Krakow, Poland – 10 November 2021 – 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 2021 financial results and a corporate update.

“In the third quarter Ryvu has achieved several important milestones for its proprietary pipeline programs”, said Pawel Przewiezlikowski, Chief Executive Officer of Ryvu.

“We are excited to announce the latest clinical and translational data for our most advanced project RVU120 at the upcoming ASH and SABCS conferences, and our preclinical data on HPK1 and STING compounds at the SITC conference in November. These encouraging data further reinforce the therapeutic potential of our programs, and we look forward to seeing how our discovery and research are translating into a tangible promise for cancer patients.”

 

Recent Highlights

• Two Poster Presentations of HPK1 and STING programs at SITC’s 36th Annual Meeting

Ryvu will present a poster on novel, orally administered HPK1 inhibitors which exhibit nanomolar activity in an immunosuppressive environment. These small molecules have shown favorable PK profiles allowing for in vivo target engagement after oral administration, and hold promising potential as a treatment in a variety of solid tumor indications.

The second poster will highlight a novel small-molecule STING agonist, RVU-27065. Selective STING pathway activation with RVU-27065 allows for repolarization of immunosuppressive tumor-associated macrophages into a pro-inflammatory phenotype without a negative impact on T-cell functioning. With favorable drug-like properties and good safety profile, RVU-27065 is a promising candidate for standalone treatment as well as targeted delivery as a payload for antibodies.

• Presentation of clinical and translational data from RVU120 and SEL24/MEN1703 at the 63rd “ASH” Annual Meeting & Exposition and the 44th Annual SABCS

On November 4, Ryvu announced that, together with its collaborators from MD Anderson Cancer Center and the Menarini Group, it will present six posters showing new data demonstrating clinical and preclinical activity of its selective CDK8/19 inhibitor RVU120 (SEL120) and selective PIM/FLT3 inhibitor SEL24 (MEN1703) during the 63rd American Society of Hematology Annual Meeting & Exposition and at the 44th Annual San Antonio Breast Cancer Symposium (SABCS).

The posters to be presented include: initial data from ongoing Phase Ib of RVU120 which demonstrates an acceptable safety profile and early signs of efficacy, including a Complete Remission (CR) within the first five dose cohorts; an ongoing dose escalation in AML and HR-MDS; translational research for RVU120 demonstrated a strong trend of efficacy in DNMT3A-mutated AML patient-derived cells; preclinical models showing potential for clinical efficacy of RVU120 in breast cancer. Ryvu licensee, Menarini Group will be presenting SEL24/MEN1703 data from the first-in-human, dose-escalation and cohort expansion CLI24-001 trial.

• Ryvu’s partner Menarini Group receives FDA Orphan Drug Designation for SEL24 (MEN1703) for the Treatment of Acute Myeloid Leukemia

On November 4, Menarini Group announced that the FDA has granted an ODD to SEL24/MEN1703, a first-in-class, orally available, dual PIM/FLT3 inhibitor, in-licensed by Menarini Group from Ryvu. Currently SEL24/MEN1703 is being examined as part of the DIAMOND-01 trial as a single agent for the treatment of patients with AML. DIAMOND-01 is a First-in-Human, Phase I/II, dose escalation and cohort expansion trial of SEL24/MEN1703, investigated as a single agent for the treatment of patients with AML.

• First patient dosed in Phase I/II study of RVU120 (SEL120) in patients with relapsed/refractory (R/R) metastatic or advanced solid tumors

On August 25, Ryvu announced that the first patient was dosed in the Phase I/II clinical trial investigating RVU120 in relapsed/refractory metastatic or advanced solid tumors. The single-agent, open-label Phase I/II trial is currently enrolling patients in Poland, and site expansion to Spain is in progress.

• Publication of research on MCT4 inhibitors in the Journal of Medicinal Chemistry

On August 8, a joint publication of researchers from Ryvu Therapeutics and Merck KGaA on the discovery, development, and optimization of selective MCT4 inhibitors was published in the Journal of Medicinal Chemistry: “Discovery of 5-{2-[5-Chloro-2-(5-ethoxyquinoline-8-sulfonamido)phenyl]ethynyl}-4-methoxypyridine-2-carboxylic Acid, a Highly Selective in Vivo Useable Chemical Probe to Dissect MCT4 Biology.”

 

In Q3 2021, Ryvu participated in the following investor conferences:

• Morgan Stanley 19th Annual Global Healthcare Conference (September 9 – 15), where Ryvu’s Chief Business Officer, Vatnak Vat-Ho participated in a fireside chat as well as hosted investor meetings during the conference.
• C. Wainwright 23rd Annual Global Investment Conference (September 13 -15), where Ryvu presented during the event as well as hosted investor meetings.

 

Ryvu 2021 Third Quarter, Financial Results

In the nine months of 2021, the Company reported PLN 19.6 million (USD 5.1 million) of revenues. Over 90% of this number were grants (PLN 18.2 million or USD 4.8 million) and the remainder consisted of income from partnering (PLN 0.5 million or USD 0.1 million), other revenues (PLN 0.5 million or USD 0.1 million) and other operating revenues in total PLN 0.4 million (USD 0.1 million).

Operating costs, excluding the non-cash expense of the Incentive Program (PLN 15.0 million or USD 3.9 million), in the audited period amounted to PLN 66.2 million (USD 17.4 million), and related primarily to research and development expenditures, while the operational loss without the Incentive Program was PLN 46.6 million (USD 12.2 million) compared to PLN 24.2 million (USD 6.1 million) reported in the corresponding period in 2020. Net loss without the Incentive Program for the nine months of 2021 amounted to PLN 45.6 million (USD 12.0 million) and the reported loss for the corresponding period of 2020 amounted to PLN 20.7 million (USD 5.3 million).

On October 31, 2021, Ryvu Therapeutics held PLN 84.9 million (USD 21.3 million) in cash, cash equivalents, and short-term investments.