09/30/2025 - 08:30 AM

2025年9月30日- 上午 8:30

VANCOUVER, Washington, Sept. 30, 2025 (GLOBE NEWSWIRE) --

華盛頓温哥華，2025年9月30日（GLOBE NEWSWIRE）--

Dear Shareholders,

親愛的股東們，

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.

隨着這一關鍵年份的不斷發展，我很高興與大家分享我們在推進 leronlimab 作為腫瘤學創新治療方面所取得的進展。我們堅信，解決這一領域的關鍵未滿足需求是創造價值並改善患者生活的最佳途徑。我們對 leronlimab 的信心基礎建立在前臨牀和臨牀證據之上。從實驗室的見解到令人鼓舞的患者生存觀察，我們的故事引人注目，並且得到了持續的驗證。在過去幾個月中呈現的數據標誌着患者和我們公司的一個重要時刻，提供了 leronlimab 有潛力重塑實體腫瘤腫瘤學治療範式的證據。隨着多個臨牀試驗的推進，我們正沿着一條明確的道路，以嚴謹和緊迫感向前邁進。

Strengthening Our Leadership

加強我們的領導力

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.

為了支持這一新篇章，我們歡迎羅伯特·E·霍夫曼（Robert E. Hoffman）擔任我們的新首席財務官。他是一位擁有數十年財務和領導經驗的行業老將，在生物技術職業生涯中擔任過多個高管和董事會職位，羅伯特已經為 CytoDyn 帶來了顯著的價值。他在資本市場和戰略規劃方面的專業知識增強了我們執行、網絡和擴展管道的能力。我們很高興他能加入我們。

Scientific Progress and Clinical Development

科學進展與臨牀發展

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.

leronlimab 的承諾核心在於其與觀察到的轉移性三陰性乳腺癌（mTNBC）患者延長生存相關的新機制。支持數據在慕尼黑的歐洲醫學腫瘤學會（ESMO）乳腺癌會議的海報環節中展示，表明 leronlimab 誘導 PD-L1 表達，與免疫檢查點抑制劑（ICIs）產生協同作用，這在實體腫瘤治療中可能是一個突破。這一發現不僅為 leronlimab 開闢了新的治療機會，也為公司代表了一個重要的市場機會。有關這一新機制及我們臨牀計劃和出版物狀態的更多信息，請參見隨信附上的科學更新。

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.

一個具有顯著價值回報潛力的適應症是 mTNBC，這是一種最具侵襲性的乳腺癌，5 年生存率約為 15%。基於在 ESMO 上展示的積極數據，我們將很快提交針對 PD-L1 陰性 mTNBC 患者的後續 II 期概念驗證（POC）方案。這些患者目前不符合 ICI 治療資格，將接受 leronlimab 加標準化療，隨後進行 leronlimab 與 ICI 的聯合治療。我們期待在 FDA 審查該方案和提供 CytoDyn 腫瘤學數據的簡報材料後分享更多細節。

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.

與此同時，我們將提交擴展使用協議（EAP），以便為第二線或更晚期的 mTNBC 患者提供治療，這些患者不符合或無法參與我們的 II 期研究。我很高興地宣佈，我們將與一位個人捐助者合作，資助這一同情使用項目的啓動。這位捐助者還表示有興趣支持一項針對複發性膠質母細胞瘤患者的研究，該研究預計將在 2026 年開始。

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.

除了乳腺癌，leronlimab 在轉移性結直腸癌（mCRC）的治療中也在不斷推進。我們的 II 期研究正在進行中，目前已啓動五個研究中心，未來幾周還將有更多中心加入。我們在試驗中招募的第五位患者將觸發數據安全監測委員會（DSMB）的安全審查，這可能會開啓研究隨機化，以包括 700 毫克劑量。重要的是，我們將密切跟蹤入組患者的 PD-L1 水平，以進一步驗證我們在實體腫瘤中的機制。考慮到這一點，我們已準備好一個滾動協議，以確保穩定的 CRC 患者可以在 48 周後繼續接受 leronlimab 治療，並允許病情進展的患者有機會以 700 毫克的劑量與 ICI 聯合接受 leronlimab 治療。

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.

最後，我很高興分享一個非常有希望的消息，涉及一位在通過其治療醫生提交的 eIND 申請獲得 leronlimab 後，前瞻性上調 PD-L1 的患者。在 2025 年初，我們收到了針對一名之前對 Keytruda 治療無反應的 mTNBC 患者的同情使用請求。這位患者之前進行了兩次組織活檢，均為 PD-L1 陰性。在 4 月，該患者開始接受 leronlimab 治療，7 月的血液檢測確認 PD-L1 水平上升。我們過去的臨牀觀察表明，上調 PD-L1 是這一患者羣體延長生存的第一步，我們對這一結果感到鼓舞，這支持了我們的工作理論。這是希望在未來一年內我們 CRC 和 TNBC 試驗中許多 PD-L1 上調結果的第一例。我對我們即將進行的 II 期試驗以及擴展使用項目充滿信心，因為我們希望重塑實體腫瘤腫瘤學的治療範式。

Update on Regulatory Matters, Resolution of SEC and DOJ Investigations

關於監管事務的更新，SEC 和 DOJ 調查的解決

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.

我也很高興地分享，我們最近收到了來自證券交易委員會（SEC）和司法部（DOJ）的確認，表示他們各自的調查現已結束，公司無需再做進一步的事情。我相信這一積極的結論反映了我們團隊的努力和我們對合規與合作的共同承諾。

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.

我仍然對我們與 FDA 的合作關係充滿信心，這使我們走上了一條富有成效的軌道。為了加快腫瘤學領域的進展，我們成立了一個專注於追求最快和最負責任的前進路徑的腫瘤學顧問委員會。FDA 最近批准了我們的會議請求，我們期待討論我們的回顧性數據集及在 TNBC 方面的相關觀察，以及我們 TNBC 開發計劃的下一步。維護與 FDA 和行業合作伙伴的良好關係和信譽仍然是我們前進的首要任務。

Commitment to our Shareholders

對股東的承諾

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.

你們的支持使公司度過了過去幾年，我們仍然致力於以你們的最佳利益為行動準則。再次感謝大家的堅持和耐心。你們的問題和反饋總是受到歡迎，最好通過公司的投資者關係電子郵件賬户：ir@cytodyn.com 進行反饋。在接下來的幾個月裏，我們將與我們的關鍵意見領袖、潛在行業合作伙伴和監管機構進行重要對話。為了支持這些努力，我們要求我們的股東關注這一過程，並尊重我們的對方。對這些第三方的過度接觸可能會無意中阻礙我們的進展。我們最近的結果和新穎的作用機制吸引了眾多患者、治療醫生和行業其他人士的關注。請知道，我們正在積極尋求合作，以最大化 leronlimab 的潛力。

A Human Reminder of Our Mission

我們使命的人性提醒

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.

最後，我想分享一個簡短的個人軼事。隨着公司努力確認 mTNBC 生存觀察並安排相關的後續測試，我有機會與幾位在公司之前的腫瘤學研究中獲得 leronlimab 的倖存患者交談。這些人曾經用盡所有其他選擇，但現在能夠與家人享受更多的時光。我有幸與一位倖存者及其配偶共進晚餐，難以用言語表達我們在回顧那晚將我們聚集在一起的非凡事件時所感受到的情感，但我可以説最突出的情感是——希望。這樣的遭遇提醒我們為什麼我們的工作是重要的，並激勵我們加快為患者帶來進展的決心。

With Gratitude,

懷着感激之情，

Jacob Lalezari, MD

CEO

首席執行官

Note Regarding Forward-Looking Statements

關於前瞻性聲明的説明

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.

本新聞稿包含與機制、臨牀試驗結果、產品開發、市場地位、未來運營和財務表現以及商業戰略等相關的前瞻性聲明。讀者應謹慎對待這些聲明，因為它們基於對未來事件的當前預期。有關這些聲明和我們公司的重要信息，包括可能導致實際結果與任何前瞻性聲明中表達的假設、預期和預測顯著不同的風險、不確定性和其他因素，讀者應查閲我們截至2025年5月31日的年度報告（Form 10-K），包括標題為 “前瞻性聲明” 的部分以及第 1A 項，以及隨後向證券交易委員會提交的報告。CytoDyn Inc.不承擔因新信息或未來事件或發展而更新任何前瞻性聲明的義務，除非法律要求。

Corporate Contact

公司聯繫方式

CytoDyn Inc.

ir@cytodyn.com

Media Contacts

媒體聯繫人

Rob Haney, Ph.D., or Ignacio Guerrero-Ros, Ph.D.

Rob Haney, Ph.D.，或 Ignacio Guerrero-Ros, Ph.D.

Russo Partners, LLC

CytoDyn@russopartnersllc.com

Science Supplement

科學補充

– September 2025–

– 2025 年 9 月–

History of leronlimab in mTNBC

leronlimab 在 mTNBC 中的歷史

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.

我們的首席顧問——臨牀前和臨牀腫瘤學的 Richard Pestell 博士，已發表臨牀前數據，證明 leronlimab 既能防止 TNBC 的轉移擴散，又能導致小鼠中已建立的轉移逆轉。這些重要觀察結果表明了 leronlimab 通過阻斷 CCR5 受體影響癌症的兩種不同機制：第一種涉及 CCR5 在細胞遷移中的作用，以及癌細胞如何劫持該受體以促進遠處轉移的擴散；第二種則涉及 leronlimab 對已建立腫瘤本身 的 直接抗癌活性，尤其是周圍的微環境。

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:

為了跟進這些臨牀前觀察，CytoDyn 於 2019 年在 mTNBC 和其他實體瘤患者中進行了三項臨牀研究。對這三項研究中 28 名 mTNBC 患者的匯總隨訪數據的分析為我們在 ESMO 的演示提供了基礎，並提供了 leronlimab 在三個重要方面的獨立活性的證據：

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.
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.
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.

令人鼓舞的生存率： 在 1 年、2 年、3 年和 4 年的總體生存率分別為 35.7%、21.4%、17.9% 和 17.9%，與以往對晚期轉移性三陰性乳腺癌（mTNBC）患者的研究結果相比，表現良好。特別是，3 年和 4 年的長期生存率均為 17.9%，這令人振奮，因為其他研究探索潛在的 mTNBC 治療時，通常甚至不報告三年的生存率。此外，4 年時的 17.9% 生存率是在沒有剔除或 “審查” 因任何原因退出的患者的情況下計算得出的，這意味着它以儘可能保守的方式呈現。
對晚期疾病的影響： 我們研究人羣中的患者在發展轉移性疾病後，平均接受了兩條之前治療方案的失敗，大多數患者在其他器官也有癌症（64% 的患者有內臟轉移，29% 的患者在入組時有腦轉移）。儘管如此，28 名患者的中位總體生存期（“mOS”）為 6.8 個月（接受>525 毫克治療的 18 名患者為 9.7 個月），這與當前的標準治療相當。考慮到我們的研究人羣通常比典型臨牀人羣的疾病更為晚期，這使得我們的結果特別令人期待。基於我們的生存觀察和對作用機制的工作理論，我們很高興探索 leronlimab 作為早期治療方案，認為早期治療可能有助於挽救更多生命。
CTC 水平降低： 在大多數患者中，觀察到在僅接受一劑 leronlimab 後循環腫瘤細胞（“CTCs”）的下降與無進展生存期和總體生存期顯著相關。Leronlimab 對 CTCs 的快速且具有預後意義的影響，似乎反映了其在原發腫瘤內的活性，為 leronlimab 作為單一藥物的活性提供了重要證據。確認 leronlimab 對原發腫瘤的全部活性是我們在未來幾個月的臨牀優先事項之一。

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

CytoDyn 在 ESMO 的演示 – 概述一種新穎的作用機制

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:

正如在 ESMO 演示之前所宣佈的，生存觀察和相關的回顧性數據共同表明，涉及 leronlimab 的新穎作用機制與免疫檢查點抑制劑（“ICIs”）結合，可能會在實體腫瘤腫瘤學中引發潛在的範式轉變。為了幫助理解這一新範式，以下是對基本步驟和公司目前工作理論的解釋：

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.

為了使癌腫瘤在體內建立並生長，它試圖避免被檢測和免疫反應。癌症可以通過劫持 CCR5（一種在某些免疫細胞表面的蛋白質受體）來實現這一點。通過 CCR5 信號傳導，腫瘤指揮宿主巨噬細胞，這是一種本應攻擊癌細胞的白血球，幫助腫瘤建立一個支持其生長的周圍區域或 “微環境”，包括提供必要營養的血液供應。生長中的腫瘤還利用 CCR5 信號傳導招募免疫抑制細胞到局部環境中，使微環境保持 “冷” 並抑制宿主免疫系統。

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).

關於上述過程，leronlimab 似乎具有干擾 CCR5 信號傳導的能力，這種信號傳導既促進癌腫瘤的生長，又保護其微環境免受宿主免疫反應的影響。通過干擾 CCR5 信號傳導，leronlimab 使宿主免疫系統（CD8+ 細胞）能夠將癌細胞識別為威脅並攻擊它們，從而使微環境變為 “熱” 或發炎狀態（表達各種炎性細胞因子）。

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.

為了應對宿主免疫系統攻擊的壓力，癌症至少在 CTCs 的證據上，具有第二道防線：表達一種稱為 PD-L1 的蛋白質，並劫持其與受體 PD-1 的關係。通常，PD-1 作為免疫系統的 “關閉開關”，與功能性免疫細胞上的 PD-L1 結合，防止它們過於強大而殺死體內的健康細胞。癌細胞利用這一系統，通過表達 PD-L1 並與侵入的宿主免疫細胞上的 “關閉開關” 結合，從而減緩免疫反應，保護腫瘤。

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.

在我們之前的研究中，幸運地接受了名為 ICI 的 PD-L1 抗體的患者觀察到，這種腫瘤的 “第二道防線” 可以被破壞。該抗體阻止 PD-L1 蛋白與 “關閉開關”（PD-1）結合，使免疫系統保持 “開啓”，並允許宿主免疫系統繼續攻擊癌症。通常，具有較高 PD-L1 表達水平的腫瘤患者從 ICI 治療中獲益最大，因為抗體有更多機會阻止與 “關閉” 開關的連接，從而允許免疫系統對抗癌細胞。

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.

關於這一過程，初步數據顯示，leronlimab 具有誘導實體腫瘤癌細胞中更高 PD-L1 表達水平的能力。這為 PD-L1 水平較低的患者打開了潛在的新治療途徑，否則他們將無法從 ICI 中獲益。

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.

上述序列是一種新穎的工作理論；然而，我們的數據首次在 ESMO 上展示，表明這就是在診斷 48 個月後仍然存活的五名患者所發生的情況。

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

我們在 ESMO 演示中的關鍵發現包括以下內容：

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.

PD-L1 上調：在開始使用 leronlimab 後的 30-90 天內，16/21（76%）的患者在循環腫瘤細胞（CTCs）上顯示出 PD-L1 表達顯著增加，無論劑量如何。這表明腫瘤微環境從 “冷” 轉變為 “熱”（從抵禦宿主免疫侵襲轉變為受到宿主免疫攻擊）。更值得注意的是，這種從 “冷” 到 “熱” 的轉變發生在接受每週 525 毫克或更高劑量 leronlimab 的 15/17（88%）患者中。將 “冷” 腫瘤轉變為 “熱” 意味着更多的三陰性乳腺癌（TNBC）患者（以及潛在的其他實體瘤患者）可能有資格接受一類稱為抗 PD-1/抗 PD-L1 治療的藥物，統稱為免疫檢查點抑制劑（ICIs）。
長期生存：在 CTCs 上觀察到的 PD-L1 增加的臨牀意義得到了確認，5/5（100%）在接受 leronlimab 治療時表現出顯著 PD-L1 表達增加並且接受了任何 ICIs 的患者至今仍然存活，已經超過 4 年。更值得注意的是，這三名患者（60%）目前被認定為沒有持續的疾病證據。這些結果的臨牀意義被一個不幸的發現所強調，即在 23 名沒有誘導顯著 PD-L1 表達或沒有與 leronlimab 一起接受 ICIs 的患者中，沒有一人今天仍然存活。

Update(s) on Colorectal Cancer and Pending Trial

結直腸癌的更新及待定試驗

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.

在生成 TNBC 數據集的過程中，我們記錄了在 CD09“籃子研究” 中先前入組的其他實體瘤患者的結果。來自五名結直腸癌（“CRC”）患者的結果在今年 7 月的巴塞羅那 ESMO GI 會議上由我們當前 CRC 研究的首席研究員、喬治城大學隆巴爾迪綜合癌症中心的 Ben Weinberg 博士進行了介紹。關於我們 CRC 試驗的更多更新以及我們將如何利用 CRC 試驗進一步建立我們關於改善生存機制的工作理論的信息如下。

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:

TNBC 觀察、數據集和工作機制理論的時機為 CytoDyn 在我們的 CRC 研究中評估這一 “冷到熱” 的範式轉變創造了獨特的機會。高達 85% 的 CRC 患者目前不符合 ICI 治療的候選資格，因為他們的腫瘤是 “冷” 的且不表達 PD-L1。我們的 mCRC 研究設計在研究的兩個組中提供 leronlimab。因此，我們已修訂協議，以包括對所有入組患者 CTCs 上 PD-L1 水平的密切監測。此外，我們正在向 FDA 提交新的滾動協議，該協議將為在母研究中經過 48 周後繼續表現良好的 CRC 患者提供持續的 leronlimab 使用，並將為在母研究中進展的患者提供 leronlimab 加 ICI。這些修訂將使我們能夠實現多個關鍵目標，包括：

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.

評估 leronlimab 作為單獨藥物（與標準護理結合）在第二種實體瘤類型中的效果；
前瞻性評估兩種不同 leronlimab 劑量水平在通常 “冷” 且通常不與 PD-L1 表達相關的實體瘤中誘導 PD-L1 表達的能力；
從在滾動協議中入組的疾病進展患者中獲取活檢組織，以將 PD-L1 水平和腫瘤組織中腫瘤微環境的變化與同時抽取的 CTCs 上的 PD-L1 表達進行關聯；
評估用 leronlimab 和 ICI 的組合治療一種常見且通常 “冷” 的癌症的可能性，這一方案在 5/5 名顯著誘導 PD-L1 的 mTNBC 患者中顯示出持久的緩解，如在 ESMO 上報告的那樣。

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.

我們在 PD-L1 數據浮出水面時啓動 CRC 研究是非常幸運的，因為這使我們能夠立即開始收集某些前瞻性確認數據。五個試驗站點已啓動。我們希望 ESMO CRC 數據，加上在滾動協議中接受 leronlimab 和 ICI 的選項，將在患者和護理人員中產生興趣，並幫助加快入組工作。

Investigator-Initiated Study in Glioblastoma

在膠質母細胞瘤中的研究

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.

除了 mTNBC 和 CRC，我們還在繼續研究 leronlimab 在膠質母細胞瘤治療中的潛在作用，這是一種第三種實體瘤類型。我們找到了一位同意資助這一項目的個人，並與兩個醫療中心達成了初步協議，以支持他們在複發性膠質母細胞瘤患者中的研究者發起的試點研究。這些患者將在待進行手術前接受 leronlimab 治療，然後在手術後開始接受 ICI。這項研究基於之前觀察到的 leronlimab 在獼猴中的中樞神經系統穿透能力，以及在接受 leronlimab 治療後其保護的腫瘤微環境被破壞的患者中，ICI 在 T 細胞上的潛在外周作用。

Other Pre-Clinical and Clinical Projects

其他前臨牀和臨牀項目

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.

我們很高興地分享，位於紐約的康奈爾大學醫學中心的阿爾茨海默病研究已獲得 FDA 和 IRB 的批准，剛剛召開了 “啓動會議”，並將在接下來的幾周內開始入組。如前所述，該研究得到了一個外部基金會的資助，我們對此非常感激，但該基金會希望此時保持匿名。

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.

此外，Oregon Health & Science University 的 Jonah Sacha 博士及其團隊的 LATCH 研究已更新，並準備提交 IRB 和 FDA。該研究將進一步探討 leronlimab 在接受 CCR5+ 供體的幹細胞移植的 HIV+ 患者潛在治癒中的作用。我們還與 Sacha 博士合作，安排外部基金會資助該研究的費用。

Pending Publications

待發表的文獻

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.

我們最重要的出版優先事項仍然是一個全面的三陰性乳腺癌（TNBC）手稿，其中包括在 ESMO 上展示的臨牀和 PD-L1 數據，以及由 Richard Pestell 博士生成的最新實驗室數據，這些數據似乎進一步強化了我們對 leronlimab 作為實體腫瘤腫瘤學範式轉變的信念。手稿的初稿將在接下來的幾周內準備好進行內部審查。

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.

公司還準備了一份關於一名轉移性三陰性乳腺癌（mTNBC）患者的病例報告，該患者的癌症已擴散至大腦和肺部，但在接受 leronlimab 加阿特珠單抗的第四線治療近 5 年後，今天仍然存活且沒有疾病證據。該手稿將很快提交同行評審。

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.

公司還在準備一份安全性手稿，總結近 1600 名在 CytoDyn 贊助的研究中接受 leronlimab 治療的患者的安全性數據。

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

公司關於 CytoDyn 之前在代謝功能障礙相關脂肪肝炎患者中研究結果的手稿最近已被接受發表。

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

最後，我們最近提交了另外兩份手稿進行同行評審，包括：

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.

一份在克利夫蘭診所進行的結直腸癌（CRC）預臨牀研究的手稿，顯示接受 leronlimab 治療的小鼠肺轉移顯著減少。
一份總結 SMC 實驗室結果的手稿，詳細説明 leronlimab 對肝纖維化、炎症和脂肪的影響。

Note Regarding Forward-Looking Statements

關於前瞻性聲明的注意事項

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.

本 2025 年 9 月的科學補充材料包含與作用機制、臨牀試驗結果、產品開發、市場地位、未來運營和財務表現以及商業戰略等相關的前瞻性聲明。讀者被警告不要依賴這些聲明，因為它們基於對未來事件的當前預期。有關這些聲明和我們公司的重要信息，包括可能導致實際結果與任何前瞻性聲明中表達的假設、期望和預測顯著不同的風險、不確定性和其他因素，讀者應查看我們截至2025年5月31日的 10-K 表格年度報告，包括標題為 “前瞻性聲明” 的部分和第 1A 項，以及隨後向證券交易委員會提交的報告。CytoDyn Inc.不承擔因新信息或未來事件或發展而更新任何前瞻性聲明的義務，法律另有要求的除外。

2025 年 9 月致股東信 | CYDY 股票新聞