Ryvu Therapeutics extends cashflow to consolidate pipeline

“We remain focused on advancing our first-in-class clinical blood cancer program RVU120, as well as promising early-stage assets”, Paweł Przewięźlikowski, Chief Executive Officer of Ryvu told European Biotechnology. “Considering our cash position, revenue projections, cost structure and the demanding market environment, we decided to optimise 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.”

Cash runway will be extended from Q1 to H2 2026 to boost three clinical Phase II studies with its  selective CDK8/CDK19 kinase inhibitor RVU120. This will be achieved by reducing the staff by approximately 30% and stopping recruitment for the Phase II RIVER-52 study of RVU120 monotherapy in patients with AML or HR-MDS. Cash runaway as of yesterday was approximately €46m in cash and other financial assets held by Ryvu. In addition, the company has secured approximately €22m in non-dilutive grant funding.

“We are also continuing two directions of our early pipeline – small molecules, including RVU305 and ADCs, but with a reduced headcount”, said Przewięźlikowski.

The new pipeline focus in 2025-2026 is that  Ryvu will continue to focus on efficient and profitable first-in-class and best-in-class  therapeutics and accelerate Phase II development of its key asset  RVU120 with three studies:  RIVER-81 (plus 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 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. Furthermore, IND/CTA-enabling studies for RVU305 are ongoing and planned to be completed in H2 2025. In preclinical discovery and research, Ryvu will pursue a dual-pronged strategy, each of which has the potential to generate multiple oncology medicines.

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 PLN26m from the Polish Agency for Enterprise Development.

The second focus is on ADC (antibody-drug conjugates) development 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 programme, which previously was focused on stand-alone 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 PLN13m.

In addition, Ryvu will further 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:

On behalf of and in partnership with Menarini Group, 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 and Ryvu continue their multi-target research collaboration on undisclosed targets within the small molecule immune-modulatory field.

Exelixis and Ryvu are working collaboratively to advance novel ADCs with STING payloads licensed from Ryvu.