OncoGenex Pharmaceuticals, Inc. (OGXI) 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) 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) and Catalyst Pharmaceutical Partners Inc. (CPRX) look more attractive with a Zacks Rank #1 (Strong Buy).
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