Full Press Release Details
- Topline data from proof-of-concept study of VRDN-001 in patients with chronic thyroid eye disease (TED) are expected in June/July 2023 -
- Selection of lead subcutaneous (SC) program in TED planned for year-end 2023 -
- Company adds multiple senior executives to its leadership team, including its first Chief Commercial Officer, as part of its ongoing growth -
- Conference call today at 4:30pm ET -
WALTHAM, Mass., May 09, 2023 (GLOBE NEWSWIRE) -- 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 and provided a corporate update for the first quarter ended March 31, 2023.
“This is an important year for Viridian as we prepare to report topline data from our proof-of-concept study examining VRDN-001 in patients with chronic TED, and later this year, initiate our THRIVE-2 Phase 3 trial, select our lead SC program, and disclose details of at least one of our preclinical programs,” said Scott Myers, President and CEO of Viridian Therapeutics. “We began 2023 building significant momentum with the VRDN-001 low dose data update in patients with active TED. We added several senior executives to our leadership team, marking a critical step in our mission to deliver potential best-in-class medicines for patients and becoming a fully integrated biopharmaceutical company.”
Program highlights
Thyroid eye disease (TED)
Intravenous (IV) program: VRDN-001Viridian’s lead product candidate, VRDN-001, is a monoclonal antibody which acts 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-003The Company is advancing VRDN-001, VRDN-002, and VRDN-003 as SC program candidates, each with the potential to be developed into a convenient, SC, self-administered pen device. Viridian believes that 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 isan 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 VRDN-006
Corporate highlights
Financial results
Conference call and webcast
The Company will host a webcast and conference call to discuss its first quarter 2023 financial results and provide a corporate update today, Tuesday, May 9, 2023 at 4:30 p.m. ET.
The webcast can be accessed under “Events and Presentations” on the Investors section of the Viridian website atviridiantherapeutics.com. To participate in the conference call, please dial 1-888-330-3622 (domestic) or 1-646-960-0662 (international) and reference code 3961606. A replay of the webcast will be available following the completion of the event.
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 program for intravenously administered VRDN-001, the Company is advancing three candidates for its subcutaneous strategy with the goal of providing a more conveniently administered therapy to patients with TED. Viridian is also developing multiple preclinical assets in autoimmune and rare diseases.
Viridian is based in Waltham, Massachusetts. For more information, please visitwww.viridiantherapeutics.com. Follow Viridian onLinkedInandTwitter.
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, 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, 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 9, 2023 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) | |||||||
| (unaudited) | |||||||
| Three Months Ended March 31, | |||||||
| 2023 | 2022 | ||||||
| Revenue: | |||||||
| Collaboration Revenue - related party | $ | 98 | $ | 216 | |||
| Total revenue | 98 | 216 | |||||
| Operating Expenses: | |||||||
| Research and development | 50,740 | 17,746 | |||||
| General and administrative | 21,831 | 8,359 | |||||
| Total operating expenses | 72,571 | 26,105 | |||||
| Loss from operations | (72,473 | ) | (25,889 | ) | |||
| Other income | |||||||
| Interest and other income | 4,487 | 196 | |||||
| Interest expense | (165 | ) | — | ||||
| Net loss | (68,151 | ) | (25,693 | ) | |||
| Change in unrealized loss on investments | 216 | (778 | ) | ||||
| Comprehensive loss | $ | (67,935 | ) | $ | (26,471 | ) | |
| Net loss | $ | (68,151 | ) | $ | (25,693 | ) | |
| Net loss per share, basic and diluted | $ | (1.61 | ) | $ | (0.98 | ) | |
| Weighted-average shares used to compute basic and diluted loss per share | 42,242,309 | 26,126,092 | |||||
| Viridian Therapeutics, Inc. | |||||||
| Selected Financial Information | |||||||
| Condensed Consolidated Balance Sheets | |||||||
| (amounts in thousands) | |||||||
| (unaudited) | |||||||
| March 31, | December 31, | ||||||
| 2023 | 2022 | ||||||
| Cash, cash equivalents, and short-term investments | $ | 373,858 | $ | 424,550 | |||
| Other assets | 12,784 | 10,541 | |||||
| Total assets | $ | 386,642 | $ | 435,091 | |||
| Total liabilities | 36,093 | 40,027 | |||||
| Total stockholders’ equity | 350,549 | 395,064 | |||||
| Total liabilities and stockholders’ equity | $ | 386,642 | $ | 435,091 | |||