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CytoDyn Inc. (CYDY)

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Previous Close5.0800
Open5.1800
Bid0.0000 x 0
Ask0.0000 x 0
Day's Range4.9000 - 5.1800
52 Week Range0.7900 - 10.0100
Volume1,802,388
Avg. Volume4,247,412
Market Cap2.991B
Beta (5Y Monthly)-0.63
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target EstN/A
  • REMINDER: CytoDyn to Hold Webcast on January 6 to Provide Timelines for Clinical and Regulatory Developments, Submission of 4 HIV BLAs and EUA Requests for COVID in Different Countries
    GlobeNewswire

    REMINDER: CytoDyn to Hold Webcast on January 6 to Provide Timelines for Clinical and Regulatory Developments, Submission of 4 HIV BLAs and EUA Requests for COVID in Different Countries

    Correction to inclusion/exclusion criteria for eIND authorizationVANCOUVER, Washington, Jan. 04, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, and Mahboob Rahman, M.D., Ph.D., Chief Scientific Officer, will host an investment community webcast on Wednesday, January 6, 2021.Management will provide an update on recent clinical and regulatory developments regarding COVID-19 clinical trials, along with other strategic priorities:1) BLA/MAA submissions to Health Canada, MHRA, EMA, and US FDA 2) HIV prevention trial/monotherapy trial 3) Potential revenue from HIV and manufacturing forecast 4) HIV Cure - amfAR 5) EUA submission timelines to same four agencies for COVID-19, if CD12 Trial results are  supportive of an EUA 6) Long-hauler clinical trial and potential data readout timelines 7) NASH trial and potential interim analysis timeline 8) Cancer trial Breakthrough Therapy designation potential timelines 9) GvHD trial status 10) Stroke/MS new trials in 2021 11) NASDAQ uplisting statusManagement will also provide approximately 30-45 minutes to address questions submitted online by analysts and investors.Date:  Wednesday, January 6, 2021 Time:  1:00 pm PT / 4:00 pm ET Dial-In:  None. Questions:   * Prior to the webcast, questions can be submitted online to CYDY_Team@cytodyn.com * During the webcast, questions can be submitted through the webcast link below.This is a “listen only” webcast, which can be accessed via CytoDyn’s corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days. Participants are encouraged to go to the website 15 minutes prior to the start of the webcast to register, download and install any necessary software. The webcast can also be accessed via the following link:https://78449.themediaframe.com/dataconf/productusers/cydy/mediaframe/42723/indexl.htmlThe replay will be available approximately 60 minutes after the conclusion of the webcast and can be accessed via the above link until February 6, 2021.Correction: In a press release dated December 30, 2020, the Company specified certain subgroups of patients will be excluded from the eIND authorization process.  The second subgroup is now corrected as: “mechanically ventilated with PEEP >=15 cmH20 with Pa02/FiO2 <=150 mmHg.”CONTACTS Investors: Michael Mulholland Office: 360.980.8524, ext. 102 mmulholland@cytodyn.com

  • CytoDyn Announces Research on Critically Ill COVID-19 Patients Published in Journal of Translational Autoimmunity
    GlobeNewswire

    CytoDyn Announces Research on Critically Ill COVID-19 Patients Published in Journal of Translational Autoimmunity

    Manuscript entitled: “Disruption of CCR5 Signaling to Treat COVID-19-Associated Cytokine Storm: Case Series of Four Critically Ill Patients Treated with Leronlimab,” by Nicholas J. Agresti, M.D.VANCOUVER, Washington, Dec. 30, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today a research manuscript submitted by Nicholas J. Agresti, M.D. has been accepted for publication in the Journal of Translational Autoimmunity. Dr. Agresti’s research findings were based on four critically ill COVID-19 patients treated with leronlimab under eIND.The manuscript Ms. No. JTAUTO-D-20-00043R1 is entitled “Disruption of CCR5 Signaling to Treat COVID-19-Associated Cytokine Storm: Case Series of Four Critically Ill Patients Treated with Leronlimab.” The research paper can be accessed here.Nicholas J. Agresti, M.D., stated, “We are very thankful with the clinical outcomes for these patients and are honored by the acceptance of our research for publication. We hope this work will continue to advance research to understand how to effectively mitigate the effects of COVID-19.”Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are appreciative of Dr. Agresti’s work and view his publication as a validation of leronlimab as an important potential therapeutic in the treatment of seriously ill COVID-19 patients. Dr. Agresti’s four patients were treated with leronlimab under eIND. All four patients were on mechanical ventilator and they fully recovered.”About Coronavirus Disease 2019 CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients). In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use. In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.  The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the Company is suspending its Phase 2 trial for acute GvHD. About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Company’s questions concerning its recent Biologics License Application (“BLA”) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.CytoDyn is also conducting a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com.Forward-Looking Statements  This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict.  Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those 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 vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable 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 unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.CONTACTS Investors: Michael Mulholland Office: 360.980.8524, ext. 102 mmulholland@cytodyn.com

  • FDA Accepts Protocol for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients
    GlobeNewswire

    FDA Accepts Protocol for Adding an Open-Label Extension to CytoDyn’s Phase 3 Trial for Severe-to-Critical COVID-19 Patients

    The agency also provided specific guidance for inclusion/exclusion criteria for patients seeking leronlimab under eIND authorizationVANCOUVER, Washington, Dec. 30, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the U.S. Food and Drug Administration (“FDA”) has accepted the protocol submitted on December 28 for adding an open-label extension to its Phase 3 trial (“CD12”). Hospitals previously participating in the CD12 trial now have the option of enrolling additional eligible patients, with all patients receiving leronlimab. Treatment for eligible patients will continue until further notified by the FDA and/or CytoDyn.The FDA also provided specific guidance for the benefit of physicians seeking access to leronlimab under an eIND for COVID-19 patients, which must first meet the inclusion/exclusion criteria of the CD12 study. The agency specified certain subgroups of patients will be excluded from the eIND authorization process: mild/moderate COVID-19, mechanically ventilated with PEEP <15 cmH20 with Pa02/FiO2 >150 mmHg and on vasopressors >48 hours.Mahboob Rahman, M.D., Ph.D., Chief Scientific Officer and Head of Clinical Development for CytoDyn, stated, “We appreciate the specificity of the guidance from the FDA, as this will facilitate a prompt and efficient review and approval process for qualified patients. As the pace of this pandemic is not slowing down in the foreseeable future, providing a safe and effective treatment is the highest priority for all.”Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are most thankful to the FDA for their acceptance of the open-label extension to allow access to leronlimab for eligible patients and the definitive criteria provided for the benefit of physicians considering an eIND for their COVID-19 patients.”About Coronavirus Disease 2019 CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. CytoDyn completed enrollment of 390 patients in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population and expects to release results in mid-January 2021.About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients). In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use. In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the Company is suspending its Phase 2 trial for acute GvHD. About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Company’s questions concerning its recent Biologics License Application (“BLA”) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.CytoDyn is also conducting a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at www.cytodyn.com. Forward-Looking Statements  This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those 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 vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable 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 unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.CONTACTS Investors: Michael Mulholland Office: 360.980.8524, ext. 102 mmulholland@cytodyn.com