On April 28, 2016 Cytokinetics, Inc. (Nasdaq:CYTK) reported total research and development revenues for the first quarter of 2016 were $8.4 million, compared to $4.4 million, during the same period in 2015 (Press release, Cytokinetics, APR 28, 2016, View Source;p=RssLanding&cat=news&id=2162959 [SID:1234511566]). The net loss for the first quarter was $12.5 million, or $0.31 per basic and diluted share. This is compared to the net loss for the same period in 2015 of $8.9 million, or $0.23 per basic and diluted share. As of March 31, 2016, cash, cash equivalents and investments totaled $108.6 million.

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"We made meaningful progress this quarter advancing our portfolio of muscle-biology directed programs," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "Notably, in partnership with Amgen we participated in several productive meetings with regulatory authorities which inform the potential Phase 3 development program for omecamtiv mecarbil. We also made strides in our ongoing skeletal muscle activator clinical development programs for tirasemtiv and CK-2127107 and decided with Astellas to move a next-generation skeletal muscle activator into IND enabling studies, further expanding our development pipeline."

Recent Highlights and Upcoming Milestones

Cardiac Muscle Program

omecamtiv mecarbil

Announced the start of a Phase 2 clinical trial of omecamtiv mecarbil in Japanese subjects with heart failure due to reduced ejection fraction. The primary objectives of the trial are to assess the pharmacokinetics, safety and tolerability of omecamtiv mecarbil. The secondary objective of the trial is to measure changes from baseline in systolic ejection time.

The manuscript, "Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure, The ATOMIC-AHF Study," published in the Journal of the American College of Cardiology. Results from this trial were first presented at the European Society of Cardiology Meeting in 2013.

Participated with Amgen in regulatory meetings with the FDA, EMA and Health Canada intended to inform the design of a potential Phase 3 development program for omecamtiv mecarbil.

Conducted various clinical, non-clinical and planning activities in collaboration with Amgen to support the potential advancement of omecamtiv mecarbil into a Phase 3 development program.

Expect to make a decision regarding the advancement of omecamtiv mecarbil to Phase 3 in the coming months.
Skeletal Muscle Program

tirasemtiv

Enrolled more than 50% of targeted patients in VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS), an ongoing, international 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.

Convened the first Data Monitoring Committee Meeting for VITALITY-ALS to review unblinded safety and efficacy data; Committee recommended continuing the trial without modifications or changes to the protocol.

Presented "Decline in Slow Vital Capacity Predicts Respiratory Insufficiency in Patients with ALS," at the Muscular Dystrophy Association’s 2016 National Clinical Conference.

The manuscript, "A Randomized, Placebo-controlled, Double-blind Phase IIb Trial Evaluating the Safety and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis," published in Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration. Results from this trial were first presented at the Annual Meeting of the American Academy of Neurology in 2014.

Participated in the ALS Guidance Development Project and the Clinical Trial Guidelines Workshop Meeting in collaboration with ALS community stakeholders.

Announced a collaboration with Origent Data Sciences to refine and prospectively validate an Origent computer model to predict ALS disease progression leveraging data from our clinical trials of tirasemtiv.

Expect to complete target enrollment of 600 patients in VITALITY-ALS in the first half of 2016.
CK-2127107

Continued enrollment of Phase 2 clinical trial of CK-2127107 in patients with spinal muscular atrophy (SMA), in collaboration with Astellas.

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-2127107 in patients with COPD in the first half of 2016.
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.

Anticipate potential advancement of one next-generation compound from each joint research program into pre-clinical development in 2016.
Corporate

Announced Cytokinetics’ Vision 2020: Empowering Our Future, a strategic initiative designed to deepen and expand our pipeline over the next five years as well as advance a portfolio of muscle-biology directed drug candidates toward late-stage development and commercialization to address unmet needs of people living with conditions characterized by impaired muscle function.

Drew down the second, $15.0 million tranche from our growth capital loan with Oxford Finance LLC and Silicon Valley Bank.

Announced support of the European Organisation for Rare Diseases (EURORDIS) and the National Organization for Rare Disorders (NORD) to raise awareness of Rare Disease Day, an international campaign dedicated to elevating the public understanding of rare diseases.

In observance of ALS Awareness Month, Cytokinetics will ring the Nasdaq closing bell on Monday, May 2, 2016.
Financials

Revenues for the first quarter of 2016 were $8.4 million, compared to $4.4 million during the same period in 2015. Revenues for the first quarter of 2016 included $4.0 million of license revenues and $3.7 million of research and development revenues from our collaboration with Astellas, $0.6 million in research and development revenues from our collaboration with Amgen and $0.2 million in research and development revenues from our collaboration with ALSA. Revenues for the same period in 2015 were comprised of $1.6 million of license revenues and $2.1 million of research and development revenues from our collaboration with Astellas, and $0.7 million of research and development revenues from our collaboration with Amgen.

Total research and development (R&D) expenses for the first quarter of 2016 were $13.5 million, compared to $9.0 million for the same period in 2015. The $4.5 million increase in R&D expenses for the first quarter of 2016, compared with the same period in 2015, was primarily due to an increase of $4.2 million in outsourced clinical costs mainly associated with the ongoing VITALITY-ALS trial, and an increase of $1.0 million in personnel related expenses due to increased headcount, partially offset by a decrease of $0.6 million in outsourced preclinical costs associated with research activities conducted in 2015.

Total general and administrative (G&A) expenses for the first quarter of 2016 were $6.8 million compared to $4.4 million for the same period in 2015. The $2.4 million increase in G&A expenses for the first quarter of 2016, compared to the same period in 2015, was primarily due to an increase of $1.1 million in personnel related expenses due to increased non-cash stock compensation expense and increased headcount, an increase of $0.6 million in outsourced costs related to medical affairs and commercial development, and an increase of $0.6 million in corporate and patent legal fees.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s first quarter results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed through the Investors & Media section of the Cytokinetics website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 29638364.

An archived replay of the webcast will be available via Cytokinetics’ website until May 5, 2016. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 29638364 from April 28, 2016 at 5:30 PM Eastern Time until May 5, 2016.