Insight Molecular Diagnostics Inc.

In the second quarter, adjusted EBITDA loss narrowed sequentially to $7.8 million. Cash burn was $10 million in the quarter, which management called the high watermark for the foreseeable future. Andrea James said the company now expects to burn approximately $8 million per quarter in the second half of this year, up from a prior expectation of roughly $6 million per quarter, mainly due to the timing of regulatory costs, registry activities, and launch preparation. The company also said it continues to expect modest revenue in the second half across laboratory services, research use-only kit sales, and GraftAssureCore, but it did not give a revenue figure or EPS. Management reiterated its target to receive FDA marketing authorization for GraftAssureDx later this year, and said the IVDR process in Europe is still planned for the second half of this year.

Josh Riggs struck an optimistic tone, saying the company has “line of sight” to expected FDA marketing authorization and believes the FDA questions were routine and addressable with existing data. He emphasized improving market conditions, including expanded Medicare reimbursement and stronger head-to-head data, and said more than half of the top 10 U.S. transplant centers are already working with the company through the FDA program or registry. He also framed the business as transitioning from product development toward commercialization, with a focus on closing business, growing the top line, and reaching breakeven and then strong profitability.

Andrea James said core spending declined further from the Q4 2025 peak and tied that peak to FDA submission activity. She cited a sequential narrowing of adjusted EBITDA loss to $7.8 million and cash burn of $10 million in Q2, while calling that the high watermark for the foreseeable future. She guided to approximately $8 million of quarterly cash burn in the second half, above the prior roughly $6 million estimate because of regulatory review costs, registry activity, and commercial launch investments. She also said the company is prudently exploring runway-extension options, continuing cost discipline, and sees Medicare’s higher testing frequency as supportive of the company’s stated $2 billion TAM for kitted transplanted organ testing, with that TAM expanding as testing frequency, therapy monitoring, and new organ indications grow.

Analysts focused on the FDA SIR meeting, the potential impact of a delayed authorization on cash runway, the economics of selling to reference labs versus transplant centers, and the implications of the new MolDX LCD for repeat surveillance testing. Management said the SIR meeting is meant to align with FDA before resubmitting data, that the FDA questions were not surprising, and that the registry is the biggest lever to extend runway if needed. On pricing, management said reimbursement is the key anchor, with volume discounts possible but significant pricing power still expected because substitutes are limited. On the LCD, management said it should help both send-out labs and centers that choose to bring testing in-house, since clinicians will want the test in hand to build their own protocols.