OncoGenex Pharmaceuticals, Inc. (OGXI) reported a loss of 68 cents per share in the third quarter of 2013, narrower than the Zacks Consensus Estimate of a loss of 69 cents but wider than the year-ago loss of 40 cents per share.
Third quarter 2013 revenues were $9.9 million, compared with $6.6 million in the year-ago quarter. Revenues were above the Zacks Consensus Estimate of $7 million. OncoGenex’ revenues comprised solely of collaboration revenues.
The year-over-year increase in revenues was driven by OncoGenex’ agreement with Teva Pharmaceutical Industries Ltd. (TEVA) for development activities associated with the AFFINITY study being conducted on oncology candidate, custirsen.
In the reported quarter, OncoGenex’ research and development expenses increased 39.6% year over year to $18 million. General and administrative expenses at OncoGenex also grew 25.9% year over year to $2.5 million in the third quarter of 2013.
The increase in OncoGenex’ operating expenses reflected patient enrollment and treatment in the AFFINITY and Borealis-1 studies, higher costs relating to investigator-sponsored studies, increased headcount to support clinical development activities and toxicology expenses of apatorsen and OGX-225.
The much talked about SYNERGY trial is ongoing with a planned interim analysis yet to take place. SYNERGY, a phase III study on custirsen, is evaluating the survival benefit of the candidate, in combination with first-line Taxotere, in men with metastatic castrate-resistant prostate cancer (:CRPC). Final results are expected by mid 2014.
OncoGenex is also conducting the phase III AFFINITY study to evaluate the overall survival benefit of custirsen plus Jevtana as second-line chemotherapy in men with metastatic CRPC.
Custirsen is in another phase III study – ENSPIRIT – which is being conducted in patients with advanced or metastatic non-small cell lung cancer (:NSCLC). The study will evaluate the potential survival benefit of custirsen plus Taxotere as second-line chemotherapy.
Apart from custirsen updates, OncoGenex provided information on phase II studies being conducted with oncology candidate, apatorsen (OGX-427). In Jul 2013, OncoGenex finished enrolling patients for the Borealis-1 study, which is being conducted to evaluate the survival benefit, safety and tolerability of OGX-427 plus Eli Lilly & Company’s (LLY) Gemzar and cisplatin for the treatment of patients with advanced bladder cancer. Data from the Borealis-1 study is expected in the second half of 2014. Patient enrolment is in progress for the Borealis-2 study, being conducted in patients suffering from advanced or metastatic bladder cancer whose disease has progressed following initial platinum-based chemotherapy treatment.
2013 Guidance Updated
The company now expects to end the year with cash, cash equivalents and investments at the lower end of its previous guidance of $25–$35 million. Additionally, net cash requirements are now expected at the higher end of the previously provided guidance of $40–$50 million.
OncoGenex carries a Zacks Rank #3 (Hold). Currently, Actelion Ltd. (ALIOF) looks well-positioned with a Zacks Rank #1 (Strong Buy).