September 2024 Letter to Shareholders
CytoDyn Inc. (CYDY) has made significant progress in 2024, as outlined in the September shareholder letter. Key developments include:
- FDA lifting the clinical hold on leronlimab in March 2024
- Submission of two clinical trial protocols to the FDA
- Settlement with Amarex, resulting in a $10 million cash influx
- Initiation of pre-clinical and clinical leronlimab trials
- Progress on developing a longer-acting therapeutic with an AI partner
The company is focusing on oncology, with a Phase II study in colorectal cancer and exploration of triple-negative breast cancer and glioblastoma. In inflammation, CytoDyn is evaluating leronlimab for HIV-related chronic inflammation, Alzheimer's Disease, and chronic fatigue syndrome. Other areas include MASH and HIV cure research. The company believes it has sufficient cash to commence clinical trials and advance development initiatives into 2025.
CytoDyn Inc. (CYDY) ha fatto significativi progressi nel 2024, come evidenziato nella lettera agli azionisti di settembre. I principali sviluppi includono:
- Rimozione della sospensione clinica da parte della FDA su leronlimab a marzo 2024
- Invio di due protocolli di sperimentazione clinica alla FDA
- Accordo con Amarex, che ha portato a un afflusso di cassa di 10 milioni di dollari
- Inizio delle sperimentazioni pre-cliniche e cliniche su leronlimab
- Progressi nello sviluppo di una terapia a lunga durata in collaborazione con un partner AI
L'azienda si sta concentrando su oncologia, con uno studio di Fase II sul cancro colorettale ed esplorazioni sul cancro al seno triplo negativo e sul glioblastoma. In infiammazione, CytoDyn sta valutando leronlimab per l'infiammazione cronica legata all'HIV, il morbo di Alzheimer e la sindrome da affaticamento cronico. Altre aree includono la ricerca su MASH e la cura dell'HIV. L'azienda crede di avere sufficienti fondi per avviare sperimentazioni cliniche e avanzare le iniziative di sviluppo fino al 2025.
CytoDyn Inc. (CYDY) ha logrado avances significativos en 2024, como se detalla en la carta a los accionistas de septiembre. Los desarrollos clave incluyen:
- La FDA levantó la restricción clínica sobre leronlimab en marzo de 2024
- Presentación de dos protocolos de ensayos clínicos a la FDA
- Acuerdo con Amarex, resultando en un ingreso de efectivo de 10 millones de dólares
- Inicio de ensayos preclínicos y clínicos de leronlimab
- Progreso en el desarrollo de una terapia de acción prolongada con un socio de IA
La empresa se concentra en oncología, con un estudio de Fase II en cáncer colorrectal y exploración de cáncer de mama triple negativo y glioblastoma. En inflamación, CytoDyn está evaluando leronlimab para la inflamación crónica relacionada con el VIH, la enfermedad de Alzheimer y el síndrome de fatiga crónica. Otras áreas incluyen investigación sobre MASH y cura del VIH. La empresa cree tener suficiente efectivo para iniciar ensayos clínicos y avanzar en iniciativas de desarrollo hasta 2025.
CytoDyn Inc. (CYDY)는 2024년 동안 중요한 발전을 이룩했으며, 이는 9월 주주 서한에 자세히 설명되어 있습니다. 주요 발전 사항은 다음과 같습니다:
- 2024년 3월 FDA가 leronlimab에 대한 임상 보류를 해제함
- FDA에 두 개의 임상 시험 프로토콜 제출
- Amarex와의 합의로 1000만 달러의 현금 유입 발생
- leronlimab의 전임상 및 임상 시험 시작
- AI 파트너와의 협력을 통한 장기 작용 치료제 개발 진전
회사는 종양학에 주력하고 있으며, 대장암에 대한 2상 연구와 삼중 음성 유방암 및 교모세포종의 탐색을 진행하고 있습니다. 염증 관련해서는 CytoDyn이 HIV 관련 만성 염증, 알츠하이머병 및 만성 피로 증후군에 대해 leronlimab을 평가하고 있습니다. 기타 분야로는 MASH 및 HIV 치료 연구가 포함됩니다. 회사는 임상 시험을 시작하고 2025년까지 개발 계획을 진행할 충분한 자금이 있다고 믿고 있습니다.
CytoDyn Inc. (CYDY) a réalisé des progrès significatifs en 2024, comme l'indique la lettre aux actionnaires de septembre. Les principaux développements comprennent :
- La FDA a levé en mars 2024 la suspension clinique sur leronlimab
- Soumission de deux protocoles d'essai clinique à la FDA
- Règlement avec Amarex, entraînant un afflux de trésorerie de 10 millions de dollars
- Initiation des essais précliniques et cliniques sur leronlimab
- Avancées dans le développement d'une thérapie à action prolongée avec un partenaire IA
L'entreprise se concentre sur oncologie, avec une étude de phase II sur le cancer colorectal et une exploration du cancer du sein triple négatif et du glioblastome. Dans le domaine de l'inflammation, CytoDyn évalue leronlimab pour l'inflammation chronique liée au VIH, la maladie d'Alzheimer et le syndrome de fatigue chronique. D'autres domaines incluent la recherche sur MASH et la guérison du VIH. L'entreprise estime avoir suffisamment de liquidités pour commencer les essais cliniques et faire avancer les initiatives de développement jusqu'en 2025.
CytoDyn Inc. (CYDY) hat 2024 erhebliche Fortschritte gemacht, wie im September-Brief an die Aktionäre dargelegt. Wichtige Entwicklungen umfassen:
- FDA hebt im März 2024 das klinische Halt auf leronlimab auf
- Einreichung von zwei klinischen Studienprotokollen bei der FDA
- Vergleich mit Amarex, der zu einem Cash-Zufluss von 10 Millionen Dollar führt
- Beginn von präklinischen und klinischen Studien zu leronlimab
- Fortschritte bei der Entwicklung einer länger wirkenden Therapie mit einem KI-Partner
Das Unternehmen konzentriert sich auf Onkologie mit einer Phase-II-Studie zu Darmkrebs und untersucht dreifach negativen Brustkrebs sowie Glioblastom. Im Bereich Entzündung evaluiert CytoDyn leronlimab hinsichtlich einer chronischen Entzündung im Zusammenhang mit HIV, Alzheimer-Krankheit und dem chronischen Erschöpfungssyndrom. Weitere Bereiche sind die Forschung zu MASH und der Heilung von HIV. Das Unternehmen glaubt, über ausreichend Kapital zu verfügen, um klinische Studien zu beginnen und Entwicklungsinitiativen bis 2025 voranzutreiben.
- FDA lifted clinical hold on leronlimab in March 2024
- Submission of two clinical trial protocols to FDA
- Settlement with Amarex resulting in $10 million cash influx
- Initiation of pre-clinical and clinical leronlimab trials
- Progress on developing longer-acting therapeutic with AI partner
- Phase II study in colorectal cancer being initiated
- Exploration of triple-negative breast cancer and glioblastoma
- Evaluation of leronlimab for HIV-related chronic inflammation
- Pilot studies planned for Alzheimer's Disease and chronic fatigue syndrome
- Partnership with amfAR for HIV LATCH study
- Acceptance of CD10 manuscript for publication in Clinical Therapeutics
- None.
VANCOUVER, Washington, Sept. 09, 2024 (GLOBE NEWSWIRE) --
Dear Shareholders,
It continues to be a transformative year for CytoDyn Inc. (“CytoDyn” or the “Company”). A year in which we have made significant strides as a company, pursuing strategic initiatives to further our clinical development pipeline and charting the path forward in support of our mission. I sincerely thank you for your continued support and remain excited for what lies ahead.
As we enter the final stretch of 2024, let me first acknowledge that there is still a great deal of work ahead of us. The board of directors and the management team of the Company remain focused on advancing our clinical pipeline and opportunities to drive value for shareholders.
We are committed to being transparent with our shareholders and it is my pleasure to provide an update on some key developments described below.
CytoDyn has accomplished a number of milestones since the FDA lifted the clinical hold on leronlimab in March 2024, including: (i) the submission of two clinical trial protocols to the FDA, (ii) the negotiation of various agreements with vendors and creditors, and (iii) the settlement of litigation with Amarex resulting in an immediate
As of today, the Company has a new and improved relationship with the FDA – one that will remain a critical priority for the management team in the coming years. We believe the Company has sufficient cash on hand to commence the contemplated clinical trials and push our development initiatives forward into 2025.
CytoDyn has made significant progress by initiating a variety of key pre-clinical and clinical leronlimab trials, to be funded by the Company and others. I am also pleased to share that we have observed considerable progress related to development of a longer-acting therapeutic with our partner, who utilizes a proprietary artificial intelligence platform to expedite the clinical development process.
As shareholders, you remain the lifeblood of the Company, and we remain committed to acting in your best interests. We are unwavering in our belief that by continuing to take the best next step, one after another, we will continue to hit key milestones in the coming year and, in the process, drive significant potential value for our shareholders.
My dedication to the Company is grounded in my belief that leronlimab has the potential to be a life-changing therapeutic. Our commitment is to drive value for you – the shareholders – and to bring better healthcare to patients in need.
Included below are updates on our top priorities. I am excited about CytoDyn’s prospects moving forward and will provide additional updates as warranted.
Sincerely,
Dr. Jacob Lalezari
CEO
Oncology – September 2024 Updates
Our top priority remains the investigation of leronlimab in the field of oncology. As recently announced, CytoDyn is initiating a Phase II study of leronlimab in patients with relapsed/refractory micro-satellite stable colorectal cancer (“CRC”). Our synopsis proposal for the study was reviewed via a meeting with the FDA in August, and our final protocol is being submitted this week. We will continue to provide updates on this trial in the coming weeks, and expect to start screening patients in early 2025.
In addition to CRC, CytoDyn is investigating the role for leronlimab in two other oncology indications via strategic and low-cost research and development opportunities, and in collaboration with several reputable institutions. I am pleased to announce that CytoDyn is working with a team of experts to resume the exploration of Triple-Negative Breast Cancer (“TNBC”), including colleagues from the University of Hawaii Cancer Center, MD Anderson Cancer Center, and the Pennsylvania Cancer and Regenerative Medicine Research Center. We will be working with this team in the coming months to design and conduct a preclinical TNBC study that will aim to confirm the mechanism of action of leronlimab in oncology and address the question of potential synergies with both antibody-drug conjugates and immune checkpoint inhibitors. The Company intends to use this preclinical study to form the basis for a potential partnership and better inform the design of a follow-up clinical study in patients with metastatic TNBC.
Finally, the results from the preclinical Glioblastoma study in mice performed by the Albert Einstein College of Medicine should be released in the coming months.
Inflammation – September 2024 Updates
Within the past several weeks, we announced our selection of Syneos Health to serve as our clinical research organization (“CRO”) and implement our FDA-approved protocol to evaluate leronlimab in the treatment of patients with HIV and chronic inflammation. This trial has been specifically designed to provide clarity around the precise mechanism of action of leronlimab on biomarkers during the treatment of chronic inflammation. We will continue to provide updates on this trial in the coming weeks, and expect to start screening patients in December 2024.
CytoDyn is pursuing two other clinical studies linked to inflammation. First, we are working on a pilot study of leronlimab in the treatment of patients with mild to moderate Alzheimer’s Disease. The study will evaluate a neuroradiology primary endpoint to determine efficacy. We are also grateful to the foundation that has tentatively agreed to fund this study but wishes to remain anonymous at this time.
Finally, CytoDyn is also in the process of organizing a pilot study in patients with chronic fatigue syndrome who demonstrate elevated markers of chronic inflammation. Additional information will be provided in future shareholder updates.
Other – September 2024 Updates
CytoDyn will soon receive results from a preclinical study of leronlimab in a mouse model of MASH. That study is meant to clarify the correct dosing of leronlimab in the MASH setting and address the question of potential synergy with Resmetirom, the only currently approved therapy for the treatment of MASH.
As previously announced, CytoDyn will be partnering with the American Foundation for AIDS Research (amfAR) to sponsor the HIV LATCH study which will use leronlimab to protect CCR5+ donor immune cells from HIV infection while aiming for a cure in the setting of bone marrow transplantation provided to an HIV+ recipient. It is the Company’s belief that the likelihood of success of the LATCH program was greatly enhanced with the recent announcement by investigators in Germany of a successful HIV cure using stem cells from a donor who was heterozygous for the CCR5 delta-32 mutation. Indeed, those same investigators have reached out to CytoDyn and asked if they too can run a similar LATCH program at their research center in Berlin, and we are currently taking steps to make this opportunity a reality.
CytoDyn has also continued to pursue publication of our existing clinical data. The CD10 manuscript describing the leronlimab trial of patients with mild to moderate Covid-19 was recently accepted for publication by Clinical Therapeutics. The CD02 HIV paper, the CD12 manuscript on severe/critical Covid, the twin papers on the TNBC study results, and the MASH manuscript are all pending either final author review or final data confirmation prior to submission. All published research will be available on the Company’s website, soon after publication.
Note Regarding Forward-Looking Statements
This letter and the accompanying Frequently Asked Questions supplement contain forward-looking statements relating to, among other things, future operating and financial performance, product development, market position 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, 2024, including the section captioned “Forward-Looking Statements” and in Item 1A. CytoDyn Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments.
CONTACT
Investor Relations
CytoDyn Inc.
ir@cytodyn.com
FAQ
What is the status of CytoDyn's (CYDY) leronlimab clinical hold as of September 2024?
What oncology indications is CytoDyn (CYDY) pursuing for leronlimab as of September 2024?
What inflammation-related trials is CytoDyn (CYDY) conducting with leronlimab as of September 2024?
What was the outcome of CytoDyn's (CYDY) settlement with Amarex in 2024?
When does CytoDyn (CYDY) expect to start screening patients for its colorectal cancer trial?
