Cytokinetics, Inc. Reports First Quarter 2018 Financial Results
April 26 2018 - 4:00PM
Completed Enrollment in Phase 2 Study of
Reldesemtiv in Patients with SMA;Data Expected in Q2 2018
Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results
for the first quarter of 2018. Net loss for the first quarter was
$30.3 million, or $0.56 per share, compared to a net loss for the
first quarter of 2017 of $25.9 million, or $0.62 per share. Cash,
cash equivalents and investments totaled $255.5 million at March
31, 2018.
“In the first quarter of 2018 we made progress
advancing our muscle biology directed drug candidates in mid- and
late-stage clinical trials across diseases and conditions of
impaired muscle function,” said Robert I. Blum, Cytokinetics’
President and Chief Executive Officer. “We completed enrollment of
our Phase 2 clinical study of reldesemtiv in patients with spinal
muscular atrophy and look forward to data from that study in the
second quarter which may inform future development of reldesemtiv
under our collaboration with Astellas. In addition, we made further
preparations to initiate the second Phase 3 clinical trial of
omecamtiv mecarbil in patients with heart failure under our
collaboration with Amgen. We also continued preclinical development
activities with the objective of advancing two drug candidates into
Phase 1 trials.”
Recent Highlights and Upcoming
Milestones
Cardiac Muscle Program
omecamtiv mecarbil (cardiac
myosin activator)
- Continued patient enrollment in 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.
Enrollment is proceeding towards 50 percent completion with
patients randomized to date having a risk profile consistent with
the trial design. The Data Monitoring Committee for GALACTIC-HF has
been meeting regularly and reviewing data arising from the trial;
there have been no major changes to the trial following these
reviews. We expect to complete enrolling patients with chronic
heart failure in GALACTIC-HF in approximately one year.
- Continued protocol development, feasibility assessments,
regulatory interactions and other readiness activities for a second
Phase 3 clinical trial of omecamtiv mecarbil. This trial is
intended to evaluate the potential effect of omecamtiv mecarbil on
exercise performance in patients with heart failure and is planned
to be conducted by Cytokinetics in collaboration with Amgen. We are
finalizing preparations to ensure readiness to begin this trial on
a timeframe to be agreed soon.
Skeletal Muscle Program
tirasemtiv (fast skeletal muscle
troponin activator (FSTA))
- Convened an advisory board of ethicists, patient advocates,
trial investigators and experts in pre-approval access to assess
whether and how best to continue providing tirasemtiv to those
people living with ALS currently in VIGOR-ALS, the open-label
extension clinical trial following VITALITY-ALS. Informed by our
advisory board, we decided to close VIGOR-ALS and transition
patients who wish to remain on tirasemtiv to a Managed Access
Program (MAP).
- The manuscript, “Respiratory Measures in Amyotrophic Lateral
Sclerosis,” published online in Amyotrophic Lateral Sclerosis and
Frontotemporal Degeneration.
- The manuscript, “VITALITY-ALS, a Phase III Trial of Tirasemtiv,
a Selective Fast Skeletal Muscle Troponin Activator, as a Potential
Treatment for Patients with Amyotrophic Lateral Sclerosis: Study
Design and Baseline Characteristics,” published online in
Amyotrophic Lateral Sclerosis and Frontotemporal
Degeneration.
reldesemtiv (CK-2127107,
next-generation FSTA)
- Completed enrollment of 70 patients in our Phase 2 clinical
trial of reldesemtiv which is designed to assess its effect on
multiple measures of muscle function in both ambulatory and
non-ambulatory patients with SMA. This trial is being conducted by
Cytokinetics in collaboration with Astellas. We expect results to
be presented on June 16 at the 2018 Annual Cure SMA
Conference.
- Continued site activation and patient enrollment in
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 which is designed to assess the
change from baseline in percent predicted slow vital capacity and
other measures of skeletal muscle function after 12 weeks of
treatment with reldesemtiv in patients with ALS. This trial has
enrolled over 150 patients toward the objective of 445 patients and
is being conducted by Cytokinetics in collaboration with Astellas.
We expect results from this clinical trial in Q4 2018.
- Continued patient enrollment in the Phase 2 clinical trial of
reldesemtiv in patients with chronic obstructive pulmonary disease
(COPD) which is designed to assess its effect on physical function.
This trial, designed to enroll 40 patients, is nearing completion
and is being conducted by Astellas in collaboration with
Cytokinetics. We expect results from this clinical trial in 2H
2018.
- Continued site activation and patient enrollment in the Phase
1b clinical trial of reldesemtiv in elderly subjects with limited
mobility which is designed to assess its effect on measures of
physical function. This trial is being conducted by Astellas in
collaboration with Cytokinetics. We expect Astellas will conduct an
interim analysis of data arising from this trial in Q4 2018.
Pre-Clinical Research and
Development
- Continued collaboration activities under our joint research
program with Astellas directed to the discovery of next-generation
skeletal muscle activators.
- Continued independent research activities directed to our other
muscle biology programs.
- Continued to advance development compounds under our
collaborations with Amgen and Astellas. We expect to advance
one of these potential drug candidates to Phase 1 in
2018.
- Continued IND-enabling studies for our unpartnered cardiac
sarcomere directed compound. We expect to advance this potential
drug candidate to Phase 1 in 2018.
Corporate
- Announced progress against our Vision 2020 initiatives designed
to advance and expand our pipeline of muscle biology directed drug
candidates in late-stage development to address urgent needs of
people living with conditions characterized by impaired muscle
function and weakness.
- Announced that Robert Califf, M.D., has been appointed to the
company’s Board of Directors. Dr. Califf is the Vice Chancellor for
Health Data Science at Duke Health and Director of the Duke
University Center for Health Data Science. He is also serving as an
advisor to the senior management team at Verily Life Sciences, a
subsidiary of Alphabet, Inc. (parent company to Google) and was
appointed an adjunct professor of medicine at Stanford University.
- Joined the global initiative to raise awareness of Rare Disease
Day®, an international campaign led by the European Organisation
for Rare Diseases (EURORDIS) and the National Organization for Rare
Disorders (NORD), dedicated to elevating the public understanding
of rare diseases.
Annual Stockholders'
Meeting
Cytokinetics’ Annual Stockholders’ Meeting will
be held on Wednesday, May 16, 2018 at 10:30 AM Pacific Time at the
Embassy Suites Hotel in South San Francisco, CA and simultaneously
webcast.
Financials
Revenues for the first quarter of 2018 consisted
of revenues from our collaboration with Astellas, including
research and development revenues of $3.6 million and license
revenues of $1.7 million.
Research and development expenses fell to $22.1
million for the first quarter of 2018 from $26.2 million for the
fourth quarter of 2017. General and administrative expenses fell to
$9.3 million for the first quarter of 2018 from $10.3 million for
the fourth quarter of 2017.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s first quarter 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 3488889.
An archived replay of the webcast will be
available via Cytokinetics’ website until May 3, 2018. 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 3488889 from April 26, 2018 at 7:30 PM
Eastern Time until May 3, 2018.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical
company focused on discovering, developing and commercializing
first-in-class muscle activators 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 increase 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 GALACTIC-HF, an
international Phase 3 clinical trial in patients with heart
failure. 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 (CK-2127107), a next-generation
FSTA. Reldesemtiv has been granted orphan drug designation by the
FDA for the potential treatment of SMA. Reldesemtiv is the subject
of three ongoing Phase 2 clinical trials enrolling patients with
spinal muscular atrophy, chronic obstructive pulmonary disease and
ALS. Astellas is also conducting a Phase 1b clinical trial of
reldesemtiv in elderly adults with limited mobility. Astellas holds
an exclusive worldwide license to develop and commercialize
reldesemtiv. Licenses held by Amgen and Astellas are subject to
Cytokinetics' specified co-development and co-commercialization
rights. Cytokinetics continues its 20-year history of innovation
with three new muscle biology directed compounds advancing from
research to development in 2018. For additional information
about Cytokinetics, visit www.cytokinetics.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 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; 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; 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(650)
624-3000
Cytokinetics,
IncorporatedCondensed Consolidated Statements of
Operations(in thousands, except per share data,
unaudited)
|
|
|
Three Months Ended |
|
|
|
March 31, 2018 |
|
|
March 31, 2017 |
|
Revenues: |
|
|
|
|
|
|
|
|
Research
and development, grant and other revenues, net |
|
$ |
3,585 |
|
|
$ |
2,707 |
|
License
revenues |
|
|
1,683 |
|
|
|
1,446 |
|
Total
revenues |
|
|
5,268 |
|
|
|
4,153 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
22,135 |
|
|
|
19,289 |
|
General
and administrative |
|
|
9,264 |
|
|
|
8,115 |
|
Total
operating expenses |
|
|
31,399 |
|
|
|
27,404 |
|
Operating loss |
|
|
(26,131 |
) |
|
|
(23,251 |
) |
Interest
expense |
|
|
(863 |
) |
|
|
(745 |
) |
Non-cash
interest expense on liability related to sale of future
royalties |
|
|
(4,129 |
) |
|
|
(2,307 |
) |
Interest
and other income, net |
|
|
842 |
|
|
|
436 |
|
Net
loss |
|
$ |
(30,281 |
) |
|
$ |
(25,867 |
) |
Net loss
per share - basic and diluted |
|
$ |
(0.56 |
) |
|
$ |
(0.62 |
) |
Weighted-average shares used to compute net loss per share — basic
and diluted |
|
|
54,062 |
|
|
|
41,578 |
|
|
Condensed Consolidated Balance
Sheets(in thousands)
|
|
|
March 31, 2018 |
|
|
December 31, 2017(1) |
|
|
|
(unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and short term investments |
|
$ |
251,454 |
|
|
$ |
268,891 |
|
Other current assets |
|
|
20,885 |
|
|
|
5,404 |
|
Total current assets |
|
|
272,339 |
|
|
|
274,295 |
|
Long-term investments |
|
|
4,015 |
|
|
|
16,518 |
|
Property and equipment, net |
|
|
3,156 |
|
|
|
3,568 |
|
Other assets |
|
|
416 |
|
|
|
429 |
|
Total assets |
|
$ |
279,926 |
|
|
$ |
294,810 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
30,469 |
|
|
$ |
22,645 |
|
Deferred revenue, current |
|
|
7,842 |
|
|
|
9,572 |
|
Other current liabilities |
|
|
235 |
|
|
|
227 |
|
Total current liabilities |
|
|
38,546 |
|
|
|
32,444 |
|
Long-term debt, net |
|
|
31,954 |
|
|
|
31,777 |
|
Liability related to the sale of future royalties, net |
|
|
108,792 |
|
|
|
104,650 |
|
Deferred revenue, non-current |
|
|
— |
|
|
|
15,000 |
|
Other long-term liabilities |
|
|
1,035 |
|
|
|
1,097 |
|
Total liabilities |
|
|
180,327 |
|
|
|
184,968 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
54 |
|
|
|
54 |
|
Additional paid-in capital |
|
|
757,405 |
|
|
|
755,526 |
|
Accumulated other comprehensive income |
|
|
489 |
|
|
|
343 |
|
Accumulated deficit |
|
|
(658,349 |
) |
|
|
(646,081 |
) |
Total stockholders’ equity |
|
|
99,599 |
|
|
|
109,842 |
|
Total liabilities and stockholders’ equity |
|
$ |
279,926 |
|
|
$ |
294,810 |
|
|
(1) Derived from the audited financial statements,
included in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2017.
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