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 third quarter ending September 30, 2022
and provided corporate updates.
Earlier today in a separate news release, the Company
announced topline clinical data from the first two cohorts in its
ongoing Phase 1/2 clinical trial of VRDN-001, an IGF-1R antibody,
in patients with thyroid eye disease (TED).
“The positive VRDN-001 clinical data reported today reinforces
our conviction in the potential for VRDN-001 to deliver improved
care for patients suffering with TED. Across all efficacy measures,
VRDN-001 continues to deliver a rapid, compelling, and clinically
meaningful improvement for patients after just two infusions,” said
Jonathan Violin, Ph.D., President and CEO of Viridian Therapeutics.
“We have continued our rapid momentum with the recent initiation of
our Phase 3 THRIVE program as we accelerate our portfolio of IV and
SC TED assets towards approval.”
Third Quarter 2022 Financial Results
Cash Position: Cash, cash equivalents, and
short-term investments were $431.3 million as of September 30,
2022, compared with $197 million as of December 31, 2021. 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.
In August 2022, the Company offered and sold 11,352,640 shares
of the Company’s common stock at a public offering price of $23.50
per share, and 28,084 shares of Series B non-voting convertible
preferred stock, par value $0.01 per share, at a public offering
price of $1,566.745 per share. The gross proceeds to the Company
from the offering were approximately $311.0 million, before
deducting underwriting discounts and commissions and other offering
expenses payable by the Company.
Earlier in 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 $22.1 million during the third quarter of 2022,
compared with $8.1 million for the same period last year. The
increase in research and development expenses was primarily driven
by personnel related costs, clinical trial costs for VRDN-001 and
VRDN-002, as well as costs related to our preclinical programs and
manufacturing costs for all of our programs. Research and
development expenses were $61.6 million during the nine months
ended September 30, 2022, compared with $34.5 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.
G&A Expenses: General and administrative
expenses were $8.9 million during the third 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 share-based
compensation charges, as well as higher consulting expenses, and
professional and license fees.
General and administrative expenses were $25.3 million during
the nine months ended September 30, 2022, compared with $18.9
million for the same period last year. The increase in general and
administrative expenses was driven by increases in
personnel-related costs, including share-based compensation
charges, as well as an increase in consulting expenses and
professional service fees.
Net Loss: The Company’s net loss was $28.9
million for the third quarter of 2022, compared with $14.0 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 September 30, 2022,
Viridian had approximately 56,217,886 shares of common stock
outstanding on an as-converted basis, which included 40,244,355
shares of common stock outstanding and an aggregate of
approximately 15,973,531 shares of common stock issuable upon the
conversion of 188,381 and 51,210 shares of Series A and Series B
preferred stock, respectively.
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 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
13732927. 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 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 September 30, |
|
Nine Months Ended September 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenue: |
|
|
|
|
|
|
|
Collaboration Revenue - related party |
$ |
1,195 |
|
|
$ |
208 |
|
|
$ |
1,667 |
|
|
$ |
2,749 |
|
Total revenue |
|
1,195 |
|
|
|
208 |
|
|
|
1,667 |
|
|
|
2,749 |
|
Operating Expenses: |
|
|
|
|
|
|
|
Research and development |
|
22,119 |
|
|
|
8,121 |
|
|
|
61,577 |
|
|
|
34,492 |
|
General and administrative |
|
8,861 |
|
|
|
6,221 |
|
|
|
25,328 |
|
|
|
18,904 |
|
Total operating expenses |
|
30,980 |
|
|
|
14,342 |
|
|
|
86,905 |
|
|
|
53,396 |
|
Loss from operations |
|
(29,785 |
) |
|
|
(14,134 |
) |
|
|
(85,238 |
) |
|
|
(50,647 |
) |
Other income |
|
|
|
|
|
|
|
Interest and other income |
|
1,044 |
|
|
|
91 |
|
|
|
1,467 |
|
|
|
180 |
|
Interest expense |
|
(164 |
) |
|
|
— |
|
|
|
(318 |
) |
|
|
— |
|
Net loss |
|
(28,905 |
) |
|
|
(14,043 |
) |
|
|
(84,089 |
) |
|
|
(50,467 |
) |
|
|
|
|
|
|
|
|
Change in unrealized loss on investments |
|
137 |
|
|
|
9 |
|
|
|
(783 |
) |
|
|
5 |
|
Comprehensive loss |
$ |
(28,768 |
) |
|
$ |
(14,034 |
) |
|
$ |
(84,872 |
) |
|
$ |
(50,462 |
) |
|
|
|
|
|
|
|
|
Net loss |
$ |
(28,905 |
) |
|
$ |
(14,043 |
) |
|
$ |
(84,089 |
) |
|
$ |
(50,467 |
) |
Net loss per share, basic and diluted |
$ |
(0.86 |
) |
|
$ |
(1.25 |
) |
|
$ |
(2.88 |
) |
|
$ |
(5.95 |
) |
Weighted-average shares used to compute basic and diluted loss per
share |
|
33,742,076 |
|
|
|
11,183,578 |
|
|
|
29,238,247 |
|
|
|
8,487,485 |
|
|
|
|
|
|
|
|
|
VIRIDIAN THERAPEUTICS,
INC.CONDENSED CONSOLIDATED BALANCE SHEET
DATA(amounts in
thousands)(unaudited)
|
|
|
|
|
|
September 30, |
December 31, |
|
|
|
2022 |
|
|
2021 |
|
Cash and cash equivalents |
$ |
431,322 |
|
$ |
196,965 |
|
Other assets |
|
9,258 |
|
|
6,744 |
|
Total assets |
$ |
440,580 |
|
$ |
203,709 |
|
Total liabilities |
|
31,573 |
|
|
15,993 |
|
Total stockholders’ equity |
|
409,007 |
|
|
187,716 |
|
Total liabilities and stockholders’ equity |
$ |
440,580 |
|
$ |
203,709 |
|
|
|
|
|
|
Investor and Media ContactJohn JordanViridian
TherapeuticsVice President, Investor Relations& Corporate
Communications617-272-4691IR@viridiantherapeutics.com
Viridian Therapeutics (NASDAQ:VRDN)
過去 株価チャート
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Viridian Therapeutics (NASDAQ:VRDN)
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から 7 2023 まで 7 2024