Insight Molecular Diagnostics Inc. (IMDX) Earnings

Management highlights

### Graft Assured DX Regulatory Progress - The company submitted Graft Assured DX to the U.S. FDA in late March 2026, and has had productive ongoing engagement with FDA reviewers during the review process. - No clock stoppages have occurred in the review to date, and all discussions have been productive. ### Commercial and Clinical Development - Completed pricing market research with over 200 likely U.S. purchasers, which confirmed the perceived value of Graft Assured DX and supports the company's ability to achieve strong gross margins. First U.S. commercial orders are expected later in 2026. - The Galactic donor-derived cell-free DNA registry study has grown to 34 interested U.S. transplant centers, up from 28 six weeks prior, against a 50-center goal. The first clinical trial agreement has been signed, moving the company closer to enrolling the first patient. - Early non-U.S. progress: a Swiss transplant hospital purchased an initial small batch of Graftassure IQ research-use kits, and first Southeast Asian orders are expected. At least one international center has secured local coverage and reimbursement for the test. ### Global Regulatory Expansion - Received Tuftsud ISO 13485 certification in February 2026. The company is targeting UK regulatory compliance in the coming months, with a planned submission for EU IVDR approval shortly after that. ### Pipeline Expansion - The company's core graft monitoring technology is organ-agnostic, so the kidney transplant assay can be adapted for heart transplant testing with minimal additional development. The company is advancing heart transplant testing development rapidly to enroll the first patient as soon as possible.

Guidance

- Total Q2 2026 revenue is projected at approximately $250,000, consistent with prior guidance. - Q2 2026 cash burn is projected to exceed $9 million, which will be the full-year high watermark, driven by one-time bonuses, working capital needs, and previously incurred FDA submission expenses. - Cash burn is expected to decline to historical levels of approximately $6 million per quarter in the second half of 2026, as one-time FDA program expenses do not recur and working capital conditions improve. Revenue growth will further reduce quarterly cash burn as it ramps. - Long-term target gross margin for Graft Assured DX is 70% or higher, but this level is not expected to be achieved in the first 6-12 months post-commercialization due to initial leader pricing for early adopters and a 10% revenue share obligation to former Chronic IP shareholders. Initial cost of goods sold per result is projected to be slightly under $100, with an ASP in the hundreds of dollars, and per-unit costs will decline over time as volume scales. - EU IVDR review timeline is expected to range from 6 months to 1 year after submission, depending on regulatory backlog, with a clearer timeline available after formal submission. - Heart transplant development investment is already baked into current cash burn and R&D projections; R&D spending will decline in H2 2026 but will remain above 2024 levels to sustain this development work.

Segment performance

Insight Molecular Diagnostics is a molecular diagnostic developer focused on transplant testing, and did not report segmented product revenue for Q1 2026. The company projected Q2 2026 total revenue of approximately $250,000, which is composed mostly of core laboratory services revenue with a very small contribution from Graftassure IQ research-use-only sales. No other segment-level revenue or profit data was provided in the call.

Risks & headwinds

- Regulatory review timelines for FDA and EU IVDR approval are subject to uncertainty, including potential agency backlogs that can extend review periods. - Reimbursement approval in international markets (particularly the EU) is uncertain, and payer decisions can delay commercial adoption even after regulatory approval. - Revenue ramp post-commercial launch is difficult to predict, which creates uncertainty around projected cash burn levels. - Initial commercial adoption rate may be limited by the need to place testing instruments at customer sites, which acts as a near-term rate limiter for sales growth after FDA clearance. - The company will not reach target 70%+ gross margins immediately after launch, due to early adopter pricing and existing revenue share obligations, which may pressure near-term profitability.

Analyst Q&A

• Q: An analyst asks what the company learned from its recent pricing market research, and how gross margins will look in the first 12-24 months post-commercialization as volume ramps. /

  A: The pricing research affirmed the company's prior projections for the $2 billion total addressable market and confirmed purchaser alignment with the company's planned pricing framework, with the Graft Assured DX ASP coming in well into the hundreds of dollars. Initial cost of goods per result will be slightly under $100, with costs declining over time at scale. A 10% revenue share is owed to the former owners of the company's core IP, and the long-term gross margin target is 70% or higher, which is not expected to be achieved for the first 6-12 months due to discounted pricing for early launch customers.

• Q: An analyst asks how quickly kit sales can grow after FDA clearance, and what hurdles remain after approval to begin commercial sales. /

  A: The primary near-term rate limiter is placement of testing instruments at transplant centers. Sites that participated in the FDA clinical trial will be the most likely day-one commercial adopters, as they already have instruments on-site. The company has completed all instrument work to support the FDA program, and will deploy additional instruments through the rest of 2026 to support broader commercial adoption.

• Q: An analyst asks how the company balances registry study participation and near-term commercial wins, and if sites will be excluded from the registry. /

  A: The company is selectively choosing registry sites, and sees registry participation and long-term commercial success as aligned rather than competing. Most centers that join the registry are expected to become long-term commercial kit customers, as the registry introduces centers to the company's testing and lets them build in-house experience ahead of full regulated product launch.

• Q: An analyst asks which market (U.S. or EU) would see larger initial launch volume if both launched at the same time. /

  A: The company notes that solved Medicare reimbursement in the U.S. makes it easier to drive initial adoption. While pent-up clinician demand is strong in Europe, and there are early positive signs of reimbursement progress (including NICE guidance and ongoing advocacy in Germany), widespread adoption will depend on additional payer approvals that are still pending. The company expects the U.S. to lead initial volume if launches are aligned.