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.
SELVITA
ONCOLOGY Consolidated Statements of
Operations (In thousands)
|
|
|
|
Three Months
Ended
June 30,
|
|
2019
|
2018
|
External
revenue
|
229
|
804
|
Grant
revenue
|
2,084
|
1,622
|
Total
revenue
|
2,313
|
2,426
|
|
|
|
Operating
expenses
|
5,326
|
3,400
|
|
|
|
EBIT
|
(3,013)
|
(974)
|
|
|
|
EBITDA (with IFRS16 impact ->
only Q1 2019)
|
(2,517)
|
(722)
|
|
|
|
EBITDA (IFRS16 impact
excluded)
|
(2,658)
|
(772)
|
|
|
|
SELVITA
CRO Consolidated Statements of
Operations (In thousands)
|
|
|
|
Three Months
Ended
June 30,
|
|
2019
|
2018
|
External
revenue
|
5,120
|
3,777
|
Internal
revenue
|
164
|
185
|
Grant
revenue
|
220
|
233
|
Total
revenue
|
5,504
|
4,195
|
|
|
|
Operating
expenses
|
4,807
|
3,579
|
|
|
|
EBIT
|
697
|
616
|
|
|
|
EBITDA (with IFRS16 impact ->
only Q1 2019)
|
1,372
|
913
|
|
|
|
EBITDA (IFRS16 impact
excluded)
|
1,167
|
913
|
|
|
|
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SOURCE Selvita