September 2024 Letter to Shareholders
Download as PDFSeptember 09, 2024 8:30am EDT
VANCOUVER, Washington, Sept. 09, 2024 (GLOBE NEWSWIRE) --
Dear Shareholders,
It continues to be a transformative year for CytoDyn Inc. (“CytoDyn” or the “Company”). A year in which we have made significant strides as a company, pursuing strategic initiatives to further our clinical development pipeline and charting the path forward in support of our mission. I sincerely thank you for your continued support and remain excited for what lies ahead.
As we enter the final stretch of 2024, let me first acknowledge that there is still a great deal of work ahead of us. The board of directors and the management team of the Company remain focused on advancing our clinical pipeline and opportunities to drive value for shareholders.
We are committed to being transparent with our shareholders and it is my pleasure to provide an update on some key developments described below.
CytoDyn has accomplished a number of milestones since the FDA lifted the clinical hold on leronlimab in March 2024, including: (i) the submission of two clinical trial protocols to the FDA, (ii) the negotiation of various agreements with vendors and creditors, and (iii) the settlement of litigation with Amarex resulting in an immediate $10 million cash influx into the Company, with an additional $2 million to be received in 2025. These important developments were necessary steps to prepare the way for CytoDyn to launch pivotal studies to address the potential role of leronlimab in the clinic.
As of today, the Company has a new and improved relationship with the FDA – one that will remain a critical priority for the management team in the coming years. We believe the Company has sufficient cash on hand to commence the contemplated clinical trials and push our development initiatives forward into 2025.
CytoDyn has made significant progress by initiating a variety of key pre-clinical and clinical leronlimab trials, to be funded by the Company and others. I am also pleased to share that we have observed considerable progress related to development of a longer-acting therapeutic with our partner, who utilizes a proprietary artificial intelligence platform to expedite the clinical development process.
As shareholders, you remain the lifeblood of the Company, and we remain committed to acting in your best interests. We are unwavering in our belief that by continuing to take the best next step, one after another, we will continue to hit key milestones in the coming year and, in the process, drive significant potential value for our shareholders.
My dedication to the Company is grounded in my belief that leronlimab has the potential to be a life-changing therapeutic. Our commitment is to drive value for you – the shareholders – and to bring better healthcare to patients in need.
Included below are updates on our top priorities. I am excited about CytoDyn’s prospects moving forward and will provide additional updates as warranted.
Sincerely,
Dr. Jacob Lalezari
Download as PDFSeptember 09, 2024 8:30am EDT
VANCOUVER, Washington, Sept. 09, 2024 (GLOBE NEWSWIRE) --
Dear Shareholders,
It continues to be a transformative year for CytoDyn Inc. (“CytoDyn” or the “Company”). A year in which we have made significant strides as a company, pursuing strategic initiatives to further our clinical development pipeline and charting the path forward in support of our mission. I sincerely thank you for your continued support and remain excited for what lies ahead.
As we enter the final stretch of 2024, let me first acknowledge that there is still a great deal of work ahead of us. The board of directors and the management team of the Company remain focused on advancing our clinical pipeline and opportunities to drive value for shareholders.
We are committed to being transparent with our shareholders and it is my pleasure to provide an update on some key developments described below.
CytoDyn has accomplished a number of milestones since the FDA lifted the clinical hold on leronlimab in March 2024, including: (i) the submission of two clinical trial protocols to the FDA, (ii) the negotiation of various agreements with vendors and creditors, and (iii) the settlement of litigation with Amarex resulting in an immediate $10 million cash influx into the Company, with an additional $2 million to be received in 2025. These important developments were necessary steps to prepare the way for CytoDyn to launch pivotal studies to address the potential role of leronlimab in the clinic.
As of today, the Company has a new and improved relationship with the FDA – one that will remain a critical priority for the management team in the coming years. We believe the Company has sufficient cash on hand to commence the contemplated clinical trials and push our development initiatives forward into 2025.
CytoDyn has made significant progress by initiating a variety of key pre-clinical and clinical leronlimab trials, to be funded by the Company and others. I am also pleased to share that we have observed considerable progress related to development of a longer-acting therapeutic with our partner, who utilizes a proprietary artificial intelligence platform to expedite the clinical development process.
As shareholders, you remain the lifeblood of the Company, and we remain committed to acting in your best interests. We are unwavering in our belief that by continuing to take the best next step, one after another, we will continue to hit key milestones in the coming year and, in the process, drive significant potential value for our shareholders.
My dedication to the Company is grounded in my belief that leronlimab has the potential to be a life-changing therapeutic. Our commitment is to drive value for you – the shareholders – and to bring better healthcare to patients in need.
Included below are updates on our top priorities. I am excited about CytoDyn’s prospects moving forward and will provide additional updates as warranted.
Sincerely,
Dr. Jacob Lalezari
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