CytoDyn Announces Funding and Initiation of Expanded Access Program for Patients with Triple-negative Breast Cancer

On January 27, 2026 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), reported that a compassionate benefactor has formally committed funding to support the Company’s Expanded Access Program (EAP) for patients with triple-negative breast cancer.

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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.

(Press release, CytoDyn, JAN 27, 2026, View Source [SID1234662288])

Cardiff Oncology Announces Executive Leadership Changes as it Transitions to Late-Stage Clinical Development

On January 27, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported a leadership transition designed to support the Company’s next phase of growth and advancement toward late-stage development and key clinical and corporate milestones.

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Mani Mohindru, PhD, a member of Cardiff Oncology’s Board of Directors since 2021 and a seasoned biotech executive, has been appointed interim Chief Executive Officer, effective immediately. Mark Erlander, PhD, Chief Executive Officer, and James Levine, Chief Financial Officer, have stepped down from their respective roles.

As part of this transition, Ms. Brigitte Lindsay has been promoted to the role of Chief Accounting Officer, ensuring continuity within the finance function. She has been with the Company for more than 14 years and was most recently the Senior Vice President of Finance. The Company has initiated a search for a permanent Chief Executive Officer and Chief Financial Officer.

Cardiff Oncology’s lead product candidate, onvansertib, a highly specific, oral PLK1 inhibitor, is currently in mid-stage clinical development for RAS-mutated metastatic colorectal cancer (mCRC) and is also being evaluated as a single agent and in combinations across multiple additional cancers in investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma, small cell lung cancer, triple-negative breast cancer, and chronic myelomonocytic leukemia. The leadership transition reflects the Company’s focus on execution and clinical advancement as its programs mature.

"As Cardiff Oncology prepares for the next stage of clinical and corporate development, the Board concluded that this was the right moment to align executive and financial leadership with the Company’s evolving needs," said Rodney S. Markin, MD, PhD, Chairman of the Board. "We want to express our sincere gratitude to Mark and Jamie for their significant contributions in guiding Cardiff to where it stands today—especially in the progress of our lead product candidate in first-line RAS-mutated mCRC, an area of high unmet need where there have not been any significant advancements in many years. Looking forward, we are confident in Dr. Mohindru’s ability to lead the Company at this key moment in onvansertib’s clinical development, as she brings a rare combination of deep scientific training, operational leadership, and capital markets expertise."

"Cardiff Oncology has built a strong scientific and clinical foundation around PLK1 inhibition, with onvansertib demonstrating encouraging activity in a challenging to treat patient population," said Mani Mohindru, PhD, interim Chief Executive Officer. "Given onvansertib’s activity in RAS-mutated mCRC as well as encouraging single agent data, there is potential to extend its benefit to other solid tumors and hematologic malignancies. I look forward to working closely with the Board and the team to sharpen our strategic priorities, advance our clinical programs, and thoughtfully position the Company for late-stage development while maintaining a disciplined approach to capital and execution."

Dr. Mohindru is an experienced biotechnology executive with leadership experience spanning drug development, corporate strategy, and capital markets. She is the founder of Roshon Therapeutics, a private biotechnology company focused on developing novel therapies for cancer and inflammatory diseases, and currently serves on the Board of Directors of CytomX Therapeutics, Inc. (Nasdaq: CTMX). Previously, Dr. Mohindru served as Chief Executive Officer and Board Director of Novasenta and CereXis, and held senior leadership roles at public biotechnology companies including Cara Therapeutics, Inc. and Curis, Inc.

Earlier in her career, Dr. Mohindru was an equity research analyst covering the biotechnology sector at UBS, Credit Suisse, and ThinkEquity. She currently serves on the Executive Advisory Board of the CLP Institute at Northwestern University and the Scientific Investment Advisory Committee of the Gates Institute at the University of Colorado. Dr. Mohindru holds a PhD in Neurosciences from Northwestern University, as well as a BS in Human Biology and a Master’s degree in Biotechnology from the All India Institute of Medical Sciences in New Delhi, India.

(Press release, Cardiff Oncology, JAN 27, 2026, View Source [SID1234662287])

AIM ImmunoTech Announces Changes to Key Dates and Terms Related to Announced Rights Offering

On January 27, 2026 AIM ImmunoTech Inc. (NYSE American: AIM) – AIM ImmunoTech Inc. ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, reported changes to the previously announced key dates relating to its proposed rights offering (the "Rights Offering"). Except as expressly amended herein, the terms of the Rights Offering remain unchanged. Assuming that the Rights Offering is fully subscribed, the Company will receive gross proceeds of $12 million, less expenses related to the Rights Offering.

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The Subscription Rights will be non-transferable and may only be exercised during the amended subscription period of Wednesday, February 11, 2026 through 5:00 p.m. Eastern Time on Friday, February 27, 2026, unless extended by AIM.

The amended calendar for the Rights Offering is now as follows:

February 9, 2026: Ownership Day – in order to be considered a stockholder of record on February 10, 2026, shares should be acquired by this date (open market purchases of Common Stock should be completed by February 9, 2026 to be considered a stockholder of record on the Record Date).
February 10, 2026: Record Date (5:00 p.m. Eastern Time)
February 11, 2026: Distribution Date; Subscription Period Begins
February 27, 2026: Subscription Period Ends 5:00 p.m. Eastern Time
The Rights Offering will include an over-subscription privilege which permits each holder of Subscription Rights that exercises such holder’s basic Subscription Right in full to purchase additional subscriptions (if any) that remain unsubscribed at the expiration of the Rights Offering. The availability of the over-subscription privilege will be subject to certain terms and restrictions set forth in the prospectus. If the aggregate subscriptions (basic subscriptions plus over-subscriptions) exceed the number of subscriptions offered in the Rights Offering, then the aggregate over-subscription amount will be pro-rated among the holders exercising their respective over-subscription privileges (in proportion to the number of subscriptions held after giving effect to all basic subscriptions).

Certain of AIM’s leadership have indicated to the Company on a non-binding basis that they intend to participate in the Rights Offering, including Board member and Chief Executive Officer Thomas K. Equels.

The Company intends to use the net proceeds from the exercise of subscriptions for general corporate purposes – including clinical trial expenses and manufacturing expenses associated with prospective Phase 2/3 pancreatic cancer trials – and allocate a portion of the net proceeds to repay, according to their terms, certain existing debt obligations.

The Rights Offering will expire at 5:00 p.m., Eastern Time, on Friday, February 27, 2026, unless it is extended or earlier terminated by the Company, If the Company elects to extend the Rights Offering, it will issue a press release announcing the extension no later than 9:00 a.m., Eastern Time, on the next business day after the most recently announced expiration date of the Rights Offering. The Company may extend the Rights Offering for additional periods in its sole discretion for any reason up to an additional 45 days. Once made, all exercises of subscriptions are irrevocable.

The Company expects that Broadridge Corporate Issuer Solutions, LLC, the information agent for the Rights Offering, will mail rights certificates and a copy of the prospectus for the Rights Offering to holders of record of Common Stock and Participating Securities as of the Record Date beginning on or about February 11, 2026. Holders of securities held in "street name" through a brokerage account, bank or other nominee will not receive physical rights certificates and must instruct their broker, bank or other nominee whether to exercise Subscription Rights on their behalf. For any questions or further information about the Rights Offering, please call Broadridge Corporate Issuer Solutions, LLC, the information agent for the Rights Offering, at (855) 793-5068 or via email at [email protected].

Neither the Company nor its Board of Directors has made or will make any recommendation to holders regarding the exercise of subscriptions. Holders should make an independent investment decision about whether or not to exercise their subscriptions based on their own assessment of the Company’s business and the Rights Offering.

A registration statement (Registration No. 333-292085) relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. The Rights Offering, which is expected to commence following the effectiveness of the registration statement, is being made only by means of a written prospectus. A preliminary prospectus relating to and describing the proposed terms of the Rights Offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s website at View Source Copies of the preliminary and final prospectuses for the Rights Offering may be obtained, when available, from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, Attention Syndicate Department, email: [email protected] or telephone (212) 895-3745.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Maxim Group LLC is acting as the dealer-manager in connection with the Rights Offering.

(Press release, AIM ImmunoTech, JAN 27, 2026, View Source [SID1234662284])

MS Pharma Group Signs Exclusive Biosimilars Partnership Agreement with Hetero

On January 26, 2026 MS Pharma Group, a leading regional pharmaceutical company in the MENA region, reported it has signed a strategic partnership agreement with Hetero Group, a global pharmaceutical company, to localize five established biosimilars across key therapeutic areas, including oncology, immunology and hematology.

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The exclusive agreement will be implemented through El Kendi – MS Pharma Group’s affiliate in Algeria and Hetero Biopharma – a subsidiary of Hetero Group. This marks Hetero’s first local partnership in the country, representing a significant step towards strengthening Algeria’s biopharmaceutical ecosystem. The combined portfolio represents an estimated total market value of USD 45million in Algeria (2024) and will be executed through a localization and technology transfer approach.

"We are pleased to collaborate with a global partner like Hetero, with whom we share a long-term commitment to knowledge transfer and improving healthcare outcomes for patients in the region. This collaboration reflects MS Pharma Group’s ongoing commitment to expanding patient access to trusted and affordable biologic treatments, while supporting the sustainability and resilience of local healthcare systems. Strategic partnerships like this enable us to build durable regional capabilities and create meaningful, long-term impact for patients and health systems across the MENA region," said Kalle Känd, CEO of MS Pharma.

"At Hetero, we are guided by a strong commitment to ensuring access to high-quality and affordable medicines for patients across the globe. We are pleased to enter into a strategic partnership with MS Pharma, a well-established and trusted healthcare leader in the Middle East and beyond. This collaboration marks an important step in advancing healthcare delivery and addressing unmet medical needs across the Middle East, Algeria, and other key markets." – Dr. Vamsi Krishna, MD, Hetero Group

(Press release, Hetero Biopharma, JAN 26, 2026, View Source [SID1234662226])

Fortitude Biomedicines Launches With $13M in Financing to Advance Novel Antibody-based Therapies for Treatment of Autoimmune Diseases and Cancer

On January 26, 2026 Fortitude Biomedicines, Inc., (Fortitude) a leading biopharmaceutical company focused on immune cell targeting biologics and molecular glue payload–enabled antibody–drug conjugates (ADCs) for the treatment of a wide range of autoimmune diseases and cancers, reported the Company’s launch following closing of a $13 million Seed financing, co-led by K2 Bio Partners, Shanghai Healthcare Angel Capital (SHAC), and Elikon Venture, with additional investment from Everjoy Fortune and Taihill Venture.

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Proceeds from the financing will support the Company’s lead immune cell targeting biologic program through Investigational New Drug (IND) enabling studies. Additionally, Fortitude is harnessing the power of its GLUE-DACTM drug discovery engine to advance other pipeline therapeutics for oncology and autoimmune diseases. GLUE-DACTM is a next-generation antibody–drug conjugate (ADC) platform powered by proprietary molecular glue payloads. Originally developed in Professor Jin Wang’s research laboratory at Baylor College of Medicine, GLUE-DACTM integrates the precision targeting of ADCs with the catalytic power of targeted protein degradation. GLUE-DACTM has the potential to expand the therapeutic window of ADCs, overcome resistance mechanisms, and unlock new therapeutic targets.

Fortitude was co-founded by serial entrepreneur, Jesse Chen, Ph.D., who previously co-founded both TRIANA Biomedicines and Avilar Therapeutics, and Professor Jin Wang, Ph.D., Director at Center for NexGen Therapeutics and Michael E. DeBakey, M.D. Endowed Professor in Pharmacology at Baylor College of Medicine. Dr. Chen will serve as President and CEO to lead the company’s research and business operations. Before launching Fortitude, he served as Chief Technology Officer at TRIANA Biomedicines and brings nearly two decades of discovery research and management experience, spanning early discovery through preclinical development.

Dr. Chen serves on Fortitude’s Board of Directors alongside independent Chair of the Board, Tim Noyes, President and CEO of Newleos Therapeutics, and institutional director Yunhai Wang, Ph.D., Managing Partner at K2 Bio Partners.

"Fortitude is at the forefront of a new era in therapeutic innovation. With proprietary antibody-based technology, we are unlocking the ability to precisely target diseases while engaging the body’s own biology in powerful, transformative ways," said Dr. Jesse Chen, President and CEO of Fortitude. "GLUE-DACTM is a powerful modality that aims to redefine precision medicines and bring new hope to patients."

"Resistance is increasingly emerging as a challenge in the current ADC therapeutic landscape. The field urgently needs payloads with distinct mechanisms of action. GLUE-DACTM technology meets this unmet need by combining the validated delivery capabilities of antibodies with the transformative potential of targeted protein degradation," said Dr. Jin Wang, Professor in Pharmacology at Baylor College of Medicine. "I am thrilled to work with Fortitude to advance their novel platform and be part of their mission to deliver a new generation of effective therapies for patients."

"Fortitude Biomedicines is dedicated to developing next-generation biologics and ADC technology for immunotherapy and oncology therapy. The founding team brings a strong global perspective, with deep expertise and a proven track record across translational research, drug development, and clinical execution. K2 Bio Partners has been conducting systematic research in the immunotherapy and oncology space and highly recognizes Fortitude’s scientific vision, differentiated technology approach, and leading position in this field," said Dr. Yunhai Wang, Managing Partner at K2 Bio Partners. "We believe that Fortitude has the potential to become a leading international enterprise in immunotherapy and oncology treatment. We look forward to working closely with the company to accelerate the development of its pipeline and bring benefits to patients worldwide."

"Fortitude employs a unique platform to develop novel payloads for antibody-drug conjugates, addressing resistance seen with conventional ADCs and extending this modality to autoimmune diseases, which is a meaningful and transformative effort for the current therapeutic landscape," said Samuel Guo, Partner of SHAC. "With the seasoned team led by Dr. Chen, we are highly confident in advancing the development of potential life-changing therapies."

(Press release, Fortitude Biomedicines, JAN 26, 2026, View Source [SID1234662222])