Cytokinetics, Inc. (NASDAQ:CYTK) reported total research and development revenues for the second quarter of 2015 were $6.5 million, compared to $7.8 millionduring the same period in 2014.  The net loss for the second quarter was $10.6 million, or $0.27 per basic and diluted share. This is compared to a net loss for the same period in 2014, of $8.4 million or $0.23 per basic share and diluted share. As of June 30, 2015, cash, cash equivalents and investments totaled $108.2 million.

“Our company marked a key milestone recently with the start of VITALITY-ALS, our Phase 3 clinical trial of tirasemtiv in patients with ALS, which is designed to confirm and extend results observed in prior clinical trials.   We are grateful for the continued commitment of patients and caregivers as we advance our novel skeletal muscle activator to the final stages of clinical testing,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer.  “Leveraging partnerships remains a core component of our corporate strategy as we mature our late-stage development pipeline. In the last quarter, we also made substantial progress with Amgen towards completing COSMIC-HF and with Astellas beginning the Phase 2 clinical trials program of CK-2127107.”

Recent Highlights and Upcoming Milestones

Skeletal Muscle Contractility

tirasemtiv

  • Started VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices afterTreatment for a Year in ALS), a Phase 3 clinical trial designed to assess effects of tirasemtiv versus placebo on slow vital capacity (SVC) and other measures of respiratory function in patients with ALS.
  • Awarded a $1.5M grant from The ALS Association from proceeds raised during the Ice Bucket Challenge to support VITALITY-ALS and the collection of plasma samples to advance the discovery of biomarkers.

CK-2127107

  • Presented results from three double-blind, randomized, placebo-controlled Phase 1 studies of CK-2127107 in healthy volunteers in poster and oral presentations at the 19th International SMA (Spinal Muscular Atrophy) Researcher Meeting held during the 2015 Annual SMA Conference.
  • Continued planning activities in anticipation of initiating a Phase 2 clinical trial of CK-2127107 in patients with SMA in collaboration with Astellas in the fourth quarter of 2015.

Cardiac Muscle Contractility

omecamtiv mecarbil

  • More than 400 patients have concluded dosing in the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure). COSMIC-HF is a Phase 2, double-blind, randomized, placebo-controlled, multicenter clinical trial designed to assess the pharmacokinetics and tolerability of omecamtiv mecarbil dosed orally in patients with heart failure and left ventricular systolic dysfunction as well as its effects on echocardiographic measures of cardiac function.  This trial is being conducted by Amgen in collaboration with Cytokinetics.
  • A paper titled, “Population Pharmacokinetic-Pharmacodynamic Modeling of Omecamtiv Mecarbil, a Cardiac Myosin Activator, in Healthy Volunteers and Patients with Stable Heart Failure,” was published in the Journal of Clinical Pharmacology. Data from three clinical trials of omecamtiv mecarbil in healthy volunteers and patients with stable heart failure were analyzed using a nonlinear mixed-effects model to investigate the pharmacokinetics of omecamtiv mecarbil and the relationship of systolic ejection time and Doppler-derived left ventricular outflow tract stroke volume to the plasma concentration of omecamtiv mecarbil.
  • Conducted collaboration activities directed to the potential advancement of omecamtiv mecarbil into a Phase 3 program.
  • Anticipate announcing data from COSMIC-HF in the fourth quarter of 2015.

Pre-Clinical Research

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

Corporate

  • Hosted an R&D Day featuring senior management and an expert clinician panel to provide discovery and development program updates, milestones and perspectives.
  • Held our Annual Stockholder’s Meeting.
  • Announced an expanded partnership with The ALS Association in which the company will provide Gold Level Sponsorship of the National Walks to Defeat ALS as well as Platinum Level Sponsorship for ALS Association Golden West Chapter initiatives. Cytokinetics also committed to a challenge grant to fund care services in the Bay Area.

Financials

Revenues for the second quarter of 2015 were $6.5 million, compared to $7.8 million during the same period in 2014. Revenues for the second quarter of 2015 included $3.0 million of license revenues and $2.9 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 $4.2 million of research and development revenues from our collaboration with Astellas, and $0.8 million of research and development revenues from our collaboration with Amgen.

Total research and development (R&D) expenses for the second quarter of 2015 were $12.6 million, compared with$11.7 million for the same period in 2014. The $0.9 million increase in R&D expenses for the second quarter of 2015, compared with the same period in 2014, was primarily due to an increase of $1.4 million in outsourced preclinical costs, partially offset by a decrease of $1.0 million in outsourced clinical costs associated with the completion of BENEFIT-ALS in the second quarter of 2014.

Total general and administrative (G&A) expenses for the second quarter of 2015 remained unchanged at $4.5 million, compared to the same period in 2014.

Revenues for the six months ended June 30, 2015 were $11.0 million, compared to $15.8 million for the same period in 2014. Revenues for the first six months of 2015 included $5.0 million of research and development revenues and $4.7 million of license revenues from our collaboration with Astellas, and $1.3 million of research and development revenues from our collaboration with Amgen. Revenues for the same period in 2014 included $9.4 million of research and development revenues and $4.8 million of license revenues from our collaboration with Astellas, and $1.5 millionof research and development revenues from our collaboration with Amgen.

Total R&D expenses for the six months ended June 30, 2015 were $21.6 million, compared to $24.2 million for the same period in 2014. The $2.6 million decrease in R&D expenses in the first six months of 2015, over the same period in 2014, was primarily due to a decrease of $4.1 million in outsourced clinical costs associated with the completion of BENEFIT-ALS in the second quarter of 2014 partially offset by an increase of $0.5 million in outsourced preclinical costs and an increase of $0.2 million in personnel expenses due to increased headcount.

Total G&A expenses for the six months ended June 30, 2015 were $8.9 million, compared to $8.7 million for the same period in 2014. The $0.2 million increase in G&A spending in the first six months of 2015 compared to the same period in 2014, was primarily due to an increase of $0.8 million in personnel cost, due to an increase in headcount, partially offset by a decrease of $0.6 million in outside services costs related to commercial development.

The net loss for the six months ended June 30, 2015, was $19.4 million, or $0.50 per basic and diluted share, compared to a net loss of $17.1 million, or $0.49 per basic and diluted share, for the same period in 2014.

Company Updates Financial Guidance

The company anticipates cash revenue to be in the range of $44 to $47 million, cash R&D expenses in the range of $58 to $61 million, and cash G&A expenses to be in the range of $18 to $21 million.  This guidance includes the $30 millionupfront payment from Astellas that will be deferred and recognized over a two year period ending in 2016 under generally accepted accounting principles. This guidance excludes the $15 million milestone payment earned in 2014 from Astellas and an estimated $3.6 million in non-cash related operating expenses primarily related to stock compensation. (Original Source)

Shares of Cytokinetics closed today at $7.06, down $0.34 or 4.59%. CYTK has a 1-year high of $8.61 and a 1-year low of $3.05. The stock’s 50-day moving average is $6.57 and its 200-day moving average is $6.93.

On the ratings front, Cytokinetics has been the subject of a number of recent research reports. In a report issued on July 24, MLV & Co. analyst Vernon Bernardino reiterated a Buy rating on CYTK, with a price target of $14, which represents a potential upside of 87.9% from where the stock is currently trading. Separately, on July 15, Cowen’s Ritu Baral initiated coverage with a Buy rating on the stock and has a price target of $9.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vernon Bernardino and Ritu Baral have a total average return of -8.6% and 22.5% respectively. Bernardino has a success rate of 33.8% and is ranked #3597 out of 3718 analysts, while Baral has a success rate of 49.3% and is ranked #89.

Cytokinetics Inc is a clinical stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions.