Ryvu Therapeutics Reports 2020 Half-Year Financial Results

KRAKOW, Poland, Sept. 15, 2020 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, reported today its 2020 H1 financial results and provided a corporate update.

"At Ryvu, we always excelled in moving forward at a rapid pace; however, the first half of 2020 was an exceptionally eventful and intensive period for us. We have managed to achieve a couple of significant clinical milestones such as 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.

"We announced a collaboration with Galapagos focused on the discovery and development of novel small molecule drugs in inflammation. In June, we completed the construction of the R&D Center for Innovative Drugs and subsequently moved into our new laboratories and offices. Soon afterward, we have announced our updated development strategy for 2020-2022, which was followed by the issue of series I shares and raise of over USD 36 million of new capital" - commented Pawel Przewiezlikowski, Chief Executive Officer of Ryvu.

"We have also secured additional non-dilutive grant financing to support the development of our targeted immuno-oncology program. Despite the global pandemic, we participated in numerous scientific and business conferences presenting very good data from our early pipeline projects. What is exceptional is that we managed to do all of this and much more during the ongoing COVID-19 pandemic, including the continuation of SEL120 Phase I study in AML/MDS in the U.S.

"The epidemiological situation required us to adopt numerous preventive measures across our entire organization to keep our scientists safe and, at the same time, assure business continuity. I believe we passed that test with flying colors, and I am proud of the work we have done at Ryvu in these six months" – adds Przewiezlikowski.

Recent Achievements

• On February 21, Ryvu signed a grant agreement for the development of targeted oncology therapies based on the synthetic lethality concept. This grant provides Ryvu with almost USD 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. The total net value of the project amounts to USD 14 million, and the anticipated project duration is until December 2023.

• On March 5, Menarini Group announced the 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. The full data from the study was 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 25^th 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. A 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 27, 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).

• On April 15, Galapagos NV (Euronext & NASDAQ: GLPG) and Ryvu Therapeutics announced a collaboration focused on the discovery and development of novel small molecule drugs in inflammation. 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. Subsequently, Ryvu has initiated its move to the new headquarters.

• On June 3, NodThera, Ryvu spin-off company, secured GBP 44.5 million (USD 54.5 million) 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 GBP 80.8 million (over USD 100 million) in three funding series. After the full completion of Series B capital increase, Ryvu owns 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 USD 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. The total net value of the project amounts to over USD 8.9 million, and the anticipated project duration is until December 2023.

• On June 15, Ryvu announced its updated development strategy for 2020-2022, which assumes, i.a.: completing Phase I clinical development of SEL120 in AML/MDS by the end of 2022, expanding therapeutic potential for SEL120 in solid tumors and launching a new Phase I study in selected indications in parallel to the ongoing hemato-oncology studies, advancing at least one program into the Phase I of clinical trials from preclinical pipeline.

Important milestones in 2020, before the report date

• On July 22, the Extraordinary General Meeting of Ryvu Therapeutics' Shareholders has decided to issue up to 2,384,245 Series I ordinary bearer shares, with the exclusion of pre-emptive rights. The share issue constituted up to 15 percent of the current Company's share capital. As a result, Ryvu Therapeutics raised over USD 36 million. Proceeds from the share issue will be allocated primarily to the Company's R&D programs.

In H1 2020, Ryvu Therapeutics participated and presented at several scientific and investor conferences, including AACR 2020 Virtual Annual Meeting, Virtual 25th Annual European Hematology Association (EHA) Congress, Jefferies 2020 Virtual Healthcare Conference, BIO Digital 2020, Solebury Trout Investor Access during JP Morgan 2020, Solebury Trout Virtual Investor Conference, BIO-Europe Spring 2020 and 32nd Annual ROTH Conference.

Ryvu 2020 Half-Year Financial Results

In the first half of 2020, Ryvu Therapeutics noted a 38%* increase in its revenues, up to PLN 24.5 million (USD 6.1 million). Revenues from partnering contracts have increased from PLN 1.9 million (USD 0.5 million ) in H1 2019, up to PLN 14.7 million (USD 3.7 million ) in H1 2020.

Operational costs related in majority to the research and development expenditures amounted in H1 2020 to PLN 36.3 million (USD 9.1 million), as compared to PLN 38.7 million (USD 10.2 million) in the same period last year. Operational loss has decreased and amounted to PLN 11.8 million (USD 3.0 million), compared to PLN 21 million (USD 5.5 million) in H1 2019.

On June 30, 2020, Ryvu Therapeutics held PLN 38.5 million  (USD 9.7 million) in cash, cash equivalents, and short-term investments. On September 10, the balance, following the share issue, amounted to PLN 176.9 million (USD 44.4 million).

*Percentage changes in the press release are calculated based on the functional currency [PLN].

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 Phase 1b clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome. The second clinical program of Ryvu is SEL24/MEN1703, a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently in Phase II clinical studies in acute myeloid leukemia.

Other Ryvu programs developed through internal discovery platform are focused on new oncology targets in kinases, synthetic lethality, immuno-oncology and immunometabolism.

The Company was founded in 2007 (until 2019 operating under the name Selvita S.A.) and currently employs more than 150 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 has been a component of sWIG80 index since March 2017. 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
[email protected]

Julia Balanova (investors)
+1 646 378 2936
[email protected]

SOURCE Ryvu Therapeutics