KRAKOW, Poland, June 10, 2020 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU) today reported its first quarter 2020 financial results and provided a corporate update.
"Q1 2020 was an exciting and eventful time for Ryvu. We have managed to achieve several important milestones including clinical ones, such as the successful completion of Phase I for SEL24/MEN1703 in acute myeloid leukemia, as well as the receipt of an Orphan Drug Designation for SEL120 for the treatment of AML patients," commented Pawel Przewiezlikowski, Chief Executive Officer of Ryvu.
"We have also secured additional non-dilutive grant financing to support the development of our synthetic lethality program. Together with very good data from our early pipeline projects, it allows us to successfully continue our mission to discover and develop drugs that will improve the lives of cancer patients and their families," adds Przewiezlikowski.
- On February 26, Ryvu signed a grant agreement for the development of targeted oncology therapies based on the synthetic lethality concept. This grant provides Ryvu with almost $8.3 million of non-dilutive financing to discover, develop and select a clinical candidate targeting cancers which had been considered in the past as largely undruggable using rational approaches. Total net value of the project amounts to $14.0 million and the anticipated project duration is until December 2023.
- On March 5, 2020 Menarini Group announced the successful completion of Phase I clinical study of SEL24/MEN1703 in Acute Myeloid Leukemia, which entitled Ryvu to receive a $1.96 million milestone payment. The full data from the study will be presented as a poster "Results of the dose escalation part of DIAMOND trial (CLI24-001): First-in-human study of SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor, in patients with acute myeloid leukemia" during the Virtual 25th EHA Congress taking place June 11-21.
Throughout the dose escalation part, SEL24/MEN1703 showed an acceptable safety profile up to the recommended dose established at 125 mg/day (14 days ON – 7 days OFF in 21-days cycles). Initial evidence of single agent efficacy was observed with 1 CR and 1 CRi in elderly patients who had exhausted standard therapeutic options. Cohort Expansion study planned in relapsed/refractory AML patients in the United States and Europe including Poland will further investigate the single agent activity and the safety profile of SEL24/MEN1703.
- On March 25, 2020 the U.S. Food and Drug Administration (FDA) granted an orphan drug designation (ODD) to Ryvu's SEL120, for the treatment of patients with acute myeloid leukemia (AML).
Important milestones in 2020, before the report date
- On April 16, Galapagos NV (Euronext &NASDAQ: GLPG) and Ryvu Therapeutics S.A. (WSE: RVU) announced a collaboration focused on the discovery and development of novel small molecule drugs in inflammation. The collaboration is based on a novel target identified by Ryvu. Ryvu will contribute its biology and chemistry platform as well as related intellectual property to the program. During the joint research collaboration, Ryvu is responsible for early drug discovery and Galapagos will be responsible for all further development of the program.
- On June 2, Ryvu obtained the occupancy permits for its newly built R&D Center for Innovative Drugs, meaning it has completed the construction of the facility. The Company plans to move to the new headquarters by the end of June 2020.
- On June 3, NodThera, Ryvu spin-off company, secured £44.5million ($54.5million) Series B financing. NodThera was founded by Epidarex Capital and Ryvu in 2016 based on world class research on NLRP3 inflammasome conducted at Ryvu (at that time Selvita) in 2012 -2016. The company focused on the development of inflammasome inhibitors has already raised over £80.8 million (over $100 million) in three funding series. After the full completion of Series B capital increase, Ryvu will own 4.8% in NodThera.
- On June 4, Ryvu signed a grant agreement for the development of targeted immuno-oncology therapy, which provides Ryvu with almost $5.6 million of non-dilutive financing to discover, develop and select a clinical candidate targeting cancers which had been considered in the past as largely undruggable using rational approaches. Total net value of the project amounts to over $8.9 million and the anticipated project duration is until December 2023.
In Q1 2020, Ryvu Therapeutics participated and presented at several investor conferences, including Solebury Trout Investor Access during JP Morgan 2020, Solebury Trout Virtual Investor Conference, BIO-Europe Spring 2020 and 32nd Annual ROTH Conference.
Ryvu First Quarter 2020, Financial Results
In the past quarter, Ryvu Therapeutics noted a 56% increase in its revenues, up to PLN 13.6 million ($3.5 million). Revenues from partnering contracts have increased from PLN 1.1 million ($0.3 million) in Q1 2019, up to PLN 7.8 million ($2.0 million) in Q1 2020.
Operational costs related in majority to the research and development expenditures, remain at a stable level and amounted to PLN 18.6 million ($4.7 million), as compared to PLN 18.4 million ($4.9 million) in same quarter last year. Operational loss has decreased and amounted to PLN 5.0 million ($1.3 million), compared to PLN 9.7 million ($2.6 million) in 1Q 2019.
On June 5, 2020, Ryvu Therapeutics held PLN 48.2 million ($11.6 million) in cash, cash equivalents, and short-term investments.
About Ryvu Therapeutics
Ryvu Therapeutics is a clinical stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology. Pipeline candidates make use of diverse therapeutic mechanisms driven by emerging knowledge of cancer biology, including small molecules directed at kinase, synthetic lethality, immuno-oncology and cancer metabolism targets. SEL120 is a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome. SEL24/MEN1703 is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group in Phase 2 clinical studies for the treatment of acute myeloid leukemia. Ryvu is listed on Warsaw Stock Exchange [WSE: RVU]. For more information, please see www.ryvu.com.
This release may contain forward-looking statements, including, among other things, statements regarding the guidance from management, financial results, timing and/or results of clinical studies, timing of the corporate split into two companies and interaction with regulators. Ryvu cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial conditions, performance or achievements of Ryvu, or industry results, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Ryvu's results, performance, financial conditions, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that Ryvu's expectations regarding development programs may be incorrect, the inherent uncertainties associated with competitive developments, clinical study and projects development activities and regulatory approval requirements, Ryvu's reliance on collaborations with third parties, and estimating the commercial potential of its development programs and Ryvu's plans regarding the corporate split and in particular its timing. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Ryvu expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
Natalia Baranowska (corporate)
Julia Balanova (investors)
SOURCE Ryvu Therapeutics