Viridian Therapeutics, Inc.

Welcome to the Viridian Therapeutics fourth quarter and full year 2022 conference call. At this time, all participants are on a listen-only mode. Later, we will conduct a question and answer session and instructions will be given at that time. As a reminder, this conference is being recorded. I would now like to hand the floor over to Ms. Louisa Stone, Manager of Investor Relations at Viridian. Please go ahead.

Thank you and welcome everyone to our fourth quarter and full year 2022 conference call. The press release reporting our financial results is available on the investors page of our corporate website at www.viridiantherapeutics.com. Joining me on the call this morning are Scott Myers, our President and Chief Executive Officer, Christian Humer, our Chief Financial and Business Officer, Dr. Deepa Rajagopalan, our Chief Product and Strategy Officer, and Todd James, Senior Vice President, Corporate Affairs and Investor Relations. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements regarding our financial outlook in addition to regulatory, product development, and commercialization plans and research activities. These statements are subject to risks and uncertainties that could cause actual results to materially differ from those forecasted. A description of these risks can be found in our most recent Form 10Q and 10K on file with the SEC. I would now like to turn the call over to Scott Myers, our President and CEO.

Thank you, Elisa. Good morning, everyone. Thanks for joining us today. This is my first quarterly conference call since joining Viridian about a month ago. For those of you who are not familiar with my background, I've spent over 30 years in the pharmaceutical and medical technology space. Earlier in my career, I held senior commercial roles in the U.S. and abroad for Johnson & Johnson and UCB. Most recently, I've served as the CEO at four companies, AMAG, Rainier, Cascadian, and Aircrime. I also have board member and chairman experience from the boards of a few public and private biopharmaceutical companies. Over the past month, since my appointment as CEO at Viridian, I have met with many new colleagues. I have spent time diving deeper into our data and development plans in TED and learning more about our exciting preclinical research, all of which have further strengthened my excitement and resolve for our company. I look forward to building on the company's previous plans and looking for ways to improve our processes and execution. We have a significant opportunity in front of us to bring potential best-in-class IV and subcutaneous administered medicines to patients with TED and expand our research and development efforts beyond TED. Our team has been growing rapidly in key areas to support our late-stage development efforts. We are focused on adding the right resources to support operational execution across the organization. I'm excited to lead and support our teams as we work together to achieve our vision of building Viridian into a fully integrated biopharmaceutical company. Now I'll review the important progress that Viridian made in 2022. Christian Humer, our CFO, will discuss our financial results, and then we look forward to taking your questions. 2022 was an impactful year across our TED programs, especially for our lead program, VRDN001, in the IV form, a humanized monoclonal antibody believed to act as a full antagonist of insulin-like growth factor 1 receptor, or IGF-1R. Over the past several quarters, we have announced a steady stream of positive top-line clinical data from three dose cohorts of the ongoing Phase I and II clinical trial evaluating the safety and efficacy of BRDN001 in patients with active TED. In early January of this year, we reported top-line data from the third low-dose cohort, showing that after just two infusions of BRDN001, 3 mg per kg, patients showed significant and rapid improvements in both signs and symptoms of TET. This data, combined with the prior 10 and 20 mg per kg results we reported in early 2022, reinforce our belief that BRDN001 may offer a differentiated efficacy and similar safety profile relative to tefritumumab. marketed under the brand name of Tepeza, which is the only FDA-approved drug to treat patients with TED. The next set of data that we will provide regarding the VRDN001 IV program will be the initial results from the proof-of-concept study evaluating VRDN001 in patients with chronic TED. We expect to report these results in the second quarter of this year. Now moving to our ongoing and planned phase 3 trials. The positive data from the phase 2 trials support our ongoing global phase 3 Thrive trial, which we initiated in December of 2022 to evaluate the efficacy and safety of VRDN001 in patients with active TED. We were proud to announce the first patient was enrolled in the study, a major milestone for Viridian and a meaningful step toward providing a new and potentially improved treatment option for patients with TED. The trial remains on track, with top-line results expected in the middle of 2024. Following the upcoming Phase 2 data in patients with chronic TED, we plan to start a second Phase 3 trial, known as Thrive 2, in the middle of 2023, with top-line results expected at the end of 2024. I'll turn now to our subcutaneous programs, which include VRDN001, VRDN002, and VRDN003. All three candidates have the potential to be developed into a convenient, patient-friendly, subcutaneous, self-administered pen device, which could significantly reduce the burden of care for patients suffering from TED. The recent low-dose data of BRDN001 support its potential as a subcutaneous program candidate. We are now planning a Phase I trial in Healthy Volunteers with results expected in the fourth quarter of this year. VRDN002 is our novel monoclonal antibody believed to act as a partial antagonist of IGF-1R. This antibody incorporates half-life extension technology, which led to a half-life of up to 43 days in our Phase 1 trial in healthy volunteers, compared to 10 to 11 days for VRDN001 and tepritumumab. Our team is currently planning a proof-of-concept trial to evaluate VRDN002 in patients with active TED with data expected by the end of this year. VRDN003 is an anti-IGF 1R monoclonal antibody with the same amino acid sequence as VRDN001, except for the addition of the half-life extension technology that is incorporated in VRDN002. We are advancing VRDN003 quickly towards an investigational new drug application in the second quarter of 2023, with Phase 1 results in healthy volunteers expected in the fourth quarter of 2023. Following the clinical data, we ultimately plan to select one of the candidates as our lead subcutaneous program before the end of 2023. The selected lead program pivotal trial is planned for the middle of 2024. We look forward to our upcoming presentations on both BRDN001 and BRDN002 at this year's annual meeting of the North American Neuro-Optimology Society, or NANOS, that's being held next week in Orlando, Florida. The team is targeting medical congresses throughout the year where we hope to present our data and further engage with the medical community, allowing us to generate awareness about Viridian and our data in TED amongst the physician and patient communities. As you can see, we have made significant progress in our research and development activities throughout our TED programs. If approved, we believe our intravenous and subcutaneous programs would represent the most complete commercial offering available for treating physicians and patients with TED. As differentiated new entrants with potentially simpler, more convenient dosing regimens, we would expect these therapies to be highly competitive in the new start market. Finally, with respect to our early stage preclinical pipeline, we intend to expand beyond TED in the coming years into rare and autoimmune diseases. The company is currently advancing multiple preclinical programs, including VRDN 004, 005, and 006. Please stay tuned as we plan to provide additional information on at least one of these programs later this year. With that, I will turn the call over to Christian, who will provide a financial review for the fourth quarter and full year ending 2022. Christian?