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) has signed an exclusive supply and distribution agreement with Biomm S.A. to sell leronlimab in Brazil, pending regulatory clearances. Leronlimab, a CCR5 antagonist, is being investigated for various conditions including Long-Hauler COVID-19, NASH, and cancer. Biomm aims to provide leronlimab to critically ill COVID-19 patients. CytoDyn's CEO expressed excitement over this advancement for Brazilian patients and a long-term partnership with Biomm.
CytoDyn Inc. (OTC.QB: CYDY) has announced a rescheduled investment community webcast set for April 7, 2021. Key executives, including CEO Nader Pourhassan, will update stockholders on recent company activities, particularly focusing on COVID-19 initiatives and multiple ongoing clinical trials. The event aims to address investor inquiries, providing a platform for questions that can be submitted online. This 60-minute webcast is available on CytoDyn’s corporate website and will be archived for 30 days.
CytoDyn Inc. (OTC.QB: CYDY) announced the completion of a $25 million convertible debt offering with an institutional investor. The note matures in two years at 10% interest and is secured by company assets. This financing aims to support the availability of leronlimab for potential COVID-19 treatment approvals. CytoDyn is also progressing in its clinical trials for HIV and metastatic cancer. The FDA has granted Fast Track designation for leronlimab in treating HIV and metastatic triple-negative breast cancer, highlighting its promising therapeutic potential.
CytoDyn Inc. (OTC.QB: CYDY) announced significant improvement in the first Compassionate Special Permit (CSP) patient in the Philippines after receiving a 700 mg injection of Vyrologix™ (leronlimab) for COVID-19. The patient, previously on high-flow oxygen, was discharged from the hospital just 35 hours post-injection. CytoDyn plans to supply at least 100,000 doses of leronlimab pending Emergency Use Authorization in the Philippines. The company highlights the treatment's potential, backed by previous clinical trials showing a significant reduction in mortality among critically ill COVID-19 patients.
CytoDyn (CYDY) announced an investment community webcast on April 6, 2021, hosted by its executive team, including CEO Nader Pourhassan and CMO Scott Kelly. The update will cover the company's recent initiatives related to COVID-19, as well as ongoing trials for NASH and cancer treatments. The session will be approximately 60 minutes long, allowing for questions submitted by analysts and investors. Participants can access the webcast on CytoDyn's corporate website and a replay will be available for 30 days afterwards.
CytoDyn Inc. (OTC.QB: CYDY) announced it will extend its leronlimab treatment for critically ill COVID-19 patients to four weeks after achieving an 82% reduction in mortality at 14 days in earlier trials. The FDA has received a new protocol as the company pursues emergency use authorizations in multiple countries, including Brazil, the UK, and Canada. CytoDyn's leronlimab also has Fast Track designation for HIV and metastatic cancer treatment.
The company plans to enroll patients and believes longer treatment will improve survival rates in patients with COVID-19.
CytoDyn Inc. (CYDY) reported significant findings from its CD12 trial of leronlimab for COVID-19 patients. Analysis showed an 82% reduction in mortality at 14 days when leronlimab was added to standard care (p=0.0233), with treated patients 5 times more likely to survive. The 7-point ordinal scale ranking improved by 400% (p=0.021). Previous analyses indicated benefits in combination with common treatments, with a 6.5% absolute reduction in mortality at day 28 and a 5.5-day reduction in hospital stay. CytoDyn aims to expedite regulatory submissions to utilize leronlimab for critically ill patients.
CytoDyn Inc. (OTC.QB: CYDY) announced promising results from a case study and its completed Phase 3 trial of leronlimab for critically ill COVID-19 patients. The study published in the Journal of Translational Autoimmunity shows significant recovery rates, with five out of six ECMO patients improving post-treatment. The FDA has granted Fast Track designation for leronlimab in two indications: HIV and triple-negative breast cancer. CytoDyn aims to refile its Biologics License Application in 2021, focusing on the therapeutic potential of leronlimab in various conditions.
CytoDyn Inc. (CYDY) announced the Philippines FDA granted a Compassionate Special Permit for its COVID-19 treatment, leronlimab. This approval allows shipping leronlimab to Chiral Pharma Corporation in the Philippines. The company aims to seek Emergency Use Authorization (EUA) for broader access and is exploring treatment for COVID-19 long-hauler patients. Leronlimab is currently being developed for various indications, including HIV and metastatic triple-negative breast cancer, and has shown promise in clinical trials with significant viral load reduction.
CytoDyn Inc. (OTC.QB: CYDY) announced an investment community webcast scheduled for March 22, 2021. Management will update stockholders on its recent COVID-19 related filings for Conditional EUA with the FDA, Interim Order in Canada, and accelerated reviews in the U.K., along with plans for similar submissions in Brazil and the Philippines. The update will also cover ongoing clinical trials related to COVID-19, NASH, and cancer, as well as expected timelines for BLA submissions for HIV in the U.S., Canada, and the U.K.