Cytodyn Inc Stock Price, News & Analysis

CytoDyn Inc. (OTCQB: CYDY) announced that the Delaware Court of Chancery has denied an activist group's motion to delay the company's annual meeting scheduled for October 28, 2021. The court emphasized that denying the meeting would harm the company, citing that necessary steps for the meeting had been completed. The company urges shareholders to vote using the BLUE proxy card, disregarding any votes for the activist group's nominees. Only shareholders of record as of September 1, 2021 are eligible to vote.

CytoDyn Inc. (OTCQB: CYDY) announced that shareholders will receive proxy materials this week for the 2021 Annual Meeting on October 28, 2021. Shareholders are urged to vote their shares immediately to ensure their votes count. Following a Delaware Court of Chancery ruling on October 13, the company will disregard director nominations from an activist group. Only votes from shareholders recorded as of September 1, 2021 will be considered valid.

The Investor Group of CytoDyn Inc. (CYDY) expressed disappointment after the Delaware Court of Chancery denied their request to allow stockholders to vote on their five nominated director candidates. They criticized the company’s management for failing to secure FDA approval for Leronlimab and being under investigation by the SEC and DOJ, while also issuing a going concern disclosure. The Investor Group believes new leadership is essential for positive change.

CytoDyn Inc. (OTC-PINK: CYDY) announced that the Delaware Court of Chancery upheld its Board of Directors' rejection of a nomination notice from an activist group led by Paul Rosenbaum and Bruce Patterson. The court ruled that the notice did not comply with the company's by-laws, lacking essential information about supporters and possible conflicts. Consequently, any proxies or votes favoring the activist group's nominees will not be counted at the upcoming 2021 Annual Meeting on October 28, 2021, where shareholders as of September 1, 2021 can vote.

CytoDyn Inc. (OTCQB: CYDY) will provide a business update at the Emerging Growth Conference on October 13, 2021, from 1:00 PM ET to 3:00 PM ET, featuring key executives including Nader Pourhassan, Ph.D., and Scott Kelly, M.D. The presentation will consist of a 30-minute overview followed by a 90-minute Q&A session. CytoDyn is advancing leronlimab, a CCR5 antagonist, with FDA Fast Track designation for treating HIV and metastatic cancer. The livestream can be accessed here.

CytoDyn Inc. (OTCQB: CYDY) announced a new clinical study targeting triple-negative breast cancer (TNBC) utilizing leronlimab, a CCR5 antagonist. Led by Dr. Jangsoon Lee at MD Anderson Cancer Center, the study aims to assess the combination of leronlimab and immune checkpoint blockade (ICB) to enhance treatment efficacy. Leronlimab has received FDA Fast Track designation for HIV and metastatic TNBC. The company plans to explore leronlimab’s potential in various therapeutic areas, including SARS COVID-19 long-haulers and nonalcoholic steatohepatitis (NASH).

CytoDyn Inc. (OTCQB: CYDY) announced key management appointments, including Dr. Christopher Recknor as Senior Executive VP of Clinical Operations and Dr. Nitya Ray as Chief Operating Officer. This restructuring aims to streamline the BLA resubmission process and advance clinical development for leronlimab, a CCR5 antagonist with potential applications in HIV and cancer. The company is also preparing for upcoming trials, including for NASH and COVID-19 long-haulers. Dr. Ray's experience is expected to enhance regulatory submissions, while a strong inventory of leronlimab supports commercial readiness.

CytoDyn Inc. (OTCQB: CYDY) has filed a lawsuit against NSF International and Amarex Clinical Research for breach of contract, alleging failure to provide agreed services and significant delays in obtaining regulatory approval for its investigational drug, leronlimab. CytoDyn claims these failures have resulted in substantial damages and avoidable delays in clinical development. The company has simultaneously initiated arbitration to seek a resolution. Meanwhile, CytoDyn plans to resubmit its Biologics License Application (BLA) by early 2022, with upcoming trial submissions expected in November.

CytoDyn Inc. (OTC-PINK: CYDY) responds to an activist group's plan, asserting it lacks compelling strategic direction for cancer therapy approval. The company emphasizes its progress in developing leronlimab, a CCR5 antagonist, achieving faster advancements than prior ownership. Key points include support from top oncologists, a focus on Breakthrough Therapy designation, and a recent Phase 3 trial clearance in Brazil for IV treatment. CytoDyn warns shareholders against the activist group's misleading statements and conflicts of interest, advising no immediate action.