Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial
results for the third quarter of 2020. Net loss for the third
quarter was $3.2 million, or $0.05 per share, compared to net loss
for the third quarter of 2019 of $29.6 million, or $0.50 per share.
Cash, cash equivalents and investments totaled $451.2 million at
September 30, 2020 and does not include $85 million expected upon
the closing of RTW Investments’ purchase of Cytokinetics’ royalty
rights on the future sales of mavacamten.
“We were pleased to recently announce positive
topline results in GALACTIC-HF which demonstrated a reduction in
the primary efficacy outcome endpoint with omecamtiv mecarbil.”
said Robert I. Blum, Cytokinetics’ President and Chief Executive
Officer. “We look forward to the presentation of the primary
results at the AHA Scientific Sessions, including pre-specified
subgroup analyses which will elaborate on patients that had
differential effects with our cardiac myosin activator. During the
third quarter, we continued to make progress on our pipeline,
highlighted by the advancement of CK-274 in REDWOOD-HCM and our
advancing a second cardiac myosin inhibitor into clinical
development. With a strong balance sheet, fortified by business
development and financing deals completed in July, we are well
positioned to continue funding the progression of our
muscle-directed drug candidates in clinical trials.”
Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac
myosin activator)
- Completed conduct of closeout
activities for 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. Topline results from the
trial were recently announced showing that treatment with omecamtiv
mecarbil achieved the primary composite efficacy endpoint and
demonstrated a statistically significant effect to reduce in
cardiovascular (CV) death or heart failure events (heart failure
hospitalization and other urgent treatment for heart failure),
compared to placebo in patients treated with standard of care (HR:
0.92; 95% CI: 0.86, 0.99, p=0.0252). No reduction in the secondary
endpoint of CV death was observed. Adverse events, including major
ischemic cardiac events, were balanced between treatment arms.
- Primary results from GALACTIC-HF
will be presented at the American Heart Association (AHA)
Scientific Sessions 2020, as part of a virtual Late Breaking
Clinical Trial session on Friday, November 13, 2020 from
10:35-10.45 a.m. CDT.
- Reviewing prespecified analyses and
supplemental analyses of results of GALACTIC-HF in collaboration
with Amgen. Discussions ongoing with Amgen on potential next
steps.
- 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. We expect enrollment to be completed
in 1H 2021. METEORIC-HF is being conducted by Cytokinetics in
collaboration with Amgen.
AMG 594 (cardiac troponin
activator)
- Convened advisory board of
consultants to discuss potential indications to inform Phase 2
trial planning. Continued discussions of potential next steps in
the development program with Amgen.
CK-3773274 (CK-274, cardiac
myosin inhibitor)
- Continued conduct of 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). Recently completed enrollment of first cohort of patients in
REDWOOD-HCM, summary data from which will inform progression to the
second cohort of the trial, expected by the end of 2020.
- Presented preclinical data at the
American Association of Pharmaceutical Scientists (AAPS) 2020
PharmSci 360 showing that CK-274 demonstrated desirable
pharmacokinetics in vivo, supporting the intended pharmacokinetic
profile of once-daily oral dosing in humans and steady state plasma
concentrations achieved within two weeks of initiation of
dosing.
CK-271 (CK-271, second cardiac
myosin inhibitor)
- Initiated a Phase 1 study of
CK-271, our second cardiac myosin inhibitor. We expect to complete
the study by the end of 2020.
Skeletal Muscle Program
reldesemtiv (next-generation
fast skeletal muscle troponin activator (FSTA))
- Convened meetings with ALS
community stakeholders to obtain feedback on endpoints and other
matters relating to the design of a potential Phase 3 trial of
reldesemtiv in patients with ALS.
- Conducted readiness activities in
preparation for the start of a potential Phase 3 clinical trial of
reldesemtiv in patients with ALS.
Pre-Clinical Development and Ongoing
Research
- Continued pre-clinical development
of CK-3762601 (CK-601), a next-generation FSTA. We expect to
continue conduct of IND-enabling studies of CK-601 in 2020.
- Published a manuscript on
pre-clinical data in the Journal of Cachexia, Sarcopenia and
Muscle, showing the fast skeletal muscle troponin activator
CK-2066260 (CK-260) increases submaximal force in conditions with
muscle weakness in vitro.
- 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
- Executed a series of transactions
with affiliates of RTW Investments, LP, and Ji Xing Pharmaceuticals
Limited related to CK-274 whereby Cytokinetics will receive a
combination of committed capital, funding and sale proceeds of up
to $250 million and is eligible to receive up to $200 million in
milestone payments plus royalties on future sales of CK-274 in
certain Asian countries
- Raised $189 million in net
proceeds, after deducting underwriting discounts and commissions,
from an underwritten public offering in July of 8,385,417 shares of
common stock including the underwriter’s exercise of their
overallotment option.
- Convened a virtual investor &
analyst day to provide updates on the company’s advancing
cardiovascular pipeline and strategies to build a commercial
franchise.
- Participated in the launch of
Kainomyx, Inc., a new biopharmaceutical company focused on the
discovery and development of small molecule therapeutics for the
treatment of parasitic diseases.
- Provided $1 million grant and
entered four-year partnership with the HCM Registry (HCMR), a
global registry of patients with hypertrophic cardiomyopathy
focused on improving predictive measures of risk for complications
and identifying biomarkers associated with adverse clinical
outcomes.
- Renewed our partnership with Cure
SMA to increase education, awareness, public policy and fundraising
for spinal muscular atrophy (SMA).
- Announced a call for proposals for
the third 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, 2020 were $41.7 million and $49.1 million,
respectively, compared to $6.1 million and $21.7 million for the
corresponding periods in 2019. The increase in revenues for the
three and nine month ended September 30, 2020 was primarily due to
$36.5 million of license revenue recognized in the third quarter
2020 for the RTW transactions.
Research and development expenses for the three
and nine months ended September 30, 2020 increased to $24.2 million
and $67.7 million, respectively, compared to $20.2 million and
$67.8 million for the same periods in 2019, respectively, due to
increased spending on readiness for reldesemtiv and an increase in
spending for our cardiac myosin inhibitor programs.
General and administrative expenses for the
three and nine months ended September 30, 2020 increased to $12.3
million and $38.9 million from $9.8 million and $29.0
million in 2019 due primarily to an increase in personnel
related costs including stock-based compensation and higher outside
spending for commercial readiness.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s third 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 3979672.
An archived replay of the webcast will be
available via Cytokinetics’ website until November 18,
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 3979672
from November 4, 2020 at 7:30 PM Eastern Time until November 18,
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, of which topline results were
recently reported, and METEORIC-HF, which is ongoing. 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. Cytokinetics is
collaborating with Astellas Pharma Inc. (Astellas) to research,
develop and commercialize other novel mechanism skeletal sarcomere
activators (excluding 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 has granted Ji
Xing Pharmaceuticals Limited an exclusive license to develop and
commercialize CK-274 in China and Taiwan, in accordance with
Cytokinetics’ planned global registration programs. 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 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, including the completion of enrollment
in METEORIC-HF and the availability of results from the first
cohort of patients in REDWOOD-HCM, 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, including the
results of GALACTIC-HF in respect of omecamtiv mecarbil; planned
interactions with regulatory authorities in connection to any of
Cytokinetics’ drug candidates 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 and the prospects for FDA and other regulatory
agency approval of omecamtiv mecarbil; the ability of Cytokinetics
to fulfill applicable contractual conditions and receive a
combination of committed capital, funding and sale proceeds of up
to $250 million or any portion of such amount from affiliates of
RTW Investments, LP, and/or Ji Xing Pharmaceuticals Limited; the
ability of Cytokinetics to earn milestone payments and royalties
from Ji Xing Pharmaceuticals Limited in connection to the
development and commercialization of CK-274 in certain Asian
countries; 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 and AMG 594; 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 Balance Sheets |
(in thousands) |
|
|
|
|
|
|
|
|
|
September 30, 2020 |
|
December 31, 2019 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and short term investments |
$ |
410,264 |
|
|
$ |
225,112 |
|
Other current assets |
|
8,148 |
|
|
|
8,640 |
|
Total current assets |
|
418,412 |
|
|
|
233,752 |
|
Long-term investments |
|
40,958 |
|
|
|
42,650 |
|
Property and equipment, net |
|
7,667 |
|
|
|
4,530 |
|
Operating lease right-of-use assets and other assets |
|
7,075 |
|
|
|
8,882 |
|
Total assets |
$ |
474,112 |
|
|
$ |
289,814 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY (DEFICIT) |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued liabilities |
$ |
21,224 |
|
|
$ |
20,283 |
|
Short-term lease liability |
|
3,943 |
|
|
|
4,616 |
|
Other current liabilities |
|
2,406 |
|
|
|
1,124 |
|
Total current liabilities |
|
27,573 |
|
|
|
26,023 |
|
Term loan, net |
|
45,920 |
|
|
|
45,052 |
|
Convertible notes, net |
|
88,102 |
|
|
|
84,205 |
|
Liability related to the sale of
future royalties, net |
|
160,395 |
|
|
|
143,276 |
|
Long-term lease and other
non-current liabilities |
|
2,517 |
|
|
|
2,195 |
|
Total liabilities |
|
324,507 |
|
|
|
300,751 |
|
Commitments and
contingencies |
|
|
|
Stockholders’ equity
(deficit): |
|
|
|
Common stock |
|
70 |
|
|
|
59 |
|
Additional paid-in capital |
|
1,096,953 |
|
|
|
853,341 |
|
Accumulated other comprehensive income |
|
958 |
|
|
|
679 |
|
Accumulated deficit |
|
(948,376 |
) |
|
|
(865,016 |
) |
Total stockholders’ equity (deficit) |
|
149,605 |
|
|
|
(10,937 |
) |
Total liabilities and stockholders’ equity (deficit) |
$ |
474,112 |
|
|
$ |
289,814 |
|
Cytokinetics, Incorporated |
Condensed Consolidated Statements of
Operations |
(in thousands except per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
September 30, 2020 |
|
September 30, 2019 |
|
September 30, 2020 |
|
September 30, 2019 |
Revenues: |
|
|
|
|
|
|
|
Research and development revenues |
$ |
5,187 |
|
|
$ |
6,055 |
|
|
$ |
12,605 |
|
|
$ |
21,656 |
|
License revenues |
|
36,501 |
|
|
|
— |
|
|
|
36,501 |
|
|
|
— |
|
Total revenues |
|
41,688 |
|
|
|
6,055 |
|
|
|
49,106 |
|
|
|
21,656 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
24,202 |
|
|
|
20,229 |
|
|
|
67,730 |
|
|
|
67,791 |
|
General and administrative |
|
12,302 |
|
|
|
9,753 |
|
|
|
38,912 |
|
|
|
29,026 |
|
Total operating expenses |
|
36,504 |
|
|
|
29,982 |
|
|
|
106,642 |
|
|
|
96,817 |
|
Operating income (loss) |
|
5,184 |
|
|
|
(23,927 |
) |
|
|
(57,536 |
) |
|
|
(75,161 |
) |
Interest expense |
|
(3,976 |
) |
|
|
(1,345 |
) |
|
|
(11,945 |
) |
|
|
(3,892 |
) |
Non-cash interest expense on liability related to the sale of
future royalties |
|
(5,461 |
) |
|
|
(5,321 |
) |
|
|
(17,062 |
) |
|
|
(15,204 |
) |
Interest and other income |
|
1,078 |
|
|
|
1,020 |
|
|
|
3,183 |
|
|
|
3,205 |
|
Net loss |
$ |
(3,175 |
) |
|
$ |
(29,573 |
) |
|
$ |
(83,360 |
) |
|
$ |
(91,052 |
) |
Net loss per share — basic and
diluted |
$ |
(0.05 |
) |
|
$ |
(0.50 |
) |
|
$ |
(1.34 |
) |
|
$ |
(1.60 |
) |
Weighted-average number of shares
used in computing net loss per share — basic and diluted |
|
68,279 |
|
|
|
58,640 |
|
|
|
62,406 |
|
|
|
57,050 |
|
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Aug 2024 to Sep 2024
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Sep 2023 to Sep 2024