Ryvu Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

• 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.

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1}Percentage change based on revenue in PLN.