ALOX12

-- New Financing of $24 Million Fully Funds the Phase 2 Clinical Program for Lead Candidate VLX-1005 -- Company Prepares to Evaluate VLX-1005 in Heparin-Induced Thrombocytopenia (HIT) FREDERICK, Md., June 20, 2023 (GLOBE NEWSWIRE) -- Veralox Therapeutics, a clinical-stage biotechnology company developing a new class of therapies targeting the 12-lipoxygenase (12-LOX) pathway to address some of medicine’s most persistent and serious immune-mediated diseases, today announced the appointment of Jonathan Mow as the company’s new chief executive officer. Mr. Mow’s appointment comes as Veralox secured $24 million in funding to advance VLX-1005 through a Phase 2a proof-of-concept study evaluating its impact on heparin-induced thromobcytopenia (HIT), a life-threatening rare disease caused by an aberrant immune response to heparin exposure. The investment round included new investors Pappas Capital and NYBC Ventures and existing investors Hatteras Venture Partners, Sanofi Ventures, JDRF T1D Fund and Genesys Capital, amongst others. In conjunction with the financing, the company welcomes Peter Young of Pappas Capital as a director and Meg Wood of NYBC Ventures as an observer. “VLX-1005 has great promise to revolutionize the treatment of HIT and other immune-mediated diseases,” Mr. Young said. “I am thrilled to join the board at such an exciting time, and to be working with a leader of Jonathan’s caliber to move into later stages of clinical development.” “This is an exciting time for Veralox as we head into our proof-of-concept Phase 2 study with VLX-1005 for HIT, a serious complication subsequent to heparin exposure that is accompanied by significant morbidity and mortality,” Mr. Mow said. “Our novel approach with 12-LOX inhibitors has great potential in this and other diseases and I would like to thank our investors for their financial support of our important mission and giving me the opportunity to lead this world-class effort and team.” Mr. Mow brings more than 25 years of accomplishments in biotechnology management to Veralox, most recently serving as CEO of PhaseBio Pharmaceuticals. At PhaseBio, he led the company’s scientific and business transformations, guiding the company from early-stage research to Phase 3 development, and through a successful initial public offering in 2018. Earlier in his career, Mr. Mow served as vice president, business development for Amylin Pharmaceuticals until its sale to Bristol-Myers Squibb in 2012; was co-founder and vice president, commercial and business development of Corus Pharma, Inc. until its acquisition by Gilead Sciences in 2006; and headed business development for PathoGenesis Corporation until its acquisition by Chiron Corporation in 2000. Mr. Mow has also held positions in marketing, marketing research and sales at Bristol-Myers Squibb, Wyeth/Lederle International and Syntex Laboratories. He holds a B.S. in mechanical engineering from University of California at Berkeley and M.B.A. from Carnegie Mellon University’s Tepper School of Business. About Veralox TherapeuticsVeralox Therapeutics Inc. is the clinical leader in developing first-in-class therapeutics targeting 12-lipoxygenase, pioneering a new class of therapies that treat the underlying pathologies of serious immune-inflammatory diseases with unmet medical needs. The company’s lead candidate, VLX-1005, is in development for the treatment of patients with heparin-induced thrombocytopenia (HIT). VLX-1005 has orphan drug designation in the United States and has been awarded Fast Track Designation by the U.S. Food and Drug Administration. Second generation therapeutic products are under development for type 1 diabetes and other immune-mediated and inflammatory diseases. For more information, visit our website: https://veralox.com/. Media Contact: Lisa GuitermanScient PR202-330-3431Lisa.guiterman@gmail.com

Development program for VLX-1005, a novel small molecule 12-LOX inhibitor, awarded Fast Track designation by US Food and Drug Administration FREDERICK, Md., June 13, 2022 /PRNewswire/ -- Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat serious immuno-inflammatory diseases with significant unmet medical needs, today announced favorable results from the Company's Phase 1 clinical program for VLX-1005, a novel 12-LOX inhibitor being developed for the treatment and prevention of heparin-induced thrombocytopenia and thrombosis (HIT). Veralox also announced that VLX-1005 has been awarded Fast Track Designation by the U.S. Food and Drug Administration (FDA). "Completion of our Phase 1 study for VLX-1005 together with announcement of Fast Track Designation for this program represent important milestones that reflect the new levels of momentum we are achieving with our clinical strategy at Veralox," said Michael Hanna, Chief Medical Officer at Veralox. "We look forward to continuing our development of VLX-1005 to address the underlying pathology of HIT, a disease that has not seen innovation in available therapies in over 20 years." Veralox completed a Phase 1a study consisting of a single ascending dose (SAD) portion and a multiple ascending dose (MAD) portion that was designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of VLX-1005. In this study VLX-1005 was found to be well tolerated with no reports of serious adverse events (SAEs), dose-limiting toxicities (DLTs) or discontinuations; adverse events (AEs) were infrequent and mild. Data analyses revealed dose linear increases in key PK metrics approaching dose proportionality with no upper limits on tolerability to the maximum dose tested. Veralox also completed a Phase 1b drug-drug interaction (DDI) study of VLX-1005 in conjunction with argatroban, an anticoagulant that is approved for the treatment of HIT in the U.S. This study was designed to evaluate the effects of coadministration of VLX-1005 and argatroban on subject safety and on a range of exploratory biomarkers. The study showed that co-administration of VLX-1005 with argatroban was well tolerated with no SAEs; AEs were infrequent and mild. Preliminary analysis of the PK and PD (as measured by APTT) data revealed no evidence of DDI. The FDA granted Fast Track designation for the VLX-1005 program on May 27, 2022, following an End-of-Phase 1 meeting with the Agency. The company will use the results of the successful Phase 1 studies as well as the standards inherent in Fast Track designation and previously announced Orphan Drug designation to finalize the design of the planned Phase 2 clinical program for VLX-1005 in HIT. About Veralox Therapeutics VERALOX Therapeutics Inc. () is the clinical leader in developing first-in-class therapeutics targeting 12-lipoxygenase, pioneering a new class of therapies that treat the underlying pathologies of serious immune-inflammatory diseases with unmet medical needs. The company's lead candidate, VLX-1005, is in development for the treatment of patients with heparin-induced thrombocytopenia (HIT). Second generation therapeutic products are under development for type 1 diabetes and other immune-mediated and inflammatory diseases. Media contact: Bill Berry Berry & Company Public Relations 212 253 8881 [email protected] SOURCE Veralox Therapeutics

FREDERICK, Md.--(BUSINESS WIRE)-- Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced it submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a Phase 1 clinical trial of VLX-1005, a first-in-class small molecule inhibitor of 12-Lipoxygenase in development for the treatment of heparin-induced thrombocytopenia (HIT). HIT is an immune complication of heparin therapy resulting in low platelet counts caused by antibodies to complexes of platelet factor 4 (PF4) and heparin. Currently, one third of hospitalized patients in the U.S., or about 12 million a year, receive heparin. HIT is the most important and most frequent drug‐induced type of thrombocytopenia. “This IND submission is a key milestone for Veralox and a tribute to the hard work and dedication of our team to advance VLX-1005 to first in human studies,” said Jeffrey Strovel, Ph.D., Chief Executive Officer of Veralox Therapeutics, Inc. “We are excited to continue our efforts to further develop this groundbreaking new therapy for patients suffering from HIT,” David Maloney, Ph.D., Chief Scientific Officer of Veralox Therapeutics. About VLX-1005 VLX-1005 is a first-in-class and selective small molecule inhibitor 12-Lipoxygenase, a key target within the arachidonic acid pathway. Preclinical data has demonstrated that VLX-1005 halts immune driven platelet activation and thrombosis thus offering the potential of a lifesaving treatment for patients with HIT. About Veralox Therapeutics VERALOX Therapeutics Inc. ( ) is developing first-in-class therapeutics that target the underlying pathologies of diseases with unmet medical needs. The company’s lead candidate, VLX-1005, will be developed initially to treat patients with heparin-induced thrombocytopenia (HIT). Second generation therapeutic products are under development for T1D and other immune-mediated and inflammatory diseases.