On February 13, 2026 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines targeting cancer, autoimmune, and inflammatory diseases, reported financial results and corporate highlights for the fiscal quarter ended December 31, 2025, as well as anticipated corporate milestones.

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"We delivered strong clinical results in 2025 with our ABILITY-1 trial and 2026 is shaping up to be a milestone-rich year across our pipeline," said Dr Fahar Merchant, President and CEO of Medicenna. "MDNA11 continues to deliver best-in-class efficacy results in multiple solid tumors, following failure of other block-buster immunotherapies where the needs of cancer patients remain largely unfulfilled. MDNA113, our tumor targeted bi-functional conditionally activated anti-PD1-IL-2, is advancing towards IND enabling studies and has demonstrated solid efficacy signals in pre-clinical models and excellent tolerability in preliminary non-human primate studies. This year, we plan to file an IND for MDNA113 and arrange an End of Phase 1 meeting with the FDA for a potential registrational trial with MDNA11. As we execute on these programs, we remain committed on advancing high-impact opportunities that have the potential to improve standards of care for patients with cancer, drive partnerships, strengthen our balance sheet and build shareholder value."

PROGRAM AND BUSINESS UPDATE
Highlights for the three months ended December 31, 2025, along with recent developments, include:

MDNA11: ‘β-Enhanced Not-α’ Interleukin 2 Super Agonist

MDNA11 Clinical Data Update:

On January 16, 2026, Medicenna updated expansion cohort data demonstrating MDNA11’s best-in-class anti-tumor activity. When administered as a 2L/3L systemic treatment or as next line following resistance to checkpoint therapy, MDNA11 achieved a monotherapy objective response rate ("ORR") of 36% and a disease control rate ("DCR") of 86% (N=14), and when combined with pembrolizumab ORR was 43% and DCR was 72% (N=14).
ABILITY-1 Enrollment and Update:

Consequently, as a result of these compelling data, Medicenna is completing enrollment in the expansion portions of the ABILITY-1 study by enrolling patients where MDNA11 will be administered as 2/3L Tx or immediately following checkpoint-resistance.

Tumor types currently enrolling are: MSI-H, TMB-H, cutaneous melanoma, endometrial (combination only), non-small cell lung cancer (combination only), and colorectal cancer (mono- and combination in TMB-H and MSI-H cohorts). NSCLC and colorectal cancer cohorts have been added due to prior data demonstrating strong potential of IL-2 therapy in these cancers and have blockbuster market opportunities. Medicenna anticipates sharing updated clinical results from the ABILITY-1 study in H2 2026.

Medicenna anticipates completing enrollment of expansion cohorts in the ABILITY-1 study and is planning for an end-of-phase 1 meeting with the FDA, allowing for alignment regarding potential registrational trials.
NEO-CYT Trial:

In collaboration with the Fondazione Melanoma Onlus, the NEO-CYT Trial is a randomized, multi-centre neoadjuvant study in high-risk, resectable Stage III melanoma, evaluating MDNA11 in combination with nivolumab, with or without ipilimumab.

NEO‑CYT is designed to prospectively evaluate the potential of MDNA11 to enhance the efficacy of standard-of-care cancer immunotherapy in the neoadjuvant setting. Specifically, whether Medicenna’s best‑in‑class IL‑2 agonist can deepen neoadjuvant pathologic responses predictive of patient outcomes when added to established anti-PD‑1 ± anti-CTLA‑4 regimens at a time when the tumor is still present to optimize the anti-tumor immune response.

Medicenna anticipates sharing interim clinical data from this study in neoadjuvant melanoma in H2 2026.

MDNA113: First-in-Class Tumor-anchored and Activatable ‘Masked’ Anti-PD-1-IL-2 BiSKIT

MDNA113 is our most advanced pre-clinical asset encompassing both, the T-MASK and BiSKIT platforms. It is a novel first-in-class tumor targeted and activatable bifunctional anti-PD1-IL-2 superkine.
MDNA113 is advancing through preclinical development with plans to commence a first-in-human trial in H2 2026.
Non-human primate studies are currently underway, with updated data demonstrating its potential to dramatically widen the therapeutic index, and has shown a favorable safety profile in non-human primates at the highest tested dose of 30 mg/kg, supporting the potential for human dosing comparable to approved anti-PD-1 therapies.

Bizaxofusp (formerly MDNA55): IL-4 Superkine – Treatment of Recurrent Glioblastoma ("rGBM")

Medicenna’s phase 3 ready asset for rGBM, bizaxofusp, to-date, has been tested in 118 patients with high grade gliomas (including 112 patients with rGBM) and most recently completed a successful Phase 2b (N=44) trial for nonresectable rGBM where it demonstrated a doubling of median overall survival ("mOS") to 13.6 months in the WHO-defined IDHWT high-dose population compared to the standard-of-care mOS of 7 months.
Medicenna will present updated internal and external data sets related to bizaxofusp (MDNA55) at the 7th Annual Glioblastoma Development Summit to be held in Boston from 17-19 February 2026.
Title: Surmounting Barriers in Non-resectable Recurrent Glioblastoma with a Single Treatment of Bizaxofusp, an Engineered IL-4R Directed Fusion Protein
Time: Thursday, February 19, 2026, at 10:00 AM Eastern Time
Presenter: Dr. Fahar Merchant, President & CEO of Medicenna Therapeutics
Medicenna is actively pursuing strategic partnerships to advance the program into a registrational trial, and is preparing the program for commercialization and its subsequent launch in various countries where marketing authorization is granted.

CHANGE TO BOARD OF DIRECTORS

Medicenna announced changes to its Board of Directors. Mr. Richard Sutin and Mr. Angelos Georgakis have been appointed to the Board of Directors of the Company. Mr. Sutin and Mr. Georgakis’s appointments to the Board follow the retirement of Ms. Karen Dawes, who has served on the Board since 2019, most recently as Chair of the Compensation Committee and as a member of the Audit Committee.

QUARTERLY FINANCIAL RESULTS

Medicenna exited the quarter ended December 31, 2025, with cash and cash equivalents of $10.6 million. Based on the Company’s current operating plan, these funds are expected to be sufficient to fund planned operations into the third quarter of 2026.

For the three months ended December 31, 2025, the Company reported total operating costs of $5.6 million compared to $5.1 million for the three months ended December 31, 2024. The increase was primarily attributable to a $0.5 million increase in research and development ("R&D") expenditures related to higher MDNA11 clinical trial costs in the current quarter relative to the comparable period. General and administrative ("G&A") costs were consistent year over year.

Net loss for the quarter ended December 31, 2025, was $4.4 million, or $0.05 per share, compared to a net loss of $5.2 million, or $0.07 per share, for the three months ended December 31, 2024. The $0.8 million decrease in net loss was primarily due to a $2.9 million increase in the gain on the fair value of the derivative warrant liability, partially offset by a $1.3 million decrease in foreign exchange gain, a $0.5 million increase in R&D expenses, and a $0.3 million decrease in finance income.

R&D expenses were $4.1 million for the quarter ended December 31, 2025, compared to $3.6 million for the same period in 2024. The increase was primarily driven by higher clinical costs associated with the expansion of the MDNA11 ABILITY-1 study to additional clinical sites and increased patient enrollment, as well as the initiation of the NEO-CYT trial during the quarter. G&A expenses were $1.5 million for the quarter ended December 31, 2025, consistent with $1.5 million for the same period in 2024, reflecting stable operating activities year over year.

Medicenna’s financial statements for the three and nine months ended December 31, 2025, and the related management’s discussion and analysis (MD&A) will be available on SEDAR+ at www.sedarplus.ca.

(Press release, Medicenna Therapeutics, FEB 13, 2026, View Source [SID1234663800])

On February 13, 2026 Akiram Therapeutics reported that the preclinical study underpinning the clinical development of lead candidate AKIR001, published in The Journal of Nuclear Medicine (JNM), has been selected as best basic investigation and overall featured article for the February issue.

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AKIR001 is developed by Akiram Therapeutics, a Swedish biotech company developing targeted radiopharmaceutical therapies for cancer. The candidate targets CD44v6 and is currently under evaluation in a first-in-human Phase 1 clinical trial.

The article presents the preclinical validation of AKIR001. The data demonstrate selective tumor uptake, favorable dosimetry, and clear antitumor effects in relevant models, strengthening the scientific foundation for the ongoing study in patients with CD44v6-positive tumors.

"We are pleased to see the study recognized both as best basic investigation and as overall featured article in JNM," says Marika Nestor, CEO of Akiram Therapeutics. "It is a strong recognition of the preclinical work behind AKIR001 and adds further weight as the program advances in clinical development."

About the Phase 1 clinical trial
The ongoing first-in-human Phase 1 trial is conducted and sponsored by Karolinska University Hospital. The study evaluates safety, tolerability, pharmacokinetics and biodistribution in patients with tumors that express CD44v6, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, gynecological squamous cell carcinoma and non-small cell lung cancer.

The trial is registered at ClinicalTrials.gov:
View Source

(Press release, Akiram Therapeutics, FEB 13, 2026, View Source [SID1234662681])

On February 13, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported a collaboration with Median Technologies (EPA: ALMDT) to bring Median’s proprietary eyonis LCS to the Tempus Pixel platform. This collaboration empowers clinical workflows with a powerful tool to support informed diagnostic and disease management decisions.

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According to a study by the American Cancer Society, only about 20% of eligible individuals in the U.S. were screened for lung cancer in 2024. Closing the gap and achieving full participation among eligible individuals could prevent an estimated 62,110 lung cancer deaths over five years. eyonis LCS is an AI-based CADe/CADx software as a medical device (SaMD) for lung cancer screening. It enables clinicians to not only detect lung nodules but also characterize and risk stratify them from the same CT image without additional steps in the workflow. eyonis LCS received 510(k) clearance from the U.S. Food and Drug Administration (FDA) earlier this month.

Through this collaboration, Tempus will integrate eyonis LCS into Tempus Pixel1, an FDA-cleared, CE-marked AI-enabled solution that provides advanced analysis, tools, and automated reporting from radiology images to help providers accurately track and quantify lesions. The integration of eyonis LCS will enable non-invasive characterization of CT identified lung nodules at the time of nodule detection with its proprietary nodule malignancy score, a feature that will allow clinical teams to stratify and prioritize patients in lung cancer screening programs.

"Activating our distribution collaboration with Tempus AI is a decisive step in bringing eyonis LCS to patients at national scale," said Fredrik Brag, CEO and Founder of Median Technologies. "Tempus’ strong leadership in AI-enabled precision medicine, deeply integrated data-technology ecosystem, and strong market presence make them an exceptional partner to drive rapid and high-impact adoption of eyonis LCS across the United States."

"We believe AI reaches its full potential when it helps clinicians identify disease earlier and more accurately," said Razik Yousfi, Tempus SVP & GM, AI Products. "By expanding our Pixel platform with sophisticated lung cancer screening AI tools, we are enabling radiologists to manage complex caseloads while prioritizing early-stage detection. Our collaboration with Median Technologies is about more than technology; it’s about improving the standard of care and preventing avoidable deaths through better screening access."

Tempus has significantly expanded its diagnostic capabilities by developing and deploying a suite of advanced algorithms across radiology and pathology, helping clinicians deliver more precise, personalized care. In 2022, Tempus acquired Arterys, incorporating its AI-driven imaging tools—ranging from lung CTs and chest X-rays to cardiac MRIs—into the Tempus ecosystem. This was followed by the acquisition of Paige, which contributed a proprietary dataset of almost 7 million clinically annotated, de-identified pathology slides to further accelerate Tempus’ efforts.

(Press release, Tempus, FEB 13, 2026, View Source [SID1234662678])

On February 13, 2026 China Medical University Hospital (CMUH) reported that, in collaboration with Ever Supreme Bio Technology, it has successfully developed the world’s first EXO 001 targeted exosome platform, a breakthrough technology that enables direct in vivo programming of T cells to generate multi-target nanobody-based CAR-T cells.

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In multiple solid tumor animal models, EXO 001 demonstrated significant therapeutic efficacy, including complete tumor eradication in select cases, offering a fundamentally new treatment strategy for patients with advanced solid malignancies.

In Vivo Immune Programming Overcomes the Limitations of Conventional CAR-T Therapy

According to CMUH Superintendent Dr. Der-Yang Cho, both autologous and allogeneic CAR-T therapies currently rely on complex and time-consuming ex vivo cell manufacturing processes. For patients with rapidly progressing solid tumors, these approaches are often too slow to meet clinical needs and remain constrained by immune rejection, manufacturing failure, and high costs.

The core innovation of EXO 001 lies in repositioning exosomes as carriers for in vivo immune programming, representing an advanced evolution of the CAR001 platform currently under clinical evaluation.

Following intravenous administration, EXO 001 circulates through key immune organs such as the spleen, where it precisely delivers Nb-CAR.BiTE genes to CD3-positive T cells. This enables direct genetic programming within the patient’s body, converting native T cells into multi-target CAR-T cells capable of infiltrating solid tumors, killing cancer cells, and dismantling the immunosuppressive tumor microenvironment.

This design enables immune cells to be "trained in vivo and deployed immediately," combining the immune compatibility of autologous CAR-T therapy with the off-the-shelf availability and scalability typically associated with allogeneic approaches—an essential factor in EXO 001’s effectiveness against solid tumors.

Compelling Animal Data

Compelling Preclinical Results: Tumor Clearance and Extended Survival

Dr. Cho noted that in mouse models of colorectal cancer, pancreatic cancer, malignant brain tumors, and ovarian cancer, intravenous administration of EXO 001 successfully generated CAR-T cells in vivo. These cells effectively penetrated the tumor microenvironment, significantly inhibited tumor growth, and extended survival by two- to three-fold. In some animals, tumors were completely eliminated with long-term, recurrence-free outcomes.

By using exosomes as a gene and drug delivery vehicle, EXO 001 achieves higher biocompatibility and safety compared with viral vectors or synthetic lipid materials. This approach reduces immunogenicity, minimizes the risk of cytokine storm and anti-drug antibody formation, and lowers overall immune-related risks.

A Platform with Clear Clinical and Industrial Advantages

Wen-Liang Huang, General Manager of Ever Supreme Bio Technology, emphasized that EXO 001 offers not only academic innovation but also strong translational and commercialization potential, including:

Single-cell-line sourcing with stable quality
Exosomes derived from a single engineered cell line minimize donor variability and support standardized production and quality control.

Scalable manufacturing aligned with international standards
Production can be carried out in fully closed, automated systems compliant with U.S. FDA regulations for cell-based therapies.

Off-the-shelf readiness
Eliminates the need for patient- or donor-specific ex vivo cell cultivation, enabling timely intervention for rapidly progressing solid tumors.

Cost advantages and improved accessibility
Significantly reduces overall production costs compared with traditional autologous CAR-T manufacturing.

Platform extensibility
Beyond solid tumors, the platform can be adapted to carry different CAR genes, nucleic acids, or small-molecule drugs, supporting multiple therapeutic indications.

Potential for long-term anti-tumor immunity
Animal studies indicate the induction of CAR-T cells with immune memory characteristics, suggesting more durable anti-cancer effects.
Global Momentum in In Vivo CAR-T Development

In recent years, in vivo CAR-T has emerged as a key focus for global pharmaceutical leaders. Companies such as Gilead Sciences (Kite), AstraZeneca, Bristol Myers Squibb, and AbbVie have actively invested in viral vectors, lipid nanoparticles, and nanocarrier-based immune programming technologies to overcome the limitations of conventional CAR-T therapy in solid tumors.

Within this global landscape, the EXO 001 targeted exosome platform—developed jointly by CMUH and Ever Supreme Bio Technology—stands out for its use of high-biocompatibility, naturally derived exosomes, offering a differentiated and internationally competitive approach.

Next Steps Toward Clinical Translation

This research has been accepted for publication in the internationally recognized journal Advanced Science (January 2026), has secured patents in the United States and other countries, and has completed technology transfer. Manufacturing development and clinical trial preparation are currently underway, with first-in-human trials anticipated as early as next year, targeting patients with colorectal cancer, pancreatic cancer, malignant brain tumors, and ovarian cancer.

The EXO 001 platform represents a new horizon for solid tumor immunotherapy and a promising step forward for patients with advanced cancer.

(Press release, Ever Supreme Bio Technology, FEB 13, 2026, View Source [SID1234662677])

On February 13, 2026 Precision Biologics, Inc. CEO Philip M. Arlen, MD reported a Keynote presentation describing in vitro and in vivo efficacy of its novel tumor-specific antibody-drug-conjugate PB-223 ADC (PB-vcMMAE-5). Recent tumor killing data showing specific non-toxic anti-tumor activity in several human cancer types expressing truncated core 2 O-glycans will be reported in "PB-223, A Novel Antibody Drug Conjugate Targeting Truncated Core-2 glycans in Solid Tumors", at the 6th Ace Drug Discovery Summit, The Insurance Hall, London, UK, February 18-19, 2026.

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"The exquisite sensitivity and specificity of our recently developed mAb enables maximum anti-tumor response to our PB-223 ADC with minimal toxicity in the preclinical animal studies. The target is found on a broad variety of human solid tumors but not on healthy tissue, suggesting a strong rationale to move this drug into clinical trials."

"We’re excited to discuss PB-223 ADC with the scientific community, to share compelling preclinical data with several human tumor types, showing animal xenograph human tumor models resulting in complete tumor eradication with minimal toxicity observed in blood and tissue analysis," he went on to say. Although some preliminary data was shown on posters at SITC (Free SITC Whitepaper) (Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)) and AACR (Free AACR Whitepaper)-Ovarian (American Association for Cancer Research, Ovarian Cancer) meetings, this is the first public talk presenting and explaining the full data in person.

Here are details of the presentation:

Title:

"PB-223, A Novel Antibody Drug Conjugate Targeting Truncated Core-2 glycans in Solid Tumors"

Date/Time:

Thursday, February 19, 12:00pm – 12:30pm – Day 2 – Presentation no. 15

Place:

6th ACE Drug Discovery Summit, The Insurance Hall, 20-21 Aldermanbury, London, UK

Keynote Speaker:

Philip Arlen, President & CEO, Precision Biologics, Inc.

(Press release, Precision Biologics, FEB 13, 2026, View Source [SID1234662676])