Business context and reporting period
This summary is of Miragen Therapeutics, Inc.’s Form 10-Q for the quarter and nine months ended September 30, 2019; the filing is not in the name of Viridian Therapeutics, Inc. Miragen was a clinical-stage microRNA therapeutics company with three clinical candidates: cobomarsen, remlarsen, and MRG-110. It had no approved products and no product-sales revenue.
Key financial metrics
| Metric | Q3 2019 | Nine months 2019 | Comparable 2018 period |
|---|---|---|---|
| Revenue | $0.7 million | $3.6 million | $0.9 million Q3; $7.9 million nine months |
| Research and development | $9.0 million | $26.4 million | $7.4 million Q3; $22.2 million nine months |
| General and administrative | $2.9 million | $9.1 million | $2.7 million Q3; $8.4 million nine months |
| Net loss | $11.2 million | $31.8 million | $9.0 million Q3; $22.4 million nine months |
| Net loss per share | $0.36 | $1.02 | $0.29 Q3; $0.77 nine months |
| Operating cash used | Not separately presented | $28.3 million | $18.7 million nine months |
Revenue was primarily Servier collaboration reimbursements and grant revenue, not product sales. Nine-month revenue declined mainly because 2018 included a $3.7 million Servier development milestone and higher grant revenue. Nine-month operating expenses rose 16%; the loss widened about 42%. No meaningful product gross margin is reported.
At September 30, 2019, cash and cash equivalents were $24.9 million and short-term investments were $9.0 million, totaling $33.8 million. Total liabilities were $15.6 million, including note payable of $9.2 million carrying value ($8.7 million principal), of which $4.0 million was current. Stockholders’ equity was $23.2 million. Cash and cash equivalents declined $7.7 million from year-end 2018; operating cash use was partly offset by $21.2 million of net investing cash inflow, chiefly investment maturities. Financing used $0.7 million, versus $41.9 million provided in the prior-year period, which included a public offering.
Material changes, outlook, and risks
- Liquidity and going concern: Management said available cash, cash equivalents, and investments were expected to fund current operations through Q2 2020, but might not cover the year following issuance of the statements without changes to plans. Management disclosed substantial doubt about the company’s ability to continue as a going concern and said further capital was required. Financing may be unavailable or dilutive; failure to raise funds could force further cuts, delays, or discontinued development.
- Servier termination: Servier gave notice in August 2019 that it intended to terminate its collaboration effective February 1, 2020. Miragen expected to complete specified activities through termination and then regain global MRG-110 rights. It was assessing development options and could not assure a new partner or continued development.
- Restructuring: The August cost plan targeted approximately 26 positions and prioritized cobomarsen and miR-29 mimics, including remlarsen, while reducing new discovery research. $1.1 million of restructuring charges was recorded through September, with approximately $0.4 million more expected in Q4 2019.
- Clinical outlook: SOLAR Phase 2 cobomarsen enrollment and site activation were slower than initially projected; primary endpoint data were expected in the second half of 2021. Remlarsen Phase 2 enrollment was complete, with interim data expected by year-end 2019. MRG-110 Phase 1 results announced in October 2019 showed biomarker findings; management viewed the program as potentially ready for Phase 2, subject to capital availability.
- Other risks and events: On October 28, 2019, Nasdaq notified Miragen that its share price had been below the $1 minimum for 30 consecutive business days, allowing until April 27, 2020 to regain compliance. The filing cited clinical, regulatory, manufacturing, intellectual-property, and financing risks. Disclosure controls were assessed as effective; no material legal proceedings were reported.
Most important facts for investors to verify
- Whether subsequent financing or strategic transactions extended the stated Q2 2020 operating runway and addressed the going-concern uncertainty.
- Servier’s termination date, any resulting MRG-110 rights and obligations, and whether Miragen secured a development partner.
- Actual SOLAR enrollment and data timing, and the reported remlarsen interim results.
- Restructuring completion, realized cost savings, and any additional reductions to programs or staff.
- Nasdaq bid-price compliance and the impact of subsequent equity sales, including dilution and available financing capacity.