Is a Bottom in Sight for CytoDyn Inc (OTCMKTS:CYDY)?

CytoDyn Inc (OTCMKTS:CYDY) just announced that a research paper entitled “Leronlimab (PRO 140) activity against 4-class drug resistant HIV-1 from Heavily Treatment Experienced Subjects” has been accepted, peer reviewed and is available as a journal pre-proof on ScienceDirect.

The study was conducted as an in-vitro study of 25 HIV-1-infected patients harboring a documented 4-class drug-resistance nucleoside reverse transcriptase inhibitors (“NRTIs”), non-nucleoside reverse transcriptase inhibitors (“NNRTIs”), protease inhibitors (“PIs”), and integrase strand transfer inhibitors (“INSTIs”) enrolled in the Italian PRESTIGIO Registry.

“We would like to thank our Italian colleagues for understanding the importance of leronlimab in the treatment of HIV. This is further proof that leronlimab can benefit CCR5 tropic HIV patients, including those patients with multidrug resistance. HIV patients deserve the opportunity for multiple, effective treatment options,” said CytoDyn’s Chief Medical Officer, Scott A. Kelly M.D.

Shares of CYDY have had it rough lately, and the company looks to this news to help pad that performance. The chart shows more than -20% added to share values of the name over the past week of action, but that move comes in the context of a larger bearish trend. 

That said, CYDY is a stock with a past that has featured a litany of sudden rips to the upside. Moreover, the listing has benefitted from a jump in recent trading volume to the tune of just under 170% above the average volume levels in play in this stock over the longer term.

CytoDyn Inc (OTCMKTS:CYDY) promulgates itself as a late-stage biotechnology company that focuses on the clinical development and commercialization of humanized monoclonal antibodies to treat human immunodeficiency virus (HIV) infection. 

Its lead product is PRO 140, a therapeutic anti-viral agent, which is in Phase IIb extension study for HIV as monotherapy, rollover study for HIV as a combination therapy, Phase IIb/III investigative trial for HIV, Phase Ib/II trial for triple-negative breast cancer, and Phase II trial for graft-versus-host disease. 

CytoDyn Inc. has strategic agreement with Samsung BioLogics Co. Ltd. for the clinical and commercial manufacturing of leronlimab. The company was formerly known as RexRay Corporation. CytoDyn Inc. was incorporated in 2002 and is based in Vancouver, Washington.

According to company materials, “CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells.  The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab (PRO 140) as a once-weekly monotherapy for HIV-infected patients and, plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab (PRO 140) can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer.”

CytoDyn Inc (OTCMKTS:CYDY) had no reported sales in its last quarterly financial data. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($6.5M against $129.6M, respectively).