Ryvu Therapeutics Reports First Quarter 2022 Financial Results and Provides Corporate Update

• Interim Data on RVU120 in Patients with AML or High-Risk MDS, and on SEL24(MEN1703) in Patients with IDH1/2-Mutated AML to be Announced at the 2022 European Hematology Association (EHA) Congress

KRAKOW, Poland, May 18, 2022 /PRNewswire/ -- Ryvu Therapeutics RVU, a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, today reported financial results for the first quarter of 2022 and provided a corporate update.

"As we prepare for several important milestones across our clinical-stage programs in 2022, we continue to execute on our mission to develop innovative new medicines that will improve the lives of cancer patients," said Pawel Przewiezlikowski, CEO of Ryvu Therapeutics. "We look forward to presenting preclinical and clinical data on the novel CDK8/19 inhibitor, RVU120, and on SEL24 (MEN1703) at the upcoming European Hematology Association (EHA) and at the American Society of Clinical Oncology Annual Meeting. These early-stage clinical readouts will provide Ryvu with valuable, data-driven insights that will help us optimize the clinical development strategy for our lead pipeline assets."  

FIRST QUARTER 2021 AND RECENT HIGHLIGHTS

Posters Presentations at the American Association for Cancer Research (AACR) Annual Meeting: Data were presented from the RVU120 Trial-In-Progress in patients with relapsed/refractory metastatic or advanced solid tumor and in vitro and in vivo data demonstrating RVU120 efficacy against hormone-independent breast cancer. Additionally, a novel MTA-cooperative PRMT5 inhibitor as a targeted therapeutic for MTAP deleted cancer was presented.

Appointment of Hendrik Nogai, M.D. as Chief Medical Officer: Dr. Nogai brings 10 years of practice in the treatment of hematological and solid tumor malignancies and 17 years of industry experience in clinical development. Dr. Nogai leads medical, clinical, and regulatory functions to accelerate the development of the company's pipeline.

Upcoming clinical and corporate milestones

RVU120

·  Clinical update from the Phase 1b dose-escalation study of RVU120 in patients with AML or high-risk myelodysplastic syndromes (HR-MDS) and preclinical data describing in vitro and in vivo effects of RVU120 treatment in DNMT3a and NPM1-mutated AML Patient-Derived Cells (PDCs) to be announced as poster presentations at the 2022 European Hematology Association Congress.

·  Update from on Phase 1/2 trial of RVU120 in patients with relapsed/refractory (r/r) metastatic or advanced solid tumors to be announced as an abstract book entry at the upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting: Phase 1/2 clinical trial is an open-label, single-agent study assessing the safety, tolerability and preliminary efficacy of RVU120 in dose-escalation cohorts in patients with r/r metastatic or advanced solid tumors.

SEL24 (MEN1703)

·  Program update from Phase 1/2 DIAMOND-01 trial of SEL24 (MEN1703), a first-in-class dual PIM/FLT3 kinase inhibitor, in patients with IDH1/2-mutated acute myeloid leukemia (AML) will be presented at ASCO by Ryvu's partner Menarini Group. Phase 1/2 DIAMOND-01 trial evaluates the single-agent clinical activity of SEL24 (MEN1703) in patients with AML.

·  Interim data from the Phase 1/2 study of SEL24 (MEN1703) in patients with IDH1/2-Mutated AML will also be presented by Menarini at the 2022 European Hematology Association Congress.

Synthetic lethality

·  Ongoing hit-to-lead optimization of the most advanced program PRMT5 with in vivo POC expected in H2 2022

·  Novel targets identification

First Quarter 2022 Financial Update

Cash Position - Cash and cash equivalents totaled $15.5M at the end of the first quarter of 2022, compared to $20.5M at the end of the fourth quarter of 2021.

Operating costs, excluding the non-cash cost of valuation of the Incentive Program ($2M), for the quarter ended March 31, 2022, amounted to $6.2M and related primarily to research and development expenditures, while the operating costs without Incentive Program for the quarter ended March 31, 2021, amounted to $5.8M.

Net Loss Attributable to Common Shareholders - Net loss attributable to common shareholders excluding the non-cash cost of valuation of the Incentive Program was $4.4M for the quarter ended March 31, 2022, as compared to a net loss of $3.6M for the quarter ended March 31, 2021.

About Ryvu Therapeutics

Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel small molecule therapies that address emerging targets in oncology. Internally discovered pipeline candidates make use of diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinase, synthetic lethality, and immuno-oncology targets.

Ryvu's most advanced programs are RVU120 - a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in Phase I clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome, and Phase I/II for the treatment of r/r metastatic or advanced solid tumors and SEL24 (MEN1703) - dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently in Phase II clinical studies in acute myeloid leukemia.

The company was founded in 2007 and is headquartered in Krakow, Poland. Ryvu is listed on the main market of the Warsaw Stock Exchange and is a component of sWIG80 index. For more information, please see www.ryvu.com.

SOURCE Ryvu Therapeutics