KRAKOW, Poland, Nov. 6,
2019 /PRNewswire/ -- 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 Second 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) Second 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.
RYVU
THERAPEUTICS
Consolidated Statements of Operations
(In thousands)
|
|
Three Months
Ended
Sept. 30,
|
|
2019
|
2018
|
External
revenue
|
313
|
556
|
Subsidies
revenue
|
1,778
|
1,477
|
Other operating
revenue
|
11
|
10
|
Total
revenue
|
2,102
|
2,043
|
Operating
expenses
|
5,473
|
3,505
|
EBIT
|
(3,371)
|
(1,462)
|
EBITDA (with IFRS16 impact ->
only Q3 2019)
|
(2,821)
|
n/a
|
EBITDA (IFRS16 impact
excluded)
|
(2,919)
|
(1,275)
|
|
|
|
SELVITA CRO
(DISCONTINUED)
Consolidated Statements of Operations
(In thousands)
|
|
Three Months
Ended
Sept. 30,
|
|
2019
|
2018
|
External
revenue
|
5,577
|
3,856
|
Internal
revenue
|
196
|
190
|
Subsidies
revenue
|
219
|
192
|
Other operating
revenue
|
61
|
38
|
Total
revenue
|
6,052
|
4,276
|
Operating
expenses
|
5,285
|
3,694
|
EBIT
|
767
|
582
|
EBITDA (with IFRS16 impact ->
only Q1 2019)
|
1,433
|
n/a
|
EBITDA (IFRS16 impact
excluded)
|
1,193
|
908
|
|
|
|
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SOURCE Ryvu Therapeutics S.A.