Ryvu Therapeutics reports financial results for 2020

KRAKOW, Poland, March 16, 2021 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported today its financial results for 2020 highlighting the increase in revenues to PLN 37.3 million, including PLN 15.4 million from partnering agreements and recapped on the most significant clinical and corporate milestones of the past year.

"The year 2020 was very eventful for us. We announced an updated development strategy, made significant progress in clinical projects and, with the move to our new headquarters, we have completed the largest investment in Ryvu 13-year history. We are working at full speed to bring new treatments to oncology patients and 2021 is shaping up to be an important year for the company" – said Pawel Przewiezlikowski, CEO of Ryvu Therapeutics.

Przewiezlikowski also draws attention to the most important achievements of the Company in the passing year:

Strengthening our resources

"We raised over USD 36 million from the share issue in July 2020, which combined with the grant financing received, gives us financial resources required to fulfill all the goals set until 2023. We have also completed an investment into our fully-owned R&D Center for Innovative Drugs in Krakow. We moved to our new laboratories, finalizing the corporate division between Ryvu and Selvita, now in distinct locations. What's more, additional research space allows us to scale up our discovery and development activities."

We are bringing oncology treatments closer to patients

"SEL24/MEN1703 has successfully completed Phase I Clinical Study in Acute Myeloid Leukemia (AML). A couple of months later, the first patient was dosed with SEL24/MEN1703 in Europe within the Expansion Cohort of Phase I/II Study also in AML.

RVU120 (formerly SEL120), our flagship, fully-owned first in class CDK8/CDK9 inhibitor, has progressed through its first Phase I study in AML and myeloid dysplastic syndrome. The Phase Ib study is on-going in six clinical sites in the U.S. In order to de-risk the study and provide a platform for future development, we decided to activate additional sites in Europe, including Poland. We have already received appropriate official approvals to start research in our country and one of the European countries.

We are also investigating the development potential of RVU120 in multiple solid tumors, which can potentially significantly increase the market potential for our molecule. We submitted appropriate applications to start clinical trials in 2021. In March this year, we signed a contract with Covance Inc. for the execution of Phase I studies for RVU120 in solid tumors.

In 2020, We have initiated and are developing a promising research collaboration with Galapagos NV in the area of inflammatory diseases.

Throughout the year, we actively presented our projects at several scientific and investor conferences.

We assured business continuity and safety of our employees during COVID-19 pandemic introducing the highest sanitary standards and preventive measures."

Major Achievements

February 2020: 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.

March 2020:

• 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 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.
• 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). The FDA's orphan drug designation allows the drug for the designated indication to be eligible for requesting a seven-year period of U.S. marketing exclusivity upon approval of the drug, as well as potential of other development assistance and financial incentives.

April 2020: 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 the further development of this program.

June 2020:

• 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. The laboratory-office complex is made up of 6 floors with a total area of ca. 108,000 sq. ft. At the heart of the new Ryvu facility is an array of laboratories incl. medicinal chemistry, biochemistry, cell & molecular biology and analytical chemistry, capable of accommodating up to 300 employees. The newly built facilities are located at Sternbach St., named after Dr. Leo Sternbach, a graduate of Jagiellonian University who went on to discover Vallium, the most prescribed drug in the history of the pharmaceutical industry. New building offers Ryvu additional research space and comfort, which turned out to be a great advantage for Ryvu during COVID-19 spatial restrictions. Cost of the investment, including the purchase of a plot of land and laboratory equipment, incurred until February, 2021, amounted to approximately USD 21.2 million, of which ca. USD 6.7 million was covered by the grant financing.
• 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% share 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.
• 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.
• On June 22-24, Ryvu presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting II the most recent data from its oncology projects, including results from the small-molecule STING agonists, dual A2A/A2B adenosine receptors antagonist program, HPK1 inhibitors and SMARCA2 (BRM) degraders program.

July 2020: Ryvu successfully closed its series I follow-on share offering, with 2,384,245 shares offered at a price of PLN 60 per share. The Company raised over USD 36 million (PLN 143 million) of new capital. Proceeds from the share issue will be allocated primarily to Company's R&D programs.

September 2020: The first patient has been treated in Europe for the cohort expansion part of Phase II DIAMOND-01 clinical trial (CLI24-001; NCT03008187) investigating SEL24/MEN1703, a first-in-class, oral dual PIM/FLT3 inhibitor, as a single agent in Acute Myeloid Leukemia (AML).

October 2020: The Management Board of the Company made a strategic decision to revise its preclinical projects' pipeline. As a consequence, the Company stopped the development of two projects: a dual adenosine receptor antagonist (A2A/A2B) and the project in the area of synthetic lethality (SMARCA2). The above decision was made after consultation with the Supervisory Board of the Company. Ryvu now intends to concentrate its resources on the SEL120 project, currently in Phase I clinical trials, as well as the remaining preclinical projects, and assign financing to newly initiated discovery and development projects in the area of synthetic lethality.

November 2020: Ryvu presented its poster regarding the STING agonists program – "Development of improved small molecule STING agonists suitable for systemic administration", at the Society for Immunotherapy of Cancer 35th Anniversary Annual Meeting (SITC 2020).

December 2020: Announcement of the positive results of the pharmacodynamic assay demonstrating target engagement in the dose escalation part of the DIAMOND-01 trial (CLI24-001; clinicaltrials.gov identifier NCT03008187), a study investigating SEL24/MEN1703 – first-in-class, orally available, dual PIM/FLT3 inhibitor as single agent in acute myeloid leukemia (AML). The poster entitled "SEL24/MEN1703 provides PIM/FLT3 Downstream Pathway Inhibition in Acute Myeloid Leukemia (AML) Blast Cells: Results of the Pharmacodynamic (PD) Assay in the Dose Escalation Part of First-in-Human DIAMOND Trial" was presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.

Throughout 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,
• Society for Immunotherapy of Cancer 35th Anniversary Annual Meeting (SITC 2020),
• 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,
• 32nd Annual ROTH Conference,
• H.C. Wainwright & Co. 22nd Annual Global Investment Conference,
• Erste Group Innovation Conference 2020,
• Trigon Investor Week,
• The Finest CEElection Investor Conference by Erste Group,
• BIO-Europe 2020 - one of the global biotechnology flagship events.

Important events in Q1 2021, until the report publication date

January 2021:

• Ryvu has submitted a new Clinical Trial Application (CTA), seeking approval to commence a Phase I/II trial, investigating the safety and efficacy of RVU120 in patients with relapsed / refractory metastatic or advanced solid tumors. The study will start in selected investigational sites in Europe, and later on at start of phase II, will expand also to other regions.
• Ryvu Therapeutics' CTA to commence the First In Human (FIH), Phase I trial investigating RVU120, a selective CDK8/CDK19 inhibitor, 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 Therapeutics can expand the clinical trial already ongoing in the United States also in Poland, aiming to assess the safety and tolerability of RVU120, as well as to determine the Recommended Phase II Dose (RP2D) of the study drug, in participants with AML or HRMDS.

March 2020: Ryvu Therapeutics has concluded a service agreement with Covance Inc. to conduct a Phase I (dose escalation) part of a Phase I/II clinical study – aimed at determining the safety and efficacy profile of RVU120 (SEL120) in patients with relapsed/refractory metastatic or advanced solid tumors.

Ryvu Financial Results 2020 acc. to IFRS

In 2020 Ryvu Therapeutics recognized total operating revenue of USD 9.6 million, which constitutes the increase of 9%* compared to the corresponding period in 2019. Revenues from partnering contracts have increased to USD 4.0 million from USD 1.0 million comparing to the corresponding period in 2019. Revenue from subsidies decreased to USD 5.5 million from USD 7.8 million in the previous period year.

Operational costs related in majority to the research and development expenditures amounted in 2020 to USD 18.7 million, as compared to USD 20.7 million in the same period last year. Operational loss has decreased and amounted to USD 9.2 million, compared to USD 11.8 million in 2019. Net loss amounted to USD 8.1 million compared to USD 11.5 million from the previous year. The realized financial result is in line with Ryvu's strategy, since the company focuses on the increase of projects value, taking into account the plan of commercialization on later stages of development.

As of December 31, 2020, the value of the Company's liquid financial resources amounted to USD 42.9 million. On March 10, 2021, all liquid financial resources amounted to USD 40.3 million – decrease is caused mainly by operating costs and capital expenditure.

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

About Ryvu Therapeutics

Ryvu Therapeutics is a clinical stage drug discovery and development 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 and immuno-oncology 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. 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.

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.

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SOURCE Ryvu Therapeutics