<p>The Phase 3 clinical trial <span style="color: rgb(85, 85, 85); font-family: Raleway, sans-serif; font-size: 15px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; display: inline !important; float: none;">clinical data was published in <span style="color: rgb(65, 65, 65); font-family: sans-serif; font-size: 14px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; display: inline !important; float: none;">the peer-reviewed journal</span> </span><i style="box-sizing: border-box; font-style: italic; color: rgb(85, 85, 85); font-family: Raleway, sans-serif; font-size: 15px; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;">Muscle and Nerve <span style="color: rgb(65, 65, 65); font-family: sans-serif; font-size: 14px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: left; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; display: inline !important; float: none;">in December 2021</span></i><span style="color: rgb(85, 85, 85); font-family: Raleway, sans-serif; font-size: 15px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; display: inline !important; float: none;">. The paper, entitled "A Randomized Placebo-Controlled Phase 3 Study of Mesenchymal Stem Cells Induced to Secrete High Levels of Neurotrophic Factors in Amyotrophic Lateral Sclerosis," </span>shows that a<span style="color: rgb(85, 85, 85); font-family: Raleway, sans-serif; font-size: 15px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; display: inline !important; float: none;">lthough the trial did not reach statistical significance on the primary or secondary endpoints,</span> <span style="color: rgb(85, 85, 85); font-family: Raleway, sans-serif; font-size: 15px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; white-space: normal; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; display: inline !important; float: none;">pre-specified and post hoc analyses show a NurOwn-induced treatment effect across both primary and secondary efficacy outcomes in those with less advanced disease.</span> </p><p>An erratum (‘correction’) to the phase 3 NurOwn clinical trial publication was published in Muscle & Nerve in August 2022. The corrected analyses strengthened previously communicated conclusions ; despite not meeting statistical significance in the primary and key secondary outcomes in the total study population, the phase 3 study demonstrated clinically meaningful and statistically significant preservation of ALS function (ALSFRS-R responder analysis and change from baseline) in NurOwn compared to placebo treated participants in the prespecified subgroup with less advanced disease (ALSFRS-R 35 or greater at baseline). Detailed post-hoc analyses that corrected for the ALSFRS-R floor effect (inability of the ALSFRS-R scale to accurately measure progression in more advanced study participants with ALSFRS-R scores at or below 25 at baseline) confirmed the observed treatment benefit. Further analyses demonstrating consistent cerebrospinal fluid biomarker treatment effects above or below the ALSFRS-R threshold of 25, confirmed consistent biological effects of NurOwn treatment vs. Placebo across ALS disease pathways, independent of the observed ALSFRS-R scale limitations in more advanced ALS study participants.</p><p>Phase 3 study results were presented at several scientific venues including:</p><p>A presentation titled “NurOwn® Phase 3 ALS Clinical Trial Update” at the Virtual 12th Annual California ALS Research Summit</p><p>The presentation titled “Relationship UNC13A Single-Nucleotide Polymorphisms to Clinical Outcomes in NurOwn® Phase 3 ALS Clinical Trial” allele presented at the 2022 Muscular Dystrophy and Association Clinical and Scientific Conference focused on pre-specified genetic analyses from the NurOwn® Phase 3 trial in ALS which suggests that NurOwn® treatment may influence disease progression in patients who possess the UNC13A risk allele.</p><p>A scientific abstract titled “CSF Biomarkers Evaluated by Principal Component Analysis in a NurOwn® Phase 3 Clinical Trial” presented at the AAN 2022 Virtual Congress</p><p>A presentation titled “Advancing novel CSF biomarkers to evaluate ALS target engagement & improve therapeutic outcomes” delivered at the ALS Drug Development Summit, Boston MA</p><p>Insights into the ALS Phase 3 primary endpoint leveraging ENCALS model patient prognosis trajectories were presented as a scientific poster at the European Network to Cure ALS (ENCALS) meeting in Edinburgh, Scotland June 1-3, 2022. </p><p>New biomarker analyses from NurOwn’s Phase 3 ALS Trial were presented at the ALS ONE Research Symposium in a presentation titled “The Relationship between CSF Biomarkers and Efficacy of Treatment with NurOwn (MSC-NTF cells).”</p><p>A scientific poster titled “Further Analysis of NurOwn Phase 3 Data Based on Baseline ALSFRS-R Status Clarifies Treatment Outcomes” was presented at the 2022 NEALS Meeting, held November 1-3, 2022 in Clearwater Beach, Florida. The presentation titled, “The Relationship between CSF Biomarkers and Efficacy of Treatment with NurOwn (MSC-NTF cells)” summarized new post hoc analyses that account for ALSFRS-R floor effects and add to the robust body of evidence supporting a clinically meaningful treatment effect with NurOwn in ALS. </p>