On May 12, 2021 Ryvu Therapeutics (WSE: RVU) reported its first quarter 2021 financial results and provided a corporate update (Press release, Ryvu Therapeutics, MAY 12, 2021, View Source [SID1234579833]).
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"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 22nd 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) (Free AACR Whitepaper) 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: View Source
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 1×1 Management Access Event, HCW Bioconnect Conference, IPOPEMA & Sova Capital: EM Medical/Healthcare Day, BIO-Europe Spring 2021 and AACR (Free AACR Whitepaper) 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.