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Viridian Therapeutics Announces Encore Presentations at the 2023 Annual Meeting of the American Academy of Ophthalmology

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Viridian Therapeutics, Inc. will present clinical and preclinical data on its pipeline candidates for the treatment of thyroid eye disease (TED) at the AAO 2023 Annual Meeting. The company will highlight VRDN-001, a full antagonist antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), including preliminary clinical results from a Phase 1/2 study. VRDN-001 is currently in Phase 3 clinical studies for active and chronic TED. Viridian will also present preclinical data for VRDN-003, a half-life extended antibody targeting IGF-1R. VRDN-003 is in a Phase 1 clinical study in healthy volunteers. The company expects to select its lead subcutaneous IGF-1R program by year end 2023 and release VRDN-001 Phase 3 topline results in mid-2024.
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 - Oral presentation of intravenous VRDN-001 preclinical and Phase 1/2 clinical data –

- Poster presentations of subcutaneous VRDN-003 preclinical data –

- Subcutaneous program selection for thyroid eye disease (TED) on track for year-end 2023, and VRDN-001 THRIVE Phase 3 topline results in active TED on track for mid-2024 –

WALTHAM, Mass.--(BUSINESS WIRE)-- Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced that multiple abstracts featuring clinical and preclinical data on the company’s pipeline candidates for the treatment of thyroid eye disease (TED) will be presented at the 2023 Annual Meeting of the American Academy of Ophthalmology (AAO 2023), to be held November 3-6, 2023, in San Francisco, California.

In an oral presentation, encore data for intravenous VRDN-001 including preliminary clinical results from a Phase 1/2 study will be highlighted. VRDN-001 is a full antagonist antibody targeting the insulin-like growth factor-1 receptor (IGF-1R) and is currently in two Phase 3 clinical studies for active and chronic TED respectively. Viridian will also present encore preclinical data for VRDN-003, which is a half-life extended antibody targeting IGF-1R that is designed to be a potentially best-in-class, self-administered, infrequent, and low-volume injection for patients. Subcutaneous VRDN-003 is currently in a Phase 1 clinical study in healthy volunteers to evaluate its pharmacokinetics and safety. Viridian is on track to select its lead subcutaneous IGF-1R program by year end 2023 and expects VRDN-001 THRIVE Phase 3 topline results in active TED in mid-2024, both as previously disclosed.

Oral Presentation

Title: VRDN-001, a Full Antagonist Antibody to IGF-1 Receptor for Thyroid Eye Disease (TED): In Vitro Pharmacology and Clinical Phase 1/2 Results
Session: OP02 Neuro-Ophthalmology Original Papers
Information: Saturday, November 4, 9:45 to 10:52 a.m. PST

Poster Presentations

Title: Antagonist Properties of VRDN-003, a Next-Generation, Half-life Extended Antibody to IGF-1 Receptor for Thyroid Eye Disease (TED)
Session: PT10 Oculoplastics Poster Theater
Information: Sunday, November 5, 3:45 to 4:45 p.m. PST
(Presentation time: 4:09 to 4:15 p.m. PST)

Title: VRDN-003, a Novel Half-life Extended IGF-1 Receptor Antibody for Thyroid Eye Disease (TED): Preclinical PK Data
Session: Electronic Poster
Information: On-Demand access available throughout the meeting

About TED

TED is a serious and debilitating rare autoimmune disease that causes inflammation within the orbit of the eye that can cause double vision, pain, and potential blindness. TED is a progressive disease consisting of an initial active phase, followed by a transition to a secondary chronic phase. More than 50,000 and 200,000 people are estimated to suffer from active and chronic TED, respectively, in the United States and Europe.

About Viridian Therapeutics

Viridian 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 TED. The company is conducting two global Phase 3 studies (THRIVE and THRIVE-2) to evaluate the safety and efficacy of VRDN-001 in patients with active and chronic TED. Simultaneously, the company is developing its subcutaneous program strategy with the goal of providing a potentially more conveniently administered therapy to patients with TED. In addition to its TED portfolio, Viridian is advancing a novel portfolio of FcRn inhibitors with the potential to be developed in multiple autoimmune diseases. Viridian is also developing additional 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 and X.

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 our expectations, plans and intentions. Forward-looking statements include, without limitation, statements regarding our expectations, strategies, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our 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 timing, progress and plans for our ongoing or future research, pre-clinical and clinical development programs, including for VRDN-003 and other risks and uncertainties, including those risks set forth under the caption "Risk Factors" in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 8, 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.

Investors:

Louisa Stone, 508-808-2400

Manager, Investor Relations

IR@viridiantherapeutics.com

Media:

Matt Fearer, 617-272-4605

Vice President, Corporate Communications

Media@viridiantherapeutics.com

Source: Viridian Therapeutics, Inc.

FAQ

What is the company presenting at the AAO 2023 Annual Meeting?

Viridian Therapeutics, Inc. is presenting clinical and preclinical data on its pipeline candidates for the treatment of thyroid eye disease (TED).

What is VRDN-001?

VRDN-001 is a full antagonist antibody targeting the insulin-like growth factor-1 receptor (IGF-1R).

What is the current status of VRDN-001?

VRDN-001 is currently in Phase 3 clinical studies for active and chronic TED.

What data will be highlighted in the oral presentation?

The oral presentation will include preliminary clinical results from a Phase 1/2 study of VRDN-001.

What is VRDN-003?

VRDN-003 is a half-life extended antibody targeting IGF-1R.

What is the current status of VRDN-003?

VRDN-003 is currently in a Phase 1 clinical study in healthy volunteers.

When does Viridian expect to select its lead subcutaneous IGF-1R program?

Viridian expects to select its lead subcutaneous IGF-1R program by year end 2023.

When are the VRDN-001 Phase 3 topline results expected?

The VRDN-001 Phase 3 topline results are expected in mid-2024.

Viridian Therapeutics, Inc.

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