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.

CytoDyn: Bulls Continue To Get Torpedoed But The Thesis Remain Afloat

VANCOUVER, Washington, Sept.  10, 2020  (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing 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 Dr. Jacob Lalezari, CytoDyn’s Chief Science Advisor and CEO of Quest Clinical Research, will host an investment community conference call on Wednesday, September 16, 2020. The invited guests are Dr. Kush Dhody, Director of clinical trials at Amarex Clinical Research, CytoDyn’s clinical research organization, and Dr. Nicholas Agresti, whose patients received leronlimab under the U.S. Food and Drug Administration (FDA) emergency IND (eIND) program. Dr. Dhody will discuss the very successful FDA meeting concerning CytoDyn’s upcoming HIV BLA submission and Dr. Agresti will speak about the experience of his patients who received leronlimab.

CytoDyn to Hold Conference Call on September 16 to Provide Update on Discussions with FDA and MHRA for COVID-19 and FDA Meeting on BLA Filing

U.S. FDA schedules Type A meeting with CytoDyn to discuss BLA filing for HIV   

U.K. MHRA Grants Meeting to CytoDyn to Discuss Fast Track Approval of Leronlimab for COVID-19 Patients

Leading experts in the fields of HIV, Oncology, Rheumatology, and NASH join together to facilitate the best approaches to utilize multiple opportunities for leronlimab

Global Health Leaders Join CytoDyn's Scientific Advisory Board

VANCOUVER, Washington, Aug.  28, 2020  (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing 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 Jacob Lalezari, M.D., Senior Science Advisor, will host an investment community conference call on Wednesday, September 2, 2020, to provide a comprehensive update on the most anticipated timelines for multiple regulatory and clinical initiatives, including COVID-19 potential approval timelines in U.S. and U.K. The conference call will focus on the following key agenda items:

CytoDyn to Hold Conference Call on September 2 to Provide Update on Timelines for Multiple Regulatory and Clinical Initiatives Including COVID-19 Potential Approvals

CytoDyn In Treatment Of COVID-19: The BP Saga

Interim analysis to commence after 28 days; results anticipated by mid-October

CytoDyn Reaches Enrollment of 195 Patients in its Phase 3 Trial for COVID-19 Patients with Severe-to-Critical Symptoms

Patient enrollment to commence immediately 

After Several Months of Providing Requested Information About Manufacturing and Safety of Leronlimab, U.K.’s MHRA Accepts CytoDyn’s Request to Enroll in its Current Phase 3 Trial for COVID-19 Patients with Severe-to-Critical Symptoms

VANCOUVER, Washington, Aug.  20, 2020  (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it will conduct its Type A meeting in writing in lieu of a teleconference with the U.S. Food and Drug Administration (FDA). The FDA has agreed to respond to the Company’s questions by September 4, 2020 concerning the additional information the FDA requires to resubmit the Biologics License Application (BLA) for leronlimab as a combination therapy for HIV.

To Avoid Delay, the FDA Recommends CytoDyn Conduct Its Type A Meeting in Writing with FDA Response Goal Date of September 4

VANCOUVER, Washington, Aug.  18, 2020  (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today David F. Welch, Ph.D. has advised the Company he has chosen not to stand for re-election to the Company’s Board of Directors at its upcoming annual meeting of stockholders. Dr. Welch joined CytoDyn’s Board in January 2019 and currently serves as Chair of its Compensation Committee. Dr. Welch is Founder and Chief Innovation Officer of Infinera Corporation, a Nasdaq-listed global supplier of networking equipment, software and services.

CytoDyn Announces Upcoming Retirement of Dr. David Welch from its Board of Directors

VANCOUVER, Washington, Aug.  18, 2020  (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Company provided its Top-line Report from its recently completed Phase 2 clinical trial for patients with mild-to-moderate COVID-19 symptoms to Medicines and Healthcare Products Regulatory Agency (MHRA), an executive agency of the U.K. government sponsored by the Department of Health and Social Care. The Company requested the regulatory pathway for Fast Track approval noting the efficacy and safety results from the Phase 2 trial.

CytoDyn Requests “Fast Track Approval” for COVID-19 Patients from U.K.’s Regulatory Agency MHRA based on its Top-line Report Showing Statistically Significant Endpoint, NEWS2 (p < 0.023) and Notable Safety Results

HIV monotherapy trials update: 215 patients completed almost one year of monotherapy. Only some were allowed to continue in extension arm; five patients reached almost 6 years. Twenty-five reached 2 to 4 years and 20 patients are 1 to 2 years

CytoDyn Will Attempt to Duplicate Berlin and London Patients’ HIV Cure by Using Leronlimab During Bone Marrow Transplant for 5 HIV Patients Who also have Cancer

The Top-line Report has been sent to the regulatory authorities in Mexico, and will be provided to U.K. MHRA, and E.U. EMA, with requests for emergency use approval

CytoDyn Submits its Top-line Report from its Phase 2 COVID-19 Trial to the U.S. FDA and Requests Emergency Use Approval

CytoDyn (CYDY) announces top-line results from a phase II study evaluating leronlimab in COVID-19 patients with mild-to-moderate symptoms.

CytoDyn Reports Top-Line Data From Phase II Coronavirus Study

VANCOUVER, Washington, Aug.  11, 2020  (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing 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 Jacob Lalezari, M.D., Senior Science Advisor, will host an investment community conference call on Wednesday, August 12, 2020, to provide a comprehensive overview of the compelling results from the Company’s recently completed Phase 2 CD10 trial for COVID-19 patients with mild-to-moderate symptoms, along with an update on its Phase 3 trial for COVID-19 patients with severe-to-critical indications and the regulatory path going forward.

CytoDyn to Hold Conference Call on August 12 to Discuss Impressive Results from its Phase 2 COVID-19 Trial

Primary endpoint shows early clinical improvement in symptom score at Day 3 in patients receiving leronlimab

CytoDyn Announces Clinically Significant Top-line Results from its Phase 2 Trial in Mild-to-Moderate COVID-19 Patients

• BLA-type submission planned this month in U.K. for HIV combination therapy with 350 mg weekly dose•  COVID-19 Phase 2 topline report to be submitted for consideration of emergency approval of leronlimab for patients with mild-to-moderate symptoms to U.K. and other countries following submission to the U.S. FDA next week

CytoDyn Seeks UK Approval of Leronlimab for HIV and COVID-19

VANCOUVER, Washington, Aug.  04, 2020  (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company, announced today an independent Data Safety Monitoring Committee (“DSMC”) completed its first safety review of the ongoing Phase 3 clinical trial (CD12) in patients with severe and critical COVID-19 and reported it saw no cause to modify the study. The DSMC reviewed compiled safety data from 149 subjects enrolled in the CD12 trial. The DSMC did not raise any concerns regarding safety and recommended that the trial continue.

CytoDyn Receives Positive DSMC Recommendation for Leronlimab Phase 3 COVID-19 Trial with No Safety Concerns

CytoDyn's progress on its lead candidate, leronlimab, will be in focus when it reports Q4 results.

CytoDyn (CYDY) to Report Q4 Earnings: What's in the Offing?

VANCOUVER, Washington, July  29, 2020  (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it completed a new non-dilutive convertible debt offering with an institutional investor, which provides $25 million of immediately available capital. The note, has a two-year maturity, bears interest at the rate of 10% per annum and is secured by all assets of the Company, excluding its intellectual property.  The note may be converted at the option of the investor into shares of the Company’s common stock at a conversion price of $10.00 per share.

CytoDyn Completes Non-dilutive $28.5 Million Convertible Note Financing with Conversion Rate at $10.00 Per Share without Warrants

CytoDyn's COVID-19 Trial Tribulations

VANCOUVER, Washington, July  27, 2020  (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing 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 Jacob Lalezari, M.D., Senior Science Advisor, will host an investment community conference call on Thursday, July 30, 2020, to provide a comprehensive update on the Company’s two trials for COVID-19 patients with mild-to-moderate and severe-to-critical indications.

CytoDyn to Hold Conference Call on July 30 to Provide Updates on its Two COVID-19 Trials

Interpretation Of Cytodyn's Mild-To-Moderate Covid-19 Results

39% (11 SAEs in 28 Patients) in Placebo Arm as Compared to Only 14% (8 SAEs in 56 Patients) in Leronlimab Arm Reported Serious Adverse Events (SAEs), Which Were Unrelated to Leronlimab. The Efficacy Portion of the Trial Will Be Announced Along With a Full Report as Soon as Statistical Analyses Are Completed

UPDATE - Impressive Results From CytoDyn’s Phase 2 COVID-19 Trial

39% of Patients in Placebo Arm Had SAEs as Compared to Only 14% of Patients in Leronlimab Arm Had SAEs, Which Were Unrelated to Leronlimab. The Efficacy Portion of the Trial Will be Announced Along With a Full Report as Soon as Statistical Analyses are Completed

News for CytoDyn Inc. Stock (CYDY)