Cytodyn Inc Stock Price, News & Analysis

CytoDyn Inc. (OTCQB: CYDY) has commenced the pivotal Phase 3 COVID-19 trial in Brazil, treating the first patient with leronlimab, a CCR5 antagonist. The trial targets 612 patients needing oxygen support across 35 sites. An interim analysis will occur 28 days after enrolling 245 patients. The trial aims to provide ANVISA with data for potential approval. CEO Nader Pourhassan expressed optimism about the trial and highlighted the team's past successes. The company continues to explore leronlimab for HIV, metastatic cancer, and other conditions, with promising results in clinical studies.

The Nominating Stockholders of CytoDyn Inc. (CYDY) have nominated five director candidates for the Company’s Board. They responded to CYDY's September 3, 2021 release, claiming it misrepresented a voluntary stipulation filed by the Nominating Stockholders in ongoing litigation. They argue that CYDY’s actions are a distraction from management issues and an attempt to prevent shareholders from voting for an alternative slate. The Nominating Stockholders emphasize their commitment to securities laws and encourage shareholders to focus on significant issues affecting the Company.

CytoDyn Inc. (OTCQB: CYDY) will host a webcast on September 8, 2021, at 1:00 pm PT to discuss recent trial data, particularly from the mTNBC trials, and updates on COVID-19 and NASH trials. The management team, including CEO Nader Pourhassan and CMO Scott Kelly, will also address the status of the resubmission of the BLA for HIV. Participants are encouraged to submit questions in advance via email. The webcast will be available for listening on CytoDyn's corporate website and will be archived for 30 days after the event.

The Board of Directors of CytoDyn (OTC-PINK: CYDY) addressed the recent Court Order regarding the activist group led by Paul Rosenbaum and Bruce Patterson. The Court found that their email solicitations violated SEC rules, mandating compliance with federal securities laws. CytoDyn's Board emphasized the group's pattern of misleading shareholders and failing transparency. They urged shareholders to disregard future communications from the group and clarified the validity of their nominations for the annual meeting scheduled for October 6, 2021.

A group of long-time stockholders of CytoDyn Inc. (OTC: CYDY) has criticized the company's current leadership for their destructive public relations campaign and inability to secure FDA approval for Leronlimab. They argue that these actions have damaged the company's value and credibility, urging fellow shareholders to vote for their five experienced director nominees using the WHITE proxy card. The group claims their leadership will implement strategies to restore value and generate revenue while emphasizing the importance of shareholder votes.

CytoDyn Inc. (OTCQB: CYDY) announced the appointment of Dr. Seenu Srinivasan as Executive Director-CMC Regulatory Affairs, bringing over 30 years of regulatory and drug development experience. Dr. Srinivasan previously served at Regeneron Pharmaceuticals, where he led the CMC strategy for the approved drug Dupixent. His expertise encompasses process development, formulation, and regulatory filing, which are crucial for advancing CytoDyn's investigational monoclonal antibody, leronlimab, aimed at treating HIV, metastatic cancer, and other conditions. The company emphasizes the significance of this appointment in achieving its strategic goals.

A group of long-time stockholders of CytoDyn Inc. (CYDY) filed a lawsuit in the Delaware Court of Chancery to allow voting on their nominated director candidates. The lawsuit challenges CYDY's previous actions to block shareholders from voting and claims the current Board has failed to secure FDA approval for Leronlimab, impacting the Company's value. The Group seeks to reinvigorate CYDY's leadership with five highly qualified nominees to pursue FDA approval and enhance shareholder value.

CytoDyn Inc. urges shareholders to ignore proxy cards from the Rosenbaum/Patterson Group, claiming these may result in disenfranchised votes. The company emphasizes that its board rejected the Group's director nominations, which are considered invalid. A federal court has granted CytoDyn an expedited discovery in ongoing litigation regarding the Group's proxy materials. The company reassures shareholders they do not need to take action at this time and will provide official proxy materials shortly, allowing votes to be retracted if previously cast on the Group's card.

CytoDyn Inc. (OTCQB: CYDY) announced promising results from its Phase 1b/2 trials of leronlimab for metastatic triple-negative breast cancer (mTNBC) patients. After treatment, 73% of the 30 patients showed a decrease in Circulating Tumor Cells (CTC), correlating with a significant increase in modified Progression Free Survival (mPFS) by 400%-660% and modified Overall Survival (mOS) by 570%-980%. The company plans to update its Breakthrough Therapy designation application for mTNBC.