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

Rhea-AI Summary

CytoDyn has completed submission of essential CMC modules for its Biologics License Application (BLA) for HIV to the FDA, with only the clinical section pending.

The submission is being processed under a rolling review, reflecting progress after previous challenges. The company is excited about upcoming submissions related to COVID-19 long-haulers and HIV data.

Additional efforts include a request for expanded use of leronlimab for multi-drug resistant HIV patients. CytoDyn aims for a successful operational year in 2022.

Positive

• Completion of major CMC modules for BLA submission indicates progress.
• Upcoming submissions for COVID-19 long-haulers and HIV data show proactive development.
• Request for expanded use in MDR HIV patients may lead to new opportunities.

Negative

• Past challenges with CRO may have delayed progress.
• The company has not yet submitted the clinical section of the BLA.

CMC section is of great importance to our other potential approvals, including potential EUA for COVID-19 and Breakthrough Designation Therapy in Cancer

FDA may initiate review of this BLA under previous rolling review granted to CytoDyn

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 (“BLA”) for HIV. This submission was made under rolling review consistent with guidance from the U.S. Food and Drug Administration (“FDA”). Only the clinical section remains to be submitted.

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are pleased to get close to completion of our HIV full BLA submission. We have only one more section (from the main three sections) to submit. With our resubmission of the non-clinical and CMC sections behind us, we are very excited to have our HIV and other activities back on track after the difficulties we experienced with our previous CRO. Our CD15, Long-Hauler’s trial for COVID-19, was submitted for peer review yesterday, and we are also very close to submitting our manuscript of HIV CD02, Phase 3, data to a peer reviewed journal. We are extremely excited about both submissions. Also, in light of recent news about multi-drug resistance (MDR) HIV patients having problems with durable viral suppression, we are working on making a request to the FDA for approval of expanded use of leronlimab in the HIV, MDR population. We are grateful to CytoDyn’s new BLA team, under the supervision of Dr. Nitya Ray and his team, and previously Dr. Chris Recknor, for their excellent work in helping us to reach these milestones. We believe this will lead to a very successful 2022 for CytoDyn.”

Nitya Ray, Ph.D., CytoDyn’s Chief Operating and Technology Officer, commented, “We are grateful for the excellent job that the CytoDyn’s dynamic CMC team has done working relentlessly alongside CytoDyn’s consultants and Dunn Regulatory Associates. In this submission we have included data of leronlimab manufacturing at Samsung Biologics. We are also grateful for the invaluable support we have received from Samsung’s Development, Manufacturing and Regulatory groups.”

About CytoDyn

CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 plays a critical role in the ability of HIV to enter and infect healthy T-cells and appears to be implicated in tumor metastasis and immune-mediated illnesses, such as NASH.

CytoDyn successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected patients who were heavily treatment-experienced individuals with limited treatment options. CytoDyn is working diligently to resubmit its BLA for this HIV combination therapy since receiving a Refusal to File in July 2020. In July 2021, CytoDyn announced that it had submitted a dose justification report to the FDA, an integral step in the resubmission process for its BLA, which it expects to complete during the first quarter of calendar 2022. CytoDyn also completed a Phase 2b/3 investigative trial with leronlimab used 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 expansion approval. Clinical results to date from two trials have shown that leronlimab can maintain a suppressed viral load in a sub-population of R5 HIV patients who chose to switch from their daily pills regimen to once-a-week subcutaneous dose of leronlimab. Several patients on leronlimab’s Phase 2b extension arm have remained virally suppressed for almost 7 years and many patients in our Phase 2b/3 investigative trial are passing two and some four years of monotherapy with suppressed viral load.

CytoDyn recently completed a Phase 2 clinical trial with leronlimab in mTNBC and a Phase 2 basket trial in solid tumor cancers (22 different cancer indications) A Phase 2 investigative trial for post-acute sequelae of SARS COV-2, also known as COVID-19 long-hauler’s, and a Phase 2 clinical trial for NASH are continuing. CytoDyn has already completed a Phase 2 and Phase 3 trial for mild-to-moderate and severe-to-critical COVID-19 patients, respectively, for which CytoDyn did not meet its primary or secondary endpoints, except for the secondary endpoint in the critically ill subpopulation. 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 provide 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 regulatory determinations of leronlimab’s efficacy to treat human immunodeficiency virus (“HIV”) patients with multiple resistance to current standard of care, COVID-19 patients, and metastatic Triple-Negative Breast Cancer (“mTNBC”), among other indications, by the U.S. Food and Drug Administration and various drug regulatory agencies in other countries; (ii) the Company’s ability to raise additional capital to fund its operations; (iii) the Company’s ability to meet its debt obligations; (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) legal proceedings, investigations or inquiries affecting the Company or its products; (xiii) general economic and business conditions; (xiv) changes in foreign, political, and social conditions; and (xv) 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211201005598/en/

Investors:

Cristina De Leon

Office: 360.980.8524

ir@cytodyn.com

Media:

Dan Zacchei / Joe Germani

Sloane & Company

dzacchei@sloanepr.com / jgermani@sloanepr.com

Source: CytoDyn Inc.

FAQ

What progress has CytoDyn made with its BLA for HIV?

CytoDyn has completed the major sections of CMC for its BLA for HIV and is awaiting the clinical section.

What does the rolling review by the FDA mean for CytoDyn?

The rolling review allows CytoDyn to submit sections of their BLA as they are completed, potentially speeding up the approval process.

What are CytoDyn's plans regarding leronlimab for COVID-19?

CytoDyn submitted a trial for COVID-19 long-haulers for peer review and is preparing another manuscript for HIV Phase 3 data.

What are the challenges CytoDyn has faced recently?

CytoDyn faced difficulties with its previous CRO, which impacted timelines, but they are now back on track.