Main remarks from Cytokinetics Inc. (Nasdaq: CYTK) last PRs and quarterly results are:
- Data from the phase II trial of ‘357 in myasthenia gravis are delayed until 1H of 2012.
- Amgen (Nasdaq: AMGN) is continuing the development of Omecamtiv mercabil (OM) in its phase IIb safety and efficacy trial, now dubbed ATOMIC-AHF. Remember that top-line data won’t be released until 1H 2013.
- Cytokinetics is collecting data from a Part A study of its phase II PK, PD, multiple dose, safety and tolerability trial of ‘357 in patients with ALS who are not getting riluzole. Data will be presented at the 22nd International Symposium on ALS and Motor Neurone Diseases Meeting in Sydney, Australia on November 30 – December 2. It initiated a Part B in patients who are also receiving riluzole on Nov 1 with results expected in 1H of 2012
- Cytokinetics has $57.6m cash on hand and has cut down on spending following a restructuring of the company in order to focus primarily on the development of ‘357 and OM
The most likely short term scenario is that the stock continues moving in the $1-$1.5 range, as there are no important catalysts until next year. It used to trade at a higher valuation not so long ago, but funds dumped a considerable amount of shares in the last few months.
It will be interesting to see how the stock moves in anticipation of the data release from the pII trial in myasthenia gravis. Although it’s a small indication in commercial terms, other companies have moved higher lately. In September Alexión reported positive results from a small 14 patient cohort of mAb Soliris that resulted in a clinical benefit over placebo. Also, keep an eye on the ALS PhI trials, previous results suggested a synergistic effect of ‘357 in plasma concentrations of riluzole.
Once its clinical pipeline advances further, Cytokinetics might be positioned as a good candidate for a buyout. Check my previous story on Cytokinetics to get a more complete overview on the company and its development programs.
Disclosure: I´m long Cytokinetics.
Additional resources: the papers published this year on The Lancet Aug 2011 Vol 378 are worth a read to gain insight on OM’s mechanism of action and efficacy results from a Phase 2 clinical trial of OM in patients with heart failure.