OncoGenex Pharmaceuticals, Inc. (OGXI) reported second quarter 2013 net loss per share of 57 cents, narrower than the Zacks Consensus Estimate of a loss of 68 cents but wider than the year-ago loss of 29 cents per share.
Second quarter 2013 revenues were $6.3 million, compared with $2.4 million in the year-ago quarter. Revenues were just above the Zacks Consensus Estimate of $6 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 109.7% year over year to $13.3 million. General and administrative expenses at OncoGenex also grew 20.8% year over year to $2.5 million in the second quarter 2013.
OncoGenex’ operating expenses increased due to patient enrollment activities in the AFFINITY and Borealis-1 studies, higher costs relating to increase in patient enrollment, increased headcount to support clinical development activities and preclinical expenses of apatorsen.
OncoGenex is currently conducting the phase III AFFINITY study to evaluate the overall survival benefit of custirsen plus Jevtana (cabazitaxel) as second-line chemotherapy in men with metastatic castrate-resistant prostate cancer (: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.
For both these studies, patient enrollment is ongoing.
SYNERGY, a phase III study on custirsen, is designed to evaluate the survival benefit of the candidate, in combination with first-line Taxotere chemotherapy, in men with metastatic CRPC. Results are expected in mid - 2014.
Cedar is the seventh phase II study being conducted with oncology candidate, apatorsen (OGX-427) after Borealis-1 (results due in the second half of 2014), Borealis-2 (patient enrolment ongoing), Pacific (patient enrolment ongoing), Spruce (patient enrolment ongoing), OGX-427-PR01 and Rainier (patient enrolment to commence shortly). The Cedar study will evaluate apatorsen in previously untreated patients suffering from advanced squamous cell lung cancer. This study will enroll around 140 patients.
OncoGenex maintained its earlier guidance of cash, cash equivalents and investments in the rangeof $25–$35 million as on Dec 31, 2013. Additionally, net cash requirements are estimated in the range of $40–$50 million for the year.
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