Earnings release
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VIRIDIAN Viridian Therapeutics Reports Third Quarter 2021 Financial Results and Provides Corporate Updates November 4 , 2021 • Submitted an investigational new drug ( IND ) application to the FDA for VRDN - 001 , an IGF - 1R antibody for the treatment of Thyroid Eye Disease ( TED ) and expect to report Phase 1/2 proof of concept clinical data in TED patients in the second quarter of 2022 • VRDN - 002 , a distinct IGF - 1R antibody incorporating validated half - life extension technology , remains on track for an IND filing before year end 2021 , and to deliver initial clinical data in mid - 2022 • Strong financial position after successful follow - on financing with pro forma cash position of $ 213.8 million to support continued company and pipeline expansion . Current cash runway expected to fund operations into 2024 WALTHAM , Mass , Nov. 04 , 2021 ( GLOBE NEWSWIRE ) -- Viridian Therapeutics , Inc. ( NASDAQ : VRDN ) ( the " Company " or " Viridian " ) , a biotechnology company advancing new treatments for patients suffering from serious diseases underserved by today's therapies , today announced financial results for the third quarter ended September 30 , 2021 , and provided corporate updates . " In the third quarter , we made substantial progress strengthening the Company with key leadership hires , a successful financing , and our recent submission of an IND for VRDN - 001 for the treatment of Thyroid Eye Disease , " stated Jonathan Violin , Ph.D. , Viridian's President and CEO . " Our pipeline is rapidly advancing , and we remain on track to report clinical data from our VRDN - 001 and VRDN - 002 programs in the second quarter of 2022 and mid - year 2022 , respectively . In addition , we continue to advance our discovery pipeline to broaden our portfolio of potential best in class therapeutics . " Third 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 TED . This antibody has previously been studied in over 100 oncology patients as AVE1642 , informing plans for rapid development in TED . The Company recently submitted an IND application for VRDN - 001 to the United States Food and Drug Administration ( FDA ) . The Company is planning to initiate a randomized , placebo - controlled Phase 1/2 clinical trial of VRDN - 001 evaluating safety , tolerability , and efficacy . The proposed clinical trial protocol allows for flexibility to assess multiple doses and treatment regimens to inform product profiles that may be superior to currently available therapies . The Company believes this clinical trial could provide key proof of concept data showing clinically meaningful improvements in signs and symptoms of TED , such as proptosis , the defining characteristic of TED , previously shown to be improved by IGF - 1R blockade . The Company expects to announce top line proof of concept clinical data in the second quarter of 2022 from the trial that includes TED patients in two randomized , placebo - controlled cohorts . 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 . Top line data from this trial are expected to be announced in mid - year 2022 and could support feasibility of a low - volume injection 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 pipeline beyond IGF - 1R and TED with a focus on opportunities that will leverage validated mechanisms and technologies 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 for an undisclosed rare disease . The Company continues to evaluate additional opportunities to expand its product pipeline for rare disease indications . Completed Financing : In September 2021 , Viridian announced the closing of an underwritten public offering of 7,344,543 shares of its common stock , which included the exercise in full by the underwriters of their option to purchase up to 1,159,089 additional shares of common stock , at a public offering price of $ 11.00 per share and 23,126 shares of Series B preferred stock at a public offering price of $ 733.37 per share , which are convertible into approximately 1,541,810 shares of common stock , subject to beneficial ownership conversion limits . The net proceeds to Viridian from the offering were approximately $ 91.9 million after deducting underwriting discounts , commissions , and other offering expenses . Scientific Presentations : The Company presented two posters featuring preclinical data on VRDN - 001 and VRDN - 002 at the 90th Annual Meeting of the American Thyroid Association ( ATA ) : • The VRDN - 001 poster showed that the antibody bound IGF - 1R with high affinity and inhibited IGF - 1R signaling with high potency . The in vitro profile of VRDN - 001 suggests favorable efficacy and / or exposure requirements for the treatment of TED patients . The full poster is available at ( click here ) . • The VRDN - 002 poster showed that the antibody demonstrated a desirable PK profile in non - human primates , suggesting potential utility for the treatment of TED . The prolonged half - life of VRDN - 002 suggests potential administration as a