CYTODYN INC - CYDY STOCK NEWS

CytoDyn Inc. (OTCQB: CYDY) has announced the FDA's acceptance of its revised "Rolling Review" timeline for the resubmission of its Biologics License Application (BLA) for leronlimab, targeted at highly treatment-experienced HIV patients. The Company expects to resubmit the non-clinical and CMC sections in November 2021, with the clinical section anticipated in early 2022. Leronlimab aims to serve multiple indications, including HIV and metastatic triple-negative breast cancer, having shown significant promise in clinical trials.

CytoDyn Inc. (OTCQB: CYDY) has initiated its pivotal Phase 3 trial (CD16) for critically ill COVID-19 patients in Brazil, treating the first patient recently. An interim analysis will assess outcomes after 127 patients are enrolled. The trial focuses on patients needing mechanical ventilation and utilizes leronlimab, a CCR5 antagonist. Compared to prior trials, new dosing methods via IV could enhance drug absorption. The company aims to file for Emergency Use Authorization after promising initial results from prior studies indicate significant survival benefits.

CytoDyn Inc. (OTCQB: CYDY) will host a webcast for the investment community on October 26, 2021, led by key executives, including CEO Nader Pourhassan. The 30-minute presentation will be followed by 60 minutes of Q&A. CytoDyn seeks investor participation ahead of its Annual Meeting set for October 28, 2021, urging votes using the blue proxy card. The company continues its development of leronlimab, which has received FDA Fast Track designation for HIV and metastatic cancer treatment. Leronlimab has shown promise in clinical trials, including significant efficacy in HIV and cancer models.

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).