Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial
results for the first quarter of 2024. Net loss for the first
quarter was $135.6 million, or $1.33 per share, compared to net
loss for the first quarter of 2023 of $131.3 million, or $1.38 per
share. Cash, cash equivalents and investments totaled $634.3
million at March 31, 2024.
“In the first quarter, we advanced our
muscle-biology portfolio anchored by the broad development program
of aficamten. In parallel with our preparation of regulatory
submissions in multiple geographies alongside executing on our
go-to-market strategies, we also furthered ongoing clinical trials,
FOREST-HCM, MAPLE-HCM and ACACIA-HCM, and opened enrollment to a
fourth clinical trial of aficamten, CEDAR-HCM, a clinical trial in
pediatric patients with obstructive HCM, another underserved cohort
of patients with HCM,” said Robert I. Blum, Cytokinetics’ President
and Chief Executive Officer. “At the same time, we progressed
CK-586 towards a Phase 2 clinical trial expected to begin later
this year. We believe that our cohesive biology anchored in cardiac
myosin positions the company well to fulfill our mission to deliver
important medicines and increase shareholder value as will be
further enabled by solid financials, access to diversified capital
and executing on capital efficient Business and Corporate
Development plans.”
Q1 and Recent Highlights
Cardiac Muscle Programs
aficamten (cardiac myosin
inhibitor)
- Announced three late-breaking
clinical trial presentations relating to SEQUOIA-HCM
(Safety, Efficacy, and
Quantitative Understanding of
Obstruction Impact of
Aficamten in HCM), at the
European Society of Cardiology Heart Failure 2024 Congress on May
13, 2024 in Lisbon, Portugal.
- Participated in two meetings with
the U.S. Food and Drug Administration (FDA) related to our New Drug
Application (NDA) for aficamten, and continued activities
supportive of our plan to submit the NDA in Q3 2024. Readied for a
Type B meeting with FDA scheduled to occur in Q2 2024 to discuss
key data that inform safety monitoring and risk minimization
strategies for aficamten.
- Continued preparing our Marketing
Authorization Application (MAA) for aficamten, which we expect to
submit to the European Medicines Agency (EMA) in Q4 2024.
- Continued commercial readiness
activities for aficamten including refining our market development
campaign and product positioning as well as initiating the design
and build of our patient support services program. Completed
profiling HCM treatment programs, finalized our Payor Clinical
Value Proposition and began development of our Payer Clinical Value
Deck.
- Presented additional data from
FOREST-HCM (Follow-up,
Open-Label, Research
Evaluation of Sustained
Treatment with Aficamten in HCM)
in April at the American College of Cardiology 73ʳᵈ Annual
Scientific Session demonstrating that treatment with aficamten for
48 weeks was associated with improvements in clinical efficacy
endpoints, New York Heart Association (NYHA) Functional Class and
cardiac biomarkers, structure and function, and was
well-tolerated.
- Opened enrollment to CEDAR-HCM
(Clinical Evaluation of
Dosing with Aficamten to
Reduce Obstruction in a Pediatric Population in
HCM), a clinical trial of aficamten in a pediatric
population with symptomatic obstructive HCM.
- Continued enrolling patients in
MAPLE-HCM (Metoprolol vs
Aficamten in Patients with
LVOT Obstruction on Exercise
Capacity in HCM), the Phase 3 clinical trial
comparing aficamten as monotherapy to metoprolol as monotherapy in
patients with symptomatic obstructive HCM. Enrollment is expected
to be completed in Q3 2024.
- Continued enrolling patients in
ACACIA-HCM (Assessment Comparing
Aficamten to Placebo on Cardiac
Endpoints In Adults with
Non-Obstructive HCM), the pivotal Phase 3 clinical
trial of aficamten in patients with non-obstructive HCM. We expect
to continue enrollment throughout 2024.
- Published the following
manuscripts:
- “Exercise Capacity in Patients with
Obstructive Hypertrophic Cardiomyopathy: SEQUOIA-HCM Baseline
Characteristics and Study Design” in the Journal of the American
College of Cardiology: Heart Failure.
- “Efficacy and Safety of Aficamten
in Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy: Results
From the REDWOOD-HCM Trial, Cohort 4” in the Journal of Cardiac
Failure.
omecamtiv mecarbil (cardiac
myosin activator)
- Withdrew the Marketing
Authorization Application (MAA) from the European Medicines Agency
(EMA) for omecamtiv mecarbil based on feedback from the Committee
for Medicinal Products for Human Use (CHMP) indicating that the
Committee will not be able to conclude that the benefits outweigh
the risks on the basis of the results from GALACTIC-HF alone.
CK-4021586 (CK-586, cardiac myosin
inhibitor)
- Announced topline data from the
Phase 1 study of CK-586. The data support progression to a Phase 2
clinical trial in patients with heart failure with preserved
ejection fraction (HFpEF) which we expect to start in Q4 2024.
CK-3828136 (CK-136, cardiac
troponin activator)
- Completed the Phase 1 study of
CK-136 and began data analyses.
Pre-Clinical Development and Ongoing
Research
- Continued pre-clinical development
and research activities directed to additional muscle biology
focused programs. We expect to initiate clinical development with
another muscle directed compound later this year.
Corporate
- Announced the appointment of Sung
Lee to serve as the Company’s Executive Vice President, Chief
Financial Officer effective as of May 8, 2024.
- Released 2023 Corporate
Responsibility Report outlining the Company’s commitment and
activities related to social and environmental responsibility,
ethics and governance and patient and community engagement.
- Awarded Cytokinetics Communications
Fellowship Grants to patient advocacy organizations serving the
HCM, heart failure and amyotrophic lateral sclerosis (ALS)
communities to support increased capacity in communications,
awareness building and community engagement.
- Announced the launch of ENACT:
Empower, Navigate, Activate for Clinical Trials, a joint initiative
with The Mended Hearts, Inc. and WomenHeart: The National Coalition
for Women with Heart Disease, to champion greater awareness and
engagement in cardiovascular clinical trials by reducing barriers,
increasing support and empowering patients in groups historically
underrepresented in clinical research.
Financials
Revenues for the first quarter 2024 were $0.8
million compared to $4.6 million for the corresponding period in
2023. The decrease in revenues was primarily due to milestone
revenue of $2.5 million received from Ji Xing Pharmaceuticals for
the start of ACACIA-HCM and higher collaboration revenues in
2023.
Research and development expenses for the first
quarter 2024 increased to $81.6 million compared to $79.4 million
for the same period in 2023, due to spending for our clinical
development activities for our cardiac myosin inhibitor
programs.
General and administrative expenses for the
first quarter 2024 decreased to $45.5 million from $49.7 million
for the same period in 2023 due to lower outside spending for
pre-commercial launch activities.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s first quarter 2024 results on a
conference call today at 4:30 PM Eastern Time. The conference call
will be simultaneously webcast and can be accessed from the
Investors & Media section of Cytokinetics’ website at
www.cytokinetics.com. The live audio of the conference call can
also be accessed by telephone by registering in advance at the
following link: Cytokinetics Q1 2024 Earnings Conference
Call. Upon registration, participants will receive a
dial-in number and a unique passcode to access the call. An
archived replay of the webcast will be available via Cytokinetics’
website for twelve months.
About Cytokinetics
Cytokinetics is a late-stage, specialty
cardiovascular 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 cardiac muscle performance is
compromised. As a leader in muscle biology and the mechanics of
muscle performance, the company is developing small molecule drug
candidates specifically engineered to impact myocardial muscle
function and contractility. Cytokinetics is preparing for
regulatory submissions for aficamten, its next-in-class cardiac
myosin inhibitor, following positive results from SEQUOIA-HCM, the
pivotal Phase 3 clinical trial in obstructive hypertrophic
cardiomyopathy. Aficamten is also currently being evaluated in
MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy
compared to metoprolol as monotherapy in patients with obstructive
HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients
with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten
in a pediatric population with obstructive HCM, and FOREST-HCM, an
open-label extension clinical study of aficamten in patients with
HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac
muscle activator, in patients with heart failure. Additionally,
Cytokinetics is developing CK-586, a cardiac myosin inhibitor with
a mechanism of action distinct from aficamten for the potential
treatment of HFpEF, and CK-136, a cardiac troponin activator for
the potential treatment HFrEF and other types of heart failure,
such as right ventricular failure resulting from impaired cardiac
contractility.
For additional information about Cytokinetics,
visit www.cytokinetics.com and follow us on X, 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 not limited to, statements, express or
implied, relating to our or our partners’ research and development
and commercial readiness activities, including the initiation,
conduct, design, enrollment, progress, continuation, completion,
timing and results of any of our clinical trials, or more
specifically, our ability to file a new drug application for
aficamten in the United States in the third quarter of 2024 or a
marketing authorisation application for aficamten in the European
Union in the fourth quarter of 2024, our ability to complete
enrollment of MAPLE-HCM in the third quarter of 2024 and to
commence a Phase 2 study of CK-586, if ever, the timing of
interactions with FDA or any other regulatory authorities in
connection to any of our drug candidates and the outcomes of such
interactions; statements relating to the potential patient
population who could benefit from aficamten, omecamtiv mecarbil,
CK-586, CK-136 or any of our other drug candidates; statements
relating to our ability to receive additional capital or other
funding, including, but not limited to, our ability to meet any of
the conditions relating to or to otherwise secure additional loan
disbursements under any of our agreements with entities affiliated
with Royalty Pharma or additional milestone payments from Ji Xing;
statements relating to our operating expenses or cash utilization
for the remainder of 2024, and statements relating to our cash
balance at year-end 2024 or any other particular date or the amount
of cash runway such cash balances represent at any particular time.
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, particularly under the caption “Risk Factors” in
Cytokinetics’ Annual Report on Form 10-K for the year 2023.
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® and the CYTOKINETICS and C-shaped
logo are registered trademarks of Cytokinetics in the U.S. and
certain other countries.
Contact:Cytokinetics Diane
WeiserSenior Vice President, Corporate Affairs(415) 290-7757
Cytokinetics, Incorporated |
Condensed Consolidated Balance Sheets |
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2024 |
|
December 31, 2023 |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and short term investments |
|
$ |
618,961 |
|
|
$ |
614,824 |
|
Other current assets |
|
|
19,743 |
|
|
|
13,227 |
|
Total current assets |
|
|
638,704 |
|
|
|
628,051 |
|
Long-term investments |
|
|
15,376 |
|
|
|
40,534 |
|
Property and equipment, net |
|
|
68,018 |
|
|
|
68,748 |
|
Operating lease right-of-use assets |
|
|
78,170 |
|
|
|
78,987 |
|
Other assets |
|
|
7,814 |
|
|
|
7,996 |
|
Total assets |
|
$ |
808,082 |
|
|
$ |
824,316 |
|
LIABILITIES AND
STOCKHOLDERS’ DEFICIT |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
53,090 |
|
|
$ |
64,148 |
|
Short-term operating lease liabilities |
|
|
18,230 |
|
|
|
17,891 |
|
Current portion of long-term debt |
|
|
11,520 |
|
|
|
10,080 |
|
Other current liabilities |
|
|
6,015 |
|
|
|
10,559 |
|
Total current liabilities |
|
|
88,855 |
|
|
|
102,678 |
|
Term loan, net |
|
|
56,822 |
|
|
|
58,384 |
|
Convertible notes, net |
|
|
549,790 |
|
|
|
548,989 |
|
Liabilities related to revenue
participation right purchase agreements, net |
|
|
390,219 |
|
|
|
379,975 |
|
Long-term operating lease
liabilities |
|
|
118,554 |
|
|
|
120,427 |
|
Other non-current
liabilities |
|
|
2 |
|
|
|
186 |
|
Total liabilities |
|
|
1,204,242 |
|
|
|
1,210,639 |
|
Commitments and
contingencies |
|
|
|
|
Stockholders’ deficit: |
|
|
|
|
Common stock |
|
|
105 |
|
|
|
102 |
|
Additional paid-in capital |
|
|
1,852,155 |
|
|
|
1,725,823 |
|
Accumulated other comprehensive loss |
|
|
(539 |
) |
|
|
(10 |
) |
Accumulated deficit |
|
|
(2,247,881 |
) |
|
|
(2,112,238 |
) |
Total stockholders’ deficit |
|
|
(396,160 |
) |
|
|
(386,323 |
) |
Total liabilities and stockholders’ deficit |
|
$ |
808,082 |
|
|
$ |
824,316 |
|
Cytokinetics, Incorporated |
Condensed Consolidated Statements of
Operations |
(in thousands except per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, 2024 |
|
March 31, 2023 |
Revenues: |
|
|
|
|
Research and development revenues |
|
$ |
835 |
|
|
$ |
2,113 |
|
Milestone revenues |
|
|
— |
|
|
|
2,500 |
|
Total revenues |
|
|
835 |
|
|
|
4,613 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
81,570 |
|
|
|
79,421 |
|
General and administrative |
|
|
45,500 |
|
|
|
49,665 |
|
Total operating expenses |
|
|
127,070 |
|
|
|
129,086 |
|
Operating loss |
|
|
(126,235 |
) |
|
|
(124,473 |
) |
Interest expense |
|
|
(7,103 |
) |
|
|
(6,961 |
) |
Non-cash interest expense on liabilities related to revenue
participation right purchase agreements |
|
|
(10,218 |
) |
|
|
(6,280 |
) |
Interest and other income, net |
|
|
7,913 |
|
|
|
6,425 |
|
Net loss |
|
$ |
(135,643 |
) |
|
$ |
(131,289 |
) |
Net loss per share — basic and
diluted |
|
$ |
(1.33 |
) |
|
$ |
(1.38 |
) |
Weighted-average number of
shares used in computing net loss per share — basic and
diluted |
|
|
101,924 |
|
|
|
95,164 |
|
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