Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial
results for the first quarter of 2021. Net loss for the first
quarter was $47.1 million, or $0.66 per share, compared to net loss
for the first quarter of 2020 of $39.4 million, or $0.66 per share.
Cash, cash equivalents and investments totaled $460.2 million at
March 31, 2021.
“We continued to execute well in the first
quarter against our ambitious plans. We recently convened a meeting
with FDA related to omecamtiv mecarbil and GALACTIC-HF and are
proceeding towards additional planned meetings this quarter with an
expected NDA submission in the second half of the year,” said
Robert I. Blum, Cytokinetics’ President and Chief Executive
Officer. “We look forward to the presentation of a secondary
analysis from GALACTIC-HF which will shed further light on the
impact of ejection fraction on patient outcomes. Additionally, we
were pleased to complete enrollment in Cohort 2 of REDWOOD-HCM and
more recently begin enrollment in the open-label extension study.
We expect results from REDWOOD-HCM mid-year and are planning to
initiate a pivotal Phase 3 trial by year-end.”
Q1 and Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac
myosin activator)
- Met with the U.S. Food and Drug
Administration (FDA) in Q1 and anticipate additional regulatory
interactions in Q2 to inform plans to submit a New Drug Application
(NDA) for omecamtiv mecarbil in 2H 2021. The planned regulatory
filing is expected to be based on a single pivotal trial,
GALACTIC-HF, which demonstrated a positive effect on the primary
composite endpoint of cardiovascular death or heart failure events
in patients receiving standard of care plus omecamtiv mecarbil
- Announced that data from a
secondary analysis of GALACTIC-HF (Global
Approach to Lowering
Adverse Cardiac Outcomes
Through Improving
Contractility in Heart
Failure) assessing the effect of omecamtiv
mecarbil on clinical outcomes in relationship to patient baseline
ejection fraction will be presented in a Late Breaking Clinical
Trial session at the American College of Cardiology 70th Annual
Scientific Session & Expo (ACC.21).
- 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. Expect to complete enrollment in Q2
and report results in early 2022.
- Conducted market research,
forecasting and other planning activities in support of the
potential commercialization of omecamtiv mecarbil.
- Published a manuscript entitled,
“Effect of Varying Degrees of Renal Impairment on the
Pharmacokinetics of Omecamtiv Mecarbil” in Clinical
Pharmacokinetics.
CK-3773274 (CK-274, cardiac
myosin inhibitor)
- Dosed the first patient in Cohort 2
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 (oHCM). We subsequently
completed enrollment in Cohort 2 of REDWOOD-HCM in Q1.
- Opened enrollment in Cohort 3 of
REDWOOD-HCM for patients whose background therapy includes
disopyramide.
- Activated the first site for
enrollment in REDWOOD-HCM OLE, the open label extension clinical
study designed to assess the long-term safety and tolerability of
CK-274 in patients with symptomatic oHCM who have participated
previously in REDWOOD-HCM.
- Received orphan drug designation
for CK-274 for the potential treatment of symptomatic HCM from the
FDA.
- Prepared for regulatory
interactions with FDA to occur in Q2 and continuing into the second
half of 2021 to inform preparations for a pivotal Phase 3 clinical
trial of CK-274 in HCM, expected to begin by year-end.
- Recently presented data related to
the optimization of CK-274, including the first disclosure of its
chemical structure, at the American Chemical Society Spring 2021
Virtual Meeting.
- Enrolled the first patient in a
Phase 1 study of CK-274 in China under the License and
Collaboration Agreement between Cytokinetics and Ji Xing
Pharmaceuticals Limited.
Skeletal Muscle Program
reldesemtiv (next-generation
fast skeletal muscle troponin activator (FSTA))
- Conducted start-up activities,
including regulatory and institutional review board submissions,
for COURAGE-ALS (Clinical
Outcomes Using
Reldesemtiv on ALSFRS-R in a
Global Evaluation in
ALS), the planned Phase 3 clinical trial of
reldesemtiv in patients with ALS, in preparation for the potential
opening of the trial to patient enrollment in 2H 2021.
- Completed joint research program
under collaboration with Astellas directed to the discovery of
next-generation skeletal muscle activators.
- Published a manuscript entitled
“Reldesemtiv in Patients with Spinal Muscular Atrophy: A Phase 2
Hypothesis-Generating Study” in Neurotherapeutics.
Pre-Clinical Development and Ongoing
Research
- Continued to advance new chemical
entities and to conduct IND-enabling studies with expectation of
our potentially advancing 1-2 potential drug candidates in
development over the next year.
- Continued research activities
directed to our other muscle biology research programs.
Corporate
- Conducted planning activities
related to the termination of the Collaboration and Option
Agreement with Amgen and the transition of rights to develop and
commercialize omecamtiv mecarbil, effective May 20, 2021.
- 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, disease awareness and community
engagement.
- Convened inaugural Heart Failure
Advisory Council meeting with patients and caregivers with heart
failure to inform the ongoing development of the company’s heart
failure directed pipeline.
Financials
Revenues for the first quarter 2021 increased to
$6.5 million from $3.8 million for the first quarter 2020 due to
increased research and development revenue from our collaborations
with Amgen and Astellas.
Research and development expenses for the first
quarter 2021 increased to $31.6 million from $21.7 million for the
first quarter of 2020. The changes were primarily due to increases
in spending for COURAGE-ALS and our clinical development activities
for our cardiac muscle inhibitor programs.
General and administrative expenses for the
first quarter of 2021 increased to $15.6 million from $12.4 million
for the first quarter in 2020, due primarily to an increase in
personnel related costs including stock-based compensation and
higher outside spending for commercial readiness.
We expect to revise our financial guidance
mid-year once we finalize strategies and potential commercial
launch plans for omecamtiv mecarbil. Executing on those strategies
and plans may result in our incurring significant additional
expenses that were not included in our current financial guidance.
We expect that some or all of those potential expenses could be
covered by our accessing additional capital through strategic
partnership(s) with near term cash infusions or by equity and/or
debt financings if deemed appropriate.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s first quarter 2021 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 6097958.
An archived replay of the webcast will be
available via Cytokinetics’ website until May 20, 2021. 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 6097958 from May 6,
2021 at 7:30 PM Eastern Time until May 20, 2021.
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 conducting regulatory interactions
for omecamtiv mecarbil, its novel cardiac muscle activator,
following positive results from GALACTIC-HF, a large, international
Phase 3 clinical trial in patients with heart failure. Cytokinetics
is conducting METEORIC-HF, a second Phase 3 clinical trial of
omecamtiv mecarbil. Cytokinetics is also developing CK-274, a
next-generation cardiac myosin inhibitor, 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 is also developing
reldesemtiv, a fast skeletal muscle troponin activator for the
potential treatment of ALS and other neuromuscular indications
following conduct of FORTITUDE-ALS and other Phase 2 clinical
trials. The company is preparing for the potential advancement of
reldesemtiv to a Phase 3 clinical trial in ALS. 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 in Q2 2021 and the release of results of METEORIC-HF
in early 2022, the availability of results from the first and
second cohorts of patients in REDWOOD-HCM by mid-year 2021, the
commencement of a Phase 3 clinical trial of CK-274 by year-end
2021, the significance and utility of pre-clinical study and
clinical trial results, including the results of GALACTIC-HF in
respect of omecamtiv mecarbil; the timing of interactions with
regulatory authorities in connection to any of Cytokinetics’ drug
candidates and the outcomes of such interactions, including the
submission of an NDA for omecamtiv mecarbil in the second half of
the year, and the prospects of regulatory approval for, and if
approved, potential commercialization of omecamtiv mecarbil; our
decision to engage in or execute, and the cost and expenses to be
incurred in connection with, any particular transition activities
from Amgen related to omecamtiv mecarbil and any particular
commercial launch readiness activities for omecamtiv mecarbil ; the
potential opening of COURAGE-ALS to patient enrollment in 2H 2021;
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; 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:CytokineticsDiane
WeiserSenior Vice President, Corporate Communications, Investor
Relations(415) 290-7757
Cytokinetics, IncorporatedCondensed
Consolidated Balance Sheets(in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2021 |
|
December 31, 2020 |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and short term investments |
|
$ |
425,577 |
|
|
$ |
464,060 |
|
Other current assets |
|
|
7,540 |
|
|
|
10,161 |
|
Total current assets |
|
|
433,117 |
|
|
|
474,221 |
|
Long-term investments |
|
|
34,664 |
|
|
|
36,954 |
|
Property and equipment, net |
|
|
23,198 |
|
|
|
13,346 |
|
Operating lease right-of-use assets and other assets |
|
|
86,083 |
|
|
|
9,282 |
|
Total assets |
|
$ |
577,062 |
|
|
$ |
533,803 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY (DEFICIT) |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
22,572 |
|
|
$ |
27,365 |
|
Current portion of long-term debt |
|
|
5,625 |
|
|
|
— |
|
Short-term lease liabilities |
|
|
5,295 |
|
|
|
2,785 |
|
Other current liabilities |
|
|
2,438 |
|
|
|
1,049 |
|
Total current liabilities |
|
|
35,930 |
|
|
|
31,199 |
|
Term loan, net |
|
|
40,874 |
|
|
|
46,209 |
|
Convertible notes, net |
|
|
90,889 |
|
|
|
89,504 |
|
Liability related to the sale of
future royalties, net |
|
|
168,890 |
|
|
|
166,068 |
|
Long-term deferred revenue |
|
|
87,000 |
|
|
|
87,000 |
|
Long-term lease liability |
|
|
85,633 |
|
|
|
440 |
|
Total liabilities |
|
|
509,216 |
|
|
|
420,420 |
|
Commitments and
contingencies |
|
|
|
|
Stockholders’ equity
(deficit): |
|
|
|
|
Common stock |
|
|
71 |
|
|
|
70 |
|
Additional paid-in capital |
|
|
1,107,135 |
|
|
|
1,105,470 |
|
Accumulated other comprehensive income |
|
|
50 |
|
|
|
149 |
|
Accumulated deficit |
|
|
(1,039,410 |
) |
|
|
(992,306 |
) |
Total stockholders’ equity (deficit) |
|
|
67,846 |
|
|
|
113,383 |
|
Total liabilities and stockholders’ equity (deficit) |
|
$ |
577,062 |
|
|
$ |
533,803 |
|
Cytokinetics, IncorporatedCondensed
Consolidated Statements of Operations(in thousands
except per share data)(unaudited) |
|
|
Three Months Ended |
|
|
March 31, 2021 |
|
March 31, 2020 |
Revenues: |
|
|
|
|
Research and development revenues |
|
$ |
6,548 |
|
|
$ |
3,825 |
|
Total revenues |
|
|
6,548 |
|
|
|
3,825 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
31,561 |
|
|
|
21,738 |
|
General and administrative |
|
|
15,598 |
|
|
|
12,449 |
|
Total operating expenses |
|
|
47,159 |
|
|
|
34,187 |
|
Operating loss |
|
|
(40,611 |
) |
|
|
(30,362 |
) |
Interest expense |
|
|
(3,988 |
) |
|
|
(4,077 |
) |
Non-cash interest expense on liability related to the sale of
future royalties |
|
|
(2,795 |
) |
|
|
(5,689 |
) |
Interest and other income |
|
|
290 |
|
|
|
723 |
|
Net loss |
|
$ |
(47,104 |
) |
|
$ |
(39,405 |
) |
Net loss per share — basic and
diluted |
|
$ |
(0.66 |
) |
|
$ |
(0.66 |
) |
Weighted-average number of shares
used in computing net loss per share — basic and diluted |
|
|
71,195 |
|
|
|
59,270 |
|
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