Krakow, Poland – 6 November 2019 – Ryvu Therapeutics (WSE:RVU) today reported third quarter 2019 financial results and provided a corporate update.

“In the past quarter, we completed the split between Ryvu Therapeutics and the Selvita research services division and dosed the first patient in the Phase 1b study of CDK8 inhibitor SEL120,” commented Pawel Przewiezlikowski, Chief Executive Officer of Ryvu. “We are encouraged to be moving forward as an independent company focused on advancing our broad portfolio of therapeutic candidates in oncology. We are on track to select an additional candidate to advance into pre-clinical development. In addition, we continue to enroll patients in our study of SEL120 with initial clinical data expected in 2020.”

 

Recent Achievements

• A Phase 1b clinical trial of SEL120 in patients with acute myeloid leukemia or high-risk myelodysplastic syndrome (HR-MDS) is currently enrolling patients at multiple sites in the U.S.
• The corporate split between Ryvu Therapeutics and the Selvita CRO division was completed, with both companies trading independently on the Warsaw Stock Exchange as of Oct. 16, 2019.
• The company announced that two abstracts have been accepted for presentation at the Society for Immunotherapy of Cancer 34th Annual Meeting (SITC 2019). One presentation is related to the novel, dual A2A/A2B antagonist immunometabolism program (Poster 797) and one presentation is related to the small molecule, direct STING agonists immuno-oncology program (Poster 661).

 

Ryvu Third Quarter and Nine Months Ended Sept. 30, 2019, Financial Results

Operating loss (EBITDA excluding IFRS16 impact) for the quarter ended Sept. 30, 2019, was $2.9 million, compared to net loss of $1.3 million for the quarter ended Sept. 30, 2018. Revenues were $2.1 million for the quarter ended Sept. 30, 2019, compared to revenues of $2.0 million for the quarter ended Sept. 30, 2018. Operating expenses were $5.5 million for the quarter ended Sept. 30, 2019, an increase of $2.0 million, compared to $3.5 million for the same period ended Sept. 30, 2018.

Operating loss (EBITDA excluding IFRS16 impact) for the nine months ended Sept. 30, 2019, was $7.7 million, compared to net loss of $2.7 million for the quarter ended Sept. 30, 2018. Revenues were $6.6 million for the nine months ended Sept. 30, 2019, compared to revenues of $6.2 million for the nine months ended Sept. 30, 2018. Operating expenses were $15.5 million for the nine months ended Sept. 30, 2019, an increase of $6.0 million, compared to $9.4 million for the same period ended Sept. 30, 2018.

At Sept. 30, 2019, Ryvu Therapeutics held $22.9 million in cash, cash equivalents, and short-term investments.

 

Selvita CRO (Discontinued) Third Quarter and Nine Months Ended Sept. 30, 2019, Financial Results

Research Services revenues for the quarter ended Sept. 30, 2019, were $6.1 million, an increase of $1.8 million compared to revenues of $4.3 million for the quarter ended Sept. 30, 2018. Operating profits (EBITDA excluding IFRS16 impact) in the Services Division were $1.2 million for the quarter ended Sept. 30, 2019, as compared with $0.9 million for the same period ended Sept. 30, 2018.

Research Services revenues for the nine months ended Sept. 30, 2019, were $16.4 million, an increase of $3.9 million compared to revenues of $12.4 million for the nine months ended Sept. 30, 2018. Operating profits (EBITDA excluding IFRS16 impact) in the Services Division were $3.3 million for the nine months ended Sept. 30, 2019, as compared with $2.6 million for the same period ended Sept. 30, 2018.

 

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 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in 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 in clinical development for the treatment of acute myeloid leukemia.
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]

Rich Allan (media) +1 646 378 2958 [email protected]

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

 

 

RYVU THERAPEUTICS
Consolidated Statements of Operations
(In thousands)

 

 

SELVITA CRO (DISCONTINUED)
Consolidated Statements of Operations
(In thousands)