Viridian Therapeutics, Inc. (NASDAQ: VRDN) (the “Company” or
“Viridian”), a biotechnology company advancing new treatments for
patients suffering from serious diseases underserved by today's
therapies, today announced financial results for the third quarter
ended September 30, 2021, and provided corporate updates.
“In the third quarter, we made substantial progress
strengthening the Company with key leadership hires, a successful
financing, and our recent submission of an IND for VRDN-001 for the
treatment of Thyroid Eye Disease,” stated Jonathan Violin, Ph.D.,
Viridian’s President and CEO. “Our pipeline is rapidly advancing,
and we remain on track to report clinical data from our VRDN-001
and VRDN-002 programs in the second quarter of 2022 and mid-year
2022, respectively. In addition, we continue to advance our
discovery pipeline to broaden our portfolio of potential best in
class therapeutics.”
Third 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
TED. This antibody has previously been studied in over 100 oncology
patients as AVE1642, informing plans for rapid development in TED.
The Company recently submitted an IND application for VRDN-001 to
the United States Food and Drug Administration (FDA). The Company
is planning to initiate a randomized, placebo-controlled Phase 1/2
clinical trial of VRDN-001 evaluating safety, tolerability, and
efficacy. The proposed clinical trial protocol allows for
flexibility to assess multiple doses and treatment regimens to
inform product profiles that may be superior to currently available
therapies. The Company believes this clinical trial could provide
key proof of concept data showing clinically meaningful
improvements in signs and symptoms of TED, such as proptosis, the
defining characteristic of TED, previously shown to be improved by
IGF-1R blockade. The Company expects to announce top line proof of
concept clinical data in the second quarter of 2022 from the trial
that includes TED patients in two randomized, placebo-controlled
cohorts.
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. Top line
data from this trial are expected to be announced in mid-year 2022
and could support feasibility of a low-volume injection 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 pipeline beyond IGF-1R
and TED with a focus on opportunities that will leverage validated
mechanisms and technologies 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 for an undisclosed
rare disease. The Company continues to evaluate additional
opportunities to expand its product pipeline for rare disease
indications.
Completed Financing: In September 2021,
Viridian announced the closing of an underwritten public offering
of 7,344,543 shares of its common stock, which included the
exercise in full by the underwriters of their option to purchase up
to 1,159,089 additional shares of common stock, at a public
offering price of $11.00 per share and 23,126 shares of Series B
preferred stock at a public offering price of $733.37 per share,
which are convertible into approximately 1,541,810 shares of common
stock, subject to beneficial ownership conversion limits. The net
proceeds to Viridian from the offering were approximately $91.9
million after deducting underwriting discounts, commissions, and
other offering expenses.
Scientific Presentations: The Company presented
two posters featuring preclinical data on VRDN-001 and VRDN-002 at
the 90th Annual Meeting of the American Thyroid Association
(ATA):
- The VRDN-001 poster showed that the
antibody bound IGF-1R with high affinity and inhibited IGF-1R
signaling with high potency. The in vitro profile of VRDN-001
suggests favorable efficacy and/or exposure requirements for the
treatment of TED patients. The full poster is available at (click
here).
- The VRDN-002 poster showed that the
antibody demonstrated a desirable PK profile in non-human primates,
suggesting potential utility for the treatment of TED. The
prolonged half-life of VRDN-002 suggests potential administration
as a low-volume, convenient subcutaneous injection, or as an
intravenous infusion requiring fewer or less frequent treatments
vs. conventional therapeutic IgG antibodies. The full poster is
available at (click here).
Management and Board of Directors
Appointments:
- Kristian Humer was 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. was
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 was 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.
Third Quarter 2021 Financial Results
Cash Position: Cash, cash equivalents and
short-term investments were $213.8 million as of September 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 $5 million to $8.1 million during
the third quarter of 2021, compared to $3.1 million during the
third 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 third quarter of 2021.
G&A Expenses: General and administrative
expenses increased by $2.3 million to $6.2 million during
the third quarter of 2021, compared to $3.9 million during the
third 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
$14.03 million for the third quarter of 2021, compared to
$5.5 million for the third quarter of 2020.
Shares Outstanding: As of November 3, 2021,
Viridian had approximately 42,365,036 shares of common stock
outstanding on an as-converted basis, which included 21,722,349
shares of common stock and approximately 20,642,687 shares of
common stock issuable upon the conversion of 286,499 and 23,126
shares of Series A and Series B preferred stock respectively.
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 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). 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. 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 safety and
efficacy profiles of VRDN-001 and VRDN-002, 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, planned trial designs,
future regulatory interactions, the timing of the Company’s IND
filing for VRDN-002 and expectations regarding the timing for data.
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 Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission (SEC) on August 12,
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 EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue (related party, $2,541 and $0 at September
30, 2021 and December 31, 2020,respectively) |
$ |
208 |
|
|
|
$ |
— |
|
|
|
$ |
2,749 |
|
|
|
$ |
681 |
|
|
Grant revenue |
— |
|
|
|
— |
|
|
|
— |
|
|
|
315 |
|
|
Total revenue |
208 |
|
|
|
— |
|
|
|
2,749 |
|
|
|
996 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
8,121 |
|
|
|
3,111 |
|
|
|
34,492 |
|
|
|
13,050 |
|
|
General and administrative |
6,221 |
|
|
|
2,299 |
|
|
|
18,904 |
|
|
|
7,728 |
|
|
Total operating expenses |
14,342 |
|
|
|
5,410 |
|
|
|
53,396 |
|
|
|
20,778 |
|
|
Loss from operations |
(14,134 |
) |
|
|
(5,410 |
) |
|
|
(50,647 |
) |
|
|
(19,782 |
) |
|
Other income (expense): |
|
|
|
|
|
|
|
Interest and other income |
91 |
|
|
|
9 |
|
|
|
180 |
|
|
|
137 |
|
|
Interest and other expense |
— |
|
|
|
(93 |
) |
|
|
— |
|
|
|
(328 |
) |
|
Net loss |
(14,043 |
) |
|
|
(5,494 |
) |
|
|
(50,467 |
) |
|
|
(19,973 |
) |
|
Change in unrealized gain
(loss) on investments |
9 |
|
|
|
— |
|
|
|
5 |
|
|
|
— |
|
|
Comprehensive loss |
$ |
(14,034 |
) |
|
|
$ |
(5,494 |
) |
|
|
$ |
(50,462 |
) |
|
|
$ |
(19,973 |
) |
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(14,043 |
) |
|
|
$ |
(5,494 |
) |
|
|
$ |
(50,467 |
) |
|
|
$ |
(19,973 |
) |
|
Net loss per share, basic and diluted |
$ |
(1.25 |
) |
|
|
$ |
(1.48 |
) |
|
|
$ |
(5.95 |
) |
|
|
$ |
(5.82 |
) |
|
Weighted-average shares used to compute basic and diluted net loss
per share |
11,183,578 |
|
|
|
3,719,186 |
|
|
|
8,487,485 |
|
|
|
3,430,867 |
|
|
VIRIDIAN THERAPEUTICS,
INC.CONDENSED CONSOLIDATED BALANCE
SHEETS(in thousands, except share and per share
data)(unaudited)
|
September 30,2021 |
|
December 31,2020 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
138,875 |
|
|
|
$ |
45,897 |
|
|
Short-term investments |
74,937 |
|
|
|
81,742 |
|
|
Prepaid expenses and other current assets |
3,649 |
|
|
|
1,972 |
|
|
Unbilled revenue |
$ |
479 |
|
|
|
— |
|
|
Total current assets |
217,940 |
|
|
|
129,611 |
|
|
Property and equipment,
net |
347 |
|
|
|
309 |
|
|
Operating lease right-of-use
asset, net |
1,461 |
|
|
|
478 |
|
|
Other assets - related
party |
— |
|
|
|
856 |
|
|
Other assets |
1,457 |
|
|
|
1 |
|
|
Total assets |
$ |
221,205 |
|
|
|
$ |
131,255 |
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
3,731 |
|
|
|
$ |
670 |
|
|
Accrued liabilities |
10,320 |
|
|
|
9,703 |
|
|
Current portion of deferred revenue (related party, $301 at Dec.
2020) |
288 |
|
|
|
301 |
|
|
Total current liabilities |
14,339 |
|
|
|
10,674 |
|
|
Other liabilities - related
party |
— |
|
|
|
501 |
|
|
Other liabilities |
2,275 |
|
|
|
43 |
|
|
Total liabilities |
16,614 |
|
|
|
11,218 |
|
|
Commitments and
contingencies |
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, series A non-voting convertible preferred stock,
$0.01 par value; 435,000 shares authorized; 321,334 and 398,487
shares issued and outstanding as of September 30, 2021 and
December 31, 2020, respectively |
145,794 |
|
|
|
180,801 |
|
|
Preferred stock, series B non-voting convertible preferred stock,
$0.01 par value; 5,000,000 shares authorized; 23,126 and 0 shares
issued and outstanding as of September 30, 2021 and
December 31, 2020, respectively |
15,669 |
|
|
|
— |
|
|
Common stock, $0.01 par value; 200,000,000 shares authorized;
19,376,634 and 4,231,135 shares issued and outstanding as of
September 30, 2021 and December 31, 2020,
respectively |
194 |
|
|
|
42 |
|
|
Additional paid-in capital |
372,291 |
|
|
|
218,089 |
|
|
Accumulated other comprehensive loss |
(3 |
) |
|
|
(8 |
) |
|
Accumulated deficit |
(329,354 |
) |
|
|
(278,887 |
) |
|
Total stockholders’ equity |
204,591 |
|
|
|
120,037 |
|
|
Total liabilities and stockholders’ equity |
$ |
221,205 |
|
|
|
$ |
131,255 |
|
|
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