On May 18, 2022 Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported financial results for the first quarter of 2022 and provided a corporate update (Press release, Ryvu Therapeutics, MAY 18, 2022, View Source [SID1234614832]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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) (Free EHA Whitepaper) and at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 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) (Free AACR Whitepaper) 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 (EHA) (Free EHA Whitepaper) 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) (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) 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 (EHA) (Free EHA Whitepaper) 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.