Ryvu Therapeutics announces strategic reorganization to extend the cash runway for the development of RVU120 and the preclinical pipeline

• 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, Feb. 25, 2025 /PRNewswire/ -- 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

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 RVU120, a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies and solid tumors. RVU120 is currently in Phase II development (i) as a monotherapy for the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS) – the RIVER-52 study, (ii) in combination with venetoclax for the treatment of patients with r/r AML – the RIVER-81 study, (iii) as a monotherapy for the treatment of patients with lower-risk myelodysplastic syndromes (LR-MDS) – the REMARK study, (iv) as a monotherapy and in combination with ruxolitinib for the treatment of patients with myelofibrosis (MF) – the POTAMI-61 study. Dapolsertib (MEN1703, SEL24) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group that is expected to start a Phase II study in diffuse large B-cell lymphoma (DLBCL) - the JASPIS-01 study in 1Q25. RVU305, a potentially best-in-class PRMT5 inhibitor aiming to treat multiple solid tumors, is currently in IND/CTA-enabling studies. Ryvu Therapeutics is also engaged in oncology collaborations with BioNTech and Exelixis. 
The company was founded in 2007 and is headquartered in Kraków, Poland. Ryvu is listed on the Warsa Stock Exchange and is a component of the mWIG40 index.

For more information, please visit www.ryvu.com

SOURCE Ryvu Therapeutics