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Viridian Therapeutics, Inc.\DE

Viridian Therapeutics, Inc.\DE Q1 FY2020 earnings call

May 10, 2020 · fiscal period ended 2020-03

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Summary

Generated 2020-05-10

Management highlights

  • Entered 2020 with a streamlined development strategy. - Addressed COVID-19 impacts by implementing safety measures for employees. - Advanced lead programs: Cobomarsen CTCL SOLAR Phase II trial had 37 patients enrolled, but COVID affected clinical activities; home infusions implemented. Cobomarsen ATLL Phase I trial showed positive data in a subset of patients, with plans to request an FDA meeting though FDA prioritization of COVID may delay it. Fibrosis programs: MRG-229 preclinical studies advanced with additional NIH funding expected to yield data in Q2; remlarsen Phase II trial for keloid formation is ongoing but COVID may delay topline data; remlarsen also being evaluated in ocular fibrotic conditions with plans to seek a collaboration partner.
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Segment performance

In the first quarter of 2020, revenue was $0.8 million, compared to $0.4 million in the first quarter of 2019. Research and development expenses were $6.1 million, down from $8.8 million in the first quarter of last year. General and administrative expenses were $2.7 million, down from $3.4 million in the first quarter of last year. Net loss was $8 million or $0.18 per share, compared to a net loss of $11.6 million or $0.38 per share in the first quarter of the previous year. Cash and cash equivalents ended the quarter at $36.1 million, up from $26.8 million at the end of 2019. Net cash provided by financing activities was $17.7 million, driven by $18.7 million in net proceeds from sales of common stock partially offset by $1 million in principal payments on notes payable.

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Guidance

  • Current cash and cash equivalents expected to fund operations into Q3 2021. - Cannot provide guidance on timing of SOLAR trial milestones due to COVID impacts. - Still on track to submit a request for an FDA meeting regarding cobomarsen in ATLL in the second quarter, but timing of the meeting is uncertain due to FDA's COVID prioritization.
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Risks

  • COVID-19 impact on clinical trials including patient dosing, site visits, and data collection for endpoints. - Uncertainty around timing of FDA meetings for cobomarsen in ATLL due to FDA's prioritization of COVID-related work. - Potential delays in reporting topline data for remlarsen Phase II trial due to COVID impacts on clinical sites.
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Q&A highlights

Q: How should we think about operating expenses in 2Q and the rest of the year versus Q1 given the COVID delays?

A: Operating expenses decreased to $8.8 million this quarter. Expect similar results next quarter, with decreasing quarterly and year-over-year as workforce and SOLAR trial expenses are expected to be lower.

Q: For the MRG-229 program for IPF, what will we see in the preclinical data and potential use in COVID-19?

A: The 229 data was focused on exploratory toxicology and efficacy studies. Regarding COVID, reviewing potential utility as MiR-29 may be decreased in COVID infection and exploring cobomarsen's role due to its anti-inflammatory activity.

Q: Clarity on the SOLAR trial delays, ORR clock, and ATLL FDA meeting?

A: SOLAR trial has site impacts, but home infusions mitigated some risks. ORR clock is interrupted due to inability to collect mSWAT data remotely. For ATLL, still on track to submit FDA meeting request in Q2, but meeting timing is uncertain due to FDA's COVID prioritization.

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Transcript

May 10, 2020

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