CDK8

KRAKOW, Poland, Dec. 12, 2024 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel therapies that address emerging targets in oncology, provided an update on clinical progress and data in the Phase II program RVU120, its fully-owned first-in-class dual CDK8/19 inhibitor, currently being developed to treat hematologic malignancies. Paweł Przewięźlikowski, co-founder and Chief Executive Officer of Ryvu Therapeutics said: - 2024 has been transformative for RVU120 development plan in hematologic malignancies, marked by activating over 100 clinical sites across Europe and North America. By the year-end, we expect to enroll almost 100 patients across all four Phase II studies launched this year, demonstrating the scale and efficiency of our global clinical efforts. This progress aligns with the budget we planned back in 2023. As we enter 2025, we are poised to carry strong enrollment momentum and the ambition to generate informative efficacy readouts in the coming months. KEY OVERALL UPDATES Ryvu successfully launched all four RVU120 Phase II clinical studies planned for 2024: RIVER-52, RIVER-81, POTAMI-61 and REMARK - with all studies progressing on track toward key efficacy analyses in H1 2025. Study sites: As of December 11, 2024, Ryvu activated 106 clinical sites in Poland, Italy, Spain, France, Germany, and Canada. The Company estimates that across all four RVU120 Phase II studies, 113 sites will have been activated by the end of 2024. Study enrollment: Enrollment is accelerating, with 78 patients enrolled as of December 11, 2024. Ryvu anticipates dosing ~100 patients by year-end. The pace of recruitment has picked up significantly since September 2024, with nearly three times as many patients expected to be treated in Q4 2024 alone compared to the combined total from Q1 to Q3. Safety: RVU120 demonstrates a favorable safety profile compared to other drugs used to treat acute myeloid leukemia (AML). Efficacy: o In the RIVER-81 study (RVU120 in combination with venetoclax in patients with relapsed/refractory AML, r/r AML, who have failed a previous venetoclax/HMA-based regimen), within eight patients treated with RVU120 at 250 mg (RP2D) that had at least one evaluable post-baseline assessment, one patient achieved a complete remission (CR), and another patient achieved a significant blast reduction. Part 1 of the study (combination dose escalation) was completed, and Part 2 is currently enrolling at the full doses of RVU120 (250 mg) and venetoclax (400 mg). o In the RIVER-52 study (RVU120 as a monotherapy in patients with r/r AML and high-risk myelodysplastic syndromes; HR-MDS), one of two evaluable patients in cohort 2 (NPM1 mutation) achieved a 50% blast reduction, while disease stabilizations and reduction of peripheral blasts were observed in patients in cohort 3 (DNMT3A mutation). o Key efficacy readouts in both RIVER-52 and RIVER-81 studies and the first efficacy data in the POTAMI-61 and REMARK trials are expected in H1 2025. All studies align with the originally planned budgets, while Ryvu's cash runway guidance to Q1 2026 remains unchanged. Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics said: - The growing body of evidence confirms that RVU120 appears to have a favorable safety profile compared to other drugs used for treating similar hematologic malignancies, both in monotherapy and in combination with venetoclax. The RIVER-81 study has progressed to Part 2 with positive signals, including a complete remission in one patient treated with RVU120 at a dose of 250 mg. Similarly, the RIVER-52 study provides early signs of efficacy, but more data are needed to evaluate RVU120 in the targeted population. With increased enrollment, we expect to obtain a representative number of patients in H1 2025. In this timeframe, we also plan to obtain the first efficacy data in the POTAMI-61 and REMARK studies. ABOUT RVU120 AND UPDATES BY PHASE II STUDY RVU120 is a selective, first-in-class dual CDK8/19 kinase inhibitor developed by Ryvu Therapeutics. RVU120 as monotherapy has demonstrated clinical activity in a Phase Ib (RIVER-51) study, where 50% of evaluable patients with r/r AML or HR-MDS achieved clinical benefit, including a complete remission, a morphologic leukemia-free state, transition to a bone-marrow transplant, two-year disease stabilization, multiple clinically significant blast reductions, hematologic improvements, and reduction of bone marrow fibrosis. In particular, early signs of efficacy were observed in patients with NPM1 and DNMT3A mutations, as well as in patients with HR-MDS. RVU120 achieved target engagement of 50-70% at a dose of 250 mg, which was selected as a recommended Phase II dose (RP2D). These levels are expected to produce robust antileukemic efficacy in Phase II studies. Following the announcement of the updated development plan for the RVU120 program in October 2023, Ryvu successfully launched all four planned Phase II studies in hematologic malignancies in 2024 (RIVER-52, RIVER-81, POTAMI-61 and REMARK). Ryvu initiated a global clinical program with the activation as of December 11, 2024, of 106 sites in Poland, Italy, Spain, France, Germany and Canada. RIVER-81: Phase II study of RVU120 in combination with venetoclax administered to patients with AML who are relapsed or refractory to prior therapy with venetoclax and a hypomethylating agent (NCT06191263). The RIVER-81 study is a multicenter, open-label clinical trial that aims to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). The study is divided into three parts. Part 1 aims to identify safe and tolerated doses of RVU120 and venetoclax when used in combination through dose escalation of both study drugs. In Part 2, the selected doses will be evaluated for safety and efficacy in a larger group of patients. Part 3 is confirmatory. The planned overall enrollment for the study is approximately 35 to 98 patients, depending on the decision on the final scope of the study, driven by the data. The first patient in the study was dosed on January 31, 2024. Since then, the study has completed Part 1 by progressing through the following dose levels: dose level 1 (125 mg of RVU120 and 200 mg of venetoclax), dose level 2 (200 mg and 200 mg respectively) and dose level 3 (250 mg and 400 mg respectively). RVU120 has demonstrated a consistent safety profile, with no new signals observed when combined with venetoclax at any dose level. The Company has successfully completed Part 1 of the study and, based on the results, decided to advance it to Part 2, which is currently enrolling. Completion of Stage 1 enrollment for Part 2 (18 patients) is expected in Q1 2025. The RIVER-81 study was initially launched at the clinical sites in Poland and Italy, followed by the activation of additional sites in Spain and France. As of December 11, 2024, all 33 sites planned for this year had been activated in these countries. As of December 11, 2024, 28 patients were enrolled, with one patient (within eight patients treated with RVU120 at 250 mg (RP2D) that had at least one evaluable post-baseline assessment) achieving a CR and another achieving a blast reduction to a level below 5%. RIVER-52: Phase II study of RVU120 as a single agent for the treatment of patients with genetically defined subtypes of AML (including NPM1 and DNMT3A mutations) and HR-MDS who have no alternative treatment options (NCT06268574). The RIVER-52 study is a multicenter, open-label clinical trial designed to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD). The study is divided into two parts. Part 1 aims to assess the level of anti-tumor activity in patients with genetically defined subtypes of AML, including NPM1 and DNMT3A mutations, as well as in patients with HR-MDS. Based on the outcomes of Part 1, Part 2 will further evaluate the safety, tolerability, and anti-tumor activity in a larger group of patients within the subtypes that exhibit the highest sensitivity to RVU120. The planned overall enrollment is approximately 40 to 140 patients, depending on the decision on the final scope of the study, driven by the data. The first patient in the study was dosed on February 14, 2024. The RIVER-52 study was initially launched at clinical sites in Poland and Italy. Starting in September 2024, the study expanded to Spain, France and Canada. As of December 11, 2024, 42 out of 44 sites planned for this year had been activated. As of December 11, 2024, 31 patients were enrolled, including 24 patients in cohorts 2-4 (NPM1-mutated, DNMT3A-mutated, and HR-MDS, respectively). One of two evaluable patients in cohort 2 achieved 50% blast reduction, while disease stabilizations and reductions of peripheral blasts were observed in patients in cohort 3. Enrollment in the study significantly accelerated in Q4 2024 and is expected to lead to key efficacy readouts in the coming months. Data from at least 10 patients in each cohorts 2-4 are expected in H1 2025. POTAMI-61: Phase II study of RVU120 as a single agent and in combination with ruxolitinib (RUX) for the treatment of patients with myelofibrosis (MF) (NCT06397313). The POTAMI-61 study is a multicenter, open-label Phase II study of RVU120, being explored as a single agent for the treatment of patients with primary or secondary MF previously treated with or ineligible for a JAK inhibitor, e.g., ruxolitinib, and in combination with ruxolitinib for patients with suboptimal response to JAK inhibitors. Key endpoints will include spleen volume reduction (SVR), total symptom score (TSS) improvement, and reduction of bone marrow fibrosis. The study has been initiated based on RVU120's clinical safety and efficacy data observed in the RIVER-51 (Phase Ib in AML/HR-MDS) study, as well as translational data in MF generated in cooperation with Prof. Raajit Rampal from Memorial Sloan Kettering Cancer Center in New York. In vivo data demonstrate the beneficial effects of CDK8 inhibition in improving symptoms of MF, i.e., splenomegaly, hepatomegaly, anemia, and thrombopenia. Importantly, disease modification properties of RVU120 were shown by the reduction of mutated allele burden. RVU120 can potentially become a novel therapeutic strategy in myeloproliferative neoplasms (MPNs), including MF. The POTAMI-61 study consists of two parts. Part A of the study, with a planned enrollment of approximately 20 patients, will comprise two cohorts: 1) single-agent therapy with RVU120 in patients resistant or refractory to prior JAK inhibitor treatment or ineligible for JAK inhibitor treatment and 2) RVU120 in combination with RUX in patients who experience a suboptimal response to prior JAK inhibitor treatment. Depending on results from Part A, cohorts 1 and/or 2 could be expanded in Part B, which will further assess safety, tolerability, and antitumor activity in a larger cohort, totaling up to approximately 230 patients for both Part A and Part B combined. RVU120 could also be investigated in a frontline setting in cohort 3. Ryvu will initially proceed with the execution of Part A of the study, while the decision on the potential initiation of Part B will be based on the outcomes of Part A. The first patient in the study was dosed on December 4, 2024, and five more patients were undergoing screening as of December 11, 2024. Part A of the study will initially enroll patients across clinical sites in Poland and Italy. If Ryvu decides to initiate Part B, the study will expand to include additional sites in the EU and non-EU countries, totaling approximately 50 clinical sites worldwide. As of December 11, 2024, 12 out of 17 sites planned for this year had been activated. Initial efficacy data is expected in Q2 2025, based on a 12-week patient observation period. REMARK: Phase II study of RVU120 as a single agent for the treatment of patients with lower-risk myelodysplastic syndromes (LR-MDS) (NCT06243458) The REMARK study is a multicenter, open-label Phase II study of RVU120, conducted as an investigator-initiated trial with the European Myelodysplastic Neoplasms Cooperative Group (EMSCO), with Prof. Uwe Platzbecker serving as the Coordinating Principal Investigator (CPI). REMARK has been initiated based on the clinical safety and efficacy data gathered so far, and strong preclinical and mechanistic rationale. MDS pathogenesis is influenced by gene expression alterations that hinder the maturation of hematopoietic cells. RVU120 triggers erythroid gene expression programs orchestrated by STAT5 and GATA1 in aberrant stem cells from MDS patients. Importantly, RVU120's activity does not lead to significant hematopoietic toxicity. As a result, RVU120 is a promising drug candidate for treating transfusion-dependent MDS patients. In the REMARK study, the planned overall enrollment is approximately 40 patients who receive RVU120 for at least 8 complete cycles (24 weeks). The primary goal is to achieve hematologic improvement in the form of an erythroid response (HI-E), with secondary goals including independence from RBC transfusions, improvement in hemoglobin levels, quality of life, disease progression, and analysis of specific gene mutations. The first patient in the study was dosed on September 19, 2024, and as of December 11, 2024, 18 patients were treated. Patient enrollment commenced across five countries: Poland, Germany, France, Spain and Italy. As of December 11, 2024, 19 out of a planned total of 24 sites were activated. Initial efficacy data is expected in Q2 2025, based on a 16-week observation period. NEXT STEPS AND UPCOMING NEWSFLOW RVU120 Phase II data update in Q2 2025. Following the key efficacy data expected in H1 2025, Ryvu plans to update stakeholders on the clinical progress of RVU120 in Q2 2025. About Ryvu Therapeutics Ryvu Therapeutics is a clinical-stage drug discovery and development company focused on novel therapies that address emerging targets in oncology. Internally discovered pipeline candidates at Ryvu use diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinases, synthetic lethality, and immuno-oncology targets. Ryvu's most advanced program is RVU120, a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies and solid tumors. RVU120 is 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) – the RIVER-52 study, (ii) in combination with venetoclax for the treatment of patients with r/r AML – the RIVER-81 study, (iii) as a monotherapy for the treatment of patients with lower-risk myelodysplastic syndromes (LR-MDS) – the REMARK study, (iv) as a monotherapy and in combination with ruxolitinib for the treatment of patients with myelofibrosis (MF) – the POTAMI-61 study. MEN1703 (SEL24) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group that is expected to start a Phase II study in diffuse large B-cell lymphoma (DLBCL), JASPIS-01, in Q4 2024. RVU305, a potentially best-in-class MTA-cooperative PRMT5 inhibitor aiming to treat multiple solid tumors, is currently undergoing IND/CTA-enabling studies. Ryvu Therapeutics is also engaged in oncology collaborations with 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 visit , , . SOURCE Ryvu Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The primary goal of the study is to evaluate the safety and efficacy of RVU120 in patients with myelofibrosis (MF), both as a single agent and in combination with ruxolitinib (RUX). The study was launched based on RVU120's activity in the RIVER-51 Phase I study in patients with acute myeloid leukemia (AML) and translational data generated in MF. KRAKOW, Poland, Dec. 5, 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, announced today that the first patient had been dosed in the POTAMI-61 study, a Phase II clinical trial investigating RVU120 in the treatment of patients with myelofibrosis (MF). Hendrik Nogai, M.D., Chief Medical Officer of Ryvu Therapeutics, said: "We are excited to announce the initiation of the RVU120 Phase II study, POTAMI-61, the fourth Phase II clinical trial included in the RVU120 development plan that Ryvu presented last year. Based on RVU120's effect on bone marrow and hematopoietic cells observed in the RIVER-51 study and translational data generated in myelofibrosis with Prof. Raajit Rampal from Memorial Sloan Kettering Cancer Center in New York, we believe there is a strong rationale for RVU120 in the treatment of patients with myelofibrosis, both as a monotherapy and in combination with JAK inhibitors. The favorable RVU120 safety profile may enable targeting patients with unmet medical needs, e.g., patients who are not eligible for or who show a suboptimal response to JAK inhibitor treatment. Additionally, synergy in translational studies indicates potential for use in the frontline setting." The POTAMI-61 study is an open-label, multicenter Phase II study of RVU120, a novel small-molecule cyclin-dependent kinase (CDK) 8/19 inhibitor, to treat patients with MF. In the POTAMI-61 study, RVU120 is being explored as a single agent for the treatment of patients with primary or secondary MF previously treated with or ineligible for a JAK inhibitor, e.g. ruxolitnib, or in combination with RUX for patients with suboptimal response to JAK inhibitors. Key endpoints will be spleen volume reduction (SVR), total symptom score (TSS) improvement, and bone marrow fibrosis reduction. The study is being initiated based on RVU120's clinical safety and efficacy data, and strong preclinical and mechanistic rationale. In vivo data demonstrate the beneficial effects of CDK8 inhibition on the improvement of symptoms, i.e., splenomegaly, hepatomegaly, anemia, and thrombopenia. Importantly, disease modification properties of RVU120 were shown by the reduction of mutated allele burden. RVU120 has the potential to become a novel therapeutic strategy in myeloproliferative neoplasms, including MF. In the POTAMI-61 study, patients will receive RVU120 until disease progression, withdrawal of consent or other reasons specified in the study protocol. The POTAMI-61 study consists of two parts. Part A of the study with a planned enrollment of approximately 20 patients will comprise two cohorts: 1) single-agent therapy with RVU120 in patients resistant or refractory to prior JAK inhibitor treatment or ineligible for JAK inhibitor treatment, and 2) RVU120 in combination with RUX in patients who experience a suboptimal response to prior JAK inhibitor treatment. Depending on results from Part A, cohorts 1 and/or 2 could be expanded in Part B which will further assess safety, tolerability, and antitumor activity in a larger cohort, totaling up to approximately 230 patients for both Part A and Part B combined. RVU120 could also be investigated in a frontline setting in cohort 3. Ryvu will initially proceed with the execution of Part A of the study, while the decision on the potential initiation of Part B will be based on the outcomes of Part A. Initially, Part A of the study will enroll patients at clinical sites in Poland and Italy. If the Ryvu Management Board decides to initiate Part B, the study will expand to include additional sites both in the EU and non-EU countries, totaling approximately 50 clinical sites worldwide. POTAMI-61 represents the fourth planned RVU120 Phase II clinical study launched in 2024. Ryvu is already treating patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (HR-MDS) in the RIVER-52 and RIVER-81 studies, as a single agent or in combination with venetoclax. RVU120 is also being investigated in the REMARK study for the treatment of patients with lower-risk myelodysplastic syndromes (LR-MDS). POTAMI-61 is part of RVU120's Development Plan presented in October 2023 and aligns with the company's cash runway. Clinical trials conducted in various hematological indications and treatment regimens (monotherapy and combination therapy) will contribute to the global RVU120 safety database, supporting potential future regulatory approvals. 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 at Ryvu use diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinases, synthetic lethality, and immuno-oncology targets. Ryvu's most advanced program is RVU120, a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies and solid tumors. RVU120 is 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) – the RIVER-52 study, (ii) in combination with venetoclax for the treatment of patients with r/r AML – the RIVER-81 study, (iii) as a monotherapy for the treatment of patients with lower-risk myelodysplastic syndromes (LR-MDS) – the REMARK study, (iv) as a monotherapy and in combination with ruxolitinib for the treatment of patients with myelofibrosis (MF) – the POTAMI-61 study. MEN1703 (SEL24) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group that is expected to start a Phase II study in diffuse large B-cell lymphoma (DLBCL) – the JASPIS-01 study, in Q4 2024. RVU305, a potentially best-in-class PRMT5 inhibitor aiming to treat multiple solid tumors, is currently undergoing IND/CTA-enabling studies. Ryvu Therapeutics is also engaged in oncology collaborations with 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 visit SOURCE Ryvu Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The total operating revenues in H1 2024 amounted to USD 12.1 million and increased by USD 4.2 million compared to H1 2023. As of September, 5 2024, Ryvu's cash position was USD 65.3 million. Together with other already secured funding sources, this cash position provides a runway through Q1 2026. On September 5, 2024, Ryvu received the third and final tranche of financing under the agreement with the European Investment Bank, amounting to EUR 6 million. The Management Board decided to advance Ryvu's potentially best-in-class PRMT5 inhibitor RVU305 to further steps of preclinical development, including toxicology and API/IMP manufacturing, targeting IND/CTA filing in H2 2025. KRAKOW, Poland, Sept. 12, 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 half year ended June 30, 2024, and provided a corporate update. Pawel Przewiezlikowski, Chief Executive Officer of Ryvu Therapeutics, said: - We are progressing with enrollment in two already launched RVU120 Phase II studies and expect to present the initial data update in December at the ASH 2024 conference. We are also close to launching two additional Phase II studies. By the end of the year, we should be enrolling patients across four independent development paths in hematologic malignancies. The next few quarters will be an important period of data generation for RVU120 and progress in the preclinical pipeline. H1 2024 SUMMARY AND RECENT CORPORATE EVENTS RVU120 clinical development plan progress In early 2024, Ryvu launched two Phase II studies with RVU120: (i) the RIVER-52 study investigating RVU120 as monotherapy in two genetically defined cohorts of patients with r/r AML and in a cohort of patients with HR-MDS, and (ii) the RIVER-81 study investigating RVU120 in combination with venetoclax in patients with AML. The RIVER-52 study was initially launched at clinical sites in Poland and Italy, and as of August 31, 16 sites had been activated for enrollment in these two countries. Starting from September 2024, Ryvu will activate additional clinical sites in Spain, France, and Canada, targeting the activation of a total of 46 sites by the end of 2024. The RIVER-81 study was initially launched at clinical sites in Poland and Italy, followed by the activation of additional sites in Spain and France. As of August 31, 27 sites had been activated for enrollment across all four countries, with a total of 34 sites planned to be activated by the end of 2024. POTAMI-61, a Phase II study evaluating the efficacy of RVU120 as a monotherapy and combination therapy in patients with myelofibrosis (MF), is expected to begin enrollment shortly, initially in Poland and Italy. REMARK, a Phase II study of RVU120 in patients with low-risk myelodysplastic syndromes (LR-MDS), will enroll patients across five countries: Poland, Germany, France, Spain, Italy, and is also expected to start enrollment shortly. 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. At the 2024 European Hematology Association (EHA) Congress (June 13-16, Madrid, Spain) Ryvu presented clinical and preclinical data from RVU120 program. Key takeaways: RIVER-52 had immature data for efficacy assessment in the target population, even though preliminary signs of clinical benefit had been observed in ongoing patients. Initial data from the RIVER-81 study demonstrated the safety of RVU120 in combination with venetoclax at the initial dose level. Translational data support the synergistic combination of RVU120 and venetoclax in patients with AML, including RVU120's potential to overcome resistance to venetoclax treatment. Translational data underscores RVU120's potential in myeloproliferative neoplasms (MPNs) phenotypes (single-agent or combined with ruxolitinib (RUX)) partly through downregulation of pro-inflammatory cytokines. Additionally, RVU120 exhibits synergy with a whole class of JAK inhibitors and the BET inhibitor pelabresib which support CDK8 inhibition as a potential novel therapeutic strategy in MPNs, with a focus on myelofibrosis (MF). Preclinical Pipeline updates PRMT5 On September 9, 2024, the Management Board decided to advance Ryvu's potentially best-in-class PRMT5 inhibitor RVU305 to further steps of preclinical development, including toxicology and API/IMP manufacturing, targeting IND/CTA filing in H2 2025. RVU305 has a potentially best-in-class profile with favorable drug-like properties, including oral administration, a strong antiproliferative effect on MTAP-deleted cell lines, and a good safety window for MTAP WT cells. Data on Ryvu's PRMT5 inhibitors were presented at AACR 2024 in April. WRN 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 exhibited pronounced tumor growth inhibition in an MSI-H colorectal cancer xenograft model and support WRN inhibition as a new, targeted cancer therapy. Data were presented at AACR 2024 in April. The company is targeting preclinical candidate selection in the upcoming quarters. Key business events From March to September 2024, Ryvu fulfilled conditions for the disbursement of all three tranches of financing from the EIB and received a total amount of EUR 22 million. In June 2024, Ryvu concluded a funding agreement with the Polish Agency for Enterprise Development ("PARP") and expects to receive approximately USD 6.6 million (PLN 26.3 million) in grant funding over five years to support its proprietary ONCO Prime discovery platform. In May 2024, Ryvu obtained the status of Associate Partner within the IPCEI Med4Cure program with its PANACEA-NOVO project – a unique platform for the discovery of new therapeutic targets with potential in the treatment of rare cancers, combined with several early discovery campaigns for innovative drugs. Ryvu expects that potential future grant funding may cover 75-80% of the total costs, which are PLN 142.5 million. In February 2024, Ryvu announced that it had achieved the second milestone under the license agreement with Exelixis and received a USD 2.0 million (PLN 7.9 million) payment. UPCOMING INDUSTRY AND INVESTOR EVENTS 6th Annual RAS-Targeted Drug Development Summit, September 24-26. Krzysztof Brzozka, Chief Scientific Officer of Ryvu Therapeutics will showcase ONCO Prime, Ryvu's discovery platform that uses isogenic primary cells and patient-derived cells to identify novel cancer targets. Dr. Brzozka's presentation on September 25, at 4:45 PM ET (Boston), will highlight ONCO Prime's application in the identification of KRAS-specific synthetic lethal targets. Trigon BioTech & MedTech Conference 2024 (online), October 2. Ryvu will host investor meetings during the conference. Erste Finest CEElection Investor Conference 2024 (Vienna, Austria), October 8-9. Ryvu will host investor meetings during the conference. ENA Symposium 2024 (Barcelona, Spain), October 23-25. Ryvu will share its scientific achievements. LSBC 2024 Central European Life Science Investment Conference (Krakow, Poland), October 23-25. Pawel Przewiezlikowski will be a panelist at the discussion titled "Poland's top Biotech Executives discuss today's challenges and the influence of AI" and will host investor and partnering meetings during the conference. H1 2024 FINANCIAL UPDATE Cash Position – On June 30, 2024, Ryvu Therapeutics held USD 63.9 million in cash, cash equivalents, and bonds, compared to USD 63.7 million on December 31, 2023. On September 5, 2024, Ryvu Therapeutics held USD 65.3 million in cash, cash equivalents, and bonds, including the third tranche of venture debt from the EIB, amounting to EUR 6 million. Operating Revenues – In H1 2024, Ryvu recognized total operating revenues (including grants) of USD 12.1 million, compared to USD 7.9 million in H1 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 in H1 2024, amounted to USD 25.4 million, compared to USD 17.7 million in H1 2023. Net Loss Attributable to Common Shareholders – In H1 2024, the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program valuation, amounted to USD 11.9 million, compared to USD 9.4 million in the previous 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 . 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