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 on May 3, 2021, an upcoming webcast scheduled for May 5, 2021, featuring CEO Nader Pourhassan, CMO Scott Kelly, and COO Chris Recknor. The session aims to provide stockholders with updates on the company's priorities, particularly its COVID-19 initiatives and ongoing trials related to COVID-19, NASH, and cancer. Investors can submit questions online for discussion during the one-hour session, which will be accessible through the company's corporate website.
CytoDyn Inc. (OTC.QB: CYDY) has announced plans for a pre-Breakthrough Therapy designation meeting to expedite preparations for a Phase 3 clinical trial involving leronlimab for 22 solid tumor cancer indications. Encouraging results from preliminary trials suggest potential for a reduced trial size. The company is optimistic about leronlimab's ability to control cancer metastasis and its role in immunotherapy. Additionally, CytoDyn is preparing to resubmit its Biologics License Application (BLA) for HIV treatment, following previous setbacks.
CytoDyn Inc. (OTC.QB: CYDY) announced progress on its HIV treatment, leronlimab, following positive results from three ongoing clinical trials. Approximately 120 patients remain in treatment extensions, with no significant safety issues reported over 4-7 years in 66 open-label patients. The company is on track to submit a Biologics License Application (BLA) for HIV therapy by July 2021, aiming to expedite additional indications, including cancer and COVID-19. Leronlimab has shown promise in controlling HIV viral load, indicating a potential breakthrough in treatment options.
CytoDyn Inc. (OTC.QB: CYDY) announced that Scott Kelly, M.D., will present on leronlimab at the Triple Negative Breast Cancer Drug Development Digital Summit 2021 on April 28. This exclusive event aims to discuss leronlimab's potential in treating triple-negative breast cancer (TNBC), with encouraging early indications noted. The FDA has granted leronlimab Fast Track designation for HIV and metastatic cancer indications. CytoDyn is conducting multiple clinical trials to explore its efficacy across various diseases.
CytoDyn Inc. (OTC.QB: CYDY) announced it secured $57 million in financing, with a recent $25 million convertible debt offering. The note has a two-year maturity at 10% interest, convertible at $10 per share. CytoDyn continues to focus on key therapeutic areas, including COVID-19 and HIV, with significant progress in its clinical trials. Key highlights include the expectation of HIV BLA resubmission by Q3 2021 and ongoing trials for long-haulers and NASH. The company has raised nearly $500 million, reflecting strong market confidence.
CytoDyn Inc. (OTC.QB: CYDY) has initiated a critical COVID-19 clinical trial protocol in the U.S. and is in discussions to start two similar trials in Brazil. The company submitted a key component of its application for an Interim Order to Health Canada for leronlimab's use in treating COVID-19, expecting to submit the remaining sections soon. Leronlimab is also undergoing trials for HIV and metastatic cancer, showing promise in reducing viral loads and tumor metastases. CytoDyn aims to expedite leronlimab's regulatory approvals and expand its therapeutic applications.
CytoDyn Inc. (OTC.QB: CYDY) announced that former Philippine President Joseph Estrada was treated with leronlimab under a Compassionate Special Permit for COVID-19. As he remains hospitalized, CytoDyn continues to supply leronlimab to the Philippines, collaborating with Chiral Pharma to potentially expand the permit. CEO Nader Pourhassan highlighted progress in trials for HIV and cancer, including plans for a resubmission of the Biologics License Application for HIV. Leronlimab's FDA Fast Track designations support its use against HIV and metastatic cancer, with positive outcomes in earlier trials.
CytoDyn Inc. (CYDY) has signed an exclusive supply agreement with Chiral Pharma Corporation to distribute 200,000 vials of leronlimab for critically ill COVID-19 patients in the Philippines under a Compassionate Special Permit. This rapid partnership aims to expedite treatment availability. CytoDyn is also working to leverage clinical trial data to seek Emergency Use Authorizations (EUAs) in other countries experiencing COVID-19 surges. The company's ongoing trials include those for HIV, metastatic breast cancer, and post-COVID syndromes, highlighting its diverse therapeutic approach.
CytoDyn Inc. (OTC.QB: CYDY) announced that its COVID-19 long-haulers study, known as CD15, is fully enrolled with 56 patients, surpassing expectations. This Phase 2 trial aims to evaluate the safety and efficacy of Vyrologix™ (leronlimab) for treating Post-Acute COVID Syndrome (PACS). Results are anticipated in July, with the trial concluding in early June. Given the pandemic's scale, an estimated 20-60 million patients could benefit from effective treatments. The FDA has previously granted Fast Track designation to leronlimab for HIV and metastatic cancer therapies.
CytoDyn Inc. (OTC.QB: CYDY) is delivering leronlimab to a Philippine hospital for 28 critically ill COVID-19 patients under a new Coordinated Special Project (CSP). The company is negotiating the potential future delivery of 100,000 vials to the Philippines. CytoDyn has received Fast Track designation from the FDA for leronlimab for HIV and metastatic cancer. The company has completed several clinical trials, including a pivotal Phase 3 trial for HIV, and is conducting trials for NASH and post-acute COVID-19 symptoms. CytoDyn aims to refile its Biologics License Application by mid-2021.