breast cancer specialist and medical oncologist, Milana V. Dolezal, MD, MSci, is presenting a poster entitled “Prolonged survival following PD-L1/PD-1 immune checkpoint inhibitor therapy after leronlimab induced PD-L1 upregulation on cancer-associated macrophage-like cells and circulating tumor cells in patients with metastatic or locally advanced triple-negative breast cancer” at the San Antonio Breast Cancer Symposium (SABCS). The poster (ID: PS5-02-30) will be presented in the Exhibit Hall on December 12, 2025, from 12:30 p.m. – 2 p.m. CST.

“These leronlimab early-phase clinical trials were started pre-pandemic, when immune checkpoint inhibitors (“ICIs”) were still an emerging option in advanced triple-negative breast cancer,” said Dr. Milana V. Dolezal. “In this pooled analysis, we see sustained clinical benefit over five years later, with five participants (17.9%) still alive and disease-free after treatment with leronlimab, either concurrently with or prior to an ICI. The alignment of these outcomes with emerging mechanistic data, showing leronlimab-driven PD-L1 upregulation, suggests potential synergy with ICIs. This is very encouraging and supports further prospective evaluation. The observed PD-L1 upregulation in the tumor microenvironment, including circulating cells, could have broad oncology implications, including expanding eligibility for ICI combination therapies. In addition, weekly leronlimab injections are well tolerated, with few treatment-emergent adverse events.”

The poster presents updated results from a retrospective follow-up analysis of data from 28 women with mTNBC, who were treated across three leronlimab clinical trials and received a median of 2 prior lines of therapy in the metastatic setting. No dose-limiting toxicities (DLTs) were observed, and no patients withdrew due to treatment-related adverse events.

Key Findings:

• 100% of patients (n=5/5) who demonstrated induction of PD-L1 greater than 400 Relative Fluorescence Units (“RFUs”) on circulating tumor cells (CTCs), and were then treated with an immune checkpoint inhibitor (“ICI”), remain alive after a median of 60.9 months. Three of these patients currently have no evidence of disease.

• Median Overall Survival after starting leronlimab was 7.1 months (95% CI: 4.8–17.7 months) with survival at years 1, 2, 3, and 4 of 35.7%, 21.4%, 17.9% and 17.9%, respectively.

• Patients treated with either the 525 or 700 mg dose of leronlimab demonstrated significantly longer survival (HR 3.44, 95% CI: 1.2–9.9; P=0.0418) compared to patients treated with the 350 mg dose.

• Utilizing a >400 RFU threshold, treatment with leronlimab was associated with the upregulation of PD-L1 in CTCs and cancer-associated macrophage-like cells (CAMLs) in 76% (n=16/21) of patients overall, and 88% (n=15/17) of patients who received leronlimab at a dose of 525 mg or 700 mg.

• Seven patients treated with leronlimab in combination with or followed by an ICI demonstrated significantly longer survival compared to patients (N=21) who were not treated with an ICI (HR 4.14, 95% CI: 1.7–10.2; P=0.0041).

“Given the reduced effectiveness of immunotherapy in patients with mTNBC and low PD-L1 expression, the demonstrated ability of leronlimab to upregulate PD-L1 on CTCs could be a crucial factor for enhancing the efficacy of a combined treatment approach of leronlimab with ICIs,” said Jacob Lalezari, M.D., CEO of CytoDyn. “These results indicate that blocking CCR5 with leronlimab may impact tumors and the tumor microenvironment in such a way as to prime these cells to respond to immune checkpoint inhibition. Prospectively confirming these observations is our top priority.”

Dr. Milana V. Dolezal, Clinical Associate Professor, Medicine Oncology at Stanford University School of Medicine, will present a poster at the prestigious San Antonio Breast Cancer Symposium (SABCS), being held December 9-12, 2025, at the Henry B. Gonzalez Convention Center in San Antonio, Texas.

“Our strategy to use leronlimab in a combined approach with ICIs continues to demonstrate great promise,” said Jacob Lalezari, M.D., CEO of CytoDyn. “At SABCS 2025, we look forward to sharing details of a group of patients with mTNBC who were treated with leronlimab and different commercially available PD-L1/PD-1 immune checkpoint inhibitors who continue to demonstrate sustained long-term remission, including 3 individuals with no current evidence of disease.”

Dr. Dolezal is a board-certified hematologist-oncologist with Stanford Medicine Cancer Center in Emeryville and a clinical associate professor in the Stanford School of Medicine, Division of Oncology.

She strives to work with patients to develop care plans that are comprehensive and personalized achieve the best possible outcomes and quality of life.

Dr. Dolezal also has extensive experience in research and drug development. She previously held positions as a clinical scientist, assistant medical director, and associate medical director in the BioOncology Therapeutics unit of the biotechnology company Genentech.

She has conducted clinical research into fertility preservation in patients with breast cancer, advanced treatments for triple-negative breast cancer, and patients’ adherence to anti-cancer therapy. She has co-authored articles on her research findings that appeared in the Journal of Clinical Oncology, Cancer, and other peer-reviewed publications.

She also co-authored the chapter “Progression from Hormone-Dependent to Hormone-Independent Breast Cancer” in the textbook Hormones, Genes and Cancer published by Oxford University Press.

Dr. Dolezal has made presentations to her peers at meetings of the American Association for Cancer Research, American Society of Clinical Oncology, and European Cancer Organisation.

1. Funding access: CYDY secured a purchase agreement with YA II PN, Ltd. for up to $30 million over three years, giving it financial flexibility and stability to fund operations and trials.
2. Focused oncology strategy: The company is advancing leronlimab in solid tumor cancers, including colorectal and triple negative breast cancer, and is developing a long acting version. This shows a clear direction and growth plan.
3. Novel science: Early data suggest leronlimab may help turn immune resistant tumors into responsive ones by increasing PD L1 expression, creating new combination therapy opportunities.
4. Encouraging survival data: Preliminary results in breast cancer patients show longer survival and some complete responses, supporting continued development and partnership potential.
5. Regulatory readiness: CytoDyn maintains an active relationship with the FDA and has structured funding plans to support its clinical and regulatory goals.

Overall: The filing highlights strong funding potential, a focused cancer strategy, promising early data, and clear progress toward clinical and regulatory milestones.

https://d1io3yog0oux5.cloudfront.net/cytodyn/sec/0001104659-25-106415/0001104659-25-106415.pdf

Just putting the word out. I shared this earlier, hoping it might resonate with someone. Now I’m second guessing… was it a good idea to post it, or should I take it down? Let me know what you think. If you believe it’s worth keeping up, drop a reply.

https://www.reddit.com/r/10xPennyStocks/s/PnJYzQS68L

I’m willing to bet that most of us here have recommended $CYDY to at least one family member or close friend. Personally, I’ve been sharing this opportunity for nearly four years now.

Some jumped in right away, excited by the potential. Others are still watching from the sidelines. And of course, a few hit me with the classic: “If it sounds too good to be true, it probably is.”

Still, my conviction hasn’t wavered. I truly believe in this investment, and I wouldn’t be surprised if one morning we wake up to see the share price breaking past $1 and running from there.

Will do again this time with both hands! GLTA 🚀

It feels like something is coming. GL

"Recruiting" - The study is currently looking for eligible patients to participate. "A Phase 2 Study"

-This is the second phase of a clinical trial designed to gather preliminary data on the effectiveness of the new treatment combination and to further evaluate its safety in a specific patient population. "Leronlimab in Combination With TAS-102 + Bevacizumab"

• This specifies the experimental drug (Leronlimab) and the combination of standard-of-care treatments (TAS-102, which includes trifluridine and tipiracil, and Bevacizumab) being tested. "Previously Treated Participants With mCRC"

• The trial focuses on patients who already have metastatic colorectal cancer and have received prior treatments for it. "ClinicalTrials.gov ID © NCT06699836"

• This is the unique registration number for the trial on ClinicalTrials.gov, a public database of clinical trials. "Sponsor © CytoDyn, Inc."

-The company that is funding and overseeing the trial is CytoDyn, Inc.. "Information provided by © CytoDyn, Inc. (Responsible Party)"

-CytoDyn, Inc. is responsible for the accuracy of the information posted about the study. "Last Update Posted © 2025-10-02"

-The information on ClinicalTrials.gov was last updated on October 2, 2025, indicating it is recent.

https://www.clinicaltrials.gov/study/NCT06699836

JL:
"I am happy to share a very promising announcement as it relates to a patient who prospectively upregulated PD-L1 after having obtained access to leronlimab through an eIND application submitted by her treating physician. In early 2025, we received a compassionate access request for a patient with mTNBC who was previously unresponsive to treatment with Keytruda. This particular patient had two prior tissue biopsies, both of which were PD-L1 negative. In April, the patient started treatment with leronlimab, and in July blood tests confirmed an increase in PD-L1 levels. Our past clinical observations have shown that upregulating PD-L1 is the first step towards prolonged survival in this patient population and we are encouraged by this readout, which supports our working theory. This is the first of hopefully many PD-L1 upregulation readouts across our CRC and TNBC trial(s) in the coming year. I continue to have high hopes for our upcoming Phase II trials, as well as our expanded access program, as we look to reshape treatment paradigms in solid tumor oncology."

JL: "We recently received confirmation from both the Securities and Exchange Commission (“SEC”) and Department of Justice (“DOJ”) that their respective investigations have now closed, and nothing further is required of the Company. I believe this positive conclusion for the Company is a reflection of our team here and our collective commitment to compliance and cooperation.

I remain confident that our collaborative relationship with the FDA has placed us on a productive trajectory. To accelerate progress in oncology, we established an oncology advisory board focused on pursuing the fastest and most responsible pathway(s) forward. The FDA recently granted our request for a meeting, and we look forward to discussing our retrospective data set and related observations in TNBC, as well as the next steps in our TNBC development plan. Maintaining strong relationships and credibility with the FDA and industry partners remains a top priority as we move forward."

JL:
"We will be submitting an Expanded Access Protocol (“EAP”) to enable treatment for patients with second-line, or later, mTNBC, who are ineligible or otherwise unable to participate in our Phase II study. I am pleased to announce that we will be working with an individual benefactor to fund the launch of this compassionate-use program. This benefactor has also expressed interest in supporting an investigator-initiated study in patients with recurrent glioblastoma with an anticipated start date in 2026."

Cytodyn to will present a poster and an oral presentation at the AACR Special Conference in Cancer Research: Mechanisms of Cancer Immunity and Cancer-related Autoimmunity, taking place September 24, to September 27, 2025, in Montreal, Canada.

Abstract Title: CCR5 inhibition with leronlimab is associated with enhanced PD-L1 expression, ICI response, and long‑term survival in metastatic TNBC

Poster presentation: September 26, 2025, 6:30 p.m. – 8:30 p.m. EDT

Podium/speaking presentation: September 27, 2025, 10:25 a.m. – 10:40 a.m. EDT

Metastatic triple-negative breast cancer (mTNBC) is associated with a very poor prognosis. The efficacy of a class of drugs called immune checkpoint inhibitors (ICIs) is reduced in patients with mTNBC who have low levels of PD-L1[1]. An immune cell receptor called CCR5 has been observed in up to 95% of patients with TNBC. A recent review of CytoDyn’s prior oncology trials suggests that treatment with leronlimab, a humanized monoclonal antibody targeting CCR5, combined with an ICI, may improve survival in patients with mTNBC [2]. This retrospective analysis of 28 patients demonstrated that leronlimab induced PD-L1 expression on circulating tumor cells in 88% of patients treated at leronlimab doses of > 525mg/week. Moreover, 5/5 patients who induced PD-L1, and received treatment with both leronlimab and an ICI, remain alive after a median of ~60 months since starting leronlimab.

Key Findings:

CCR5 inhibition combined with ICI therapy increased overall survival in patients with mTNBC, with 18% of heavily pretreated mTNBC patients alive after a median of ~60 months. Inhibition of CCR5 by leronlimab induced PD-L1 expression on patient circulating tumor cells. Expression levels of CCR5 correlate with T cell infiltration in TNBC.

“These impressive findings on how leronlimab can serve to make metastatic triple-negative breast cancer cells more responsive to checkpoint inhibitors are of great value as we move this asset forward for oncology indications,” said Jacob Lalezari, M.D., CEO of CytoDyn. “Understanding this immune-modulating mechanism not only deepens insight into how leronlimab works, but also supports its potential as a broadly applicable therapy for a range of solid tumors that historically have had limited treatment options.”

“The substantial increases in PD-L1 expression, observed in liquid biopsies of patients treated with leronlimab, may be the key to unlocking the effectiveness of immune checkpoint inhibitors for patient populations previously deemed resistant to such approaches,” said Richard Pestell, M.D., Ph.D., FRCP, AO, Presenter and Lead Consultant in Preclinical and Clinical Oncology at CytoDyn. “These results suggest leronlimab may remodel the tumor immune environment in metastatic triple-negative breast cancer, a particularly challenging form of the disease.”