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 2014 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,” saidRobert 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 oftirasemtiv 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

tirasemtiv

  • Initiated enrollment in VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment ofLongitudinal Indices after Treatment for a Year in ALS), a Phase 3 clinical trial designed to assess the effects of tirasemtiv 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

omecamtiv mecarbil

  • Recently announced positive results from COSMIC-HF (Chronic Oral Study of Myosin Activation toIncrease Contractility in Heart Failure) 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 omecamtiv mecarbil 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 omecamtiv mecarbil 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 costs and lab expenses and an increase of $0.6 million in personnel related expenses, 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 third quarter of 2015 were $5.3 millioncompared to $4.0 million for the same period in 2014.  The $1.3 million increase in G&A expenses for the third quarter of 2015, compared to the same period in 2014, was primarily due to an increase of $0.7 million in outsourced costs, $0.4 million in legal fees, and $0.2 million in personnel related expenses due to an increase in headcount.

Revenues for the nine months ended September 30, 2015 were $18.9 million, compared to $25.2 million for the same period in 2014. Revenues for the first nine months of 2015 included $8.8 million of license revenues and $8.2 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. Revenues for the same period in 2014 were comprised of $7.6 million of license revenues and $14.1 million of research and development revenues from our collaboration with Astellas, and $3.4 million of research and development revenues from our collaboration withAmgen.

Total R&D expenses for the nine months ended September 30, 2015 were $33.1 million, compared to $35.6 million for the same period in 2014. The $2.5 million decrease in R&D expenses in the first nine months of 2015, over the same period in 2014, was primarily due to a decrease of $5.0 millionin outsourced clinical costs associated with the completion of BENEFIT-ALS in the second quarter of 2014, partially offset by an increase of $0.8 million in outsourced preclinical costs, an increase of$0.6 million in lab expenses, and an increase of $1.0 million in personnel related expenses due to increased headcount.

Total G&A expenses for the nine months ended September 30, 2015 were $14.1 million, compared to $12.7 million for the same period in 2014. The $1.4 million increase in G&A spending in the first nine months of 2015 compared to the same period in 2014, was primarily due to an increase of$0.8 million in personnel related costs due to an increase in headcount, an increase of $0.6 in legal fees, and an increase of $0.1 million in outsourced costs.

The net loss for the nine months ended September 30, 2015, was $28.3 million, or $0.73 per basic and diluted share, compared to a net loss of $23.1 million, or $0.65 per basic and diluted share, for the same period in 2014.

Financial Guidance

Cytokinetics also announced updated financial guidance for 2015. The company anticipates cash revenue will be in the range of $44 to $47 million, cash R&D expenses will be in the range of $51 to $54 million, and cash G&A expenses will be in the range of $18 to $21 million. This guidance includes approximately $30.0 million in revenue which will be deferred and recognized over a two year period ending in 2016 under generally accepted accounting principles. This guidance excludes an estimated $4.6 million in non-cash related operating expenses primarily related to stock compensation expense. (Original Source)

Shares of Cytokinetics opened today at $7.52 and are currently trading up at $8.963. CYTK has a 1-year high of $9.23 and a 1-year low of $3.45. The stock’s 50-day moving average is $7.05 and its 200-day moving average is $6.71.

On the ratings front, Cytokinetics has been the subject of a number of recent research reports. In a report issued on October 23, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on CYTK, with a price target of $18, which represents a potential upside of 139.4% from where the stock is currently trading. Separately, on September 15, FBR’s Vernon Bernardino reiterated a Buy rating on the stock and has a price target of $14.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Vernon Bernardino have a total average return of -5.4% and -19.7% respectively. Pantginis has a success rate of 34.8% and is ranked #3750 out of 3808 analysts, while Bernardino has a success rate of 25.0% and is ranked #3781.

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.