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])

On June 26, 2026 Astrazeneca and Daiichi Sankyo reported that Datroway (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

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Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the TROPION-Breast02 phase 3 trial, which were presented at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.

In TROPION-Breast02, Datroway demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) versus investigator’s choice of chemotherapy (hazard ratio [HR]=0.79; 95% confidence interval [CI]: 0.64-0.98; p=0.0291). Median OS was 23.7 months for patients treated with Datroway versus 18.7 months for those treated with chemotherapy. Datroway reduced the risk of disease progression or death by 43% compared to chemotherapy (HR=0.57; 95% CI: 0.47-0.69; p<0.0001) as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 10.8 months for patients treated with Datroway versus 5.6 months for those treated with chemotherapy in patients with metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway was also associated with more robust treatment responses compared to chemotherapy, with an objective response rate (ORR) of 62.5% versus 29.3% for those treated with chemotherapy.

"Triple negative breast cancer remains one of the most aggressive types of breast cancer, with limited treatment options for patients with metastatic disease who are not candidates for immunotherapy and are currently treated with traditional chemotherapy," said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. "This positive recommendation by the CHMP underscores the potential for Datroway to replace traditional chemotherapy in this setting and we look forward to working closely with the EMA to bring this new indication to patients in the EU."

"As one of the hardest cancers to treat, today only 15% of patients with metastatic triple negative breast cancer survive beyond five years," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. "This positive opinion from the CHMP marks an important step forward in bringing the potential of Datroway to transform outcomes for patients with this type of cancer in the EU."

The safety profile of Datroway (6 mg/kg) was evaluated in 319 patients with TNBC who received Datroway in TROPION-Breast02. The most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis, increased amylase, nausea, alopecia, decreased hemoglobin, decreased white blood cells, constipation, decreased calcium, decreased lymphocytes, fatigue, decreased neutrophils, increased alanine aminotransferase, increased aspartate aminotransferase, dry eye, keratitis, decreased albumin, vomiting, musculoskeletal pain, decreased sodium and increased blood alkaline phosphatase. Serious adverse reactions occurred in 17% of patients who received Datroway. Serious adverse reactions in more than 1% of patients who received Datroway included pneumonia, vomiting, COVID-19 and anemia. One patient fatality was attributed to interstitial lung disease/pneumonitis.

Datroway was approved in the U.S. in May 2026 for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. Additional reviews are underway in China and Japan, as well as Australia, Canada, Singapore and Switzerland as part of Project Orbis.

About TROPION-Breast02
TROPION-Breast02 is a global, multicenter, randomized, open-label phase 3 trial evaluating the efficacy and safety of Datroway versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumors did not express PD-L1 as well as patients with PD-L1 expressing tumors who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.

The dual primary endpoints of TROPION-Breast02 are OS and PFS as assessed by BICR. Secondary endpoints include PFS as assessed by investigator, ORR, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

About Triple Negative Breast Cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.1,2 In Europe, there are an estimated 83,000 diagnoses of TNBC each year.1,3 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.4,5,6 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.4,7,8

While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.4 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.4 For patients with metastatic disease with PD-L1 expressing tumors, the addition of immunotherapy to chemotherapy has improved outcomes in the first-line setting.9,10 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy was the standard first-line treatment.11

TROP2 is a protein broadly expressed in several solid tumors, including TNBC.12 TROP2 is associated with increased tumor progression and poor survival in patients with breast cancer.13,14

About Datroway
Datroway (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Datroway is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. Datroway is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Datroway (6 mg/kg) is approved in Brazil, Russia and the U.S. for the treatment of adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy based on the results from the TROPION-Breast02 trial.

Datroway (6 mg/kg) is approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

Datroway (6 mg/kg) is approved in Russia and the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy, based on the results from TROPION-Lung05 and TROPION-Lung01 trials. Continued approval for this indication in the U.S. may be contingent upon verification and description of clinical benefit in a confirmatory trial.

(Press release, AstraZeneca, JUN 26, 2026, View Source [SID1234668976])

On June 26, 2026 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported the U.S. Food and Drug Administration (FDA) approval and launch of the BESREMi Pen (ropeginterferon alfa-2b-njft) device for adult patients with polycythemia vera (PV). The device offers a more convenient self-administration option than the currently available pre-filled syringe. The BESREMi Pen is expected to become commercially available in the U.S. in the coming weeks.

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"The U.S. approval of the BESREMi Pen is a significant milestone both for our company, as well as the patients we serve," said Samuel Lin, Head of Global Operations, PharmaEssentia. "With this new device, we’re empowering more people living with PV to manage their condition with greater ease and confidence. It reflects our continued commitment to delivering not only innovative therapeutics, but also smarter, more intuitive ways to support long-term care."

"I’m very excited to see the FDA approval of the BESREMi Pen as a new option for patients," said Dr. John Mascarenhas, Director of the Center of Excellence for Blood Cancers and Myeloid Disorders at Mount Sinai in New York City. "Treatment consistency is critical for managing PV, and this device has the potential to make a meaningful positive impact on patients’ lives by simplifying self-administration and supporting better adherence."

(Press release, PharmaEssentia, JUN 26, 2026, View Source [SID1234668975])

On June 26, 2026 FibroBiologics, Inc. (NASDAQ: FBLG) ("FibroBiologics" or the "Company"), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 4,081,633 shares of common stock (or pre-funded warrants in lieu thereof), series A warrants to purchase up to 4,081,633 shares of common stock and short-term series B warrants to purchase up to 4,081,633 shares of common stock at a purchase price of $0.735 per share of common stock (or per pre-funded warrant in lieu thereof) and accompanying warrants in a private placement priced at-the-market under Nasdaq rules. The series A warrants and the short-term series B warrants will have an exercise price of $0.735 per share and will be exercisable on or after the effective date of stockholder approval (the "Stockholder Approval Date") of the issuance of the shares of common stock upon exercise of the warrants (the "Stockholder Approval"). The series A warrants will expire five years from the later of the Stockholder Approval Date and the effective date (the "Effective Date") of the resale registration statement registering the shares of common stock issuable upon exercise of the series warrants, and the short-term series B warrants will expire eighteen months from the later of the Stockholder Approval Date and the Effective Date. The private placement is expected to close on or about June 29, 2026, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds from the offering are expected to be approximately $3.0 million, before deducting placement agent’s fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the series A and series B warrants, if fully exercised on a cash basis, will be approximately $6.0 million. No assurance can be given that any of the series warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the series warrants. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the securities issued in the private placement and shares of common stock underlying the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with investors, the Company has agreed to file a resale registration statement covering the securities described above.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, FibroBiologics, JUN 26, 2026, View Source [SID1234668973])

On June 26, 2026 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its two clinical-stage immunotherapy programs were presented at the New York Academy of Sciences’ Frontiers in Cancer Immunotherapy symposium this week.

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The presentations highlighted Anixa’s breast cancer vaccine, being developed in collaboration with Cleveland Clinic, which recently completed a Phase 1 clinical trial in which all major primary endpoints were met and protocol-defined immune responses were generated in 74% of participants, and Anixa’s ovarian cancer CAR-T therapy, liraltagene autoleucel, or lira-cel, which is being evaluated in an ongoing Phase 1 clinical trial in collaboration with Moffitt Cancer Center.

Both presentations may be accessed on the Events page of Anixa Biosciences’ website: View Source

"Presenting both of our clinical-stage immunotherapy programs at this symposium was an important opportunity to highlight the progress of our pipeline and the strength of the collaborations supporting these programs," said Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "Our breast cancer vaccine and ovarian cancer CAR-T therapy are being advanced with leading clinical and scientific institutions, and we believe these presentations underscore the potential of Anixa’s approach to treating and preventing cancer."

The Company’s breast cancer vaccine presentation, titled "Phase I Trial of an Alpha-Lactalbumin (aLA) Vaccine for Breast Cancer," was given by Dr. Emily Esakov Rhoades, FDA/IND Trial Program Manager, Cleveland Clinic Cancer Institute. The presentation reported final Phase 1 findings for the investigational vaccine, including that all major primary endpoints were met, the vaccine was safe and well tolerated at the maximum tolerated dose based on safety and tolerability, and protocol-defined immune responses were elicited in 74% of trial participants.

The Company’s lira-cel presentation, titled "A Phase I Clinical Trial of an Infusion of Autologous T cells Genetically Engineered with a Chimeric Receptor to Target the Follicle-Stimulating Hormone Receptor in Patients with Recurrent Ovarian Cancer," was given by Dr. Pamela D. Garzone, Chief Development Officer of Anixa Biosciences. The presentation reported the clinical trial design and objectives, as well as the current status of Anixa’s ongoing Phase 1 clinical trial of lira-cel, including survival observations of multiple patients living over one year past treatment.

About Anixa’s Breast Cancer Vaccine
Anixa’s breast cancer vaccine represents a novel approach to the prevention and treatment of breast cancer. The vaccine is based on immunizing against human α-lactalbumin, a protein associated with lactation that is highly expressed in certain types of breast cancer. This "retired" protein vaccine strategy aims to selectively prime the immune system to prevent tumor formation while avoiding harm to normal tissue.

About Lira-cel, Anixa’s CAR-T Therapy for Recurrent Ovarian Cancer
Liraltagene autoleucel, or lira-cel, uniquely targets the follicle-stimulating hormone receptor (FSHR), which is selectively expressed on ovarian and testis cells, tumor vasculature, and certain cancer cells, but not in other healthy tissue. The ongoing Phase 1 trial (ClinicalTrials.gov NCT05316129) is enrolling adult women with recurrent ovarian cancer who are platinum resistant and have progressed after at least two prior therapies.

(Press release, Anixa Biosciences, JUN 26, 2026, View Source [SID1234668972])