SHANGHAI, March 26, 2020 /PRNewswire/ -- CStone
Pharmaceuticals ("CStone"; HKEX: 2616), a leading biopharmaceutical
company focused on developing and commercializing innovative
immuno-oncology (IO) therapies and molecularly-targeted precision
medicines for the treatment of cancer, today released its audited
annual financial results for the year ended December 31, 2019.
"2019 was a transformational year for the company as we
continued to advance the development of our IO and precision
medicine products. Among the multiple critical milestones achieved,
we initiated 9 new pivotal studies, for a total of 13 registration
studies that are ongoing," said Dr. Frank
Jiang, Chairman and Chief Executive Officer of CStone. "In
2019, we presented key data of our three IO backbone assets, which
have demonstrated promising safety and efficacy profiles. In
particular, CS1001 (anti-PD-L1), our lead IO monoclonal antibody
showed efficacy in multiple tumor types, with especially
outstanding activity in esophageal cancer and natural killer T-cell
lymphoma ("NKTL"), indicating its potential to be a best-in-class
drug candidate. We have also made major progress with our precision
medicine portfolio, novel IO combinations, and other early phase
programs. We have further enhanced our external partnership,
including an IO combination collaboration with Bayer Healthcare LLC
and a licensing partnership with Numab Therapeutics AG. In addition
to the pipeline progress, we have entered into agreement for the
construction of our own global R&D headquarters and
manufacturing facility in Suzhou, laying the foundation for
cutting-edge research and sustainable drug supply in the future.
More importantly, we embarked on the journey of commercialization
by having Ms. Shirley Zhao (MD, MBA)
join us to lead and scale up a full-fledged commercial
organization."
Looking forward, we expect to receive New Drug Application
("NDA") approval in Taiwan for
TIBSOVO® (ivosidenib) in relapsed/refractory acute
myeloid leukemia ("R/R AML") this year. We will submit several NDAs
/ Biologics License Applications in China across multiple indications for our lead
assets including CS1001, avapritinib and pralsetinib; and expect
data readouts of seven critical clinical studies. We also aspire to
establish a Pipeline 2.0 with more first-in-class/best-in-class
therapies. Moreover, we anticipate to further scale up our
commercialization in 2020 and drive successful launches of our lead
assets in the coming years.
FINANCIAL HIGHLIGHTS
Non-International Financial Reporting Standards ("Non-IFRS")
Measures:
The research and development expenses excluding the share-based
payment expenses increased by RMB461.8
million from RMB726.9 million
for the year ended December 31, 2018
to RMB1,188.7 million for the year
ended December 31, 2019, primarily
attributable to additional trials which increased clinical
development costs.
The administrative expenses excluding the share-based payment
expenses increased by RMB58.3 million
from RMB79.3 million for the year
ended December 31, 2018 to
RMB137.6 million for the year ended
December 31, 2019, primarily
attributable to increase in employee costs.
The loss excluding the effect of the fair value changes of the
conversion feature of preferred shares and share-based payment
expenses increased by RMB468.7
million from RMB672.6 million
for the year ended December 31, 2018
to RMB1,141.3 million for the year
ended December 31, 2019, primarily
due to increase in research and development expenses and
administrative expenses, while partially offset by increase in
interest income.
International Financial Reporting Standards ("IFRS")
Numbers:
- Other income increased by RMB63.5
million from RMB20.5 million
for the year ended December 31, 2018
to RMB84.0 million for the year ended
December 31, 2019, primarily
attributable to increase in interest income from bank deposits and
time deposits.
- Other gains and losses decreased by RMB104.6 million from losses of RMB742.0 million for the year ended December 31, 2018 to losses of RMB637.4 million for the year ended December 31, 2019, primarily attributable to a
narrowed loss on fair value changes of derivative financial
liabilities, which was a non-cash, one-time adjustment upon the
listing as required under the IFRS.
- Research and development expenses increased by RMB545.4 million from RMB850.2 million for the year ended December 31, 2018 to RMB1,395.6 million for the year ended
December 31, 2019, primarily
attributable to additional trials which increased clinical
development costs.
- Administrative expenses increased by RMB150.5 million from RMB191.0 million for the year ended December 31, 2018 to RMB341.5 million for the year ended December 31, 2019, primarily attributable to
increase in employee costs.
- As a result of the above factors, the loss for the year
increased by RMB515.3 million from
RMB1,793.1 million for the year ended
December 31, 2018 to RMB2,308.4 million for the year ended
December 31, 2019, primarily due to
increase in research and development expenses and administrative
expenses, while partially offset by increase in interest
income.
BUSINESS HIGHLIGHTS
On February 26, 2019 (the "Listing
Date"), the Company was successfully listed on The Stock Exchange
of Hong Kong Limited (the "Stock Exchange"). Over the past year,
significant advancement has been made with respect to our product
pipeline and business operations:
Late-stage assets:
- CS1001 (PD-L1 antibody) - In 2019, we have made notable
progress to advance our lead immuno-oncology ("IO") asset CS1001 in
the clinic, qualifying it as a promising anti-PD-L1 with unique
advantage and significant differentiation. Data presented at 3
major congresses (Chinese Society of Clinical Oncology ("CSCO"),
European Society for Medical Oncology ("ESMO"), and The American
Society of Hematology ("ASH") have demonstrated that CS1001 is safe
and efficacious in multiple solid tumors and lymphomas, including
esophageal, gastric, cholangiocarcinoma/ gall bladder, and
microsatellite instability-high ("MSI-H")/mismatch repair deficient
("dMMR") cancer, as well as NKTL. Its outstanding activity in
esophageal cancer and NKTL in particular reveals the potential of
CS1001 as a best-in-class drug candidate. Based on these
proof-of-concept data, we have initiated two additional
registrational trials of CS1001 in China for patients with advanced gastric
cancer and esophageal cancer, and dosed the first patient in
April 2019 and December 2019, respectively. Together with the 4
initiated in 2018 (Stage III non- small cell lung cancer ("NSCLC"),
stage IV NSCLC, NKTL and classical Hodgkin lymphoma ("cHL")), we
are currently conducting 6 registrational trials for CS1001. We
expect top-line results of the Phase III trial of CS1001 in
combination with standard-of- care chemotherapies in patients with
first-line Stage IV squamous or non-squamous NSCLC to be available
in the second half of 2020. Furthermore, we plan to consult with
Center for Drug Evaluation ("CDE") on our cHL and NKTL regulatory
strategy and expect to submit an NDA in China for cHL and potentially also NKTL in the
second half of 2020.
- CS1003 (PD-1 antibody) - Preliminary data of the Phase Ia study
of CS1003 monotherapy were presented at the CSCO 2019 annual
meeting, which showed that CS1003 was safe and tolerable.
Anti-tumor activity of CS1003 was observed in multiple tumor types.
We have initiated a global Phase III trial of CS1003 in combination
with LENVIMA® (lenvatinib), a standard-of-care tyrosine
kinase inhibitor ("TKI") in patients with advanced hepatocellular
carcinoma ("HCC") and dosed the first patient in December 2019.
- Ivosidenib (CS3010) - In May
2019, an NDA for the isocitrate dehydrogenase-1 inhibitor
TIBSOVO® (ivosidenib) has been submitted to the Taiwan
Food and Drug Administration ("TFDA") for the treatment of adult
patients with R/R AML containing an isocitrate dehydrogenase-1
mutation ("IDH1m"); marketing approval is expected in 2020. Two
registrational trials in IDH1m AML are ongoing in China: one in IDH1m R/R AML, anticipating
trial completion in 2020 and NDA submission in China by the first half of 2021; and another
in newly diagnosed IDH1m AML patients who are not eligible for
intensive therapy.
- Avapritinib (CS3007) - On January 9,
2020, the KIT/PDGFRA inhibitor AYVAKITTM
(avapritinib) received U.S. Food and Drug Administration ("U.S.
FDA") approval for the treatment of adults with unresectable or
metastatic gastrointestinal stromal tumor ("GIST") harboring a
PDGFRA exon 18 mutation, including PDGFRA D842V mutations. As a
result, we plan to submit an NDA in Taiwan in the first half of 2020 for this
indication. Two registration trials for the avapritinib were
initiated in China in patients
with unresectable or metastatic GIST. One trial is a China
pharmacokinetics bridging study for the indication of advanced GIST
with a PDGFRA exon 18 mutation. We expect the top-line results from
the trial to become available and to submit an NDA in China in the first half of 2020. Another trial
is conducted in third-line GIST as part of a global Phase III trial
comparing avapritinib with regorafenib. Enrollment has been
completed for this study and top-line results from the global trial
are expected to be available in the second quarter of 2020 with NDA
submission in China in the second
half of 2020.
- Pralsetinib (CS3009) - As part of a global pivotal Phase I/II
trial of pralsetinib, an investigational RET inhibitor, for the
treatment of RET-altered NSCLC, medullary thyroid cancer ("MTC"),
and other advanced solid tumors, we have completed enrollment in
China for the cohort study for the
indication of RET fusion-positive NSCLC as a second-line treatment
and expect an NDA submission for this indication in China in the second half of 2020. Furthermore,
we have initiated an additional registrational cohort for
first-line RET fusion-positive NSCLC and expect to dose the first
patient in the first half of 2020.
Early-stage assets:
- Novel combinations-With combination therapy as a core strategy
and the unique advantage of leveraging our 3 IO backbone agents
(anti-PD-L1, anti-PD-1, and anti-CTLA4), a total of six
combinations with assets from our internal pipeline and external
partners are in development: i) CS1002 (CTLA-4 antibody) plus
CS1003 (PD-1 antibody), with the first patient dosed in
January 2020; ii) CS1001 with
fisogatinib (CS3008; FGFR4 inhibitor) in HCC; iii) CS1001 with
regorafenib; iv) CS1003 with regorafenib; all with first-patient-
dosed achieved in December 2019; and
two other combination studies planned, including v) CS1001 with a
PARP inhibitor (IMP4297); and vi) CS1001 with a multi-kinase
inhibitor (donafenib).
- Other early-stage assets-We have also made significant headway
on other early clinical- stage programs including CS3005 (A2aR
antagonist), CS3002 (CDK4/6 inhibitor), CS3003 (HDAC6 inhibitor)
and CS3006 (MEK inhibitor). In January
2020, we dosed the first patient for CS3002 and CS3005 in
the respective phase I studies.
Business development and other key activities:
- We have continued to enhance our value through external
collaborations with global leading biotechs and biopharmaceutical
companies.
- In May
2019, we entered into a global clinical collaboration with
Bayer HealthCare LLC ("Bayer") to evaluate CS1001 in combination
with Bayer's oral multi-kinase inhibitor Stivarga®
(regorafenib) (targeting VEGFR, KIT, RET, BRAF, FGFR and CSF1R,
etc.), as a treatment for multiple types of cancer including
gastric cancer. In December 2019, the
first patient was dosed in a Phase Ib trial of CS1001 in
combination with regorafenib.
- In April 2019, we entered into an
exclusive regional licensing agreement with Numab Therapeutics AG
("Numab") for the development and commercialization of NM21-1480
(ND021), a potential best-in-class monovalent, tri-specific
antibody- based molecule targeting PD-L1, 4-1BB, and human serum
albumin. The agreement provides us exclusive rights to develop and
commercialize NM21-1480 in Greater
China, South Korea and
Singapore and can potentially
provide us with access to Numab's novel multi-specific technology
platform.
- Moving forward, we will focus on pursuing strategic partnership
that will accelerate CStone value creation.
- In March 2019, we appointed four
internationally-renowned oncologists: Paul
A. Bunn, Jr., MD, Elizabeth M.
Jaffee, MD, Weiping Zou, MD,
Ph.D. and Richard S. Finn, MD, as
members of our Scientific Advisory Board. The addition of these
four experts will considerably augment our public profile in the
oncology field and provide valuable insights into our R&D
strategies and processes.
- In August 2019, we entered into
an agreement (with a state-owned enterprise under the Suzhou
Industrial Park) to build an approximately 100,000 square meters
R&D center and manufacturing facility in the Suzhou Industrial
Park for large and small molecule drug development and commercial
production. We expect the construction of the facility to commence
in the first half of 2020.
- In October 2019, we entered into
an agreement with Jiangsu Industrial Technology Research Institute (JITRI) and formed JITRI-CStone
Innovation Center to further promote a two-way collaboration with
industry partners and innovation centers in China and around the world.
- In December 2019, Ms.
Shirley Zhao, MD, MBA, joined us as
the General Manager for Greater
China and Head of Commercial to lead and scale up a
full-fledged commercial organization. Ms. Zhao will be responsible
for continuing to scale up the commercial team and infrastructure
in preparation for multiple product launches in mainland China,
Hong Kong and Taiwan over the next two years. Upon
regulatory approval, we expect to launch ivosidenib by the end of
2020 and avapritinib in 2021 in Taiwan, and to launch avapritinib, pralsetinib
and CS1001 (PD-L1 antibody) in 2021 in mainland China with
well-established local operation.
Since the outbreak of the novel coronavirus ("COVID – 19"), the
Company has adopted immediate measures to maintain effective and
high-quality level of operation. We are proactively managing the
progress of ongoing trials to ensure that study protocols are
followed and no significant disruptions will affect delivery of the
results. Also, we are actively supporting the nation's battle
against the coronavirus with a donation to Suzhou Charity
Federation after the outbreak in Suzhou. We will make our best
efforts to advance our development, aim to deliver data and launch
our products within the expected timeline, while maintaining our
commitment to our patients, employees and a broader community.
***
Conference Call Information
The Company will host a live conference call and webcast at
10AM HKT, March 27, 2020 to present its financial results
for the year ended December 31, 2019.
The conference call may be accessed by dialing 4001203170
(China Mainland), +852 30082034
(Hong Kong), +18455071610 (US) and
+61 283733610 (International) and referring to conference ID /
Passcode 8576303 / CStone. A webcast of the conference call will be
available in the Investor Relations section of the Company' website
at http://www.cstonepharma.com/en/relation/calendar.html (Passcode
: CStone).
About CStone
CStone is a biopharmaceutical company focused on developing and
commercializing innovative immune-oncology and molecularly-targeted
drugs to address unmet medical needs for cancer patients in
China and worldwide. Since the
Company's inception in 2015, CStone has assembled a world-class
management team that has a full spectrum of complementary skillsets
from preclinical research to clinical development and
commercialization. With combination therapies as a core strategy,
the Company has built a rich oncology pipeline of 15 oncology drug
candidates. Currently five late-stage drug candidates are at or
near pivotal trials. With an experienced team, a rich pipeline, a
robust clinical development-driven business model, and substantial
funding, CStone's vision is to become globally recognized as a
leading Chinese biopharmaceutical company by bringing innovative
and differentiated oncology therapies to cancer patients
worldwide.
For more information about CStone, please visit:
www.cstonepharma.com.
Forward-looking Statement
The forward-looking statements made in this article relate only
to the events or information as of the date on which the statements
are made in this article. Except as required by law, we undertake
no obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future events
or otherwise, after the date on which the statements are made or to
reflect the occurrence of unanticipated events. You should read
this article completely and with the understanding that our actual
future results or performance may be materially different from what
we expect. In this article, statements of, or references to, our
intentions or those of any of our Directors or our Company are made
as of the date of this article. Any of these intentions may alter
in light of future development.
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SOURCE CStone Pharmaceuticals