CytoDyn Inc (OYCMKTS:CYDY) is a name that we have covered quite a bit in the past here at Insider Financial. The company’s lead drug PRO 140 has been touted by many as the ultimate HIV treatment. CytoDyn even attracted international press when Charlie Sheen came on board. However, no matter the science or the potential of PRO 140 have been able to move the stock. Look at the chart for the past 5 years. The stock has been trading around the $.50 baseline except for a few spikes to $1.50 and then back down.
This is honestly why we stopped covering it here at Insider Financial. We stopped getting excited about the stock because it never did anything. We got tired of waiting. As we take another look, we are looking to see if anything has changed with CytoDyn?
First up, for those that are not familiar with CytoDyn, here’s a little background info. CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab (PRO 140), a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 plays a key role in the ability of HIV to enter and infect healthy T-cells.
CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. The Company plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biological License Application (BLA) in the first quarter of 2019 for that indication.
CytoDyn has announced plans to aggressively develop PRO 140 as a therapeutic for metastatic cancers, and previously reported the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to conduct a Phase 1b/2 clinical trial with PRO 140 as a therapy for patients with metastatic triple-negative breast cancer.
This pivot comes after the acquisition of Prostagene, LLC for approximately $15 million. Prostagene Founder and CEO Richard Pestell is now the Chief Medical Officer of CytoDyn. He brings a wealth of experience in cancer research having directed two National Cancer Institute (NCI)-Designated Cancer Centers and has served on the advisory board of seven NCI cancer centers and several international research centers. CytoDyn Chairman Anthony Caracciolo said:
“Richard is a driving force in CCR5 antagonist research and we gain significant expertise and intellectual property with this acquisition that advances the development of PRO 140 as a novel cancer metastasis therapeutic. We are privileged to have Richard join CytoDyn to expand our executive and scientific team, and we enthusiastically welcome him as the newest member of our board of directors.”
With the acquisition of Prostagene, CytoDyn acquired PCaTest. The Company intends to initiate a clinical study designed to further demonstrate the superiority of the PCaTest compared with current genetic tests in predicting outcomes of individuals with prostate cancer. The PCaTest employs 14 gene biomarker signatures for prognostication and therapeutic substratification of prostate cancer using sophisticated proprietary artificial intelligence algorithms. Results from three clinical studies in a total of 348 patient samples show the test as superior in hazards ratio to five currently marketed genetic-based prostate cancer prognostic tests.
Currently trading with a market cap of $142 million, CYDY is an exciting story among small caps. We believe that the problems behind CYDY have been related to poor execution by management rather than any issues with the science. We are optimistic that new CMO Richard Pestell can take the company down the field and bring PRO 140 to commercialization. With Dr. Nitya Ray back as Chief Technology Officer, everyone is banking on 2019 being a breakout year for CytoDyn.
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Disclosure: We have no position in CYDY and have not been compensated for this article.
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