Medicenna Therapeutics Reports Fiscal Year 2026 Financial Results and Operational Highlights

On June 26, 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 year ended March 31, 2026, as well as anticipated corporate milestones.

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"Fiscal 2026 was a year of important execution across our Superkine pipeline, highlighted by compelling efficacy of MDNA11 in at least three different advanced cancer indications complemented by the impressive pre-clinical profile of MDNA113 in the breakthrough era of bi-functional immunotherapies," said Fahar Merchant, Ph.D., President and CEO of Medicenna. "As we look ahead, we believe that the upcoming MDNA11 clinical data readouts from both the ABILITY-1 and NEO-CYT studies will form the foundation of a broad development strategy and expedite collaboration, partnering, registrational, and commercial opportunities in select cancers. In parallel, MDNA113 continues to demonstrate a highly differentiated profile, with preclinical data showing its potential to dramatically widen the therapeutic window without sacrificing efficacy. With patent cliffs for key checkpoint inhibitors on the horizon, we aspire to provide better and safer options to patients where mega-blockbuster therapies have failed. With our recent financing activities, advances in partnering efforts, and continued focus on disciplined execution, we are well positioned to achieve multiple value-driving milestones across our pipeline this fiscal year."

Program highlights for the fiscal year ended March 31, 2026, along with recent developments, include:

MDNA11: IL-2 Superkine Program

MDNA11 continues to exhibit compelling deep and durable anti-tumor activity in difficult-to-treat solid tumors with best-in-class potential relative to competing IL-2 programs
Updated results from the Phase 1/2 ABILITY-1 study presented at ESMO (Free ESMO Whitepaper)-IO Congress 2025 and earlier this calendar year demonstrate response rates in the 30-40% range in the 2L/3L Tx setting or as next-line following resistance to checkpoint inhibitor therapy
During the second half of 2026, Medicenna plans to present updated clinical results from both the monotherapy and combination arms of the Phase 1/2 ABILITY-1 study and Phase 1b NEO-CYT study in earlier line settings
Medicenna plans to solidify its Phase 2b development strategy for MDNA11 by the end of this calendar year, including strategies for evaluation of MDNA11 in tumor types with accelerated approval potential

MDNA113: First-in-Class Anti-PD-1-IL-2 Bifunctional Superkine

Anti-PD-1-IL-2 bispecifics have emerged as a promising class of immuno-oncology therapies due to cis-binding synergies
At the 2026 AACR (Free AACR Whitepaper) Annual Meeting, the Company presented new preclinical data highlighting the differentiated and first-in-class potential of MDNA113, its IL-13Rα2 targeted anti-PD-1-IL-2 bifunctional superkine, which is designed to widen the therapeutic window through its tumor-targeting and activation within the tumor micro-environment
The AACR (Free AACR Whitepaper) presentation highlighted MDNA113’s capability to be dosed at a level consistent with or exceeding that of standard-of-care commercial anti-PD-1 therapies with data demonstrating dosing up to 50 mg/kg in non-human primates
Superior safety and dosing capabilities were also demonstrated compared to a competing anti-PD-1-IL-2a-biased design
Medicenna is advancing its novel first-in-class anti-PD-1 x IL-2 bifunctional superkine through IND-enabling studies with a planned IND submission in Q4 2026 followed by the initiation of a first-in-human trial soon thereafter

Bizaxofusp (formerly MDNA55): Empowered IL-4 Superkine Program

The Company is currently pursuing partnership opportunities for its phase-3 ready IL-4 Superkine for recurrent glioblastoma (rGBM). Bizaxofusp, which holds both FastTrack and Orphan drug status from the FDA and FDA/EMA, respectively, is Medicenna’s Phase 3-ready asset for rGBM which has been tested in 118 patients with high grade gliomas (including 112 patients with rGBM).

Anticipated Milestones for Fiscal 2027

Complete patient enrollment in ABILITY-1 study in MDNA11 monotherapy and combination arms across prioritized indications (cutaneous melanoma, endometrial cancer, MSI-H/dMMR and MSS/TMB-H cancers) including any new expansion cohorts (for e.g., CRC and NSCLC) with a focus on 2L/3L in post–anti-PD1 settings
Report updated clinical data from MDNA11 monotherapy and combination expansion cohorts including 2L/3L and last-line anti-PD1–treated patients enrolled within the ABILITY-1 study
Share interim clinical data from the Phase 1b NEO-CYT study of MDNA11 in neoadjuvant melanoma trial
Secure FDA guidance on first potential registrational trial of MDNA11 in at least one advancer cancer indication in 2L/3L setting post-ICI therapy, including dose selection for Project Optimus
File an investigational new drug (IND) application for MDNA113 in Q4 2026 and initiate a Phase 1 trial soon thereafter
Strengthen the balance sheet through partnership and/or financing in preparation for registrational trial for MDNA11 and commence FIH trial for MDNA113
Present new clinical data on bizaxofusp in recurrent GBM in Q4 2026
Advance and close a strategic collaboration or partnership for bizaxofusp

Annual Financial Results

Medicenna exited the fiscal year ended March 31, 2026 with cash and cash equivalents of $6.3 million. Subsequent to year end, the Company announced the closing of its previously announced $4.4 million public offering of units and the execution of a term sheet related to a structured financing arrangement with Sorbie Bornholm LP and Sorbie Investments LLP ("Sorbie") pursuant to which the Company may ultimately receive more or materially less than $8.0 million (the "Sorbie Transaction"). The completion of the Sorbie Transaction and the execution of the required documentation are each subject to the satisfaction of customary closing conditions, including the receipt of all necessary regulatory and stock exchange approvals. The proceeds from these financings, in conjunction with cash on hand, are expected, if completed as contemplated, to provide the Company with sufficient capital to execute its current planned expenditures through the first quarter of calendar 2027.

For the year ended March 31, 2026, the Company reported total operating costs of $22.4 million compared to total operating costs of $20.4 million for the year ended March 31, 2025. The increase is related to an increase in research and development expenses of $2.4 million which was partially offset by a reduction in general and administrative expenses of $0.4 million as discussed further below.

Net loss for the year ended March 31, 2026, was $18.4 million ($0.22 loss per share), compared to a net loss of $11.8 million ($0.15 loss per share) for the year ended March 31, 2025. The increase in net loss during the current period relative to the year ended March 31, 2025 is primarily due to an increase in R&D expenses of $2.4 million, a decrease in the gain recognized on the change in fair value of the warrant derivative of $2.1 million, a decrease in finance income of $0.8 million and a decrease in foreign exchange gain of $1.7 million.

Research and development expenses of $16.9 million were incurred during the year ended March 31, 2026, compared with $14.4 million incurred in the year ended March 31, 2025. The increase in research and development expenses in the current fiscal year is primarily attributed to increased clinical costs during the current year due to the expansion of the MDNA11 ABILITY-1 Study to new clinical sites, the inclusion of more patients in the study relative to the prior year, and the commencement of the NEO-CYT study during the current year.

General and administrative expenses of $5.5 million were incurred during the year ended March 31, 2026, compared with $6.0 million during the year ended March 31, 2025. The decrease in G&A expenses in the current year primarily relates to lower stock-based compensation expense associated with option grants made during the current year.

Medicenna’s financial statements for the year ended March 31, 2026 and the related management’s discussion and analysis (MD&A) will be available on SEDAR+ at www.sedarplus.ca.

(Press release, Medicenna Therapeutics, JUN 26, 2026, View Source [SID1234668977])

CHMP recommendation advances Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab as a potential standard of care for relapsed/refractory multiple myeloma

On June 26, 2026 Johnson & Johnson reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension of TECVAYLI (teclistamab) in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

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Advancing complementary immunotherapies to improve patient outcomes
Teclistamab and daratumumab work in a mechanistically complementary manner by engaging multiple tumour and immune directed pathways.1,2 When combined, daratumumab modulates the immune system to create a more favourable immune microenvironment and enhances T-cell fitness and activation, amplifying teclistamab-mediated killing of myeloma cells.1,2 This combination improves patient outcomes by using immunotherapies earlier in the treatment journey when patients’ immune systems are more robust.1,2

Expert and company perspectives support the earlier use of teclistamab combination in multiple myeloma care
"Unprecedented data show a meaningful extension in overall survival and minimal progression events observed after the first six months. More than 90% of patients receiving the combination who were progression-free at six months remained progression-free at three years, highlighting the potential for durable long-term disease control." said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. "This CHMP opinion marks an important step towards establishing the off-the-shelf immunotherapy combination of teclistamab plus daratumumab as a new standard of care earlier in the treatment pathway for multiple myeloma."

"At Johnson & Johnson our ambition is to leverage the full potential of our comprehensive multiple myeloma portfolio, to strengthen patient outcomes at every stage of the treatment continuum," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "By advancing innovative immunotherapies such as teclistamab and combining them with a well-established standard of care like daratumumab, we are building on our deep scientific expertise to deliver more integrated, combination-based approaches that can continue to raise expectations for patient care."

Teclistamab plus daratumumab SC achieves meaningful and sustained improvements in patient outcomes
The CHMP recommendation is supported by data from the Phase 3 MajesTEC-3 study (NCT05083169), evaluating the efficacy and safety of teclistamab plus daratumumab subcutaneous (SC) formulation versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients who have received 1–3 prior lines of therapy.3

At nearly three years of follow-up, results show an 83.4% reduction in the risk of disease progression or death in patients treated with teclistamab plus daratumumab SC, compared to standard of care (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; p<0.0001).1 More than 90% of patients who remained progression-free at six months (n=249) remained progression-free at three years, demonstrating sustained disease control over time.1 Overall survival (OS) favoured teclistamab plus daratumumab SC (HR, 0.46; 95% CI, 0.32-0.65; p<0.0001), with treatment benefit observed across all prespecified subgroups.1,2 At three years, OS rates were 83.3% for the combination and 65.0% for standard of care.1 Both progression-free survival and OS benefits were clinically meaningful and statistically significant.1

Manageable safety profile observed with teclistamab combination
Teclistamab plus daratumumab SC demonstrated a safety profile consistent with the well-known profiles of the individual therapies.1,3,4 All cases of cytokine release syndrome were Grade 1/2, did not lead to treatment discontinuation, and were manageable and resolved.1 Rates of Grade 3/4 treatment-emergent adverse events (TEAEs) were comparable to standard of care regimens (95.1% vs. 96.6%) with cytopenia and infection most commonly observed.1 Grade ≥3 infections decreased over time with the use of immunoglobulin supplementation and infection prophylaxis, along with a switch to monthly dosing.2 Discontinuations due to TEAEs were low and similar between study arms (4.6% vs. 5.5%).1

About the MajesTEC-3 Study
MajesTEC-3 (NCT05083169) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab plus daratumumab subcutaneous (SC) (n=291) versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (n=296) (DPd/DVd) in patients with relapsed or refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy.5 The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD) negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety.5 The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen.5

About Teclistamab
Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.6 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.7

Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.3,8 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer.1,3 Teclistamab is currently being evaluated in several combination studies.5,9,10,11

To date, more than 26,000 patients have been treated worldwide with teclistamab.12

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: View Source

▼ In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring.

About Daratumumab and Daratumumab SC
Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease.

In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 748,000 patients worldwide.13 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.5,14 Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training.5,15 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.5,16 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.5 Daratumumab may also have an effect on normal cells.5 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.17,18,19,20,21,22,23,24,25,26

For further information on daratumumab, please see the Summary of Product Characteristics at: View Source

About Multiple Myeloma
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.27,28 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.29,30 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.31 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.32,33,34 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.

(Press release, Johnson & Johnson, JUN 26, 2026, View Source [SID1234668978])

Siren Biotechnology Awarded $8M in Non-Dilutive Grant Funding from the California Institute for Regenerative Medicine (CIRM) to Support Clinical Development of SRN-101 in High-Grade Glioma

On June 26, 2026 Siren Biotechnology, pioneers of Universal AAV Immuno-Gene Therapy for cancer, reported that the California Institute for Regenerative Medicine (CIRM) has awarded the Company an $8M non-dilutive CLIN2 grant to support the clinical development of SRN-101, Siren’s lead investigational AAV immuno-gene therapy for high-grade glioma brain cancers.

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The award follows the U.S. Food and Drug Administration’s (FDA) clearance of Siren’s first Investigational New Drug (IND) application earlier this year, which advanced the Company to clinical stage and enabled a Phase 1/2 trial in adult patients with recurrent high-grade glioma. CIRM’s transformative CLIN2 funding will support the conduct of that trial and the activities required to evaluate SRN-101 in patients.

SRN-101 is built on Siren’s Universal AAV Immuno-Gene Therapy platform, designed to enable localized, durable delivery of immune-modulating payloads directly within tumors. The program has received Fast Track, Orphan Drug and Rare Pediatric Disease designations from the FDA. CIRM previously supported the program at the translational stage with a $4M non-dilutive TRAN1 grant, and today’s award extends that support into the clinic.

We are profoundly grateful to CIRM, who backed this science at its earliest stage and is now standing with us as we enter the clinic," said Nicole K. Paulk, PhD, Founder, CEO, and President of Siren Biotechnology. "High-grade gliomas remain among the hardest cancers to treat, and the patients who live with them cannot wait. This funding propels SRN-101 toward the patients who need it, made possible by the vision of the people of California."

This research is supported by the California Institute for Regenerative Medicine (CIRM), a State of California agency that funds regenerative medicine, stem cell, and gene therapy research (Grant numbers: CLIN2-19526 and TRAN1-15325).

About High-Grade Glioma
High-grade gliomas, including glioblastoma, are among the most aggressive and lethal primary brain tumors. Current treatments include surgery, radiation, and chemotherapy, all of which offer limited benefit. Novel therapeutic approaches are urgently needed.

(Press release, Siren Biotechnology, JUN 26, 2026, View Source [SID1234668979])

Curis Announces Eleven Active Clinical Sites in TakeAim CLL Study, Reaffirms Patient Dosing Guidance, and Reports Stockholder Approval of Reverse Stock Split

On June 26, 2026 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported that eleven clinical sites have been initiated and are now open for patient enrollment in its Phase 2 TakeAim CLL study evaluating emavusertib in combination with zanubrutinib in patients with Chronic Lymphocytic Leukemia. The Company also reaffirmed its guidance for the dosing of the initial five patients in the TakeAim CLL study by the end of July 2026, with data expected in December 2026. In addition, the Company reported that its stockholders approved a reverse stock split proposal at the special meeting of stockholders held on June 25, 2026.

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TakeAim CLL Update

Eleven clinical sites are now open for enrollment in the TakeAim CLL study, reflecting strong investigator interest in the combination of emavusertib and zanubrutinib as a strategy to enable dual blockade of NF-kB, a key driver of CLL disease. The Company reaffirmed its expectations to announce the dosing of the initial five patients in the TakeAim CLL combination study with zanubrutinib by the end of July 2026, with data expected in December 2026.

"We are pleased with both our operational progress in the CLL study and the strong support from our shareholders as we work to regain compliance with the NASDAQ bid price listing requirement," said James Dentzer, President and CEO of Curis, "and we look forward to building on those successes in the weeks and months to come."

Special Meeting Vote Results

At the Company’s special meeting of stockholders held on June 25, 2026, stockholders approved a proposal to amend the Company’s Restated Certificate of Incorporation to effect a reverse stock split of its issued and outstanding shares of common stock at a ratio ranging from 1-for-5 to 1-for-25, in furtherance of the Company’s regaining compliance with Nasdaq’s $1.00 bid price rule, with the final ratio to be determined at the discretion of the Company’s Board of Directors. The Company intends to announce the specific ratio and effective date in advance of the reverse stock split becoming effective. Curis’s shares of common stock will continue to trade on the Nasdaq Capital Market under the ticker symbol "CRIS."

Additional information regarding the reverse stock split proposal can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on June 5, 2026, available at www.sec.gov and www.curis.com.

About the TakeAim CLL Study

The TakeAim CLL is an open label phase 2 study of emavusertib in combination with zanabrutinib in patients with CLL (CA-4948-203, NCT07271667). Participants in the study must be in a partial response (PR) or partial response with lymphocytosis (PR-L), measurable residual disease positive (MRD+) as determined by the ClonoSEQ assay and actively taking zanubrutinib for at least 12 months.

(Press release, Curis, JUN 26, 2026, View Source,-Reaffirms-Patient-Dosing-Guidance,-and-Reports-Stockholder-Approval-of-Reverse-Stock-Split [SID1234668964])

Lantheus Receives Complete Response Letter from FDA for LNTH-2501 (Ga 68 edotreotide)

On June 26, 2026 Lantheus Holdings, Inc. ("Lantheus" or "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for LNTH-2501 (Gallium 68 edotreotide), a PET diagnostic imaging kit targeting somatostatin receptor-positive (SSTR+) neuroendocrine tumors (NETs).

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The FDA stated that the agency cannot approve the NDA by the Prescription Drug User Fee Act (PDUFA) action date of June 29, 2026, due to unresolved third-party facility manufacturing-related conditions. The third-party facility is responsible for drug product manufacturing. Satisfactory resolution of the unresolved facility inspection-related conditions is required before the LNTH-2501 NDA may be approved.

The CRL did not identify any concerns regarding the data submitted by Lantheus in support of the application, nor did it identify any issues related to the safety or efficacy of LNTH-2501.

"We remain confident in LNTH-2501 and are committed to bringing this imaging agent to NETs patients and healthcare providers as soon as possible," said Mary Anne Heino, Executive Chairperson and Chief Executive Officer, Lantheus. "The feedback received from the FDA relates solely to our third-party manufacturer, and not to the clinical performance of the product. We are working closely with our partner and the Agency to address these facility manufacturing-related conditions and advance the program."

About LNTH-2501 (Ga 68 edotreotide)
LNTH-2501 (Kit for Preparation of Ga 68 edotreotide Injection), is an investigational radioactive diagnostic kit indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. LNTH-2501 is supplied as a 2-vial kit to radiopharmacies which allows for direct preparation of Ga 68 edotreotide injection with the eluate of Gallium from an on-site generator at the radiopharmacy. LNTH-2501 is not currently approved by the FDA and is not yet available for sale in the United States.

(Press release, Lantheus, JUN 26, 2026, View Source [SID1234668965])