Omnix Medical Receives U.S. FDA Approval of a Phase II Trial of its Next-Generation Anti-Infective OMN6

Phase I data show safety and tolerability at clinically significant dose levels New class of anti-infectives to treat infections with Gram-negative bacteria JERUSALEM, Israel, November 20, 2023 — Omnix Medical , a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has approved a planned Phase II trial of the Company´s novel anti-infective OMN6. The multinational, multicenter trial will assess the safety and pharmacokinetics of OMN6 in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC). Omnix Medical´s lead compound OMN6 is a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) is based on a totally novel principle compared to conventional anti-infectives: the compound destroys bacterial cell membranes, enabling a fast and effective onset of action regardless of bacterial genotype or resistance phenotype. In a randomized, double-blind, placebo-controlled, single ascending dose Phase I study with over 80 healthy volunteers, OMN6 has demonstrated excellent safety and tolerability at clinically significant dose levels. Moreover, complete clearance of the drug could be shown, allowing for multiple daily infusions as is common with anti-infective treatments. “We are very pleased that the U.S. FDA has approved our planned Phase II study,” said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical. “As we have seen very encouraging results in our previous Phase I trial, we hope that the Phase II data will confirm these data. This would be a key milestone in the development of a novel class of anti-infectives that are not associated with a development of antimicrobial resistance.” Dr. Niv Bachnoff, CSO of Omnix Medical, added: “We look forward to initiating this Phase II trial in the coming months. Our goal is to provide a potent alternative to conventional anti-infectives and to save the lives of millions of patients worldwide who no longer respond to currently available antibiotics.” About Omnix Medical Omnix Medical was founded in 2015 to address the urgent unmet need for new life-saving anti-infective drugs. Omnix´ proprietary technology eliminates bacteria by mimicking the innate immune system of insects which uses unique molecules to efficiently and selectively kill resistant bacterial strains without toxic effects. This mechanism, which is at the core of Omnix´ technology, kills bacteria upon contact and has successfully evolved over 200 million years. The Company’s lead compound is being developed for the treatment of life-threatening hospital-acquired infections (HIA) and has shown significantly higher potency than currently available treatments. Most importantly, Omnix´ technology prevents the development of new resistances and is thus well positioned to become the first-line-treatment to win the war against AMR. About OMN6 OMN6 is a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) is based on disruption of bacterial cell membranes and is therefore effective regardless of bacterial genotype or resistance phenotype, and unlike conventional bacteriostatic antibiotics, it is fast acting and bactericidal. OMN6 has been optimized from the original AMP by Omnix Medical´s proprietary technology to exhibit not only remarkable efficacy, potency, and safety, but also high stability while maintaining bioactivity. As a result, Omnix Medical believes that its novel peptides can be considered a new class of antimicrobial drugs. OMN6, the Company’s lead compound, is intended for the treatment of life-threatening infections caused by Gram-negative bacteria such as Acinetobacter baumannii. Corporate Contacts Moshik Cohen-Kutner, CEO +972-50-8698218 Niv Bachnoff, CSO +972-54-238-6023 [email protected] Media Inquiries akampion Dr. Ludger Wess / Ines-Regina Buth Managing Partners [email protected] Tel. +49 40 88 16 59 64 / Tel. +49 30 23 63 27 68 Related Links Twitter https://twitter.com/MedicalOmnix LinkedIn http://linkedin.com/company/omnix-medical More To Explore EU-Funded PEPTAMR Project Officially Kicks Off On 9-10 September, the five PEPTAMR consortium partners came together in Athens, Greece, for the first time. The productive two-day kickoff meeting marked the beginning Omnix Medical Celebrates European Research Partnership at the President’s Residence Celebrating Israeli excellence and 30 years of research and innovation partnership between Israel and Europe. Omnix Medical was honoured to take part in a celebration Omnix Medical Launches New Horizon Europe PEPTAMR Infectious Disease Consortium — EUR ~8M grant supports the late-stage clinical development of Omnix’s antimicrobial OMN6 — Leading European partners join forces to advance OMN6 for the treatment Contact Us Name Email Phone Company Message By checking this box, I acknowledge that I have read and accept the Privacy Policy and the Terms of Use , and I agree to the processing of my personal data as described therein. Send Reach US High-Tech Village Givat Ram Campus, Jerusalem Israel 972 25 320 870 /1+ [email protected] (opens email client) Linkedin Twitter A-2-Z - Digital Accessibility and Marketing Cookie Notice Privacy Policy Omnix Medical Ltd. is committed to making its website and all its electronic information easier to use and more accessible for people with disabilities. The company’s website was created and/or updated according to the provisions of the Equal Rights for People with Disabilities Law, 5748-1998, and the delegated legislation stemming from it, and it fully complies with the W3C Web Content Accessibility Guidelines 2.0, AA level. Omnix Medical Ltd. will continue its efforts to constantly improve the accessibility of its website and information in the belief that it is our collective moral obligation to allow seamless, accessible, and unhindered use also for those of us with disabilities. This project has received funding from the European Union under Grant Agreements No 966627 (OMN6) and 101287207 (PeptAMR).

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