With every day passing, and the headlines getting further hogged by worrisome developments regarding the spread of the coronavirus, the need for a treatment or vaccine becomes more acute.
The market has recognized the need, too. While the bloodbath across all the major indexes continues, apart from a few outliers, the biotech companies searching for solutions are among the only names to have experienced any upward movement recently. Which brings us to small-cap biotech firm CytoDyn Inc. (CYDY).
Yesterday, CytoDyn reported it had filed an Investigational New Drug (IND) application to launch a Phase 2 trial in the U.S. with leronlimab (PRO 140) in patients infected with the COVID-19 coronavirus.
CytoDyn’s management have noted that deaths caused by COVID-19 are mostly a result of acute respiratory distress syndrome (ARDS), as the virus in human lungs causes an influx of macrophage and immune cells and the cytokines released result in even more influx of immune cells and inflammation. As an immunomodulator, leronlimab could disrupt this cycle and reduce ARDS-related mortality. Additionally, CytoDyn is in talks with licensing partners in China and Taiwan to develop leronlimab to treat cancer as well as coronavirus infections.
The company has successfully completed a Phase 3 trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients which met its primary endpoint. CytoDyn has submitted the first section (non-clinical) of its Biological License Application (BLA) for that indication, while the clinical and CMC (chemistry, manufacturing and controls) portions of the BLA are still being worked on.
H.C. Wainwright’s Yi Chen argues the successful data on other indications for leronlimab will stand the company in good stead. Chen said, “In our view, since leronlimab has already shown solid safety in multiple clinical trials in HIV and cancer, it has an edge vs. other therapies currently only undergoing preclinical testing. There are over 110,000 confirmed COVID-19 cases globally, with the epidemic approaching 4,000 deaths worldwide. leronlimab may become a lifesaving drug if its efficacy against COVID-19 and ARDS can be proven in a Phase 2 trial.”
As a result, Chen reiterates a Buy rating on CytoDyn shares, alongside a price target of $1.50. Investors could see upside of 38%, should the target be met over the next twelve months. (To watch Chen’s track record, click here)
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