VANCOUVER, Washington, April 5, 2021 (GLOBE NEWSWIRE) – CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a biotechnology company in the late stage of development of leronlimab (PRO 140), a CCR5 antagonist with potential for multiple therapeutic indications, today announced that it has finalized an offer additional potentially non-dilutive convertible debt with an institutional investor, who provides $ 25 million of immediately available capital. The note has a two-year maturity, bears interest at a rate of 10% per annum and is secured by all of the assets of the Company, excluding its intellectual property. The Note may be converted at the option of the investor into common shares of the Company at a conversion price of $ 10.00 per share.
Nader Pourhassan, Ph.D., President and CEO of CytoDyn, said: “We are very pleased with the confidence the institution has shown and its understanding of the positioning of léronlimab on its regulatory trajectory. This capital injection will help ensure that we have sufficient quantities of leronlimab available on any potential approval for COVID-19 treatment. We believe that the power of leronlimab to help the critically ill population of COVID-19 is incomparable. In the meantime, we are very excited to sell leronlimab in the Philippines under CSP and potentially in other countries in similar situations. “
About Léronlimab (PRO 140)
The United States Food and Drug Administration (FDA) has granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat HIV and metastatic cancer. The first indication is combination therapy with HAART for patients infected with HIV, and the second is for triple negative metastatic breast cancer (mTNBC). Leronlimab is an experimental humanized IgG4 mAb that blocks CCR5, a cellular receptor important in HIV infection, tumor metastasis and other diseases, including NASH (nonalcoholic steatohepatitis). Leronlimab has been studied in 11 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal phase 3 trial (leronlimab in combination with standard antiretroviral therapy in previously treated HIV-infected patients ).
Leronlimab is an inhibitor of viral entry in HIV / AIDS. It masks CCR5, thereby protecting healthy T cells from viral infection by preventing the predominant subtype of HIV (R5) from entering these cells. Nine clinical trials have shown that leronlimab can significantly reduce or control the viral load of HIV in humans. The leronlimab antibody appears to be a potent antiviral agent with fewer side effects and less frequent dosing requirements than the daily drug therapies currently in use.
Cancer research has shown that CCR5 may play a role in tumor invasion, metastasis, and control of the tumor microenvironment. The increased expression of CCR5 is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastasis in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by over 98% in a murine xenograft model. As a result, CytoDyn is conducting two Phase 2 human clinical trials, one in mTNBC, which achieved Fast Track designation by the FDA in 2019, and a second in a collaborative trial that encompasses 22 different solid cancers.
The CCR5 receptor appears to play a central role in modulating the traffic of immune cells to sites of inflammation. After completing two clinical trials with COVID-19 patients (a phase 2 and a phase 3), CytoDyn has initiated a phase 2 investigative trial for the post-acute sequelae of SARS COV-2 (PASC), also known as COVID-19 Long-Haulers. This trial will assess the effect of leronlimab on clinical symptoms and laboratory biomarkers in order to better understand the pathophysiology of PASC. It is currently estimated that between 10 and 30% of people infected with COVID-19 develop long-term sequelae. Common symptoms include fatigue, cognitive impairment, trouble sleeping, and shortness of breath. If this trial is successful, CytoDyn plans to continue clinical trials to assess the effect of leronlimab on immunologic deregulation in other post-viral syndromes, including myalgic encephalomyelitis / chronic fatigue syndrome (ME / CFS).
CytoDyn is also conducting a phase 2 clinical trial for NASH to assess the effect of leronlimab on fatty liver and liver fibrosis. Preclinical studies have shown a significant reduction in NAFLD and a reduction in hepatic fibrosis with leronlimab. There is currently no FDA approved treatment for NASH. NASH is one of the main causes of liver transplants. About 30 to 40 percent of adults in the United States are living with NAFLD and 3 to 12 percent of adults in the United States are living with NASH.
CytoDyn is an advanced biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T cells. The CCR5 receptor also appears to be involved in tumor metastasis and immune-mediated diseases, such as GvHD and NASH.
CytoDyn has successfully completed a pivotal phase 3 trial using leronlimab in combination with standard antiretroviral therapy in previously treated HIV-infected patients. CytoDyn has worked diligently to file its Biologics License Application (“BLA”) for this HIV combination therapy since it received a refusal to file in July 2020 and then met with the FDA by phone to respond to its written instructions regarding the deposit. CytoDyn plans to re-file its BLA in the first half of calendar year 2021 or shortly thereafter.
CytoDyn has also completed a phase 3 investigative trial with leronlimab used as monotherapy once a week for patients with HIV infection. CytoDyn plans to initiate a registration-led study of the indication for leronlimab monotherapy. If successful, it could support label extension approval. Clinical results to date from several trials have shown that leronlimab can significantly reduce the viral load in people with HIV infection. In addition, a phase 2 clinical trial has shown that leronlimab as monotherapy can prevent viral leakage in patients infected with HIV; several patients in the phase 2 monotherapy extension arm of leronlimab remained virally suppressed for more than six years. No strong safety signal has been identified in patients who received leronlimab in multiple disease spectra, including patients with HIV, COVID-19 and oncology.
CytoDyn is also conducting a phase 2 clinical trial with leronlimab in mTNBC, 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-Haulers, and a Phase 2 clinical trial for NASH. CytoDyn has already completed two trials in COVID-19 patients (a phase 2 and a phase 3) and is in the process of conducting an additional Phase 3 COVID-19 trial for critically ill and mechanically ventilated COVID-19 patients. More information on www.cytodyn.com.
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and phrases that reflect optimism, satisfaction or disappointment with current prospects, as well as words such as “believes”, “hopes”, “intention”, “believes”, “expects” to ”,“ plans ”,“ plans ”,“ anticipates ”and their variations, or the use of the future, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements regarding leronlimab, its ability to provide positive health results, the possible results of clinical trials, studies or other programs or the ability to continue such programs, the ability to obtain regulatory approval for commercial sales and the actual commercial sales market. The Company’s forward-looking statements are not guarantees of performance, and actual results could differ materially from those contained or expressed by such statements due to risks and uncertainties, including: (i) Company, (ii) the ability to raise additional capital to finance its operations, (iii) the ability of the Company to honor its debts, if any, (iv) the ability of the Company to enter into partnership agreements or licensing with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely manner, (vi) the Company’s ability to obtain approval of a salable product, (vii ) the design, implementation and conduct of the Company’s clinical trials, (viii) the results of the Company’s clinical studies clinical trials, including the possibility of adverse clinical trial results, (ix) the market and the marketing of any approved product, (x) the existence or development of vaccines, drugs or other treatments that are considered by healthcare professionals or patients to be superior to the Company’s products, (xi) regulatory initiatives, compliance government regulations and regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political and social conditions, and (xiv) various other matters, many of which are beyond the control of the Company. The Company urges investors to specifically consider the various risk factors identified in its most recent Form 10-K, and any risk factors or caveats included in any subsequent Form 10-Q or 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company assumes no responsibility to update forward-looking statements to reflect events or circumstances that occur after the date of this press release.
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