“2015 was a transformational year for Cytokinetics and we start 2016 strong with momentum across our three muscle biology-directed development programs. As we recently outlined in our Vision 2020 strategic initiative, over the next five years our goal is to expand our portfolio of novel muscle activators and mature operations to enable commercialization of our multiple, first-in-class compounds for the potential treatment of people living with diseases of impaired muscle function,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “In 2016, we look forward to the potential advancement of the clinical development program for omecamtiv mecarbil in patients with heart failure under our collaboration with Amgen, and the enrollment of patients in our Phase 2 trial of CK-2127107 in patients with Spinal Muscular Atrophy under our collaboration with Astellas. At the same time, we are also focused on completing enrollment in VITALITY-ALS, our Phase 3 trial of tirasemtiv in patients with ALS. This is a truly exciting year for our company and our key stakeholders.”
Recent Highlights
Cardiac Muscle Program
omecamtiv mecarbil
- Announced presentation of data from the expansion phase of COSMIC-HF (Chronic Oral Study ofMyosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial of omecamtiv mecarbil in patients with heart failure, in a Late-Breaking Clinical Trial session at the American Heart Association (AHA) Scientific Sessions 2015 in Orlando, Fla. The clinical trial met its primary pharmacokinetic objective and demonstrated statistically significant improvements in all pre-specified secondary measures of cardiac function in the treatment group employing pharmacokinetic-based dose titration. Adverse events, including serious adverse events, in patients on omecamtiv mecarbil were similar to those on placebo. COSMIC-HF was conducted byAmgen in collaboration with Cytokinetics.
- Conducted planning activities in collaboration with Amgen to support the potential advancement of omecamtiv mecarbil into a Phase 3 program.
Skeletal Muscle Program
tirasemtiv
- Continued enrollment in VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal 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.
- Amended the protocol of VITALITY-ALS to increase the number of patients to be enrolled from approximately 445 to approximately 600 patients. Increasing the number of patients in VITALITY-ALS may enable increased statistical power to detect a difference in the primary endpoint (change from baseline in SVC at 24 weeks) between tirasemtiv and placebo.
- Announced the presentation of exploratory analyses of data from EMPOWER, a Phase 3 clinical trial of dexpramipexole in patients with ALS, which demonstrated the rate of decline of SVC predicts the risk of meaningful clinical events, including a decline in the three respiratory questions of the ALSFRS-R, as well as the time to the first occurrence of respiratory insufficiency, tracheostomy or death.
CK-2127107
- Recently announced the start of a Phase 2 clinical trial of CK-2127107 in patients with spinal muscular atrophy (SMA), in collaboration with Astellas.
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
- Announced an expanded partnership with Cure SMA to increase education, awareness and fundraising for SMA. As a National Gold Partner, Cytokinetics will lend support to key national and local initiatives to advance understanding of, and research toward potential treatments for SMA.
- Recently drew down the second, $15.0 million tranche from our existing growth capital loan withOxford Finance LLC and Silicon Valley Bank, with the tranche being funded in February 2016.
Financials
Revenues for the fourth quarter of 2015 were $9.8 million, compared to $21.8 million during the same period in 2014. Revenues for the fourth quarter of 2015 included $5.1 million of license revenues and $4.0 million of research and development revenues from our collaboration with Astellas, and $0.6 million in research and development revenues from our collaboration withAmgen. Revenues for the same period in 2014 were comprised of $2.3 million of license revenues,$3.3 million of research and development revenues and $15.0 million in milestone revenues from our collaboration with Astellas, $1.1 million of research and development revenues from our collaboration with Amgen, and $0.1 million in milestone revenues from our collaboration withMyoKardia.
Total research and development (R&D) expenses for the fourth quarter of 2015 were $13.2 million, compared to $8.8 million for the same period in 2014. The $4.4 million increase in R&D expenses for the fourth quarter of 2015, compared with the same period in 2014, was primarily due to an increase of $3.9 million in outsourced clinical and preclinical costs and an increase of $0.7 million in personnel related expenses.
Total general and administrative (G&A) expenses for the fourth quarter of 2015 were $5.5 millioncompared to $4.6 million for the same period in 2014. The $0.9 million increase in G&A expenses for the fourth quarter of 2015, compared to the same period in 2014, was primarily due to an increase of $0.8 million in outsourced expenses and $0.6 million in personnel related expenses due to an increase in headcount, partially offset by a decrease of $0.5 million in legal fees.
Revenues for the twelve months ended December 31, 2015 were $28.7 million, compared to $46.9 million for the same period in 2014. Revenues for the twelve months of 2015 included $13.9 millionof license revenues and $12.2 million of research and development revenues from our collaboration with Astellas, and $2.5 million of research and development revenues from our collaboration with Amgen. Revenues for the same period in 2014 were comprised of $9.8 million of license revenues, $17.0 million of milestone revenues and $15.4 million of research and development revenues from our collaboration with Astellas, $4.5 million of research and development revenues from our collaboration with Amgen and $0.1 million in milestone revenue from our collaboration with MyoKardia.
Total R&D expenses for the twelve months ended December 31, 2015 were $46.4 million, compared to $44.4 million for the same period in 2014. The $2.0 million increase in R&D expenses in the twelve months of 2015, over the same period in 2014, was primarily due to an increase of$2.0 million in outsourced preclinical costs, an increase of $1.8 million in personnel related expenses due to increased headcount, and an increase of $0.4 million in lab expenses, partially offset by a decrease of $2.1 million in outsourced clinical costs associated with the completion of BENEFIT-ALS in the second quarter of 2014.
Total G&A expenses for the twelve months ended December 31, 2015 were $19.7 million, compared to $17.3 million for the same period in 2014. The $2.4 million increase in G&A spending in the twelve months of 2015 compared to the same period in 2014, was primarily due to an increase of $1.4 million in personnel related costs due to an increase in headcount and an increase of $0.8 million in outsourced costs.
The net loss for the twelve months ended December 31, 2015, was $37.5 million, or $0.97 per basic and diluted share, compared to a net loss of $14.6 million, or $0.41 per basic and diluted share, for the same period in 2014.
2016 Financial Guidance
Cytokinetics also announced financial guidance for 2016. The company anticipates cash revenue will be in the range of $13 to $16 million, cash R&D expenses will be in the range of $67 to $70 million, and cash G&A expenses will be in the range of $21 to $24 million. This guidance excludes approximately $20.5 million in deferred revenue from the expansion of our collaboration with Astellas in 2015, which will be recognized in 2016 under generally accepted accounting principles, as well as any potential milestones that may be achieved in accordance with our collaboration agreements with our partners Amgen and Astellas. This guidance excludes an estimated $4.5 million in non-cash related operating expenses primarily related to stock compensation expense.
2016 Corporate Milestones
Cardiac Muscle Program
omecamtiv mecarbil
- Expect to make a decision regarding the potential advancement to Phase 3 in the coming months.
Skeletal Muscle Program
tirasemtiv
- Expect to complete enrollment of VITALITY-ALS in the first half of 2016.
CK-2127107
- Expect to complete enrollment of our Phase 2 clinical trial of CK-2127107 in patients with SMA in the second half of 2016.
- Expect Astellas will initiate a Phase 2 clinical trial of CK-107 in patients with COPD in the first half of 2016.
Pre-Clinical Research
- Expect to continue 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.
- Anticipate potential advancement of one next-generation compound from each joint research program into pre-clinical development in 2016. (Original Source)
Shares of Cytokinetics are falling nearly 8% in after-hours trading. CYTK has a 1-year high of $13.18 and a 1-year low of $5.50. The stock’s 50-day moving average is $8.43 and its 200-day moving average is $8.54.
On the ratings front, Cytokinetics has been the subject of a number of recent research reports. In a report issued on January 19, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on CYTK, with a price target of $22, which represents a potential upside of 209.0% from where the stock is currently trading. Separately, on January 4, Piper Jaffray’s Charles Duncan reiterated a Buy rating on the stock and has a price target of $24.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Charles Duncan have a total average return of -15.0% and -13.2% respectively. Pantginis has a success rate of 28.0% and is ranked #3567 out of 3579 analysts, while Duncan has a success rate of 26.3% and is ranked #3465.
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.