On April 27, 2017 Cytokinetics, Inc. (Nasdaq:CYTK) reported total revenues for the first quarter of 2017 were $4.2 million, compared to $8.4 million, during the same period in 2016 (Press release, Cytokinetics, APR 27, 2017, View Source [SID1234518715]). Net loss for the first quarter was $25.9 million, or $0.62 per basic and diluted share, respectively. This is compared to a net loss for the same period in 2016 of $12.5 million, or $0.31 per basic and diluted share. As of March 31, 2017, cash, cash equivalents and investments totaled $257.2 million.

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"In the first quarter of 2017, we advanced our novel muscle biology-directed programs through important late-stage clinical trial milestones. In particular, the last patients enrolled in VITALITY-ALS moved through their primary efficacy endpoint visits towards the conclusion of the Phase 3 trial and we look forward to results expected later this year," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "We also made key progress with Astellas in the expansion of our clinical trials programs for CK-2127107, opening enrollment for Cohort 2 in our ongoing Phase 2 trial in adolescent and adult patients living with spinal muscular atrophy, and preparing to start additional trials in patients with ALS and elderly subjects with limited mobility."

Recent Highlights and Upcoming Milestones

Skeletal Muscle Program

tirasemtiv

Convened the third Data Monitoring Committee Meeting for VITALITY-ALS (Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS); the Committee recommended the continuation of VITALITY-ALS without modification.

Continued conduct of VITALITY-ALS and enrollment in VIGOR-ALS (Ventilatory Investigations in Global Open-Label Research in ALS), an open-label extension clinical trial designed to assess the long-term safety and tolerability of tirasemtiv, in patients with ALS who have completed participation in VITALITY-ALS.

Announced the advancement of our research collaboration with Origent Data Sciences to prospectively validate Origent’s computer model designed to predict the course of disease progression using baseline data from VITALITY-ALS. The model is expected to be completed prior to analyzing results of VITALITY-ALS.

Conducted clinical, regulatory, non-clinical and other planning activities intended to support potential regulatory filings and registration of tirasemtiv in North America and Europe.

Engaged Health Technology Assessment organizations to understand payor interests and to inform market access activities in ALS.

Expect to continue to enroll patients who complete VITALITY-ALS into VIGOR-ALS throughout 2017.

Expect results from VITALITY-ALS in Q4 2017.
CK-2127107

Announced pre-clinical data for CK-2127107 showing that this next-generation fast skeletal troponin activator (FSTA) improves muscle function in mouse models of spinal muscular atrophy (SMA). The results were presented at the MDA Scientific Conference in Arlington, VA.

Completed enrollment of Cohort 1 in the Phase 2 clinical trial of CK-2127107 in patients with SMA, conducted by Cytokinetics in collaboration with Astellas; announced that Cohort 2 opened enrollment.

Expect data from the Phase 2 clinical trial of CK-2127107 in patients with SMA in 2H 2017.

Expect Astellas to continue enrollment in a Phase 2 clinical trial of CK-2127107 in patients with COPD in 2017.

Expect Astellas to begin a Phase 1b clinical trial of CK-2127107 in elderly patients with limited mobility in Q2 2017.

Expect to begin a Phase 2 clinical trial of CK-2127107 in patients with ALS in mid-2017.
Cardiac Muscle Program

omecamtiv mecarbil

Announced additional results from COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, showing that omecamtiv mecarbil improved measures of left ventricular myocardial deformation, a marker of myocardial function that has been related to outcomes. These results further support the direct effect of omecamtiv mecarbil to improve myocardial contractile function. The results were presented in a Poster Session at the American College of Cardiology’s 66th Annual Scientific Session (ACC.17) in Washington, D.C.

Continued to activate sites and enroll patients in GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil which is being conducted by Amgen, in collaboration with Cytokinetics.

Expect data from a Phase 2 clinical trial of omecamtiv mecarbil in Japanese patients with chronic heart failure in Q3 2017.

Expect continued enrollment of patients with chronic heart failure in GALACTIC-HF throughout 2017.
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

Agreed to sell to Royalty Pharma a 4.5% royalty on potential worldwide sales of omecamtiv mecarbil for $90 million and $10 million of Cytokinetics common stock.

Agreed to exercise an option under our collaboration agreement with Amgen to co-invest $40 million in the Phase 3 development program of omecamtiv mecarbil. As a result, Cytokinetics is eligible to receive an incremental royalty of up to 4% on increasing worldwide sales of omecamtiv mecarbil outside of Japan. Exercising our option and co-funding affords Cytokinetics the right to co-promote omecamtiv mecarbil in institutional care settings in North America, with reimbursement by Amgen for certain sales force activities.

Joined the global initiative with 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.
Financials

Revenues for the first quarter of 2017 were $4.2 million, compared to $8.4 million during the same period in 2016. Revenues for the first quarter of 2017 included $2.7 million of research and development revenues and $1.4 million of license revenues from our collaboration with Astellas, $0.9 million in research and development revenues from our collaboration with Amgen, and $0.3 million in research and development revenues from our collaboration with The ALS Association. Revenues from our collaboration with Amgen were offset by a payment of $1.3 million to Amgen related to the option to co-fund the Phase 3 development program of omecamtiv mecarbil in exchange for an increased royalty upon potential commercialization. Revenues for the same period in 2016 were comprised of $4.0 million of license revenues and $3.7 million of research and development revenues from our collaboration with Astellas, and $0.6 million of research and development revenues from our collaboration with Amgen.

Total research and development (R&D) expenses for the first quarter of 2017 were $19.3 million, compared to $13.5 million for the same period in 2016. The $5.8 million increase in R&D expenses for the first quarter of 2017, compared with the same period in 2016, was primarily due to an increase of $2.5 million in outsourced clinical costs mainly associated with VITALITY-ALS, our ongoing Phase 3 trial of tirasemtiv, $1.4 million in outsourced research and pre-clinical costs mainly associated with clinical manufacturing activities, $1.3 million in personnel related expenses due to increased headcount costs, and $0.2 million in laboratory expenses.

Total general and administrative (G&A) expenses for the first quarter of 2017 were $8.1 million compared to $6.8 million for the same period in 2016. The $1.3 million increases in G&A expenses for the first quarter of 2017, compared to the same period in 2016, was primarily due to an increase of $0.7 million in personnel-related expenses due to increased headcount and non-cash stock compensation expense and $0.8 million in outsourced costs primarily related to commercial development, partially offset by a decrease in corporate legal fees of $0.5 million.