Recombinant Human Plasma Gelsolin(BioAegis Therapeutics)

Collaboration aims to identify biological signatures and patient subpopulations most likely to benefit from BioAegis’ recombinant human plasma gelsolin (rhu-pGSN), a novel immune modulator for inflammatory diseases NORTH BRUNSWICK, N.J., April 21, 2026 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering clinical-stage biotech company developing innovative therapies for inflammatory diseases, announces a strategic collaboration with Prenosis ® , a leader in biology-driven artificial intelligence solutions for precision medicine, to evaluate biomarkers and patient subpopulations that may demonstrate enhanced response to BioAegis’ gelsolin therapy. BioAegis’ portfolio is built around plasma gelsolin, a highly conserved and critical immune regulatory protein which rebalances dysfunctional inflammation without suppressing immune function. Under the collaboration, Prenosis will apply its precision medicine platform to analyze biospecimens and clinical data from BioAegis’ ongoing 600-patient Phase 2 clinical trial, BTI-203, which is evaluating recombinant human plasma gelsolin (rhu-pGSN) for the treatment of moderate-to-severe acute respiratory distress syndrome (ARDS) ( NCT05947955 ), a life-threatening condition characterized by severe lung inflammation and respiratory failure. The goal of the collaboration is to identify biological signatures and patient subgroups that may preferentially benefit from gelsolin therapy, further advancing a precision medicine approach to critical care. “Solving the most challenging inflammatory diseases is achievable with the integrated power of host-directed therapeutics and precision analytics,” comments Susan Levinson, Ph.D., CEO of BioAegis. “In collaboration with Prenosis, we expect to transform how inflammatory disease is treated.” Prenosis’ platform integrates multi-dimensional biological data with machine learning to identify clinically meaningful patterns in complex diseases. This collaboration builds on Prenosis’ broader mission to combine diagnostics and therapeutics to enable more personalized treatment strategies in critical care conditions such as sepsis and ARDS. Prenosis’ recent momentum includes a $20 million contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) under the U.S. Department of Health and Human Services (under contract number 75A50125C00016), to support development of its precision medicine platform and AI-enabled companion diagnostics. These efforts are focused on identifying patients most likely to benefit from specific therapies, aligning closely with the objectives of this collaboration. “We are incredibly grateful for the opportunity to partner with the team at BioAegis on this initiative,” states Bobby Reddy, Jr., Ph.D., CEO and co-founder of Prenosis. “This collaboration is one more step towards our vision, and we are excited to work with BioAegis toward a future where treatment decisions are guided by each patient’s unique biological profile.” This collaboration represents an important step toward integrating therapeutic innovation with advanced diagnostic insights, with the goal of improving outcomes in ARDS and other inflammation-driven diseases. BTI-203 is BioAegis’ global Phase 2 study enrolling 600 patients across sites in the United States, Canada, and Europe. This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00067. Gelsolin: A Transformative Approach to Treating Inflammatory Disease Gelsolin is a naturally occurring human protein that plays a critical role in regulating the body’s inflammatory response and supporting innate immune function. Levels of plasma gelsolin are depleted in patients with severe inflammation, and replenishment with rhu-pGSN has the potential to restore immune balance, enhance pathogen clearance, and reduce tissue damage. Gelsolin holds immense promise as a therapeutic intervention for serious acute and chronic conditions due to its multifaceted mechanism of action. In critical illness, gelsolin levels collapse, causing adverse outcomes. Supplementing gelsolin addresses this deficit directly, restoring immune balance while preserving host defense. Gelsolin has been shown in both animals and humans to: Modulate the activation of the NLRP3 inflammasome. Enhance uptake and killing of microbial pathogens by innate immune cells. Bind to and remove harmful inflammatory mediators and toxic actin released from damaged cells. Regulate macrophage phenotype to modulate inflammation. Unlike conventional anti-inflammatory therapies, recombinant gelsolin restores immune balance without suppressing the body’s ability to fight infection. About BioAegis Therapeutics BioAegis Therapeutics Inc. is a clinical-stage private company focused on developing novel therapies for diseases driven by inflammation. The company’s lead product, recombinant human plasma gelsolin (rhu-pGSN), is a host-directed therapy designed to modulate inflammation, enhance immune response, and improve clinical outcomes across a range of acute and chronic conditions. BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. It holds over 40 patents issued for coverage of inflammatory disease, infection, renal failure, neurologic disease, and frailty. BioAegis will also have U.S. biologics exclusivity and has recently filed new IP in areas of unmet need. About Prenosis ® Prenosis, Inc. is a biology-based technology company redefining the standard of care for critical conditions. We believe healthcare should not follow a one-size-fits-all model. Instead, our mission is to tailor healthcare to each patient’s biology through the creation and delivery of integrated diagnostics and therapeutics. We use deep data and AI to build tools that augment clinical diagnosis of critical conditions based on each patient’s unique biological profile. Unlike other AI-driven diagnostics, we go further by developing therapies that help providers deliver personalized care. Our Immunix™ platform powers the development of a variety of AI-based diagnostics, including Sepsis ImmunoScore ® , the first FDA-authorized AI diagnostic tool for sepsis. At Prenosis, we see people differently. For more information, visit us on LinkedIn. Investor Inquiries: Steven Cordovano 203-952-6373 scordovano@bioaegistx.com Media Inquiries: Christine Lagana clagana@bioaegistx.com This press release contains express or implied forward-looking statements, which are based on current expectations of management. These statements relate to, among other things, our expectations regarding management’s plans, objectives, and strategies. These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. BioAegis assumes no obligation to update any forward-looking statements appearing in this press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.

600-patient study to assess efficacy of rhu-pGSN, an immune system regulator that interrupts the NLRP3 inflammasome and boosts macrophage clearance of pathogens. Results from this landmark study expected to inform therapeutic strategies beyond ARDS, positioning rhu-pGSN as a promising intervention across a spectrum of acute and chronic inflammatory diseases. NORTH BRUNSWICK, N.J., May 06, 2025 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for acute and chronic inflammatory diseases, announces that patient recruiting is underway across all 13 targeted countries for its Phase 2 study of rhu-pGSN for the treatment of ARDS. (NCT05947955). The Company’s portfolio is built around gelsolin (GSN), a highly conserved and critical immune regulatory protein which controls dysfunctional inflammation without suppressing immune function. Large Global Phase 2 Clinical Trial of rhu-pGSN UnderwayThe randomized, double-blind, placebo-controlled trial of rhu-pGSN added to standard of care will evaluate the efficacy (survival without organ failure on Day 28) of six doses of rhu-pGSN administered intravenously to hospitalized moderate-to-severe ARDS subjects (P/F ratio ≤150) caused by infection. It will also measure the safety and tolerability of treatment along with secondary outcomes. Sites are recruiting patients in 13 countries including US, Canada, UK and the EU (Belgium, France, Italy, Germany, Netherlands, Spain, and others). Enrollment is targeted for 600 subjects. This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00067. "We are excited with our significant progress in this important study. Focusing this study on the moderate to severe patient who will have severely depleted plasma gelsolin levels promises to address ARDS with a novel approach employing the protein whose role in the body is to balance the inflammation-healing axis,” stated Susan Levinson, Ph.D., Chief Executive Officer of BioAegis. Effectively Treating ARDS Will Alleviate Massive Healthcare BurdenARDS is a condition that can develop as a severe complication of sepsis, trauma, pneumonia or other infectious diseases, resulting in life-threatening lung injury with fluid leakage into the lungs. Breathing becomes difficult, and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system. Even with aggressive medical management, 40% of ARDS patients do not survive, and those who do may suffer from long-term complications, including impaired lung function and reduced quality of life. In the U.S. alone, ARDS affects over 500,000 patients per year, or roughly 10% of all ICU admissions With no effective therapies currently available for ARDS and its high mortality driven by excessive inflammation, there is an urgent need for innovative treatments in this field. Gelsolin: A Multitasking Protein for Complex Inflammatory Conditions Gelsolin holds immense promise as a therapeutic intervention for serious acute and chronic conditions due to its multifaceted mechanism of action. Depleted gelsolin is effectively restored in both animals and humans and has demonstrated the ability to: Modulate the activation of the NLRP3 inflammasome.Enhance uptake and killing of microbial pathogens by innate immune cells.Bind to and remove harmful inflammatory mediators and toxic actin released from damaged cells.Regulate macrophage phenotype to modulate inflammation. Gelsolin is a naturally occurring human protein found in the bloodstream, but is depleted by the inflammatory process. Supplementation with the recombinant gelsolin protein holds promise to address the overzealous inflammatory response associated with ARDS and many inflammatory diseases. About BioAegisBioAegis Therapeutics Inc. is a NJ-based clinical-stage, private company whose mission is to capitalize on a key regulatory component of the body’s immune system, plasma gelsolin, to prevent adverse outcomes in diseases driven by inflammation. BioAegis has the exclusive license to broad, worldwide intellectual property through Harvard-Brigham and Women’s Hospital. It holds over 40 patents issued for coverage of inflammatory disease, infection, renal failure, neurologic disease, and frailty. BioAegis will also have U.S. biologics exclusivity and has recently filed new IP in areas of unmet need. Investor Inquiries:Steven Cordovano203-952-6373scordovano@bioaegistx.com Media Inquiries:Christine Laganaclagana@bioaegistx.com This press release contains express or implied forward-looking statements, which are based on current expectations of management. These statements relate to, among other things, our expectations regarding management’s plans, objectives, and strategies. These statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. BioAegis assumes no obligation to update any forward-looking statements appearing in this press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.