Cytokinetics Announces Vision 2025 and Outlines 2020 Corporate Milestones
January 13 2020 - 7:30AM
Cytokinetics, Inc. (Nasdaq: CYTK) today announced its Vision 2025
and provided guidance for corporate milestones expected to occur in
2020. The company’s Vision 2025: “Leading with Science, Delivering
for Patients,” articulates its five-year key imperatives enabling
Cytokinetics to be the leading muscle biology biopharmaceutical
company that meaningfully improve the lives of patients with
diseases of impaired muscle function through access to novel
medicines arising from its research.
Key imperatives for Vision 2025 include:
- Achieve regulatory approvals for at least two drugs arising
from our pipeline
- Build commercial capabilities to market and sell our medicines
reflective of their innovation and value
- Generate sustainable and growing revenues from product
sales
- Double our development pipeline to include ten therapeutic
programs
- Expand our discovery platform to muscle energetics, growth and
metabolism
- Be the science-driven company people want to join and partner
with
“Our company transformation began five years ago
when we outlined our Vision 2020,” said Robert I. Blum,
Cytokinetics’ President and Chief Executive Officer. “We
effectively executed on those initiatives so that we are now well
positioned to look forward to the next five-year horizon and the
profound privilege to potentially bring forward to patients at
least two new medicines from our pioneering muscle biology focused
research. We expect to deliver on the promise of our science and to
double our pipeline of novel mechanism drug candidates and expand
the breadth of our discovery platform. As we execute against our
vision, we will support disease advocacy groups elevating the
patient voice and live by our values of integrity, fairness and
compassion in all that we do.”
In addition, the company announced its expected
2020 milestones.
“To ensure that we deliver on the promise of our
science for patients, we recognize that we must continue to plan
and execute well in connection with expected milestones in 2020,”
continued Mr. Blum. “This will be a pivotal year for Cytokinetics
as we now expect trial results from GALACTIC-HF by the end of the
year and we need to prepare commercial readiness and co-promotion
plans accordingly. In addition, we expect to both advance and
expand our pipeline to enable two other programs to potentially
advance to late-stage trials while another two programs may advance
in earlier-stage trials. We look forward to another highly
productive year aligned with our vision.”
Expected 2020 Milestones
Cardiac Muscle Programs
Omecamtiv mecarbil (cardiac
myosin activator)
- Second interim analysis of GALACTIC-HF (Global
Approach to Lowering
Adverse Cardiac
Outcomes Through
Improving Contractility in
Heart Failure), the Phase 3
cardiovascular outcomes clinical trial of omecamtiv mecarbil, in Q1
2020.
- Topline results from GALACTIC-HF in Q4 2020.
- Complete enrollment in METEORIC-HF
(Multicenter Exercise
Tolerance Evaluation of
Omecamtiv Mecarbil Related to
Increased Contractility in
Heart Failure), the second Phase
3 trial of omecamtiv mecarbil, in 2020.
- Conduct commercial readiness and develop co-promotion plan in
collaboration with Amgen in 2020.
AMG 594 (cardiac troponin
activator)
- Complete Phase 1 SAD/MAD study of AMG 594 in 2H 2020.
CK-3773274 (CK-274, cardiac
myosin inhibitor)
- Conduct REDWOOD-HCM, the Phase 2 clinical trial of CK-274
designed to determine the safety and tolerability of CK-274 in
patients with obstructive hypertrophic cardiomyopathy (oHCM), in
2020.
CK-3772271 (CK-271, cardiac
myosin inhibitor)
- File IND and initiate Phase 1 study in 1H 2020.
Skeletal Muscle Programs
Reldesemtiv (fast skeletal
muscle troponin activator, FSTA)
- Engage with regulatory and reimbursement authorities in 2020 to
prepare for a potential Phase 3 clinical trial and registration
program for reldesemtiv in patients with ALS (amyotrophic lateral
sclerosis).
CK-3762601
(CK-601, next-generation FSTA)
- Advance CK-601 in IND-enabling studies in 2020.
Ongoing Research
- Continue research activities directed to the cardiac and
skeletal sarcomere and our other muscle biology research
programs.
- Expect to continue research in collaboration with Astellas
directed to the discovery of next-generation skeletal muscle
activators through 2020, subject to current negotiations.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical
company focused on discovering, developing and commercializing
first-in-class muscle activators and next-in-class muscle
inhibitors as potential treatments for debilitating diseases in
which muscle performance is compromised and/or declining. As a
leader in muscle biology and the mechanics of muscle performance,
the company is developing small molecule drug candidates
specifically engineered to impact muscle function and
contractility. Cytokinetics is collaborating with Amgen Inc.
(Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle
activator. Omecamtiv mecarbil is the subject of an international
clinical trials program in patients with heart failure including
GALACTIC-HF and METEORIC-HF. Amgen holds an exclusive worldwide
license to develop and commercialize omecamtiv mecarbil with a
sublicense held by Servier for commercialization in Europe and
certain other countries. Cytokinetics is collaborating
with Astellas Pharma Inc. (Astellas) to develop reldesemtiv, a
fast skeletal muscle troponin activator (FSTA). Astellas currently
holds an exclusive worldwide license to develop and commercialize
reldesemtiv. Licenses held by Amgen and Astellas are subject to
specified co-development and co-commercialization rights of
Cytokinetics. Cytokinetics is also developing CK-274, a novel
cardiac myosin inhibitor that company scientists discovered
independent of its collaborations, for the potential treatment of
hypertrophic cardiomyopathies (HCM). Cytokinetics is conducting
REDWOOD-HCM, a Phase 2 trial of CK-274 in patients with obstructive
HCM. Cytokinetics continues its over 20-year history of pioneering
innovation in muscle biology and related pharmacology focused to
diseases of muscle dysfunction and conditions of muscle
weakness.
For additional information
about Cytokinetics, visit www.cytokinetics.com and follow
us on Twitter, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
This press release contains forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995 (the “Act”). Cytokinetics claims the protection of the
Act’s Safe Harbor for forward-looking statements. Examples of such
statements include, but are not limited to, statements relating to
Cytokinetics’ and its partners’ research and development and
commercial readiness activities, including the initiation, conduct,
design, enrollment, progress, continuation, completion, timing and
results of clinical trials, Cytokinetics’ ability to ensure
commercial readiness and develop co-promotion plans in
collaboration with Amgen; the significance and utility of
pre-clinical study and clinical trial results; planned interactions
with regulatory authorities and the outcomes of such interactions,
including discussions in preparation for a potential Phase 3
clinical trial and registration program for reldesemtiv in patients
with ALS; the expected timing of events and milestones; and the
properties and potential benefits of Cytokinetics’ drug candidates.
Such statements are based on management's current expectations, but
actual results may differ materially due to various risks and
uncertainties, including, but not limited to Cytokinetics’ need for
additional funding and such additional funding may not be available
on acceptable terms, if at all; potential difficulties or delays in
the development, testing, regulatory approvals for trial
commencement, progression or product sale or manufacturing, or
production of Cytokinetics’ drug candidates that could slow or
prevent clinical development or product approval; patient
enrollment for or conduct of clinical trials may be difficult or
delayed; the FDA or foreign regulatory agencies may delay or limit
Cytokinetics’ or its partners’ ability to conduct clinical trials;
Amgen’s and Astellas’ decisions with respect to the design,
initiation, conduct, timing and continuation of development
activities for omecamtiv mecarbil and reldesemtiv, respectively;
Cytokinetics may incur unanticipated research and development and
other costs; standards of care may change, rendering Cytokinetics’
drug candidates obsolete; and competitive products or alternative
therapies may be developed by others for the treatment of
indications Cytokinetics’ drug candidates and potential drug
candidates may target. For further information regarding these and
other risks related to Cytokinetics’ business, investors should
consult Cytokinetics’ filings with the Securities and Exchange
Commission. Forward-looking statements are not guarantees of future
performance, and Cytokinetics' actual results of operations,
financial condition and liquidity, and the development of the
industry in which it operates, may differ materially from the
forward-looking statements contained in this press release. Any
forward-looking statements that Cytokinetics makes in this press
release speak only as of the date of this press release.
Cytokinetics assumes no obligation to update its forward-looking
statements whether as a result of new information, future events or
otherwise, after the date of this press release.
Contact:Diane WeiserVice
President, Corporate Communications, Investor Relations(415)
290-7757
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