Ryvu Therapeutics Reports Annual 2019 Financial Results

KRAKOW, Poland, April 9, 2020 /PRNewswire/ -- Ryvu Therapeutics (WSE:RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, today reported its annual 2019 financial results and provided a corporate update.

Major Achievements

• In March 2019, the U.S. Food and Drug Administration (FDA) has cleared Ryvu’s IND application to conduct a Phase 1b study of selective CDK8 inhibitor SEL120 in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS). The first patient enrolled in the Phase 1b study of SEL120, was dosed in September 2019 and the clinical trial is currently open at six sites in the U.S.
• In April 2019 Ryvu presented data from multiple oncology programs at the 2019 AACR Annual Meeting. Poster presentations included SEL120, novel dual A2A/A2B adenosine receptor antagonists and next-generation small molecule direct STING agonists.
• In June 2019 posters on the dual PIM/FLT3 inhibitor SEL24/MEN1703 were presented at the 24^th EHA Congress and ASCO Annual Meeting.
• In August 2019, Setareh Shamsili, M.D., Ph.D. joined Ryvu Therapeutics as the Chief Medical Officer, and in October 2019 was appointed to the Executive Management Board. Dr. Shamsili, a seasoned veteran, brings more than 20 years of clinical oncology and drug development experience to Ryvu.
• The corporate split between Ryvu Therapeutics and the Selvita CRO division has been completed, with both companies trading independently on the Warsaw Stock Exchange as of October 16, 2019. During the split each Ryvu shareholder received one Selvita share in addition to each Ryvu share they already held. As of April 7, 2020 the market capitalization of spin-off company reached USD 129 million, up from USD 69 million reference level on the day of the split.
• In November 2019, Ryvu presented two poster presentations at the Society for Immunotherapy of Cancer 34th Annual Meeting: the novel, dual A2A/A2B antagonist immunometabolism program, and the small molecule, direct STING agonists immuno-oncology program.
• In December 2019, Ryvu presented progress in translational, preclinical studies and introduction to a Phase Ib clinical trials for SEL120, at the 61^st American Society of Hematology (ASH) Annual Meeting.
• Also in December 2019, Ryvu was awarded a grant funding by the Polish National Centre for Research and Development for advancing research on targeted oncology therapies based on the synthetic lethality concept. This provides Ryvu with almost USD 8.3 million of non-dilutive financing. The agreement was signed in February 2020.
• Early R&D portfolio has matured to advance projects into clinical development in upcoming years. A preclinical candidate for the A2A/A2B project was selected and non-GLP Tox studies initiated. The STING agonist program advanced to the lead stage with planned preclinical stage in 2020.

Most important milestones in 2020, before the report date

• On March 5, 2020 Menarini Group announced successful completion of Phase I clinical study of SEL24/MEN1703 in Acute Myeloid Leukemia, which entitled Ryvu to receive a USD 1.96 million milestone payment. According to the information from Menarini SEL24/MEN1703 will start enrolling patients in the dose expansion Phase 2 study in the US. and in Europe.
• 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).

Throughout 2019, Ryvu presented at numerous investor conferences including: Annual J.P. Morgan Healthcare Conference, Solebury Trout Access event, JP Morgan Conference, H.C. Wainwright 21st Annual Global Investment Conference, Jefferies 2019 Healthcare Conference, UBS 2019 Global Healthcare Conference, Biotech Showcase 2019, Ipopema Biotech Day 2019, Erste Group – Innovation Conference 2019, GPW Innovation Day, 9th Central European Life Science Investment Conference and BIO-Europe 2019.

“The past year has been very productive for Ryvu Therapeutics. We have achieved numerous corporate, research and clinical milestones which set us on a great path into 2020. After the successful spinning out of the CRO activities and creating significant incremental value for Ryvu shareholders, we are operating now as a pure-play small molecule oncology therapeutics company,” commented Pawel Przewiezlikowski, Chief Executive Officer of Ryvu.

“With first patients being treated in our Phase I study of SEL120, successful completion of Phase I by SEL24/MEN1703, exciting data for our STING agonist and A2A/A2B antagonist programs, as well as additional non-dilutive financing from grants, we are ready to continue with our mission to discover and develop drugs that will improve the lives of cancer patients and their families.”

Ryvu Annual 2019, Financial Results under IFRS

Operating expenses were USD 5.0 million for the quarter ended Dec. 31, 2019, a decrease of USD 0.7 million, compared to USD 5.7 million for the same period ended Dec. 31, 2018. Revenues were USD 2.1 million for the quarter ended Dec. 31, 2019, compared to revenues of USD 3.3 million for the quarter ended Dec. 31, 2018. EBITDA excluding IFRS16 impact for the quarter ended Dec. 31, 2019, was USD 2.4 million, compared to USD 2.0 million for the quarter ended Dec. 31, 2018.

Operating expenses were USD 20.7 million for the twelve months ended Dec. 31, 2019, an increase of USD 4.6 million, compared to USD 16.1 million for the same period ended Dec. 31, 2018. Revenues were USD 8.9 million for the twelve months ended Dec. 31, 2019, compared to revenues of USD 10.2 million for the twelve months ended Dec. 31, 2018. EBITDA excluding IFRS16 impact for the twelve months ended Dec. 31, 2019, was USD 10.2 million, compared to USD 5.0 million for the twelve months ended Dec. 31, 2018.

At Dec. 31, 2019, Ryvu Therapeutics held USD 19.0 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 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 clinical development for the treatment of acute myeloid leukemia.

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

Forward-Looking Statements

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.

Contacts:
Natalia Baranowska (corporate)
+48-784-069-418
natalia.baranowska@ryvu.com

Julia Balanova (investors)
+1-646-378-2936
jbalanova@troutgroup.com

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SOURCE Ryvu Therapeutics

Company Codes: Warsaw:RVU