Current Report Filing (8-k)
October 02 2020 - 07:30AM
Edgar (US Regulatory)
0001061983 False 0001061983 2020-10-02 2020-10-02 iso4217:USD xbrli:shares iso4217:USD xbrli:shares
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________
FORM 8-K
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of
the Securities Exchange Act of 1934
Date of Report (Date of earliest
event reported): October 2,
2020
_______________________________
Cytokinetics,
Incorporated
(Exact name of registrant as specified in its charter)
_______________________________
Delaware
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000-50633
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94-3291317
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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280
East Grand Avenue
South
San Francisco, California
94080
(Address of Principal Executive Offices) (Zip Code)
(650)
624-3000
(Registrant's telephone number, including area code)
Not Applicable
(Former name or former address, if changed since
last report)
_______________________________
Check the appropriate box below if
the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section
12(b) of the Act:
Title of
each class
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Trading Symbol(s)
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Name of each
exchange on which registered
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Common Stock, par value $0.001
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CYTK
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The
Nasdaq Stock Market LLC
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Indicate by check mark whether the
registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule
12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01. Other Events.
On October 2, 2020, Cytokinetics, Incorporated ("Cytokinetics")
announced that a manuscript detailing the baseline characteristics from GALACTIC-HF (Global Approach
to Lowering Adverse Cardiac Outcomes Through Improving
Contractility in Heart Failure), the Phase 3 event driven cardiovascular outcomes clinical
trial of omecamtiv mecarbil, was published in the European Journal of Heart Failure. Omecamtiv mecarbil,
a selective cardiac myosin activator, is being developed for the potential treatment of heart failure with reduced ejection fraction under
a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier.
GALACTIC-HF is designed to evaluate whether
treatment with omecamtiv mecarbil, dosed twice-daily in accordance with a pharmacokinetic-guided dose optimization regimen, when
added to standard of care, reduces the risk of heart failure events (heart failure hospitalization or other urgent, unscheduled treatment
for heart failure) and cardiovascular (CV) death in patients with chronic heart failure and reduced ejection fraction (HFrEF). Patients
enrolled in GALACTIC-HF were required to have a diagnosis of HFrEF with left ventricular ejection fraction (LVEF) ≤35% and elevated
natriuretic peptides. Patients were either currently hospitalized for heart failure (25% of total enrollment), or had a recent hospitalization,
or a visit to an emergency room or urgent care facility for heart failure within the preceding year.
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Overall (8256)
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Current HF
Hospitalization
(“Inpatient”)
(N=2084)
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Recent HF
Hospitalization or
ED Visit Within
One Year
(“Outpatient”)
(N=6172)
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Demographics
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Age (years), mean (SD)
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64.5 (11.3)
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65.0 (11.3)
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64.4 (11.4)
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Sex, female, n (%)
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1756 (21.3)
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411 (19.7)
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1345 (21.8)
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Race, n (%)
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White
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6421 (77.8)
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1706 (81.9)
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4715 (76.4)
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Asian
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710 (8.6)
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184 (8.8)
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526 (8.5)
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Black or African American
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562 (6.8)
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105 (5.0)
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457 (7.4)
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Other*
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563 (6.8)
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89 (4.3)
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474 (7.7)
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Ethnicity, Hispanic/Latino n (%)
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1771 (21.5)
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355 (17.0)
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1416 (22.9)
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Geographic Region, n (%)
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Eastern Europe/ Russia
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2705 (32.8)
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915 (43.9)
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1790 (29.0)
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Western Europe/ South Africa/ Australasia
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1921 (23.3)
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486 (23.3)
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1435 (23.3)
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Latin and South America
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1574 (19.1)
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326 (15.6)
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1248 (20.2)
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US and Canada
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1386 (16.8)
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180 (8.6)
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1206 (19.5)
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Asia
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670 (8.1)
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177 (8.5)
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493 (8.0)
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Clinical Characteristics
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Medical Conditions, n (%)
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Coronary artery disease
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5144 (62.3)
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1317 (63.2)
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3827 (62.0)
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Peripheral artery disease
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847 (10.3)
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215 (10.3)
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632 (10.2)
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Stroke
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753 (9.1)
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197 (9.5)
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556 (9.0)
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Atrial fibrillation or flutter history
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3472 (42.1)
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995 (47.7)
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2477 (40.1)
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Hypertension
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5800 (70.3)
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1495 (71.7)
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4305 (69.8)
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Hypercholesterolemia
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4553 (55.1)
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1094 (52.5)
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3459 (56.0)
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Type 2 diabetes mellitus
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3313 (40.1)
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870 (41.7)
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2443 (39.6)
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Heart Failure History
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LVEF (%), mean (SD)
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26.6 (6.3)
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26.5 (6.4)
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26.6 (6.2)
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MAGGIC Score, mean (SD)
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23.3 (6.3)
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25.0 (6.3)
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22.8 (6.3)
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NYHA classification, n (%)
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Class II
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4391 (53.2)
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767 (36.8)
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3624 (58.7)
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Class III
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3616 (43.8)
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1190 (57.1)
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2426 (39.3)
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Class IV
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248 (3.0)
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126 (6.0)
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122 (2.0)
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Ischemic heart failure etiology, n (%)
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4458 (54.0)
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1148 (55.1)
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3310 (53.6)
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KCCQ Total Symptom Score, mean (SD)
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66.4 (25.1)
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52.6 (25.4)
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71.0 (23.2)
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Vitals and Laboratory Parameters
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NT-proBNP (pg/mL),
median (Q1-Q3)
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1971
(961-4033)
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2457
(1185-5073)
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1858
(900-3749)
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hsTnI (ng/mL), median (Q3)
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0.030 (0.049)
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0.036 (0.066)
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0.029 (0.044)
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eGFR (mL/min/1.73m2),
median (Q1-Q3)
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59 (41-74)
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54 (41-70)
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60 (45-75)
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Stage ≤2; >60
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3922 (47.7)
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838 (40.2)
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3084 (50.0)
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Stage 3: 30-59
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3806 (46.1)
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1077 (51.7)
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2729 (44.2)
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Stage 4: 15-29
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523 (6.3)
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169 (8.1)
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354 (5.7)
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Stage 5: <15
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5 (<0.1)
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0 (0.0)
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5 (<0.1)
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Medications and Cardiac Devices,
n (%)
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ACEi, ARB or ARNi
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7161 (86.7)
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1729 (83.0)
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5432 (88.0)
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ARNi
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1594 (19.3)
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328 (15.7)
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1266 (20.5)
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BB
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7763 (94.0)
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1931 (92.7)
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5832 (94.5)
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MRA
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6358 (77.0)
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1686 (80.9)
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4672 (75.7)
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(ACEi, ARB, or ARNi) + MRA + BB
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5367 (65.0)
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1360 (65.3)
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4007 (64.9)
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SGLT2 Inhibitors
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219 (2.7)
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56 (2.7)
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163 (2.6)
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Ivabradine
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533 (6.5)
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156 (7.5)
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375 (6.1)
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Cardiac Resynchronization Therapy
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1156 (14.0)
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267 (12.8)
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889 (14.4)
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Implantable Cardioverter Defibrillator
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2614 (31.7)
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598 (28.7)
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2016 (32.7)
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*Includes American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, or Multiple self-identified races
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Data are as published in the manuscript
and may change with final review
Forward-Looking Statements
This filing contains forward-looking statements for purposes of
the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update
these forward-looking statements and 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 the GALACTIC-HF clinical trial, including the expected timing of the availability
of top-line results; statements relating to the METEORIC-HF clinical trial; the potential benefits of omecamtiv mecarbil,
including its ability to represent a novel therapeutic strategy to increase cardiac muscle function and restore cardiac performance; Cytokinetics' and
its partners' research and development activities; the design, timing, results, significance and utility of preclinical and clinical results;
and the properties and potential benefits of Cytokinetics' other 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,
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; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign
regulatory agencies may delay or limit Cytokinetics' or its partners' ability to conduct clinical trials; Cytokinetics may
be unable to obtain or maintain patent or trade secret protection for its intellectual property; the nature of Amgen's decisions with
respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; standards
of care may change, rendering Cytokinetics' drug candidates obsolete; competitive products or alternative therapies may be developed
by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target; and risks
and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential
product sales under Cytokinetics' collaboration agreements with such partners. For further information regarding these and other
risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and
Exchange Commission.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report
to be signed on its behalf by the undersigned hereunto duly authorized.
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Cytokinetics, Incorporated
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Date: October 2, 2020
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By:
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/s/ Ching Jaw
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Ching Jaw
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Senior Vice President, Chief Financial Officer
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