Spectral Medical (Edtxf) ( (EDTXF) ) has released its Q2 earnings. Here is a breakdown of the information Spectral Medical (Edtxf) presented to its investors.
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Spectral Medical Inc., a late-stage theranostic company, focuses on advancing therapeutic options for sepsis and septic shock, primarily through its unique product, Toraymyxin (PMX), a hemoperfusion device targeting endotoxin removal from the bloodstream. The company is currently in the process of seeking U.S. FDA approval for PMX, which is already approved for use in Japan and Europe.
In the second quarter of 2025, Spectral Medical reported significant clinical and operational progress, particularly with its Tigris trial, a Phase III study evaluating PMX for endotoxic septic shock. The company completed patient enrollment in April and is on track to release topline results in mid-August 2025. These results are anticipated to support the company’s Premarket Approval submission to the FDA.
Key financial highlights include a 73% increase in revenue for the three months ended June 30, 2025, compared to the same period last year, driven by product sales to Vantive for marketing purposes. Operating expenses decreased by 47% for the quarter, primarily due to finance income from a promissory note. However, the company reported a net loss of $1.933 million for the quarter, a decrease from the previous year’s loss of $4.402 million.
Spectral Medical’s strategic initiatives include ongoing collaboration with Vantive for post-approval commercialization planning and a focus on regulatory and clinical execution. The company secured non-dilutive funding through a $10 million promissory note agreement with Vantive, providing financial flexibility for its regulatory processes and commercialization plans.
Looking ahead, Spectral Medical remains optimistic about the potential FDA approval of PMX and is focused on executing its regulatory, clinical, and commercial strategies. The upcoming release of the Tigris trial results represents a critical milestone in the company’s path toward bringing PMX to the U.S. market.