Results Expected from VITALITY-ALS, Our Phase 3
Clinical Trial of Tirasemtiv, in Q4 2017
Cytokinetics, Incorporated (Nasdaq:CYTK) reported total
revenues for the second quarter of 2017 were $3.1 million,
compared to $5.8 million, during the same period in 2016. Net loss
for the second quarter was $29.1 million, or $0.60 per share,
respectively, compared to a net loss for the same period in 2016 of
$11.6 million, or $0.29 per share. As of June 30, 2017, cash, cash
equivalents and investments totaled $332.1 million.
“We made key progress during the second quarter in
anticipation of results from VITALITY-ALS expected later this year
and recently initiated two additional clinical trials of CK-2127107
– one in ALS and one in elderly people with frailty under our
collaboration with Astellas – underscoring the broad potential of
fast skeletal muscle troponin activation across multiple diseases
and conditions of impaired muscle function and weakness,” said
Robert I. Blum, Cytokinetics’ President and Chief Executive
Officer. “With similar progress made for omecamtiv mecarbil under
our collaboration with Amgen, we believe that Cytokinetics is
executing well across the breadth of our business, advancing
late-stage development of several first-in-class programs while
also readying for the potential registration and commercialization
of tirasemtiv in North America and Europe.”
Recent Highlights and Upcoming
Milestones
Skeletal Muscle Program
tirasemtiv (fast skeletal muscle
troponin activator)
- Continued conduct of VITALITY-ALS (Ventilatory
Investigation of Tirasemtiv and
Assessment of Longitudinal
Indices after Treatment for a
Year in ALS) and enrollment in
VIGOR-ALS (Ventilatory
Investigations in Global
Open-Label Research in
ALS), an open-label extension 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, market research, market access and
other commercial readiness activities in support of potential
registration and commercialization of tirasemtiv in North America
and Europe.
- Expect to continue to enroll patients who complete VITALITY-ALS
into VIGOR-ALS throughout 2017.
- Expect results from VITALITY-ALS in Q4 2017.
CK-2127107 (next generation fast
skeletal muscle troponin activator)
- Announced that the Office of Orphan Products Development of the
U.S. Food and Drug Administration (FDA) has granted orphan drug
designation to CK-2127107 for the potential treatment of spinal
muscular atrophy (SMA).
- Recently announced data relating to patient baseline
characteristics and the reasons for patient screen failure, both
from the first cohort of the Phase 2 clinical trial of CK-2127107
in patients with SMA, presented at the CureSMA 2017 Annual SMA
Conference in Orlando, FL.
- Recently 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.
- Recently 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.
- 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.
Cardiac Muscle Program
omecamtiv mecarbil (cardiac muscle
myosin activator)
- Announced that results from the dose escalation phase of
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 in a Rapid Fire Abstract Presentation at
Heart Failure 2017, the annual congress of the Heart Failure
Association of the European Society of Cardiology.
- Continued to activate sites and enroll patients 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.
- Recently announced topline data from a Phase 2 clinical trial
of omecamtiv mecarbil in Japanese patients with chronic heart
failure. The trial met its pharmacokinetic primary endpoint and
demonstrated statistically significant improvements in systolic
ejection time (SET).
- 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 one potential drug candidate from
research programs for development in 2017.
Corporate
- Raised $83 million in net proceeds, after deducting
underwriting discounts and commissions, from an underwritten public
offering of 6,049,000 shares of common stock including the
underwriter’s exercise of their overallotment option. Morgan
Stanley LLC acted as the sole underwriter of the
offering.
- Raised an additional $12 million from sales of common stock
through an at-the-market equity vehicle.
- Received an additional $11 million from the exercise of
warrants issued in connection with our June 2012 equity offering.
- Announced that Cytokinetics has been selected for addition to
the S&P SmallCap 600 GICS Biotechnology Sub-Industry Index.
- Announced with The ALS Association (ALSA) the continuation of
our partnership in the fight against ALS which includes
Cytokinetics’ renewal of its Gold Level Sponsorship of the National
Walks to Defeat ALS® and Premier Level National ALS Advocacy
Conference Sponsorship as well as Platinum Level Sponsorship for
initiatives led by The ALS Association Golden West Chapter.
Financials
Revenues for the three and six months ended June
30, 2017 were $3.1 million and $7.2 million, respectively, compared
to $5.8 million and $14.2 million for the corresponding periods in
2016. Revenues for the first six months of 2017 included $6.7
million of research and development revenues and $6.4 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 six months of 2017 were offset
by $7.5 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.
Research and development expenses for the three and
six months ended June 30, 2017 increased to $19.8 million and $39.1
million, respectively, from $9.7 million and $23.3 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, as well as increased
personnel.
General and administrative expenses for the three
and six months ended June 30, 2017 increased to $8.4 million and
$16.6 million from $7.1 million and $13.9 million for the
same periods in 2016, primarily due to increased personnel,
non-cash stock compensation expense and increased commercial
readiness activities.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s second 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 46688062.
An archived replay of the webcast will be available
via Cytokinetics’ website until August 9, 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 46688062 from August 2, 2017 at 7:30 PM
Eastern Time until August 9, 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; 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.
Cytokinetics, Incorporated |
Condensed Consolidated Statements of
Operations |
(in thousands, except per share
data) |
(unaudited) |
|
|
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development, grant and other |
|
|
|
|
|
|
|
|
|
|
|
|
revenues,
net |
$ |
(1,889 |
) |
|
$ |
3,852 |
|
|
$ |
818 |
|
|
$ |
8,299 |
|
License
revenues from related parties |
|
4,942 |
|
|
|
1,950 |
|
|
|
6,388 |
|
|
|
5,923 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenues |
|
3,053 |
|
|
|
5,802 |
|
|
|
7,206 |
|
|
|
14,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
19,809 |
|
|
|
9,723 |
|
|
|
39,098 |
|
|
|
23,256 |
|
General
and administrative |
|
8,438 |
|
|
|
7,090 |
|
|
|
16,553 |
|
|
|
13,931 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating expenses |
|
28,247 |
|
|
|
16,813 |
|
|
|
55,651 |
|
|
|
37,187 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(25,194 |
) |
|
|
(11,011 |
) |
|
|
(48,445 |
) |
|
|
(22,965 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and other income (expense), net |
|
(3,887 |
) |
|
|
(600 |
) |
|
|
(6,503 |
) |
|
|
(1,101 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
$ |
(29,081 |
) |
|
$ |
(11,611 |
) |
|
$ |
(54,948 |
) |
|
$ |
(24,066 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share – basic and diluted |
$ |
(0.60 |
) |
|
$ |
(0.29 |
) |
|
$ |
(1.22 |
) |
|
$ |
(0.61 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares used in computing net loss per share – basic and
diluted |
|
48,218 |
|
|
|
39,666 |
|
|
|
44,910 |
|
|
|
39,629 |
|
Cytokinetics, Incorporated |
Condensed Consolidated Balance
Sheets |
(in thousands) |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016(1) |
|
|
|
(unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
100,711 |
|
$ |
66,874 |
|
|
|
|
|
|
|
|
Short
term investments |
|
211,340 |
|
|
89,375 |
|
|
|
|
|
|
|
|
Accounts
receivable |
|
- |
|
|
24 |
|
|
|
|
|
|
|
|
Other
current assets |
|
4,945 |
|
|
2,360 |
|
|
|
|
|
|
|
|
Total
current assets |
|
316,996 |
|
|
158,633 |
|
|
|
|
|
|
|
|
Property
and equipment, net |
|
3,268 |
|
|
3,637 |
|
|
|
|
|
|
|
|
Long-term investments |
|
20,087 |
|
|
7,672 |
|
|
|
|
|
|
|
|
Other
assets |
|
279 |
|
|
200 |
|
|
|
|
|
|
|
|
Total assets |
$ |
340,630 |
|
$ |
170,142 |
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
revenue, current |
$ |
7,942 |
|
$ |
8,060 |
|
|
|
|
|
|
|
|
Other
current liabilities |
|
23,117 |
|
|
25,198 |
|
|
|
|
|
|
|
|
Total
current liabilities |
|
31,059 |
|
|
33,258 |
|
|
|
|
|
|
|
|
Long-term debt |
|
22,844 |
|
|
27,381 |
|
|
|
|
|
|
|
|
Deferred
revenue, non-current |
|
15,067 |
|
|
15,000 |
|
|
|
|
|
|
|
|
Liability related to sale of future royalties |
|
96,657 |
|
|
- |
|
|
|
|
|
|
|
|
Other
non-current liabilities |
|
2 |
|
|
142 |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
175,001 |
|
|
94,361 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
340,630 |
|
$ |
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. |
|
Contact:
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(650) 624-3000
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