Ryvu Therapeutics S.A.. (3/15/22). "Press Release: Ryvu Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update". Krakow.

	Organisation	Ryvu Therapeutics S.A. (WSE: RVU)
	Organisation 2	Galapagos N.V. (Euronext + Nasdaq: GLPG)
	Group	Galapagos (Group)
	Product	RVU120 (Ryvu) (formerly SEL120 (Selvita))
	Product 2	SEL24 (MEN1703) (dual PIM/FLT3 kinase inhibitor, Selvita / Menarini)
	Index term	Galapagos–Ryvu Therapeutics: anti-inflammatory drugs, 202004– collab RnD small molecules against new target w excl license option for Galapagos
	Person	Przewiezlikowski, Pawel (Selvita 201309 CEO + Co-Founder)

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 fourth quarter and the full year ended December 31, 2021, and provided a corporate update.

“Over the recent months, we continued to advance our promising oncology pipeline, strengthened our management team, and granted an exclusive, royalty-bearing license to our partner Galapagos”, said Pawel Przewiezlikowski, CEO of Ryvu Therapeutics. “We expect a milestone-rich 2022, including additional Phase 1 data in AML and initial solid tumor data from ongoing RVU120 studies and data readouts from Phase 2 SEL24 treatment in AML, and potential partnering deals as we advance new programs into the clinic.”

FOURTH QUARTER 2021 AND RECENT HIGHLIGHTS

Appointment of Hendrik Nogai, M.D. to Chief Medical Officer

Ryvu appointed Hendrik Nogai, M.D. to the role of Chief Medical Officer. Dr. Nogai brings 10 years of practice in the treatment of hematological and solid tumor malignancies and 17 years of industry experience in clinical development. Dr. Nogai will lead medical, clinical, and regulatory functions to support and guide the development of the company’s pipeline.

License and Collaboration Agreement with Galapagos

Galapagos NV (Euronext & NASDAQ: GLPG) exercised its exclusive worldwide option to continue the research, development, and potential commercialization of novel small molecules for inflammatory diseases based on Ryvu’s compounds. Under the terms of the agreement, Ryvu received an option exercise fee and is eligible to receive milestone payments and royalties on future sales.

RVU120 data readout at the 63rd American Society of Hematology Annual Meeting and the 44th San Antonio Breast Cancer Symposium

Clinical and translational data for RVU120 from the first-in-human Phase 1b dose-escalation trial in relapsed/refractory (R/R) acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) were presented at the 63rd American Society of Hematology Annual Meeting and the 44th San Antonio Breast Cancer Symposium. RVU120 achieved a complete remission (CR) in an AML patient harboring mutations in DNMT3A and NPM1 and an erythroid response (ER) in an HR-MDS patient who had relapsed after several lines of previous treatment. RVU120 also showed an acceptable safety profile in 6 patients completing safety evaluations for cycle 1. Additionally, RVU120 demonstrated strong anticancer activity in a xenograft model of triple-negative breast cancer (TNBC).

HPK1 and STING Programs Updates

Ryvu presented HPK1 and STING Programs update at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting. Ryvu’s HPK1 inhibitors have shown favorable PK profiles allowing for in vivo target engagement after oral administration, which supports the potential of this drug class as a treatment across a variety of solid tumors. STING agonist, RVU-27065, expressed favorable drug-like properties and a good safety profile, showing its potential both as a single-agent treatment as well as potential for use as a targeted delivery payload.

Upcoming clinical and corporate milestones

RVU120
> Additional Phase 1 data from the safety expansion cohort in AML in H1 2022
> Initial efficacy and safety data readout in solid tumors in H1 2022

SEL24 (MEN1703)
> New data in IDHm AML in mid2022

Synthetic lethality
> Ongoing hit-to-lead optimization of the most advanced program PRMT5 with in-vivo POC expected in H2 2022
> Identification of novel targets

Immuno-oncology:
> Further progress on STING program through pre-clinical development as a standalone molecule or as part of an ADC

Potential partnering deals in the early pipeline

Fourth Quarter and Full-Year 2021 Financial Update

Cash Position – Cash and cash equivalents totaled PLN 83.2M (USD 20.5M) at the end of the fourth quarter of 2021, compared to PLN 136.2M (USD 36.2M) at the end of the fourth quarter of 2020. Full-year 2021 net cash flow amounted to an outflow of PLN 53.0M (USD 13.7M) as a result of the development of Ryvu’s pipeline, especially RVU120, compared to an inflow of PLN 64.1M (USD 16.4M) for the full year 2020 when equity financing was performed. As of March 10, 2022 the cash position was PLN 68.2M (USD 15.7M)

Operating costs, excluding the non-cash cost of valuation of the Incentive Program (PLN 23.0M or USD 5.9M), in full-year 2021 amounted to PLN 92.4M (USD 23.8M) of which PLN 26.1M (USD 6.5M) was incurred in the fourth quarter, and related primarily to research and development expenditures, while the operational loss without Incentive Program was PLN 54.9M (USD 14.2M) in full-year 2021, of which PLN 8.3M (USD 2.0M) was incurred in the fourth quarter, compared to PLN 35.7M (USD 9.2M) and PLN 11.5M (USD 3.0M) reported in 2020, respectively for full-year and fourth quarter.

Net Loss Attributable to Common Shareholders – Net loss attributable to common shareholders excluding the non-cash cost of valuation of the Incentive Program was PLN 8.9 M (USD 2.2M), for the fourth quarter 2021, compared to the PLN 10.9M (USD 2.9M), for the fourth quarter 2020. Net loss excluding the non-cash cost of valuation of the Incentive Program for the year ended December 31, 2021, was PLN 54.5 (USD 14.1M), as compared to a net loss of PLN 31.7M (USD 8.1M) for the year ended December 31, 2020.

Record changed: 2023-06-05