Ryvu Therapeutics Reports 2022 Half-Year Financial Results and Provides Corporate Update

KRAKOW, Poland, Sept. 28, 2022 /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 half of 2022 and provided a corporate update.

• In August, Ryvu secured €22 million in funding from the European Investment Bank to support Ryvu's pipeline development.
• In July, Ryvu signed an exclusive license agreement with Nasdaq-listed Exelixis to develop novel STING agonist-based targeted cancer therapies.
• RVU120 clinical and preclinical data were presented at the 2022 European Hematology Association (EHA) Congress.
• In August, Ryvu presented its development plans, including broad development for RVU120 in hematologic and solid tumors and preclinical advancement of the synthetic lethality and immuno-oncology pipeline.
• On September 19, Ryvu's shareholders voted in favor of a resolution granting the Management and Supervisory Board the right to issue authorized capital, providing an important potential source of future financing.

- The first half of 2022 has been productive and progressive for Ryvu. Investors have appreciated the progress in our research and partnering and have supported our proposal to issue authorized capital at our discretion to finance development plans over the coming years. We are happy to have a quality investor base with such a great trust and understanding of our needs and potential – said Pawel Przewiezlikowski, co-founder, largest shareholder and CEO of Ryvu Therapeutics.

FIRST HALF 2022 AND RECENT HIGHLIGHTS

- Despite challenging market conditions, our ability to secure additional debt financing and establish an important new corporate partnership reflects the quality of our scientific expertise and clinical development capabilities – said Pawel Przewiezlikowski.

European Investment Bank (EIB) €22 million financing to accelerate the development of blood cancers and solid tumor therapies: The funding is provided under the EIB's venture debt instrument and will finance Ryvu's pipeline development of new cancer treatments. The funding is guaranteed by the European Fund for Strategic Investments, the financial pillar of the Investment Plan for Europe.

Exclusive License Agreement with Exelixis to develop new targeted therapies utilizing Ryvu's STING (STimulator of INterferon Genes) technology: Under the terms of the agreement, Exelixis paid Ryvu an upfront fee of $3 million in exchange for certain rights to Ryvu's STING agonist small molecules. Exelixis will be responsible for all research, development, and commercialization activities for which Ryvu will be eligible to receive milestone payments, as well as tiered royalties on the annual net sales of any products that are successfully commercialized under the collaboration.

Promotion of Ryvu's Chief Medical Officer, Hendrik Nogai, and Chief Business Officer, Vatnak Vat-Ho to the Management Board: Dr. Nogai has served as Chief Medical Officer at Ryvu since February 2022 and Mr. Vat-Ho has been Ryvu's Chief Business Officer since April 2021. The promotions reflect each individual's significant contributions toward advancing Ryvu's lead candidate, RVU120, and expanding Company's business development activities.

Presentation of Clinical and Preclinical Data on RVU120 at the 2022 European Hematology Association (EHA) Congress: Data from the ongoing Phase 1b dose-escalation study of RVU120 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (HR-MDS) demonstrated single-agent activity with one complete remission (CR) and stable diseases (SD) with blast reductions in several ongoing patients who failed multiple prior lines of therapy.

Additionally, data on SEL24/MEN1703, an orally available dual PIM/FLT3 inhibitor was presented. SEL24/MEN1703 was well tolerated, with no drug discontinuations or deaths due to treatment-related adverse events (TRAEs) in patients with relapsed or refractory (R/R) IDHm AML. Promising efficacy was observed, with overall response rates (ORR) and complete remission (CR) / CR with incomplete hematologic recovery (CRi) / CR with partial hematologic recovery (CRh) of 13% for the IDHm cohort.

Key Opinion Leader Webinar on RVU120 for the Treatment of Hematological Malignancies and Solid Tumors: The webinar featured a presentation by KOL Dr. Michael Savona, MD, from Vanderbilt University School of Medicine, who discussed the current treatment landscape and unmet medical need in treating patients with AML and HR-MDS. Additionally, Ryvu's leadership team discussed the underlying mechanism of action of RVU120 and provided an update on the Phase I data for RVU120.

Project updates from RVU120 and SEL24 programs presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting: Updates from the Phase 1/2 study of SEL24/MEN1703, a first-in-class dual PIM/FLT3 kinase inhibitor, in patients with IDH1/2-mutated acute myeloid leukemia and Phase I/II trial of RVU120, a CDK8/CDK19 inhibitor in patients with relapsed/refractory metastatic or advanced solid tumors were presented.

Poster Presentations at the American Association for Cancer Research (AACR) Annual Meeting: Data were presented from the RVU120 Trial-In-Progress in patients with relapsed/refractory metastatic or advanced solid tumors and in vitro and in vivo data demonstrating RVU120 efficacy against hormone-independent breast cancer. Additionally, a novel MTA-cooperative PRMT5 inhibitor as a targeted therapeutic for MTAP deleted cancer was presented.

Shareholders meeting convened and approved authorized capital on September 19: At an extraordinary shareholders meeting, shareholders voted in favor of a resolution to approve authorized capital, which provides the Management and Supervisory Board the flexibility to issue equity at its discretion when optimal.

- We are really appreciative of the overwhelming support that we received at our shareholders' meeting, which further enables Ryvu to execute our mission of discovering and developing drugs that will improve the lives of cancer patients and their families while maximizing the Company's value – underlined Pawel Przewiezlikowski.

UPCOMING CLINICAL AND CORPORATE MILESTONES:

RVU120

• Data update from the ongoing Phase I clinical study in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS) and the ongoing Phase I clinical study in solid tumors will be presented in Q4 2022

Synthetic lethality

• Data on Ryvu's novel MTA-cooperative PRMT5 inhibitors as targeted therapeutics for MTAP deleted cancers to be presented in Q4 2022.

In August, Ryvu also highlighted its development plans for 2022-2024, which are focused on rapidly advancing its pipeline to treat cancer patients:

• Broad development of RVU120, including a potential fast-to-market strategy in AML/HR-MDS,
• Advancing into Phase I clinical trials one additional program,
• Strengthening of the Synthetic Lethality Platform and discovery of novel targets,
• Acceleration in the early pipeline,
• Executing milestones from existing collaborations (i.e. Menarini, Galapagos, Exelixis), and adding at least one new partnering deal per year.

FIRST HALF 2022 FINANCIAL UPDATE:

Cash Position - On September 21, 2022, Ryvu Therapeutics held $9.7M in cash, cash equivalents, and short-term investments, compared to $20.5M at the end of 2021.

Operating costs, excluding the non-cash cost of valuation of the Incentive Program ($3.8M) and valuation of NodThera shares ($1.8M), for the 6 months period ended June 30, 2022, amounted to $13M 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 $11.5M.

Net Loss Attributable to Common Shareholders – Net loss attributable to common shareholders excluding the non-cash cost of valuation of the Incentive Program was $11M for the 6 months period ended June 30, 2022, as compared to a net loss without the Incentive Program of $8.2M 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 make use of 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 I clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome, 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, currently in phase II clinical studies in acute myeloid leukemia. Ryvu Therapeutics has signed ten partnering and licensing deals with global companies, including Merck, Menarini Group, Galapagos 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 sWIG80 index. For more information, please see www.ryvu.com.

SOURCE Ryvu Therapeutics