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KRAKOW, Poland, May 12, 2021 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU) reported today its first quarter 2021 financial results and provided a corporate update.

"Q1 2021 was an eventful quarter for Ryvu and developments around RVU120 played a key role in it" - commented Pawel Przewiezlikowski, Chief Executive Officer of Ryvu. "We have submitted a clinical trial application to conduct a Phase I/II study of RVU120 in patients with solid tumors, and shortly after that we received an approval to expand the ongoing Phase I of RVU120 in AML and high risk MDS from US sites to Poland. We have also secured a non-dilutive grant to finance the RVU120 solid tumor study. Despite the recent partial clinical hold imposed on RVU120 Phase Ib study, we have achieved meaningful research progress in our clinical and pre-clinical pipeline in these first months of 2021. Patient safety is Ryvu's priority, and we are working diligently to answer the FDA questions and expect to resume study enrollment as soon as possible. At the same time we believe that RVU120 continues to be a promising treatment option for cancer patients and we hope to soon resume investigating the therapeutic potential which this compound holds" – adds Przewiezlikowski.

Recent Achievements

• RVU120 Solid Tumor CTA submission

On January 04, Ryvu submitted a new Clinical Trial Application (CTA), seeking approval to commence a Phase I/II trial, investigating the safety and efficacy of RVU120 (SEL120), a first-in-class, selective oral CDK8/19 inhibitor, in patients with relapsed/refractory metastatic or advanced solid tumors. The CTA has been submitted to the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and to the study Central Ethics Committee. Following the approval of the CTA, expected in H1 2021, Ryvu Therapeutics will be able to activate the selected clinical sites in Poland and start enrolling patients.

• RVU120 AML CTA approval

On January 07, Ryvu announced that its Clinical Trial Application (CTA) to commence the first-in-human (FIH), Phase I trial investigating RVU120, in patients with Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (HRMDS), who have failed the prior standard treatment, has been fully approved by the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, and the respective Central Ethics Committee. Following these approvals, Ryvu can expand the clinical trial ongoing in the United States to Poland, aiming to assess the safety and tolerability of RVU120 and to determine the recommended Phase II dose (RP2D) of the study drug, in participants with AML or HRMDS.

• USD 5 million non-dilutive grant financing secured

On January 18, Ryvu announced that its project titled "Clinical development of an innovative drug candidate in solid tumors", which focuses on Phase I/II evaluation of RVU120 in patients with solid tumors, has been approved for financing by the National Center for Research and Development (NCBiR). This grant provides Ryvu with $5.0 million of non-dilutive financing. The total net value of the project amounts to $11.1 million and the anticipated project duration is until December 2023.

• Distinction in Warsaw Stock Exchange Company of the Year competition

On March 16, Ryvu was awarded third place in the "Products and Services Innovation" category in the Warsaw Stock Exchange Company of the Year competition. The Stock Exchange Company of the Year competition is organized by "Puls Biznesu" – one of the largest business daily publications in Poland. It was the 22^nd edition of the competition, the oldest and the most prestigious ranking in the Polish capital market. Every year the best publicly traded companies on the Warsaw stock exchange are awarded by a jury comprised of market analysts, investment advisers and managers, institutional investors, and securities house representatives.

Important milestones in 2021, before the report date

• On April 10-15, Ryvu presented recent data from multiple oncology programs at the American Association of Cancer Research (AACR) Virtual Annual Meeting 2021. Data presented included results from the RVU120, a CDK8/CDK19 inhibitor program, as well as data from small-molecule STING agonists and HPK1 inhibitor projects. Presented posters can be downloaded from Ryvu's website: https://ryvu.com/investors-media/publications/.
• On April 08, Ryvu announced the U.S. Food and Drug Administration placed a partial clinical hold on the first-in-human Phase Ib, dose escalation clinical trial of RVU120 in patients with relapsed/refractory (R/R) AML and high-risk MDS, being conducted in the United States. Patients who are currently taking RVU120 may continue treatment in the study, but no new patients may be enrolled in the study until the partial clinical hold is lifted by the FDA.
• The partial clinical hold was initiated following Ryvu's recent report to the FDA of a Serious Adverse Event involving a patient death, classified as possibly related to RVU120. One of the two patients enrolled in Cohort 5, 110 mg dose level, of RVU120 experienced a fatal incidence of "Worsening Pancreatitis". The other patient in the same dose cohort, completed the 1st treatment cycle without any serious adverse events (SAE) reported by the investigational site and entered Cycle 2. There are currently two patients continuing to receive treatment with RVU120 in the study.
• On April 26, Ryvu announced the appointment of Vatnak Vat-Ho to the role of Chief Business Officer. As CBO, Mr. Vat-Ho will be responsible for a wide scope of corporate and business development activities at Ryvu including strategic positioning, partnering discussions, alliance management as well as investor interactions.

In Q1 2021, Ryvu Therapeutics participated and presented at several investor conferences, including Solebury Trout 1x1 Management Access Event, HCW Bioconnect Conference, IPOPEMA & Sova Capital: EM Medical/Healthcare Day, BIO-Europe Spring 2021 and AACR Virtual Annual Meeting 2021.

Ryvu First Quarter 2021, Financial Results

In the past quarter, Ryvu Therapeutics noted a 51% decrease in its revenues, down to PLN 6.6 million ($1.8 million). Revenues from subsidies have slightly increased from PLN 5.7 million ($1.5 million) in Q1 2020, up to PLN 6.1 million ($1.6 million) in Q1 2021, however, there were no significant partnering revenues in Q1 2021 compared to Q1 2020, when milestone from SEL24 / MEN1703 was recognized.

Operational costs related in majority to the research and development expenditures, increased by 20% to PLN 22.3 million ($5.9 million), as compared to PLN 18.6 million ($4.7 million) in first quarter last year. Operational loss has increased and amounted to PLN 15.7 million ($4.1 million), compared to PLN 5.0 million ($1.3 million) in Q1 2020.

On May 5, 2021, Ryvu Therapeutics held PLN 129.3 million ($32.6 million) in cash, cash equivalents, and short-term investments.

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 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. RVU120 (SEL120) is a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in Phase 1b 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, currently in Phase II clinical studies in acute myeloid leukemia.

The Company was founded in 2007 (until 2019 operating under the name Selvita S.A.) and currently employs over 160 associates, including more than 80 PhDs. Ryvu is headquartered in Krakow, Poland. Ryvu Therapeutics is listed on the main market of the Warsaw Stock Exchange, and is a component of sWIG80 index. 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.

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SOURCE Ryvu Therapeutics