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Actionable news in CYTK: Cytokinetics, Incorporated,

Cytokinetics, Inc. Reports Third Quarter 2015 Financial Results

The following excerpt is from the company's SEC filing.

Recently Announced Positive Top-line Results From COSMIC-HF; Data Demonstrated Statistically

Significant Improvements in Several Pre-Specified Measures of Cardiac Function

Company Lowers 2015 R&D Expense Guidance

SOUTH SAN FRANCISCO, CA, October 29, 2015

Cytokinetics, Inc. (Nasdaq: CYTK) reported total research and development revenues for the third quarter of 2015 were $7.9 million, compared to $9.4 million during the same period in 2014. The net loss for the third quarter was $8.8 million, or $0.23 per basic and diluted share. This is compared to a net loss for the same period in 2 014 of $6.0 million, or $0.16 per basic share and diluted share. As of September 30, 2015, cash, cash equivalents and investments totaled $98.0 million.

With the recently announced positive results from COSMIC-HF, Cytokinetics has entered a transformative time in the maturation of our company. We look forward to working with our partners at Amgen to prepare for potential progression of

omecamtiv mecarbil

to Phase 3, said Robert I. Blum, Cytokinetics President and Chief Executive Officer. During the quarter, we achieved another key milestone for the company with the start of our first Phase 3 clinical trial of

tirasemtiv

in patients with ALS and prepared to advance CK-2127107 into a Phase 2 clinical trial in patients with SMA, in collaboration with Astellas. This is truly an exciting time for our company and our key stakeholders.

Recent Highlights and Upcoming Milestones

Skeletal Muscle Program

Initiated enrollment in VITALITY-ALS (

entilatory

nvestigation of

ssessment of

ongitudinal

ndices after

reatment for a

ear in

), a Phase 3 clinical trial designed to assess the effects of

versus placebo on slow vital capacity (SVC) and other measures of skeletal muscle strength in patients with ALS.

Achieved first milestone in accordance with a $1.5M grant from The ALS Association to support VITALITY-ALS and the collection of plasma samples to advance the discovery of biomarkers for ALS.

CK-2127107

Continued planning for the initiation of a Phase 2 clinical trial of CK-2127107 in patients with spinal muscular atrophy (SMA), in collaboration with Astellas, to occur in the fourth quarter of 2015.

Anticipate Astellas will initiate a Phase 2 clinical trial of CK-2127107 in patients with COPD in the first half of 2016.

Cardiac Muscle Program

Recently announced positive results from COSMIC-HF (

hronic

tudy of

yosin Activation to

ncrease

ontractility in

ailure) which demonstrated statistically significant improvements in several pre-specified echocardiographic measures of cardiac function, including systolic ejection time, stroke volume and N-terminal-pro-brain natriuretic peptide, at 20 weeks following randomization. These pharmacodynamic effects of

were generally dose dependent. Data from the expansion phase of COSMIC-HF showed that pharmacokinetic-guided dose titration adequately controlled patient exposure to

omecamtiv mecarbil

and resulted in statistically significant decreases in cardiac dimensions and heart rate in the dose-titration group

Adverse events, including serious adverse events, in patients on

omecamtiv mecarbil,

appeared comparable to those on placebo. COSMIC-HF was conducted by Amgen in collaboration with Cytokinetics.

Conducted planning in collaboration with Amgen, for the potential advancement of

into a Phase 3 program.

Pre-Clinical Research

Continued research activities under our joint research program with Amgen directed to the discovery of next-generation cardiac muscle activators and under our joint research program with Astellas directed to the discovery of next-generation skeletal muscle activators. In addition, company scientists continued independent research activities directed to our other muscle biology programs.

Corporate

Established a $40 million Controlled Equity Offering line with Cantor Fitzgerald.

Entered into a $40 million tranched growth capital loan with Oxford Financial LLC and Silicon Valley Bank, with the first tranche of $15 million funded in October 2015.

Participated in several events associated with Gold Level Sponsorship of the National Walks to Defeat ALS and Platinum Level Sponsorship of the ALS Association Golden West Chapter.

Financials

Revenues for the third quarter of 2015 were $7.9 million, compared to $9.4 million during the same period in 2014. Revenues for the third quarter of 2015 included $4.1 million of license revenues and $3.2 million of research and development revenues from our collaboration with Astellas, and $0.6 million in research and development revenues from our collaboration with Amgen. Revenues for the same period in 2014 were comprised of $2.7 million of license revenues and $4.8 million of research and development revenues from our collaboration with Astellas, and $1.9 million of research and development revenues from our collaboration with Amgen.

Total research and development (R&D) expenses for the third quarter of 2015 were $11.6 million, compared to $11.4 million for the same period in 2014. The $0.2 million increase in R&D expenses for the third quarter of 2015, compared with the same period in 2014, was primarily due to an increase of $0.6 million in outsourced preclinical...


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