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 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. […]

Investment Thesis In listening carefully to Cytokinetics’ (CYTK) comments over the last three months, I am convinced that the Company will consult with the FDA and EMEA about the design of a new phase 3 trial of tirasemtiv in ALS. They will ask for approval to use the respiratory measure of sustained vital capacity (SVC) […]

I think that there is a strong possibility that Cytokinetics (to the surprise of Wall Street) could announce sometime in coming months that it will undertake a phase 3 registrational trial for tirasemtiv in ALS. After tirasemtiv failed to reach the primary endpoint of ALSFRS-r in the phase 2 BENEFIT-ALS trial, the stock crashed and […]

Overview Cytokinetics held a conference call on the results of the BENEFIT-ALS trial on the morning of April 30. The Company announced on April 25, that the trial had failed to meet its primary endpoint of change in ALSFRS-r and that results on secondary endpoints were mixed. Based on this, investors concluded that tirasemtiv was […]