- Cash runway is extended from Q1 to H2 2026 with approximately €46 million (PLN 192 million) in cash and other financial assets held by Ryvu as of February 23, 2025. In addition, the company has secured approximately €22 million (PLN 91 million) in non-dilutive grant funding.
- Ryvu’s workforce will be reduced by approximately 30%.
- Three Phase II RVU120 studies are in progress as planned: RIVER-81 (combination with venetoclax in AML), POTAMI-61 (monotherapy/combination with ruxolitinib in myelofibrosis), and REMARK (monotherapy in LR-MDS).
- The Phase II RIVER-52 study of RVU120 monotherapy in patients with AML or HR-MDS, will not enroll new patients to focus investment on the other RVU120 development paths.
- The next data update for RVU120 is planned in Q2 2025.
- The Company will hold an investor webinar at 10:15 am CET today, February 25.
Krakow, Poland – February 25, 2025 – Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel oncology therapies that address emerging targets in oncology, announced a strategic reorganization that will extend Ryvu’s cash runway to H2 2026 to focus on driving the RVU120 clinical program and the early pipeline to key data inflection points.
Paweł Przewięźlikowski, Chief Executive Officer and the largest shareholder of Ryvu said:
“We remain focused on advancing our first-in-class clinical blood cancer program RVU120, as well as promising early-stage assets. Considering our cash position, revenue projections, cost structure and the demanding market environment, we decided to optimize expenses so that the company has sufficient cash runway to generate key data for RVU120 and the preclinical pipeline, expecting that our achievements over the next year will support future cash inflows.”
Pipeline Focus in 2025-2026
Ryvu continues to pursue its mission of delivering efficacious medicines to cancer patients and, accordingly, will continue to focus on first-in-class and best-in-class novel therapeutics that have the potential to help patients and deliver value to shareholders.
RVU120: emphasis on rapid study enrollment and quality data generation in 2025
- Three Phase II studies of RVU120 are in progress as planned: RIVER-81 (combination study with venetoclax in patients with AML), POTAMI-61 (monotherapy/combination study with ruxolitinib in patients with myelofibrosis) and REMARK (monotherapy study in patients with LR-MDS).
- The Phase II RIVER-52 study of RVU120 monotherapy in patients with AML or HR-MDS, will not enroll new patients to focus investment on the other RVU120 development paths. Currently enrolled patients will continue to receive treatment per protocol.
- The decision to progress RIVER-81 and suspend enrollment in RIVER-52 was based on data analysis and feedback from advisory boards in February 2025.
- The next data update for RVU120 is planned in Q2 2025.
RVU305: IND/CTA-enabling studies are ongoing and planned to be completed in H2 2025.
Preclinical discovery and research: Ryvu will pursue a dual-pronged strategy, each of which has the potential to generate multiple oncology medicines.
- ONCO Prime – novel small molecule precision medicine: as part of its proprietary ONCO Prime platform, Ryvu will continue to advance several novel precision oncology targets, including synthetic lethality targets. ONCO Prime combines data from patient-derived cells and isogenic cell lines to discover first-in-class oncology targets in defined patient populations. ONCO Prime is supported by a grant of approximately PLN 26 million from the Polish Agency for Enterprise Development.
- ADCs (antibody-drug conjugates) with novel payloads: Ryvu will continue to develop ADCs with next-generation novel payloads, including synthetically lethal and immunomodulatory mechanisms. Ryvu will work on novel ADCs internally and through the existing collaboration with Exelixis (STING-based ADCs). The WRN program, which previously was focused on standalone development, will be developed as a novel ADC payload to differentiate on efficacy, resistance profile and safety versus competitors. Ryvu’s ADC research and development will also be supported by grant funding totaling approximately PLN 13 million.
Ryvu continues to advance three key biopharma partnerships; in each of these partnerships, Ryvu is fully reimbursed for its expenses and has the potential to earn multiple financial milestones:
- Menarini: On behalf of and in partnership with Menarini, Ryvu is conducting the Phase II JASPIS-01 study of dapolsertib (MEN1703, SEL24) in patients with diffuse large B-cell lymphoma (DLBCL). Dapolsertib is a PIM/FLT3 inhibitor discovered by Ryvu and licensed to Menarini.
- BioNTech: BioNTech and Ryvu continue their multi-target research collaboration on undisclosed targets within the small molecule immune-modulatory field.
- Exelixis: Exelixis and Ryvu are working collaboratively to advance novel ADCs with STING payloads licensed from Ryvu.
Operational Reorganization and Cash Position
To focus on achieving meaningful catalysts, Ryvu is extending its cash runway from Q1 to H2 2026. As part of the pipeline focus outlined above, Ryvu is reducing its current workforce by approximately 30%. After these reductions, Ryvu will employ approximately 200 colleagues. Ryvu is dedicated to providing affected employees with support during this reorganization. With this cash runway, Ryvu expects to deliver key clinical data on RVU120 and progress in the preclinical pipeline that could potentially support partnering or internal development.
As of February 23, 2025 Ryvu held approximately €46 million (PLN 192 million) in cash and other financial assets. In addition, the company has secured approximately €22 million (PLN 91 million) in non-dilutive grant funding.
Investor Webinar
Ryvu management will host a webinar today, February 25, at 10:15 am CET. The webinar can be accessed at the following link: https://ryvu.clickmeeting.com/investor-meeting