Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical
company advancing new treatments for patients suffering from
serious diseases but underserved by today’s therapies, today
announced financial results for the fourth quarter and year ended
December 31, 2020 and provided corporate updates.
“2020 was a transformative year for Viridian. We completed the
acquisition of private Viridian Therapeutics and a concurrent
financing, revamped our business and added $115.0 million to our
balance sheet in the fourth quarter. We have also strengthened our
management team and now have multiple product candidates with the
potential to become meaningful treatments for patients suffering
from TED,” said Jonathan Violin, Ph.D., President and Chief
Executive Officer of Viridian. “As we enter 2021, we look forward
to reaching important R&D milestones in our TED programs,
continuing to build out our team and expanding our pipeline beyond
TED.”
Recent Highlights
- Jonathan Violin, Ph.D. appointed President, CEO and
Director – Dr. Violin co-founded privately-held Viridian
Therapeutics, which was acquired by the Company in October 2020.
Dr. Violin also founded and served as CEO of two drug discovery
companies, Quellis Biosciences and Dianthus Therapeutics, and
co-founded and held several executive positions at Trevena,
Inc.
- Barrett Katz M.D. joined Viridian as Chief Medical
Officer (CMO) – Dr. Katz is an internationally recognized
neuro-ophthalmologist. He comes to Viridian from BridgeBio Pharma,
Inc. where he developed therapeutics to treat orphan eye diseases.
Prior to BridgeBio, he was CMO at GenSight Biologics where he
oversaw early- and late-stage clinical programs.
- Vahe Bedian, Ph.D. appointed as Chief
Scientist – Dr. Bedian co-founded privately-held Viridian
Therapeutics. Dr. Bedian also co-founded and served as Chief
Scientific Officer of Quellis Biosciences and Dianthus
Therapeutics. He also previously held leadership positions in
therapeutic antibody research and development at AstraZeneca and
Pfizer.
- Changed Company name to Viridian Therapeutics
–The new name reflects the evolution of the Company and its
patient-centric model of innovation.
Development Pipeline Overview and Update
Viridian is developing multiple product candidates to treat
patients who suffer from thyroid eye disease (TED), a debilitating
auto-immune disease that causes inflammation and fibrosis of the
orbit and tissues surrounding the eye which can lead to proptosis,
or bulging of the eyes, redness and swelling, double vision, pain,
and potential blindness. TED significantly impacts quality of life,
imposing a high physical and mental burden on patients. There is
currently one Food and Drug Administration (FDA)-approved treatment
for TED, which is an intravenously administered monoclonal antibody
that targets the insulin-like growth factor-1 receptor
(IGF-1R).
Viridian’s most advanced product candidate is VRDN-001, an
intravenously administered anti-IGF-1R monoclonal antibody licensed
from ImmunoGen, Inc. This antibody had previously been developed in
oncology as AVE-1642 and studied in over 100 patients. The
pharmacokinetics, pharmacodynamics, safety, and tolerability data
from that clinical program has informed the Company’s plans to
further evaluate VRDN-001 in TED. Manufacturing is underway and the
Company expects to file an IND in the fourth quarter of 2021, with
initial proof of concept data in patients expected in the second
quarter of 2022.
Viridian’s second product candidate, VRDN-002, is a distinct
anti-IGF-1R antibody that incorporates half-life extension
technology and is intended for subcutaneous administration.
VRDN-002 manufacturing is underway, and the Company expects to file
an IND before 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 VRDN-002 in healthy volunteers. Data from this trial
is expected in mid-year 2022 and the Company expects to initiate
the dosing of patients later in 2022.
Viridian is also pursuing multiple hypotheses within the
VRDN-003 program that may offer additional improvements to the
class of IGF-1R targeted therapeutic antibodies. In addition, the
Company continues to advance its efforts beyond IGF-1R and TED and
is focused on opportunities that will leverage validated
mechanisms, technologies, and modalities to bring new therapeutic
options to patients underserved by today’s options. The most
advanced of these programs is VRDN-004, a therapeutic antibody
program currently in discovery stage. The Company also continues to
evaluate other targets and indications for a future VRDN-005
program.
2020 Financial Results
Cash Position and Runway: Cash, cash equivalents and short-term
investments were $127.6 million as of December 31, 2020,
compared to $30.1 million as of September 30, 2020 and
$26.8 million as of December 31, 2019. Viridian believes
that its current cash, cash equivalents and short-term investments
will be sufficient to fund its operations into the second half of
2023.
Revenue: Revenue was $0.1 million during the fourth quarter and
$1.1 million for the year ended December 31, 2020, compared to $0.9
million and $4.5 million, respectively for the comparable periods
in 2019. The decrease in revenue was primarily due to a decrease in
research and development activities related to legacy microRNA
assets that were reimbursable to the Company under a prior
collaboration agreement.
Research and Development Expenses: Research and development
expenses were $15.3 million for the fourth quarter of 2020 and
$28.3 million for the year ended December 31, 2020,
compared to $8.4 million and $34.8 million, respectively
for the comparable periods in 2019. The increase in research and
development expenses during the fourth quarter was primarily
attributable to increased license fees related to the Company’s
license agreement with Xencor. The year over year decrease in
research and development expenses was primarily attributable to a
decrease in clinical and related manufacturing development
activities primarily associated with the Company’s legacy microRNA
programs and decreases in personnel related costs including
restructuring charges in 2020. These decreases were partially
offset by an increase in licensing fees primarily attributable to
the Company’s license agreement with Xencor.
Acquired In-Process Research and Development (IPR&D)
Expense: Acquired IPR&D expense was $69.9 million during the
fourth quarter of 2020 and for the year ended December 31,
2020. IPR&D expense resulted from the acquisition of private
Viridian Therapeutics in October 2020. The acquisition cost
allocated to acquired IPR&D with no alternative future use was
recorded as expense at the acquisition date. No acquired IPR&D
expenses were incurred in 2019.
General and Administrative Expenses: General and administrative
expenses were $5.5 million for the fourth quarter of 2020 and
$13.3 million for the year ended December 31, 2020,
compared to $2.5 million and $11.6 million, respectively
for the comparable periods in 2019. The fourth quarter and year
over year increases in general and administrative expenses were due
primarily to increases in professional and personnel related costs,
including consulting and contract labor.
Net Loss: The Company’s net loss was $90.7 million, or
$23.07 per share, for the fourth quarter of 2020, and
$110.7 million, or $31.13 per share for the year ended
December 31, 2020, compared to $10.1 million, or $4.69
per share, for the fourth quarter of 2019 and $41.9 million,
or $20.04 per share for the year ended December 31, 2019.
Shares Outstanding: As of March 15, 2021, Viridian had
30,886,700 shares of common stock outstanding on an as-converted
basis, which included 7,230,651 shares of common stock and
23,656,049 shares of common stock issuable upon the conversion of
354,823 shares of preferred stock.
Conference Call Information
The Viridian Therapeutics management team will host a conference
call and webcast today at 4:30 p.m. ET to provide corporate updates
and discuss the Company’s financial results for the fourth quarter
and year ended December 31, 2020. To access the call, please dial
877-407-0789 (domestic) or 201-689-8562 (international) and provide
the passcode 13717079. A live webcast of the call will be available
on the Investors section of the Viridian Therapeutics website at
www.viridiantherapeutics.com and a replay of this conference call
will be available approximately one hour after its completion.
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 an anti-IGF-1R monoclonal antibody in development for
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 Boulder,
Colorado, and Waltham, Massachusetts. Learn more about Viridian and
our 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
Viridian’s expectation, strategy, 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, including
the therapeutic potential and clinical benefits thereof, and
pipeline, 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 the effects
from the COVID-19 pandemic on the company’s clinical activities,
business and operating results; uncertainty and potential delays
related to clinical drug development; smaller than anticipated
market opportunities for the company’s product candidates;
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; and those risks set forth under the caption
“Risk Factors” in the Company’s Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission (SEC) on November 12,
2020 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 EndedDecember
31, |
|
Year EndedDecember 31, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenue: |
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
54 |
|
|
$ |
837 |
|
|
$ |
735 |
|
|
$ |
4,308 |
|
Grant revenue |
|
— |
|
|
43 |
|
|
315 |
|
|
153 |
|
Total revenue |
|
54 |
|
|
880 |
|
|
1,050 |
|
|
4,461 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
15,254 |
|
|
8,417 |
|
|
28,304 |
|
|
34,794 |
|
General and administrative |
|
5,537 |
|
|
2,534 |
|
|
13,265 |
|
|
11,646 |
|
Acquired in-process research and development |
|
69,861 |
|
|
— |
|
|
69,861 |
|
|
— |
|
Total operating expenses |
|
90,652 |
|
|
10,951 |
|
|
111,430 |
|
|
46,440 |
|
Loss from operations |
|
(90,598 |
) |
|
(10,071 |
) |
|
(110,380 |
) |
|
(41,979 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest and other income |
|
36 |
|
|
123 |
|
|
173 |
|
|
941 |
|
Interest and other expense |
|
(180 |
) |
|
(170 |
) |
|
(508 |
) |
|
(835 |
) |
Net loss |
|
(90,742 |
) |
|
(10,118 |
) |
|
(110,715 |
) |
|
(41,873 |
) |
Change in unrealized gain
(loss) on investments |
|
— |
|
|
(3 |
) |
|
(8 |
) |
|
3 |
|
Comprehensive loss |
|
$ |
(90,742 |
) |
|
$ |
(10,121 |
) |
|
$ |
(110,723 |
) |
|
$ |
(41,870 |
) |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(90,742 |
) |
|
$ |
(10,118 |
) |
|
$ |
(110,715 |
) |
|
$ |
(41,873 |
) |
Net loss per share, basic and diluted |
|
$ |
(23.07 |
) |
|
$ |
(4.69 |
) |
|
$ |
(31.13 |
) |
|
$ |
(20.04 |
) |
Weighted-average shares used to compute basic and diluted net loss
per share |
|
3,932,917 |
|
|
2,158,695 |
|
|
3,557,065 |
|
|
2,089,094 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Viridian Therapeutics, Inc.Selected
Financial InformationCondensed Consolidated
Balance Sheet Data(amounts in
thousands)(unaudited) |
|
|
|
December 31, |
|
2020 |
|
2019 |
|
|
|
|
Cash and cash equivalents |
$ |
45,897 |
|
|
$ |
24,846 |
|
Short-term investments |
$ |
81,742 |
|
|
$ |
1,999 |
|
Total assets |
$ |
131,255 |
|
|
$ |
30,262 |
|
Notes payable, inclusive of
current portion |
$ |
— |
|
|
$ |
8,304 |
|
Total liabilities |
$ |
11,218 |
|
|
$ |
14,508 |
|
Total stockholders’
equity |
$ |
120,037 |
|
|
$ |
15,754 |
|
|
|
|
|
|
|
|
|
Viridian Therapeutics (NASDAQ:VRDN)
過去 株価チャート
から 6 2024 まで 7 2024
Viridian Therapeutics (NASDAQ:VRDN)
過去 株価チャート
から 7 2023 まで 7 2024