Expert Financial Analysis and Reporting

Investment Thesis in Brief By the end of 2015, Cytokinetics (CYTK) will have tirasemtiv in a phase 3 trial in ALS and might also have omecamtiv in a phase 3 trial in heart failure. There is no financing overhang as the Company has $118 million of cash which can last for over 20 months. This […]

SmithOnStocks Mailbox April 28, 2015 A Quick Take on Recent Events If you have a question for the mailbox, contact me. Purpose of this Note I have written extensively on Antares, Agenus, Cytokinetics and Discovery Laboratories. I have Buys on Antares, Agenus and Cytokinetics. I have a Hold on Discovery (what a troubled history), but […]

Investment Overview I have listened to management presentations at recent brokerage conferences and have then followed up with questions. There are two important, potentially stock moving events that I see for 2015. The most important information from a data standpoint will be the phase 2b results of the COSMIC-HF trial of the oral dosage form […]

Catalysts for 2015 During the conference call on February 12, 2015 discussing 4Q, 2014 results Cytokinetics discussed key catalysts for 2015 which are as follows: A phase 3 trial of tirasemtiv in patients with ALS will start in 2Q, 2015 Cytokinetics expects enrollment of patients in the expansion phase of COSMIC-HF to conclude in this […]

The BIO CEO Conference is being held in New York at the Waldorf Astoria on February 9 and 10 with a broad agenda of companies. You can go the websites of each company to hear their presentations. This note gives some highlights from the first day. Northwest Biotherapeutics; A paper discussing results from the phase […]

Cytokinetics held a conference call on January 5th in which they added some detail on the collaboration with Astellas on CK-107 for the first indication of spinal muscular atrophy. I discussed this collaboration in a note on December 24, 2014 and you may want to read that note for more background. The Company provided some additional […]

The strength followed the announcement of a new collaboration agreement with Astellas on CYTK’s unique skeletal muscle activators program This added an important third product to CYTK’s portfolio of products in advanced human trials We may hear on a scheduled January 5 conference call if there is a path forward for a phase 3 trial […]

This deal adds a third leg to the development pipeline at Cytokinetics along with omecamtiv for congestive heart failure and tirasemtiv for ALS. My Buy recommendation has been based on the possibility that tirasemtiv will begin a phase 3 in ALS in 2015. Investors had written this product off after a phase 2b disappointment. This […]

Investment Thinking Cytokinetics could announce the decision on whether it will advance tirasemtiv into a pivotal phase 3 trial by the end of 2014. In my opinion, management will only make this decision if the FDA agrees under a Special Protocol Assessment that a new primary endpoint of slow vital capacity, SVC, can be used. […]

Cytokinetics (CYTK) has announced   that it is planning a phase 3 trial for tirasemtiv using sustained vital capacity-SVC- as a primary endpoint. The new trial could begin in 2015, but the gating factor almost certainly will be whether the FDA agrees to a Special Protocol Assessment- SPA- in which the agency agrees that SVC […]