VANCOUVER, Washington – (COMMERCIAL THREAD) – CytoDyn Inc. (OTCQB: CYDY) (âCytoDynâ or the âCompanyâ), a biotechnology company in the late stages of development of leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today That shareholders will receive proxy materials starting this week from the Company in connection with its next 2021 Annual Meeting of Shareholders on October 28, 2021 (the âAnnual Meetingâ).
The Company urges all shareholders to vote for their shares immediately on the Company card upon receipt of the proxy to ensure that their votes count in time for the Annual Meeting. Shareholders should expect to be contacted by the Company’s attorney, Morrow Sodali, to provide them with personalized voting assistance.
As a reminder, the Delaware Court of Chancellery ruled that CytoDyn’s board of directors had correctly rejected a notice of appointment presented by the activist group. In the light of the Court’s judgment of 13 Octobere, the Company will not take into account the nominations of directors of the group, and no proxy or vote in favor of its candidates will be recognized or counted at the 2021 Annual Meeting, except for judicial intervention requiring otherwise.
Shareholders of record on September 1, 2021 are entitled to vote at the annual meeting.
If you have any questions or need help voting for your shares, please contact our legal counsel:
Morrow Sodali LLC
Call to shareholders toll free: (800) 662-5200
Banks, brokers, trustees and other candidates Call collect: (203) 658-9400
Email: [email protected]
CytoDyn is an advanced biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 plays a critical role in the ability of HIV to penetrate and infect healthy T cells and appears to be involved in tumor metastasis and immune-mediated diseases, such as NASH.
CytoDyn has successfully completed a pivotal Phase 3 trial using leronlimab in combination with standard antiretroviral therapy in HIV-infected patients who were highly experienced individuals with limited treatment options. CytoDyn has been working diligently to resubmit its BLA for this HIV combination therapy since receiving a refusal to file in July 2020. In July 2021, CytoDyn announced that it had submitted a dose justification report to FDA, an integral step in the resubmission process for its BLA, which it plans to complete by the first quarter of calendar year 2022. CytoDyn has also completed a Phase 2b / 3 investigative trial with the leronlimab used as monotherapy once a week for patients with HIV infection. CytoDyn plans to initiate a registration-led study of the indication for leronlimab monotherapy. If successful, it could support label extension approval. Clinical results to date from two trials have shown that leronlimab can maintain a suppressed viral load in a subpopulation of HIV R5 patients who have chosen to switch from their daily pill regimen to a weekly subcutaneous dose of leronlimab. Several patients in the phase 2b extension arm of leronlimab remained virally suppressed for nearly 7 years, and many patients in our investigative phase 2b / 3 trial succeed two and some four years of monotherapy with a suppressed viral load.
CytoDyn recently completed a phase 2 clinical trial with leronlimab in mTNBC and a phase 2 basket trial in solid tumor cancers (22 different cancer indications) A phase 2 investigative trial for post-acute sequelae SARS COV-2, also known as long-haul COVID-19 and a Phase 2 clinical trial for NASH continues. CytoDyn has already completed a Phase 2 and Phase 3 trial for mild to moderate and severe to critical COVID-19 patients, respectively, for whom CytoDyn did not meet its primary or secondary endpoints, except of the secondary endpoint in the critical phase. diseased subpopulation. More information on www.cytodyn.com.
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and phrases reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes”, “hopes”, “intention”, “esteem”, “expect”, âPlansâ, âplansâ, âanticipatesâ and their variations, or the use of the future, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements regarding leronlimab, its ability to provide positive health results, the possible results of clinical trials, studies or other programs or the ability to continue such programs, the ability to obtain regulatory approval for commercial sales and the market for actual commercial sales. The Company’s forward-looking statements are not guarantees of performance, and actual results could differ materially from those contained or expressed by such statements due to risks and uncertainties, including: (i) regulatory determinations of effectiveness leronlimab to treat human immunodeficiency virus (âHIVâ) patients with multiple resistance to current standard care, COVID-19 patients and metastatic triple negative breast cancer (âmTNBCâ), among other indications, by the United States Food and Drug Administration and various drug regulatory agencies in other countries; (ii) the ability of the Company to raise additional capital to finance its operations; (iii) the ability of the Company to honor its debts; (iv) the Company’s ability to enter into partnership or licensing agreements with third parties; (v) the Company’s ability to identify patients to register for its clinical trials in a timely manner; (vi) the Company’s ability to obtain approval of a salable product; (vii) the design, implementation and conduct of the Company’s clinical trials; (viii) the results of the Company’s clinical trials, including the possibility of adverse clinical trial results; (ix) the market and marketing of any approved product; (x) the existence or development of vaccines, drugs or other treatments which are considered by healthcare professionals or patients to be superior to the Company’s products; (xi) regulatory initiatives, compliance with government regulations and the regulatory approval process; (xii) legal proceedings, inquiries or inquiries affecting the Company or its products; (xiii) general economic and commercial conditions; (xiv) changes in foreign, political and social conditions; (xv) actions or shareholder proposals with regard to the Company, its management or its board of directors; and (xvi) various other matters, many of which are beyond the control of the Company. The Company urges investors to specifically consider the various risk factors identified in its most recent Form 10-K, and any risk factors or caveats included in any subsequent Form 10-Q or 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company assumes no responsibility to update forward-looking statements to reflect events or circumstances that occur after the date of this press release.
CytoDyn intends to file with the SEC a definitive proxy statement and associated proxy card in connection with the proxy solicitation for the Company’s 2021 annual meeting. Details regarding the nominees to the Board of Directors of the Company for election at the 2021 annual meeting will be included in the proxy circular. BEFORE MAKING ANY VOTING DECISIONS, THE COMPANY’S INVESTORS AND SHAREHOLDERS ARE INVITED TO READ ALL RELEVANT DOCUMENTS FILED OR PROVIDED TO THE SEC, INCLUDING THE COMPANY’S FINAL PROXY STATEMENT AND ANY SUPPLEMENTARY INFORMATION IMPORTANT. Investors and shareholders will be able to obtain a copy of the final proxy statement and other documents filed by the Company free of charge on the SEC’s website, www.sec.gov. Shareholders of the Company will also be able to obtain, free of charge, a copy of the final proxy statement and other relevant filed documents by mailing a request to CytoDyn Inc. at 1111 Main Street, Suite 660, Vancouver, Washington 98660.
Participants in the call for tenders
The Company, its directors and certain of its executive officers will be considered as participants in the solicitation of proxies from shareholders with respect to the 2021 Annual Meeting. Information concerning the names of the directors and officers of the Company and their Respective interests in the Company by securities or otherwise are disclosed in the Company’s annual report on Form 10-K for the year ended May 31, 2021, filed with the SEC. July 30, 2021, as amended by Amendment # 1 filed with the SEC on September 28, 2021, and the Company’s definitive proxy statement for the 2020 annual meeting, filed with the SEC on September 1, 2020 To the extent that the holdings of these participants in the securities of the Company have changed from the amounts described in the proxy circular for the 2020 annual meeting, these changes have been reflected on the initial declarations of beneficial ownership on the Form 3 or the change of ownership statements on Form 4 filed with the SEC. These documents can be obtained free of charge from the sources indicated above. Additional information regarding the interests of such participants in any proxy solicitation and a description of their direct and indirect interests, by title or otherwise, will also be included in any proxy circular and other relevant documents to be filed with the SEC, if and when they become available.