Ryvu Therapeutics Reports Third Quarter 2022 Financial Results and Provides Corporate Update

• Updated Phase Ib data on RVU120 in relapsed/refractory acute myeloid leukemia (r/r AML) or high-risk myelodysplastic syndrome (HR-MDS) to be presented at the 2022 American Society of Hematology (ASH) Annual Meeting
• Positive clinical data on RVU120 in advanced solid tumors and preclinical data on novel MTA-cooperative PRMT5 inhibitors presented at EORTC-NCI-AACR symposium

KRAKOW, Poland, Nov. 23, 2022 (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 announced third quarter 2022 financial results and provided a corporate update.

"We continue to make considerable progress across our pipeline, and we are particularly excited to announce updated Phase Ib efficacy and safety data on RVU120 in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) and preclinical data on SEL24 (MEN1703) at this year's ASH Meeting," said Pawel Przewiezlikowski, Chief Executive Officer of Ryvu. "To date, RVU120 showed a complete response and disease stabilizations in 10 patients with r/r AML and HR-MDS. We also recently presented data from a Phase I/II dose-escalation study in advanced solid tumors demonstrating RVU120 therapeutic benefit in the form of disease stabilizations. We are pleased with RVU120's efficacy across hematologic diseases and solid tumors, and we believe RVU120 has the potential clinical utility to improve outcomes for cancer patients."

THIRD QUARTER 2022 AND RECENT HIGHLIGHTS

Updated Clinical and Preclinical Data on RVU120 at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium: Updated data from the ongoing dose-escalation Phase I/II trial in relapsed/refractory metastatic or advanced solid tumors showed four disease stabilizations in a heavily pre-treated patient group, with three of those lasting more than 4 months. RVU120 was safe and well-tolerated, and the data support the continuation of dose escalation.

Additionally, data from preclinical studies were presented showing that RVU120 enhances the efficacy of ADCC-promoting drugs in-vivo and in-vitro. The combination therapy resulted in complete tumor regressions in preclinical models.

Lastly, preclinical data of proprietary MTA-cooperative PRMT5 inhibitors were presented. These inhibitors selectively target MTAP deficiency, which occurs in 10-15% of all tumors, and demonstrated antitumor efficacy and target engagement in-vivo.

UPCOMING CLINICAL AND CORPORATE MILESTONES:

RVU120

• Safety and efficacy data from the ongoing Phase Ib clinical study in acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS) will be presented at the 2022 American Society of Hematology (ASH) Annual Meeting. To date, RVU120 demonstrated single-agent activity with a complete response and disease stabilizations in 10 patients with r/r AML or HR-MDS.
• On-target activity of RVU120 in AML and HR-MDS patient samples will also be presented at ASH. As of the cut-off date, inhibition of pSTAT5 reached >50%, a threshold that based on preclinical predictions is sufficient for robust efficacy in certain groups of super-responder patients.

Synthetic lethality

• Novel targets identification
  

SEL24 (MEN1703)

• Ryvu's partner Menarini Group will present preclinical data showing SEL24 (MEN1703) potential for clinical efficacy in multiple myeloma (MM), Hodgkin's lymphoma (HL), and diffuse large B-cell lymphoma (DLBCL) at the upcoming ASH Meeting.
  

THIRD QUARTER 2022 FINANCIAL RESULTS

Cash Position - On November 17, 2022, Ryvu Therapeutics held $6.9M 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 ($4.5M) and valuation of NodThera shares ($1.8M) for the 9-month period ended September 30, 2022, amounted to $19.2M and related primarily to research and development expenditures, while the operating costs without the Incentive Program and valuation of NodThera shares for the same period last year amounted to $17.3M.

Net Loss Attributable to Common Shareholders - Net loss attributable to common shareholders excluding the non-cash cost of valuation of the Incentive Program was $12.5M for the 9 months period ended September 30, 2022, as compared to a net loss without the Incentive Program of $12.0M for the corresponding period in 2021.

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 (AML) and high-risk myelodysplastic syndrome (HR-MDS), 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 multiple 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.

For further information, please contact:

For investor inquiries: John Fraunces Relationship Manager [phone] [e-mail]

For corporate inquiries: Natalia Baranowska Ryvu Therapeutics [phone] [e-mail]