The demand from both new and current investors highlights confidence in CytoDyn’s clinical progress and its versatile development strategy in immuno-oncology, exploring a number of potential roles for leronlimab – the Company’s first-in-class humanized monoclonal antibody that targets the CCR5 receptor.

“The successful completion of this financing in a challenging capital markets environment reflects meaningful investor support for our clinical strategy,” said Robert E. Hoffman, CFO of CytoDyn. “The financing strengthens our balance sheet and is expected to fund current operations into 2027, supporting continued advancement of our clinical programs and strategic priorities. We appreciate the support of both new and existing investors, which underscores confidence in the continued development of leronlimab and its potential role in oncology, as we remain focused on disciplined execution and long-term value creation.”

Net proceeds from the financing will primarily support the advancement of CytoDyn’s clinical development programs, including ongoing and planned trials, regulatory engagement, and data analysis. Additional funds may be allocated toward manufacturing readiness, regulatory and compliance infrastructure, and general working capital.

For more information on the Company’s recent fundraising activities, including key terms and conditions of some of the agreements, please see CytoDyn’s filings with the Securities and Exchange Commission, including its Current Report on Form 8-K filed on March 5, 2026.

About CytoDyn

CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide.

For more information, please visit www.cytodyn.com and follow us on LinkedIn.

Note Regarding Forward-Looking Statements

This news release may contain forward-looking statements relating to, among other things, the success of the fundraising initiative, the anticipated benefits and timelines discussed above, the mechanism of action of leronlimab, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law.

Corporate Contact

CytoDyn Inc.
ir@cytodyn.com

Media Contacts

David Schull or Ignacio Guerrero-Ros, Ph.D.  
Russo Partners, LLC 
CytoDyn@russopartnersllc.com 

Durable Clinical Observations and Favorable Safety Profile Observed in Heavily Pretreated mTNBC Patients

VANCOUVER, Washington, Feb. 20, 2026 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer (“mTNBC”) and colorectal cancer (“mCRC”), today announced that new preclinical, translational, and clinical data supporting leronlimab’s proposed role in the treatment of metastatic triple-negative breast cancer was presented at the AACR Immuno-Oncology Conference (AACR IO), held February 18-21, 2026 in Los Angeles, California.

Leronlimab is being evaluated for its ability to modulate the tumor immune microenvironment by targeting the CCR5 receptor, a key regulator of immune function implicated in cancer progression and immune resistance. The data presented explore mechanisms of immune checkpoint resistance in TNBC and offer insight into how CCR5 blockade may enhance responses to immune checkpoint inhibitors (“ICIs”).

“In this study, we continued to explore how CCR5 signaling may contribute to immune checkpoint resistance in metastatic triple-negative breast cancer by integrating patient-derived datasets with molecular, cellular, and translational analyses involving leronlimab,” said Professor Richard Pestell, M.D., Ph.D., FRCP, AO, Lead Consultant in Preclinical and Clinical Oncology at CytoDyn. “Mechanistic findings suggest that CCR5 blockade with leronlimab may modulate pathways associated with T-cell exhaustion and PD-L1/PD1 regulation, providing a mechanistic rationale for combination strategies with immune checkpoint inhibitors.”

Key findings:

• Across multiple TNBC patient gene expression datasets, CCR5 expression correlated with elevated cytotoxic T-lymphocyte signatures and T-cell exhaustion profiles, identifying immune states potentially amenable to CCR5 inhibition.
• PD-L1 and PD1, the abundance of which correlates with improved response to immune checkpoint therapies, was increased by leronlimab.
  • In cell culture and histology analyses, CCR5 inhibition with leronlimab increased the abundance of PD-L1 in breast cancer cells.
  • In Rhesus monkeys, leronlimab induced PD1 in T cells.
• CCR5 activity was associated with the secretion of immunosuppressive mediators from triple-negative breast cancer cells, [sB7-H3 (CD276), BAFF (sTNFSF13B), and sTyro3], which were significantly reduced following leronlimab treatment.
• In a pooled retrospective clinical analysis of 28 heavily pretreated patients with metastatic triple-negative breast cancer from three clinical trials, leronlimab demonstrated a favorable safety profile with no therapy-limiting toxicities, and 5 of 28 patients (17.9%) remain alive after a median follow-up of more than 63 months.

“These data strengthen the clinical case for leronlimab in metastatic TNBC by aligning mechanistic insights with encouraging safety and long-term survival observations, while adding important clinical perspective to the emerging role of CCR5 inhibition in this disease,” said Dr. Jacob Lalezari, M.D., Chief Executive Officer of CytoDyn. “The consistency of the mechanistic and clinical findings supports our decision to continue the clinical development and investigation of leronlimab, including further evaluation in combination immunotherapy settings.”

Associate Professor Xuanmao Jiao of the Pennsylvania Cancer and Regenerative Medicine Center at the Baruch S. Blumberg Institute presented the poster, titled “Leronlimab is associated with long‑term survival in metastatic TNBC: Enhancing PD-L1 expression, ICI response, and the role of T cell exhaustion,” on February 19, 2026, from 12:15 p.m. – 3:25 p.m. PST. A copy of the poster will be made available on CytoDyn’s website under the Publications & Posters section.

About CytoDyn
CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide.

For more information, please visit www.cytodyn.com and follow us on LinkedIn.

Note Regarding Forward-Looking Statements
This news release may contain forward-looking statements relating to, among other things, the mechanism of action of leronlimab, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law.

Corporate Contact
CytoDyn Inc.
ir@cytodyn.com

Media Contacts
David Schull or Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
CytoDyn@russopartnersllc.com

The benefactor, who has chosen to remain anonymous, has a longstanding interest in patient access initiatives, the potential of leronlimab, and how the Company’s recent data and mechanism of action theories might serve to offer experimental avenues to patients who have exhausted all approved treatment options. This strategic funding initiative will enable CytoDyn to set up and administer a program to expand access to leronlimab for a group of eligible patients, as determined by the U.S. Food and Drug Administration (FDA) guidelines, with advanced disease but who do not otherwise meet the enrollment criteria for the Company’s ongoing clinical trials.

“We are honored by this benefactor’s commitment to accelerating patient access to promising cancer therapies such as leronlimab,” said Jacob Lalezari, M.D., CEO of CytoDyn. “This support allows us to responsibly broaden the availability of leronlimab while continuing to advance our promising clinical programs as we generate data to inform future regulatory pathways.”

With Every Patient (WEP Clinical) has been engaged to serve as the clinical research organization (CRO) for the EAP, and the Company expects to formally open the program for patient referral in March 2026, assuming FDA’s allowance of the Company's revised protocol submission. In addition to providing compassionate access to patients who have exhausted other treatment options and are otherwise unable to participate in the Company's upcoming Phase 2 trial, the EAP program will serve as another potential avenue to observe PD-L1 induction following treatment with leronlimab, and thereby – in theory – opening a treatment pathway towards sustained remission when combined with an immune checkpoint inhibitor (“ICI”). The EAP will operate under applicable FDA guidelines, and additional information for physicians and eligible patients will be available on the Company’s website (www.cytodyn.com) as the program is rolled out in the coming weeks.

About CytoDyn

CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide.

For more information, please visit www.cytodyn.com and follow us on LinkedIn.

Note Regarding Forward-Looking Statements

This news release may contain forward-looking statements relating to, among other things, mechanism of action, clinical development programs, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law.

Corporate Contact

CytoDyn Inc.
ir@cytodyn.com

Media Contacts

David Schull or Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
CytoDyn@russopartnersllc.com

Dear Shareholders,

As we close out the year and step with confidence and purpose into 2026, I want to extend my sincere appreciation for your support, patience, and continued belief in CytoDyn’s (the “Company”) mission. I will remember 2025 as the year in which we first presented our astonishing survival observations and compelling data on the emerging role of leronlimab in solid tumor oncology. This past year has been one of disciplined execution, operational rebuilding, and meaningful scientific progress. Today, we are a far stronger, more focused, and more capable company than we were twelve months ago.

In February, we announced increased survival rates in patients with metastatic Triple-Negative Breast Cancer (“mTNBC”) who were treated with leronlimab in prior studies. In May, after further evaluation of the underlying data and treatment profiles on the group of long-term survivors, we shared our exciting new proposed mechanism of action (“MOA”) for leronlimab. Among the long-term survivors with sustained remission, we observed three common factors: (i) treatment with leronlimab, (ii) subsequent expression of PD-L1 levels on circulating tumor cells above a common threshold, and (iii) treatment with an immune checkpoint inhibitor (“ICI”). All five patients who were treated in this manner are alive today, five years later, and three of these individuals currently show no evidence of disease. The patient profiles and underlying data, albeit retrospective, suggest that leronlimab can convert “cold” (PD-L1–negative) tumors into “hot” (PD-L1–positive) tumors by blocking CCR5, thereby enabling a potential “prime and pair” regimen in which leronlimab primes the tumor microenvironment which then allows ICIs to unleash an immune response.

Once prospectively confirmed, leronlimab’s ability to induce a “hot” tumor microenvironment should be a game changer in solid tumor oncology. This is our top clinical priority, and data supporting this concept are being collected in our active Phase 2 colorectal cancer (“CRC”) trial and will be collected in our Phase 2 mTNBC trial set to commence in 2026.

Calendar 2025 in Review

Throughout 2025, our team delivered on several critical priorities designed to restore momentum and position CytoDyn for long-term success:

Operational Strengthening. We advanced essential regulatory preparations, refined our clinical strategy, and improved internal processes. This included strengthening data integrity standards, enhancing trial oversight, and engaging more consistently and constructively with regulators and investigators.

Clinical Program Advancement. Our scientific team made significant progress across our therapeutic focus areas. While early-stage milestones rarely generate headlines, this foundational work ultimately determines a biotech company’s trajectory. By improving study design, aligning with clinical experts, and prioritizing areas of unmet need, we have created a roadmap that is realistic, executable, and value-creating. A detailed Clinical Update supplement is attached at the end of this letter.

Financial Discipline. 2025 was marked by prudent financial stewardship. We remained focused on extending our runway, improving our cost structure, and ensuring that resources are directed toward programs with the highest probability of success and the greatest potential benefit for patients.

The progress we made this year is tangible. As we continue towards prospectively confirming our MOA theories, the progress above is not theoretical and our team has positioned the company to move confidently into its next phase. We have tightened operations, clarified our approach, strategically resolved legal issues, and established the infrastructure needed to deliver meaningful results. Our optimism for 2026 is grounded firmly in the work completed in 2025.

Looking Ahead to Calendar 2026

As we enter 2026, CytoDyn stands on the cusp of several important clinical and regulatory inflection points. I am optimistic about the near-term milestones ahead, including:

• Advancements in our ongoing clinical studies
  
• Near-term data readouts towards prospectively confirming our MOA theories
  
• Continued progress in regulatory interactions that may unlock new clinical pathways
  
• Strengthening relationships with key clinicians, investigators, and potential partners
  
  

With the fundamentals in place and our programs advancing, 2026 is poised to be the year CytoDyn re-enters the industry conversation with force and credibility. We believe the coming year will showcase:

• Strong clinical execution
  
• Clear scientific validation
  
• Data-driven milestones
  
• Pathways that may enable new opportunities with clinicians, researchers, and industry partners
  
  

Biotech requires rigor, patience, and adherence to the regulatory process, but we have every reason to believe that the groundwork laid in 2025 will begin to show tangible results in 2026.

Closing Thoughts
Thank you for standing with us. Thank you for believing in our mission to develop therapies with the potential to improve lives. And thank you for your continued commitment to CytoDyn as we enter what I believe will be the most important and transformative year in our company’s history. We are ready. We are focused. And in 2026, we intend to make waves.

Wishing everyone a safe and joyful holiday season,
Jacob Lalezari, MD
CEO

Note Regarding Forward-Looking Statements 
This news release contains forward-looking statements relating to, among other things, the mechanism of action of leronlimab, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, and in subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments other than as required by law. 

Corporate Contact 
CytoDyn Inc. 
ir@cytodyn.com

Media Contacts 
David Schull or Ignacio Guerrero-Ros, Ph.D. 
Russo Partners, LLC 
CytoDyn@russopartnersllc.com 

Clinical Update
– December 2025 –

Our Phase II study of patients with mCRC was launched in July 2025, to evaluate the safety and efficacy of leronlimab (350 mg versus 700 mg) added to a backbone of Bevacizumab and Tipiracil. As of this writing, the study has enrolled 16 patients with another 23 patients in screening. Based upon current projections, we anticipate 20 patients to be enrolled by the end of the year, and to have the trial fully enrolled in or around May 2026.

Early results from the mCRC trial have been very encouraging, and we have already submitted abstracts for at least two presentations on the CRC study in 2026– one presentation on biomarker results, and a second focused on clinical outcomes. In addition, the study design is being amended so that patients who have a clinical progression will have the option of adding an ICI to their treatment regimen. As a result, the final CRC study design will allow us to evaluate leronlimab both as a “stand-alone” agent on its own (added to the background regimen) and as a “prime and pair” agent used in conjunction with ICIs.

We recently received feedback from FDA on two proposed protocols for patients with mTNBC, including a Phase II study combining leronlimab with ICIs as well as an Expanded Access Program (EAP). We are incorporating FDA’s helpful comments and will be submitting revised protocols for both initiatives in the near future.

The Phase 2 trial in patients with mTNBC will enroll individuals onto a dosing regimen of weekly leronlimab along with chemotherapy for several cycles after which time they will be randomized to immediate versus deferred treatment with an ICI. The primary endpoint of the study will be clinical evaluation of Overall Response Rate (ORR) with secondary endpoints including both Progression-Free Survival (PFS) and Overall Survival (OS). Two exploratory endpoints will include evaluation of changes in PD-L1 on circulating tumor cells as well as changes in circulating tumor DNA (ctDNA). This study is intentional and dynamic, meant to provide prospective confirmation of the “prime and pair” paradigm that we believe will be of particular interest to potential industry partners, as well as evaluate leronlimab’s potential for monotherapy benefit.

With Every Patient (WEP Clinical) has been engaged to serve as our clinical research organization (CRO) for the EAP, and we expect to open the program for patient referral in or around February 2026, assuming FDA’s allowance of our revised protocol submission. In addition to providing compassionate access to patients who have exhausted other treatment options and are otherwise unable to participate in our upcoming Phase 2 trial, the EAP program will serve as another potential avenue to observe PD-L1 induction following treatment with leronlimab, and thereby – in theory – opening a treatment pathway towards sustained remission when combined with an ICI. As previously shared, we are grateful to a high-net worth individual who has agreed to cover the cost of the first 20 patients enrolled in this two-year program.

In 2025 there was a marked increase in incoming requests for CytoDyn to collaborate with investigators from a variety of academic centers. I am pleased to announce that we are proceeding with four such initiatives, and that all four are being funded in part or entirely by outside third parties. First, an investigator at City of Hope has received institutional approval for a study of subcutaneous leronlimab given in combination with a regimen of chemotherapy administered through the hepatic artery in treatment-naïve patients with mCRC who have metastatic disease confined to the liver. This study seeks to leverage CytoDyn’s previously announced data demonstrating leronlimab’s ability to mitigate liver toxicity in prior preclinical studies, as well as certain preliminary results from the phase II CRC study. This study is intended to provide CytoDyn with important tumor tissue from patients treated with leronlimab. This tissue will enable us to correlate tumor levels of PD-L1 with levels concurrently measured in blood on circulating tumor cells. This tissue will also provide CytoDyn the opportunity to further clarify and understand the leronlimab-induced changes in the tumor microenvironment (TME) that lie at the heart of the “Prime and Pair” paradigm.

Second, in keeping with our focus on solid tumor oncology, CytoDyn is collaborating with several academic centers on a pilot study of patients with recurrent Glioblastoma. This study proposes to treat patients with leronlimab in advance of their scheduled surgery for recurrent disease. After surgery, patients will begin treatment with an ICI in the hope that a leronlimab-disrupted TME can then be treated with an ICI and provide clinical benefit to patients.

In addition to the above, CytoDyn has been working with several investigators on two exciting projects outside oncology. Our collaborator at Cornell has finalized a 12-week pilot study of leronlimab in patients with mild to moderate Alzheimer’s Disease. All the necessary approvals have been received, and the study is scheduled to begin screening after requisite equipment is installed at Cornell in April 2026.

Lastly, we continue work with Dr. Jonah Sacha, and others at Oregon Health Sciences University and the University of Washington, on an HIV cure project involving stem cell transplantation. The final protocol is now complete and submission to both institutional IRBs and FDA will commence shortly.

Remarkably longer survival was observed in patients treated with leronlimab in combination with or followed by an immune checkpoint inhibitor

VANCOUVER, Washington, Dec. 08, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer (“mTNBC”) and colorectal cancer (“mCRC”), today announced that 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.”

A copy of the presentation will be made available on CytoDyn’s website under the Publications & Posters section after it is presented at the symposium.

About CytoDyn
CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide.

For more information, please visit www.cytodyn.com and follow us on LinkedIn.

Note Regarding Forward-Looking Statements
This news release may contain forward-looking statements relating to, among other things, the mechanism of action of leronlimab, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law.

Corporate Contact
CytoDyn Inc.
ir@cytodyn.com

Media Contacts
David Schull or Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
CytoDyn@russopartnersllc.com

The parties reached an agreement in principle to resolve the matter on November 23, 2025. The agreement is subject to final court approval. Additional information is included in the Company’s current report on Form 8-K filed with the Securities and Exchange Commission (the “SEC”) on December 1, 2025, and will also be disclosed in subsequent reports filed with the SEC.

“The settlement provides meaningful clarity and finality for this matter and is beneficial to all of our Company’s stakeholders, including our stockholders and prospective pharma partners”, said Tyler Blok, Chief Legal Officer at CytoDyn. “Subject to final court approval of the settlement, this matter will be closed. We are focused on moving forward with our clinical development programs.”

Jacob Lalezari, M.D., CEO of CytoDyn, added, “Bringing closure to this matter has been a priority since I was hired as CEO. The stockholders deserve this finality, and we are pleased to achieve a resolution that reinforces our stability and allows us to pursue our mission. It comes at an especially exciting moment for the company, as a growing body of clinical evidence continues to validate the scientific promise of leronlimab. With new Phase II studies moving forward in metastatic colorectal cancer and metastatic triple-negative breast cancer, and the progress with our Expanded Access Program, we are more optimistic than ever about leronlimab’s potential to benefit cancer patients who struggle today with limited treatment options.”

About CytoDyn

CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. By unlocking a well-validated mechanism of action with broad therapeutic potential, CytoDyn is developing a versatile platform designed to address serious unmet medical needs and serve multiple high-value markets. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide.

For more information, please visit www.cytodyn.com and follow us on LinkedIn.

Note Regarding Forward-Looking Statements

This news release may contain forward-looking statements relating to, among other things, final court approval of the class action settlement, mechanism of action of leronlimab, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law.

Corporate Contact

CytoDyn Inc.
ir@cytodyn.com

Media Contacts

David Schull or Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
CytoDyn@russopartnersllc.com

VANCOUVER, Washington, Nov. 24, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer (mTNBC) and colorectal cancer (mCRC), announced today that 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.

Currently, mTNBC is associated with a poor prognosis. The efficacy of immune checkpoint inhibitors (ICIs) is reduced in patients with mTNBC who have low levels of PD-L1^[1]. A recent review of CytoDyn’s prior oncology trials suggests that treatment with leronlimab was associated with an increase in levels of PD-L1, and that when combined with an ICI or preceded by treatment with an ICI, it may improve survival in patients with mTNBC^[2].

“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.”

Details of the poster presentation are as follows: 

• Title: 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
  
  
• Presenter: Dr. Milana V. Dolezal, MD, MSci, Clinical Associate Professor, Medicine Oncology at Stanford University School of Medicine
  
  
• Poster ID: PS5-02-30
  
  
• Date/Time: December 12, 2025, 12:30 PM–2:00 PM CST
  
  
• Location: Exhibit Hall
  
  

A copy of the presentations will be made available on CytoDyn’s website under the Publications & Posters section after it is presented at the symposium.

About CytoDyn

CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide.

For more information, please visit www.cytodyn.com and follow us on LinkedIn.

Note Regarding Forward-Looking Statements

This news release may contain forward-looking statements relating to, among other things, the mechanism of action of leronlimab, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law.

Corporate Contact
CytoDyn Inc.
ir@cytodyn.com

Media Contacts
Rob Haney, Ph.D., or Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
CytoDyn@russopartnersllc.com

1. Winer et al. Lancet Oncol 2021. 22 (4)
2. Pestell, R. et al. 369P ESMO Breast Munich, Germany. May 15, 2025

Under the terms of the agreement, CytoDyn has the right to sell, and Yorkville has the obligation to purchase up to $30 million worth of CytoDyn’s common stock over the next 36 months. CytoDyn, at its sole discretion, will control the timing of all sales of common stock to Yorkville, and there are no warrants, derivatives, or other share classes associated with the funding arrangement. CytoDyn is not obligated to utilize any of the $30 million available, there are no minimum commitments or minimum use penalties, and the arrangement does not impose any restrictions on the Company’s operating activities.

“This funding commitment from Yorkville is a solid step in the right direction for CytoDyn,” said Robert E. Hoffman, CFO of CytoDyn. “We will utilize this underlying commitment to further develop our program centered around the ability of leronlimab to upregulate PD-L1. This type of discretionary arrangement allows us continued flexibility as we look to bring in additional capital, whether it be through additional financings or strategic partnerships.”

For more information on the funding commitment secured from Yorkville, including key terms and conditions of the agreement, please see CytoDyn’s filings with the Securities and Exchange Commission, including its Current Report on Form 8-K filed on November 3, 2025.

About CytoDyn

CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide.

For more information, please visit www.cytodyn.com and follow us on LinkedIn.

Note Regarding Forward-Looking Statements

This news release may contain forward-looking statements relating to, among other things, the issuance of shares under the agreement with Yorkville, the anticipated benefits of the agreement with Yorkville, mechanism of action of leronlimab, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law.

Corporate Contact

CytoDyn Inc.
ir@cytodyn.com

Media Contacts

Rob Haney, Ph.D., or Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
CytoDyn@russopartnersllc.com

VANCOUVER, Washington, Oct. 09, 2025 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including triple-negative breast cancer (TNBC) and metastatic colorectal cancer (mCRC), announced that CFO Robert E. Hoffman will present a corporate overview at the LD Micro Main Event XIX Investor Conference from October 19 – 21, 2025 at the Hotel Del Coronado in San Diego, California.

Mr. Hoffman will be available for one-on-one meetings with conference attendees. To request a meeting to discuss the Company’s current development strategy and upcoming milestones, please contact CytoDyn@russopartnersllc.com.

About LD Micro

LD Micro is dedicated to being the definitive resource in the small-cap space. From its industry-recognized index and robust data to hosting some of the most influential events each year, LD Micro’s mission is to provide unparalleled access and insight for those seeking the next generation of great companies.

To learn more about LD Micro, visit:
http://www.ldmicro.com

To learn more about Freedom US Markets LLC, visit:
https://www.freedomcapmkts.com/

About CytoDyn

CytoDyn is a clinical-stage oncology company dedicated to advancing leronlimab, a first-in-class humanized monoclonal antibody that targets the CCR5 receptor, a key regulator of immune function implicated in cancer, infectious diseases, and autoimmune disorders. Guided by a mission to improve patients’ quality of life through therapeutic innovation, CytoDyn is committed to integrity, responsibility, and service as it works to bring transformative treatments to patients worldwide.

For more information, please visit www.cytodyn.com and follow us on LinkedIn.

Note Regarding Forward-Looking Statements

This news release may contain forward-looking statements relating to, among other things, mechanism of action, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, as well as subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except as required by applicable law.

Corporate Contact

CytoDyn Inc.
ir@cytodyn.com

Media Contacts

Rob Haney, Ph.D., or Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
CytoDyn@russopartnersllc.com

Dear Shareholders,

As this pivotal year continues to take shape for CytoDyn Inc. (“CytoDyn” or the “Company”), I am pleased to share the progress we have made in advancing leronlimab as an innovative treatment in oncology. We remain confident that addressing critical unmet needs in this field is the best way to build value while improving the lives of patients. The foundation of our conviction in leronlimab rests on both preclinical and clinical evidence. From laboratory insights to encouraging patient survival observations, our story is compelling and one of consistent validation. The data presented over the past several months marks a watershed moment for both patients and our Company, providing evidence that leronlimab has the potential to reshape treatment paradigms in solid tumor oncology. With multiple clinical trials advancing, we are moving with discipline and urgency along a well-defined path forward.

Strengthening Our Leadership

To support this next chapter, we welcomed Robert E. Hoffman as our new Chief Financial Officer. An industry veteran with decades of financial and leadership experience, holding various executive and board positions in his biotech career, Robert has already brought significant value to CytoDyn. His expertise in capital markets and strategic planning strengthens our ability to execute, network, and expand our pipeline. We are delighted to have him aboard.

Scientific Progress and Clinical Development

At the heart of leronlimab’s promise is a novel mechanism of action (“MOA”) associated with prolonged survival observed in a group of patients with Metastatic Triple-Negative Breast Cancer (“mTNBC”). Supporting data, presented at a poster session at the European Society for Medical Oncology (“ESMO”) breast cancer meeting in Munich, suggest that leronlimab induces PD-L1 expression, creating synergy with immune checkpoint inhibitors (ICIs), a potential breakthrough in solid tumor treatment. This finding not only opens new therapeutic opportunities for leronlimab, but also represents a significant market opportunity for the Company. For additional information on this novel MOA and the status of our clinical initiatives and publications, please see the science update included with this letter.

One indication that carries the potential for significant value return is leronlimab in mTNBC, the most aggressive form of breast cancer, with 5-year survival rates around 15%. Based on the positive data presented at ESMO, we will shortly submit a follow-up Phase II proof of concept (POC) protocol for PD-L1-negative patients with mTNBC. These patients, currently ineligible for ICI therapy, will receive leronlimab plus standard chemotherapy, followed by a regimen of leronlimab with an ICI. We look forward to sharing more details after the FDA review of the protocol and briefing package that provides a complete summary of CytoDyn’s oncology data.

In parallel, 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.

Beyond breast cancer, leronlimab continues to advance in the treatment of metastatic Colorectal Cancer (mCRC). Enrollment in our Phase II study is underway with five sites initiated and several more onboarding in the next several weeks. The enrollment of our fifth patient in the trial will trigger the Data Safety Monitoring Board (DSMB) safety review, which could then open study randomization to include the 700 mg dose. Importantly, we will be closely tracking PD-L1 levels of enrolled patients to further validate our MOA across solid tumors. With that in mind, we have prepared a rollover protocol to ensure that CRC patients who remain stable can continue leronlimab treatment beyond 48 weeks and to allow patients with disease progression the opportunity to receive leronlimab at a dose of 700 mg in combination with an ICI.

Finally, 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.

Update on Regulatory Matters, Resolution of SEC and DOJ Investigations

I am also pleased to share that 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.

Commitment to our Shareholders

Your support has carried the Company through the last several years and we remain committed to acting in your best interests. I want to thank you all again for your perseverance and patience. Your questions and feedback are always appreciated and best received through the Company’s IR email account: ir@cytodyn.com. In the coming months, we will be engaging in critical conversations with our key opinion leaders, potential industry partners and regulators. In support of these efforts, we ask our shareholders to be mindful of the process and respectful of our counterparties. Excessive outreach to these third parties can inadvertently hinder our progress. Our recent results and the novel MOA have attracted the attention of numerous patients, treating physicians, and others across the industry. Please know that we are actively pursuing collaborations to maximize the potential of leronlimab.

A Human Reminder of Our Mission

In closing, I’d like to share a brief personal anecdote. As the Company has worked to confirm the mTNBC survival observations and arranged for related follow-up testing, I’ve had the opportunity to speak with several of the surviving patients who accessed leronlimab during the Company’s prior oncology studies. These are individuals who had exhausted all other options yet are now enjoying more time with their families. I had the privilege of sharing a meal with one survivor and her spouse and it is difficult to put into words the emotions we all felt when reflecting on the remarkable sequence of events that brought us together that night, but I can name the most prominent – hope. Encounters like these remind us why our work matters and fuel our determination to accelerate progress for patients everywhere.

With Gratitude,

Jacob Lalezari, MD
CEO

Note Regarding Forward-Looking Statements

This news release contains forward-looking statements relating to, among other things, mechanism of action, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, and in subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments other than as required by law.

Corporate Contact

CytoDyn Inc.
ir@cytodyn.com

Media Contacts
Rob Haney, Ph.D., or Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
CytoDyn@russopartnersllc.com

Science Supplement

– September 2025 –

History of leronlimab in mTNBC

Dr. Richard Pestell, our Lead Consultant – Preclinical and Clinical Oncology, has published preclinical data demonstrating that leronlimab both prevented the metastatic spread of TNBC and caused reversal of established metastases in mice. These important observations speak to two different mechanisms by which leronlimab's blockade of the CCR5 receptor appears to impact cancer: the first involves the role that CCR5 plays in cell migration and how that receptor is hijacked by cancer cells to promote the spread of distant metastases; the second speaks to the direct anti-cancer activity of leronlimab on an established tumor itself and, in particular, the surrounding microenvironment.

To follow up on these preclinical observations, CytoDyn conducted three clinical studies in patients with mTNBC and other solid tumors starting in 2019. Analysis of pooled follow-up data from the 28 patients with mTNBC enrolled across these studies formed the basis for our presentation at ESMO and provided evidence of leronlimab’s stand-alone activity in three important ways:

1. Promising survival rates: Overall survival rates at years 1, 2, 3, and 4 (35.7%, 21.4%, 17.9%, and 17.9%) compare favorably with previous studies of patients with advanced mTNBC. In particular, the long-term survival rates of 17.9% at both years 3 and 4 are very exciting, considering other studies exploring potential mTNBC treatments typically don’t even report survival rates out to three years. Moreover, the survival rate of 17.9% at year 4 was calculated without removing or “censoring” patients who dropped out for any reason, meaning it is presented in the most conservative way possible.
   
   
2. Impact on advanced disease: Patients in our study population had failed a median of two prior lines of treatment after developing metastatic disease, and a majority had cancer in other organs (64% had visceral metastases and 29% had brain metastases at entry into the studies). Despite that, the median overall survival (“mOS”) of 6.8 months for all 28 patients (9.7 months for the 18 patients receiving > 525 mg) appears comparable to the current standard of care. This makes our results especially promising, given our study population had, generally speaking, more advanced disease than typical clinical populations. Given our survival observations and working theory on the mechanism of action, we are excited to explore leronlimab as an earlier line of therapy with the idea that earlier treatment could serve to save more lives. 
   
   
3. Decreased CTC levels: The decline in circulating tumor cells (“CTCs”) observed in most patients after as little as one dose of leronlimab was significantly associated with both progression-free and overall survival. Leronlimab’s rapid and prognostically significant impact on CTCs, which appears to reflect activity within the primary tumor itself, provides important evidence of leronlimab’s activity as a stand-alone agent. Confirming the full extent of leronlimab’s activity on the primary tumor is on our short list of clinical priorities in the coming months.
   

CytoDyn’s Presentation at ESMO – Outlining a Novel Mechanism of Action

As announced leading up to the ESMO presentation, the survival observations and related retrospective data collectively suggest a potential paradigm shift in solid tumor oncology involving leronlimab’s novel mechanism of action in conjunction with Immune Checkpoint Inhibitors (“ICIs”). To help understand this new paradigm, the following is an explanation of the basic steps and the Company’s working theory at this time:

For a cancerous tumor to establish itself and grow in the body, it attempts to avoid detection and an immune response. One way a cancer can do this is by hijacking CCR5, a protein receptor on the surface of certain immune cells. Through CCR5 signaling, the tumor commandeers host macrophages, a type of white blood cell that would otherwise attack the cancer cells, to help the tumor build a surrounding area or “microenvironment” to support its growth, including a blood supply that provides necessary nutrients. The growing tumor also uses CCR5 signaling to recruit immunosuppressive cells to the local environment that keep the microenvironment “cold” and the host immune system at bay. 

As to the above processes, it appears leronlimab has the ability to disrupt the CCR5 signaling that both promotes the cancer tumor’s growth and protects its microenvironment from the host immune response. By disrupting CCR5 signaling, leronlimab allows the host immune system (CD8+ cells) to identify the cancer cells as a threat and attack them in what has now become a “hot” or inflamed microenvironment (expressing various inflammatory cytokines). 

To counter the pressure of an attack from the host immune system, the cancer, at least as evidenced on the CTCs, has a secondary line of defense: expressing a protein called PD-L1 and hijacking its relationship to its receptor, PD-1. Ordinarily, PD-1 acts as the immune system’s “off switch”, binding with PD-L1 on functioning immune cells and preventing them from being so strong that they kill healthy cells in the body. Cancer cells capitalize on this system by expressing PD-L1 and binding to the “off switch” on the invading host immune cells, in turn slowing an immune response, thereby protecting the tumor.

As observed in patients who were fortunate enough to receive a PD-L1 antibody called an ICI in our prior studies, this “secondary defense” of the tumor can be thwarted. The antibody prevents the PD-L1 protein from binding to the “off switch” (PD-1), keeping the immune system “on” and allowing the host immune system’s attack on the cancer to continue. Typically, patients who have tumors with higher levels of PD-L1 expression derive the most benefit from treatment with an ICI, given there are more opportunities for the antibody to block connections to the “off” switch and allow the immune system to fight the cancer cells.

As to this process, preliminary data indicate that leronlimab has the ability to induce higher levels of PD-L1 expression in solid tumor cancer cells. This opens potential new treatment pathways for patients with low PD-L1 levels who would have otherwise been unable to derive benefit from an ICI.

The foregoing sequence is a novel working theory; however, our data, first presented at ESMO, suggest that this is what happened in the five patients who are alive today, 48 months after diagnosis. 

The key findings from our presentation at ESMO included the following:

• PD-L1 Upregulation: 16/21 (76%) of patients showed a significant increase in PD-L1 expression on CTCs within 30-90 days after starting leronlimab, regardless of dose. This suggests that the tumor microenvironment was turned from “cold” to “hot” (from being protected against host immune invasion to being under host immune attack). Even more remarkably, this shift from “cold” to “hot” occurred in 15/17 (88%) patients who received weekly leronlimab doses of 525 mg or higher. Turning “cold” tumors “hot” means that far more patients with TNBC (and potentially other solid tumors) may become eligible for a class of drugs known as anti-PD-1/anti-PD-L1 treatments and collectively referred to as ICIs.
  
  
• Long Term Survival: The clinical significance of the increase in PD-L1 observed on the CTCs was driven home by the confirmation that 5/5 (100%) of patients who demonstrated a significant increase in PD-L1 expression while receiving leronlimab and received any ICI are alive today, 4+ years later. More remarkably, three of these individuals (60%) are currently identified as having no ongoing evidence of disease. Underscoring the clinical significance of these results is the unfortunate finding that none of the 23 patients who didn’t induce significant PD-L1 expression or didn’t receive an ICI with leronlimab are alive today. 
  

Update(s) on Colorectal Cancer and Pending Trial

While generating the TNBC dataset, we documented outcomes in patients with other solid tumors previously enrolled in the CD09 “Basket Study.” The results from five such patients with colorectal cancer (“CRC”) were presented at the ESMO GI meeting in Barcelona this past July by the Principal Investigator for our current CRC study, Dr. Ben Weinberg from the Lombardi Comprehensive Cancer Center at Georgetown University. Additional updates on our CRC trial and how we will be using the CRC trial to further establish our working theory on the mechanism of action driving improved survival are included below.

The timing of the TNBC observations, data set, and working mechanism of action theory creates a unique opportunity for CytoDyn to evaluate this “cold to hot” paradigm shift in the context of a second solid tumor during our CRC study. Up to 85% of patients with CRC are not currently candidates for ICI therapy because their tumors are “cold” and do not express PD-L1. Our mCRC study design provides leronlimab in both arms of the study. As such, we have amended the protocol to include close monitoring of PD-L1 levels on the CTCs in all enrolled patients. In addition, we are submitting a new rollover protocol to the FDA, which will provide ongoing access to leronlimab for those patients with CRC who continue to do well after 48 weeks on the parent study and will now offer leronlimab plus an ICI to those patients who progress on the parent study. These amendments will allow us to achieve multiple critical goals, including: 

• Evaluate leronlimab as a stand-alone agent (in combination with Standard of Care) in a second solid tumor type;
• Prospectively evaluate the ability of 2 different leronlimab dose levels to induce PD-L1 expression on CTCs in a solid tumor that is typically “cold” and not usually associated with PD-L1 expression;
• Obtain biopsy tissue from patients with disease progression enrolling in the rollover protocol to correlate PD-L1 levels and changes in the tumor microenvironment on tumor tissue with PD-L1 expression on concurrently drawn CTCs; and
• Evaluate the possibility of treating patients with a common and typically “cold” cancer with the combination of leronlimab and an ICI, the same regimen that demonstrated long-lasting remission in 5/5 patients with mTNBC who significantly induced PD-L1, as reported at ESMO.

It is fortuitous that we launched the CRC study just as the PD-L1 data came to light, as it allows us to immediately commence efforts to collect certain prospective confirmatory data. Five trial sites have been initiated. It is our hope that the ESMO CRC data, together with the option of receiving leronlimab and an ICI during the rollover protocol, will generate interest among both patients and caregivers and help to expedite enrollment efforts.

Investigator-Initiated Study in Glioblastoma

In addition to mTNBC and CRC, we are continuing our investigation into a possible role for leronlimab in the treatment of glioblastoma, a third solid tumor type. We have found an individual who has agreed to fund this venture, and we have reached a tentative agreement with two medical centers to support their investigator-initiated pilot study in patients with recurrent glioblastoma. These patients will receive leronlimab in advance of their pending surgery and then start an ICI after surgery. This study is predicated on the prior observation of CNS penetration of leronlimab in macaques, as well as the potentially peripheral site of activity of ICI on T Cells in patients who had their protected tumor microenvironment disrupted while receiving leronlimab prior to surgery.

Other Pre-Clinical and Clinical Projects

We are pleased to share that the Alzheimer’s study at Cornell University Medical Center in New York has received both FDA and IRB approval, a “kickoff meeting” was just conducted, and enrollment will begin in the coming weeks. As previously noted, this study has been funded by an outside foundation to whom we are very grateful, but that wishes to remain anonymous at this time.

Additionally, the LATCH study with Dr. Jonah Sacha and his team at Oregon Health & Science University has been updated and is now ready for IRB and FDA submission. The study will further explore the role of leronlimab in the potential cure of HIV+ patients who receive a stem cell transplant from CCR5+ donors. We were also able to work with Dr. Sacha to arrange for commitments from outside foundation(s) to fund the costs of this study.

Pending Publications

Our top publication priority remains a comprehensive TNBC manuscript that includes the clinical and PD-L1 data presented at ESMO, as well as recent laboratory data generated by Dr. Richard Pestell that appears to reinforce our belief in leronlimab as a paradigm shift in solid tumor oncology. The initial draft of the manuscript will be ready for internal review in the coming weeks.

The Company has also prepared a case report of a patient with mTNBC whose cancer had spread to both brain and lungs, but who is alive today without evidence of disease, almost 5 years after receiving fourth-line treatment with leronlimab plus atezolizumab. That manuscript will be submitted for peer review shortly.

The company is also preparing a safety manuscript summarizing the safety data in almost 1,600 patients who have now been treated with leronlimab in CytoDyn-sponsored studies.

The company’s manuscript describing the results of CytoDyn’s prior study in patients with Metabolic Dysfunction-Associated Steatohepatitis was recently accepted for publication.

Finally, we have recently submitted two additional manuscripts for peer-review, including:

• A manuscript of a preclinical study of CRC performed at the Cleveland Clinic, which demonstrated a significant reduction in lung metastasis in mice treated with leronlimab.
• A manuscript summarizing results from SMC Laboratories detailing the effects of leronlimab on liver fibrosis, inflammation, and fat.

Note Regarding Forward-Looking Statements

This September 2025 Science Supplement contains forward-looking statements relating to, among other things, mechanism of action, clinical trial results, product development, market position, future operating and financial performance, and business strategy. The reader is cautioned not to rely on these statements, which are based on current expectations of future events. For important information about these statements and our Company, including the risks, uncertainties and other factors that could cause actual results to vary materially from the assumptions, expectations and projections expressed in any forward-looking statements, the reader should review our Annual Report on Form 10-K for the fiscal year ended May 31, 2025, including the section captioned “Forward-Looking Statements” and in Item 1A, and in subsequent reports filed with the Securities and Exchange Commission. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments other than as required by law.