Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial
results for the first quarter of 2020. Net loss for the first
quarter was $39.4 million, or $0.66 per share, compared to net loss
for the first quarter of 2019 of $29.4 million, or $0.54 per share.
Cash, cash equivalents and investments totaled $237.2 million at
March 31, 2020.
“While we face challenges due to the COVID-19
pandemic, we believe we are on track to achieve our key strategic
objectives in 2020, in particular, the sharing of top-line results
from GALACTIC-HF, expected in the fourth quarter of this year,”
said Robert I. Blum, Cytokinetics’ President and Chief Executive
Officer. “We are fortunate to have ended the first quarter with
more than two years of forward cash runway based on our expected
net cash spending of $105-115 million in 2020. We will continue to
assess the impact of the pandemic to our business, with an eye
toward prudently managing our cash and other resources and to
prioritizing our strategic programs in our pipeline.”
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 the second and final planned interim analysis, which
considered pre-specified criteria for futility and superiority. We
expect top-line results in Q4 2020. GALACTIC-HF is being conducted
by Amgen in collaboration with Cytokinetics.
- Published patient baseline
characteristics and demographics from GALACTIC-HF during the
Virtual American College of Cardiology 69th Annual Scientific
Session together with the World Congress of Cardiology (ACC.20/WCC
Virtual). Patients enrolled in the trial represent a population at
risk for heart failure events despite being well-treated in
accordance with international guidelines.
- Announced the publication of a
manuscript relating to the design of GALACTIC-HF in the Journal of
American College of Cardiology: Heart Failure (JACC: HF).
- 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, in Q1. In response to the COVID-19
pandemic, Cytokinetics and Amgen recently agreed to
temporarily suspend enrollment in METEORIC-HF to protect the safety
and health of clinical trial participants and healthcare
professionals. Clinical site start-up activities are continuing to
be prioritized with an objective to activate new sites throughout
North America and Europe. We believe enrollment may be completed by
the end of Q4 2020 if enrollment can be reactivated by the end of
Q2 2020. METEORIC-HF is being conducted by Cytokinetics in
collaboration with Amgen.
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 in Q1. In response to the COVID-19 pandemic,
Amgen and Cytokinetics recently agreed to temporarily
suspend enrollment in the Phase 1 study of AMG 594 to protect the
safety and health of clinical study participants and healthcare
professionals. This Phase 1 study is being conducted by Amgen in
collaboration with Cytokinetics.
- Presented preclinical data at the
Keystone Symposium “Charting a New Course for Heart Failure: From
Discovery to Data,” showing that AMG 594 selectively increases
calcium sensitivity of cardiac muscle fibers and increased cardiac
contractility.
CK-3773274 (CK-274, cardiac
myosin inhibitor)
- Prepared for and started
REDWOOD-HCM (Randomized
Evaluation of Dosing
With CK-274 in Obstructive
Outflow Disease in
HCM), the Phase 2 clinical trial designed to
determine the safety and tolerability of CK-274 in patients with
obstructive hypertrophic cardiomyopathy (HCM). REDWOOD-HCM started
in Q1 2020 and will continue through 2020. In response to the
COVID-19 pandemic, Cytokinetics recently temporarily suspended
enrollment in REDWOOD-HCM, to protect the safety and health of
clinical study participants and healthcare professionals. Clinical
site start-up activities are continuing to be prioritized with an
objective to activate new sites throughout North America and
Europe. We believe data from the first cohort of patients enrolled
in REDWOOD-HCM can be available in 2H 2020 if enrollment in the
first cohort can be completed by mid-year.
- Presented preclinical data at the
Biophysical Society 64th Annual Meeting demonstrating that CK-274
has a distinct binding site on cardiac myosin, and selectively
reduces cardiac myosin activity in vitro.
CK-271 (CK-271, second cardiac
myosin inhibitor)
- Submitted IND and plan to start
Phase 1 study of CK-271 in Q2 2020.
Skeletal Muscle Program
reldesemtiv (next-generation
fast skeletal muscle troponin activator (FSTA))
- Convened a Type C meeting with FDA
and continued regulatory interactions with FDA and EMA in Q1. In
addition, we conducted additional feasibility and other planning
activities in preparation for the potential advancement of
reldesemtiv to a Phase 3 clinical trial in patients with
amyotrophic lateral sclerosis (ALS). We do not expect that the
COVID-19 pandemic will affect 2020 objectives relating to this
program.
- Received European Orphan
Designation for reldesemtiv for the potential treatment of ALS from
the European Medicines Agency (EMA).
Pre-Clinical Development and Ongoing
Research
- Continued pre-clinical development
of CK-3762601 (CK-601), a next-generation FSTA. We expect to
continue the conduct of IND-enabling studies of CK-601 in
2020.
- Continued research in collaboration
with Astellas directed to the discovery of next-generation skeletal
muscle activators.
- Continued independent research
activities directed to our other muscle biology research
programs.
Corporate
- Unveiled Cytokinetics’ Vision 2025,
“Leading with Science, Delivering for Patients,” articulating the
company’s five-year key imperatives enabling Cytokinetics to be the
leading muscle biology biopharmaceutical company that meaningfully
improves the lives of patients with diseases of impaired muscle
function through access to novel medicines arising from our
research.
- Joined with 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.
- Awarded Cytokinetics Communications
Fellowship Grants to patient advocacy organizations serving the
heart failure, HCM, ALS and SMA communities to support increased
capacity in communications, awareness building and community
engagement.
- Entered into agreements with
Astellas, which, taken together, amend and restate our research,
development and commercialization collaboration agreement with
Astellas in follow up to the previously disclosed agreement in
principle which now provide, amongst other terms, that:
- Cytokinetics has exclusive control
and responsibility for the development and commercialization of
reldesemtiv, CK-601 and other fast skeletal regulatory activator
(FSRA) compounds. Astellas agreed to pay certain costs which may be
incurred in connection with Cytokinetics’ potential Phase 3
clinical trial of reldesemtiv in ALS. Astellas has agreed to
non-cash contributions to Cytokinetics including the transfer of
its inventories of active pharmaceutical ingredient of reldesemtiv
and CK-601 and the continued conduct of ongoing stability studies
at its cost. Cytokinetics will pay Astellas a low- to mid- single
digit royalty on sales of reldesemtiv in certain
countries.
- Astellas extended the joint
research program at Cytokinetics through 2020, with a minimum of
fifteen (15) research FTE’s being supported by Astellas, and has
exclusive rights to co-develop and commercialize skeletal sarcomere
activators (other than FSRA compounds) in all indications, subject
to certain Cytokinetics’ development and commercialization rights;
Cytokinetics may co-promote and conduct certain commercial
activities in the U.S., Canada and/or Europe.
Financials
Revenues for the first quarter of 2020 decreased
to $3.8 million from $8.5 million for the first quarter of 2019,
primarily due to decreased research and development revenue from
our collaborations with Astellas and Amgen.
Research and development expenses for the first
quarter 2020 decreased to $21.7 million from $23.5 million for the
first quarter of 2019. The changes were primarily due to the
completion of clinical studies for reldesemtiv in 2019 offset by an
increase in clinical development activities for our cardiac muscle
inhibitor programs.
General and administrative expenses for the
first quarter of 2020 increased to $12.4 million from $9.4 million
for the first quarter in 2019, due primarily to personnel related
costs including stock-based compensation and outside services.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s first quarter 2020 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
+1 (706) 679-3078 (international) and typing in the
passcode 9063637.
An archived replay of the webcast will be
available via Cytokinetics’ website until May 20, 2020. The
replay will also be available via telephone by dialing (855)
859-2056 (United States and Canada) or +1 (404) 537-3406
(international) and typing in the passcode 9063637 from May 6,
2020 at 7:30 PM Eastern Time until May 20, 2020.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical
company focused on discovering, developing and commercializing
first-in-class muscle activators and next-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
developing reldesemtiv, a fast skeletal muscle troponin activator
(FSTA) for the potential treatment of ALS and other neuromuscular
indications following conduct of FORTITUDE-ALS and other Phase 2
clinical trials. The company is considering potential advancement
of reldesemtiv to Phase 3 pending ongoing regulatory interactions.
Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas)
to research, develop and commercialize other novel mechanism
skeletal sarcomere activators (not including FSTAs). 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 (HCM).
Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of
CK-274 in patients with obstructive HCM. 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 related to
the potential impact of the COVID-19 pandemic on our research and
development activities and business operations, including our
anticipated cash expenditures during the 2020 calendar year,
statements relating to Cytokinetics’ and its partners’ research and
development and commercial readiness activities, including the
initiation, conduct, design, enrollment, progress, continuation,
completion, timing and results of clinical trials, Cytokinetics’
ability to ensure commercial readiness and develop co-promotion
plans in collaboration with Amgen; the significance and
utility of pre-clinical study and clinical trial results; planned
interactions with regulatory authorities and the outcomes of such
interactions, including discussions in preparation for a potential
Phase 3 clinical trial and registration program for reldesemtiv in
patients with ALS; 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;
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 decisions with respect to the
design, initiation, conduct, timing and continuation of development
activities for omecamtiv mecarbil; 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 WeiserSenior Vice
President, Corporate Communications, Investor Relations(415)
290-7757
|
|
Cytokinetics, Incorporated |
Condensed Consolidated Statements of
Operations |
(in thousands except per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, 2020 |
|
March 31, 2019 |
|
Revenues: |
|
|
|
|
|
Research and development revenues |
|
$ |
3,825 |
|
|
$ |
8,464 |
|
|
Total revenues |
|
|
3,825 |
|
|
|
8,464 |
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
|
21,738 |
|
|
|
23,545 |
|
|
General and administrative |
|
|
12,449 |
|
|
|
9,437 |
|
|
Total operating expenses |
|
|
34,187 |
|
|
|
32,982 |
|
|
Operating loss |
|
|
(30,362 |
) |
|
|
(24,518 |
) |
|
Interest expense |
|
|
(4,077 |
) |
|
|
(1,170 |
) |
|
Non-cash interest expense on liability related to the sale of
future royalties |
|
|
(5,689 |
) |
|
|
(4,819 |
) |
|
Interest and other income |
|
|
723 |
|
|
|
1,141 |
|
|
Net loss |
|
$ |
(39,405 |
) |
|
$ |
(29,366 |
) |
|
Net loss per share — basic and
diluted |
|
$ |
(0.66 |
) |
|
$ |
(0.54 |
) |
|
Weighted-average number of shares
used in computing net loss per share — basic and diluted |
|
|
59,270 |
|
|
|
54,821 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cytokinetics, Incorporated |
Condensed Consolidated Balance Sheets |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2020 |
|
December 31, 2019 |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and short term investments |
|
$ |
220,706 |
|
|
$ |
225,112 |
|
Other current assets |
|
|
5,232 |
|
|
|
8,640 |
|
Total current assets |
|
|
225,938 |
|
|
|
233,752 |
|
Long-term investments |
|
|
16,510 |
|
|
|
42,650 |
|
Property and equipment, net |
|
|
5,162 |
|
|
|
4,530 |
|
Operating lease right-of-use assets and other assets |
|
|
8,972 |
|
|
|
8,882 |
|
Total assets |
|
$ |
256,582 |
|
|
$ |
289,814 |
|
LIABILITIES AND
STOCKHOLDERS’ DEFICIT |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
13,204 |
|
|
$ |
20,283 |
|
Short-term lease liability |
|
|
5,030 |
|
|
|
4,616 |
|
Other current liabilities |
|
|
2,507 |
|
|
|
1,124 |
|
Total current liabilities |
|
|
20,741 |
|
|
|
26,023 |
|
Term loan, net |
|
|
45,340 |
|
|
|
45,052 |
|
Convertible notes, net |
|
|
85,455 |
|
|
|
84,205 |
|
Liability related to the sale of
future royalties, net |
|
|
148,983 |
|
|
|
143,276 |
|
Long-term lease liability |
|
|
1,774 |
|
|
|
2,195 |
|
Total liabilities |
|
|
302,293 |
|
|
|
300,751 |
|
Commitments and
contingencies |
|
|
|
|
Stockholders’ deficit: |
|
|
|
|
Common stock |
|
|
59 |
|
|
|
59 |
|
Additional paid-in capital |
|
|
857,038 |
|
|
|
853,341 |
|
Accumulated other comprehensive income |
|
|
1,613 |
|
|
|
679 |
|
Accumulated deficit |
|
|
(904,421 |
) |
|
|
(865,016 |
) |
Total stockholders’ deficit |
|
|
(45,711 |
) |
|
|
(10,937 |
) |
Total liabilities and stockholders’ deficit |
|
$ |
256,582 |
|
|
$ |
289,814 |
|
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