Ryvu Therapeutics Reports 2024 Q3 Financial Results and Provides Corporate Update

• In Q1-Q3 2024, Ryvu recognized total operating revenues (including grants) of USD 18.6 million, compared to USD 11.9 million in Q1-Q3 2023.
• Ryvu reports an acceleration in patient enrollment for its RVU120 Phase II clinical studies, attributed in part to a significant increase in the number of activated clinical sites. As of October 31, a total of 66 sites have been activated in the most advanced RIVER-81 and RIVER-52 studies, and this number is expected to grow further by the end of the year.
• The Investor Event focusing on the progress and data update of RVU120 Phase II studies is scheduled for December 12 at 10:00 AM CET.
• As of November 4, 2024, Ryvu's cash position was USD 58.1 million. Together with other already secured funding sources, this cash position provides a runway through Q1 2026.

KRAKOW, Poland  , Nov. 7, 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 third quarter ended September 30, 2024, and provided a corporate update.

Pawel Przewiezlikowski, Chief Executive Officer of Ryvu Therapeutics, said:

- We have significantly accelerated enrollment in RVU120 Phase II studies since September thanks to the activation of numerous new sites in the RIVER-52 and RIVER-81 studies for patients with r/r AML and HR-MDS and the launch of the REMARK study for patients with LR-MDS. We are looking forward to launching the fourth RVU120 Phase II study ? POTAMI-61 ? shortly, which will focus on patients with myelofibrosis. By the end of the year, we plan to summarize the initial data from the most advanced RVU120 clinical development paths at an investor event scheduled for December 12. In parallel, we are preparing to launch JASPIS-01, a Phase II study of MEN1703 (SEL24) in patients with DLBCL, while also advancing our promising preclinical pipeline.

Q1-Q3 2024 SUMMARY AND RECENT CORPORATE EVENTS

Pipeline 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 relapsed or refractory (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 r/r AML.
  
  • 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. During the summer, the site activation process was slower than expected, primarily due to the limited availability of site staff. This staff shortage, combined with the presence of competing clinical studies at several sites impacted the actual enrollment rate vs. original estimates. Increased site activation efforts and additional measures to maximize enrollment resulted in a return to expected patient enrollment levels starting in September 2024. As of October 31, 2024, 33 sites had been activated for enrollment, more than doubling the number of active sites since the status reported on August 31, 2024, when 16 sites were active. Ryvu aims to activate a total of 46 sites by the end of Q4 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 October 31, 2024, 33 sites had been activated out of a total of 34 sites that the Company plans to activate in the aforementioned four countries by the end of the year.

• In September, Ryvu announced the dosing of the first patient in REMARK, a Phase II study evaluating the efficacy of RVU120 as a monotherapy for the treatment of patients with low-risk myelodysplastic syndromes (LR-MDS). The REMARK study has commenced enrollment of patients across five countries: Poland, Germany, France, Spain and Italy. Up to approximately 25 clinical sites are planned to be activated across these countries. REMARK is being 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.
• POTAMI-61, a Phase II study investigating RVU120 both as a monotherapy and in combination therapy to treat patients with myelofibrosis (MF), was initially launched at clinical sites in Poland and Italy. As of October 31, 2024, five clinical sites have been activated for enrollment, with a total of 18 sites planned to be activated across these two countries by the end of 2024. Patient dosing is expected to commence shortly.
• At the 2024 EORTC-NCI-AACR (ENA) Symposium (October 23-25, Barcelona, Spain), Ryvu presented clinical and preclinical data from RVU305 (MTA-cooperative PRMT5 inhibitor), the ONCO Prime discovery platform, RVU120 (CDK8/19 inhibitor), and the WRN inhibitor program. Key takeaways: 
  • Ryvu has developed a potentially best-in-class MTA-cooperative PRMT5 inhibitor, RVU305, demonstrating favorable drug-like properties and effective PRMT5 inhibition dependent on MTA binding.
  • Ryvu has developed a proprietary platform, ONCO Prime, to discover novel synthetic lethal (SL) inhibitors targeting key oncogenic drivers such as KRAS and other mutations. ONCO Prime uses human intestinal stem cell (hISC)-derived cancer model cells, patient-derived xenografts (PDXs), and clinical samples to conduct genomic and functional analyses.
  • Ryvu is developing a series of potent and selective WRN helicase inhibitors that demonstrate pronounced efficacy in tumors with high microsatellite instability (MSI-H). The compounds exhibit favorable pharmacokinetics, achieving optimal exposure and target engagement, further enhancing their therapeutic potential in MSI-H cancers.
  • RVU120 is being tested in patients with solid tumors in an ongoing Phase I/II clinical trial, AMNYS-51. RVU120 has demonstrated a manageable safety profile across multiple dose levels and dosing schedules in patients with advanced or metastatic solid tumors with early signs of activity in patients with adenoid cystic carcinomas (ACC).

• 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.

Key business events

• In October 2024, Ryvu Therapeutics and nCage Therapeutics announced a research collaboration to develop a next-generation antibody-drug conjugate (ADC) platform.
• In October 2024, Ryvu announced the conclusion of an agreement for the operational execution of the MEN1703 (SEL24) Phase II clinical trial in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), known as the JASPIS-01 study. The agreement pertains to the operational execution of Part 1 of the JASPIS-01 study. The company's partner, Menarini Group, will fully reimburse all costs associated with the agreement.
• From March to September 2024, Ryvu fulfilled conditions for the disbursement of all three tranches of financing from the EIB. In total, Ryvu has now received EUR 22 million from the EIB.
• 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 Ryvu's total project costs, which are estimated to be 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

• Central European Technology Forum ? CETEF'24, (Krakow, Poland) November 18-19. Pawe? Przewi??likowski, CEO of Ryvu, will deliver a presentation entitled: "From discovery to a new hope for blood cancer patients".
• Life Science Open Space Summit, (Krakow, Poland) November 28-29. Kamil Sitarz, COO of Ryvu, will deliver a presentation entitled: "Building project value through clinical development". 
• Investor Event: RVU120 Program Progress and Data Update - Thursday, December 12, 10:00 AM CET to discuss the ongoing RVU120 Phase II studies.

Q3 2024 FINANCIAL UPDATE

Cash Position ? On September 30, 2024, Ryvu Therapeutics held USD 65.2 million in cash, cash equivalents, and bonds, compared to USD 63.7 million on December 31, 2023. On November 4, 2024, Ryvu Therapeutics held USD 58.1 million in cash, cash equivalents, and bonds.

Operating Revenues ? In the first three quarters of 2024, Ryvu recognized total operating revenues (including grants) of USD 18.6 million, compared to USD 11.9 million in corresponding period of 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 for the first three quarters of 2024, amounted to USD 38.2 million, compared to USD 27.4 million for the same period last year.

Net Loss Attributable to Common Shareholders ? In the first three quarters of 2024, the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program, amounted to USD 18.5 million, compared to USD 13.5 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 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. 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 www.ryvu.com

SOURCE Ryvu Therapeutics