Full Press Release Details
Viridian Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides
Positive data reported from ongoing Phase 1/2 trial evaluating low-dose VRDN-001 in patients
with thyroid eye disease (TED) -
- First patient enrolled in THRIVE Phase 3 trial in patients with active TED, with results expected
- Initial results from the proof-of-concept study of VRDN-001 in patients with chronic TED are
expected in the second quarter of 2023 -
- Selection of lead subcutaneous program in TED planned for year-end 2023 -
- Conference call today at 8:00am ET -
WALTHAM, Mass., March 8, 2023 Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing
potential best-in-class medicines for serious and rare diseases, today announced financial results for the fourth quarter and full year ended December 31, 2022.
2022 was a productive year for Viridian, as we made significant progress and reached multiple important milestones in our TED program with VRDN-001, our lead product candidate. Building on this positive momentum, we are strategically positioned to continue the advancement of our pipeline of TED programs in 2023, said Scott Myers, President and
CEO of Viridian Therapeutics. As part of my recent appointment as CEO, I look forward to advancing our recently initiated THRIVE Phase 3 trial of VRDN-001 in patients with active TED, generating data in
patients with chronic TED, continuing the development of our subcutaneous programs, and beginning to establish our commercial capabilities. These activities support our overall goal to build a fully integrated biopharmaceutical company.
Added Mr. Myers: We also look forward to providing additional details on one of our preclinical programs later this year. Our preclinical programs
have the potential to expand our current pipeline beyond TED and build on our strategy of developing best-in-class medicines that address known limitations of current
Thyroid eye disease (TED)
(IV) program: VRDN-001
Viridian s lead product candidate,
VRDN-001, is a monoclonal antibody believed to act as a full antagonist of insulin-like growth factor-1 receptor (IGF-1R). VRDN-001 is being evaluated in clinical trials for the treatment of active and chronic TED.
Subcutaneous (SC) programs: VRDN-001, VRDN-002, and VRDN-003
The Company is advancing VRDN-001, VRDN-002, and VRDN-003 as SC program candidates. All three candidates have the potential to be developed into a convenient, SC, self-administered pen device. VRDN-001 IV s low-dose data support its potential as a SC candidate. VRDN-002 is a novel anti-IGF-1R monoclonal antibody incorporating half-life extension technology. VRDN-003 is an
anti-IGF-1R monoclonal antibody with the same amino acid sequence as VRDN-001, except for the addition of the half-life extension
technology that is incorporated in VRDN-002.
Preclinical programs in autoimmune and rare disease
VRDN-004, VRDN-005, and
Corporate highlights
Conference call and webcast
The Company will host a webcast and conference call to discuss its fourth quarter and full year 2022 financial results today, Wednesday, March 8 at 8:00
The webcast can be accessed under Events and Presentations on the Investors section of the Viridian website at
viridiantherapeutics.com. To participate in the conference call, please dial 1-877-407-0789 (domestic) or 1-201-689-8562 (international) and reference code 13736278. A replay of the webcast will be available following the completion of the
About Viridian Therapeutics
Viridian Therapeutics is a biopharmaceutical company focused on engineering and developing potential best-in-class medicines for patients with serious and rare diseases. Viridian s expertise in antibody discovery and engineering enables it to develop differentiated therapeutic candidates for previously
validated drug targets in commercially established disease areas.
Viridian is advancing multiple candidates in the clinic for the treatment of patients
with thyroid eye disease (TED). The Company recently initiated its first global Phase 3 trial called THRIVE to evaluate the safety and efficacy of VRDN-001 in patients with active TED. Viridian is
also evaluating VRDN-001 in a Phase 2 proof-of-concept trial in patients with chronic TED. In addition to its intravenously
administered VRDN-001 program, the Company is advancing two candidates for its subcutaneous strategy with the goal of providing a more conveniently administered therapy to patients with TED. Viridian is
developing multiple preclinical assets in autoimmune and rare diseases.
Viridian is based in Waltham, Massachusetts. For more information,
please visit www.viridiantherapeutics.com. Follow Viridian 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,
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, VRDN-002 and VRDN-003 for the treatment of TED; the relationship between the results from the positive
data from the Phase 1/2 clinical trial of VRDN-001 and the results of ongoing or future clinical trials; the timing, progress and plans for the Company s ongoing and future research and clinical
development programs; expectations regarding the timing for data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in the Company s clinical programs; manufacturing risks; the
Company s ability to develop a subcutaneous formulation; the Company s ability to build a fully integrated biopharmaceutical company; 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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(amounts in thousands, except share and per share data)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration Revenue - related party | $ | 105 | $ | 214 | $ | 1,772 | $ | 2,963 | ||||||||
| Total revenue | 105 | 214 | 1,772 | 2,963 | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 39,317 | 22,394 | 100,894 | 56,886 | ||||||||||||
| General and administrative | 9,854 | 6,901 | 35,182 | 25,805 | ||||||||||||
| Total operating expenses | 49,171 | 29,295 | 136,076 | 82,691 | ||||||||||||
| Loss from operations | (49,066 | ) | (29,081 | ) | (134,304 | ) | (79,728 | ) | ||||||||
| Other income | ||||||||||||||||
| Interest and other income | 3,449 | 138 | 4,916 | 318 | ||||||||||||
| Interest expense | (168 | ) | (3 | ) | (486 | ) | (3 | ) | ||||||||
| Net loss | (45,785 | ) | (28,946 | ) | (129,874 | ) | (79,413 | ) | ||||||||
| Change in unrealized loss on investments | 300 | (154 | ) | (233 | ) | (149 | ) | |||||||||
| Comprehensive loss | $ | (45,485 | ) | $ | (29,100 | ) | $ | (130,107 | ) | $ | (79,562 | ) | ||||
| Net loss | $ | (45,785 | ) | $ | (28,946 | ) | $ | (129,874 | ) | $ | (79,413 | ) | ||||
| Net loss per share, basic and diluted | $ | (1.13 | ) | $ | (1.31 | ) | $ | (4.05 | ) | $ | (6.66 | ) | ||||
| Weighted-average shares used to compute basic and diluted loss per share | 40,541,507 | 22,109,530 | 32,087,293 | 11,918,712 |
Viridian Therapeutics, Inc.
Selected Financial Information
Condensed Consolidated Balance Sheets
(amounts in thousands)
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| Cash, cash equivalents and short term investments | $ | 424,550 | $ | 196,965 | ||||
| Other assets | 10,541 | 6,744 | ||||||
| Total assets | $ | 435,091 | $ | 203,709 | ||||
| Total liabilities | 40,027 | 15,993 | ||||||
| Total stockholders equity | 395,064 | 187,716 | ||||||
| Total liabilities and stockholders equity | $ | 435,091 | $ | 203,709 |
Source: Viridian Therapeutics, Inc.
Louisa Stone, 617-272-4604
Manager, Investor Relations
Todd James, 617-272-4691
Senior Vice President, Corporate Affairs and Investor Relations
Matt Fearer, 617-272-4605
Vice President, Corporate Communications