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.

NEW YORK, Jan. 10, 2022 /PRNewswire/ -- Regnum Corp. (OTCMKT: RGMP) ("Regnum"), CytoDyn Inc. (OTC.QB: CYDY) ("CytoDyn"), and SevenScore Pharmaceuticals, LLC ("SevenScore"), today announced the assignment of the Commercialization and License Agreement ("CLA") and a related Supply Agreement to commercialize leronlimab (PRO 140) in the U.S. for the treatment of HIV from SevenScore to Regnum.  The CLA was signed between Vyera Pharmaceuticals, LLC ("Vyera") and CytoDyn on December 17, 2019 and assigned to SevenScore on October 29, 2020.

Regnum Signs Assignment and Assumption Agreement with CytoDyn and SevenScore Pharmaceuticals to Commercialize Leronlimab in the U.S. for the Treatment of HIV

CytoDyn has updated investors on its efforts to push Leronlimab forward on several fronts, including NASH, COVID-19, and HIV. These programs are moving closer to the finish line and should deliver potent catalysts in the coming years.

CytoDyn: Moving Leronlimab Forward On All Fronts

CytoDyn Inc announced positive results from the 350 mg weekly dose of its Phase 2 Nonalcoholic steatohepatitis (NASH) clinical trial.  The Vancouver, British Columbia-based company said that the trial was conducted in two parts.

CytoDyn announces positive results from part two of Phase 2 Nonalcoholic steatohepatitis clinical trial

VANCOUVER, Wash.--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the U.S. District Court for the District of Maryland has granted CytoDyn's previously-announced motion for a preliminary injunction against NSF International, Inc. and its subsidiary Amarex Clinical Research (“Amarex”), the Company's former Contract Res

CytoDyn Announces Favorable Ruling Granting Injunction Against Former CRO

CytoDyn Inc said it has received a positive response from the US Food and Drug Administration (FDA) to conduct a Phase III randomized, double-blind, placebo-controlled trial for evaluating the efficacy and safety of leronlimab on critically ill coronavirus (COVID-19) pneumonia patients. The trial will be performed in combination with the standard of care for COVID-19 pneumonia patients with the need for Invasive Mechanical Ventilation (IMV) or Extracorporeal Membrane Oxygenation (ECMO), the company said.

CytoDyn receives positive response from US FDA for conducting a Phase III trial in critically ill COVID-19 pneumonia patients

VANCOUVER, Wash.--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that it has received a positive response from the U.S. Food and Drug Administration (“FDA”) to conduct a Phase 3, randomized, double blind, placebo controlled trial to evaluate the efficacy and safety of leronlimab in combination with standard of care for cr

CytoDyn Receives Positive Response From FDA in Regard to its Phase 3, Registrational Trial in COVID-19 Critically Ill Population

CytoDyn Inc announced positive preliminary results from the 20-patient-cohort who have completed the open-label portion of the Phase 2 trial for nonalcoholic steatohepatitis (NASH). The Vancouver-based company's current Phase 2 NASH trial is designed to test in 90 patients whether leronlimab may inhibit the devastating liver fibrosis associated with NASH.

CytoDyn announces positive preliminary results in Phase 2 trial open-label portion for nonalcoholic steatohepatitis

VANCOUVER, Washington, Dec. 10, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, 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, Nitya Ray, Ph.D., Chief Operating Officer and Chief Technology Officer and Christopher Recknor, M.D., Senior Executive VP of Clinical Operations of CytoDyn will host an investment community webcast on Tuesday, December 14, 2021.

CytoDyn to Hold Webcast and Live Q/A on December 14

CytoDyn Inc. (OTCQB:CYDY) told investors it has filed a request with the US Food and Drug Administration (FDA) for approval of expanded access use of leronlimab for multi-drug resistance (MDR) HIV patients.  The company said it has also previously sought FDA approval to charge for leronlimab used in this patient population and is preparing to file the last portion of the request.

CytoDyn files for expanded access use of leronlimab for multi-drug resistance HIV patients.

VANCOUVER, Washington--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that it has submitted a Phase 3, randomized, double blind, placebo controlled trial with the U.S. Food and Drug Administration (“FDA”) to evaluate the efficacy and safety of leronlimab in combination with standard of care for critically ill patients wit

CytoDyn Submits Protocol with the FDA for Phase 3 Registrational Trial of Leronlimab for Critically Ill COVID-19 Population

VANCOUVER, Wash.--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today filed a request with the U.S. Food and Drug Administration (“FDA”) for approval of expanded access use of leronlimab for multi-drug resistance (MDR) HIV patients. The Company has also previously sought FDA approval for CytoDyn to charge for leronlimab used in this pat

CytoDyn Files for Expanded Access Use of Leronlimab for Multi-Drug Resistance HIV Patients

CytoDyn Inc. (OTCQB:CYDY) has announced that its contract research organization (CRO) in Brazil, Albert Einstein Israelite Hospital, has met with the Brazilian Health Regulatory Agency (ANVISA) and received its agreement to modify the CD16 trial for critically ill coronavirus (COVID-19) patients. Following ANVISA's authorization, the company said it will submit the revised protocol for CD16 providing for a reduction in total enrollment from 330 to 126 patients, with interim efficacy analysis by a data safety monitoring board (DSMB) after 40% of patients are enrolled and have completed follow-up to Day 28.

CytoDyn says Brazil's health regulator agrees to modify CD16 trial for critically ill coronavirus patients

VANCOUVER, Wash.--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that its CRO in Brazil (Academic Research Organization (ARO) Albert Einstein Israelite Hospital (AEIH)) met with the Brazilian Health Regulatory Agency (ANVISA) and received its agreement to modify the CD16 trial for critically ill COVID-19 patients. ANVISA

CytoDyn's CRO in Brazil Met with ANVISA to Modify CD16 Trial for Critically Ill COVID-19 Patients to Expedite Interim Analysis After 51 Patients, Potentially in 1Q2022

CytoDyn Inc announced more progress for its leronlimab candidate as a treatment for HIV, saying it has now submitted all the major sections of the chemistry, manufacturing, and controls (CMC) to the Food & Drug Administration (FDA) - the US regulator. This CMC is a critical part of the biotech's Biologics License Application (BLA) for HIV - the request for permission to commercialize a product.

CytoDyn completes submission of all major sections of CMC to FDA for HIV Biologics License Application

VANCOUVER, Wash.--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it has completed submission of all the major sections of CMC modules to FDA, some remaining supporting documentation will be submitted under Regional Information before the end of this week. CMC is a critical part of CytoDyn's Biologics License Application (

CytoDyn Submits CMC (Manufacturing) Section of HIV BLA to FDA Under Previously Authorized Rolling Review; Last (Clinical) Section Will Complete Full BLA Submission

VANCOUVER, Wash.--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB:CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reminded investors that Dr. Scott Kelly, CytoDyn's Chairman of the Board, Chief Medical Officer and Head of Business Development, will present at the World Antiviral Congress being held tomorrow, November 30, 2021 through Thursday, December 2, 2021. Dr. Kelly will speak tomo

CytoDyn's Chairman, CMO, and Head of Business Development Dr. Scott A. Kelly to Present at World Antiviral Congress 2021 Beginning Tomorrow

VANCOUVER, Wash.--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced the preliminary vote results from the 2021 Annual Meeting of Stockholders (the “Annual Meeting”), which was held today. Shareholders approved all four proposals up for consideration at the Annual Meeting, including: The election of six directors to serve on the Bo

CytoDyn Announces Preliminary Results from 2021 Annual Meeting

CytoDyn Inc has told investors that data from its trial treating non-alcoholic steatohepatitis (NASH) with its flagship drug leronlimab are “encouraging” and an “exciting step forward” in demonstrating the potential of the drug for inhibiting the liver fibrosis associated with NASH. The late-stage biotechnology company said the open-label NASH results continue to show reductions in fat and fibrosis suggestive of a potential therapy not only for non-alcoholic fatty liver deposit but also in NASH.

CytoDyn says data from leronlimab trial is a step forward, demonstrating the drug's potential for inhibiting liver fibrosis

CytoDyn continues to report noteworthy updates regarding their flagship product, Leronlimab, which has been able to post impressive results in numerous indications. The bears have been on a winning streak as the company falls behind on clinical trials and regulatory actions.

CytoDyn: Looking For A Turnaround Following Positive Updates

CytoDyn Inc announced that its research paper on leronlimab has been accepted by Frontiers in Immunology — a leading journal in its field. publishing rigorously peer-reviewed research across basic, translational and clinical immunology.

CytoDyn says its research paper on leronlimab accepted by leading journal Frontiers in Immunology

VANCOUVER, Wash.--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that its research paper entitled “CCR5 receptor occupancy analysis reveals increased peripheral blood CCR5+CD4+ T cells following treatment with the anti-CCR5 antibody Leronlimab” has been accepted by Frontiers in Immunology, a leading journal in its field p

CytoDyn Research Paper on Leronlimab Published in Frontiers in Immunology Journal

CytoDyn Inc has announced that Health Canada has authorized the emergency use of leronlimab for the treatment of a patient with metastatic triple-negative breast cancer (mTNBC). The company also said it will be filing for expanded access use for mTNBC patients in the US shortly.

CytoDyn receives emergency use authorization from Health Canada for leronlimab to treat metastatic triple-negative breast cancer patient

Management Team Will Present on Company's Strategy Going Forward

CytoDyn Reminds Stockholders to Register 24 hours before November 24th Annual Meeting

CytoDyn's main product candidate is Vyrologix, an injectable antibody that shows promise as an anti-viral agent The company is preparing to release data from a Phase 2b/3 coronavirus study Two Phase 3 HIV trials have been completed What CytoDyn does: CytoDyn Inc (OTCMKTS:CYDY), a Vancouver, Washington-based late-stage biotechnology company, is developing Vyrologix (leronlimab or PRO 140) to battle multiple diseases. Most significantly, it is working to develop a significant advance in HIV treatment beyond the “AIDS cocktail” combination of pills that has kept millions of people alive since the mid-1990s.

CytoDyn has multiple shots on goal with its flagship drug Vyrologix to treat HIV, various cancers and even coronavirus

CytoDyn Inc. (OTCQB:CYDY), a late-stage biotechnology company developing its flagship drug leronlimab for multiple indications, revealed that it has initiated the resubmission of its Biologics License Application (BLA) for HIV (human immunodeficiency virus) under rolling review consistent with guidance from the US Food and Drug Administration (FDA). In a statement, CytoDyn CEO Nader Pourhassan said: “We are pleased to begin the HIV BLA resubmission process with continued guidance from the FDA.

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