Timelines:
5 months past @ March 18th:
* TNBC -- Two previously announced preclinical studies in TNBC that will identify treatment strategies to optimize the design of future studies are now underway.
A third study has begun to further examine the apparent mechanism behind the observed increase in survival as compared to existing treatment paths.
* GBM -- A preclinical study at the Albert Einstein College of Medicine sequencing temozolomide and leronlimab is now underway.
* AD -- The study is fully funded, and our colleagues at Cornell are engaged to move the project forward through Cornell’s institutional review process and FDA submission.
* Stroke -- CytoDyn is working with Dr. Carmichael and Dr. Kate Schunke at the University of Hawaii to conduct a preclinical study of stroke in transgenic mice that express human CCR5.
* Fibrosis -- we are continuing discussions with potential partners who have expressed interest in funding studies of leronlimab in the treatment of patients with organ fibrosis
* amfAR LATCH -- we look forward to the launch of this program in 2025.
* A manuscript summarizing the results of treatment with leronlimab on liver fibrosis from SMC is in preparation.
* As previously announced, CytoDyn is preparing a manuscript summarizing the integrated safety data from the almost 1,600 patients who have already received leronlimab. The final draft of that safety summary will be completed shortly.
_____
April 29th is right @ 3 1/2 months:
“We are also excited to share information about the apparent mechanism of action in long-term surviving patients that we see as a potentially paradigm-shifting development in solid tumor oncology.”
May 13, 2025 is right @ 3 months:
CytoDyn’s results indicate that 15/17 (88%) of patients who received a weekly dose of 525 mg or higher experienced a significant increase in PD-L1 expression on their CTCs over a 30-to-90-day period after starting leronlimab.
Increasing expression of PD-L1 can be likened to turning “cold” tumors “hot”, elevating PD-L1 levels to the level necessary for patients to potentially derive benefit from further treatment with a class of drugs known as immune checkpoint inhibitors (“ICIs”).
___
June 24, 2025 is right @ 2 months:
CytoDyn Announces First Patient Dosed in Phase II Oncology Trial in Colorectal Cancer:
Enrollment is now underway across multiple clinical sites, in partnership with Syneos Health
In partnership with Syneos Health, the Company has engaged eight clinical sites and counting, and patient enrollment and processing efforts are underway.
The lead principal investigator for the trial is Dr. Ben Weinberg, MD, from Georgetown University and the MedStar Health Alliance.
colorectal cancer is the third most common cancer type worldwide, and the second most common cause of cancer-related deaths globally. IARC’s most recently published figures estimate that there are about 1.9 million new cases of colorectal cancer and more than 900,000 deaths due to colorectal cancer worldwide each year.
_________
S-3 has been filed for up to $100m --- as needed.
5 months past @ March 18th:
* TNBC -- Two previously announced preclinical studies in TNBC that will identify treatment strategies to optimize the design of future studies are now underway.
A third study has begun to further examine the apparent mechanism behind the observed increase in survival as compared to existing treatment paths.
* GBM -- A preclinical study at the Albert Einstein College of Medicine sequencing temozolomide and leronlimab is now underway.
* AD -- The study is fully funded, and our colleagues at Cornell are engaged to move the project forward through Cornell’s institutional review process and FDA submission.
* Stroke -- CytoDyn is working with Dr. Carmichael and Dr. Kate Schunke at the University of Hawaii to conduct a preclinical study of stroke in transgenic mice that express human CCR5.
* Fibrosis -- we are continuing discussions with potential partners who have expressed interest in funding studies of leronlimab in the treatment of patients with organ fibrosis
* amfAR LATCH -- we look forward to the launch of this program in 2025.
* A manuscript summarizing the results of treatment with leronlimab on liver fibrosis from SMC is in preparation.
* As previously announced, CytoDyn is preparing a manuscript summarizing the integrated safety data from the almost 1,600 patients who have already received leronlimab. The final draft of that safety summary will be completed shortly.
_____
April 29th is right @ 3 1/2 months:
“We are also excited to share information about the apparent mechanism of action in long-term surviving patients that we see as a potentially paradigm-shifting development in solid tumor oncology.”
May 13, 2025 is right @ 3 months:
CytoDyn’s results indicate that 15/17 (88%) of patients who received a weekly dose of 525 mg or higher experienced a significant increase in PD-L1 expression on their CTCs over a 30-to-90-day period after starting leronlimab.
Increasing expression of PD-L1 can be likened to turning “cold” tumors “hot”, elevating PD-L1 levels to the level necessary for patients to potentially derive benefit from further treatment with a class of drugs known as immune checkpoint inhibitors (“ICIs”).
___
June 24, 2025 is right @ 2 months:
CytoDyn Announces First Patient Dosed in Phase II Oncology Trial in Colorectal Cancer:
Enrollment is now underway across multiple clinical sites, in partnership with Syneos Health
In partnership with Syneos Health, the Company has engaged eight clinical sites and counting, and patient enrollment and processing efforts are underway.
The lead principal investigator for the trial is Dr. Ben Weinberg, MD, from Georgetown University and the MedStar Health Alliance.
colorectal cancer is the third most common cancer type worldwide, and the second most common cause of cancer-related deaths globally. IARC’s most recently published figures estimate that there are about 1.9 million new cases of colorectal cancer and more than 900,000 deaths due to colorectal cancer worldwide each year.
_________
S-3 has been filed for up to $100m --- as needed.
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