CYTODYN INC - CYDY STOCK NEWS

A group of long-term stockholders of CytoDyn Inc. (CYDY) has nominated five director candidates, challenging the current management's effectiveness in securing FDA approval for Leronlimab. They criticize CEO Nader Pourhassan's leadership, alleging distraction tactics to retain positions and compensation. The nominees aim to streamline the FDA approval process and enhance shareholder value. Additionally, a proxy statement has been filed with the SEC for the upcoming shareholder vote, with details available on the company's website.

CytoDyn Inc. (OTCQB: CYDY) is facing a hostile takeover attempt from the Rosenbaum/Patterson Group, which has been accused of misleading shareholders. The Company alleges that the group's updated proxy filings contain misrepresentations and hidden financial backers, including former directors and secretive investment funds. Despite the turmoil, CytoDyn remains focused on advancing its BLA for HIV treatment and initiating COVID-19 trials in Brazil. The FDA has provided feedback on the dose justification report, which is crucial for the BLA resubmission, indicating potential progress in the coming months.

CytoDyn Inc. (OTCQB: CYDY) has received feedback from the FDA regarding its Biologics License Application (BLA) for leronlimab, a CCR5 antagonist. The company plans to address these comments and resubmit the CMC and non-clinical sections by September 2021. CEO Nader Pourhassan expressed optimism about progressing with HIV therapies and upcoming COVID-19 trials in Brazil. Despite previous challenges, including a Refusal to File in July 2020, CytoDyn is focusing on advancing its clinical trials, particularly for COVID-19 long-haulers and HIV treatment.

CytoDyn Inc. (OTCQB: CYDY) has filed a lawsuit against the Rosenbaum/Patterson Group, aiming to prevent the activist group's alleged misleading actions towards shareholders and their proxy contest attempt for Board control. The Company contends that more than 50 aspects of the group's director nomination notice were invalid. CytoDyn claims that the Group's members, including Bruce Patterson, have undisclosed prior ties to the Company and have made misleading statements. The lawsuit emphasizes CytoDyn's focus on advancing its HIV treatment, leronlimab, which has shown promising clinical trial results.

CytoDyn Inc. (OTCQB: CYDY) announced that Brazil’s regulatory authority ANVISA has approved its clinical trial protocol to begin patient enrollment in the CD17 trial for severe COVID-19 patients. This Phase 3 trial, to be conducted by Albert Einstein Israelite Hospital, aims to enroll up to 612 hospitalized patients needing oxygen support to prevent disease progression. An interim analysis will occur after 245 patients are enrolled. CytoDyn’s CEO expressed gratitude for the approval, highlighting the significance of leronlimab in treating COVID-19 and outlining expectations for interim analysis results in 3-4 months.

CytoDyn (OTCQB: CYDY) announced that the director nominations from the Rosenbaum/Patterson Group were invalid due to significant deficiencies in their submission. The group aimed to replace current board members, but their nomination notice failed to comply with company bylaws. Notably, the notice did not disclose the group's past affiliations or conflicts of interest. Consequently, their nominations will not be recognized at the upcoming Annual Meeting on October 28, 2021. CytoDyn is committed to engaging with shareholders and advancing its treatment, leronlimab, for various indications.

CytoDyn Inc. (OTCQB: CYDY) announced a webcast on July 22, 2021, hosted by CEO Nader Pourhassan and other executives to discuss recent clinical trial results for leronlimab, their CCR5 antagonist. The webcast will cover updates on mTNBC, COVID-19, and NASH trials, as well as the status of the BLA resubmission for HIV. Participants can submit questions online before and during the event. The archived webcast will be available for 30 days post-event.

CytoDyn Inc. (OTCQB: CYDY) announced plans to seek FDA guidance on an expedited regulatory path for leronlimab, which has received Fast Track designation for metastatic triple-negative breast cancer (mTNBC). Preliminary Phase 1b/2 trial results show that 72% of treated patients experienced a decrease in CAMLs after a month, correlating with increased progression-free survival by ~300% and overall survival by ~450%. CytoDyn aims to further discuss the regulatory process based on these promising outcomes.

CytoDyn Inc. (OTCQB: CYDY) announced its advancement in the clinical trial of leronlimab for metastatic triple-negative breast cancer, moving from Phase 1b to Phase 2. The trial will administer a 700 mg dosage in combination with carboplatin, with preliminary efficacy data expected in about two weeks. Leronlimab, targeting CCR5, has strong potential across various cancers and has previously achieved primary endpoints in HIV trials. The FDA has granted it Fast Track designation for both HIV and metastatic cancer indications, signaling regulatory support for CytoDyn's innovative approach.