CytoDyn Inc. reports developments for leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor. The company is a clinical-stage oncology issuer focused on CCR5 biology in difficult-to-treat cancers, including metastatic triple-negative breast cancer and metastatic colorectal cancer.
Recurring news includes clinical and translational data presentations, Phase 2 colorectal cancer study updates, expanded access activity for triple-negative breast cancer, and preclinical work in glioblastoma. Company updates also cover financing actions used to support leronlimab development and corporate webcasts addressing scientific, operational, clinical, and financial progress.
CytoDyn Inc. (OTC.QB: CYDY) announced positive results from its Phase 3 trial of leronlimab for treating critically ill COVID-19 patients. The study showed a 24% reduction in mortality and a 6-day shorter hospital stay compared to placebo. Additionally, the probability of being 'discharged alive' at Day 28 was 28% for leronlimab patients against 11% for the placebo group. The Company is in discussions with regulatory agencies to expedite approval. These outcomes highlight leronlimab’s potential as a safe and effective treatment for this vulnerable patient group.
CytoDyn Inc. (OTC.QB: CYDY) announced a new “universal shelf” registration statement on Form S-3 with the SEC, replacing the previous registration expiring on March 7, 2021. This allows CytoDyn to maintain registration of unexercised warrants and provides flexibility for future capital access. No immediate plans to offer securities exist, and no sales can occur until the registration becomes effective. The shelf registration has been active since 2016, enabling timely capital market access.
CytoDyn Inc. (OTC.QB: CYDY) has unblinded the data from its CD12 clinical trial for COVID-19 and expects to conclude discussions with regulatory agencies within 2 to 3 weeks. The trial involved 394 patients and evaluated the efficacy of Vyrologix™ (leronlimab-PRO 140). The FDA has granted leronlimab Fast Track designation for treatment of critical illnesses, including a combination therapy for HIV and metastatic triple-negative breast cancer. The company anticipates refiling its Biologics License Application in the first half of 2021.
CytoDyn (OTC.QB: CYDY) announced its collaboration with Chiral Pharma Corp. to provide 200,000 vials (100,000 doses) of leronlimab for potential sales in the Philippines, specifically targeting COVID-19 patients. The company seeks a Compassionate Special Permit (CSP) for registration, aiming to conduct trials and gather data from Philippine patients receiving the treatment. CytoDyn's Phase 2 clinical trial for COVID-19 showed significant results, with expectations to release more data soon. The FDA has granted Fast Track designation for leronlimab for critical medical conditions.
CytoDyn Inc. (OTC.QB: CYDY) announced an investment community webcast on October 20, 2020, at 2:00 pm PT to discuss the Data Safety Monitoring Committee's recommendations following an interim analysis of 195 patients in its Phase 2b/3 clinical trial for severe-to-critical COVID-19. The webcast will feature a presentation and a Q&A session. The event is accessible via the company's website and will be archived for 30 days after the event.
CytoDyn Inc. (OTC.QB: CYDY) announced an upcoming investment community webcast on October 20, 2020, to discuss recommendations from the Data Safety Monitoring Committee (DSMC) based on an interim analysis of the Phase 2b/3 trial for severe-to-critical COVID-19. Key management, including President Nader Pourhassan, will provide insights into a potential regulatory path forward. The webcast will feature a presentation followed by a Q&A session. Access will be through CytoDyn's corporate website, with replay available for 30 days.
CytoDyn (OTC.QB: CYDY) announced the appointment of Chiral Pharma Corporation to register leronlimab (PRO 140) for potential COVID-19 treatment approval in the Philippines. The company is conducting Phase 2 and Phase 3 trials for COVID-19, with interim results expected mid-October. Leronlimab has received Fast Track designation for indications in HIV and metastatic triple-negative breast cancer. The drug has shown promising results in multiple clinical trials, significantly reducing HIV viral load and tumor metastasis.
CytoDyn Inc. (OTC.QB: CYDY) announces its 2020 Virtual Annual Meeting of Stockholders, scheduled for September 30, 2020, at 9:30 am PT. Due to health concerns from the coronavirus pandemic, in-person attendance is not allowed. Stockholders can log in to participate via the provided webcast link, and questions can be submitted online during the meeting with the passcode CYDY2020. Dr. Nader Pourhassan, CEO, will present a company overview post-business session, with materials available on the company website.