KRAKOW, Poland, Sept. 28,
2022 /PRNewswire/ -- Ryvu Therapeutics (WSE: RVU), a
clinical-stage drug discovery and development company focusing
on novel small molecule therapies that address emerging targets
in oncology, today reported financial results for the first
half of 2022 and provided a corporate update.
- In August, Ryvu secured €22 million in funding from the
European Investment Bank to support Ryvu's pipeline
development.
- In July, Ryvu signed an exclusive license agreement with
Nasdaq-listed Exelixis to develop novel STING agonist-based
targeted cancer therapies.
- RVU120 clinical and preclinical data were presented at the
2022 European Hematology Association (EHA) Congress.
- In August, Ryvu presented its development plans, including
broad development for RVU120 in hematologic and solid tumors and
preclinical advancement of the synthetic lethality and
immuno-oncology pipeline.
- On September 19, Ryvu's
shareholders voted in favor of a resolution granting the Management
and Supervisory Board the right to issue authorized capital,
providing an important potential source of future
financing.
- The first half of 2022 has been productive and progressive
for Ryvu. Investors have appreciated the progress in our research
and partnering and have supported our proposal to issue authorized
capital at our discretion to finance development plans over the
coming years. We are happy to have a quality investor base with
such a great trust and understanding of our needs and potential
– said Pawel Przewiezlikowski, co-founder, largest shareholder and
CEO of Ryvu Therapeutics.
FIRST HALF 2022 AND RECENT HIGHLIGHTS
- Despite challenging market conditions, our ability to
secure additional debt financing and establish an important new
corporate partnership reflects the quality of our scientific
expertise and clinical development capabilities – said Pawel
Przewiezlikowski.
European Investment Bank (EIB) €22 million financing to
accelerate the development of blood cancers and solid tumor
therapies: The funding is provided under the EIB's venture debt
instrument and will finance Ryvu's pipeline development of new
cancer treatments. The funding is guaranteed by the European Fund
for Strategic Investments, the financial pillar of the Investment
Plan for Europe.
Exclusive License Agreement with Exelixis to develop new
targeted therapies utilizing Ryvu's STING (STimulator of INterferon
Genes) technology: Under the terms of the agreement, Exelixis
paid Ryvu an upfront fee of $3
million in exchange for certain rights to Ryvu's STING
agonist small molecules. Exelixis will be responsible for all
research, development, and commercialization activities for which
Ryvu will be eligible to receive milestone payments, as well as
tiered royalties on the annual net sales of any products that are
successfully commercialized under the collaboration.
Promotion of Ryvu's Chief Medical Officer, Hendrik Nogai, and Chief Business Officer,
Vatnak Vat-Ho to the Management Board: Dr. Nogai has served as
Chief Medical Officer at Ryvu since February
2022 and Mr. Vat-Ho has been Ryvu's Chief Business Officer
since April 2021. The promotions
reflect each individual's significant contributions toward
advancing Ryvu's lead candidate, RVU120, and expanding Company's
business development activities.
Presentation of Clinical and Preclinical Data on RVU120 at
the 2022 European Hematology Association (EHA) Congress: Data
from the ongoing Phase 1b
dose-escalation study of RVU120 in patients with acute myeloid
leukemia (AML) or high-risk myelodysplastic syndromes (HR-MDS)
demonstrated single-agent activity with one complete remission (CR)
and stable diseases (SD) with blast reductions in several ongoing
patients who failed multiple prior lines of therapy.
Additionally, data on SEL24/MEN1703, an orally available dual
PIM/FLT3 inhibitor was presented. SEL24/MEN1703 was well tolerated,
with no drug discontinuations or deaths due to treatment-related
adverse events (TRAEs) in patients with relapsed or refractory
(R/R) IDHm AML. Promising efficacy was observed, with overall
response rates (ORR) and complete remission (CR) / CR with
incomplete hematologic recovery (CRi) / CR with partial hematologic
recovery (CRh) of 13% for the IDHm cohort.
Key Opinion Leader Webinar on RVU120 for the Treatment
of Hematological Malignancies and Solid Tumors: The
webinar featured a presentation by KOL Dr. Michael Savona, MD, from Vanderbilt University School of Medicine, who
discussed the current treatment landscape and unmet medical need in
treating patients with AML and HR-MDS. Additionally, Ryvu's
leadership team discussed the underlying mechanism of action of
RVU120 and provided an update on the Phase I data for RVU120.
Project updates from RVU120 and SEL24 programs presented at
the 2022 American Society of Clinical Oncology (ASCO) Annual
Meeting: Updates from the Phase 1/2 study of SEL24/MEN1703, a
first-in-class dual PIM/FLT3 kinase inhibitor, in patients with
IDH1/2-mutated acute myeloid leukemia and Phase I/II trial of
RVU120, a CDK8/CDK19 inhibitor in patients with relapsed/refractory
metastatic or advanced solid tumors were presented.
Poster Presentations at the American Association for Cancer
Research (AACR) Annual Meeting: Data were presented from the
RVU120 Trial-In-Progress in patients with relapsed/refractory
metastatic or advanced solid tumors and in vitro and in
vivo data demonstrating RVU120 efficacy against
hormone-independent breast cancer. Additionally, a novel
MTA-cooperative PRMT5 inhibitor as a targeted therapeutic for MTAP
deleted cancer was presented.
Shareholders meeting convened and approved authorized capital
on September 19: At an
extraordinary shareholders meeting, shareholders voted in favor of
a resolution to approve authorized capital, which provides the
Management and Supervisory Board the flexibility to issue equity at
its discretion when optimal.
- We are really appreciative of the overwhelming support that
we received at our shareholders' meeting, which further enables
Ryvu to execute our mission of discovering and developing drugs
that will improve the lives of cancer patients and their families
while maximizing the Company's value – underlined Pawel
Przewiezlikowski.
UPCOMING CLINICAL AND CORPORATE MILESTONES:
RVU120
- Data update from the ongoing Phase I clinical study in acute
myeloid leukemia (AML) and high-risk myelodysplastic syndrome
(HR-MDS) and the ongoing Phase I clinical study in solid tumors
will be presented in Q4 2022
Synthetic lethality
- Data on Ryvu's novel MTA-cooperative PRMT5 inhibitors as
targeted therapeutics for MTAP deleted cancers to be presented in
Q4 2022.
In August, Ryvu also highlighted its development plans for
2022-2024, which are focused on rapidly advancing its pipeline to
treat cancer patients:
- Broad development of RVU120, including a potential
fast-to-market strategy in AML/HR-MDS,
- Advancing into Phase I clinical trials one additional
program,
- Strengthening of the Synthetic Lethality Platform and discovery
of novel targets,
- Acceleration in the early pipeline,
- Executing milestones from existing collaborations (i.e.
Menarini, Galapagos, Exelixis), and adding at least one
new partnering deal per year.
FIRST HALF 2022 FINANCIAL UPDATE:
Cash Position - On September 21,
2022, Ryvu Therapeutics held $9.7M in cash, cash equivalents, and short-term
investments, compared to $20.5M at the end of 2021.
Operating costs, excluding the non-cash cost of
valuation of the Incentive Program ($3.8M) and valuation of NodThera shares
($1.8M), for the 6 months period
ended June 30, 2022, amounted to
$13M and related primarily to
research and development expenditures, while the operating costs
without Incentive Program and valuation of Nodthera shares for
the same period last year amounted to $11.5M.
Net Loss Attributable to Common Shareholders – Net loss
attributable to common shareholders excluding the non-cash cost of
valuation of the Incentive Program was $11M for the 6 months period ended June 30,
2022, as compared to a net loss without the Incentive Program of
$8.2M for the same period last
year.
About Ryvu Therapeutics
Ryvu Therapeutics is a clinical-stage drug discovery and
development company focused on novel small molecule therapies that
address emerging targets in oncology. Internally discovered
pipeline candidates make use of diverse therapeutic mechanisms
driven by emerging knowledge of cancer biology, including small
molecules directed at kinase, synthetic lethality and
immuno-oncology targets.
Ryvu's most advanced programs are RVU120 — a selective
CDK8/CDK19 kinase inhibitor with potential for the treatment of
hematological malignancies and solid tumors currently in phase I
clinical development for the treatment of acute myeloid leukemia
and myelodysplastic syndrome, and phase I/II for the treatment of
r/r metastatic or advanced solid tumors — and SEL24 (MEN1703), a
dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group,
currently in phase II clinical studies in acute myeloid leukemia.
Ryvu Therapeutics has signed ten partnering and licensing deals
with global companies, including Merck, Menarini Group, Galapagos
and Exelixis.
The company was founded in 2007 and is headquartered in Kraków,
Poland. Ryvu is listed on the
Warsaw Stock Exchange and is a component of the sWIG80 index. For
more information, please see www.ryvu.com.
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SOURCE Ryvu Therapeutics