On November 12, 2015 OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) reported third quarter 2015 financial results and provided a summary of clinical developments and anticipated milestones (Press release, OncoGenex Pharmaceuticals, NOV 12, 2015, View Source [SID:1234508223]).
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Clinical Developments and Anticipated Near-term Milestones
Custirsen – Phase 3 Prostate Cancer Trials
On September 27, 2015, OncoGenex announced results from additional exploratory analyses of the Phase 3 SYNERGY trial demonstrating that custirsen treatment significantly lowered serum clusterin (sCLU) levels from baseline in men with metastatic castrate-resistant prostate cancer (mCRPC). In addition, these data presented at the 2015 European Cancer Congress (ECC 2015) in Vienna showed that sCLU reductions after custirsen treatment resulted in higher two-year survival rates in patients who were at increased risk for poor outcomes. Of those patients with lower sCLU levels, the data also showed a correlation to an overall survival benefit for custirsen-treated patients who were at increased risk for poor outcomes.
On October 8, 2015, OncoGenex announced that the European Medicines Agency (EMA) completed its review of the proposed amendment to the company’s Phase 3 AFFINITY protocol and statistical analysis plan. Both the U.S. Food and Drug Administration (FDA) and the EMA have now completed their reviews and are supportive of the proposed amendment to the AFFINITY protocol and statistical analysis plan.
Final results from the first of two analyses of the custirsen Phase 3 AFFINITY trial are expected by the end of this year. The first of these two analyses will determine the ability of custirsen to extend survival in a subgroup of men who are at increased risk for poor outcomes. This group is comprised of men having two or more of five common clinical features, including poor performance status, elevated prostate-specific antigen (PSA), elevated lactate dehydrogenase (LDH), decreased hemoglobin, and the presence of liver metastasis. If the final analysis shows efficacy in this subgroup, OncoGenex would proceed with discussions with the FDA and a new drug application filing.
At the same time as the final analysis for the subgroup, interim analyses for both futility and efficacy is scheduled to occur in the intent to treat, or entire patient population, of the AFFINITY trial. If this interim analysis shows early efficacy, OncoGenex would proceed with an NDA filing for the entire trial population. If the early efficacy interim analysis does not show a highly significant difference, the study will continue as planned with final results are expected in the second half of 2016.
Apatorsen – Phase 2 Bladder, Lung Cancer Trials
On September 27, 2015, the company announced additional analyses from the Borealis-1 trial for its other lead product candidate, apatorsen. The results confirmed that patients with advanced bladder cancer at increased risk for poor outcomes had increased baseline levels of both circulating tumor cells (CTC) and serum heat shock protein 27 (Hsp27). The study showed that baseline Hsp27 and CTC levels were additional risk factors for survival outcomes. These results were presented at ECC 2015 and have been accepted for oral presentation at the upcoming 7th European Multidisciplinary Meeting on Urological Cancers (EMUC 2015).
On September 30, 2015, the company announced that Borealis-2, an investigator-sponsored, randomized Phase 2 trial, met its target enrollment of 200 patients. The trial is designed to evaluate apatorsen in combination with docetaxel in patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy. Borealis-2 is sponsored by Hoosier Cancer Research Network and being conducted at 27 sites across the United States. Results are expected in 2016.
Primary progression-free survival (PFS) results from the Spruce trial are expected in the first quarter of 2016, with continued survival follow up expected later next year. The Spruce trial is an investigator-sponsored, randomized, placebo-controlled Phase 2 trial designed to determine if adding apatorsen to carboplatin and pemetrexed therapy can extend PFS outcome in patients with previously untreated advanced non-squamous NSCLC.
"This is a pivotal time in the company’s history with results expected by the end of this year from the first of two custirsen Phase 3 AFFINITY trial final analyses. We look forward to this important milestone," said Scott Cormack, President and CEO of OncoGenex. "We anticipate additional milestones throughout 2016 including final survival analysis of all patients from the AFFINITY study and possible ENSPIRIT lung cancer results, as well as several upcoming Phase 2 data readouts in our apatorsen program."
Financial Update and Results
As of September 30, 2015, our cash, cash equivalents and short-term investments increased to $65.9 million from $47.1 million as of December 31, 2014.
Based on our current expectations, we believe that our cash, cash equivalents, and short-term investments will be sufficient to fund our currently planned operations into the first quarter of 2017, which may include:
announcing AFFINITY trial results, including final results of the poor prognosis subpopulation by the end of 2015 and final analysis for the ITT population in the second half of 2016, depending on timing of the event-driven final analysis;
announcing ENSPIRIT trial results, which could be available in the second half of 2016;
announcing Spruce trial results for the primary PFS endpoint in the first quarter of 2016;
announcing Borealis-2 trial results in 2016;
completing enrollment in the Pacific trial; and,
continuing enrollment in the Spruce-2 trial, formerly referred to as the Cedar Trial
Revenue for the three months ended September 30, 2015 increased to $6.7 million from $4.8 million for the three months ended September 30, 2014. Revenue for the nine months ended September 30, 2015 decreased to $12.1 million from $21.5 million for the nine months ended September 30, 2014.
Total operating expenses for the three and nine months ended September 30, 2015 were $11.4 million and $27.4 million, respectively, compared to $12.0 million and $44.3 million for the three and nine months ended September 30, 2014, respectively.
Net loss for the three and nine months ended September 30, 2015 was $4.6 million, or $0.16 per diluted common share, and $15.1 million, or $0.60 per diluted common share, respectively, compared with $4.9 million, or $0.23 per diluted common share, and $20.6 million, or $1.21 per diluted common share for the three and nine months ended September 30, 2014, respectively.
As of November 12, 2015, OncoGenex had 29,804,273 shares outstanding.