Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial
results for the first quarter of 2019. Net loss for the first
quarter was $29.4 million, or $0.54 per share, compared to net loss
for the first quarter of 2018 of $30.3 million, or $0.56 per share.
Cash, cash equivalents and investments totaled $176.6 million at
March 31, 2019.
“We are pleased with the progress made across
our pipeline of muscle-directed investigational medicines during
the first quarter of 2019,” said Robert I. Blum, Cytokinetics’
President and Chief Executive Officer. “Recently, we shared
encouraging data from FORTITUDE-ALS demonstrating consistency of
effect for doses, endpoints and timepoints in patients treated with
reldesemtiv and we believe the results may support progression to
further clinical trials toward potential registration. We also
passed through the first planned interim analysis of GALACTIC-HF
and opened enrollment in METEORIC-HF while we also independently
continued the conduct of the Phase 1 study of CK-274 and prepared
for potential progression to Phase 2. Our strategy to advance
multiple drug candidates, under our collaborations and
independently, continues to generate upside potential for patients
and shareholders.”
Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac
myosin activator)
- Continued conduct 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, following first planned
interim analysis for futility. We expect screening in this
event-driven trial to complete in the second quarter of 2019.
- Opened METEORIC-HF, (Multicenter
Exercise Tolerance
Evaluation of Omecamtiv Mecarbil
Related to Increased
Contractility in Heart
Failure), the second Phase 3 trial of omecamtiv
mecarbil, to enrollment. METEORIC-HF is a randomized,
placebo-controlled, double-blind, parallel group, multicenter
clinical trial designed to evaluate the effect of treatment with
omecamtiv mecarbil compared to placebo on exercise capacity as
determined by cardiopulmonary exercise testing (CPET) following 20
weeks of treatment. We expect to continue enrollment of METEORIC-HF
throughout 2019.
- John Teerlink, M.D., Professor of Clinical Medicine, University
of California San Francisco and Director of Heart Failure, San
Francisco Veterans Affairs Medical Center, presented additional
results from COSMIC-HF (Chronic
Oral Study of
Myosin Activation to Increase
Contractility in Heart
Failure) at the American College of Cardiology’s
68th Annual Scientific Session. The results of a post hoc subgroup
analysis of the COSMIC-HF data showed that, between 32 patients
with atrial fibrillation (AF) and 117 patients without AF, there
were no statistically significant differences in the effects of
treatment with omecamtiv mecarbil on cardiac function, including
systolic ejection time and stroke volume, as well as ventricular
volumes, heart rate, and NT-proBNP.
AMG 594 (cardiac troponin
activator)
- Continued conduct of the Phase 1 study of AMG 594 to assess its
safety, tolerability, pharmacokinetics and potential to increase
cardiac function in healthy volunteers. AMG 594 is a novel,
selective, oral, small molecule cardiac troponin activator,
discovered under a joint research program with Amgen. This Phase 1
study is being conducted by Amgen in collaboration with
Cytokinetics. We expect the conduct of this study to continue
throughout 2019.
CK-3773274 (CK-274, cardiac
myosin inhibitor)
- Continued conduct of the Phase 1 double-blind, randomized,
placebo-controlled, multi-part, single and multiple ascending dose
clinical study of CK-274 in healthy adult subjects. CK-274 is a
wholly-owned, novel cardiac myosin inhibitor, discovered by company
scientists, in development for the potential treatment of
hypertrophic cardiomyopathy (HCM). We expect results from this
study in the third quarter of 2019 and are preparing for potential
progression of CK-274 to Phase 2 in the second half of 2019.
Skeletal Muscle Program
reldesemtiv (next-generation
fast skeletal muscle troponin activator (FSTA))
- Results from FORTITUDE-ALS (Functional
Outcomes in a Randomized
Trial of Investigational
Treatment with CK-2127107 to
Understand Decline in
Endpoints – in ALS), the Phase 2
clinical trial of reldesemtiv in patients with amyotrophic lateral
sclerosis (ALS), were presented during a platform presentation at
the American Academy of Neurology 71st Annual Meeting in
Philadelphia on Sunday, May 5, 2019.
- FORTITUDE-ALS did not achieve statistical significance for a
pre-specified dose-response relationship in its primary endpoint of
change from baseline in slow vital capacity (SVC) after 12 weeks of
dosing (p=0.11). Similar analyses of ALSFRS-R and slope of the
Muscle Strength Mega-Score yielded p values of 0.09 and 0.31,
respectively. While the dose-response analyses for the primary and
secondary endpoints did not achieve statistical significance at the
level of 0.05, in a post-hoc analysis pooling the doses together,
patients who received reldesemtiv in FORTITUDE-ALS declined less
than patients who received placebo. The trial showed effects
favoring reldesemtiv across dose levels and timepoints with
clinically meaningful magnitudes of effect observed at 12 weeks for
the primary and secondary endpoints. The differences between
reldesemtiv and placebo in SVC and ALSFRS-R total score observed
after 12 weeks of treatment were still evident at follow-up, four
weeks after the last dose of study drug.
Pre-Clinical Development and Ongoing
Research
- Continued pre-clinical development of CK-3762601 (CK-601), a
next-generation fast skeletal muscle troponin activator (FSTA),
under our collaboration with Astellas.
- Continued research in collaboration with Astellas directed to
the discovery of next-generation skeletal muscle activators;
Astellas is sponsoring Cytokinetics’ activities through
2019.
- Continued independent research activities directed to our other
muscle biology research programs.
Corporate
- Joined the European Organisation for Rare Diseases (EURORDIS)
and the National Organization for Rare Disorders (NORD) to
recognize Rare Disease Day®, an international campaign elevating
the public understanding of rare diseases.
Financials
Revenues for the first quarter of 2019 increased
to $8.5 million from $5.3 million for the first quarter of 2018,
primarily due to increased research and development revenues from
our collaborations with Astellas and Amgen. License revenues in the
first quarter of 2018 were related to the Phase 2 study of
reldesemtiv in spinal muscle atrophy completed in 2018.
Research and development expenses for the first
quarter of 2019 increased to $23.5 million from $22.1 million for
the first quarter of 2018, primarily due to increased spending
related to the opening of METEORIC-HF and development of CK-274,
offset in part by reduced spending for reldesemtiv as well as for
tirasemtiv, following suspension of development of tirasemtiv in
late 2017. General and administrative expenses increased slightly
to $9.4 million for the first quarter of 2019 from $9.3 million for
the first quarter of 2018.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s first quarter 2019 results via a webcast
and conference call today at 4:30 PM 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 4486595.
An archived replay of the webcast will be
available via Cytokinetics’ website until May 16, 2019. 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 4486595 from May 9,
2019 at 7:30 PM Eastern Time until May 16, 2019.
About Cytokinetics
Cytokinetics is a late-stage
biopharmaceutical company focused on discovering, developing and
commercializing first-in-class muscle activators and best-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 Phase 3 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 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.
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
activities, including the initiation, conduct, design, enrollment,
progress, continuation, completion, timing and results of clinical
trials; the significance and utility of pre-clinical study and
clinical trial results; planned interactions with regulatory
authorities and the outcomes of such interactions; the expected
timing of events and milestones, including the receipt of milestone
payments; 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
Cytokinetics,
IncorporatedCondensed Consolidated Statements of
Operations(in thousands, except per share
data)(unaudited)
|
|
Three Months Ended |
|
|
|
March 31,
2019 |
|
|
March 31,
2018 |
|
Revenues: |
|
|
|
|
|
|
|
|
Research and development revenues |
|
$ |
8,464 |
|
|
$ |
3,585 |
|
License revenues |
|
|
— |
|
|
|
1,683 |
|
Total revenues |
|
|
8,464 |
|
|
|
5,268 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
23,545 |
|
|
|
22,135 |
|
General and administrative |
|
|
9,437 |
|
|
|
9,264 |
|
Total operating expenses |
|
|
32,982 |
|
|
|
31,399 |
|
Operating loss |
|
|
(24,518 |
) |
|
|
(26,131 |
) |
Interest expense |
|
|
(1,170 |
) |
|
|
(863 |
) |
Non-cash interest expense on liability related to sale of future
royalties |
|
|
(4,819 |
) |
|
|
(4,129 |
) |
Interest and other income, net |
|
|
1,141 |
|
|
|
842 |
|
Net loss |
|
$ |
(29,366 |
) |
|
$ |
(30,281 |
) |
Net loss per share — basic and diluted |
|
$ |
(0.54 |
) |
|
$ |
(0.56 |
) |
Weighted-average shares in net loss per share — basic and
diluted |
|
|
54,821 |
|
|
|
54,062 |
|
Cytokinetics,
IncorporatedCondensed Consolidated Balance
Sheets (in thousands)
|
|
March 31,
2019 |
|
|
December 31, 2018(1) |
|
|
|
|
(unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and short term investments |
|
$ |
176,622 |
|
|
$ |
198,731 |
|
Other current assets |
|
|
9,778 |
|
|
|
8,943 |
|
Total current assets |
|
|
186,400 |
|
|
|
207,674 |
|
Property and equipment, net |
|
|
3,175 |
|
|
|
3,204 |
|
Other assets |
|
|
9,036 |
|
|
|
300 |
|
Total assets |
|
$ |
198,611 |
|
|
$ |
211,178 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
15,491 |
|
|
$ |
19,521 |
|
Current portion of long-term debt |
|
|
6,212 |
|
|
|
2,607 |
|
Short-term lease liability |
|
|
4,499 |
|
|
|
— |
|
Other current liabilities |
|
|
75 |
|
|
|
66 |
|
Total current liabilities |
|
|
26,277 |
|
|
|
22,194 |
|
Long-term debt, net |
|
|
36,382 |
|
|
|
39,806 |
|
Liability related to the sale of future royalties, net |
|
|
127,308 |
|
|
|
122,473 |
|
Long-term lease liability |
|
|
5,272 |
|
|
|
— |
|
Other long-term liabilities |
|
|
— |
|
|
|
771 |
|
Total liabilities |
|
|
195,239 |
|
|
|
185,244 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
55 |
|
|
|
55 |
|
Additional paid-in capital |
|
|
775,401 |
|
|
|
768,703 |
|
Accumulated other comprehensive income |
|
|
606 |
|
|
|
500 |
|
Accumulated deficit |
|
|
(772,690 |
) |
|
|
(743,324 |
) |
Total stockholders’ equity |
|
|
3,372 |
|
|
|
25,934 |
|
Total liabilities and stockholders’ equity |
|
$ |
198,611 |
|
|
$ |
211,178 |
|
(1) Derived from the audited financial statements,
included in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2018.
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