• Updated Clinical Data from the Ongoing Phase Ib Dose-Escalation Study of RVU120 in Patients with AML or High-Risk MDS and Preclinical Data from the Combination Study of RVU120 and Ruxolitinib in Myeloproliferative Neoplasms to be Presented at the upcoming 2023 EHA Congress;
• Anticipated commencement of three Ryvu-sponsored Phase II trials of RVU120 in solid tumors and AML/HR-MDS in 2H 2023;
• Updated in vivo data from the MTA-cooperative PRMT5 inhibitor program presented at AACR Annual Meeting 2023;

Krakow, Poland – May 16, 2022 – 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 quarter ended March 31, 2023, and provided a corporate update.

“We continue to make strong progress across our clinical programs and remain on track to advance the ongoing RVU120 trials in AML/MDS and relapsed/refractory metastatic or advanced solid tumors to Phase 2 in the second half of 2023,” said Pawel Przewiezlikowski, CEO of Ryvu Therapeutics. “We are excited to share a clinical update from the ongoing Phase 1b dose-escalation trial of RVU120 in relapsed/refractory AML and HR-MDS at this year’s EHA Congress, which continues to demonstrate early signs of efficacy and a favorable safety profile.”

Mr. Przewiezlikowski continued, “We are very pleased to be named the Warsaw Stock Exchange Company for 2022 – a recognition of our accomplishments throughout the year, including significant progress in clinical projects, two partnering deals with Exelixis and BioNTech, venture debt from the EIB, and a successful secondary public offering. Building upon this success, we look forward to continued execution of our mission to develop innovative new medicines that will improve the lives of cancer patients.”

 

First Quarter 2023 and Recent Highlights; Upcoming Events

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

Data from Ryvu’s MTA-cooperative PRMT5 inhibitor program was presented during the 2023 AACR Annual Meeting. These molecules can selectively inhibit the growth of MTAP-deleted cancer cells in prolonged 3D culture, which correlates with the inhibition of PRMT5-dependent protein symmetric dimethylation (SDMA). Selectivity effects between MTAP deleted and WT cells exceed 100-fold both for SDMA and growth inhibition. Efficacy studies with the lead compound resulted in tumor growth inhibition in a MTAP-deleted model, accompanied by significant inhibition of the target proximal pharmacodynamic biomarker.

Ryvu Therapeutics Named the Stock Exchange Company of the Year

Ryvu was named the Best Company on the Warsaw Stock Exchange (WSE) for 2022 in an annual competition organized by “Puls Biznesu” – one of the largest business daily publications in Poland. Ryvu was also the winner in three other categories: “Investor Relations”, “Development Perspectives”, and “Products and Services Innovation”. This year marked the 24^th edition of the competition, which is broadly considered the most prestigious ranking in the Polish capital market. A panel of 103 experts (68 analysts and 35 fund managers) graded 140 of the largest firms trading on the WSE (20 from WIG20, 40 from mWIG, and 80 from sWIG) across five categories: management board competencies, success, products, and services innovation, investor relations, and development perspectives.

Agreements with Labcorp Drug Development Inc. to provide Phase II clinical studies-related services for RVU120

On March 3^rd, 2023, Ryvu Therapeutics executed a service agreement with Labcorp Drug Development Inc. to conduct Phase II of Phase I/II clinical study – aimed at determining the safety and efficacy profile of RVU120 in patients with relapsed/refractory metastatic or locally advanced solid tumors. The start of the Phase II clinical study for RVU120 in solid tumors is planned after the determination of the RP2D under the already approved Ph I/II study protocol.

On April 20^th, 2023, Ryvu entered into two agreements with Labcorp Drug Development Inc. to conduct Phase 2 study start-up services for the clinical development of RVU120 in hematologic malignancies: (i) RIVER-52 (in patients with AML/HR-MDS; RVU120 monotherapy) and (ii) RIVER-81 (in patients with AML; RVU120 combination). The commencement of the studies is expected in the second half of 2023.

Updated data on RVU120 to be presented at the 2023 EHA Congress

Updated clinical data from the ongoing Phase Ib dose-escalation study of RVU120 in patients with AML and HR-MDS to be presented at the upcoming 2023 EHA Congress. Further advanced data will be presented at a major medical conference later this year. In addition, preclinical data of RVU120 in combination with JAK1/2 inhibitor Ruxolitinib in myeloproliferative neoplasms will be presented at the upcoming 2023 EHA Congress.

Initiation of Phase 2 trials of RVU120 in solid tumors and AML/HR-MDS is expected in 2H 2023.

In Q2 2023, Ryvu will participate in the following scientific, business, and investor conferences:

• ASCO Annual Meeting, taking place June 02 – 06, in Chicago, IL, where Ryvu will be represented by an extended scientific and executive teams;
• BIO International Convention, taking place June 05 – 08, in Boston, MA, where Ryvu will be represented by the executive team;
• EHA (European Hematology Association) 2023 Congress, taking place 8 – 11 June in Frankfurt, Germany, where Ryvu scientific and executive teams will present two poster presentations;
• Future in CEE – ERSTE Consumer & Technology Conference 2023, taking place May 31 – June 01 in Warsaw, Poland, where Ryvu executive team will take part in investor meetings;
• Pekao Technology Conference, taking place virtually on June 06, where Ryvu Management Board will take part in investor meetings;

 

First Quarter Financial Update

Cash Position – On March 31, 2023, Ryvu Therapeutics held $73.1M in cash, cash equivalents, and bonds, compared to $23.2M at the end of 2022. As of May 11, 2023, Ryvu Therapeutics held $71.8M in cash, cash equivalents, and bonds.

Operating costs,  excluding the non-cash cost of valuation of the Incentive Program ($0.7M) and valuation of NodThera shares ($0.2M), for the first quarter ended March 31, 2023, amounted to $7.5M 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 $6.1M.

Net Loss Attributable to Common Shareholders – Net loss attributable to common shareholders, excluding the non-cash cost of valuation of the Incentive Program, was $3.3M for the first quarter ended March 31, 2023, as compared to a net loss without the Incentive Program of $4.4 M for the same period last year.