Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that
it has agreed to a series of transactions with certain companies
wholly owned by investment funds managed by RTW Investments, LP,
and Ji Xing Pharmaceuticals Limited (“Ji Xing”), related to
CK-3773274 (“CK-274”), a next-generation cardiac myosin inhibitor
that Cytokinetics is developing for the potential treatment of
hypertrophic cardiomyopathies (HCM’s) and other clinical
indications that may be associated with excessive cardiac muscle
contractility. Pursuant to these transactions, Cytokinetics will
receive a combination of committed capital, funding and sale
proceeds of up to $250 million from RTW and is eligible to receive
up to $200 million in milestone payments plus royalties on future
sales of CK-274 in certain Asian countries.
“These deals afford us the opportunity to dial
up development of CK-274 in multiple indications and across a wider
span of geographies,” said Robert I. Blum, Cytokinetics’ President
and Chief Executive Officer. “We have built our company by
leveraging innovative science and deals and are pleased to enter
into another set of transactions to diversify access to capital and
extend and expand our cardiovascular pipeline.”
“As a differentiated, next-generation cardiac
myosin inhibitor, CK-274 holds promise as an innovative treatment
for hypercontractility that underlies hypertrophic cardiomyopathies
and other indications,” said Roderick T. Wong, MD, Managing
Partner, RTW Investments, LP. “We are pleased to partner with
Cytokinetics in China as well as to invest in upside that CK-274
may provide globally.”
Amongst these deals is a license from
Cytokinetics to Ji Xing, a biopharmaceutical company backed by RTW
and focused on the development and commercialization of innovative
medicines in the People’s Republic of China (including the Hong
Kong SAR and Macau SAR) and Taiwan. Cytokinetics has granted to Ji
Xing an exclusive license to develop and commercialize CK-274 in
China and Taiwan, in accordance with Cytokinetics’ planned global
registration programs. Cytokinetics will receive an upfront payment
and is eligible to receive up to $200 million in development and
commercial milestone payments and royalties on future sales of
CK-274 in certain Asian countries.
Under a separate funding agreement, Cytokinetics
receives options for additional funding from RTW for the further
development of CK-274 in HCMs. Upon initiation of a global
registration program for CK-274 in each of obstructive HCM and
non-obstructive HCM, Cytokinetics is eligible for funding, at its
option, in the amount of $45 million from RTW in exchange for a
royalty payable by Cytokinetics of 2% on sales of CK-274 in the
United States and certain European countries. If Cytokinetics
utilizes the full $90 million in development from RTW, it would be
responsible to pay RTW a 4% royalty on sales of CK-274 in the
United States and certain European countries. The royalties payable
by Cytokinetics are subject to royalty reductions if CK-274 is
developed for potential other indications.
In addition, RTW has agreed to purchase from
Cytokinetics its royalty rights on future sales of mavacamten, for
a cash purchase price of $85 million, subject to certain closing
conditions. In parallel with these agreements, RTW has purchased
$50 million of Cytokinetics’ common stock at $25 per share.
Conference Call and Webcast
Information
Members of Cytokinetics' senior management team
will host a conference call and webcast today at 8:30 AM Eastern
Time. The webcast can be accessed through the Investors & Media
section of the Cytokinetics website at www.cytokinetics.com. The
live audio of the conference call can also be accessed by telephone
by dialing either (866) 999-CYTK (2985) (United States and Canada)
or (706) 679-3078 (international) and typing in the passcode
2979275.
An archived replay of the webcast will be
available via Cytokinetics' website until July 28, 2020. The
replay will also be available via telephone by dialing (855)
859-2056 (United States and Canada) or (404) 537-3406
(international) and typing in the passcode 2979275 from July 14,
2020 at 11:30 AM Eastern Time until July 28, 2020.
About CK-274 and
REDWOOD-HCM
CK-274 is a novel, oral, small molecule cardiac
myosin inhibitor that company scientists discovered independent of
its collaborations. CK-274 arose from an extensive chemical
optimization program conducted with careful attention to
therapeutic index and pharmacokinetic properties that may translate
into next-in-class potential in clinical development. CK-274 was
designed to reduce the hypercontractility that is associated with
hypertrophic cardiomyopathy (HCM). In preclinical models, CK-274
reduces myocardial contractility by binding directly to cardiac
myosin at a distinct and selective allosteric binding site, thereby
preventing myosin from entering a force producing state. CK-274
reduces the number of active actin-myosin cross bridges during each
cardiac cycle and consequently reduces myocardial
contractility.
REDWOOD-HCM is a multi-center, randomized,
placebo-controlled, double-blind, dose-finding Phase 2 clinical
trial in patients with symptomatic, obstructive HCM. The primary
objective of the trial is to determine the safety and tolerability
of CK-274. The secondary objectives are to describe the
concentration-response and dose-response relationship of CK-274 on
the resting and post-Valsalva left ventricular outflow tract
gradient as measured by echocardiography during 10 weeks of
treatment.
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
developing reldesemtiv, a fast skeletal muscle troponin activator
(FSTA) for the potential treatment of ALS and other neuromuscular
indications following conduct of FORTITUDE-ALS and other Phase 2
clinical trials. The company is considering potential advancement
of reldesemtiv to Phase 3 pending ongoing regulatory interactions.
Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas)
to research, develop and commercialize other novel mechanism
skeletal sarcomere activators (not including FSTAs). 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.
About Ji Xing
Pharmaceuticals
Backed by RTW Investments, Ji Xing is a privately held, leading
Shanghai-based biotechnology company committed to bringing
innovative science and medicines to underserved Chinese patients
with serious and life-threatening diseases.
About RTW Investments
RTW Investments, LP (“RTW”) is a New York-based,
global, full life-cycle investment firm that focuses on identifying
transformational and disruptive innovations in biopharmaceutical
and medical technologies. As a leading partner of industry and
academia, RTW combines deep scientific expertise with a
solution-oriented investment approach to support emerging medical
therapies and the companies and/or academics developing them. For
further information about RTW, please visit www.RTWfunds.com.
Forward-Looking Statements
This press release contains forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995 (the "Act"). Cytokinetics disclaims any intent or
obligation to update these forward-looking statements and 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 the GALACTIC-HF clinical trial,
including the expected timing of the availability of top-line
results; statements relating to the METEORIC-HF clinical trial; the
potential benefits of omecamtiv mecarbil, including its ability to
represent a novel therapeutic strategy to increase cardiac muscle
function and restore cardiac performance; statements relating to
the REDWOOD-HCM clinical trial; statements relating to the
potential benefits of CK-274; statements relating to the potential
sales of CK-274; statements relating to our interactions with
regulatory authorities in connection to the potential advancement
of a Phase 3 clinical trial of reldesemtiv in patients with ALS;
the potential benefits of reldesemtiv; Cytokinetics' and its
partners' research and development activities; the design, timing,
results, significance and utility of preclinical and clinical
results; and the properties and potential benefits of Cytokinetics'
other 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,
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; Cytokinetics' drug candidates may have adverse
side effects or inadequate therapeutic efficacy; the FDA or foreign
regulatory agencies may delay or limit Cytokinetics' or its
partners' ability to conduct clinical trials; Cytokinetics may be
unable to obtain or maintain patent or trade secret protection for
its intellectual property; the nature of Amgen's decisions with
respect to the design, initiation, conduct, timing and continuation
of development activities for omecamtiv mecarbil; standards of care
may change, rendering Cytokinetics' drug candidates obsolete;
competitive products or alternative therapies may be developed by
others for the treatment of indications Cytokinetics' drug
candidates and potential drug candidates may target; and risks and
uncertainties relating to the timing and receipt of payments from
its partners, including milestones and royalties on future
potential product sales under Cytokinetics' collaboration
agreements with such partners. For further information regarding
these and other risks related to Cytokinetics' business, investors
should consult Cytokinetics' filings with the Securities and
Exchange Commission.
Contact: Cytokinetics Diane Weiser Senior Vice
President, Corporate Communications & Investor Relations (415)
290-7757
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