- Romaciclib in relapsed or refractory acute myeloid leukemia: On August 26, Ryvu dosed the first patient in the expansion cohort of approximately 30 patients with r/r AML in the RIVER-81 Phase II study, to confirm the efficacy observed with the 150 mg once daily (QD) romaciclib + 400 mg QD venetoclax (VEN) dose combination.
- Romaciclib in medulloblastoma: In August, The Children's Memorial Health Institute (IPCZD) launched the MEDWAY study – a Phase I investigator-initiated study evaluating romaciclib in combination with everolimus in pediatric medulloblastoma.
- Dapolsertib in myelofibrosis: On July 22, Ryvu concluded an amendment to its global license agreement with Menarini Group to expand dapolsertib's clinical development into a new Phase II study, which will investigate dapolsertib primarily as monotherapy in myelofibrosis (SPHENE-01).
- Approximately PLN 150 million (approx. €35 million) of new early pipeline grant funding: Ryvu continued to secure non-dilutive funding for its discovery platforms. The PANACEA-NOVO (PLN 106.7 million / approx. €25.1 million) and DUALIS (PLN 22.2 million / approx. €5 million) projects were recommended for grant funding in August and September, respectively, following the PLN 20.0 million (approx. €4.7 million) PERO grant agreement concluded in March.
- Keelira launch: On August 18, Ryvu launched Keelira, a dedicated early clinical development services business providing biotech and pharma companies with integrated support for oncology programs across European markets. Keelira commercializes the Company's clinical development expertise and is intended to generate a complementary revenue stream for Ryvu, while Ryvu's strategic priority remains the advancement of its own oncology pipeline.
- Total operating revenues in H1 2026 amounted to €9.1 million, compared to €10.1 million in H1 2025. Driven by a deliberate concentration of resources on the highest-value programs and continued cost discipline, operating costs fell to €15.9 million from €22.6 million and the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program, narrowed to €6.0 million from €13.5 million in H1 2025.
KRAKOW, Poland, September 18, 2026 / Biotech Newswire / -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel therapies that address emerging targets in oncology, today reported financial results for the half year ended June 30, 2026, and provided a corporate update.
Pawel Przewiezlikowski, co-founder and Chief Executive Officer of Ryvu Therapeutics, said: "H1 2026 was a period of decisions for romaciclib –and the coming months will be the decisive ones. The data we presented at EHA 2026 reinforced our confidence in the drug's activity in relapsed/refractory AML and led us to concentrate our resources on romaciclib's development in the AML pathway. As a result, in August we dosed the first patient in the RIVER-81 expansion cohort under the study protocol updated in line with regulatory guidance. At the same time, we strengthened our footprint in myelofibrosis by expanding dapolsertib's development with Menarini into this indication. Beyond the pipeline, the launch of Keelira opens up a capital-efficient revenue stream built on already-proven capabilities we developed while running our own clinical programs. Together with record-high grant support for our early-stage platforms, these steps put us in a stronger position entering the most important stretch in the Company's development."
Krzysztof Brzozka, Ph.D., Executive Vice President and Chief Scientific Officer, said: "Our early pipeline delivered important milestones in H1 2026. Most notably, RVU305 — a potentially best-in-class, oral, brain-penetrant, MTA-cooperative PRMT5 inhibitor – completed GLP toxicology in two species with a favorable safety profile and has GMP clinical material manufactured. The ONCO Prime platform generated new synthetic lethal target discoveries in colorectal cancer, presented at the AACR Annual Meeting and the CRISPR MEDiCiNE Conference, while our first-in-class ADC payload program RVU602 led to tumor regressions in vivo. The recommendation of PANACEA-NOVO and DUALIS for grant funding further validates our discovery strategy and provides additional non-dilutive support to advance multiple new programs."
H1 2026 SUMMARY AND RECENT CORPORATE EVENTS
Romaciclib (RVU120) clinical development plan progress
RIVER-81 study progress: Ryvu continued to advance the clinical development of romaciclib, a first-in-class selective CDK8/CDK19 inhibitor, prioritizing its development in relapsed or refractory acute myeloid leukemia (r/r AML), the indication with the greatest unmet medical need and the most compelling clinical data generated to date.
- Data update at EHA 2026: At the European Hematology Association (EHA) Congress (June 11–14, Stockholm, Sweden), Ryvu presented longer follow-up data from the RIVER-81 Phase II study. At the recommended 150 mg QD romaciclib + 400 mg QD venetoclax dose, the composite CR/CRi rate was 43% (3/7), including two complete remissions (CR) and one CR without full hematologic recovery (CRi). Across other dose levels, 6 additional CRh/CRi responses were reported among 51 treated patients. The mean duration of response of the CRs was 156 days (data cut-off: May 12, 2026).
- IND reactivation by FDA: On January 13, the FDA held a Type C meeting requested by Ryvu and raised no objections to opening a U.S. expansion cohort with romaciclib 150 mg QD in combination with venetoclax, while providing guidance on dose optimization and future registrational study design. Following completion of the required regulatory steps, the FDA reactivated the IND for the RIVER-81 study on May 28, 2026.
- First patient dosed in the dose-expansion cohort: Ryvu decided to expand RIVER-81 by approximately 30 additional r/r AML patients to confirm the efficacy observed at the 150 mg QD romaciclib + 400 mg QD venetoclax (VEN) dose combination. The updated protocol was approved in Europe through CTIS on July 31, and the first patient in the expansion cohort was dosed on August 26. The study is supported by a PLN 62.3 million (approx. €14.7 million) grant from the Polish Medical Research Agency (ABM).
POTAMI-61 study enrollment discontinuation: Following completion of Part A (23 patients) and initial enrollment in Part B (5 patients), the Management Board decided not to proceed with further enrollment, closing the POTAMI-61 Phase II study in myelofibrosis. Romaciclib demonstrated a favorable safety profile and encouraging spleen volume reductions and hematologic tolerability, as also reported at EHA 2026. Eight patients who continued to derive clinical benefit were transferred into the ROVER-01 rollover study. Ryvu retains the option to resume a modified MF development program.
MEDWAY study launched: The investigator-initiated Phase I study evaluating romaciclib in combination with everolimus in pediatric medulloblastoma, sponsored by the Children's Memorial Health Institute (IPCZD) under an approximately PLN 40 million (approx. €9.4 million) grant from the ABM, was launched in August 2026.
Dapolsertib (MEN1703, SEL24)
The Phase II JASPIS-01 study, evaluating dapolsertib as a monotherapy and in combination with glofitamab in relapsed/refractory diffuse large B-cell lymphoma (DLBCL), continued to enroll patients in Poland, France, Spain, and the United Kingdom. A Trial-in-Progress poster presented at the ASH Annual Meeting in December 2025 reported 11 patients enrolled. JASPIS-01 remains fully funded by Menarini Group, with Ryvu acting as operational partner.
New Phase II SPHENE-01 study: On July 22, Ryvu concluded an amendment to its global license agreement with Menarini Group to expand dapolsertib's clinical development into a new Phase II study in myelofibrosis (MF), based on preclinical data indicating activity in MF models. Ryvu will act as study sponsor and operational lead, with Menarini funding all study activities and fully reimbursing Ryvu's costs. SPHENE-01 will evaluate dapolsertib primarily as monotherapy and is expected to be conducted in Europe, with initiation planned for Q1 2027.
RVU305
RVU305, a potentially best-in-class, oral, brain-penetrant, MTA-cooperative PRMT5 inhibitor targeting MTAP-deleted cancers, achieved key preclinical milestones in H1 2026. Non-clinical GLP toxicology studies were completed in two species with a favorable safety profile, informing the calculation of the first-in-human starting dose. In parallel, synthesis of a GMP batch and manufacturing of the clinical drug product were completed. With the GLP toxicology package, GMP drug substance and clinical drug product all in place, RVU305 is now CTA-ready: Ryvu is finalizing the Clinical Trial Application dossier, with submission dependent on securing a development partnership.
ONCO Prime and ADC discovery platforms
During H1 2026, Ryvu advanced multiple ONCO Prime programs, delivering new target discoveries in colorectal cancer and progressing the corresponding drug discovery efforts. In parallel, novel targets were further characterized under the PERO program using a base-editing tiling approach that identified functional pockets in targets with first-in-class potential. Recent progress was presented in April at the AACR Annual Meeting (San Diego, US) and the 3rd CRISPR MEDiCiNE Conference (Copenhagen, Denmark).
Under the ADCraft project (co-financed by the Medical Research Agency from KPO funds), Ryvu developed a methodological cascade for the selection and optimization of novel ADC payloads, obtaining a conjugate with sub-nanomolar cellular activity and a profile differentiated from the market-dominant DXd and MMAE payload classes, targeting a novel, undisclosed biological target with no direct market competition. Work continued from the Company's own resources, with further-generation payloads demonstrating high antitumor activity in vitro and tumor regressions in vivo. These results form the basis for the work towards the selection of a lead payload candidate and novel ADCs.
Extension of the research collaboration with BioNTech: On March 16, Ryvu reported that it amended its research collaboration and exclusive license option agreement with BioNTech, originally disclosed in November 2022, extending the collaboration by one year, until November 2028. Multiple research initiatives are underway as part of the broader BioNTech multi-target research collaboration and the separate clinical collaboration supporting site activation and patient enrollment for BioNTech's oncology programs in Poland.
Keelira launch: On August 18, Ryvu launched Keelira, a dedicated early clinical development services business providing biotech and pharma companies with integrated support for clinical programs across European markets, from preparation for clinical entry through Phase I and Phase II, with a particular focus on oncology, hemato-oncology, and rare oncology indications. Keelira's service model combines Clinical Execution, Strategic Advisory, and Central Lab services, built on operating capabilities developed to support Ryvu's own pipeline and already applied in its external clinical collaborations. Keelira operates within Ryvu under a dedicated operating model, quality management system, and governance rules for external clients, and is led by Kamil Sitarz, Ryvu’s Vice-President of the Management Board and Chief Operating Officer, who serves as Keelira's General Manager. Keelira is intended to develop a complementary revenue stream for Ryvu, while Ryvu's strategic priority remains the development of its own oncology pipeline.
Approximately PLN 150 million (approx. €35 million) of new non-dilutive funding in 2026: Ryvu continued to strengthen its discovery platforms with grant funding during and after the reporting period:
- PERO: On March 11, 2026, Ryvu concluded a grant agreement with the National Centre for Research and Development (NCBR) for the PERO project (functional validation of therapeutic target protein pockets in oncology), with a total net project value of PLN 32.4 million (approx. €7.6 million) and recommended funding of PLN 20.0 million (approx. €4.7 million) over a planned 51-month duration.
- PANACEA-NOVO: On August 10, 2026, following a successful appeal, NCBR included Ryvu's PANACEA-NOVO project (a technology platform for discovery and validation of novel therapeutic targets for rare cancers) on the ranked list recommended for funding, with a total net project value of PLN 134.6 million (approx. €31.7 million) and funding of PLN 106.7 million (approx. €25.1 million) over a planned 58-month duration.
- DUALIS: On September 7, 2026, the Polish Agency for Enterprise Development (PARP) placed Ryvu's DUALIS project (a platform for discovery of next-generation bivalent ADC payloads) on the ranked list recommended for funding under the SMART Path call, with a total net project value of PLN 30.9 million (approx. €7.3 million) and recommended funding of PLN 22.2 million (approx. €5.2 million) over a planned 54-month duration.
KEY UPCOMING INDUSTRY AND INVESTOR EVENTS
Ryvu will host partnering and investor meetings at all of the below conferences:
- China Great Bay ADC & Antibody Forum (Guangzhou, China), Sept 22-23
- Drug Discovery Innovation Programme (DDIP) Europe 2026 (Basel, Switzerland), Sept 29
- 2026 European Society for Medical Oncology (ESMO) Congress (Madrid, Spain), Oct 23-27
- BioCentury-BayHelix China Healthcare Summit (Shanghai, China), Nov 2-4
- ADC Payload Summit (Boston, US), Nov 3-4
- BIO-Europe 2026 (Cologne, Germany), Nov 9-11
- 2026 EORTC-NCI-AACR (ENA) Symposium (Barcelona, Spain), Nov 18-20
- 2026 American Society of Hematology (ASH) Annual Meeting (New Orleans, US), Dec 12-15
H1 2026 FINANCIAL UPDATE
Cash Position – On June 30, 2026, Ryvu Therapeutics held €17.4 million in cash, cash equivalents, bonds, and investment funds, compared to €25.5 million on December 31, 2025. As of September 10, 2026, the Company held €14.4 million in cash, cash equivalents, bonds, and investment funds. In addition, the Company had approximately €17.0 million (PLN 73.3 million) of non-dilutive funding secured under signed grant agreements. This amount excludes the PANACEA-NOVO and DUALIS projects (approx. €30.3 million combined), which have been recommended for funding but for which grant agreements have not been signed.
Operating Revenues – In H1 2026, Ryvu recognized total operating revenues (including grants) of €9.1 million, compared to €10.1 million in H1 2025.
Operating Costs – related primarily to research and development expenditures, excluding the valuation of NodThera shares and non-cash cost of valuation of the Incentive Program, amounted to €15.9 million in H1 2026, compared to €22.6 million in H1 2025.
EBITDA result – EBITDA loss in H1 2026 was €5.8 million, compared to €14.4 million in H1 2025.
Net Loss Attributable to Common Shareholders – In H1 2026, the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program, amounted to €6.0 million, compared to €13.5 million in H1 2025.
AI Semantic Keywords: Acute Myeloid Leukemia; Myelofibrosis; Diffuse Large B-Cell Lymphoma; Romaciclib; dapolsertib; glofitamab; RVU305; PRMT5; MTAP-deleted cancers; ONCO Prime; POTAMI-61; JASPIS-01; Phase II; monotherapy; relapsed/refractory diffuse large B-cell lymphoma; MTA-cooperative PRMT5 inhibitor; oral; brain-penetrant; BioNTech; research collaboration; Ryvu Therapeutics; Keelira; capital-efficient revenue stream; non-dilutive funding; PLN 150 million; €35 million; 2026 Half-Year Financial Results; grant support; AML pathway; drug development; cancer therapeutics
About Ryvu Therapeutics
Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel oncology therapies that address emerging targets in oncology. Internally discovered pipeline candidates at Ryvu use diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules and antibody-drug conjugates directed at kinases, synthetic lethality, and immuno-oncology targets.
Ryvu's most advanced program is romaciclib (RVU120, SEL120), a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies and solid tumors. Romaciclib is currently in Phase II development in combination with venetoclax for the treatment of patients with r/r AML – the RIVER-81 study – and is also being evaluated in an investigator-initiated Phase I study in pediatric medulloblastoma – the MEDWAY study. Dapolsertib (MEN1703, SEL24) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently being investigated in a Phase II study in diffuse large B-cell lymphoma (DLBCL) – the JASPIS-01 study – with a further Phase II study in myelofibrosis (SPHENE-01) planned to start in Q1 2027. RVU305, a potentially best-in-class, brain-permeable PRMT5 inhibitor aiming to treat multiple solid tumors, has completed IND/CTA-enabling studies. Ryvu Therapeutics is also engaged in oncology collaborations with BioNTech and Exelixis, and offers dedicated early clinical development services to biotech and pharma partners through its Keelira business.
Ryvu was founded in 2007 and is headquartered in Kraków, Poland. It is listed on the Warsaw Stock Exchange and is a component of the sWIG80 index.
Contact
Ryvu Therapeutics
Anna Wilk
+48 532 698 425
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Source: Biotech Newswire