CytoDyn Closes $ 28.5 Million Non-Dilutive Convertible Note Funding with Conversion Rate of $ 10.00 Per Share Without Warrants
VANCOUVER, Washington, July 29, 2020 (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 a new non-dilutive convertible debt offering with an institutional investor, which provides $ 25 million of immediately available capital. The note, with a two-year maturity, bears interest at a rate of 10% per annum and is secured by all 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 continued support and great confidence shown by the fourth round of funding this institution with us. They clearly understand the opportunity before us and we now have the cash flow to accelerate our business plan without tapping into the increased share authorizations recently approved by our shareholders. This capital injection will help us provide leronlimab to patients as soon as the regulatory path is clear for potentially COVID-19 (for three different populations), cancer (23 different indications) and HIV (combination, monotherapy, treatment of HIV and Prep) . I am very happy to share with all of our stakeholders the enthusiasm we have around our COVID-19 therapies during tomorrow’s conference call, as well as our expected timelines. “
About coronavirus disease 2019
CytoDyn has met its goal of recruiting 75 patients in its Phase 2 clinical trial for COVID-19, a randomized clinical trial for the mild to moderate COVID-19 population in the United States and recruitment continues in its randomized clinical trial of phase 2b / 3 for severe and critically ill COVID-19 population in several hospitals across the country.
SARS-CoV-2 has been identified as the cause of an outbreak of respiratory disease first detected in Wuhan, China. The origin of SARS-CoV-2 causing COVID-19 disease is uncertain and the virus is highly contagious. COVID-19 is typically transmitted from person to person through respiratory droplets, typically resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing disease in humans and others circulating among animals. For confirmed COVID-19 infections, symptoms include fever, cough, and shortness of breath. Symptoms of COVID-19 can appear as little as two days or up to 14 days after exposure. Clinical manifestations in patients have ranged from nonexistent to severe and fatal. Currently, there are minimum treatment options for COVID-19.
About Léronlimab (PRO 140)
The FDA has granted Fast Track designation to CytoDyn for two potential indications of leronlimab for life-threatening illnesses. The first as a combination therapy with HAART for HIV infected patients and the second is for triple negative metastatic breast cancer. Leronlimab is an experimental humanized IgG4 mAb that blocks CCR5, a cellular receptor important in HIV infection, tumor metastasis and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including achievement of its primary endpoints in a pivotal phase 3 trial (leronlimab in combination with standard antiretroviral therapy in previously treated HIV-infected patients ).
In the context of HIV / AIDS, leronlimab is an inhibitor of viral entry; it masks CCR5, thereby protecting healthy T cells from viral infection by preventing the predominant HIV subtype (R5) from entering these cells. Leronlimab has been the subject of nine clinical trials, each of which has 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 potentially resulting in fewer side effects and less frequent dosing requirements compared to daily drug therapies currently in use.
In 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. CytoDyn is therefore conducting a phase 1b / 2 human clinical trial in triple-negative metastatic breast cancer and obtained the Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating the traffic of immune cells to sites of inflammation. It can be crucial in the development of acute graft versus host disease (GvHD) and other inflammatory conditions. Clinical studies by others support the concept that blocking CCR5 using a chemical inhibitor may reduce the clinical impact of acute GvHD without significantly affecting the transplant of transplanted bone marrow stem cells. . CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on transplanted cells is essential for the development of acute GvHD, preventing the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to alleviate acute GvHD. . The FDA has granted an “orphan drug” designation to leronlimab for the prevention of GvHD.
CytoDyn is an advanced biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a new 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 with leronlimab in combination with standard antiretroviral therapy in previously treated HIV-infected patients. The Company is working diligently to provide the information required by the FDA to resubmit its biologic license application for this combination therapy. CytoDyn is also conducting a phase 3 investigative trial with leronlimab 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 a label extension. Clinical results to date from several trials have shown that leronlimab can significantly reduce the viral load in people with HIV infection. No serious drug-related injection site reactions have been reported in approximately 800 patients treated with leronlimab and no drug-related SAEs have been reported in patients treated with a 700 mg dose of leronlimab. In addition, a phase 2b clinical trial has shown that leronlimab as monotherapy can prevent viral leakage in HIV-infected patients; some patients on leronlimab monotherapy remained 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 triple negative metastatic breast cancer. 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 about leronlimab, its ability to have 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 market for actual commercial sales. 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.
Cristina De Leon
Office: 360.980.8524, ext. 106