Cytokinetics, Incorporated (Nasdaq: CYTK) and Royalty Pharma plc
(Nasdaq: RPRX) today announced they have entered into a strategic
funding collaboration providing capital to support the
commercialization of aficamten and advance the company’s expanding
cardiovascular pipeline while diversifying access to capital as the
company advances its muscle biology-directed specialty cardiology
business.
“We have enjoyed a longstanding relationship
with Royalty Pharma and this expanded strategic collaboration
reinforces our shared conviction in the value of our cardiac myosin
focused pipeline of drug candidates,” said Robert I. Blum,
Cytokinetics’ President and Chief Executive Officer. “This
diversified access to capital from a trusted partner supports our
launch of aficamten while also fortifying our capital structure and
lowering our cost of capital as we become a sustainable company. We
believe this deal delivers on stated objectives of advancing our
later-stage portfolio of potential medicines alongside our goal of
increasing shareholder value.”
“We are excited to support Cytokinetics as the
company advances towards commercialization of aficamten,” said
Pablo Legorreta, Royalty Pharma’s founder and Chief Executive
Officer. “This is our third transaction with Cytokinetics and
highlights our ability to structure creative, win-win funding
solutions and underscores the breadth of our funding capabilities.
Aficamten has demonstrated an impressive clinical profile in its
pivotal Phase 3 study, and we believe it has the potential to
significantly improve the lives of patients with HCM, if approved
by the FDA.”
“Both omecamtiv mecarbil and CK-586 represent
strategic opportunities to expand our specialty cardiology pipeline
in adjacent cardiovascular indications and help underserved
patients,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive
Vice President of Research & Development. “Building on feedback
from the FDA and EMA, we have designed a confirmatory Phase 3
clinical trial intended to replicate treatment effects previously
observed with omecamtiv mecarbil among higher risk patients with
heart failure with reduced ejection fraction. In addition, we look
forward to advancing CK-586 to Phase 2 to further assess the
pharmacology of cardiac myosin inhibition in sicker patients with
heart failure with preserved ejection fraction.”
The transaction includes funding for planned
commercialization, development funding, royalty restructuring and
revenue sharing and the purchase of Cytokinetics equity, together,
affording Cytokinetics $250 million on closing and up to a total of
$575 million to support the company’s further maturation and
corporate development.
The key components of this strategic funding
collaboration include:
- Commercial launch
funding: Cytokinetics to receive $50 million and is
eligible to draw an additional $175 million within 12 months of
approval of aficamten in oHCM; the capital will be repayable over
10 years in quarterly installments (totaling 1.9x).
- Royalty
restructuring: Royalty Pharma’s royalty on aficamten was
restructured so that Royalty Pharma will now receive 4.5% up to
$5.0 billion of annual net sales of aficamten and 1% above $5.0
billion of annual net sales compared to the prior 4.5% up to $1.0
billion of annual net sales and 3.5% above $1.0 billion of annual
net sales.
- Development
funding: Cytokinetics will receive $100 million in upfront
capital to fund a confirmatory Phase 3 clinical trial of omecamtiv
mecarbil in patients with heart failure and reduced ejection
fraction. If the Phase 3 clinical trial is positive and FDA
approval is received within specified time frames, Royalty Pharma
will receive fixed payments totaling $100 million following
approval, as well as an incremental 2.0% royalty on annual net
sales and/or fixed quarterly payments. If the Phase 3 trial is not
successful or does not lead to FDA approval, Cytokinetics will
repay Royalty Pharma up to $237.5 million over eighteen or
twenty-two quarters, in fixed quarterly
payments.Development funding: Cytokinetics to
receive $50 million in upfront capital to fund a proof-of-concept
Phase 2 clinical trial for CK-586 in patients with heart failure
and preserved ejection fraction and Royalty Pharma will have an
option to invest up to an additional $150 million to fund Phase 3
development of CK-586, for which it would be eligible to receive a
$150 million milestone payment upon FDA approval and a 4.5% royalty
on annual net sales of CK-586.If Royalty Pharma does not opt-in to
fund Phase 3 development, Royalty Pharma will receive a 1.0%
royalty on annual net sales of CK-586.
- Equity Purchase:
Royalty Pharma will purchase $50 million of Cytokinetics’ common
stock in a private placement that will be concurrent with the
underwritten public offering that Cytokinetics plans to launch
today.
From these transactions, Cytokinetics
anticipates receipt of up to $250 million in nearer-term funding.
Together with its proforma cash at the end of the first quarter of
2024, this funding from Royalty Pharma enables Cytokinetics
extended cash runway based on expected 2024 expenditures, inclusive
of planned commercialization activities and expanded pipeline
development programs.
Advisors
Cooley LLP and Morrison & Foerster LLP acted
as legal advisors to Cytokinetics on the transactions. Goodwin
Procter LLP, Fenwick & West LLP, Maiwald GmbH, and Wolf,
Greenfield & Sacks, P.C., acted as legal advisors to Royalty
Pharma. Evercore served as a financial advisor to Cytokinetics on
the transactions.
About Aficamten
Aficamten is an investigational selective,
small molecule cardiac myosin inhibitor discovered following an
extensive chemical optimization program that was conducted with
careful attention to therapeutic index and pharmacokinetic
properties and as may translate into next-in-class potential in
clinical development. Aficamten was designed to reduce
the number of active actin-myosin cross bridges during each cardiac
cycle and consequently suppress the myocardial hypercontractility
that is associated with hypertrophic cardiomyopathy (HCM). In
preclinical models, aficamten reduced 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.
The development program for aficamten is
assessing its potential as a treatment that improves exercise
capacity and relieves symptoms in patients with HCM as well as its
potential long-term effects on cardiac structure and function.
Aficamten was evaluated in SEQUOIA-HCM
(Safety, Efficacy, and
Quantitative Understanding of
Obstruction Impact of
Aficamten in HCM), a positive
pivotal Phase 3 clinical trial in patients with symptomatic
obstructive hypertrophic cardiomyopathy (HCM). Aficamten received
Breakthrough Therapy Designation for the treatment of symptomatic
obstructive HCM from the U.S. Food & Drug Administration (FDA)
as well as the National Medical Products Administration (NMPA) in
China. Cytokinetics expects to submit a New Drug Application (NDA)
to the FDA in Q3 2024 and a Marketing Authorization Application
(MAA) to the European Medicines Agency (EMA) in Q4 2024.
About Omecamtiv
Mecarbil
Omecamtiv mecarbil is an investigational,
selective, small molecule cardiac myosin activator, the first of a
novel class of myotropes1 designed to directly target the
contractile mechanisms of the heart, binding to and recruiting more
cardiac myosin heads to interact with actin during
systole. Omecamtiv mecarbil is designed to increase the
number of active actin-myosin cross bridges during each cardiac
cycle and consequently augment the impaired contractility that is
associated with heart failure with reduced ejection fraction
(HFrEF). Preclinical research has shown that omecamtiv
mecarbil increases cardiac contractility without increasing
intracellular myocyte calcium concentrations or myocardial oxygen
consumption.2-4
The development program for omecamtiv
mecarbil assessed its potential for the treatment of HFrEF.
Positive results from GALACTIC-HF demonstrated a statistically
significant effect of treatment with omecamtiv
mecarbil to reduce risk of the primary composite endpoint of
cardiovascular (CV) death or heart failure events (heart failure
hospitalization and other urgent treatment for heart failure)
compared to placebo in patients treated with standard of care
Adverse events and treatment discontinuation of study drug were
balanced between the treatment arms.
In February 2023, the U.S. Food and Drug
Administration (FDA) issued a Complete Response Letter (CRL)
regarding the New Drug Application (NDA) for omecamtiv mecarbil,
stating that GALACTIC-HF was not sufficiently persuasive to
establish substantial evidence of effectiveness for reducing the
risk of heart failure events and cardiovascular death in adults
with chronic heart failure with reduced ejection fraction, in lieu
of evidence from at least two adequate and well-controlled clinical
investigations. In May 2024, Cytokinetics withdrew the Marketing
Authorization Application (MAA) from the European Medicines Agency
(EMA) for omecamtiv mecarbil based on feedback from the Committee
for Medicinal Products for Human Use (CHMP) indicating that the
Committee would not be able to conclude that the benefits outweigh
the risks on the basis of the results from GALACTIC-HF alone.
Cytokinetics is planning to start an additional Phase 3 trial of
omecamtiv mecarbil in Q4 2024 in advanced HFrEF patients with
objective to confirm and elaborate on positive results previously
observed in GALACTIC-HF.
About CK-4021586 (CK-586)
CK-4021586 (CK-586) is a novel, selective, oral,
small molecule cardiac myosin inhibitor designed to reduce the
hypercontractility associated with heart failure with preserved
ejection fraction (HFpEF). In preclinical models, CK-586 reduced
cardiac hypercontractility by decreasing the number of active
myosin cross-bridges during cardiac contraction thereby reducing
the contractile force, without effect on calcium transients. In
some patients, HFpEF is a condition that resembles non-obstructive
hypertrophic cardiomyopathy (HCM) in that the patients have higher
ejection fractions, thickened walls of their heart, elevated
biomarkers, and symptoms of heart failure. In a Phase 2 clinical
trial in patients with non-obstructive HCM, aficamten, a
cardiac myosin inhibitor also developed by the Company, was well
tolerated, improved patient reported outcomes (Kansas City
Cardiomyopathy Questionnaire (KCCQ) and New York Heart
Association (NYHA) Functional Class) and biomarkers, measures
that are also relevant to HFpEF, lending support for this mechanism
of action in HFpEF.
The Phase 1 study of CK-586 met its primary
endpoint and secondary objectives, demonstrating that CK-586 was
safe and well-tolerated in healthy participants with linear
pharmacokinetics. These data are supportive of advancing CK-586 to
a Phase 2 clinical trial in patients with HFpEF which is expected
to begin in Q4 2024.
About Cytokinetics
Cytokinetics is a late-stage, specialty
cardiovascular 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 cardiac muscle performance is
compromised. As a leader in muscle biology and the mechanics of
muscle performance, the company is developing small molecule drug
candidates specifically engineered to impact myocardial muscle
function and contractility. Cytokinetics is preparing for
regulatory submissions for aficamten, its next-in-class cardiac
myosin inhibitor, following positive results from SEQUOIA-HCM, the
pivotal Phase 3 clinical trial in obstructive hypertrophic
cardiomyopathy. Aficamten is also currently being evaluated in
MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy
compared to metoprolol as monotherapy in patients with obstructive
HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients
with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten
in a pediatric population with obstructive HCM, and FOREST-HCM, an
open-label extension clinical study of aficamten in patients with
HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac
muscle activator, in patients with heart failure. Additionally,
Cytokinetics is developing CK-586, a cardiac myosin inhibitor with
a mechanism of action distinct from aficamten for the potential
treatment of HFpEF, and CK-136, a cardiac troponin activator for
the potential treatment HFrEF and other types of heart failure,
such as right ventricular failure resulting from impaired cardiac
contractility.
For additional information
about Cytokinetics, visit www.cytokinetics.com and follow us
on X, LinkedIn, Facebook and YouTube.
About Royalty Pharma
Founded in 1996, Royalty Pharma is the largest
buyer of biopharmaceutical royalties and a leading funder of
innovation across the biopharmaceutical industry, collaborating
with innovators from academic institutions, research hospitals and
non-profits through small and mid-cap biotechnology companies to
leading global pharmaceutical companies. Royalty Pharma has
assembled a portfolio of royalties which entitles it to payments
based directly on the top-line sales of many of the industry’s
leading therapies. Royalty Pharma funds innovation in the
biopharmaceutical industry both directly and indirectly – directly
when it partners with companies to co-fund late-stage clinical
trials and new product launches in exchange for future royalties,
and indirectly when it acquires existing royalties from the
original innovators. Royalty Pharma’s current portfolio includes
royalties on more than 35 commercial products, including Vertex’s
Trikafta, GSK’s Trelegy, Roche’s Evrysdi, Johnson & Johnson’s
Tremfya, Biogen’s Tysabri and Spinraza, AbbVie and Johnson &
Johnson’s Imbruvica, Astellas and Pfizer’s Xtandi, Novartis’
Promacta, Pfizer’s Nurtec ODT and Gilead’s Trodelvy, and 17
development-stage product candidates.
Cytokinetics 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 timing or availability of
additional sale proceeds or loan disbursements from Royalty Pharma;
Cytokinetics’ research and development and commercialization
activities; anticipated cash runway, 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, 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; Cytokinetics’ drug candidates may have
adverse side effects or inadequate therapeutic efficacy; the FDA or
foreign regulatory agencies may delay or limit Cytokinetics’
ability to conduct clinical trials; Cytokinetics may be
unable to obtain or maintain patent or trade secret protection for
its intellectual property; 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. For further
information regarding these and other risks related to
Cytokinetics’ business, investors should consult Cytokinetics’
filings with the Securities and Exchange Commission,
particularly under the caption “Risk Factors” in Cytokinetics’
latest Quarterly Report on Form 10-Q.
CYTOKINETICS® and the C-shaped logo are
registered trademarks of Cytokinetics in the U.S. and certain other
countries.
Royalty Pharma Forward Looking
Statements
The information set forth herein does not
purport to be complete or to contain all of the information you may
desire. Statements contained herein are made as of the date of this
document unless stated otherwise, and neither the delivery of this
document at any time, nor any sale of securities, shall under any
circumstances create an implication that the information contained
herein is correct as of any time after such date or that
information will be updated or revised to reflect information that
subsequently becomes available or changes occurring after the date
hereof.
This document contains statements that
constitute “forward-looking statements” as that term is defined in
the United States Private Securities Litigation Reform Act of 1995,
including statements that express the company’s opinions,
expectations, beliefs, plans, objectives, assumptions or
projections regarding future events or future results, in contrast
with statements that reflect historical facts. Examples include
discussion of Royalty Pharma’s strategies, financing plans, growth
opportunities and market growth. In some cases, you can identify
such forward-looking statements by terminology such as
“anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,”
“project,” “expect,” “may,” “will,” “would,” “could” or “should,”
the negative of these terms or similar expressions. Forward-looking
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assumptions and on information currently available to the company.
However, these forward-looking statements are not a guarantee of
Royalty Pharma’s performance, and you should not place undue
reliance on such statements. Forward-looking statements are subject
to many risks, uncertainties and other variable circumstances, and
other factors. Such risks and uncertainties may cause the
statements to be inaccurate and readers are cautioned not to place
undue reliance on such statements. Many of these risks are outside
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differ materially from those it thought would occur. The
forward-looking statements included in this document are made only
as of the date hereof. The company does not undertake, and
specifically declines, any obligation to update any such statements
or to publicly announce the results of any revisions to any such
statements to reflect future events or developments, except as
required by law.
Certain information contained in this document
relates to or is based on studies, publications, surveys and other
data obtained from third-party sources and the company’s own
internal estimates and research. While the company believes these
third-party sources to be reliable as of the date of this document,
it has not independently verified, and makes no representation as
to the adequacy, fairness, accuracy or completeness of, any
information obtained from third-party sources. In addition, all of
the market data included in this document involves a number of
assumptions and limitations, and there can be no guarantee as to
the accuracy or reliability of such assumptions. Finally, while the
company believes its own internal research is reliable, such
research has not been verified by any independent source.
For further information, please reference
Royalty Pharma’s reports and documents filed with the U.S.
Securities and Exchange Commission (“SEC”) by visiting EDGAR on the
SEC’s website at www.sec.gov.
Contacts:
CytokineticsDiane WeiserSenior Vice President, Corporate Affairs
415-290-7757
Royalty Pharma Investor Relations and Communications+1 (212)
883-6772ir@royaltypharma.com
References:
- Psotka MA, Gottlieb SS, Francis GS et al. Cardiac Calcitropes,
Myotropes, and Mitotropes. JACC. 2019; 73:2345-53.
- Planelles-Herrero VJ, Hartman JJ, Robert-Paganin J. et al.
Mechanistic and structural basis for activation of cardiac myosin
force production by omecamtiv mecarbil. Nat Commun.
2017;8:190.
- Shen YT, Malik FI, Zhao X, et al. Improvement of cardiac
function by a cardiac myosin activator in conscious dogs with
systolic heart failure. Circ Heart Fail. 2010; 3: 522-27.
- Malik FI, Hartman JJ, Elias KA, Morgan BP, Rodriguez H, Brejc
K, Anderson RL, Sueoka SH, Lee KH, Finer JT, Sakowicz R. Cardiac
myosin activation: a potential therapeutic approach for systolic
heart failure. Science. 2011 Mar 18;331(6023):1439-43.
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