VANCOUVER, Washington, May 16, 2024 (GLOBE NEWSWIRE) --
Dear Shareholders,
I write today to provide an update on CytoDyn Inc. (“CytoDyn” or “Company”), as we approach the end of our 2024 fiscal year (May 31, 2024), and to sincerely thank you for your unwavering support.
Fiscal year 2024 was a significant year for CytoDyn, and one that I believe will be remembered as the beginning of a turnaround. The Company achieved the lifting of the FDA’s clinical hold in late February 2024 and is now working to return to the clinic. Over the past several months, the Company has made significant internal progress on key initiatives which we believe will lead to marked external developments in the form of the commencement of clinical trials, the rollout of a number of pre-clinical research initiatives, and the continued publication of leronlimab data.
Shortly after my appointment as the Company’s CEO in November 2023, I hosted an investment update at which I committed to prioritizing the following: (i) getting off clinical hold, which required the submission of a revised trial protocol to the FDA; (ii) publishing clinical data that had not yet been released; and (iii) exploring how to extend leronlimab’s platform wherever it made sense. As I reflect on my first six months as CEO, I am pleased with the progress, but our work is not yet done.
Over the next six months, we expect to commence at least one, and potentially two clinical trials. The prospective clinical trials, in order of priority, are: (i) a Phase II study of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer; and (ii) a Phase II study exploring leronlimab’s effects on inflammation. The Company’s priority will be the oncology trial which, if successful, will put us on track towards a commercial approval of leronlimab in that indication. The inflammation study is aimed at clarifying certain provocative observations related to leronlimab, and to help define the dose and underlying mechanism of anti-inflammatory action. It is imperative that the Company generate unassailable results in the clinic and I believe the above trials can accomplish this. Starting the oncology study and related fundraising is the top priority of the Company at this time, but our current hope is that we can initiate both studies before the end of this calendar year.
Research and development partnership opportunities are important to the Company as we search for cost-effective ways to further build out our product development portfolio. We have identified several such opportunities that we believe are intriguing, and anticipate finalizing agreements with these partners in the very near future. Such potential partnerships include an investigator-initiated pilot study of leronlimab in patients with Alzheimer’s Disease, and a project that will evaluate the use of leronlimab in patients living with HIV who are undergoing stem cell transplantation in a proof of cure study. Following lifting of the clinical hold, we have observed a significant increase in third parties that are interested in partnering with the Company. We will continue to review opportunities as they arise, given the potential for significant value return at little or no cost to the Company.
Finally, as promised, CytoDyn has submitted several leronlimab manuscripts for peer review and is in the process of completing final drafts of several others. The clinical endpoint data from the Long COVID trial (CD 15) was recently published in the Journal of Infection. All publications will be available on the Company’s website soon after publication.
I believe the Company is building for success and has made significant strides toward initiating a number of key pre-clinical and clinical leronlimab trials. I am also pleased to share that things are progressing well as to the development of a longer-acting therapeutic with our partner who utilizes its proprietary artificial intelligence platform.
As shareholders, you are the lifeblood of the Company and we remain committed to acting in your best interests. Your questions and feedback are always appreciated. Included herewith is a copy of the May 2024 “Frequently Asked Questions” supplement. This FAQ supplement is something that is also posted on the Company’s website and updated from time to time. You are always welcome to submit questions to the Company’s IR email account: ir@cytodyn.com.
I understand that the Company’s historical challenges may have tested your confidence, and I am grateful for your ongoing support and trust. My dedication to the Company is founded in my belief that leronlimab has the potential to be a life-changing therapeutic. As always, our commitment is to bring better healthcare to patients in need, and to maximize shareholder value.
Sincerely,
Dr. Jay Lalezari
CEO
