#Poland #Ryvu Therapeutics #RVU120 #Kraków #Oncology Program

Ryvu Therapeutics Unveils New Strategic Direction

In a significant development for the healthcare sector, Ryvu Therapeutics, known for its innovative cancer therapies, has announced a strategic reorganization aimed at ensuring sustainability and extending its financial resources. This pivotal decision is expected to prolong the company’s cash runway until the second half of 2026, allowing it to prioritize the advancement of its leading oncology candidate, RVU120, alongside its preclinical pipeline.

Financial Overview and Future Directions

As of February 23, 2025, Ryvu holds approximately €46 million (about PLN 192 million) in cash and other financial assets. Additionally, the company has successfully secured around €22 million (PLN 91 million) in non-dilutive grants which will bolster its financial stability. However, in a move to optimize operational efficiency, Ryvu will reduce its workforce by approximately 30%, bringing the total employee count to around 200. This decision reflects the challenging market conditions and aims at maintaining a fiscally responsible structure while pursuing critical developmental milestones.

Paweł Przewięźlikowski, the Chief Executive Officer and largest shareholder of Ryvu, emphasized the company's dedication to advancing its first-in-class clinical blood cancer program RVU120. He remarked on the importance of optimizing expenses to ensure that resources are effectively allocated towards generating essential clinical data that may lead to further cash inflows.

Advancements in the RVU120 Program

Ryvu Therapeutics currently has three ongoing Phase II studies for RVU120: 1) RIVER-81, which is exploring a combination treatment with venetoclax for acute myeloid leukemia (AML); 2) POTAMI-61, focusing on monotherapy and combinatory approaches with ruxolitinib for myelofibrosis; and 3) REMARK, assessing RVU120 as a monotherapy for lower-risk myelodysplastic syndromes (LR-MDS).

The company has decided to suspend new enrollments for the Phase II RIVER-52 study designed for patients with AML or high-risk myelodysplastic syndromes (HR-MDS) in order to channel more resources toward these prioritized trials. This strategic move is based on thorough data analysis and advisory feedback earlier this month.

Ryvu aims to present an updated report on RVU120’s progress in the second quarter of 2025, showcasing the ongoing commitment to advancing cancer treatments.

Dual-Pronged Research Strategy

Aside from RVU120, Ryvu is dedicated to progressing its preclinical pipeline through a dual-pronged strategy involving: 1) ONCO Prime, which is focused on uncovering novel small molecule precision medicines based on synthetic lethality targets; and 2) developing antibody-drug conjugates (ADCs) with next-generation payloads. This strategy is supported by a substantial grant from the Polish Agency for Enterprise Development, emphasizing Ryvu's commitment to pioneering innovative cancer therapies.

Partnerships also play a crucial role in Ryvu's strategy. The company is actively collaborating with Menarini in the Phase II JASPIS-01 study of dapolsertib, while maintaining research cooperations with BioNTech and Exelixis to develop novel ADCs utilizing STING payloads.

Conclusion and Investor Engagement

On February 25, 2025, at 10:15 AM CET, Ryvu will host an investor webinar to discuss its recent reorganization and strategic focus. This session is expected to provide valuable insights into Ryvu's future trajectory amidst the evolving landscape of oncology therapies.

As Ryvu Therapeutics moves forward with its restructured approach, the commitment to delivering effective treatments to cancer patients remains paramount. The company’s emphasis on innovation, partnership, and a streamlined operation positions it well for upcoming challenges and opportunities to contribute substantial advancements in oncology.