• The total operating revenues amounted to $7.9M and increased by 131% compared to H1 2022.
• Updated clinical and preclinical data on RVU120 were presented at the European Hematology Associated (EHA) Congress in June 2023.
• Preparation for the execution of Phase II clinical trials of RVU120 in AML and HR-MDS are in advanced stages.
• Warsaw Stock Exchange has included Ryvu stock in the mWIG40 index, which groups medium-sized companies.
• $14M in non-dilutive grant funding was secured from the Medical Research Agency (ABM) – the largest grant obtained to date by Ryvu.

Krakow, Poland – September 13, 2023 – 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 today financial results for the first half of 2023 and provided a corporate update.

“The last months of 2023 were a productive period for Ryvu as we made significant developments across our clinical programs, collaboration activity, and strengthening our balance sheet”, said Pawel Przewiezlikowski, CEO of Ryvu Therapeutics. “In the first half of 2023, we recognized an increase of 131% in our total operating revenues thanks to the achievement of a milestone from Exelixis and the ongoing research collaboration with BioNTech. At the same time, in the last few weeks, we secured the most significant grant financing in Ryvu’s history from the Medical Research Agency, amounting to over $14 million. We now enter the second half of 2023 well-positioned to execute our goals, prioritizing advancing RVU120 to Phase II studies.”

 

First Half 2023 and Recent Highlights

Ryvu enters the mWIG40 index

As a result of the quarterly index revision on the Warsaw Stock Exchange (WSE), starting from September 18, 2023, Ryvu will be included in the mWIG40 index, which groups 40 companies from the main market (outside the WIG20) with the highest position in the ranking determined primarily on the basis of market trading volume and capitalization.

Ryvu entered into two agreements with Fortrea to execute RIVER-52 and RIVER-81 Phase II trials

Under the terms of the agreements, Fortrea (formerly known as LabCorp’s Clinical Development and Commercialization Services), a global Contract Research Organization (CRO), will operationally execute two Phase II clinical trials of RVU120: as a monotherapy (RIVER-52 study) and in combination therapy with venetoclax (RIVER-81 study), for the treatment of patients with Acute Myeloid Leukemia/High-Risk Myelodysplastic Syndrome (AML/HR-MDS). In both studies, Fortrea will provide services related to the operational execution of clinical trials, including but not limited to clinical project management, medical and safety monitoring, as well as clinical site management and monitoring.

PLN 62.3 million (approx. $14 million) financing agreement with the Medical Research Agency to conduct the RIVER-81 Phase II trial of RVU120 in combination with venetoclax

Ryvu entered into a strategic agreement with the Medical Research Agency (ABM) to secure funding for a project centered around the execution of the RIVER-81 study. The primary objective of the project, financially supported by the ABM, is to develop a new treatment strategy for AML through the execution of the Phase II, multicenter, open-label clinical trial that will evaluate the safety and efficacy of RVU120 in combination with venetoclax in patients with relapsed/refractory AML, who have failed prior therapy with venetoclax and a hypomethylating agent.

Ryvu announced an agreement with Clinical Services International (CSI) to secure the venetoclax supply chain for the RIVER-81 study

The scope of the agreement is to provide supply chain-related services, including management, procurement, storage, delivery, labeling, QP release, status monitoring, returns, and utilization of venetoclax in the RIVER-81 clinical study.

Agreements with Clinscience for data management and biostatistics-related services for RVU120 Phase II clinical trials in hematology: RIVER-52 and RIVER-81

Clinscience will provide data management and biostatistics services, including building and hosting of an Electronic Data Capture (EDC) system.

Agreements with Zakłady Farmaceutyczne Polpharma S.A. for RVU120 active substance (API) production for Phase II clinical trials

Ryvu Therapeutics signed two agreements with Polpharma CDMO, a globally recognized partner in the development and contract manufacturing of active substances. The RIVER-81 study-related agreement is focused on the development and optimization of the production process, as well as RVU120 API manufacturing under cGMP (current Good Manufacturing Practice) requirements for the Phase II study of RVU120 in combination therapy with venetoclax in the treatment of AML.

The RIVER-52 study-related agreement is the execution of the API manufacturing campaign for RVU120 in the registration cGMP standard – a key element in preparing for the potential fast-to-market strategy implementation for the Phase II study of RVU120 as monotherapy in the treatment of patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (HR-MDS).

Updated data on RVU120 presented at the 2023 EHA Congress

The latest data cut from 24 evaluable patients enrolled in the ongoing Phase 1b dose-escalation trial of RVU120 as a monotherapy in heavily pre-treated AML and HR-MDS patients showed a manageable safety profile and promising evidence of anti-leukemic activity, with 11 out of 24 evaluable patients demonstrating clinical benefit. RVU120 monotherapy continues to be generally well-tolerated across all the dose levels.

Treatment with RVU120 monotherapy and in combination with ruxolitinib resulted in significant reductions of disease manifestation, specifically reductions in WBCs, disease reporter percentages, splenomegaly, and bone marrow/spleen fibrosis, as well as stimulated normal hematopoiesis. These data warrant further clinical development of RVU120 in combination with JAK1/2 inhibition as a potential novel therapeutic strategy in myeloproliferative neoplasms.

MTA-cooperative PRMT5 inhibitors presented at American Association for Cancer Research (AACR) Annual Meeting

Data from Ryvu’s MTA-cooperative PRMT5 inhibitor program were presented during the 2023 AACR Annual Meeting. Efficacy studies with the lead compound resulted in tumor growth inhibition in an MTAP-deleted model, accompanied by significant inhibition of the target proximal pharmacodynamic biomarker.

Achievement of the first milestone from the exclusive license agreement with Exelixis Inc.

Ryvu has achieved a milestone in the amount of USD 1 million from the exclusive license agreement with Exelixis Inc. The agreement combines Ryvu’s proprietary small molecule STING agonists and STING biology know-how with Exelixis’ network of expertise and resources in antibody engineering, antibody-drug conjugate (ADC) technologies, and oncology therapeutics development and commercialization experience.

 

Upcoming Events; In H2 2023, Ryvu will participate in the following scientific and business conferences:

• AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, October 11 – 15, in Boston, MA
• ESMO Congress 2023, October 20-24, in Madrid, Spain
• BIO-Europe 2023, November 6-8, Munich, Germany
• ASH Annual Meeting and Exposition 2023, December 9-12, in San Diego, CA

 

First Half 2023 Financial Update

Cash Position – On June 30, 2023, Ryvu held $69.9M in cash, cash equivalents, and bonds, compared to $23.2M at the end of 2022. As of September 7, 2023, Ryvu held $65.5M in cash, cash equivalents, and bonds.

Operating Revenues – In the first half year of 2023, Ryvu recognized total operating revenues (including grants) of $7.9M, which constitutes an increase of 131%, compared to the corresponding period of 2022, when the total operating revenue amounted to $3.4M. 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 the Incentive Program ($1.4M) and valuation of NodThera shares ($0.5M), for the six months ended June 30, 2023, operating costs amounted to $17.7M 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 $13M.

Net Loss Attributable to Common Shareholders – Net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program, was $9.4M for the six months ended June 30, 2023, as compared to a net loss without the Incentive Program of $11M for the same period last year.