RNS-60

Reduced hospital stays with more patients discharged to home when treated with RNS60 Results presented during oral presentation at the American Academy of Neurology 2025 Annual Meeting TACOMA, Wash., April 9, 2025 /PRNewswire/ -- Revalesio, a clinical-stage pharmaceutical company developing treatments for acute and chronic neurological disorders, today announced new data from its completed Phase 2 RESCUE clinical trial of RNS60 in acute ischemic stroke patients, demonstrating that patients were discharged on average 4.8 days sooner (p=0.022) from the hospital following treatment with RNS60 plus standard of care endovascular thrombectomy (EVT) than patients who received an EVT alone. Patients who received RNS60 also experienced a reduction in infarct volume growth (brain tissue loss) post-EVT by more than 50% (p<0.05). These results were presented during an oral presentation at the American Academy of Neurology (AAN) 2025 Annual Meeting being held in San Diego, CA from April 5-9, 2025. "There is a lot of discussion currently taking place on improving human health while lowering the cost of healthcare. Given RNS60's Phase 2 results showing reduced brain tissue loss, improved function, and reductions in both hospital stay and the need for long-term care, RNS60 has the potential to greatly benefit patients and their families while lowering the economic burden of stroke," said Bert van den Bergh, Revalesio's Executive Chairman of the Board of Directors, and former President of Neuroscience Products at Eli Lilly and Company. "Revalesio's choice to capture infarct growth post-EVT is a great example of how Phase 2 clinical trials should be designed to properly evaluate cytoprotective drugs with the use of imaging to confirm results," said David S. Liebeskind, M.D., Director of the Neurovascular Imaging Research Core at UCLA. "I congratulate the investigators and Revalesio on their results and look forward to seeing RNS60 in a Phase 3 trial." Oral Presentation Highlights from the oral presentation to include: RNS60 high dose significantly lowered infarct growth by 50% (p<0.05) Subjects treated with RNS60 high dose were discharged 4.8 days sooner from the hospital (p=0.022) 55% of subjects treated with RNS60 high dose were discharged to their home compared to 21% of subjects treated with placebo 72% of subjects on RNS60 high dose were independent compared to 37% on placebo based on dichotomized modified Rankin Scale (0-2) at Day 90 RNS60 was safe and well tolerated "Our Phase 2 trial results sum up a decade's worth of research where the consistency in results has been remarkable. In preclinical models of stroke and traumatic brain injury, RNS60 reduced brain loss by up to 50%," said Greg Archambeau, President of Revalesio and co-inventor of RNS60. "Upon a potential FDA approval, we will be ready to rapidly scale our specialized U.S. manufacturing capability for RNS60 so patients won't have to wait." About the RESCUE Phase 2 Clinical Trial In RESCUE, a multi-center, double-blinded, placebo-controlled, randomized Phase 2 clinical trial, Revalesio evaluated the safety and initial efficacy of RNS60. Eighty-two participants with AIS eligible for endovascular thrombectomy (EVT) were enrolled and received intravenous RNS60 0.5 mL/kg/h (low dose), RNS60 1.0 mL/kg/h (high dose), or placebo starting before completion of the EVT and continuing for 48 hours. The trial had two primary endpoints: safety and mortality. Secondary endpoints for the study evaluated disability based on the well-established modified Rankin Scale (mRS), change in the size of the stroke as measured by MRI at 48 hours, and additional endpoints including Barthel Index, NIHSS, and EQ-5D-5L. About RNS60 RNS60 is an investigational therapeutic being developed to provide disease modifying and potentially restorative treatments for neurological diseases. In preclinical studies, RNS60 activated intracellular signaling pathways to increase mitochondrial biogenesis and function and reduce inflammation. RNS60 safely protected neurons and oligodendrocytes and modulated the activity of immune cells to restore homeostasis. About Revalesio Revalesio is a clinical-stage pharmaceutical company with a vision to change the future of treatment for acute and chronic neurological disorders. The company's lead clinical program for RNS60 is ischemic stroke with additional programs in ALS and other neurological disorders. The company's pioneering technology, founded in physics, addresses fundamental mechanisms involved with proper cellular function to slow disease progression and improve quality of life. For more information, please visit revalesio.com and engage with us on LinkedIn. Media: Lori Murray [email protected] SOURCE Revalesio Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Lowering of infarct growth – brain tissue loss – by 50% in patients treated in less than 12 hours following last known well Lowering of infarct growth correlated with clinically meaningful improvements in several functional stroke measures that evaluate a patient's recovery TACOMA, Wash., Feb. 5, 2025 /PRNewswire/ -- Revalesio, a clinical-stage pharmaceutical company developing treatments for acute and chronic neurological disorders, today announced new analyses of its completed Phase 2 RESCUE clinical trial of RNS60 in acute ischemic stroke (AIS) patients, demonstrating a nominally significant lowering of infarct growth, or brain tissue loss, in patients treated in less than 12 hours following the last time a patient was known to be well. The lowering of infarct growth correlated with clinically meaningful improvements in several functional stroke measures that evaluate a patient's recovery, including the modified Rankin Scale (mRS), Barthel Index (BI), and National Institute of Health Stroke Scale (NIHSS). These results were presented today during an oral presentation at the International Stroke Conference (ISC) 2025 in Los Angeles, CA. "This analysis of the RESCUE trial adds further information regarding the beneficial effects of RNS60, confirming that it has favorable effects on MRI-confirmed ischemic lesion growth that translated into improved clinical outcomes," said Dr. Marc Fisher, Neurologist Beth Israel Deaconess Medical Center, Harvard Medical School, and former World Stroke Organization President. "These are exciting results that suggest that RNS60 should be evaluated in a large Phase 3 clinical trial that will hopefully confirm its benefits and lead to approval as the first therapeutic agent in decades to demonstrate significant efficacy in improving outcomes for acute ischemic stroke patients." In RESCUE, a multi-center, double-blinded, placebo-controlled, randomized Phase 2 clinical trial, Revalesio evaluated the safety and initial efficacy of RNS60. Eighty-two participants with AIS eligible for endovascular thrombectomy (EVT) were enrolled and received intravenous RNS60 0.5 mL/kg/h (low dose), RNS60 1.0 mL/kg/h (high dose), or placebo starting before completion of the EVT and continuing for 48 hours. The trial had two primary endpoints: safety and mortality. Secondary endpoints for the study evaluated disability based on the well-established modified Rankin Scale (mRS), change in the size of the stroke as measured by MRI at 48 hours, and additional standard stroke scales (BI and NIHSS). Highlights from the oral presentation include: RNS60 high dose significantly lowered infarct growth by 50% (nominal p<0.05) when compared to placebo based on imaging performed at approximately 48 hours compared to immediately post EVT both in patients treated within 12 hours and 24 hours of last known well. RNS60 high dose was also numerically better than placebo for each prespecified functional endpoint: Modified Rankin Score at Day 90: 72% of subjects on RNS60 high dose were independent (mRS of 0-2) at Day 90 compared to 37% on placebo. Barthel Index at Day 90: 72% of subjects on RNS60 high dose returned to normal activities of daily living (BI³ 95) compared to 37% on placebo. Patient Health Status at Day 90 (as measured by the EQ-5D-5L Index with 1.0 being ideal) was 0.79 for RNS60 subjects and 0.57 for placebo. RNS60 was safe and well tolerated Details of the oral presentation at ISC 2025 are below: "As the number one cause of disability worldwide, the impact of stroke is staggering, accounting for $721 billion annually to the global healthcare system. Additionally, more than 80% of patients in the U.S. have no treatment options following a stroke, underscoring the significant need for new and effective treatment options," said Bert van den Bergh, Revalesio's Executive Chairman of the Board of Directors, and former President of Neuroscience Products at Eli Lilly and Company. "These highly encouraging results further demonstrate the potential of RNS60 to greatly reduce the likelihood of disability in patients following a stroke, and we plan to advance RNS60 into a Phase 3 clinical trial in order to bring this promising therapy to patients." Initial topline results of the RESCUE Phase 2 study were presented as a late-breaking oral presentation at ISC 2024, which evaluated patients who were 24 hours from last known well. About RNS60 RNS60 is an investigational therapeutic being developed to provide disease modifying and potentially restorative treatments for neurological diseases. In preclinical studies, RNS60 activated intracellular signaling pathways to increase mitochondrial biogenesis and function and reduce inflammation. RNS60 safely protected neurons and oligodendrocytes and modulated the activity of immune cells to restore homeostasis. About Revalesio Revalesio is a clinical-stage pharmaceutical company with a vision to change the future of treatment for acute and chronic neurological disorders. The company's lead clinical program for RNS60 is ischemic stroke with additional programs in ALS and other neurological disorders. The company's pioneering technology, founded in physics, addresses fundamental mechanisms involved with proper cellular function to slow disease progression and improve quality of life. For more information, please visit revalesio.com and engage with us on LinkedIn. Media: Lori Murray [email protected] SOURCE Revalesio Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED