Viridian Therapeutics, Inc.\DE Q2 FY2020 earnings call

• Bill Marshall thanked the miRagen team and discussed progress with cobomarsen, including clinical data in adult T-cell leukemia/lymphoma (ATLL) and cutaneous T-cell lymphoma (CTCL), and preclinical data on MRG-229 for pulmonary fibrosis. - Diana Escolar provided updates on the SOLAR trial for cobomarsen in CTCL, noting 32 patients had uninterrupted treatment, and discussed the Phase 1 trial in ATLL. - Lee Rauch joined as Chief Operating Officer in June. - MRG-229 preclinical data was announced, with plans for nonhuman primate toxicology studies and additional data by year-end.

Revenue for the second quarter of 2020 was $0.2 million, down from $2.5 million in the second quarter of 2019. Research and development expenses were $3.8 million for Q2 2020, compared to $8.6 million in Q2 2019. General and administrative expenses were $2.7 million in Q2 2020, down from $2.9 million in Q2 2019. Cash and cash equivalents ended the quarter at $30.6 million. Net cash used in operating activities was $6.8 million for the quarter, which was down from previous periods.

• Scheduled meeting with the FDA to discuss cobomarsen's development path in ATLL before the end of 2020. - Anticipate announcing new data from the MRG-229 program before the end of 2020. - Current cash and cash equivalents are expected to fund operations through the third quarter of 2021.

• COVID-19 impacting clinical trial activities, including potential delays in data collection for the SOLAR trial as in-person patient visits are required. - Uncertainty around the timing of milestones due to the ongoing COVID-19 pandemic.

Q: First, it seems like the ATLL meeting with the FDA has maybe slipped a little bit again. And I wonder if that's an actual delay? Or are you just still waiting for firm guidance on timing from the agency? Secondly, I guess, given that the majority of SOLAR patients have been able to get uninterrupted treatment, do you have any idea when we might be able to see data? I know we were expecting – pre-COVID, we're expecting it this quarter. Obviously, that's been interrupted. Do you have a sense of how many patients have had interrupted data collection and what that means for overall data timing there? And then lastly, of the multiple partner-ready programs that you've expressed an interest in developing out-license relationship or a collaboration on, can you say which you think has gotten the most interest from the rest of the industry?

A: On the ATLL front, we have a meeting scheduled with the agency, not guiding on exact timing but before end of 2020. On SOLAR, 32 patients have uninterrupted doses, 34 of 37 remain on study; monitoring data quality. On partnerable programs, discussions around MRG-110, remlarsen, and pipeline programs.

Q: I know we're expecting more preclinical data coming from the 239, the next-gen miR-29 mimic program this year. I was wondering if you had, at this point, any more guidance on time line to IND-enabling studies being completed and being able to move forward into the class?

A: Ongoing nonhuman primate study and smaller dose-ranging studies; will provide guidance when data is solid.

Q: Regarding cobomarsen and the communications that you're going to have with the FDA. Do those discussions have any – are they around any potential indication expansions into the other T-cell leukemias or B-cell malignancies?

A: Discussions focused on cobomarsen in adult T-cell leukemia/lymphoma, stepwise approach to broader indications.

Q: Can you remind us of where the clinical trial sites are for SOLAR? And what difficulties do you anticipate encountering in those site visits?

A: SOLAR trial is global, sites in Europe and US; effects include centers reorienting resources for COVID or restricting endpoint monitoring, but 32 patients have uninterrupted dosing.