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CytoDyn announced it has submitted a dose justification report to the U.S. Food and Drug Administration, which will be followed by an official submission to CytoDyn's IND. This is an integral step in the resubmission process for the Biologics License Application for HIV patients with multiple resistance to current standard of care. The dose justification report is a key component for the BLA and includes receptor occupancy analysis, among other factors, to determine the optimal marketed dose for leronlimab. Following FDA feedback on this critical step, CytoDyn will begin submission of BLA modules by specified timelines in accordance with FDA guidance and approval. Chris Recknor, M.D., CytoDyn's Chief Operating Officer and Head of Clinical Development, commented, "Our team has done a great job and remains focused on the goal of a BLA for HIV. We have a great molecule with many opportunities being evaluated in parallel to the BLA, including COVID, NASH and Oncology. We are on track for the top line report for the COVID-19 long-haulers symptoms/biomarker trial and will soon start two COVID-19 trials in Brazil. Our Phase 2 NASH trial has enrolled the 60th patient on schedule. We are working on our CCR5 solid tumor cancers basket trial and our triple-negative breast cancer dose escalation portion is completed with the main trial beginning in July. We are very excited about all we have ahead of us this year."

CytoDyn announced preliminary results after unblinding the data from its COVID-19 long-haulers clinical trial The purpose of this clinical trial was to assess the safety and efficacy of leronlimab administered as weekly subcutaneous injection in subjects experiencing prolonged symptoms of COVID-19. The primary outcome was change from baseline in daily COVID-19-related symptom severity score through Day 56. Secondary outcomes included progression of COVID-19-associated symptoms through Day 56 compared to baseline. Patient symptoms were self-reported daily throughout the 56-day evaluation period and reported electronically. The symptom scores were rated as severe, moderate, mild, and none. Chris Recknor, M.D., CytoDyn's Chief Operating Officer and Head of Clinical Development, commented, "We are very pleased with the preliminary results from our long-haulers trial, which showed a greater improvement in the leronlimab patient group over placebo in 18 of 24 COVID-19 symptoms. Although the study was not designed to show statistically significant differences due to the small sample size of 56 patients, clinically meaningful improvements in leronlimab over placebo were observed for cough, stuffy/runny nose, shortness of breath, tightness of chest, feeling of fast heartbeat, fatigue, muscle aches/cramps, muscle weakness, joint pain/swelling, chills/shivering, feeling hot or feverish, difficulty in concentration, sleep disturbance/insomnia, headache, dizziness, tingling/numbness, sense of taste, and sense of smell. Of the remaining 6 symptoms, sore throat, exertional malaise, anxiety, nausea, and vomiting had no clinically meaningful change. Diarrhea was worse in leronlimab treated compared to placebo. Biomarkers at multiple timepoints are being analyzed to help determine reasons for response and to provide better insight into the mechanism of action of leronlimab. As in other previous trials with leronlimab, no adverse safety signals were noted. Once our final analysis is performed, we will seek to hold discussions with the FDA regarding next steps."