Correction to inclusion/exclusion criteria for eIND authorization
VANCOUVER, 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
Cancer trial Breakthrough Therapy designation potential timelines
9) GvHD trial status
10) Stroke/MS new trials in 2021
11) NASDAQ uplisting status
Management 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/prod...ndexl.html
The 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
VANCOUVER, 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
Cancer trial Breakthrough Therapy designation potential timelines 9) GvHD trial status
10) Stroke/MS new trials in 2021
11) NASDAQ uplisting status
Management 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/prod...ndexl.html
The 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
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