OncoGenex Pharmaceuticals, Inc. reported first quarter 2013 net loss per share of 46 cents, narrower than the Zacks Consensus Estimate of a loss of 68 cents and the year-ago loss of 67 cents per share.
First quarter 2013 revenues were $5.1 million, compared with $1.3 million in the year-ago quarter. Revenues barely beat the Zacks Consensus Estimate of $5 million. Revenues comprised solely of collaboration revenues.
The year-over-year increase in revenues was driven by the company’s agreement with Teva Pharmaceutical Industries Ltd. (TEVA - Analyst Report) for development activities associated with the AFFINITY study being conducted with oncology candidate, custirsen.
In the reported quarter, OncoGenex’s research and development expenses increased 113.6% year over year to $10.9 million. General and administrative expenses at OncoGenex grew 43.9% year over year to $2.5 million in the first quarter 2013.
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 Sanofi’sTaxotere 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 the first half of 2014.
Rainier is the sixth phase II study being conducted with OGX-427 after Borealis-1, Borealis-2, Pacific, Spruce and OGX-427-PR01. Rainier will evaluate the survival benefit of adding OGX-427 to Abraxane plus Gemzar in previously untreated metastatic pancreatic cancer patients. Patient enrollment is expected to begin in mid-2013.
The Borealis-1 study is designed to evaluate the survival benefit, safety and tolerability of combining OGX-427 with gemcitabine and cisplatin in the first-line treatment of patients with advanced bladder cancer. OncoGenex expects to complete patient enrolment in the second half of 2013.
The Borealis-2 study is being conducted in patients suffering from advanced or metastatic bladder cancer whose disease has progressed following initial platinum-based chemotherapy treatment.
The Pacific study is evaluating the benefit of OGX-427 plus Zytiga in men with CRPC. It is currently enrolling patients.
The Spruce study is being conducted for the treatment of previously untreated advanced non-squamous non-small cell lung cancer (NSCLC) patients. Patient enrollment is expected to begin in mid-2013. OGX-427-PR01 is evaluating the benefit of OGX-427 plus prednisone in CRPC 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 expected in the range of $40–$50 million for the year.
OncoGenex and Teva currently carry a Zacks Rank #3 (Hold). Currently, companies like Lannett Company, Inc. (LCI - Snapshot Report) and Catalyst Pharmaceutical Partners Inc. (CPRX - Analyst Report) look more attractive with a Zacks Rank #1 (Strong Buy).