Business Context and Reporting Period
This Form 8-K is filed by Miragen Therapeutics, Inc. (not Viridian Therapeutics, Inc.) on August 11, 2017, reporting events occurring on August 10, 2017. The filing covers the departure and election of directors, the release of financial results for the three months ended June 30, 2017, and updates on clinical trial progress for product candidates MRG-106 and MRG-201.
Key Financial Metrics
The filing references a press release (Exhibit 99.1) containing financial results for the three-month period ended June 30, 2017. However, the text of this 8-K does not provide specific values for revenue, profit, cash flow, margins, debt, or liquidity. The filing notes that the registrant is an emerging growth company.
Material Changes and Corporate Governance
- Board Resignations: Kyle A. Lefkoff and John W. Creecy resigned from the Board of Directors and all committees effective August 10, 2017. The resignations were not due to disagreements regarding operations or policies.
- Board Appointments: Jeffrey S. Hatfield and Christopher Bowden, M.D., were elected to the Board effective August 10, 2017, to fill the vacancies. Both are deemed independent directors.
- Compensation:
- Mr. Hatfield: $35,000 annual cash for Board service, $7,500 for Audit Committee service, plus an initial option grant for 24,000 shares vesting over 36 months.
- Dr. Bowden: $35,000 annual cash for Board service, $5,000 for Compensation Committee service, plus an initial option grant for 24,000 shares vesting over 36 months.
Clinical Updates and Outlook
- MRG-106 (miR-155 inhibitor): Interim Phase 1 results for mycosis fungoides showed improvement in total skin disease (mSWAT scores). As of July 26, 17 of 18 systemically treated subjects showed improvement; 7 of 9 subjects on treatment for over one month showed 50% or greater improvement. Intravenous infusion appeared more effective than subcutaneous injection. The drug was generally safe and well-tolerated. The company initiated rapid intravenous dosing and plans to evaluate additional oncology indications (T-cell leukemia/lymphoma, diffuse large B-cell lymphoma, chronic lymphocytic leukemia).
- MRG-201 (miR-29 replacement): The Phase 1 trial in induced cutaneous fibrosis is complete. Final results are expected at a scientific conference before year-end. A Phase 2a trial for keloid formation is planned for 2018. Future indications may include fibrotic diseases of the eye and lung.
Investor Verification Checklist
- Review Exhibit 99.1 (Press Release) for specific financial figures (revenue, net loss, cash position) for the quarter ended June 30, 2017, as they are not detailed in the 8-K text.
- Verify the vesting schedule and exercise price of the 24,000 share option grants issued to new directors Hatfield and Bowden.
- Monitor upcoming scientific conferences for the final presentation of MRG-201 Phase 1 data.
- Track the initiation of rapid intravenous dosing for MRG-106 and the expansion into new oncology indications.