VITALITY-ALS Proceeding towards Planned Database
Lock and Read-out in Q4;
Cytokinetics, Incorporated (Nasdaq:CYTK) reported total
revenues for the third quarter of 2017 were $6.2 million,
compared to $59.0 million, during the same period in 2016. Net loss
for the third quarter was $32.4 million, or $0.60 per basic and
diluted share, respectively, compared to net income for the same
period in 2016 of $33.4 million, or $0.84 and $0.77 per basic and
diluted share, respectively. As of September 30, 2017, cash, cash
equivalents and investments totaled $308.2 million.
“We are proud of the key milestones we recently
achieved in preparation for the planned release of results from
VITALITY-ALS, and potential regulatory filings and
commercialization of tirasemtiv in North America and Europe,” said
Robert I. Blum, Cytokinetics’ President and Chief Executive
Officer. “In the third quarter, we also advanced CK-2127107 into
two additional mid-stage clinical trials, one in patients with ALS
and another in elderly subjects with limited mobility; we look
forward to data from four clinical trials in this program in 2018.
Finally, we are pleased that patient enrollment in
GALACTIC-HF continues on target and commenced in Japan triggering a
$10 million milestone payment to Cytokinetics.”
Recent Highlights and Upcoming
Milestones
Skeletal Muscle Program
tirasemtiv (fast skeletal muscle
troponin activator)
- Completed dosing of patients in VITALITY-ALS
(Ventilatory Investigation of
Tirasemtiv and Assessment of
Longitudinal Indices after
Treatment for a Year in
ALS), our Phase 3 clinical trial of tirasemtiv in
patients with ALS.
- Continued enrollment in VIGOR-ALS (Ventilatory
Investigations in Global
Open-Label Research in
ALS), an open-label clinical trial designed to
assess the long-term safety and tolerability of tirasemtiv in
patients with ALS who have completed participation in
VITALITY-ALS.
- Conducted clinical, regulatory, non-clinical and other
activities intended to support potential regulatory filings and
registration of tirasemtiv in North America and Europe.
- Conducted manufacturing, logistical planning, market research,
market access and other commercial readiness activities intended to
support potential registration and commercialization of tirasemtiv
in North America and Europe.
- Proceeding to collection of final data from VITALITY-ALS and
clinical trial database lock in Q4 2017. We plan to conduct
analyses of data from VITALITY-ALS and present results from this
clinical trial on December 8, 2017 at the 28th International
Symposium on ALS/MND in Boston.
- Expect to continue to enroll patients who complete VITALITY-ALS
into VIGOR-ALS throughout 2017.
CK-2127107
(next-generation fast skeletal muscle troponin activator)
- Announced the start of a Phase 1b, double-blind, randomized,
placebo-controlled, multiple dose, two-period crossover study to
assess the effect of CK-2127107 on measures of physical function in
elderly adults with limited mobility. This study is being conducted
by Astellas, in collaboration with Cytokinetics.
- Announced the start of FORTITUDE-ALS
(Functional Outcomes in a
Randomized Trial of
Investigational Treatment with
CK-2127107 to Understand Decline
in Endpoints – in ALS). This
Phase 2 clinical trial is designed to assess the change from
baseline in the percent predicted slow vital capacity (SVC) and
other measures of skeletal muscle function after 12 weeks of
treatment with CK-2127107 in patients with ALS. This trial is being
conducted by Cytokinetics, in collaboration with Astellas.
- “Reasons for Screen Failures and Baseline Characteristics of
Randomized Patients from the First Cohort of the Phase 2 Clinical
Trial of CK-2127107 in Patients with SMA,” presented by Stacy
Rudnicki, M.D., Director, Clinical Research, Cytokinetics, at the
Cure SMA 2017 Annual SMA Conference in Orlando, FL.
- Expect to complete enrollment of Cohort 2 of the Phase 2
clinical trial of CK-2127107 in patients with SMA in 2017.
- Expect data from the Phase 2 clinical trial of CK-2127107 in
patients with SMA in Q1 2018.
- Expect Astellas to continue enrollment in a Phase 2 clinical
trial of CK-2127107 in patients with COPD in 2017.
- Expect Astellas to continue enrollment in a Phase 1b clinical
trial of CK-2127107 in adults with limited mobility in
2017.
- Expect to continue enrollment in FORTITUDE-ALS, a Phase 2
clinical trial of CK-2127107 in patients with ALS in 2017.
Cardiac Muscle Program
omecamtiv mecarbil (cardiac
muscle myosin activator)
- Announced that the Phase 2 clinical trial of omecamtiv mecarbil
in Japanese patients with heart failure met its pharmacokinetic
primary endpoint and demonstrated statistically significant
improvements in systolic ejection time (SET), a secondary
endpoint.
- Announced that the first patient has been dosed in Japan 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 which
is being conducted by Amgen, in collaboration with Cytokinetics.
Coincident with patient dosing in Japan, Cytokinetics earned a $10
million milestone payment from Amgen.
- Announced that additional results from COSMIC-HF
(Chronic Oral
Study of Myosin Activation to
Increase Contractility in
Heart Failure), a Phase 2 trial
evaluating omecamtiv mecarbil in patients with chronic heart
failure, were presented by John Teerlink, M.D., Professor of
Clinical Medicine at the University of California San Francisco and
Director of Heart Failure at the San Francisco Veterans Affairs
Medical Centers in a Rapid Fire Abstracts Presentation at the 21st
Annual Heart Failure Society of America Scientific Meeting in
Dallas, TX. The results suggest that omecamtiv mecarbil may produce
similar results with regard to cardiac function, heart rate,
biomarkers and adverse events in patients with ischemic and
non-ischemic heart failure due to left ventricular systolic
dysfunction.
- Continued to enroll patients in GALACTIC-HF, the Phase 3
cardiovascular outcomes clinical trial of omecamtiv mecarbil,
conducted by Amgen, in collaboration with Cytokinetics.
- Expect continued enrollment of patients with chronic heart
failure in GALACTIC-HF throughout 2017.
Pre-Clinical Research
- Continued research activities under our joint research program
with Amgen directed to the discovery of next-generation cardiac
muscle activators and under our joint research program with
Astellas directed to the discovery of next-generation skeletal
muscle activators. In addition, company scientists continued
independent research activities directed to our other muscle
biology programs.
- Expect to nominate at least 2 compounds from ongoing Research
programs (partnered and unpartnered) as potential drug candidates
by the end of 2017.
Financials
Revenues for the three and nine months ended
September 30, 2017 were $6.2 million and $13.4 million,
respectively, compared to $59.0 million and $73.3 million for the
corresponding periods in 2016. Revenues for the first nine months
of 2017 included the $10 million milestone payment from Amgen as
well as $8.8 million of research and development revenues and $6.7
million of license revenues from our collaboration with Astellas
and $1.3 million of research and development revenues from our
collaboration with Amgen. Revenues for the first nine months of
2017 were offset by $13.8 million (out of the total of $40 million)
for payments to Amgen related to our option to co-fund the Phase 3
development program of omecamtiv mecarbil in exchange for an
increased royalty upon potential commercialization. Revenues in
2016 were primarily due to license revenue from the September 2016
expansion of our collaboration with Astellas. Astellas paid us $65
million in connection with the expanded collaboration.
Total research and development expenses for the
three and nine months ended September 30, 2017 increased to $24.9
million and $64.0 million, respectively, from $17.9 million and
$41.1 million for the same periods in 2016, primarily due to
increased clinical activity, including activity for VITALITY-ALS
and other activities intended to support potential regulatory
filings and registration of tirasemtiv in North America and Europe,
increased CK-2127107 clinical trials activity, as well as increased
personnel.
General and administrative expenses for the
three and nine months ended September 30, 2017 increased to $9.7
million and $26.2 million from $7.2 million and $21.1 million for
the same periods in 2016, primarily due to increased personnel,
non-cash stock compensation expense and commercial readiness
activities.
Financial Guidance
The Company also announced updated financial
guidance for 2017. The Company anticipates cash research and
development expenses will be in the range of $103 to $107 million,
cash revenue will be in the range of $16 to $18 million, and cash
general and administrative expenses will remain in the range of $30
million to $32 million.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s third 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 46689063.
An archived replay of the webcast will be
available via Cytokinetics’ website until November 2,
2017. 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 46689063 from
October 26, 2017 at 7:30 PM Eastern Time until November 2,
2017.
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’ lead drug candidate is tirasemtiv,
a fast skeletal muscle troponin activator (FSTA). Tirasemtiv is the
subject of VITALITY-ALS, an international Phase 3 clinical trial in
patients with ALS. Tirasemtiv has been granted orphan drug
designation and fast track status by the U.S. Food and Drug
Administration (FDA) and orphan medicinal product designation by
the European Medicines Agency for the potential treatment of ALS.
Cytokinetics is preparing for the potential commercialization of
tirasemtiv in North America and Europe and has granted an option to
Astellas Pharma Inc. (“Astellas”) for development and
commercialization in other countries. Cytokinetics is collaborating
with Astellas to develop CK-2127107, a next-generation FSTA.
CK-2127107 has been granted orphan drug designation by the FDA for
the potential treatment of SMA. CK-2127107 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 CK-2127107
in elderly adults with limited mobility. 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. Astellas holds an exclusive worldwide
license to develop and commercialize CK-2127107. Licenses held by
Amgen and Astellas are subject to Cytokinetics' specified
co-development and co-commercialization rights. For additional
information about Cytokinetics, visit
http://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 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 Cytokinetics’ and its partners’
research and development activities, including the initiation,
conduct, design, enrollment, progress, continuation, completion and
results of clinical trials; the significance and utility of
pre-clinical study and clinical trial results, the expected
availability of clinical trial results; planned interactions with
regulatory authorities and the outcomes of such interactions; the
significance and utility of pre-clinical study and clinical trial
results; the potential benefits of Cytokinetics’ expanded
collaboration with Astellas; the expected timing of events and
milestones; the timing and 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; the FDA and/or other regulatory
authorities may not accept effects on slow vital capacity as a
clinical endpoint to support registration of tirasemtiv for the
treatment of ALS; 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, including risks that current and
past results of clinical trials or pre-clinical studies may not be
indicative of future clinical trials results; 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 CK-2127107, respectively; Cytokinetics may
incur unanticipated research and development and other costs;
Cytokinetics may be unable to enter into future collaboration
agreements for its drug candidates and programs on acceptable
terms, if at all; 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 |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
September 30, |
|
September 30, |
|
|
2017 |
2016 |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development, grant and other |
|
|
|
|
|
|
|
|
|
|
|
|
revenues,
net |
$ |
5,862 |
|
$ |
6,014 |
|
$ |
6,680 |
|
$ |
14,313 |
|
License
revenues |
|
318 |
|
|
53,033 |
|
|
6,706 |
|
|
58,956 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
6,180 |
|
|
59,047 |
|
|
13,386 |
|
|
73,269 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
24,947 |
|
|
17,865 |
|
|
64,045 |
|
|
41,121 |
|
General
and administrative |
|
9,657 |
|
|
7,217 |
|
|
26,210 |
|
|
21,149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
34,604 |
|
|
25,082 |
|
|
90,255 |
|
|
62,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
(28,424 |
) |
|
33,965 |
|
|
(76,869 |
) |
|
10,999 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and other income (expense), net |
|
(3,933 |
) |
|
(603 |
) |
|
(10,436 |
) |
|
(1,703 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
(loss) income |
$ |
(32,357 |
) |
$ |
33,362 |
|
$ |
(87,305 |
) |
$ |
9,296 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
(loss) income per share – basic |
$ |
(0.60 |
) |
$ |
0.84 |
|
$ |
(1.82 |
) |
$ |
0.23 |
|
Net
(loss) income per share – diluted |
$ |
(0.60 |
) |
$ |
0.77 |
|
$ |
(1.82 |
) |
$ |
0.22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares used in computing net (loss) income per
share – basic |
|
53,719 |
|
|
39,926 |
|
|
47,879 |
|
|
39,729 |
|
Weighted
average shares used in computing net (loss) income per share
– diluted |
|
53,719 |
|
|
43,217 |
|
|
47,879 |
|
|
42,247 |
|
Cytokinetics,
IncorporatedCondensed Consolidated Balance
Sheets (in thousands) |
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016(1) |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
116,320 |
|
$ |
66,874 |
|
|
|
|
|
|
|
|
Short
term investments |
|
191,247 |
|
|
89,375 |
|
|
|
|
|
|
|
|
Accounts
receivable |
|
10,000 |
|
|
24 |
|
|
|
|
|
|
|
|
Other
current assets |
|
4,420 |
|
|
2,360 |
|
|
|
|
|
|
|
|
Total
current assets |
|
321,987 |
|
|
158,633 |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
3,294 |
|
|
3,637 |
|
|
|
|
|
|
|
|
Long-term investments |
|
583 |
|
|
7,672 |
|
|
|
|
|
|
|
|
Other
assets |
|
449 |
|
|
200 |
|
|
|
|
|
|
|
|
Total assets |
$ |
326,313 |
|
$ |
170,142 |
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
revenue, current |
$ |
9,570 |
|
$ |
8,060 |
|
|
|
|
|
|
|
|
Other
current liabilities |
|
32,787 |
|
|
25,198 |
|
|
|
|
|
|
|
|
Total
current liabilities |
|
42,357 |
|
|
33,258 |
|
|
|
|
|
|
|
|
Long-term debt |
|
20,471 |
|
|
27,381 |
|
|
|
|
|
|
|
|
Deferred
revenue, non-current |
|
15,872 |
|
|
15,000 |
|
|
|
|
|
|
|
|
Liability related to sale of future royalties |
|
100,575 |
|
|
- |
|
|
|
|
|
|
|
|
Other
non-current liabilities |
|
- |
|
|
142 |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
147,038 |
|
|
94,361 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity
|
$ |
326,313 |
|
$ |
170,142 |
|
(1) Derived from the audited financial statements,
included in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2016.
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