KRAKOW, Poland, June 10,
2020 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU) today
reported its first quarter 2020 financial results and provided a
corporate update.
"Q1 2020 was an exciting and eventful time for Ryvu. We have
managed to achieve several important milestones including clinical
ones, such as the successful completion of Phase I for
SEL24/MEN1703 in acute myeloid leukemia, as well as the receipt of
an Orphan Drug Designation for SEL120 for the treatment of AML
patients," commented Pawel Przewiezlikowski, Chief
Executive Officer of Ryvu.
"We have also secured additional non-dilutive grant financing
to support the development of our synthetic lethality program.
Together with very good data from our early pipeline projects, it
allows us to successfully continue our mission to discover and
develop drugs that will improve the lives of cancer patients and
their families," adds Przewiezlikowski.
Recent Achievements
- On February 26, Ryvu signed a
grant agreement for the development of targeted oncology therapies
based on the synthetic lethality concept. This grant provides Ryvu
with almost $8.3 million of
non-dilutive financing to discover, develop and select a clinical
candidate targeting cancers which had been considered in the past
as largely undruggable using rational approaches. Total net value
of the project amounts to $14.0
million and the anticipated project duration is until
December 2023.
- On March 5, 2020 Menarini Group
announced the successful completion of Phase I clinical study of
SEL24/MEN1703 in Acute Myeloid Leukemia, which entitled Ryvu to
receive a $1.96 million milestone
payment. The full data from the study will be presented as a poster
"Results of the dose escalation part of DIAMOND trial (CLI24-001):
First-in-human study of SEL24/MEN1703, a dual PIM/FLT3 kinase
inhibitor, in patients with acute myeloid leukemia" during the
Virtual 25th EHA Congress taking place June 11-21.
Throughout the dose escalation part, SEL24/MEN1703 showed an
acceptable safety profile up to the recommended dose established at
125 mg/day (14 days ON – 7 days OFF in 21-days cycles). Initial
evidence of single agent efficacy was observed with 1 CR and 1 CRi
in elderly patients who had exhausted standard therapeutic options.
Cohort Expansion study planned in relapsed/refractory AML patients
in the United States and
Europe including Poland will further investigate the single
agent activity and the safety profile of SEL24/MEN1703.
- On March 25, 2020 the U.S. Food
and Drug Administration (FDA) granted an orphan drug designation
(ODD) to Ryvu's SEL120, for the treatment of patients with acute
myeloid leukemia (AML).
Important milestones in 2020, before the report date
- On April 16, Galapagos NV
(Euronext & NASDAQ: GLPG) and Ryvu Therapeutics S.A. (WSE: RVU)
announced a collaboration focused on the discovery and development
of novel small molecule drugs in inflammation. The collaboration is
based on a novel target identified by Ryvu. Ryvu will contribute
its biology and chemistry platform as well as related intellectual
property to the program. During the joint research collaboration,
Ryvu is responsible for early drug discovery and Galapagos will be
responsible for all further development of the program.
- On June 2, Ryvu obtained the
occupancy permits for its newly built R&D Center for Innovative
Drugs, meaning it has completed the construction of the facility.
The Company plans to move to the new headquarters by the end of
June 2020.
- On June 3, NodThera, Ryvu
spin-off company, secured £44.5million ($54.5million) Series B financing. NodThera was
founded by Epidarex Capital and Ryvu in 2016 based on world class
research on NLRP3 inflammasome conducted at Ryvu (at that time
Selvita) in 2012 -2016. The company focused on the development of
inflammasome inhibitors has already raised over £80.8 million (over
$100 million) in three funding
series. After the full completion of Series B capital increase,
Ryvu will own 4.8% in NodThera.
- On June 4, Ryvu signed a grant
agreement for the development of targeted immuno-oncology therapy,
which provides Ryvu with almost $5.6
million of non-dilutive financing to discover, develop and
select a clinical candidate targeting cancers which had been
considered in the past as largely undruggable using rational
approaches. Total net value of the project amounts to over
$8.9 million and the anticipated
project duration is until December
2023.
In Q1 2020, Ryvu Therapeutics participated and presented at
several investor conferences, including Solebury Trout Investor
Access during JP Morgan 2020, Solebury Trout Virtual Investor
Conference, BIO-Europe Spring 2020 and 32nd Annual ROTH
Conference.
Ryvu First Quarter 2020, Financial Results
In the past quarter, Ryvu Therapeutics noted a 56% increase in
its revenues, up to PLN 13.6 million ($3.5
million). Revenues from partnering contracts have increased
from PLN 1.1 million ($0.3 million)
in Q1 2019, up to PLN 7.8 million ($2.0
million) in Q1 2020.
Operational costs related in majority to the research and
development expenditures, remain at a stable level and amounted to
PLN 18.6 million ($4.7 million), as
compared to PLN 18.4 million ($4.9
million) in same quarter last year. Operational loss has
decreased and amounted to PLN 5.0 million ($1.3 million), compared to PLN 9.7 million
($2.6 million) in 1Q 2019.
On June 5, 2020, Ryvu Therapeutics
held PLN 48.2 million ($11.6
million) in cash, cash equivalents, and short-term
investments.
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/CDK19 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 Phase 2 clinical
studies for the treatment of acute myeloid leukemia. Ryvu is listed
on Warsaw Stock Exchange [WSE: RVU]. 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.
Contacts:
Natalia Baranowska
(corporate)
+48-784-069-418
natalia.baranowska@ryvu.com
Julia Balanova (investors)
+1-646-378-2936
jbalanova@troutgroup.com
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SOURCE Ryvu Therapeutics