Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management
update and financial results for the second quarter of 2024.
“Cytokinetics made substantial progress during
the second quarter across our pipeline and aligned to near-term
goals as well as our longer-term vision to build a sustainable
specialty cardiology business. In May, we secured contingent access
to more than $1 billion in funding to support the potential global
launch of aficamten as well as to continue conduct of
label-expanding clinical trials of aficamten worldwide and to
advance our later-stage pipeline including omecamtiv mecarbil and
CK-586,” said Robert I. Blum, Cytokinetics’ President and Chief
Executive Officer. “These three programs, anchored in our
pioneering science of myosin modulation, provide synergistic
opportunities in adjacent specialty cardiology indications that we
believe will unlock shareholder value while making good on our
promise to patients.”
Q2 and Recent Highlights
Cardiac Muscle Programs
aficamten (cardiac myosin
inhibitor)
- Presented primary results from
SEQUOIA-HCM (Safety, Efficacy,
and Quantitative Understanding of
Obstruction Impact of
Aficamten in HCM) at the European
Society of Cardiology Heart Failure 2024 Congress, demonstrating
statistically significant and clinically meaningful improvements in
the primary efficacy endpoint of peak oxygen uptake (pVO2) and all
secondary endpoints with results consistent across all prespecified
subgroups. Additional results presented from SEQUOIA-HCM showed
that treatment with aficamten resulted in predictable dosing with
no dose interruptions or associated heart failure due to left
ventricular ejection fraction (LVEF) <50% and improved a novel
integrated exercise performance metric. Improvements in pVO2 were
shown to be highly correlated with improvements in cardiac
structure and function.
- Participated in a Type B meeting
with the U.S. Food and Drug Administration (FDA) to discuss
potential strategies related to safety monitoring and risk
mitigation for aficamten and included a review of how results from
SEQUOIA-HCM and intrinsic properties of aficamten may inform risk
mitigation. The Company expects to propose a distinct risk
mitigation approach specific to aficamten with the New Drug
Application (NDA) for which the rolling submission is underway. The
Company is on track to complete the rolling NDA submission for
aficamten in Q3 2024.
- The FDA recently cleared a protocol
amendment for FOREST-HCM (Follow-up,
Open-Label, Research
Evaluation of Sustained
Treatment with Aficamten in HCM)
reducing the frequency of echocardiographic monitoring for patients
with obstructive HCM to every 6 months during maintenance treatment
for patients with LVEF >55%.
- Participated in meetings with the
European Medicines Agency (EMA) and National Agencies in the EU
during which the company confirmed plans to submit a Marketing
Authorization Application (MAA) for aficamten in Q4 2024 and
discussed the content of the expected filing.
- Coordinated with Ji Xing
Pharmaceuticals to support the planned submission of an NDA for
aficamten to the Center for Drug Evaluation (CDE) of the National
Medical Products Administration (NMPA) in China in 2H 2024.
- Continued commercial readiness
activities for aficamten including refining our market development
campaign, designing the treatment experience inclusive of
distribution and patient support programs, advancing key market
research, and finalizing the structure for the field-based sales
team. Began pre-approval information exchange activities to
proactively share health care economic and scientific information
with payers and initiated development of U.S. and global value
dossiers.
- Initiated a Phase 1 study
evaluating the pharmacokinetics, safety and tolerability of
aficamten in healthy Japanese and Caucasian participants. We expect
to continue enrollment throughout 2024.
- 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. We expect to continue
enrollment in CEDAR-HCM throughout 2024.
- 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. We expect to complete
enrollment in MAPLE-HCM 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 in ACACIA-HCM throughout 2024 and complete
enrollment in 2025.
- Published the following
manuscripts:
- “Aficamten for Symptomatic
Obstructive Hypertrophic Cardiomyopathy” in the New England Journal
of Medicine.
- “The Prognostic Value of Peak
Oxygen Uptake in Obstructive Hypertrophic Cardiomyopathy: A
Literature Review to Inform Economic Model Development” in the
Journal of Medical Economics.
- “Safety and Efficacy of Aficamten
in Patients with Non-Obstructive Hypertrophic Cardiomyopathy: A
36-Week Analysis from FOREST-HCM” in the European Journal of Heart
Failure.
- “Aficamten is a Small-Molecule
Cardiac Myosin Inhibitor Designed to Treat Hypertrophic
Cardiomyopathy” in Nature Cardiovascular Research.
- “Dosing and Safety Profile of
Aficamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy:
Results From SEQUOIA-HCM” in the Journal of the American Heart
Association.
omecamtiv mecarbil (cardiac
myosin activator)
- Participated in a Type C meeting
with the FDA that addressed design features of a confirmatory Phase
3 clinical trial of omecamtiv mecarbil with discussion of patient
population, endpoints, as well as several additional pragmatic
elements related to clinical trial conduct.
- Advanced preparations to conduct a
confirmatory Phase 3 clinical trial of omecamtiv mecarbil in
patients with heart failure with reduced ejection fraction (HFrEF)
expected to start in Q4 2024.
CK-4021586 (CK-586, cardiac
myosin inhibitor)
- Announced topline data from the
Phase 1 study of CK-586 and expect to present primary data in Q3
2024. Data from the Phase 1 study support progression to a Phase 2a
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 analyses of the Phase 1
study of CK-136, which met its primary objective to assess the
safety, tolerability and pharmacokinetics of single and multiple
doses of CK-136 in healthy participants. Due to the Company’s
strategic prioritization of its other clinical trial programs,
further development of CK-136 has been discontinued.
Pre-Clinical Development and Ongoing
Research
- Continued pre-clinical development
and research activities directed to additional muscle biology
focused programs. In 2024, we expect to initiate Phase 1 clinical
development of a fast skeletal troponin activator with potential
therapeutic application to a specific type of muscular
dystrophy.
Corporate
- Hosted the inaugural CLIMB Research
Symposium: Contemporary
Landscapes In
Muscle Biology, a one-day
research symposium that brought scientists, researchers and
emerging professionals together to share innovative research in the
field of muscle biology.
Second Quarter 2024 Financial
Results
Cash, Cash Equivalents and
Investments
As of June 30, 2024, the company had
approximately $1.4 billion in cash, cash equivalents and
investments compared to $634.3 million at March 31, 2024. In the
second quarter, the company completed a public offering of
11,274,510 shares of its common stock which included the
underwriters’ exercise in full of their option to purchase
additional shares, raising approximately $563.2 million in net
proceeds, after deducting underwriting discounts and commissions.
On May 22, 2024, the company entered into a strategic funding
collaboration with Royalty Pharma totaling up to $575 million to
support the commercialization of aficamten and to advance the
company’s expanding cardiovascular pipeline as the company advances
its muscle biology-directed specialty cardiology business. The
company received $250 million upon execution, including $100
million to fund a confirmatory Phase 3 trial of omecamtiv mecarbil,
$50 million to fund a proof-of-concept Phase 2a clinical trial for
CK-586, $50 million term loan to support the potential commercial
launch of aficamten in obstructive HCM, and $50 million from the
purchase of Cytokinetics’ common stock in a private placement.
Under the terms of the collaboration, the company, at its option,
can borrow up to $175 million upon satisfaction of certain
conditions and receive up to $150 million investment in a Phase 3
clinical trial of CK-586 subject to Royalty Pharma exercising its
option to participate in the funding of such a trial in exchange
for an additional revenue interest in the net sales of CK-586.
Revenues
- Total revenues for the second
quarter of 2024 were $0.2 million compared to $0.9 million for the
same period in 2023.
Research and Development (R&D)
Expenses
- R&D expenses for the second
quarter of 2024 were $79.6 million which included $11.5 million of
non-cash stock-based compensation expense, compared to $83.2
million for the same period in 2023 which included $8.2 million of
non-cash stock-based compensation expense. The decrease was
primarily driven by the timing of clinical trial activities and
wind down activities for COURAGE-ALS which ended in the first
quarter of 2023.
General and Administrative (G&A)
Expenses
- G&A expenses for the second
quarter of 2024 were $50.8 million which included $13.1 million of
non-cash stock-based compensation expense, compared to $39.7
million for the same period in 2023 which included $10.5 million in
non-cash stock-based compensation expense. The increase was
primarily driven by investments toward commercial readiness and
personnel related expenses.
Net Income (Loss)
- Net loss for the second quarter of
2024 was $143.3 million, or $(1.31) per share, basic and diluted,
compared to a net loss of $128.6 million, or $(1.34) per share,
basic and diluted, for the same period in 2023.
2024 Financial Guidance
The company is updating its full year 2024
financial guidance:
|
Current Guidance |
Previous Guidance |
GAAP Operating Expense[1] |
$555m to $575m |
$535m to $555m |
Non-cash Expense[2] Included in GAAP Operating Expense |
$110m to $105m |
$115m to $105m |
Non-GAAP Operating Expense[3] |
$445m to $470m |
$420m to $450m |
Net Cash Utilization[4] |
$400m to $420m |
$390m to $420m |
The financial guidance does not include the
effect of GAAP adjustments caused by events that may occur
subsequent to the publication of this guidance including but not
limited to business development activities.
[1]GAAP operating expense comprised of R&D
and G&A expenses.[2]Non-cash operating expense comprised of
stock-based compensation and depreciation.[3]Non-GAAP operating
expense comprised of R&D and G&A expenses but excludes
non-cash operating expense.[4]Net cash utilization is a non-GAAP
financial measure that we define as our ending 2023 cash, cash
equivalents, and investments balance of $655 million plus the net
proceeds of $707 million received from the sale of common stock
(through the at-the-market facility, public offerings, and stock
purchase agreement with Royalty Pharma) plus proceeds of $200
million received from the structured financing agreement with
Royalty Pharma announced on May 22, 2024 minus our projected ending
2024 cash, cash equivalents, and investments balance of between
$1,142 million and $1,162 million.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s second 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 Q2 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 muscle biology directed drug
candidates 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 which were published in the
New England Journal of Medicine. 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.
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, our ability
to complete enrollment of ACACIA-HCM in 2025, our ability to start
a new Phase 3 confirmatory trial of omecamtiv mecarbil in the
fourth quarter of 2024, and to commence a Phase 2a 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) |
|
|
|
|
|
|
|
June 30, 2024 |
|
December 31, 2023 |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and short term investments |
|
$ |
1,056,775 |
|
|
$ |
614,824 |
|
Other current assets |
|
|
11,035 |
|
|
|
13,227 |
|
Total current assets |
|
|
1,067,810 |
|
|
|
628,051 |
|
Long-term investments |
|
|
305,361 |
|
|
|
40,534 |
|
Property and equipment, net |
|
|
65,689 |
|
|
|
68,748 |
|
Operating lease right-of-use assets |
|
|
77,249 |
|
|
|
78,987 |
|
Other assets |
|
|
7,679 |
|
|
|
7,996 |
|
Total assets |
|
$ |
1,523,788 |
|
|
$ |
824,316 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT) |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
49,283 |
|
|
$ |
64,148 |
|
Short-term operating lease liabilities |
|
|
18,507 |
|
|
|
17,891 |
|
Current portion of long-term debt |
|
|
11,520 |
|
|
|
10,080 |
|
Derivative liabilities measured at fair value |
|
|
13,200 |
|
|
|
— |
|
Other current liabilities |
|
|
10,267 |
|
|
|
10,559 |
|
Total current liabilities |
|
|
102,777 |
|
|
|
102,678 |
|
Term
loan, net |
|
|
92,831 |
|
|
|
58,384 |
|
Convertible notes, net |
|
|
550,600 |
|
|
|
548,989 |
|
Liabilities related to revenue participation right purchase
agreements, net |
|
|
435,112 |
|
|
|
379,975 |
|
Long-term operating lease liabilities |
|
|
116,718 |
|
|
|
120,427 |
|
Liabilities related to RPI Transactions measured at fair value |
|
|
117,200 |
|
|
|
— |
|
Other
non-current liabilities |
|
|
— |
|
|
|
186 |
|
Total liabilities |
|
|
1,415,238 |
|
|
|
1,210,639 |
|
Commitments and contingencies |
|
|
|
|
Stockholders’ equity (deficit): |
|
|
|
|
Common stock |
|
|
117 |
|
|
|
102 |
|
Additional paid-in capital |
|
|
2,500,654 |
|
|
|
1,725,823 |
|
Accumulated other comprehensive loss |
|
|
(1,022 |
) |
|
|
(10 |
) |
Accumulated deficit |
|
|
(2,391,199 |
) |
|
|
(2,112,238 |
) |
Total stockholders’ equity (deficit) |
|
|
108,550 |
|
|
|
(386,323 |
) |
Total liabilities and stockholders’ equity (deficit) |
|
$ |
1,523,788 |
|
|
$ |
824,316 |
|
|
|
Cytokinetics, Incorporated |
Condensed Consolidated Statements of
Operations |
(in thousands except per share data) |
(unaudited) |
|
|
|
|
|
|
|
Three Months Ended |
|
|
June 30, 2024 |
|
June 30, 2023 |
Revenues: |
|
|
|
|
Research and development revenues |
|
$ |
249 |
|
|
$ |
867 |
|
Milestone revenues |
|
|
— |
|
|
|
— |
|
Total revenues |
|
|
249 |
|
|
|
867 |
|
Operating expenses: |
|
|
|
|
Research and development |
|
|
79,597 |
|
|
|
83,194 |
|
General and administrative |
|
|
50,824 |
|
|
|
39,722 |
|
Total operating expenses |
|
|
130,421 |
|
|
|
122,916 |
|
Operating loss |
|
|
(130,172 |
) |
|
|
(122,049 |
) |
Interest expense |
|
|
(12,732 |
) |
|
|
(7,045 |
) |
Non-cash interest expense on liabilities related to revenue
participation right purchase agreements |
|
|
(11,567 |
) |
|
|
(6,322 |
) |
Interest and other income, net |
|
|
11,553 |
|
|
|
6,779 |
|
Change in fair value of derivative liabilities |
|
|
(600 |
) |
|
|
— |
|
Change in fair value of liabilities related to RPI
Transactions |
|
|
200 |
|
|
|
— |
|
Net
loss |
|
$ |
(143,318 |
) |
|
$ |
(128,637 |
) |
Net loss
per share — basic and diluted |
|
$ |
(1.31 |
) |
|
$ |
(1.34 |
) |
Weighted-average number of shares used in computing net loss per
share — basic and diluted |
|
|
109,240 |
|
|
|
95,755 |
|
Cytokinetics (NASDAQ:CYTK)
過去 株価チャート
から 8 2024 まで 9 2024
Cytokinetics (NASDAQ:CYTK)
過去 株価チャート
から 9 2023 まで 9 2024