KRAKOW, Poland, May 22,
2019 /PRNewswire/ -- 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."
Recent Achievements
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.
Research services
- 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.
About Selvita
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.
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.
SELVITA
ONCOLOGY
|
Consolidated
Statements of Operations
|
(In
thousands)
|
|
|
Three Months
Ended
March 31,
|
|
2019
|
2018
|
External
revenue
|
281
|
735
|
Grant
revenue
|
1,992
|
1,106
|
Total
revenue
|
2,272
|
1,841
|
|
|
|
Operating
expenses
|
4,778
|
2,652
|
|
|
|
EBIT
|
(2,505)
|
(810)
|
|
|
|
EBITDA (with IFRS16 impact ->
only Q1 2019)
|
(2,063)
|
(642)
|
|
|
|
EBITDA (IFRS16 impact
excluded)
|
(2,191)
|
(642)
|
|
|
|
SELVITA
CRO
|
Consolidated
Statements of Operations
|
(In
thousands)
|
|
|
Three Months
Ended
March 31,
|
|
2019
|
2018
|
External
revenue
|
4,580
|
3,601
|
Internal
revenue
|
145
|
225
|
Grant
revenue
|
231
|
191
|
Total
revenue
|
4,956
|
4,016
|
|
|
|
Operating
expenses
|
4,448
|
3,443
|
|
|
|
EBIT
|
508
|
574
|
|
|
|
EBITDA (with IFRS16 impact ->
only Q1 2019)
|
1,170
|
848
|
|
|
|
EBITDA (IFRS16 impact
excluded)
|
944
|
848
|
|
|
|
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SOURCE Selvita