Company Announcements

• The total operating revenues in H1 2024 amounted to USD 12.1 million and increased by USD 4.2 million compared to H1 2023.
• As of September, 5 2024, Ryvu's cash position was USD 65.3 million. Together with other already secured funding sources, this cash position provides a runway through Q1 2026.
• On September 5, 2024, Ryvu received the third and final tranche of financing under the agreement with the European Investment Bank, amounting to EUR 6 million.
• The Management Board decided to advance Ryvu's potentially best-in-class PRMT5 inhibitor RVU305 to further steps of preclinical development, including toxicology and API/IMP manufacturing, targeting IND/CTA filing in H2 2025.

KRAKOW, Poland , Sept. 12, 2024 /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 half year ended June 30, 2024, and provided a corporate update.

Pawel Przewiezlikowski, Chief Executive Officer of Ryvu Therapeutics, said:

- We are progressing with enrollment in two already launched RVU120 Phase II studies and expect to present the initial data update in December at the ASH 2024 conference. We are also close to launching two additional Phase II studies. By the end of the year, we should be enrolling patients across four independent development paths in hematologic malignancies. The next few quarters will be an important period of data generation for RVU120 and progress in the preclinical pipeline. 

H1 2024 SUMMARY AND RECENT CORPORATE EVENTS

RVU120 clinical development plan progress

• In early 2024, Ryvu launched two Phase II studies with RVU120: (i) the RIVER-52 study investigating RVU120 as monotherapy in two genetically defined cohorts of patients with r/r AML and in a cohort of patients with HR-MDS, and (ii) the RIVER-81 study investigating RVU120 in combination with venetoclax in patients with AML.
• The RIVER-52 study was initially launched at clinical sites in Poland and Italy, and as of August 31, 16 sites had been activated for enrollment in these two countries. Starting from September 2024, Ryvu will activate additional clinical sites in Spain, France, and Canada, targeting the activation of a total of 46 sites by the end of 2024.
• The RIVER-81 study was initially launched at clinical sites in Poland and Italy, followed by the activation of additional sites in Spain and France. As of August 31, 27 sites had been activated for enrollment across all four countries, with a total of 34 sites planned to be activated by the end of 2024.
• POTAMI-61, a Phase II study evaluating the efficacy of RVU120 as a monotherapy and combination therapy in patients with myelofibrosis (MF), is expected to begin enrollment shortly, initially in Poland and Italy.
• REMARK, a Phase II study of RVU120 in patients with low-risk myelodysplastic syndromes (LR-MDS), will enroll patients across five countries: Poland, Germany, France, Spain, Italy, and is also expected to start enrollment shortly. 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, as the Coordinating Principal Investigator.
• At the 2024 European Hematology Association (EHA) Congress (June 13-16, Madrid, Spain) Ryvu presented clinical and preclinical data from RVU120 program. Key takeaways:
  • RIVER-52 had immature data for efficacy assessment in the target population, even though preliminary signs of clinical benefit had been observed in ongoing patients.
  • Initial data from the RIVER-81 study demonstrated the safety of RVU120 in combination with venetoclax at the initial dose level. Translational data support the synergistic combination of RVU120 and venetoclax in patients with AML, including RVU120's potential to overcome resistance to venetoclax treatment.
  • Translational data underscores RVU120's potential in myeloproliferative neoplasms (MPNs) phenotypes (single-agent or combined with ruxolitinib (RUX)) partly through downregulation of pro-inflammatory cytokines. Additionally, RVU120 exhibits synergy with a whole class of JAK inhibitors and the BET inhibitor pelabresib which support CDK8 inhibition as a potential novel therapeutic strategy in MPNs, with a focus on myelofibrosis (MF).

Preclinical Pipeline updates

PRMT5

• On September 9, 2024, the Management Board decided to advance Ryvu's potentially best-in-class PRMT5 inhibitor RVU305 to further steps of preclinical development, including toxicology and API/IMP manufacturing, targeting IND/CTA filing in H2 2025.
• RVU305 has a potentially best-in-class profile with favorable drug-like properties, including oral administration, a strong antiproliferative effect on MTAP-deleted cell lines, and a good safety window for MTAP WT cells. Data on Ryvu's PRMT5 inhibitors were presented at AACR 2024 in April.

WRN

• Ryvu's WRN inhibitor program demonstrates target engagement and selective potency with a synthetic lethal effect, providing pharmacological proof-of-concept; in vivo efficacy studies exhibited pronounced tumor growth inhibition in an MSI-H colorectal cancer xenograft model and support WRN inhibition as a new, targeted cancer therapy. Data were presented at AACR 2024 in April.
• The company is targeting preclinical candidate selection in the upcoming quarters.

Key business events

• From March to September 2024, Ryvu fulfilled conditions for the disbursement of all three tranches of financing from the EIB and received a total amount of EUR 22 million.
• In June 2024, Ryvu concluded a funding agreement with the Polish Agency for Enterprise Development ("PARP") and expects to receive approximately USD 6.6 million (PLN 26.3 million) in grant funding over five years to support its proprietary ONCO Prime discovery platform.
• In May 2024, Ryvu obtained the status of Associate Partner within the IPCEI Med4Cure program with its PANACEA-NOVO project – a unique platform for the discovery of new therapeutic targets with potential in the treatment of rare cancers, combined with several early discovery campaigns for innovative drugs. Ryvu expects that potential future grant funding may cover 75-80% of the total costs, which are PLN 142.5 million.
• In February 2024, Ryvu announced that it had achieved the second milestone under the license agreement with Exelixis and received a USD 2.0 million (PLN 7.9 million) payment.  

UPCOMING INDUSTRY AND INVESTOR EVENTS

• 6th Annual RAS-Targeted Drug Development Summit, September 24-26. Krzysztof Brzozka, Chief Scientific Officer of Ryvu Therapeutics will showcase ONCO Prime, Ryvu's discovery platform that uses isogenic primary cells and patient-derived cells to identify novel cancer targets. Dr. Brzozka's presentation on September 25, at 4:45 PM ET (Boston), will highlight ONCO Prime's application in the identification of KRAS-specific synthetic lethal targets.
• Trigon BioTech & MedTech Conference 2024 (online), October 2. Ryvu will host investor meetings during the conference.
• Erste Finest CEElection Investor Conference 2024 (Vienna, Austria), October 8-9. Ryvu will host investor meetings during the conference.
• ENA Symposium 2024 (Barcelona, Spain), October 23-25. Ryvu will share its scientific achievements.
• LSBC 2024 Central European Life Science Investment Conference (Krakow, Poland), October 23-25. Pawel Przewiezlikowski will be a panelist at the discussion titled "Poland's top Biotech Executives discuss today's challenges and the influence of AI" and will host investor and partnering meetings during the conference.

H1 2024 FINANCIAL UPDATE

Cash Position – On June 30, 2024, Ryvu Therapeutics held USD 63.9 million in cash, cash equivalents, and bonds, compared to USD 63.7 million on December 31, 2023. On September 5, 2024, Ryvu Therapeutics held USD 65.3 million in cash, cash equivalents, and bonds, including the third tranche of venture debt from the EIB, amounting to EUR 6 million.

Operating Revenues – In H1 2024, Ryvu recognized total operating revenues (including grants) of USD 12.1 million, compared to USD 7.9 million in H1 2023.

Operating costs, related primarily to research and development expenditures, excluding the valuation of NodThera shares and non-cash cost of valuation of the Incentive Program in H1 2024, amounted to USD 25.4 million, compared to USD 17.7 million in H1 2023.

Net Loss Attributable to Common Shareholders – In H1 2024, the net loss attributable to common shareholders, excluding the non-cash cost of the Incentive Program valuation, amounted to USD 11.9 million, compared to USD 9.4 million in the previous 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 include RVU120, a selective CDK8/CDK19 kinase inhibitor with the potential to treat hematological malignancies and solid tumors, currently in Phase II development (i) as a monotherapy for the treatment of patients with relapsed/refractory acute myeloid leukemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS) as well as (ii) in combination with venetoclax for the treatment of patients with r/r AML. Another clinical program, SEL24 (MEN1703), is 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 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 mWIG40 index.

For more information, please see www.ryvu.com.

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