Cytokinetics, Incorporated (Nasdaq:CYTK) reported financial results
for the third quarter of 2019. Net loss for the third quarter was
$29.6 million, or $0.50 per share, compared to net loss for the
third quarter of 2018 of $22.0 million, or $0.40 per share. Cash,
cash equivalents and investments totaled $166.0 million at
September 30, 2019.
“In the third quarter of 2019, we achieved major
milestones in both our cardiovascular and neuromuscular programs
representing progress on key priorities across our pipeline of
muscle-directed therapies,” said Robert I. Blum, Cytokinetics’
President and Chief Executive Officer. “Completion of enrollment of
GALACTIC-HF represents a significant step forward towards the
completion of this important trial which holds promise for
advancing the treatment of millions of patients suffering from
heart failure. Additionally, recently presented Phase 1 data for
CK-274 reaffirms its next-generation profile and supports advancing
this program into a Phase 2 trial in patients with obstructive
hypertrophic cardiomyopathy this year. Furthermore, additional
analyses of results from FORTITUDE-ALS, as well as ongoing
regulatory interactions, provide support for a potential Phase 3
trial of reldesemtiv in patients with ALS next year. We believe
this progress positions us well to leverage our leadership in
muscle pharmacology to benefit a wide array of patients suffering
from varied diseases of muscle dysfunction.”
Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac
myosin activator)
- Completed 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.
GALACTIC-HF enrolled over 8,200 patients in 35 countries. We expect
GALACTIC-HF to continue throughout 2019 and the second planned
interim analysis of GALACTIC-HF to occur in the first quarter of
2020.
- Continued conduct of METEORIC-HF (Multicenter
Exercise Tolerance
Evaluation of Omecamtiv Mecarbil
Related to Increased
Contractility in Heart
Failure), the second Phase 3 trial of omecamtiv
mecarbil. 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.
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 our 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)
- Presented data from the Phase 1 study of CK-274 at the Heart
Failure Society of America’s 23rd Annual Scientific Meeting in
Philadelphia. The study met its primary and secondary objectives to
assess the safety and tolerability of single and multiple oral
doses of CK-274, describe the pharmacokinetics of CK-274 and its
pharmacodynamic effects as measured by echocardiography, as well as
to characterize the PK/PD relationship with regards to cardiac
function. These data support the advancement of CK-274 into a Phase
2 clinical trial in patients with obstructive hypertrophic
cardiomyopathy (HCM) which is expected to begin in Q4 2019.
- Presented preclinical data at the American Heart Association’s
Basic Cardiovascular Sciences Scientific Sessions in Boston
demonstrating that CK-274 produces exposure related effects on
cardiac contractility in healthy animals and mouse models of HCM
and support the therapeutic hypothesis relating to onset of action
and reversibility.
Skeletal Muscle Program
reldesemtiv (next-generation,
fast skeletal muscle troponin activator (FSTA))
- Presented post-hoc analyses from FORTITUDE-ALS
(Functional Outcomes in a
Randomized Trial of
Investigational Treatment with
CK-2127107 to Understand Decline
in Endpoints – in ALS), at the
2019 Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting in
Clearwater Beach, FL. The analyses demonstrated that, in the
combined middle and faster progressing tertiles of patients, the
decline in the ALSFRS-R total score from baseline to week 12 in
patients who received any dose of reldesemtiv was significantly
smaller than the decline on placebo, while no significant
difference between reldesemtiv and placebo was observed in slower
progressing patients.
- Held regulatory interactions and conducted feasibility and
other planning activities in preparation for the potential
advancement of reldesemtiv to a Phase 3 trial in patients in ALS in
2020.
- Received European Orphan Designation for reldesemtiv for the
potential treatment of spinal muscular atrophy (SMA) by the
European Medicines Agency (EMA).
Pre-Clinical Development and Ongoing
Research
- Announced the publication of “Fast Skeletal Muscle Troponin
Activator CK-2066260 Increases Fatigue Resistance by Reducing the
Energetic Cost of Muscle Contraction,” in The Journal of
Physiology, demonstrating that a FSTA can decrease skeletal muscle
fatigue by increasing the metabolic efficiency of muscle
contraction. CK-2066260 is a preclinical FSTA tool
compound.
- Continued pre-clinical development of CK-3762601 (CK-601), a
next-generation 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’ research activities through
2019.
- Continued independent research activities directed to our other
muscle biology research programs.
Corporate
- We and Astellas have agreed in principle to revise the terms of
our collaboration agreement so that Cytokinetics would have the
exclusive right to develop and commercialize all FSTAs, including
reldesemtiv and CK-601. Astellas’ future contributions would be to
provide partial co-funding for certain Phase 3 clinical trial costs
for reldesemtiv in ALS and to provide other in-kind support. In
exchange, Astellas would receive a low- to mid- single digit
royalty on reldesemtiv to be payable by Cytokinetics. We have also
agreed in principle to extend our joint research program for
another year with Astellas sponsoring research at Cytokinetics
through 2020.
- The above agreements in principle are non-binding and
contingent upon our finalizing amendments to our collaboration
agreement and, absent such agreement, the terms of the existing
agreement remain in place.
- Announced the continuation of our partnership with Cure SMA to
increase education, awareness, public policy and fundraising for
SMA. The partnership includes support for several of Cure SMA’s
national initiatives as well as local community events.
- Announced a call for proposals for the second annual
Cytokinetics Communications Fellowship Grant program. The program
provides $100,000 in grants to five selected patient advocacy
organizations serving the ALS, heart failure, HCM, or SMA
communities, and is intended to support increased capacity in
communications, awareness building and community engagement.
Financials
Revenues for the three and nine months ended
September 30, 2019 were $6.1 million and $21.7 million,
respectively, compared to $10.6 million and $22.1 million for the
corresponding periods in 2018. The decrease in revenues for the
three and nine months ended September 30, 2019 was due primarily to
the winding down of FORTITUDE-ALS in addition to a lack of license
revenue in 2019. License revenues in the third quarter and first
nine months of 2018 were related to the Phase 2 trial of
reldesemtiv in spinal muscular atrophy completed in 2018.
Research and development expenses for the three
and nine months ended September 30, 2019 were $20.2 million and
$67.8 million, respectively compared to $21.4 million and $65.9
million for the same periods in 2018, respectively. The changes
were primarily due to reduced spending for reldesemtiv as well as
tirasemtiv following suspension of development of tirasemtiv in
late 2017 offset by increased spending related to METEORIC-HF and
the development of CK-274.
General and administrative expenses for the
three and nine months ended September 30, 2019 increased to $9.8
million and $29.0 million, respectively, from $7.2 million and
$23.7 million for the same periods in 2018, respectively, due
primarily to an increase in outside legal counsel and personnel
related costs including stock-based compensation.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s third 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 9440838.
An archived replay of the webcast will be
available via Cytokinetics’ website until November 7,
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 9440838 from
October 31, 2019 at 7:30 PM Eastern Time until November 7,
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
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) for diseases of
neuromuscular dysfunction, including SMA and ALS. 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; the agreement in principle to revise the terms of the
collaboration agreement between Astellas and Cytokinetics; 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 |
|
Nine Months Ended |
|
|
September 30, 2019 |
|
September 30, 2018 |
|
September 30, 2019 |
|
September 30, 2018 |
Revenues: |
|
|
|
|
|
|
|
|
Research and development revenues |
|
$ |
6,055 |
|
|
$ |
8,726 |
|
|
$ |
21,656 |
|
|
$ |
16,991 |
|
License revenues |
|
|
— |
|
|
|
1,915 |
|
|
|
— |
|
|
|
5,133 |
|
Total revenues |
|
|
6,055 |
|
|
|
10,641 |
|
|
|
21,656 |
|
|
|
22,124 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
20,229 |
|
|
|
21,391 |
|
|
|
67,791 |
|
|
|
65,858 |
|
General and administrative |
|
|
9,753 |
|
|
|
7,164 |
|
|
|
29,026 |
|
|
|
23,724 |
|
Total operating expenses |
|
|
29,982 |
|
|
|
28,555 |
|
|
|
96,817 |
|
|
|
89,582 |
|
Operating loss |
|
|
(23,927 |
) |
|
|
(17,914 |
) |
|
|
(75,161 |
) |
|
|
(67,458 |
) |
Interest expense |
|
|
(1,345 |
) |
|
|
(867 |
) |
|
|
(3,892 |
) |
|
|
(2,628 |
) |
Non-cash interest expense on liability related to the sale of
future royalties |
|
|
(5,321 |
) |
|
|
(4,559 |
) |
|
|
(15,204 |
) |
|
|
(13,026 |
) |
Interest and other income |
|
|
1,020 |
|
|
|
1,323 |
|
|
|
3,205 |
|
|
|
3,291 |
|
Net (loss) income before income taxes |
|
|
(29,573 |
) |
|
|
(22,017 |
) |
|
|
(91,052 |
) |
|
|
(79,821 |
) |
Income tax benefit |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net loss |
|
$ |
(29,573 |
) |
|
$ |
(22,017 |
) |
|
$ |
(91,052 |
) |
|
$ |
(79,821 |
) |
Net loss per share — basic and diluted |
|
$ |
(0.50 |
) |
|
$ |
(0.40 |
) |
|
$ |
(1.60 |
) |
|
$ |
(1.47 |
) |
Weighted-average shares in net loss per share — basic and
diluted |
|
|
58,640 |
|
|
|
54,626 |
|
|
|
57,050 |
|
|
|
54,329 |
|
Cytokinetics,
IncorporatedCondensed Consolidated Balance
Sheets (in thousands)
|
|
September 30, 2019 |
|
December 31, 2018(1) |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and short term investments |
|
$ |
166,039 |
|
|
$ |
198,731 |
|
Other current assets |
|
|
10,496 |
|
|
|
8,943 |
|
Total current assets |
|
|
176,535 |
|
|
|
207,674 |
|
Property and equipment, net |
|
|
3,615 |
|
|
|
3,204 |
|
Other assets |
|
|
7,243 |
|
|
|
300 |
|
Total assets |
|
$ |
187,393 |
|
|
$ |
211,178 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
16,551 |
|
|
$ |
19,521 |
|
Current portion of long-term debt |
|
|
- |
|
|
|
2,607 |
|
Short-term lease liability |
|
|
4,577 |
|
|
|
— |
|
Other current liabilities |
|
|
389 |
|
|
|
66 |
|
Total current liabilities |
|
|
21,517 |
|
|
|
22,194 |
|
Long-term debt, net |
|
|
44,762 |
|
|
|
39,806 |
|
Liability related to the sale of future royalties, net |
|
|
137,726 |
|
|
|
122,473 |
|
Long-term lease liability |
|
|
3,257 |
|
|
|
— |
|
Other long-term liabilities |
|
|
— |
|
|
|
771 |
|
Total liabilities |
|
|
207,262 |
|
|
|
185,244 |
|
Stockholders’ equity: |
|
|
|
|
Common stock |
|
|
59 |
|
|
|
55 |
|
Additional paid-in capital |
|
|
813,729 |
|
|
|
768,703 |
|
Accumulated other comprehensive income |
|
|
719 |
|
|
|
500 |
|
Accumulated deficit |
|
|
(834,376 |
) |
|
|
(743,324 |
) |
Total stockholders’ equity |
|
|
(19,869 |
) |
|
|
25,934 |
|
Total liabilities and stockholders’ equity |
|
$ |
187,393 |
|
|
$ |
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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