Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial
results for the second quarter of 2020. Net loss for the second
quarter was $40.8 million, or $0.68 per share, compared to net loss
for the second quarter of 2019 of $32.1 million, or $0.56 per
share. Cash, cash equivalents and investments totaled $213.1
million at June 30, 2020.
After the quarter, Cytokinetics executed a
series of transactions which contribute up to $250 million in cash
plus committed cash, as well as up to $200 million in potential
milestone payments plus royalties. Also, after the quarter, the
company raised $189 million through a public offering of common
stock. Cytokinetics expects to end 2020 with more than $500 million
in cash plus committed cash, subject to closing conditions.
“Despite challenges related to the COVID-19
pandemic, Cytokinetics achieved significant progress against our
key objectives during the second quarter,” said Robert I. Blum,
Cytokinetics’ President and Chief Executive Office. “After
suspending enrollment in METEORIC-HF and REDWOOD-HCM earlier in the
quarter, we resumed screening and enrollment in both trials during
June. In addition, GALACTIC-HF continued toward conclusion on
schedule with top-line results expected in the fourth quarter.
Moreover, our recent licensing collaboration, royalty monetization
deals and follow-on offering position the company operationally and
financially to expand development activities and execute our Vision
2025.”
Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac
myosin activator)
- Received Fast Track designation for
omecamtiv mecarbil for the potential treatment of chronic heart
failure with reduced ejection fraction (HFrEF).
- Continued conduct of and initiated
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. We expect top-line results in
Q4 2020. GALACTIC-HF is being conducted by Amgen in collaboration
with Cytokinetics.
- 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. After suspending enrollment in
METEORIC-HF due to the COVID-19 pandemic earlier this year, we
resumed enrollment in June. We expect enrollment to be completed in
early 2021. METEORIC-HF is being conducted by Cytokinetics in
collaboration with Amgen.
- Collaborated with Amgen and Servier
on preparations for a potential Marketing Application dossier for
omecamtiv mecarbil and prepared for possible meetings with
regulatory authorities as may be requested to discuss Phase 3 trial
results and potential Marketing Applications.
- Continued to conduct commercial
readiness activities in collaboration with Amgen, in preparation
for the commercialization of omecamtiv mecarbil, including market
research related to product branding elements, potential
positioning, physician preferences and potential customer
accounts.
- Continued joint disease state
education with Amgen to educate the heart failure community on the
unmet needs of heart failure patients and the role of cardiac
contractility related to cardiac performance in HFrEF.
- Collaborated with providers and
healthcare systems to generate health economics and outcomes
research related to the healthcare costs associated with the
treatment of heart failure patients.
- Conducted analyses related to the
United States heart failure institutional care market segment,
including potential target account assessment and prioritization
for planned commercialization.
AMG 594 (cardiac troponin
activator)
- The Phase 1 study of AMG 594 is now
complete with data analyses ongoing. Amgen and Cytokinetics are
discussing potential next steps in the development program.
- Conducted market research relating
to potential indications to inform Phase 2 trial planning.
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). After suspending enrollment in REDWOOD-HCM due to the
COVID-19 pandemic earlier this year, we resumed enrollment in June.
We expect data from the first cohort of patients in REDWOOD-HCM,
which will inform progression of the trial to the second cohort, to
be available by the end of 2020.
CK-271 (CK-271, second cardiac
myosin inhibitor)
- Prepared for the start of a Phase 1
study of CK-271 which is expected to begin in Q3 2020.
Skeletal Muscle Program
reldesemtiv (next-generation
fast skeletal muscle troponin activator (FSTA))
- Obtained advice from the European
Medicines Agency (EMA) through Protocol Assistance related to the
design of a potential Phase 3 clinical trial of reldesemtiv in
patients with ALS.
- Convened meetings with clinical
experts, ALS patient advocates and health technology assessment
organizations to obtain feedback on endpoints and other matters
relating to the design of the trial.
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
- 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.
- Executed a series of transactions
in July with 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.
- Amended our agreement with
Astellas, whereby Cytokinetics obtained exclusive rights for the
development and commercialization of reldesemtiv, CK-601 and other
fast skeletal regulatory activator (FSRA) compounds. Astellas
agreed to pay for certain costs associated with the conduct of a
potential Phase 3 clinical trial of reldesemtiv in ALS in exchange
for a low- to mid-single digit royalty on sales of reldesemtiv in
ALS. Astellas and Cytokinetics also extended the joint research
program through 2020.
- Announced the continuation of our
partnership with The ALS Association in the fight against
ALS.
- Supported the Patient Focused Drug
Development Meeting hosted by the HCMA to shed light on the burden
of disease and challenges faced by patients with HCM.
Financials
Revenues for the three and six months ended June
30, 2020 were $3.6 million and $7.4 million, respectively, compared
to $7.1 million and $15.6 million for the corresponding periods in
2019. The decrease in revenues for the three and six month ended
June 30, 2020 was due primarily to the completion of FORTITUDE-ALS
in 2019.
Research and development expenses for the three
and six months ended June 30, 2020 decreased to $21.8 million and
$43.5 million, respectively, compared to $24.0 million and $47.6
million for the same periods in 2019, respectively, due to
decreased spending primarily related to the completion of
FORTITUDE-ALS in 2019 offset by an increase in spending for
REDWOOD-HCM.
General and administrative expenses for the
three and six months ended June 30, 2020 increased to $14.2 million
and $26.6 million from $9.8 million and $19.3 million in 2019
due primarily to an increase in personnel related costs including
stock-based compensation and higher outside spending for commercial
readiness.
Financial Guidance
The company also updated financial guidance for
2020. The company still anticipates cash revenue will be in the
range of $18 to $22 million and operating expenses will be in the
range of $120 to $130 million. Guidance for net cash utilization
has been narrowed to the range of $110 to $115 million for
2020.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s second 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 5588711.
An archived replay of the webcast will be
available via Cytokinetics’ website until August 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 5588711 from August
6, 2020 at 7:30 PM Eastern Time until August 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. 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 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, including the
completion of GALACTIC-HF, 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 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) |
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2020 |
|
December 31, 2019 |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and short term investments |
|
$ |
213,063 |
|
|
$ |
225,112 |
|
Other current assets |
|
|
5,891 |
|
|
|
8,640 |
|
Total current assets |
|
|
218,954 |
|
|
|
233,752 |
|
Long-term investments |
|
|
— |
|
|
|
42,650 |
|
Property and equipment, net |
|
|
5,611 |
|
|
|
4,530 |
|
Operating lease right-of-use assets and other assets |
|
|
7,930 |
|
|
|
8,882 |
|
Total assets |
|
$ |
232,495 |
|
|
$ |
289,814 |
|
LIABILITIES AND
STOCKHOLDERS’ DEFICIT |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
16,608 |
|
|
$ |
20,283 |
|
Short-term lease liability |
|
|
5,075 |
|
|
|
4,616 |
|
Other current liabilities |
|
|
1,013 |
|
|
|
1,124 |
|
Total current liabilities |
|
|
22,696 |
|
|
|
26,023 |
|
Term loan, net |
|
|
45,631 |
|
|
|
45,052 |
|
Convertible notes, net |
|
|
86,743 |
|
|
|
84,205 |
|
Liability related to the sale
of future royalties, net |
|
|
154,914 |
|
|
|
143,276 |
|
Long-term lease liability |
|
|
591 |
|
|
|
2,195 |
|
Total liabilities |
|
|
310,575 |
|
|
|
300,751 |
|
Commitments and
contingencies |
|
|
|
|
Stockholders’ deficit: |
|
|
|
|
Common stock |
|
|
60 |
|
|
|
59 |
|
Additional paid-in capital |
|
|
865,724 |
|
|
|
853,341 |
|
Accumulated other comprehensive income |
|
|
1,337 |
|
|
|
679 |
|
Accumulated deficit |
|
|
(945,201 |
) |
|
|
(865,016 |
) |
Total stockholders’ deficit |
|
|
(78,080 |
) |
|
|
(10,937 |
) |
Total liabilities and stockholders’ deficit |
|
$ |
232,495 |
|
|
$ |
289,814 |
|
Cytokinetics, Incorporated |
Condensed Consolidated Statements of
Operations |
(in thousands except per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, 2020 |
|
June 30, 2019 |
|
June 30, 2020 |
|
June 30, 2019 |
Revenues: |
|
|
|
|
|
|
|
|
Research and development revenues |
|
$ |
3,593 |
|
|
$ |
7,137 |
|
|
$ |
7,418 |
|
|
$ |
15,601 |
|
Total revenues |
|
|
3,593 |
|
|
|
7,137 |
|
|
|
7,418 |
|
|
|
15,601 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
21,790 |
|
|
|
24,017 |
|
|
|
43,528 |
|
|
|
47,562 |
|
General and administrative |
|
|
14,161 |
|
|
|
9,836 |
|
|
|
26,610 |
|
|
|
19,273 |
|
Total operating expenses |
|
|
35,951 |
|
|
|
33,853 |
|
|
|
70,138 |
|
|
|
66,835 |
|
Operating loss |
|
|
(32,358 |
) |
|
|
(26,716 |
) |
|
|
(62,720 |
) |
|
|
(51,234 |
) |
Interest expense |
|
|
(3,892 |
) |
|
|
(1,377 |
) |
|
|
(7,969 |
) |
|
|
(2,547 |
) |
Non-cash interest expense on liability related to the sale of
future royalties |
|
|
(5,912 |
) |
|
|
(5,064 |
) |
|
|
(11,601 |
) |
|
|
(9,883 |
) |
Interest and other income |
|
|
1,382 |
|
|
|
1,044 |
|
|
|
2,105 |
|
|
|
2,185 |
|
Net loss |
|
$ |
(40,780 |
) |
|
$ |
(32,113 |
) |
|
$ |
(80,185 |
) |
|
$ |
(61,479 |
) |
Net loss per share — basic and
diluted |
|
$ |
(0.68 |
) |
|
$ |
(0.56 |
) |
|
$ |
(1.35 |
) |
|
$ |
(1.09 |
) |
Weighted-average number of
shares used in computing net loss per share — basic and
diluted |
|
|
59,605 |
|
|
|
57,648 |
|
|
|
59,438 |
|
|
|
56,242 |
|
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