NodThera Ltd.

Results presented at the American Society of Hematology (ASH) Annual Meeting in December 2025 confirmed the clinical activity of romaciclib (RVU120) in patients with relapsed/refractory acute myeloid leukemia (r/r AML), who have historically poor outcomes following venetoclax-based therapy. In the Phase II RIVER-81 study, complete and incomplete remission rates reached 43% in the 150 mg once-daily cohort, with a favorable safety profile. Romaciclib Phase II POTAMI-61 study in myelofibrosis (MF), which included patients previously exposed or refractory to JAK inhibitors, brought early signals of spleen volume reduction (SVR) and symptom improvement (total symptom score; TSS) without significant myelosuppression. SVR rate of at least 25% (SVR25) was met by 4 out of 14 evaluable patients (29%). At the same time SVR10 was achieved by 7 patients (50%). The Company is progressing research and clinical collaborations with BioNTech, Exelixis, and Menarini Group, as well as strengthening its long-term value drivers with progress in fully owned early pipeline projects. Total operating revenues for the full year 2025 were €20.7 million, compared to €23.7 million for the same period in 2024. EBITDA loss was reduced to €23.2 million, compared to €25.9 million in the previous year. For Q4 alone, those figures were €3.5 million and €8.8 million, respectively. As of March 9, 2026, Ryvu’s cash position was €20.7 million. In addition, Ryvu has secured approximately €20.9 million in non-dilutive grant funding. Krakow, Poland – March 19, 2026 – Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel therapies that address emerging targets in oncology, reports its financials for the 2025 fiscal year and provides a corporate update. Pawel Przewiezlikowski, co-founder and Chief Executive Officer of Ryvu Therapeutics, said: – In 2025, we continued to focus on disciplined execution across our clinical programs while maintaining strict cost control. Our priority remains the efficient advancement of romaciclib (RVU120), for which we presented positive Phase II clinical data demonstrating efficacy in difficult-to-treat hematologic malignancies, including acute myeloid leukemia and myelofibrosis. At the same time, we continued to prepare RVU305 for clinical development and to advance multiple early pipeline programs. Thanks to ongoing partnerships and strategic reorganization implemented in Q1 2025, we are generating stable revenue streams and have significantly reduced operating costs. Importantly, we entered 2026 with new grant funding to support our preclinical discovery and research. Krzysztof Brzozka, Ph.D., Executive Vice President and Chief Scientific Officer, said: – Our discovery and research strategy continues to generate promising opportunities in precision oncology. The ONCO Prime platform remains a key engine of innovation, enabling the identification of novel precision oncology targets, including synthetic lethal approaches, in genetically defined cancers. In parallel, we continue to explore next-generation ADC payloads leveraging both synthetically lethal and immunocytotoxic mechanisms. Together with new projects – such as our PERO project (Predictive Engineering for Rational Oncology), which secured significant grant funding in March 2026 – these initiatives are designed to drive the development of future oncology therapies that address high unmet medical needs. 2025 SUMMARY AND RECENT CORPORATE EVENTS Romaciclib (RVU120) clinical development plan progress Ryvu continued to advance the clinical development of romaciclib (RVU120), a first-in-class selective CDK8/CDK19 inhibitor, across multiple hematologic malignancies. Current data support continued development of romaciclib in AML and MF, including further exploration of combination strategies. Throughout 2025, three Phase II studies continued as planned: RIVER-81 (combination with venetoclax in r/r AML), POTAMI-61 (monotherapy and combination with ruxolitinib in MF), and REMARK (monotherapy in LR-MDS; investigator-initiated trial). Ryvu generated further clinical insights and presented updated clinical data from the RIVER-81 and POTAMI-61 studies at the American Society of Hematology (ASH) Annual Meeting. RIVER-81 The Phase II RIVER-81 study evaluates the combination of romaciclib (RVU120), a selective CDK8/CDK19 inhibitor, with venetoclax (VEN) in unfit patients with r/r AML following frontline VEN plus hypomethylating agent (HMA) therapy, a patient population of high unmet need with no approved therapies. In the cohort testing romaciclib dose of 150 mg QD (once daily) and VEN 400 mg , 3 of 7 treated patients (43%) achieved CR/CRi (CRx) and 2 of 7 patients (28%) achieved CR. Overall, the mean duration of response at 150 mg QD was 141 days.   These data support expansion of the RIVER-81 study and present opportunities for investigation in additional AML settings, including the frontline setting. In January 2026, the U.S. Food and Drug Administration (FDA) held the Type C meeting requested by Ryvu. The FDA raised no objections to opening the expansion cohort in the United States with romaciclib at 150 mg QD in combination with VEN. POTAMI-61 The Phase II POTAMI-61 study evaluates romaciclib as monotherapy and in combination with ruxolitinib (RUX) in patients with MF who have failed or shown suboptimal response to JAK inhibitor therapy. Of the 14 patients evaluable for spleen volume evaluation at 12 weeks or more, 9 achieved spleen volume reduction, with 7 (50%) achieving at least SVR10 and 4 (29%) achieving SVR25 or better. One patient achieved a 59% reduction in spleen volume at week 36. Patients with a high-risk mutation in ASXL1 derived clinical benefit from romaciclib.  Significant and durable TSS improvement was achieved in patients in both cohorts.  These early data indicate that romaciclib is well tolerated and shows initial clinical activity, supporting continued evaluation of romaciclib as a potential therapeutic option for patients with MF. In September 2025, Ryvu announced the initiation of a collaboration with the Children’s Memorial Health Institute as part of the MEDWAY project, an investigator-initiated Phase I clinical study evaluating romaciclib in combination with everolimus in children with recurrent or progressive Group 3 or 4 medulloblastoma. FPFV (First Patient, First Visit) is expected in Q2 2026. Dapolsertib (MEN1703, SEL24): The JASPIS-01 Phase II study evaluates dapolsertib in patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) as a monotherapy and in combination with glofitamab. The first patient was dosed in March 2025. JASPIS-01 is fully funded by the Menarini Group and operationally executed by Ryvu. RVU305: Ryvu continues development of RVU305, its potentially best-in-class brain-permeable, MTA-cooperative PRMT5 inhibitor, which is completing IND/CTA-enabling studies in preparation for clinical development. In October 2025, the Company presented preclinical data on RVU305 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, highlighting its brain-permeable profile and potential in MTAP-deleted cancers. Ryvu continues to advance its dual-pronged preclinical discovery and research strategy, focused on the ONCO Prime platform (novel small-molecule precision medicine, including synthetic lethality targets) and ADCs (antibody-drug conjugates) with novel payloads. Grant funding for the ADCraft project: on April 23, 2025, Ryvu announced signing a grant agreement with the Medical Research Agency (in Polish: Agencja Badań Medycznych, “MRA”) for the “ADCraft – next-generation small-molecule payloads for antibody-drug conjugates in oncology” project. The aim of the Project is to develop methods for discovering and testing a new generation of ADC payloads along with a portfolio of R&D activities focused on new therapeutic modalities used in oncology. The Company expects to receive PLN 9.9 million to support the project of a total net value of PLN 13.2 million. Grant funding for the PERO project: on March 11, 2026, the Company signed the grant agreement with the National Centre for Research and Development (in Polish: Narodowe Centrum Badan I Rozwoju; NCBR) for the PERO (“Predictive Engineering for Rational Oncology”) project. The objective of PERO is to establish an innovative technological platform for the functional validation of structural protein pockets of potential therapeutic targets in oncology. The project addresses a significant technological gap by enabling an in-depth, currently unavailable level of functional target validation based on integrated genomic, structural, and pharmacological data. The funding, PLN 20.0 million of a PLN 32.4 million project, will significantly fund the development of an innovative platform for functional target validation in oncology. Ryvu continues to advance partnerships with Menarini Group, BioNTech, and Exelixis, under which the Company is fully reimbursed for its expenses and has the potential to receive multiple financial milestones. Clinical collaboration with BioNTech: on September 2, 2025, Ryvu announced an expansion of its collaboration with BioNTech. Based on the new agreement, Ryvu supports BioNTech in accelerating site activation and patient enrollment for several of BioNTech’s priority oncology clinical programs in Poland, including indications such as lung, breast, and colorectal cancers. Extension of the research collaboration with BioNTech: on March 16, 2026, Ryvu informed about amending its research collaboration option exclusive license agreement with BioNTech, originally disclosed in November 2022. Under the amendment, the parties agreed to extend its research collaboration by an additional period of one year – until November 2028. KEY UPCOMING INDUSTRY AND INVESTOR EVENTS Ryvu will host partnering and investor meetings at all of the below conferences, with scientific presentations where noted: BIO-Europe Spring (Lisbon, Portugal), March 23-25 LSX World Congress (Lisbon, Portugal), March 24-25 AACR Annual Congress (San Diego, CA), April 17-22: Data to be presented on the ONCO Prime platform BIO Equity Europe (Prague, Czech Republic), May 4-6 ASCO Annual Meeting (Chicago, IL), May 29 to June 2 EHA Annual Congress (Stockholm, Sweden), June 12-15 BIO International Convention (San Diego, CA), June 22-25 2025 FISCAL YEAR FINANCIAL UPDATE Cash Position – On December 31, 2025, Ryvu Therapeutics held €25.5 million in cash, cash equivalents, and investment funds, compared to €52.7 million at the end of 2024. On March 9, 2026, the Company held €20.7 million in cash, cash equivalents and investment funds. In addition, Ryvu has secured approximately €20.9 million in non-dilutive grant funding. Operating Revenues – In 2025, Ryvu recognized total operating revenues (including grants) of €20.7 million, compared to €23.7 million in 2024. Operating costs, related primarily to research and development expenditures, excluding the valuation of NodThera shares and the non-cash cost of valuation of the Incentive Program for 2025, amounted to €43.0 million, compared to €51.1 million in 2024. EBITDA result – EBITDA loss for full-year 2025 was reduced to €23.2 million, compared to €25.9 million in the previous year. EBITDA loss in Q4 2025 was €3.5 million, compared to €8.8 million in the previous year. Net Loss Attributable to Common Shareholders – In 2025, the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program, amounted to €23.2 million, compared to €24.9 million in the previous year. RYVU Therapeutics Leona Henryka Sternbacha 2 30-394 Kraków, Poland

J&J's subcutaneous Darzalex nabs another MM approvalUK biotech VC deals post strong 2025 showingEpidarex raises $145M to fuel early UK-US life science betsTox finding scuttles Phase I study of AstraZeneca heart drugTRexBio raises $50M to fund tissue-targeted Treg therapiesJ&J's subcutaneous Darzalex nabs another MM approvalThe FDA on Tuesday approved Johnson & Johnson's Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant. The regulatory clearance was based on findings from the Phase III CEPHEUS study, which showed that at a median follow-up of 22 months, patients with MM who received the combination saw an overall negativity rate for minimal residual disease (MRD) of 52.3%, compared with 34.8% for those taking VRd alone. The FDA OK marks Darzalex Faspro's twelfth indication overall, and its fifth in newly diagnosed MM. Last year, the drug was approved in the US and EU for adults with high-risk smouldering MM (see – Spotlight On: J&J's fastest growing drugs).UK biotech VC deals post strong 2025 showing A report from the BioIndustry Association (BIA) suggests that the UK ended 2025 with "clear signs" of renewed momentum and increased investor confidence. The analysis showed that the UK retained its position as Europe's leading national biotech market, representing 30% of all venture financing in the region, despite a 13.2% year‑on‑year drop in venture capital investment, totalling nearly £1.8 billion ($2.5 billion) across 58 deals.The report indicated that despite the start of 2025 being characterised by investor caution, the final quarter delivered a positive shift, with 22 completed deals. In terms of figures, almost 47% of total capital raised last year came from two transactions in the first quarter — Isomorphic Labs and Verdiva Bio — with average deal size rising to £30.8 million, from £18.7 million in 2024."If 2024 was marked by a rebound, 2025 has been a year of caution and strategic maturation," said Jane Wall, managing director of BIA, although she cautioned that "the geopolitical landscape is precarious and the IPO window is entering its fifth year of restricted activity."Epidarex raises $145M to fuel early UK-US life science betsEpidarex Capital has secured more than $145 million in a first close of its fourth fund, as the transatlantic life science venture firm doubles down on company creation and early-stage investing across the UK and US."We believe that the next three years represent a highly attractive window for investing in a new wave of biotech innovation," said managing partner Sinclair Dunlop. Backers include the British Business Bank, Strathclyde Pension Fund, the Scottish National Investment Bank and other international investors.Fund IV will support up to 15 therapeutic and medical device startups built around "breakthrough science" in areas including cardiometabolic, autoimmune and neurological diseases, as well as oncology. The firm said its "strategy is to lead early-stage financings, bridging the equity funding gap to build globally leading companies at scale."Its portfolio includes Apellis Pharmaceuticals, Enterprise Therapeutics, Harpoon Medical, Kynos Therapeutics and Nodthera. Epidarex last raised capital in 2020, closing its third fund at £102.1 million ($141 million).Tox finding scuttles Phase I study of AstraZeneca heart drugAstraZeneca has terminated a Phase I trial of AZD0233, an oral small molecule targeting the CX3CR1 receptor for dilated cardiomyopathy, according to an update posted on ClinicalTrials.gov this week. The first-in-human trial, which enrolled 84 healthy volunteers, was stopped after an "adverse finding in a non-clinical, chronic toxicology study."AZD0233 was positioned as a possible immune-modulating approach to heart failure, aiming to reduce inflammatory cell infiltration in cardiac tissue by selectively targeting CX3CR1, a transmembrane receptor found on certain leukocytes, including monocytes, T cells and NK cellsThe programme entered the clinic in April 2024. Preclinical data published last November in Circulation suggested that modulating CX3CR1 has cardiac protective effects, improving cardiac function in a mouse model of dilated cardiomyopathy.TRexBio raises $50M to fund tissue-targeted Treg therapiesTRex Bio closed a $50-million financing the biotech will use to advance its clinical and preclinical programmes, led by the purpose-engineered TNFR2 agonist TRB-061. The candidate, which is currently in a Phase Ia/b study for atopic dermatitis, is designed to selectively activate regulatory T-cells (Tregs) in inflammatory diseases affecting skin and other barrier tissues. The funding round included new investors Janus Henderson Investors, Balyasny Asset Management and Affinity Asset Advisors, as well as existing backers such as Alexandria Venture Investments, Avego BioScience Capital, Delos Capital, Eli Lilly, Johnson & Johnson Innovation, Pfizer Ventures, Polaris Partners and SV Health Investors.  TRexBio's pipeline also includes TRB-071 and TRB-081, designed to address a range of inflammatory and autoimmune conditions, with Phase I studies expected to start in 2027. The company's programmes have emerged from its Deep Biology Platform, which maps human tissue Treg behaviour to disease processes to identify and characterise novel targets.Anna Bratulic and Elizabeth Eaton contributed to this report.

Today, a brief rundown of news from Halozyme Therapeutics and Cytokinetics, as well as updates from Boehringer Ingelheim, GSK and Epidarex Capital that you may have missed.Alongside an announcement about its financial guidance, Halozyme Therapeutics on Wednesday revealed that it acquired privately held drug delivery specialist Surf Bio. Halozyme is paying $300 million upfront and potentially $400 million overall for Surf, which has a technology that enables multiple drug types to be quickly delivered via high-concentration, subcutaneous injections. That technology is being used across a wide range of therapeutic areas, Halozyme said. The deal should enhance the company's long-term growth prospects, wrote Leerink Partners analyst David Risinger. Ben FidlerCytokinetics on Tuesday officially launched in the U.S. its drug Myqorzo for people with symptomatic obstructive hypertrophic cardiomyopathy, an inherited form of heart failure. Myqorzo, which was approved by regulators last month, will compete for market share with Bristol Myers Squibbs Camzyos, a similar type of medicine that was on track to top $1 billion in sales last year. At a conference earlier this month, Cytokinetics revealed Myqorzo will have a yearly per-patient list price of $108,400. That price equates to parity-slight-pluscompared to Camzyos, as the company is not so much competing on price, but on the clinical and physician patient experience,CEO Robert Blum said at the meeting. A yearly supply of Camzyos has a current wholesale acquisition cost of about $104,800. Ben FidlerBoehringer Ingelheim grabbed partial rights to an experimental inflammatory bowel disease drug discovered by Nanjing, China-based Simcere Pharmaceutical Group. The companies didnt specify in a Tuesday statement how much Boehringer is paying in guaranteed upfront cash, but Simcere could receive a total of about 1.06 billion euros, or $1.27 billion, in payouts if the drug hits a variety of targets. Simceres drug is a bispecific antibody aimed at TL1A and IL-23, both well-known targets in IBD. Startup Caldera Therapeutics is pursuing a similar strategy via a licensing deal with a different Chinese drugmaker. Ben FidlerThe European Commission on Monday broadened use of GSKs RSV vaccine, clearing the shot for use in adults aged 18 and older. In Europe, the shot, known as Arexvy, was previously only allowed in adults aged 60 years and older, as well as in people between 50 and 59 who are at high risk of severe disease. The new approval adds to an edge for Arexvy, which has had a dominant market presence over rival shots from Pfizer and Moderna.GSK is working to widen use in other areas, including Japan and the U.S. Delilah AlvaradoEpidarex Capital, a life sciences venture firm, announced Tuesday it closed $145 million in funding to build drug or medical device startups from research in the U.S. and U.K. The investor, which previously backed companies like Apellis Pharmaceuticals and NodThera, plans to lead early-stage financings and distribute the capital among as many as 15 startups. Its backers include British Business Bank, Strathclyde Pension Fund and the Scottish National Investment Bank. Gwendolyn Wu '