|
$ |
(14,479 |
) |
Net loss per share, basic and diluted |
$ |
(2.21 |
) |
|
$ |
(1.82 |
) |
|
$ |
(5.04 |
) |
|
$ |
(4.41 |
) |
Weighted-average shares used to compute basic and diluted net loss
per share |
8,106,765 |
|
|
3,538,490 |
|
|
7,226,447 |
|
|
3,285,123 |
|
VIRIDIAN THERAPEUTICS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(in thousands, except share and per share
data)(unaudited)
|
June 30,2021 |
|
December 31,2020 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
27,704 |
|
|
$ |
45,897 |
|
Short-term investments |
81,597 |
|
|
81,742 |
|
Prepaid expenses and other current assets |
4,110 |
|
|
1,972 |
|
Unbilled revenue - related party |
2,051 |
|
|
— |
|
Total current assets |
115,462 |
|
|
129,611 |
|
Property and equipment,
net |
298 |
|
|
309 |
|
Operating lease right-of-use
asset, net |
1,567 |
|
|
478 |
|
Other assets - related
party |
778 |
|
|
856 |
|
Other assets |
97 |
|
|
1 |
|
Total assets |
$ |
118,202 |
|
|
$ |
131,255 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
2,392 |
|
|
$ |
670 |
|
Accrued liabilities |
14,150 |
|
|
9,703 |
|
Current portion of deferred revenue - related party |
288 |
|
|
301 |
|
Total current liabilities |
16,830 |
|
|
10,674 |
|
Other liabilities - related
party |
1,293 |
|
|
501 |
|
Other liabilities |
1,167 |
|
|
43 |
|
Total liabilities |
19,290 |
|
|
11,218 |
|
Commitments and
contingencies |
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, series A non-voting convertible preferred stock,
$0.01 par value; 435,000 shares authorized; 340,219 and 398,487
shares issued and outstanding as of June 30, 2021 and
December 31, 2020, respectively |
154,363 |
|
|
180,801 |
|
Preferred stock, $0.01 par value; 5,000,000 shares authorized; 0
shares issued and outstanding as of June 30, 2021 and
December 31, 2020, respectively |
|
— |
|
|
|
— |
|
Common stock, $0.01 par value; 200,000,000 shares authorized;
8,608,886 and 4,231,135 shares issued and outstanding as of
June 30, 2021 and December 31, 2020, respectively |
86 |
|
|
42 |
|
Additional paid-in capital |
259,786 |
|
|
218,089 |
|
Accumulated other comprehensive loss |
(12 |
) |
|
(8 |
) |
Accumulated deficit |
(315,311 |
) |
|
(278,887 |
) |
Total stockholders’ equity |
98,912 |
|
|
120,037 |
|
Total liabilities and stockholders’ equity |
$ |
118,202 |
|
|
$ |
131,255 |
|
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