On October 7, 2026 Valerio Therapeutics (FR0010095596 – ALVIO), a pioneering biotechnology company in the field of next-generation precision therapies ("Valerio", or the "Company"), reported an update on its operations and presents its financial results for the half-year ended 30 June 2026.

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"The first half of 2026 marked a decisive milestone in the consolidation of our strategic refocusing and in the transformation of Valerio Therapeutics. The operational launch of InVimmune, the strengthening of our partnerships, the signing of the definitive agreement for the acquisition of Etherna and the governance transition demonstrate our ability to implement our roadmap with determination, consistency and discipline. These complementary advances strengthen our positioning and open up new prospects for therapeutic development. We now have a solid foundation on which to accelerate the development of our targeted RNA delivery platform, deepen scientific and operational synergies within the Group, and advance our proprietary programmes towards key milestones that are likely to create sustainable value for our patients, partners and shareholders," said Gilles Besin, Chief Executive Officer of Valerio Therapeutics.

Consolidation of the group’s strategic refocusing

Valerio Therapeutics has continued the strategic refocus initiated in 2025, aimed at positioning the Company as a specialist in the development of RNA-based precision therapies, with a focus on targeted delivery beyond the liver. This consolidation has resulted in several significant milestones.

The Company launched InVimmune, its subsidiary dedicated to the development of differentiated in vivo cell therapy approaches, with a first indication announced in oncology.

As part of a planned governance transition, Gilles Besin took up his position as Chief Executive Officer of the Company on 1 July 2026, succeeding Julien Miara, to lead this new phase of development focused on RNA-based medicines and targeted delivery.

In addition, the Company’s partnership strategy has been strengthened through the conclusion of key partnerships:

– Valerio has entered into a definitive collaboration agreement and an exclusive global licence, providing for an upfront payment of 740,000 euros and an additional payment of 500,000 US dollars upon the signing of the definitive collaboration and licence agreement on 29 May 2026. It also provides for conditional future payments of up to US$200 million, to which sales royalties may be added,

– Valerio has also entered into a binding term sheet with Abivax SA ("Abivax") setting out the key terms of an exclusive global research and development collaboration1. This term sheet provides for an initial payment of up to 2.4 million euros, supplemented – subject, in particular, to the conclusion of the definitive co-ownership and licence agreement and the achievement of the corresponding milestones – by milestone payments and royalties.

The Company also reached a major milestone with the signing, on 24 August 2026, of a definitive share purchase agreement as part of the acquisition of 100% of the share capital and voting rights of Etherna Immunotherapies NV; the integration of this company brings together, within a single platform, proprietary capabilities in V-Body, active targeting, chemistry and bioconjugation, mRNA and lipid nanoparticle technologies, as well as manufacturing capabilities, within a single platform. The general meeting held on 6 October 2026 approved the capital increase in consideration for contributions in kind and the capital increases by way of set-off against certain claims held by lenders and directors of Etherna. The completion of the transaction is scheduled on 8 October.

In August 2026, the Company carried out a capital increase of c. €40.25 million, achieved through the issue of 68,220,333 new shares at a subscription price of €0.59 per share, supported by its existing shareholders and new investors2.

Financial results for the first half of 2026

Turnover: The Group recorded consolidated turnover of €3,102,000 for the period ending 30 June 2026, compared with €126,000 as at 30 June 2025.
Financial result: The financial result as of 30 June 2026 was a loss of €137 000, compared with a loss of €285 000 as of June 30, 2025.
Consolidated net profit: Consequently, the consolidated net result as of 30 June 2026 was a loss of €2 361 000, compared with a loss of €208 000 as of 30 June 2025.
Cash position: The Group’s balance of cash and cash equivalents as at 30 June 2026 stood at €656,000, compared with €1,053,000 as at 31 December 2025. As of the date of the half-year financial report, based on its current operating plan and expenditure forecasts, and taking into account its cash and cash equivalents, the Company estimates that it has sufficient resources to finance its operations and capital expenditure for at least 12 months.
Shareholders General Meeting of 6 October 2026

The shareholders general meeting held on 6 October 2026 approved all the resolutions recommended by the Board of Directors.

The results of the votes will be made available on the Company’s website (View Source).

(Press release, Valerio Therapeutics, OCT 7, 2026, View Source [SID1234673268])

On October 7, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the enrollment of the first patients in a new Signatera-guided trial in melanoma (NCT07504796), sponsored by NYU Langone Health.

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The study uses Signatera to guide treatment escalation for patients with advanced or metastatic melanoma, an aggressive form of skin cancer. The current standard of care for these patients is combination immunotherapy until clinical progression. This trial is designed to identify patients who may need earlier intervention by detecting persistent molecular residual disease (MRD) prior to radiographic progression.

After six weeks of first-line treatment (Nivolumab+Relatlimab), patients who are Signatera-positive without radiographic progression will be randomized into one of two different treatment arms: either continuation of first-line treatment until clinical progression; or intensification of first-line treatment with the addition of Ipilimumab. The primary endpoint is progression-free survival.

"This trial takes a more proactive therapeutic approach from the standard of care, which is to treat with immunotherapy until evidence of radiographic progression," said Janice M. Mehnert, M.D., principal investigator of the study. "By using Signatera to identify patients who do not clear ctDNA early in the treatment regimen, we can act sooner to escalate therapies for those who need it as we aim to improve outcomes."

"We are pleased to collaborate with NYU Langone Health on this important trial in melanoma," said Michael Krainock, M.D., Ph.D., MBA, medical director, oncology, Natera. "By integrating Signatera into the trial design, we hope to improve patient selection for therapy escalation – distinguishing those who may be able to continue their current treatment without disease progression from others who need more intensified therapy. If the results are positive, this could be an important step toward changing clinical practice patterns in how we manage melanoma."

(Press release, Natera, OCT 7, 2026, View Source [SID1234673267])

On October 7, 2026 Tempus (NASDAQ: TEM) reported an expanded, multi-year collaboration to support the potential commercialization of intismeran autogene (V940/mRNA-4157), a novel, potential first-in-class individualized neoantigen therapy (INT) being evaluated in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with completely resected stage IIB-IV melanoma and other cancer types. Intismeran autogene is jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada. The collaboration builds on joint efforts initiated last year and will support preparations for the potential commercialization of intismeran autogene.

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As part of the collaboration, Tempus will manage the timely collection and transfer of tumor tissue and blood samples required for next-generation sequencing (NGS). Subject to applicable regulatory approvals, Tempus will also provide NGS services to support the intismeran autogene design and manufacturing process. Financial terms of the collaboration were not disclosed.

"Bringing an individualized therapy like intismeran autogene from clinical development toward potential commercialization requires a seamless, highly reliable diagnostic network," said Said Francis, Moderna’s Chief Business Officer and General Manager, Individualized Neoantigen Therapies. "Working with Tempus allows us to leverage their commercial footprint and advanced sequencing capabilities as we work to deliver individualized neoantigen therapies to patients at scale."

"What makes individualized neoantigen therapies so exciting is that every treatment is designed around the biology of an individual patient’s tumor. That requires a carefully coordinated end-to-end process, from collecting a patient’s tumor sample and generating sequencing data to designing and manufacturing an individualized therapy," said Jannie Oosthuizen, President, Global Oncology and MSD International. "Collaborations like this one with Tempus are helping build the infrastructure needed to bring this innovative approach to patients."

"Individualized therapies represent the future of precision medicine, but delivering on their promise requires an end-to-end clinical workflow that works in the real world," said Eric Lefkofsky, founder and CEO of Tempus. "By combining our operational scale and deep clinical integration with Merck and Moderna’s mRNA innovation, we are building the infrastructure needed to bring individualized cancer vaccines to patients."

(Press release, Tempus, OCT 7, 2026, View Source [SID1234673266])

On October 7, 2026 Pfizer Inc. (NYSE: PFE) reported that the U.S. Food and Drug Administration (FDA) has approved TUKYSA (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive (HER2+) breast cancer following induction treatment. The approval expands the use of TUKYSA to frontline, an earlier stage of metastatic disease, offering a new chemotherapy-free maintenance treatment option that may help further delay disease progression.

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"Since its first approval in 2020, TUKYSA has become an important treatment for patients with second-line HER2+ metastatic breast cancer. Today’s FDA approval marks the next chapter for TUKYSA, bringing it into the front-line maintenance setting and offering patients a chemotherapy-free option that can help delay disease progression after initial treatment. This approval reflects Pfizer’s commitment to advancing therapies across the breast cancer treatment journey and delivering meaningful new options for people living with metastatic breast cancer."

– Aamir Malik, Executive Vice President, Chief U.S. Commercial Officer, Pfizer

"The treatment landscape for HER2+ metastatic breast cancer has evolved dramatically over the past decade, but many patients still experience disease progression despite initial benefit from therapy. The HER2CLIMB-05 findings support TUKYSA plus trastuzumab and pertuzumab as a chemotherapy-free maintenance strategy that allows us to target HER2-positive tumors from multiple angles and can help prolong disease control."

– Erika Hamilton, M.D., principal investigator of HER2CLIMB-05 and Chief Development Officer, Late Phase & Director, Breast Cancer Research for Sarah Cannon Research Institute (SCRI)

Key Results from the HER2CLIMB-05 Phase 3 Trial

Prolonged Median Progression-Free Survival (PFS): The primary endpoint analysis showed a 35.9% reduction in the risk of disease progression or death among patients treated with TUKYSA, trastuzumab, and pertuzumab compared to those treated with placebo, trastuzumab, and pertuzumab, following induction treatment, as assessed by the investigator (hazard ratio of 0.64, 95% confidence interval (CI): 0.51-0.80; 2-sided p<0.0001). Median investigator-assessed PFS for patients in the TUKYSA arm was 24.9 months (95% CI, 21.3-not reached) compared to 16.3 months (95% CI, 12.6-18.7) in the placebo arm, representing a difference of 8.6 more months that patients lived without their cancer worsening.
Safety Profile: The safety and tolerability of TUKYSA was generally consistent with its known safety profile, with the exception of increased severity of hepatotoxicity. The majority of hepatotoxicity events were generally asymptomatic and reversible with dose modification and/or discontinuation. The most commonly reported adverse events (≥20%) were diarrhea, musculoskeletal pain, hepatotoxicity, nausea, fatigue, rash, and vomiting. Serious adverse reactions in ≥1% of patients included hepatotoxicity (3.9%), including one patient who experienced a fatal adverse reaction of drug-induced liver injury.
Published Previously: Results from HER2CLIMB-05 were published in the Journal of Clinical Oncology and presented at the 2025 San Antonio Breast Cancer Symposium (SABCS).
About the Phase 3 HER2CLIMB-05 Trial

The HER2CLIMB-05 trial is a randomized, double blind, placebo-controlled, pivotal Phase 3 study evaluating the efficacy and safety of TUKYSA compared to placebo, both in combination with trastuzumab and pertuzumab, as maintenance therapy for patients with HER2+ metastatic breast cancer (MBC) following induction therapy in the front-line setting.
HER2 is overexpressed in up to 15-20% of breast cancers and is associated with poor prognosis, with an estimated five-year survival rate of 41% to 47%, depending on hormone receptor status.1-3
Trial participants who completed induction therapy of trastuzumab, pertuzumab, and a taxane, with no evidence of progression, were randomized to receive TUKYSA in combination with trastuzumab plus pertuzumab (n=326) or placebo in combination with trastuzumab plus pertuzumab (n=328).
The primary endpoint is PFS as assessed by the investigator. Overall survival is a key secondary endpoint.
Continuing Pfizer’s Legacy of Leadership in Breast Cancer
Pfizer has been a leader in breast cancer for over 25 years, and today we have five medicines and one biosimilar approved to treat different subtypes of the disease, reaching over 4.9 million patients worldwide.

In the U.S., TUKYSA is already a National Comprehensive Cancer Network (NCCN) Category 1 second-line plus treatment for HER2+ MBC patients. This approval extends the reach of TUKYSA as part of a front-line maintenance regimen, bringing patients a new option to delay disease progression without the need for continued chemotherapy and helping physicians further individualize treatment plans to best meet the needs of each unique patient.

About TUKYSA (tucatinib)
TUKYSA (tucatinib) is an orally administered tyrosine kinase inhibitor of HER2. TUKYSA is approved in combination with trastuzumab and pertuzumab for the maintenance treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment. TUKYSA has also been approved in combination with trastuzumab and capecitabine to treat adults with HER2-positive advanced unresectable or MBC, including patients with brain metastases who have received one or more prior anti-HER2 breast cancer treatments in the metastatic setting.

The full U.S. Prescribing Information for TUKYSA can be found here. There may be a delay as the document is updated with the latest information. It will be available as soon as possible. Please check back for the updated full information shortly.

(Press release, Pfizer, OCT 7, 2026, View Source [SID1234673265])

On October 7, 2026 OncoBayes, a privately held clinical-stage pharmaceutical company, reported the successful completion of preclinical work with OB-001, demonstrating the product’s potential to tackle two major unmet needs in oncology: ADC resistance and the brain penetration of tyrosine kinase inhibitors (TKIs).

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OB-001 is a highly selective and effective inhibitor of two key efflux pumps (P-gp and BCRP), which are present both on the blood-brain barrier and on tumour cells. The product is being developed as a once-daily oral tablet, which will be used in combination with a number of gold standard oncology treatments in order to optimise their efficacy.

In perfused-brain mouse studies, OB-001 pretreatment significantly raised brain exposure of four gold standard kinase inhibitors – whilst systemic (plasma) exposure remained broadly unchanged. Data presented at AACR (Free AACR Whitepaper) 2026 demonstrated that OB-001 could increase the brain exposure of osimertinib by almost 400% with minimal systemic changes[1],[2]. Based on a translational PK-PD-TGI model for osimertinib, this increase is projected to deliver a step-change in CNS progression-free survival for EGFRm NSCLC patients. The improved control of brain metastases is still a major area of unmet need in NSCLC and breast cancer.

The same efflux pumps have also been identified as a key resistance mechanism impacting ADCs – with the over-expression of these pumps leading to reduced payload concentrations in the tumour. Preclinical work using a bidirectional transporter assay demonstrated that OB-001 reduces efflux for several leading payloads, including SN-38 (e.g. sacituzumab govitecan, Trodelvy), DM4 (e.g. mirvetuximab soravtansine, Elahere) and DXd (e.g. trastuzumab deruxtecan, Enhertu).

Plans are currently underway to move into a parallel clinical trial programme to generate POC data in combination with osimertinib, and also evaluate T-DXd re-sensitisation.

"This is a critical milestone for our team, and we are now well positioned to initiate our clinical plans with OB-001" said Jim Millen, Chief Executive Officer for OncoBayes. "OB-001 is on track to become a first-in-class drug with broad potential as a simple, oral adjunct to a range of blockbuster oncology therapies. This is truly a pipeline in a product opportunity."

(Press release, OncoBayes, OCT 7, 2026, View Source [SID1234673264])