– Investigational New Drug (IND) application to conduct a Phase 1 study of selective CDK8 inhibitor SEL120 cleared by U.S. Food and Drug Administration (FDA) –
– Dosing of first patient in Phase 1 study of SEL120 expected in the third quarter of 2019 –
– Split of oncology therapeutics and research services divisions into independent public companies expected to be completed in the fourth quarter of 2019 –
Krakow, Poland – 22 May 2019 – Selvita (WSE:SLV) today reported first quarter 2019 financial results and provided a corporate update.
“In the first quarter of the year, we advanced our wholly-owned therapeutic candidate SEL120 into the clinic and announced the intent to split development and services divisions into independent companies,” commented Pawel Przewiezlikowski, Chief Executive Officer of Selvita. “We are enthusiastic about the opportunities for growth for each company and expect to complete the split in the fourth quarter of 2019. We expect to dose the first patient in our Phase 1 study of CDK8 inhibitor SEL120 in the third quarter of 2019. In addition, we continue to evaluate compounds generated by our platforms for discovery of differentiated oncology therapeutics. We are on track to select an additional candidate for clinical development by the end of the year.”
“Revenues from research services continue to grow, with self-sustaining operations within the services division,” commented Boguslaw Sieczkowski, co-founder and Chief Operating Officer of Selvita. “We have continued to develop additional capabilities and reinforce our position as a pre-eminent global provider based in Europe. Looking forward, our goal is to build on our reputation for quality, pursuing both organic growth and a strategy of consistent, sustainable acquisitions of contract research businesses.”
Oncology therapeutics research, discovery and clinical programs
- The U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) application to conduct a Phase 1 study of selective CDK8 inhibitor SEL120 in patients with acute myeloid leukemia or high-risk myelodysplastic syndromes.
- An abstract providing details of the Phase 1/2 study of SEL24/MEN1703, an oral dual PIM/FLT3 kinase discovered by Selvita, was accepted as a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place from May 31 to June 4, 2019, in Chicago.
- An abstract relating to the Phase 1/2 study of SEL24/MEN1703 was accepted as a poster presentation at the 24th Congress of the European Hematology Association taking place June 13-16, 2019, in Amsterdam.
- In March, Selvita presented preclinical data from the SEL120 CDK8 kinase inhibitor program as well as data from small-molecule STING agonist and dual A2A/A2B adenosine receptors antagonist programs at the American Association for Cancer Research (AACR) Annual Meeting.
- Selvita CRO expanded its range of capabilities offered, with updated specialized equipment and infrastructure for medicinal chemistry, increased automation, hit identification, screening, and mammalian protein expression. Investment in new technologies impacted Chemistry, Biology and Analytical Laboratory Departments, allowing increased efficiencies and expanded collaborations.
- Tom Coulter, Ph.D., an experienced developer responsible for contributing to the advancement of 15 discovery programs candidates into clinical development, was appointed to the position of Director of Integrated Drug Discovery.
- The Services Division backlog as of May 2019 reached $14.2 million and is 31 percent higher than the portfolio of orders as of May 2018.
Selvita Oncology First Quarter 2019 Financial Results
Net loss (EBITDA excluding IFRS16 impact) for the quarter ended March 31, 2019, was $2.2 million, compared to net loss of $0.6 million for the quarter ended March 31, 2018. Revenues attributable to non-dilutive grant sources were $1.9 million for the quarter ended March 31, 2019, compared to grant revenues of $1.1 million for the quarter ended March 31, 2018.
Research and development expenses were $4.9 million for the quarter ended March 31, 2019, an increase of $2.2 million, compared to $2.7 million for the same period ended March 31, 2018. The increase in research and development expenses was primarily attributable to increase in costs of SEL120 development, as well as intensified research and development activities relating to early discovery pipeline.
At March 31, 2019, Selvita Oncology held $21 million in cash, cash equivalents, and short-term investments.
Selvita CRO First Quarter 2019 Financial Results
Research Services revenues for the quarter ended March 31, 2019, were $5.0 million, an increase of $1.0 million compared to revenues of $4.0 million for the quarter ended March 31, 2018. Operating profits (EBITA excluding IFRS16 impact) in the Services Division were $0.9 million for the quarter ended March 31, 2019, as compared with $0.9 million for the same period ended March 31, 2018.
Selvita is developing novel small molecule therapies that address emerging targets in oncology with industry-leading research expertise supported by a research services division. 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 the treatment of additional hematological malignancies and in solid tumors. 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 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 conceived, incubated and launched by Selvita. In March 2019, Selvita announced the intent to split its oncology development and research services divisions into separate companies.
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.
Consolidated Statements of Operations
|Three Months Ended
|EBITDA (within IFRS16 impact – only Q1 2019)||(2,063)||(642)|
|EBITDA (IFRS16 impact excluded)||(2,191)||(642)|
Consolidated Statements of Operations
|Three Months Ended
|EBITDA (within IFRS16 impact – only Q1 2019)||1,170||848|
|EBITDA (IFRS16 impact excluded)||944||848|
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