CMTX-101

Following successful Phase 1b completion, Clarametyx is initiating the Phase 2a portion to assess CMTX-101 as an adjunct to standard of care for chronic infections COLUMBUS, Ohio--(BUSINESS WIRE)-- Clarametyx Biosciences, Inc . (“Clarametyx”), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced that it has completed the initial Phase 1b portion of its clinical trial evaluating the novel immune-enabling antibody therapy CMTX-101 to treat cystic fibrosis (CF)-associated pulmonary infections and is now initiating the Phase 2a portion of the trial. “The CF population is vulnerable to recurrent and chronic lung infections, resulting in the need for interventions that can enable more effective clearance of the bacteria to reduce courses of antibiotics,” said Jerry Nick, MD, Professor in the Division of Pulmonary, Critical Care and Sleep Medicine at the National Jewish Health Department of Medicine, and primary investigator of the study. “We are encouraged by the initial data from the 1b portion of the study, which demonstrated no safety signals with CMTX-101. If clinically confirmed to disrupt bacterial defenses and improve response to antibiotics and natural immunity, CMTX-101 will add a new treatment strategy for people with CF.” This double-blind, randomized, placebo-controlled trial is designed to assess the safety and tolerability, PK, immunogenicity, reduction of pulmonary P. aeruginosa burden, and exploratory endpoints of CMTX-101 as an adjunct therapy to standard of care antibiotics in people with CF. Following the completion of the Phase 1b period and a review of safety data and recommendation by independent safety review committees, the Phase 2a study portion now aims to enroll up to 41 adults diagnosed with CF to evaluate the safety and tolerability of CMTX-101. The company expects to report initial findings from the study in 2025. More information on the study and participating sites is available at ClinicalTrials.gov ( ) using the identifier NCT06159725 . The advancement of the technology in CF-associated infections is aligned with the company’s strategic focus on addressing recalcitrant and chronic infections caused by a range of bacterial pathogens. The company recently concluded an early-stage clinical study of CMTX-101 in community-acquired bacterial pneumonia, generating valuable safety, tolerability, pharmacokinetic and immunogenicity data, along with exploratory efficacy insights. Importantly, the study found no major safety signals, minimal anti-drug antibodies and no neutralizing antibodies. Clarametyx is presenting positive topline findings from the study on October 18th at IDWeek in Los Angeles. “We recognize that recurrent infections are a significant challenge for people living with cystic fibrosis and their families, and believe that a truly novel approach to help the patient’s immune system and today’s antibiotics more effectively clear these infections can not only alleviate the burden on these patients but also support greater antibiotic stewardship and potentially reduce resistance issues,” said David Richards, Chief Executive Officer. “With encouraging early data from the Phase 1b portion of our CF study, we are eager to advance into the next phase of development to demonstrate the strong potential of our technology to redefine treatment paradigms for chronic and persistent infections.” About CMTX-101 CMTX-101 is an immune-enabling antibody therapy designed to precisely and rapidly destroy the universal underlying structure of bacterial biofilms to undermine extracellular bacterial defenses and enable more effective antibiotic and immune intervention. Because the target is universally present across bacteria, the technology can be employed to treat a range of bacterial infections, many of which are characterized by the presence of multiple types of bacteria. CMTX-101 is intended to be administered concomitantly with a wide range of standard-of-care antibiotics that target both Gram-negative and Gram-positive bacteria. The goal of treatment is to dramatically improve the effectiveness of antibiotic therapies and innate immune system effectors, improving the time to resolution of the infection and reducing the need for repeated courses of antibiotics. About Clarametyx Biosciences Clarametyx Biosciences is combating the formidable challenge of persistent and recalcitrant infections through an innovative technology platform targeting the biofilm—a protective layer around bacteria—to enable a more effective immune response and antibiotic intervention. The Columbus, Ohio-based company is building a pipeline of immune-enabling therapies and vaccines for life-threatening bacterial infections associated with biofilms, with a near-term focus on challenging respiratory infections. For more information, visit us on the web or on LinkedIn . Contacts Kellie Hotz khotz@clarametyx.com +1-703-887-6242

Newly established relationship with Cystic Fibrosis Foundation enables clinical studies targeting cystic fibrosis-associated infections COLUMBUS, Ohio--(BUSINESS WIRE)-- Clarametyx Biosciences Inc. (“Clarametyx”), a clinical stage company developing targeted, immune-enabling biologic therapies to counter persistent infections associated with biofilms, today announced the successful completion of a $33 million Series A round. The proceeds from the round will enable the company to accelerate efforts across its pipeline, including specifically to evaluate the potential of Clarametyx’s lead therapeutic candidate CMTX-101 to combat infection in people with cystic fibrosis (CF), a progressive, genetic disease that affects the lungs, pancreas and other organs. Clarametyx was launched in 2020 to advance a novel, immune-enabling antibody technology licensed from Nationwide Children’s Hospital. The powerful non-antibiotic and pathogen-agnostic approach is designed to target and remove universal structural elements within the bacterial biofilm, with the goal of rapid biofilm collapse that renders bacteria vulnerable to immune or antibiotic intervention. The company is evaluating its anti-biofilm technology in both therapeutic and preventive settings to address the global challenge of persistent bacterial infection and antibiotic resistance. “We graciously welcome our new investors and appreciate the continued commitment of our existing investors. This successful raise enables us to expand our clinical evaluations of a platform that we believe will address critical unmet needs in infectious disease management,” said David Richards, Chief Executive Officer. “We are especially grateful for the support of the Cystic Fibrosis Foundation to evaluate this technology’s promise to improve the lives of people with cystic fibrosis, a population particularly vulnerable to persistent bacterial infections. We believe this research will further support the broad applicability of this first-in-class technology.” In coordination with the fundraising, Clarametyx has initiated a Phase 1b/2a clinical trial evaluating its lead candidate, CMTX-101, in people with CF. This study will evaluate the safety and tolerability, PK, immunogenicity, reduction of pulmonary P. aeruginosa burden, and exploratory endpoints of CMTX-101 as an adjunct therapy to standard of care antibiotics in people with CF. More information on the study is available at ClinicalTrials.gov ( ) using the identifier NCT06159725. In addition to new support from the CF Foundation, the Series A financing was led by the Ohio Innovation Fund, with participation from current investors Nationwide Children’s Hospital, Rev1 Ventures, JobsOhio Growth Capital, C Bio Investors and 1776 Fund. “Global health authorities continue to raise alarms about persistent bacterial infections and the rise in antimicrobial resistance associated with overuse of antibiotics,” added William Baumel, Managing Director of lead investor Ohio Innovation Fund. “There is a clear and urgent need for novel technologies that can enhance the effectiveness of today’s antibiotics to address these challenging infections, and the Clarametyx technology represents a compelling strategy that we can propel into broader clinical studies to serve this need.” About Clarametyx Biosciences Clarametyx Biosciences is combating the formidable challenge of persistent and recalcitrant infections through an innovative technology platform targeting the biofilm—a protective layer around bacteria—to enable a more effective immune response and antibiotic intervention. The Columbus, Ohio-based company is building a dynamic pipeline of immune-enabling therapies and vaccines for life-threatening bacterial infections associated with biofilms, with a near-term focus on challenging respiratory infections. For more information, visit us on the web or on LinkedIn.