0RKT Selvita Sa

KRAKOW, Poland, Sept. 5, 2019 /PRNewswire/ -- Selvita (WSE: SLV) today reported second quarter 2019 financial results and provided a corporate update.

"We continue to execute on the priorities we set out early in the year," commented Pawel Przewiezlikowski, Chief Executive Officer of Selvita. "We expect to see our oncology therapeutics and research services divisions operate as independent public companies in the fourth quarter of 2019, and our portfolio programs continue to advance as expected. Dosing of the first patient in our Phase 1 study of CDK8 inhibitor SEL120 is expected in the third quarter of 2019 and we expect to select an additional candidate to advance into clinical development by the end of 2019."

Recent Achievements

• In June, a poster relating to the Phase 1/2 study of SEL24/MEN1703, an oral dual PIM/FLT3 kinase discovered by Selvita, was presented at the 24th Congress of the European Hematology Association (Abstract PF281).
• In June, a poster relating to the Phase 1/2 study of SEL24/MEN1703 at the American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS7062).

Selvita Oncology Second Quarter and Six Months Ended June 30, 2019 Financial Results

Operating loss (EBITDA excluding IFRS16 impact) for the quarter ended June 30, 2019, was $(2.7) million, compared to net loss of $(0.8) million for the quarter ended June 30, 2018. Revenues attributable to non-dilutive grant sources were $2.1 million for the quarter ended June 30, 2019, compared to grant revenues of $1.6 million for the quarter ended June 30, 2018. Research and development expenses were $5.0 million for the quarter ended June 30, 2019, an increase of $1.8 million, compared to $3.2 million for the same period ended June 30, 2018. The increase in research and development expenses was primarily attributable to the fact that the Group strongly focuses on the development of its own research projects and preparing them for commercialization at the later stages of development.

Operating loss (EBITDA excluding IFRS16 impact) for the six months ended June 30, 2019, was $(4.9) million, compared to net loss of $(1.4) million for the quarter ended June 30, 2018. Revenues attributable to non-dilutive grant sources were $4.1 million for the six months ended June 30, 2019, compared to grant revenues of $2.7 million for the six months ended June 30, 2018. Research and development expenses were $9.5 million for the six months ended June 30, 2019, an increase of $4.0 million, compared to $5.5 million for the same period ended June 30, 2018.

At June 30, 2019, Selvita Oncology held $20 million in cash, cash equivalents, and short-term investments.

Selvita CRO Second Quarter and Six Months Ended June 30, 2019 Financial Results

Research Services revenues for the quarter ended June 30, 2019, were $5.5 million, an increase of $1.3 million compared to revenues of $4.2 million for the quarter ended June 30, 2018. Operating profits (EBITDA excluding IFRS16 impact) in the Services Division were $1.2 million for the quarter ended June 30, 2019, as compared with $0.9 million for the same period ended June 30, 2018.

Research Services revenues for the six months ended June 30, 2019, were $10.4 million, an increase of $2.2 million compared to revenues of $8.2 million for the quarter ended June 30, 2018. Operating profits (EBITDA excluding IFRS16 impact) in the Services Division were $2.1 million for the quarter ended June 30, 2019, as compared with $1.8 million for the same period ended June 30, 2018.

About Selvita

Selvita is developing novel small molecule therapies that address emerging targets and novel pathways in oncology with industry-leading research expertise. 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 in Phase 1 clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndromes, with potential for development in multiple hematological cancers and solid tumor indications. SEL24/MEN1703 is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group in Phase 1/2 clinical development for the treatment of acute myeloid leukemia. Selvita is headquartered in Krakow, Poland, with offices in the U.S. and U.K. Ardigen, a provider of precision medicine and artificial intelligence services, and NodThera, a company developing a new class of medicines to treat chronic inflammation, were launched by Selvita. In March 2019, Selvita announced the intent to split its oncology development and research services divisions into separate companies.

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. Selvita 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 Selvita, 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 Selvita'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 Selvita'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, Selvita's reliance on collaborations with third parties, and estimating the commercial potential of its development programs and Selvita'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. Selvita 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.

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SOURCE Selvita