Miromatrix Medical Inc.

Miromatrix ended Q2 2023 with unrestricted cash and investments of $20.4 million, which it said is sufficient to operate through Q2 2024. Operating loss was $6.7 million for the quarter and $14.8 million for the six months ended June 30, 2023, versus $8.2 million and $15.4 million in the prior-year periods. Net loss was $6.5 million, or $0.24 per share, for Q2 and $14 million, or $0.56 per share, for the first six months, versus $8.2 million, or $0.40 per share, and $15.4 million, or $0.75 per share, a year ago. Management said the decreases were mainly due to lower research and development lab supply costs and, for net loss, $527,000 of employee retention credits recorded as other income in Q1 2023. Forward-looking guidance remained that a full FDA response should be submitted in the second half of 2023, with potential authorization to treat acute liver failure patients shortly thereafter; the company did not give more specific timing or any revenue guidance.

Jeff Ross emphasized that Miromatrix is prioritizing miroliverELAP because it is the fastest path to treating organ failure patients and provides learning for its fully implantable organ programs. He said the company has already started the two key remaining studies tied to the FDA hold, is nearing completion on the in-life work for the animal study, and expects the biocompatibility study to finish by month-end. His tone was constructive and confident, with repeated emphasis that the team is doing the work needed for a strong FDA response and to move quickly into Phase 1 once cleared.

Jim Douglas said unrestricted cash and investments were $20.4 million at June 30, 2023, and that this should fund operations through Q2 2024. He also noted subsequent receipt of $457,000 of the $527,000 employee retention credit receivable, with the remainder confirmed for upcoming IRS receipt. On the income statement, he cited operating loss of $6.7 million for Q2 and $14.8 million year to date, and net loss of $6.5 million, or $0.24 per share, for Q2 and $14 million, or $0.56 per share, for the six-month period, attributing the improvement mainly to lower R&D lab supply costs and the employee retention credit.

Analysts focused on the timing of the FDA resubmission, the status of the preclinical animal model, and readiness of clinical trial sites. Ross declined to narrow the resubmission timing beyond the second half of 2023 but said seven of eight animals in the safety study were complete and the new mobilization model had been stable when the therapy was delivered. He also said the company had narrowed potential trial sites to eight and prequalified at least five that could be ready upon IND clearance.