Ryvu Therapeutics First Quarter 2024 Financial Results and Corporate Update

• Total operating revenues in Q1 2024 amounted to $6.4M, compared to $4.3M in Q1 2023.
• As of May 9, 2024, Ryvu's cash position was $59.0M, inclusive of the first tranche of €8M in venture debt from the EIB, obtained in March. This cash position, and other secured funding sources, provide a runway through Q1 2026.
• In Q1 2024, Ryvu announced the initiation of two Phase II studies of RVU120 in relapsed/refractory acute myeloid leukemia (r/r AML) and high-risk myelodysplastic syndromes (HR-MDS). Updated clinical data on RVU120 in patients with r/r AML/HR-MDS as well as preclinical data in myelofibrosis (MF) will be presented at the upcoming 2024 EHA Congress, June 13-16. Additionally, a webinar highlighting RVU120's potential in myelofibrosis (MF) will take place on Friday, May 17, at 3:00 PM (CEST).
• In February 2024, Ryvu announced that it had achieved the second milestone under the license agreement with Exelixis and received $2.0M.
• In March 2024, Ryvu announced that it would receive a approximately $6.6M (26 million PLN) in grant funding over five years from the Polish Agency for Enterprise Development (PARP) to support Ryvu's proprietary ONCO Prime discovery platform.

KRAKOW, Poland, May 15, 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 first quarter, ended March 31, 2024, and provided a corporate update.

Pawel Przewiezlikowski, co-founder, largest shareholder, and Chief Executive Officer of Ryvu Therapeutics, said:
"We are progressing rapidly with our clinical and preclinical pipeline programs and expect several key milestones in 2024. With RVU120 now in Phase II, we have achieved our development goals established last year. By the end of this year, we anticipate RVU120, our first-in-class CDK8/19 inhibitor, enrolling patients across four independent and potentially high-value development paths. We are well-positioned with a cash runway through Q1 2026 and numerous potential non-dilutive capital sources ahead of us."

Q1 2024 SUMMARY AND RECENT CORPORATE EVENTS

RVU120 clinical development plan progress

• In early 2024, Ryvu launched two Phase II studies with RVU120: the RIVER-52 study investigating RVU120 as monotherapy in two genetically defined cohorts of patients with r/r AML or HR-MDS, and the RIVER-81 study investigating RVU120 in combination with venetoclax in patients with AML.
• POTAMI-61, a Phase II study evaluating the efficacy of RVU120 in patients with myelofibrosis (MF), is expected to initiate in Q3 2024. On March 28, Ryvu signed an agreement with Fortrea for the operational execution of POTAMI-61 clinical study.
• REMARK, a Phase II study of RVU120 in patients with low-risk myelodysplastic syndromes (LR-MDS), is expected to initiate in mid-2024. 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.
• The company plans to enroll approximately 100 patients across all RVU120 Phase II studies this year and aims to present initial Phase II data by the end of 2024.

Preclinical updates

• At the 2024 American Association for Cancer Research (AACR) Annual Meeting (April 5-10, San Diego, California), Ryvu presented preclinical data from its synthetic lethality pipeline and RVU120:
• Ryvu's PRMT5 inhibitors have potentially best-in-class profiles and favorable drug-like, oral administration properties, including a solid antiproliferative effect on MTAP-deleted cell lines and a good safety window for MTAP WT cells. Ryvu anticipates nominating a PRMT5 clinical candidate and initiation of IND-enabling studies in 2024.
• 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 showed pronounced tumor growth inhibition in an MSI-H colorectal cancer xenograft model and supported WRN inhibition as a new, targeted oncological therapy.
• RVU120 shows efficacy both as a monotherapy and synergistically in combination with ruxolitinib in preclinical myeloproliferative neoplasms models (MPN), including myelofibrosis (MF) and polycythemia vera.

UPCOMING INDUSTRY AND INVESTOR EVENTS

• Myelofibrosis Webinar, Friday, May 17 at 3:00 PM CEST: Ryvu will host a webinar discussing RVU120 and spotlighting MF. Registration is available at: https://ryvu.clickmeeting.com/pre-eha2024-webinar-rvu120-progress-and-opportunity-in-mf/register
• 10^th Annual Oncology Innovation Forum, Chicago, May 31: Ryvu will give a corporate presentation and conduct investor/partner meetings.
• Pekao I Technology & Consumer Conference, Warsaw, June 3: Ryvu will conduct investor meetings
• Erste | CEE Consumer & Technology Conference 2024, Warsaw, June 4: Ryvu will conduct investor meetings
• EHA Congress, Madrid, June 13-16: Ryvu will present clinical and preclinical data from RVU120 and host an exhibition booth; three posters will be presented on RVU120:
  • Updated data from the Phase Ib trial of RVU120 in patients with relapsed/refractory acute myeloid leukemia (r/r AML) or high-risk myelodysplastic syndromes (HR-MDS) demonstrate promising clinical activity.
  • Preclinical data support the synergistic combination of RVU120 and venetoclax in patients with AML, including RVU120's potential to overcome resistance to venetoclax treatment.
  • In vivo data further supported CDK8 inhibition as a potential novel therapeutic strategy in myeloproliferative neoplasms (MPNs), focusing on myelofibrosis (MF).

Q1 2024 FINANCIAL UPDATE

Cash Position – On March 31, 2024, Ryvu Therapeutics held $62.7M in cash, cash equivalents, and bonds, compared to $63.7M on December 31, 2023.  On May 9, 2024, Ryvu Therapeutics held $59.0M in cash, cash equivalents, and bonds, including €8M of venture debt from the EIB, received on March 13. 2023.

Operating Revenues— In Q1 2024, Ryvu recognized total operating revenues (including grants) of $6.4M, compared to $4.3M in Q1 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 ($0.3M) in Q1 2024, amounted to $11.7M, compared to $7.5M in Q1 2023.

Net Loss Attributable to Common Shareholders – In Q1 2024, the net loss attributable to common shareholders, excluding the non-cash cost of valuation of the Incentive Program, amounted to $4.6M compared to $3.3M in 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 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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SOURCE Ryvu Therapeutics