PRMT5 inhibitors(Suzhou Youli Biomedical)

Total operating revenues in Q1 2024 amounted to $6.4M, compared to $4.3M in Q1 2023. As of May 9, 2024, Ryvu's cash position was $59.0M, inclusive of the first tranche of €8M in venture debt from the EIB, obtained in March. This cash position, and other secured funding sources, provide a runway through Q1 2026. In Q1 2024, Ryvu announced the initiation of two Phase II studies of RVU120 in relapsed/refractory acute myeloid leukemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS). Updated clinical data on RVU120 in patients with r/r AML/HR-MDS as well as preclinical data in myelofibrosis (MF) will be presented at the upcoming 2024 EHA Congress, June 13-16. Additionally, a webinar highlighting RVU120's potential in myelofibrosis (MF) will take place on Friday, May 17, at 3:00 PM (CEST). In February 2024, Ryvu announced that it had achieved the second milestone under the license agreement with Exelixis and received $2.0M. In March 2024, Ryvu announced that it would receive a approximately $6.6M (26 million PLN) in grant funding over five years from the Polish Agency for Enterprise Development (PARP) to support Ryvu's proprietary ONCO Prime discovery platform. KRAKOW, Poland, May 15, 2024 /PRNewswire/ -- Ryvu Therapeutics (WSE: 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, ended March 31, 2024, and provided a corporate update. Pawel Przewiezlikowski, co-founder, largest shareholder, and Chief Executive Officer of Ryvu Therapeutics, said: "We are progressing rapidly with our clinical and preclinical pipeline programs and expect several key milestones in 2024. With RVU120 now in Phase II, we have achieved our development goals established last year. By the end of this year, we anticipate RVU120, our first-in-class CDK8/19 inhibitor, enrolling patients across four independent and potentially high-value development paths. We are well-positioned with a cash runway through Q1 2026 and numerous potential non-dilutive capital sources ahead of us." Q1 2024 SUMMARY AND RECENT CORPORATE EVENTS RVU120 clinical development plan progress In early 2024, Ryvu launched two Phase II studies with RVU120: the RIVER-52 study investigating RVU120 as monotherapy in two genetically defined cohorts of patients with r/r AML or HR-MDS, and the RIVER-81 study investigating RVU120 in combination with venetoclax in patients with AML. POTAMI-61, a Phase II study evaluating the efficacy of RVU120 in patients with myelofibrosis (MF), is expected to initiate in Q3 2024. On March 28, Ryvu signed an agreement with Fortrea for the operational execution of POTAMI-61 clinical study. REMARK, a Phase II study of RVU120 in patients with low-risk myelodysplastic syndromes (LR-MDS), is expected to initiate in mid-2024. REMARK will be conducted as an investigator-initiated study through the EMSCO network with Prof. Uwe Platzbecker, a globally renowned expert in the field of LR-MDS, as the Coordinating Principal Investigator. The company plans to enroll approximately 100 patients across all RVU120 Phase II studies this year and aims to present initial Phase II data by the end of 2024. Preclinical updates At the 2024 American Association for Cancer Research (AACR) Annual Meeting (April 5-10, San Diego, California), Ryvu presented preclinical data from its synthetic lethality pipeline and RVU120: Ryvu's PRMT5 inhibitors have potentially best-in-class profiles and favorable drug-like, oral administration properties, including a solid antiproliferative effect on MTAP-deleted cell lines and a good safety window for MTAP WT cells. Ryvu anticipates nominating a PRMT5 clinical candidate and initiation of IND-enabling studies in 2024. Ryvu's WRN inhibitor program demonstrates target engagement and selective potency with a synthetic lethal effect, providing pharmacological proof-of-concept; in vivo efficacy studies showed pronounced tumor growth inhibition in an MSI-H colorectal cancer xenograft model and supported WRN inhibition as a new, targeted oncological therapy. RVU120 shows efficacy both as a monotherapy and synergistically in combination with ruxolitinib in preclinical myeloproliferative neoplasms models (MPN), including myelofibrosis (MF) and polycythemia vera. UPCOMING INDUSTRY AND INVESTOR EVENTS Myelofibrosis Webinar, Friday, May 17 at 3:00 PM CEST: Ryvu will host a webinar discussing RVU120 and spotlighting MF. Registration is available at: 10th Annual Oncology Innovation Forum, Chicago, May 31: Ryvu will give a corporate presentation and conduct investor/partner meetings. Pekao I Technology & Consumer Conference, Warsaw, June 3: Ryvu will conduct investor meetings Erste | CEE Consumer & Technology Conference 2024, Warsaw, June 4: Ryvu will conduct investor meetings EHA Congress, Madrid, June 13-16: Ryvu will present clinical and preclinical data from RVU120 and host an exhibition booth; three posters will be presented on RVU120: Updated data from the Phase Ib trial of RVU120 in patients with relapsed/refractory acute myeloid leukemia (r/r AML) or high-risk myelodysplastic syndromes (HR-MDS) demonstrate promising clinical activity. Preclinical data support the synergistic combination of RVU120 and venetoclax in patients with AML, including RVU120's potential to overcome resistance to venetoclax treatment. In vivo data further supported CDK8 inhibition as a potential novel therapeutic strategy in myeloproliferative neoplasms (MPNs), focusing on myelofibrosis (MF). Q1 2024 FINANCIAL UPDATE Cash Position – On March 31, 2024, Ryvu Therapeutics held $62.7M in cash, cash equivalents, and bonds, compared to $63.7M on December 31, 2023. On May 9, 2024, Ryvu Therapeutics held $59.0M in cash, cash equivalents, and bonds, including €8M of venture debt from the EIB, received on March 13. 2023. Operating Revenues— In Q1 2024, Ryvu recognized total operating revenues (including grants) of $6.4M, compared to $4.3M in Q1 2023. Operating costs, related primarily to research and development expenditures, excluding the valuation of NodThera shares and non-cash cost of valuation of the Incentive Program ($0.3M) in Q1 2024, amounted to $11.7M, compared to $7.5M in Q1 2023. Net Loss Attributable to Common Shareholders – In Q1 2024, the net loss attributable to common shareholders, excluding the non-cash cost of valuation of the Incentive Program, amounted to $4.6M compared to $3.3M in the same period last year. 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 use 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 include RVU120, a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies and solid tumors, 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) as well as (ii) in combination with venetoclax for the treatment of patients with r/r AML. Another clinical program, SEL24 (MEN1703), is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group. Ryvu Therapeutics has signed multiple partnering and licensing deals with global companies, including BioNTech and Exelixis. The Company was founded in 2007 and is headquartered in Kraków, Poland. Ryvu is listed on the Warsaw Stock Exchange and is a component of the mWIG40 index. For more information, please see . SOURCE Ryvu Therapeutics

The total operating revenues amounted to $11.9M and increased by 42% compared to Q3 2022.Updated data from Phase Ib study of RVU120 in AML/HR-MDS to be presented at the upcoming American Society of Hematology (ASH) Annual Meeting in December. Preparations for executing Phase II clinical trials of RVU120 in AML and HR-MDS are in advanced stages.Ryvu’s PRMT5 program and synthetic lethality platform were highlighted with preclinical data recently presented at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The current cash position of $64.5M, together with other already secured funding sources provides a runway until Q1 2026. KRAKOW, Poland, Nov. 29, 2023 (GLOBE NEWSWIRE) -- Ryvu Therapeutics (WSE: 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 third quarter of 2023 and provided a corporate update. “The third quarter and the last months of 2023 proved to be an exceptionally productive period for our company,” said Pawel Przewięźlikowski, CEO of Ryvu Therapeutics. “In October, we announced the updated development plan for the RVU120 program. Considering the attractive development opportunities, we plan to advance RVU120 into multiple Phase II studies, focusing on hematologic malignancies. We have also entered into key partnerships with service providers that will enable a quick study start for planned studies. As our clinical-stage pipeline advances, we continue to make significant progress in our earlier-stage pipeline, highlighted by the presentation of data from our synthetic lethality program at this year’s AACR-NCI-EORTC meeting, including our potentially best-in-class MTA-cooperative PRMT5 inhibitors. Looking ahead, Ryvu remains well capitalized to execute our clinical development strategy, with our cash runway still through the first quarter of 2026.” Third Quarter 2023 and Recent Highlights Announced updated clinical development plan for RVU120 In Q4 2023, Ryvu expects to initiate two Phase II studies evaluating RVU120 as a single agent in two cohorts of genetically defined patients with AML or HR-MDS (RIVER-52) and in combination with venetoclax in patients with AML (RIVER-81).Ryvu will financially support a dedicated Phase II clinical trial in patients with low-risk myelodysplastic syndromes (LR-MDS) – the REMARK study. REMARK will be conducted as an investigator-initiated study through the EMSCO network, with Prof. Uwe Platzbecker, a globally renowned expert in the field of LR-MDS, taking on the role of Coordinating Principal Investigator. The start-up activities for the study have already been initiated, and patient enrollment is planned to start in H1 2024.Ryvu will initiate a new study, POTAMI-61, evaluating RVU120 in patients with myelofibrosis (MF). Start-up activities for the study are ongoing, with patient enrollment planned to begin in Q2 2024.Translational research in solid tumors will be ongoing, including combination studies in multiple solid tumor types, as well as academic collaborations on medulloblastoma and sarcoma.The updated RVU120 clinical development plan includes studies that may lead to three drug approvals in 2026-2027 (RIVER-52, RIVER-81, and POTAMI-61 studies). Presented preclinical data on PRMT5 and Ryvu’s synthetic lethality platform at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics On October 16, 2023, the Company hosted a virtual webinar focused on PRMT5 data and the synthetic lethality pipeline, including WRN and novel target discovery.Poster presentations from the conference highlighted preclinical data from Ryvu’s PRMT5 program in MTAP-deficient cancers and its synthetic lethality platform in colorectal cancer models.Ryvu has developed potentially best-in-class MTA-cooperative PRMT5 inhibitors that exhibit significantly improved pharmacokinetics relative to other PRMT5 inhibitors currently in development. Given their in vivo target engagement and remarkable anti-tumor efficacy, Ryvu anticipates further development and progression to IND-enabling studies in 2024.Separately, Ryvu’s partner Menarini presented preclinical data at the conference on MEN1703 (SEL24), showing promising anti-tumor activity in B-cell lymphomas, supporting the Phase II clinical program. Expanded development of MEN1703 (SEL24) with global licensee, Menarini, for a new study in advanced diffuse large B-cell lymphoma (DLBCL) A new Phase II study will explore the activity of MEN1703 in patients with DLBCL in combination with standard-of-care therapy and as a single agent, based on strong preclinical activity of MEN1703 in lymphoma. MEN1703 has completed Phase II studies in patients with relapsed/refractory AML, including an expansion cohort in patients with IDH-mutated AML. The studies demonstrated an acceptable safety profile and early signs of single-agent activity. Based on these data, the development of MEN1703 will continue with a focus on DLBCL and potentially other indications. AML will be deprioritized given the existing data and competitive landscape. Initiation of the Phase II study in DLBCL is expected in H1 2024.Under the terms of the license agreement executed in 2017, Menarini is the global development and commercial licensee. Ryvu remains a strategic partner through the existing Joint Steering Committee and is now, as part of an amended agreement, an operational partner to execute clinical studies on behalf of Menarini.Menarini continues to be responsible for all research and development costs, including full reimbursement to Ryvu for all study execution expenses; the license and financial terms of the original agreement remain unchanged. In Q4 2023, Ryvu will participate in the following scientific conferences: American Society of Hematology (ASH) Annual Meeting, December 9-12, in San Diego, California Updated data from the Phase Ib trial of RVU120 in relapsed/refractory acute myeloid leukemia (r/r AML) or high-risk myelodysplastic syndromes (HR-MDS) demonstrate clinically relevant benefit in 50% of evaluable patients.Preclinical and clinical data support RVU120 as a novel agent for the treatment of patients with lower-risk MDS (LR-MDS) and show cytotoxic and differentiating effects on leukemic stem cells.The published data strongly supports the updated RVU120 Phase II development plan presented in October. San Antonio Breast Cancer Symposium, December 5-9, in San Antonio, Texas Translational data demonstrate synergistic activity of RVU120 and MEK inhibitors in hormone receptor-negative breast cancer. Third Quarter 2023 Financial Update Cash Position – On November 24, 2023, Ryvu Therapeutics held $64.5M in cash, cash equivalents, and bonds, compared to $23.2M at the end of 2022. Operating Revenues – In the first three quarters of 2023, Ryvu recognized total operating revenues (including grants) of $11.9M, which constitutes an increase of 42%1, compared to the corresponding period of 2022, when the total operating revenue amounted to $8.0M. The increase in revenues resulted mostly from the achievement of a milestone from Exelixis Inc. and ongoing research collaboration with BioNTech SE. Operating costs - Excluding the non-cash cost of valuation of the Incentive Program ($1.7M) and valuation of NodThera shares ($0.2M), for the first three quarters ended September 30, 2023, amounted to $27.4M and related primarily to research and development expenditures, while the operating costs without Incentive Program and valuation of NodThera shares for the same period last year amounted to $19.2M. Net Loss Attributable to Common Shareholders – Net loss attributable to common shareholders, excluding the non-cash cost of valuation of the Incentive Program, was $13.5M for the first three quarters ended September 30, 2023, as compared to a net loss without the Incentive Program of $12.5M for the same period last year. 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 use 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 Ib clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndromes, and phase I/II for the treatment of r/r metastatic or advanced solid tumors — and SEL24 (MEN1703), a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group. Ryvu Therapeutics has signed multiple partnering and licensing deals with global companies, including BioNTech, Exelixis, Menarini, and Merck. The Company was founded in 2007 and is headquartered in Kraków, Poland. Ryvu is listed on the Warsaw Stock Exchange and is a component of the mWIG40 index. For more information, please see www.ryvu.com. Contacts: Investors John Fraunces LifeSci Advisors +1 917-355-2395 jfraunces@lifesciadvisors.comCorporateNatalia Baranowska Ryvu Therapeutics +48 784 069 418natalia.baranowska@ryvu.com ______________________1Percentage change based on revenue in PLN.