On June 22, 2026 RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported the closing of its previously announced private placement for the purchase and sale of an aggregate of 8,571,429 American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), each ADS representing ten thousand (10,000) ordinary shares of the Company, series A-1 warrants to purchase up to an aggregate of 8,571,429 ADSs and series A-2 warrants to purchase up to an aggregate of 8,571,429 ADSs, at a combined purchase price of $0.70 per ADS (or ADS equivalent in lieu thereof) and accompanying warrants. The Series A-1 warrants have an exercise price of $0.86 per ADS, are exercisable immediately and have a term of five years following the Effectiveness Date (as defined below), and the Series A-2 warrants have an exercise price of $0.70 per ADS, are exercisable immediately and have a term of 18 months following the Effectiveness Date.

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The upfront proceeds are expected to strengthen RedHill’s near-term liquidity and support a strategic, transformative, potential acquisition of commercial-stage, revenue-generating pharmaceutical product assets, which, if completed, would significantly expand the Company’s commercial portfolio and revenue base. No definitive acquisition agreement has been executed, and the potential transaction remains subject to various conditions. There can be no assurance that any such transaction will be completed.

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

The gross proceeds to the Company from this offering were approximately $6 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the series A-1 warrants and the series A-2 warrants, if fully exercised on a cash basis, will be approximately $13.4 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 securities described above were 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 ordinary shares of the Company represented by ADSs 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 ordinary shares of the Company represented by ADSs 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 the investors, the Company has agreed to file a resale registration statement covering the securities described above (such date of effectiveness of the resale registration statement, the "Effectiveness Date").

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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, RedHill Biopharma, JUN 22, 2026, View Source [SID1234668879])

On June 22, 2026 Delphi Diagnostics reported the publication of findings from the GEICAM/9906 clinical trial demonstrating that the company’s Endocrine Activity Index (EAI) can identify patients with hormone receptor-positive, HER2-negative (HR+/HER2−) breast cancer who derive meaningful benefit from adjuvant chemotherapy containing weekly paclitaxel.

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The study, published in Clinical Cancer Research, is titled "Sensitivity to endocrine therapy index predicts benefit from weekly adjuvant paclitaxel for hormone receptor-positive breast cancer in the GEICAM/9906 trial," and was conducted by investigators from the GEICAM Spanish Breast Cancer Group and The University of Texas MD Anderson Cancer Center.

This prospective-retrospective analysis independently validated previous findings and further helps to establish EAI as the first genomic assay shown to predict benefit from a contemporary taxane-based chemotherapy regimen in HR+/HER2− breast cancer.

The study evaluated tumor samples and outcomes from patients enrolled in the landmark GEICAM/9906 randomized phase III trial. Investigators found that patients with very low endocrine activity, score of <0.75 as measured by EAI, experienced significantly improved distant recurrence-free outcomes when weekly paclitaxel was added to anthracycline-based chemotherapy. In contrast, patients with higher endocrine activity did not demonstrate additional benefit from paclitaxel treatment.

"This study represents an important milestone for precision oncology and provides independent confirmation that endocrine activity within an HR+/HER2- breast tumor can predict sensitivity to specific chemotherapy approaches," said Federico A. Monzon, MD, Chief Medical Officer at Delphi Diagnostics. "These findings support the potential for EAI to help clinicians personalize treatment decisions and select chemotherapy regimens more likely to benefit individual patients."

The results build upon previous clinical evidence and demonstrate reproducibility across two independent randomized clinical trials. Together, these studies suggest that EAI may provide oncologists with actionable information beyond traditional prognostic tests by helping determine not only whether chemotherapy should be considered, but which chemotherapy strategy is most likely to provide clinical benefit.

"Current genomic assays primarily estimate recurrence risk, but they generally do not predict which specific chemotherapy regimen will be most effective," said Winz Casagrande, Chief Executive Officer, Delphi Diagnostics. "EAI represents a new generation of predictive biomarkers designed to guide treatment selection and help deliver more individualized care for patients with breast cancer."

The GEICAM/9906 analysis showed that approximately 16% of HR+/HER2− tumors exhibited low endocrine activity and were associated with improved outcomes from weekly paclitaxel-containing therapy. The findings support the growing role of biologically informed treatment selection and may help reduce unnecessary exposure to treatments unlikely to provide benefit.

(Press release, Delphi Diagnostics, JUN 22, 2026, View Source [SID1234668881])

On June 22, 2026 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported the initiation of a randomized Phase 1 trial evaluating TG4070, a novel individualized immunotherapy fully designed and developed in-house by Transgene, in combination with nivolumab in the adjuvant treatment of resected non-small cell lung cancer (NSCLC).

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TG4070, Transgene’s second Individualized Neoantigen Therapeutic Vaccine (INTV) candidate, reflects the strategic expansion of the myvac platform. Following TG4050, currently being evaluated in the Phase 2 part of a randomized Phase 1/2 trial in head and neck cancer (NTC4183166), TG4070 supports the expansion of the myvac platform into NSCLC while integrating Transgene’s proprietary AI-driven neoantigen selection and cell line manufacturing capabilities. Like TG4050, it leverages Transgene’s clinically validated Modified Vaccinia Ankara (MVA) viral vector, ensuring technological consistency of the myvac platform.

This integrated proprietary ecosystem strengthens Transgene’s control over critical steps of INTV development, with an optimized manufacturing process, aiming at shortening turnaround time (compared to CEF[3] based production), improving scalability and reproducibility, while potentially accelerating development timelines across multiple indications.

"The initiation of this randomized Phase 1 trial of TG4070 represents an important step in Transgene’s strategy to expand the myvac platform beyond TG4050 in head and neck cancer, into additional early-stage solid tumor indications," said Alessandro Riva, MD, Chairman and Chief Executive Officer of Transgene.

"The program reflects the growing integration of Transgene’s proprietary capabilities across AI-driven neoantigen selection through SNIPER and scalable manufacturing infrastructure designed to support broader platform deployment."

SNIPER: Proprietary AI Platform Enabling High-Precision Neoantigen Selection

To support the development of TG4070 and future myvac-derived candidates, Transgene has developed its own in-house, AI-driven bioinformatics tool, SNIPER (Specific Neoantigen Identification and Prediction of Elicited Response). SNIPER is the central component underpinning the neoantigen selection and design of TG4070.

With its multiple integrated computational models, SNIPER is designed to identify and prioritize highly immunogenic neoantigens through a proprietary scoring framework, including tumor-specific expression and antigen presentation intended to optimize candidate selection and support INTV design.

SNIPER highlights Transgene’s strong capabilities in AI-driven neoantigen selection, empowering robust computational development and enabling the scalable development of myvac-derived candidates across additional oncology indications.

In addition, VacDesignR, fully integrated into the myvac platform, is Transgene’s patented in-house computational design engine that optimizes genetic construct for MVA vectors. This integration streamlines design process and significantly improves production reliability and vector quality – key features to achieving reliable, timely and efficient product supply.

Cell-line optimized manufacturing to support broader development

TG4070 is manufactured using a scalable and transposable cell-line based process designed to support broader deployment of INTV candidates while ensuring reliable vaccine supply. Compared with conventional CEF-based manufacturing, the optimized process enables more efficient and automated production, improved lead times and scalability.

Preclinical data demonstrated comparable performance to CEF-based product, supporting continuity with existing clinical data while significantly enhancing scalability.

This manufacturing evolution supports broader deployment of the myvac platform across additional indications and larger patient populations. Transgene also plans to use cell-line based manufacturing in potential future TG4050 clinical trials. TG4050 is currently being evaluated in Phase 2 in head and neck cancer.

TG4070: Expanding the myvac Platform into resected non-small cell lung cancer

The Phase 1 trial will evaluate the safety and tolerability of TG4070 in combination with nivolumab in resected NSCLC patients after neoadjuvant nivolumab plus chemotherapy (EUCT 2025-520946-31-00).

While a perioperative approach with an immunotherapy-based regimen has reshaped the treatment landscape of early-stage NSCLC, approximately 65% of patients do not achieve a major pathological response[4] and remain at high risk of relapse[5].

"Patients with resected non-small cell lung cancer who do not achieve a major pathological response after neoadjuvant chemo-immunotherapy remain at significant risk of relapse. TG4070 represents a compelling approach in this setting, as individualized neoantigen therapeutic vaccines can induce highly specific and durable anti-tumor immune responses. In combination with an immune checkpoint inhibitor such as nivolumab, this strategy has the potential to further enhance T-cell activity and improve outcomes in this high-risk population," said Nicolas Girard, MD, PhD, Professor of Thoracic Oncology at Curie Institute and Principal Investigator of the TG4070 trial.

Transgene will host a webcast on June 29, 2026, at 3:00 p.m. CET / 9:00 a.m. ET (in English).

During this live event, Transgene’s team, including Alessandro Riva, Chairman and CEO, and Prof. Nicolas Girard, MD, PhD, (Institut Curie), will discuss the expansion of the myvac platform, the medical need for early-stage NSCLC patients and the potential benefit of TG4070 in this indication.

(Press release, Transgene, JUN 22, 2026, View Source [SID1234668817])

On June 22, 2026 Phanes Therapeutics, Inc. (Phanes), a clinical-stage biotech company focused on innovative drug discovery and development in immuno-oncology (IO), reported the completion of enrollment in its Phase 2 study of spevatamig in combination of standard of care chemotherapy for metastatic PDAC in the 1L setting.

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"This marks an important milestone in our mission to advance innovative therapies that help improve outcomes for patients with hard-to-treat cancers," said Ming Wang, PhD, MBA, CEO of Phanes. "PDAC is the first cancer type we are targeting with spevatamig; there is more to come."

Spevatamig is a bispecific antibody targeting CLDN18.2 and CD47 that functions as an innate immunity enhancer (I2E), an emerging class of IO agents. I2Es are expected to activate macrophages and dendritic cells to recognize and destroy cancer cells, providing an alternative immune-stimulating mechanism complementary to immune checkpoint inhibitors (ICIs) to attack tumors, especially "cold tumors" that are less likely to respond to ICIs.

Spevatamig is being evaluated in various GI cancers, including 1L metastatic PDAC, and has been dosed in over 200 patients globally. PDAC is a devastating cancer, and treatment has been largely limited to systemic chemotherapy which only offers a short duration of benefit due to development of resistance and cumulative toxicity. The impact on society is only expected to increase, as incidence of PDAC is rising. Thus, novel approaches capable of producing more durable responses are urgently needed. Although immunotherapies such as agents targeting PD-1/PD-L1 or CTLA-4 have been explored in many PDAC trials, few have demonstrated meaningful therapeutic benefit.

"Spevatamig was discovered in our lab in San Diego; its unique molecular design enables targeting solid tumors without causing significant hematological toxicity, an issue that has been seen with other CD47-targeting agents in the past," said Phanes’ CEO. "We believe our approach can be applied to other tumor types. This could be a new frontier for targeting solid tumors."

ABOUT SPEVATAMIG

Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and was granted Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma in 2024. In 2023, Phanes entered into a clinical collaboration agreement with Merck (known as MSD outside the US and Canada) to study spevatamig in combination with pembrolizumab.

Phanes is conducting clinical trials with spevatamig in multiple cancer indications, including a Phase 2 study evaluating the safety, tolerability and efficacy of spevatamig in combination with chemotherapy in patients with PDAC in the first-line setting. Spevatamig is an innate immunity enhancer (I2E), an emerging class of immuno-oncology (IO) agents. It has the potential to become the first I2E for a solid tumor indication and is combinable with various anti-cancer therapies.

(Press release, Phanes Therapeutics, JUN 22, 2026, View Source [SID1234668883])

On June 22, 2026 Hamlet BioPharma AB (publ) reported the signing of a clinical trial agreement with the University of Iowa, one of the leading U.S. centers for bladder cancer research and therapy. The new study advances the clinical development of Alpha1H, a human breast milk derived treatment for bladder cancer, to include Carcinoma In Situ (CIS); a severe surface-spreading and therapy-resistant form of bladder cancer where patients may need to remove their bladders to avoid systemic disease.

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Professor O’Donnell, a key opinion leader and driver of the international bladder cancer therapy field, has identified a significant unmet medical need among patients with CIS and initiated discussions with Hamlet BioPharma and scientists at Lund University, regarding this clinical expansion of the Alpha1H drug development program. This collaboration follows an extensive scientific and clinical evaluation of Alpha1H by the University of Iowa, including review of published clinical data and the mechanism of action described in peer-reviewed publications.

Bladder cancer is one of the most common urological malignancies worldwide. A substantial proportion of patients experience recurrence following treatment, creating a significant need for new therapies that can reduce recurrence rates and preserve bladder function. The clinical study is planned to be conducted under Hamlet BioPharma’s existing Investigational New Drug (IND) application for Alpha1H in the United States through submission of a new clinical protocol amendment to the U.S. Food and Drug Administration (FDA).

"The signing of this agreement establishes a collaboration with the University of Iowa group, led by Professor O’Donnell, who are pioneers in the field and have defined multiple novel therapies in bladder cancer. Expanding the clinical indications to include CIS allows us to evaluate Alpha1H in a patient population with severe and resistant disease and a substantial unmet medical need," says Catharina Svanborg, Professor at Lund University and Chairman of the Board of Hamlet BioPharma.

"Despite advances in bladder cancer treatment, high recurrence rates remain a major challenge. Many patients with CIS have exhausted all available treatments, without a cure, and are faced with the prospect of bladder removal. Based on our evaluation of Alpha1H and the clinical results generated to date, we believe the Alpha1H treatment warrants further investigation in this patient group. We look forward to working with Hamlet BioPharma and the scientists at Lund University to explore the potential of Alpha1H in patients with treatment resistant CIS," says Michael O’Donnell, Professor and Director of Urologic Oncology at the University of Iowa.

(Press release, HAMLET Pharma, JUN 22, 2026, View Source [SID1234668884])