Spectral Medical has reported a 54% rise in revenue for the second quarter as the Canadian company looks ahead to the completion of a confirmatory trial for its septic shock treatment, Toraymyxin.
Spectral notched up $471,000 in revenue, up from $306,000 in the same period last year. Loss for the quarter was $4.4m, a $0.02 per share decrease compared to a loss of $4.2m from Q2 last year. Cash reserves were solidified with funding, with $7.5m now in the coffers compared with just under $3m available at the end of 2023.
Shares in the Toronto Stock Exchange-listed company opened 3% higher on 12 August compared to a pre-announcement market close. Spectral has a market cap of $173.2m.
In its Q2 earnings release, Spectral emphasised its Tigris study – a confirmatory trial evaluating Toraymyxin. Also known as a polymyxin B hemoperfusion (PMX), Toraymyxin is a haemoperfusion device that removes endotoxin, a toxic substance produced by bacteria, from the bloodstream.
The Tigris trial is evaluating the device in patients with endotoxemia and septic shock. Spectral said that a total of 126 patients have been randomised in the trial across the 23 onboarded sites. The study, which has a 150-patient enrolment goal, is slated for completion by December 2024.
PMX is already approved in Japan and Europe and has won breakthrough device designation from the US Food and Drug Administration (FDA). The company gained US rights for the technology from Toray Industries in 2009.
Spectral has been eyeing up partnerships for the therapy and said that it has been “working closely with Baxter” on post-approval marketing plans for commercialisation. This includes branding, pricing and roll-out strategy for the product. The two companies amended an existing agreement earlier this year, resulting in Baxter having exclusive rights to supply and distribute PMX products for ten years following FDA marketing authorisation.
“Baxter has communicated its intention to undertake a broad marketing campaign on day one of FDA approval for PMX,” Spectral announced in its 12 August press release.
Spectral has been working on a sub-study to obtain FDA clearance for haemoperfusion for Baxter’s Prismax device, as it anticipates that this will be the primary intensive care unit (ICU) device used for PMX treatments.
Spectral’s CEO Chris Seto said: “The potential to sustain our current pace of enrolment could see us rapidly advance the trial towards completion in the late 2024 timeframe. Additionally, with the receipt of gross proceeds of approximately $11m since the beginning of April, we have secured funding to finalise Tigris enrollment.”
Spectral’s chief medical officer Dr John Kellum said: “We are committed alongside our trial sites to advancing Tigris and believe PMX, if ultimately approved, will play a major role in reducing the tragic rates of mortality caused by sepsis.”
