CytoDyn Inc.

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CytoDyn, Inc. is a clinical-stage biotechnology company, which focuses on the clinical development of innovative treatments for multiple therapeutic indications based on its product candidate, leronlimab, a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5. Its pipeline includes Leronlimab Clinical Development Pipeline and Long-Acting CCR5 Inhibitor Development Pipeline. The company was founded by Allen D. Allen on May 2, 2002 and is headquartered in Vancouver, WA.

Dr. Recknor will continue to oversee the Company's COVID-19 long-haulers and Phase 2 NASH trials

CytoDyn Appoints Christopher Recknor, M.D., as Chief Operating Officer

RADNOR, Pa., March 15, 2021 /PRNewswire/ -- The law firm of Kessler Topaz Meltzer & Check, LLP is currently investigating potential violations of the federal securities laws on behalf of shareholders of CytoDyn Inc. ("CytoDyn") (OTCMKTS: CYDY).

INVESTIGATION ALERT: Kessler Topaz Meltzer & Check, LLP is Investigating Securities Fraud Claims on Behalf CytoDyn Inc. Investors

RADNOR, Pa.--(BUSINESS WIRE)---- $CYDY #classaction--Kessler Topaz Meltzer & Check, LLP Investigates CytoDyn Inc. for Potential Violations of federal securities laws on behalf of investors.

Kessler Topaz Meltzer & Check, LLP Is Investigating Securities Fraud Claims on Behalf of CytoDyn Inc. (OTCMKTS: CYDY) Investors

CytoDyn's drug leronlimab (PRO-140) is not a failure. Bears are dismissing the efficacy of the drug by focusing solely on the shortcomings of management.

CytoDyn: Far From Failure

CytoDyn recently reported Leronlimab's CD12 severe-to-critical data. The numbers were lackluster and failed to hit endpoints. Consequently, the bears have remerged and have triggered a substantial sell-off. After some analysis, the company revealed a subset of patients who benefited from Leronlimab. Now the company has to build upon that data to prove Leronlimab has a place.

CytoDyn: Preparing For Capitulation After A Successful Failure

CytoDyn Inc (OTCQB:CYDY) announced Thursday that 20 patients have been enrolled and dosed in the first 10 days of its Phase 2 trial of its drug Vyrologix (leronlimab-PRO 140) as a treatment for COVID-19 long-haulers symptoms.  The randomized, double-blind, placebo-controlled trial is designed to enroll 50 patients, with each receiving eight weekly doses of Vyrologix (or a placebo), followed by four weeks of safety evaluation.

CytoDyn says 20 patients enrolled and dosed so far in Vyrologix trial in coronavirus long-haulers

VANCOUVER, Washington, March 11, 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 20 patients have been enrolled and dosed in the first 10 days of its Phase 2 trial for COVID-19 long-haulers symptoms. The trial is designed to enroll 50 patients.

CytoDyn's Long-Haulers COVID-19 Trial Enrolled 20 Patients Within 10 Days; Enrollment to be Completed This Month

CytoDyn Inc (OTCQB:CYDY) said a Phase III trial of its leronlimab treatment, known as Vyrologix, for severe-to-critical patients with coronavirus (COVID-19) has demonstrated continued safety, a substantial improvement in the survival rate, and faster hospital discharge in critically ill COVID-19 patients.  The biotechnology company said the trial data has been reported to the US Food and Drug Administration (FDA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada (HC), and that it is in discussions with each regulator to determine the best path forward for the approval of leronlimab for the treatment of COVID-19 in the critically ill population.

CytoDyn says Phase III trial shows safety, mortality reduction, and faster hospital discharge for COVID-19 patients treated with leronlimab

These trial results are currently being prepared to be submitted for publication

CytoDyn to Release CD12 Trial Detailed Results via Form 8-K After Investment Community Webcast, Monday, March 8

U.S. FDA Reviewing Protocol for More COVID-19 Critical Patients to be Enrolled to Support Potential EUA

CytoDyn to File Accelerated Rolling Review with MHRA and Interim Order (IO) with Health Canada for COVID-19

VANCOUVER, Washington, March 08, 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, reported today the Phase 3 trial of leronlimab for the treatment of severe-to-critical patients with COVID-19 demonstrated continued safety, substantial improvement in the survival rate, and faster hospital discharge in critically ill COVID-19 patients. The trial's data has been reported to the U.S. Food and Drug Administration (“FDA”), the U.K.'s Medicines & Healthcare product Regulatory Agency (“MHRA”) and Health Canada (“HC”), and the Company is in discussions with each to determine the best path forward for approval of leronlimab for treatment of COVID-19 in critically ill population. A manuscript of the trial's data is being prepared and will be submitted for publication in one or more major medical journals.

CytoDyn's Phase 3 Trial Demonstrates Safety, a 24% Reduction in Mortality and Faster Hospital Discharge for Mechanically Ventilated Critically Ill COVID-19 Patients Treated with Leronlimab

VANCOUVER, Washington, March 05, 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 and Chief Medical Officer, Mahboob Rahman, M.D., Ph.D., Chief Scientific Officer and Harish Seethamraju, M.D., Medical Director for the Mount Sinai Lung Transplantation Program, will host an investment community webcast on Monday, March 8, 2021.

CytoDyn to Hold Webcast on March 8 to Provide Overview of CD12 Trial Data and Regulatory Path Forward with the U.S., U.K., Canada, Philippines and Brazil

VANCOUVER, Washington, March 03, 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 it has filed a “universal shelf” registration statement on Form S-3 (the “Registration Statement”) with the U.S. Securities and Exchange Commission (the “SEC”) to replace its previous shelf registration originally filed with the SEC on February 23, 2018 and set to expire on March 7, 2021.

CytoDyn Files Form S-3 to Replace Expiring Shelf Registration Statement

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CytoDyn Inc (OTCQB:CYDY) announced Monday that study results have been unblinded from the CD12 trial of its drug Vyrologix (leronlimab or PRO-140) in coronavirus (COVID-19) patients, and the company will reveal them once discussions with regulators are complete.   The Phase 2b/3 trial enrolled 394 severe-to-critical COVID-19 patients, who were randomized to receive either 700 milligrams of Vyrologix or a placebo once a week by injection.

CytoDyn says data from its Phase 2b/3 Vyrologix coronavirus trial will be made public, pending regulatory talks

CytoDyn expects to release CD12 data and complete discussions with various regulatory agencies within 2 to 3 weeks

CytoDyn in Discussions with U.S. FDA, MHRA and Health Canada After Unblinding its CD12 Trial Data for Severe-to-Critically Ill COVID-19 Patients

CytoDyn will dedicate at least 200,000 vials (100,000 doses) of leronlimab from its inventory to Chiral Pharma Corp. for potential sales in the Philippines

Chiral Pharma Corp. to Assist Philippine Physicians Apply for Compassionate Special Permit (CSP) to Access CytoDyn's Leronlimab for COVID-19 Patients, as Philippines FDA Reviews Each Application for Approval to Sell Leronlimab for CSP Use

CytoDyn and Humanigen are running high-visibility trials focused on ameliorating COVID-19 acute inflammation. Acute inflammation plays a major role in the hospitalizations and deaths of patients with COVID-19.

CytoDyn And Humanigen: Ticking Time Bombs, Impending Results Likely To Fail

Correction to inclusion/exclusion criteria for eIND authorization

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

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.

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

The agency also provided specific guidance for inclusion/exclusion criteria for patients seeking leronlimab under eIND authorization

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

VANCOUVER, Washington, Dec. 29, 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 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.

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

The agency will also consider eINDs for patients in other hospitals who qualify for inclusion criteria similar to CD12

FDA Provides Guidance for Adding an Open-Label Extension to CytoDyn's Phase 3 Trial for Severe-to-Critical COVID-19 Patients Until Trial Data is Unblinded

FDA's decision will enable CytoDyn to respond to ongoing requests for leronlimab until Phase 3 trial data is unblinded

FDA Resumes eIND Approval for Severe-to-Critical COVID-19 Patients Use of Vyrologix™ (leronlimab) Following Full Enrollment in CytoDyn's Phase 3 Trial

CytoDyn (CYDY) completes full enrollment for its phase III registrational study of Vyrologix for the treatment of patients with severe-to-critical COVID-19.

News for CytoDyn Inc. Stock (CYDY)