CytoDyn Inc (OTCMKTS: CYDY) is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions. CytoDyn’s core areas of clinical development are HIV, nonalcoholic steatohepatis (“NASH”), and solid tumors in oncology. The current areas of clinical focus in HIV are the multi-drug resistant HIV population, creating a long-acting formulation of leronlimab, and HIV cure using adenovirus vectors. In NASH, the Company’s focus will be on the general population of those affected by NASH, and the subpopulation of patients with NASH and HIV.  

In July 2020, CytoDyn received a Refusal to File letter from the FDA regarding its BLA submission for leronlimab as a combination therapy with highly active antiretroviral therapy (“HAART”) for highly treatment-experienced HIV patients. The FDA informed the Company that the BLA did not contain certain information and data needed to complete a substantive review and, therefore, the FDA would not file the BLA. CytoDyn is working with consultants to cure the cited BLA deficiencies. In November 2021, the Company resubmitted the non-clinical and chemistry, manufacturing, and controls (“CMC”) sections of the BLA and is currently reevaluating the feasibility and timelines over which it expects to complete the clinical section. As of March 2022, the FDA had commenced its review of the CMC section. 

On March 31, 2022, the Company announced that the FDA had placed a full clinical hold on its COVID-19 program and a partial clinical hold on its HIV program in the United States. Under each of these clinical holds, no new clinical studies may be initiated until the clinical hold is resolved. The partial clinical hold on the HIV program allowed patients who were enrolled in the extension trials to transition to other available therapeutics. Under the full clinical hold on the COVID-19 program, no new clinical studies may be initiated until the clinical hold is resolved. The Company previously notified the FDA that it was pausing its COVID-19 trials in Brazil. CytoDyn voluntarily withdrew the Investigational New Drug Application (“IND”) for COVID-19 in the United States. 

$cydy weekly chart flipped SAR. Also MACD turned up.#BULLISH pic.twitter.com/80Bkdhiw7p

— Friar Tuck (@tomyarborough) February 17, 2023

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CytoDyn is in the process of evaluating the data obtained from our former CRO, results of the audit, and implications of the HIV partial clinical hold. The Company will update the status and strategy of our anticipated resubmission of the clinical section of the BLA once we complete our evaluation. 

CytoDyn is currently focused on the following potential strategies: 

1. Strengthening its pharmacovigilance program enabling the Company to remove the FDA clinical holds placed on its HIV and COVID-19 programs to allow it to conduct future clinical studies.
2. Advancing the Company’s NASH program to a Phase 2b or Phase 2b/3 trial for steatosis and liver fibrosis associated with NASH.
3. Exploring a study for patients with HIV and NASH.
4. Contining CytoDyn’s Phase 2 program for metastatic triple-negative breast cancer with current standard of care, explore a Phase 2 colon cancer trial with current standard of care, and explore other solid tumor indications.
5. Continuing work to evaluate the feasibility and timelines for the HIV BLA resubmission and explore other cancer and immunologic indications for leronlimab, continue our work on developing a long-acting version of leronlimab, and pursue proof of concept studies for HIV cure using leronlimab and AAV vectors.
6. Reviewing the Company’s strategy for its COVID-19 program.

CytoDyn new President is Cyrus Arman, Ph.D. a biotech executive who previously held positions with a number of biotechnology companies, most recently serving as Chief Business Officer of Nimble Therapeutics, Inc., a company focused on engineering peptides. Prior to Nimble he was Vice President of Corporate Development and Strategy of NEUVOGEN, Inc., an immune-oncology company developing therapeutic whole cell cancer vaccines, from 2019 until 2021. Beginning in 2017, he served as cofounder and managing partner of BioVega Capital, LLC, a life sciences hedge fund, for four years, and as Director of Corporate Strategy at Amgen (NASDAQ: AMGN), a leading independent biotechnology company, for two years. For three years prior to 2017, Dr. Arman was Global Director and Head of Competitive Intelligence and Strategy at Amgen. He received an M.S. degree in biomedical engineering and a Ph.D. in neuroscience from the University of Southern California and an M.B.A from the UCLA Anderson School of Management. 

$CYDY Phase 3 trial w/est Feb completion date NCT04901689: https://t.co/K9WpxftXUu Trial Tracker: https://t.co/aR7q5osthn

— FDA Tracker (@fda_tracker) February 13, 2023

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Currently trading at a $250 million market valuation CYDY os is 835,915,159 with 556,016,522 shares in the public float. The previous years have been rough on the Company’s balance sheet with Nadir running the Company and raking up over $100 million in liabilities. However, at current levels, CYDY is at the top of many speculators watch lists, CYDY can move fast and ran from current levels to $1.25 at the end of last year. As stated, there is plenty for new President Cyrus Arman to sink his teeth into after taking over the job from the previous CEO Nadir who is under multiple investigations. NASH and solid tumors, each represent multi-billion dollar valuation opportunities for CytoDyn, and management believes Leronlimab has the potential to become the standard of care in these indications in the future.  CytoDyn is currently focused on getting the FDA clinical holds placed on its HIV and COVID-19 programs removed. Advancing the Company’s NASH program to a Phase 2b or Phase 2b/3 trial for steatosis and liver fibrosis and continuing to evaluate the feasibility and timelines for the HIV BLA resubmission and explore other cancer and immunologic indications for leronlimab.  We will be updating on CYDY when more details emerge so make sure you are subscribed to newsytrends.com by entering your email below.

Disclosure: we hold no position in CYDY either long or short and we have not been compensated for this article.