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VIRIDIAN Viridian Therapeutics Reports Second Quarter 2021 Financial Results and Provides Corporate Updates August 11 , 2021 • Completed a successful pre - IND meeting with the FDA for VRDN - 001 , a differentiated monoclonal antibody targeting IGF - 1R for the treatment of Thyroid Eye Disease • On track to submit an IND filing with the FDA for VRDN - 001 in the fourth quarter of 2021 and for key proof of concept clinical data in Thyroid Eye Disease patients in the second quarter of 2022 • First VRDN - 001 clinical trial data has potential to show rapid and substantial reduction in proptosis , the defining symptom of Thyroid Eye Disease • Multiple abstracts accepted for upcoming presentation at the American Thyroid Association ( ATA ) Annual Meeting , highlighting preclinical data for Viridian's differentiated IGF - 1R antibodies • Strengthened management team with appointments of Kristian Humer as Chief Financial Officer and Chief Business Officer and Deepa Rajagopalan , M.D. as SVP of New Product and Portfolio Development • Reported $ 109 million in cash , cash equivalents and short - term investments as of June 30 , 2021 , providing cash runway into 2024 WALTHAM , Mass . , Aug. 11 , 2021 ( GLOBE NEWSWIRE ) -- Viridian Therapeutics , Inc. ( Nasdaq : VRDN ) ( the " Company " or " Viridian " ) , a biopharmaceutical company advancing new treatments for patients suffering from serious diseases and underserved by current therapies , today announced financial results for the second quarter ended June 30 , 2021 , and provided corporate updates . " We continue to make rapid progress with our lead TED program , VRDN - 001 , " said Jonathan Violin , Ph.D. , President and Chief Executive Officer of Viridian . " Following a highly collaborative pre - IND dialogue with the FDA for VRDN - 001 , we remain on track to submit IND filings for both VRDN - 001 and VRDN - 002 to the FDA in the fourth quarter of 2021. This would put us on track to report key Phase 1/2 proof of concept clinical data in TED patients in the second quarter of 2022 for VRDN - 001 , quickly followed by Phase 1 first - in - human data in mid - year 2022 for VRDN - 002 . We are also progressing our discovery programs as we expand our pipeline beyond IGF - 1R and TED , advancing our strategy to discover and develop novel and differentiated monoclonal antibodies . " Second 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 Thyroid Eye Disease ( TED ) . This antibody has previously been studied in over 100 oncology patients as AVE1642 , informing plans for rapid development in TED . The Company recently completed a successful pre - Investigational New Drug ( IND ) meeting with the U.S. Food and Drug Administration ( FDA ) and gained alignment on initial development plans and the proposed design for a randomized , placebo - controlled Phase 1/2 clinical proof of concept trial . This trial will evaluate safety , tolerability , and efficacy with the potential for clinically meaningful improvement in proptosis , the defining characteristic of TED , previously shown to be improved by IGF - 1R blockade . The protocol allows for flexibility to subsequently assess multiple doses and treatment regimens to inform product profiles that may be superior to currently available therapies . The Company remains on track to file an IND in the fourth quarter of 2021 , with initial proof of concept clinical data in TED patients expected in the second quarter of 2022 . 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 . Data from this trial are expected by mid - year 2022 , and could demonstrate feasibility of a low - volume 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 discovery pipeline beyond IGF - 1R and TED , with a focus on opportunities that will leverage validated mechanisms , technologies , and modalities 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 . The Company continues to evaluate additional opportunities to expand its product pipeline for rare disease indications and remains focused on opportunities to leverage validated mechanisms and technologies to bring new therapeutic options to patients underserved by current therapies . Scientific Presentations : The Company announced that it will present preclinical data on VRDN - 001 and VRDN - 002 at the American Thyroid Association ( ATA ) Annual Meeting , which will be held virtually from September 30 to October 3 , 2021. Details of the Company's presentations will be announced in the coming weeks .