Spectral Medical (EDT) Q3 2024 earnings summary

Executive summary

• Enrolled 135 out of 150 target patients in the Tigris trial as of Q3 2024, with robust year-to-date enrollment and a focus on completing the trial for FDA submission and potential approval.

• Enrollment slowed in October due to Hurricane Helene's impact on saline supply, shifting expected trial completion to early 2025.

• Ongoing collaboration with Baxter for PMX commercialization and FDA clearance for hemoperfusion on the Prismax device.

Financial highlights

• Q3 2024 revenue was $502,000, up 26% year-over-year; nine-month revenue was $1,641,000, up 33%.

• Product revenue for Q3 2024 increased 47% year-over-year to $274,000; nine-month product revenue rose 50% to $841,000.

• Operating expenses for Q3 2024 rose 158% year-over-year to $10,497,000, mainly due to a $6,075,000 increase in fair value adjustment for derivative liabilities and higher interest expense.

• Net loss for Q3 2024 was $9,995,000 ($0.04/share) versus $3,804,000 ($0.01/share) in Q3 2023; nine-month net loss was $18,556,000 ($0.07/share) versus $9,184,000 ($0.03/share) in the prior year.

• Cash at September 30, 2024 was $5,759,000, up from $2,952,000 at December 31, 2023.

Outlook and guidance

• Tigris trial expected to complete enrollment in Q1 2025 due to supply chain disruptions.

• Sufficient funding secured to finalize Tigris enrollment, with $11 million gross proceeds raised since April 2024.

• Anticipates broad marketing campaign for PMX upon FDA approval, in partnership with Baxter.