Krakow, Poland – November 19, 2020 – Ryvu Therapeutics (WSE: RVU), a clinical-stage biopharmaceutical company developing novel small molecule therapies that address emerging targets in oncology, reported today its Q3 2020 financial results and provided a corporate update.
“After an exceptionally eventful and intensive period of the H1 2020, third quarter of 2020 kept us equally busy and engaged.
We have successfully closed an I series of a Follow On offering, raising over USD 36 million of equity. The Expansion Cohort of Phase I/II Clinical Study of SEL24/MEN1703 in Acute Myeloid Leukemia (AML) was expanded to include the European sites, with first patient dosed in September.
Phase Ib clinical study in AML/MDS for our flagship compound SEL120 was active in six U.S. clinical sites. In order to diversify the recruitment risk associated with the current COVID-19 pandemic, we decided to activate the clinical sites in Europe, including Poland.
What is more, we began planning and preparations for the initiation of Phase I/II of SEL120 in selected solid tumor indications. The study is expected to commence in early 2021.
We have participated in numerous events and conferences presenting the most recent data in our pipeline to the potential biotech and pharma industry partners, as well as investors.
At the same time, we continue to operate in the altered reality caused by the COVID-19 pandemic, switching our business development activities into remote mode, continuing to adopt numerous preventive measures across our entire organization to keep our employees safe and, at the same time, assure business continuity.” – says Pawel Przewiezlikowski, Chief Executive Officer at Ryvu Therapeutics.
- In July, the Company has completed its move to the newly built headquarters – R&D Center for Innovative Drugs. 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.
- On July 13, 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. On July 15 the Management Board of Ryvu set an issue price at PLN 60 per share.
- On July 22, 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 including: the clinical development of SEL120 in the area of solid tumors (27%) and in AML/MDS (9%), further development of preclinical (20%) and discovery programs (22%). The share issue constitutes one of the elements of Ryvu Therapeutics development strategy for 2020-2022
- On September 15, 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 single agent in Acute Myeloid Leukemia (AML).
- On October 15, Ryvu announced that its abstract regarding the STING agonists program has been accepted for presentation at the upcoming Society for Immunotherapy of Cancer 35th Anniversary Annual Meeting (SITC 2020) taking place November 9-14, 2020. Currently, the poster “Development of improved small molecule STING agonists suitable for systemic administration” can be downloaded from the company website: https://ryvu.com/investors-media/publications/
In Q3 2020, Ryvu Therapeutics participated and presented at several scientific and investor conferences, including 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 and one of the global biotechnology flagship events – BIO-Europe 2020.
Important events before the report date
- On October 21, the Management Board of the Company made a decision to revise its preclinical projects’ pipeline. As a consequence, the Company took a decision stop 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.
Ryvu Q3 YTD 2020 and Q3 Financial Results
In the first nine months of 2020, Ryvu Therapeutics noted a 16%* increase in its revenues, up to PLN 30.0 mln (USD 7.6 mln). Revenues from partnering contracts have increased from PLN 3.1 mln (USD 0.8 mln) in Q3YTD 2019, up to PLN 15.2 mln (USD 3.8 mln) in Q3YTD 2020.
Operational costs related in majority to the research and development expenditures amounted in Q3YTD 2020 to PLN 54.2 mln (USD 13.8 mln), as compared to PLN 60.1 mln (USD 15.7 mln) in the same period last year. Operational loss has decreased and amounted to PLN 24.2 mln (USD 6.1 mln), compared to PLN 34.3 mln (USD 9.0 mln) in Q3YTD 2019.
Q3 revenues decreased by 32% from PLN 8.1 mln (USD 2.1 mln) to PLN 5.5 mln (USD 1.4 mln) mainly as a result of lower expenditure on subsidy projects and higher on projects not subsidized. Third quarter 2020 costs was PLN 17.9 mln (USD 4.7 mln) as compared to PLN 21.5 mln (USD 5.5 mln) in comparable quarter of 2019. Operating loss has decreased to PLN 12.4 mln (USD 3.3 mln) from PLN 13.3 mln (USD 3.4 mln).
On November 12, 2020, Ryvu Therapeutics held PLN 151.8 mln (USD 39.3 mln) in cash, cash equivalents, and short-term investments.
* Percentage changes in the press release are calculated based on the functional currency [PLN].
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.