conference date: October 31, 2014 @ 8:00 AM Pacific Time
for quarter ending: September 30, 2014 (Q3, third quarter 2014)
Overview: Little revenue, but reported results from Prophage glioblastoma study while working to advance the pipeline.
Basic data (GAAP):
Revenue was $1.6 million, down sequentially from $3.1 million and up from $.07 million year-earlier.
Net income was negative $8.2 million, down sequentially from negative $7.8 million, and down from negative $7.3 million year-earlier.
Earnings per share (EPS) were negative $0.13, down sequentially from negative $0.12, and improved from negative $0.24 year-earlier.
The focus is now to advance the checkpoint modulator (CPM) programs. Agenus is also looking for partnerships based on the good prior Prophage glioma and HerpV results.
GBM (glioblastoma multiforme, a kind of brain cancer) Phase 2 Prophage vaccine data final results were announced in July. It was an open label, single arm trial. Half the patients lived almost 2 years, compared to 16 months for standard of care alone. 33% of patients were alive at 2 years. Agenus is exploring options to advance the therapy and has had its end-of-study meeting with the FDA.
Agenus made progress in creating 2 CPM antibodies for its deal with Merck, which are separate from Agenus's own 6 CPM programs. Agenus may file to start clinical trials with its CPMs some time in 2015, following IND filings with the FDA.
In the quarter GlaxoSmithKline files for approval, in Europe, for a malaria vaccine that uses an Agenus ingredient, QS-21. Agenus will receive another milestone payment upon regulatory approval.
As a development stage biotechnology company, Agenus is focused on pipeline development, including QS-21 Stimulon, immunotherapy, and heat shock protein vaccines. Along with partners, Agenus has 22 programs in clinical development.
Cost of sales was $0 million. Research and development expense was $5.3 million. General and administrative expense was $54.9 million. Contingent fair-value adjustment benefit of $1.0 million. Leaving operating income at negative $7.7 million. Other expense was $0.4 million.
Cash and equivalents balance ended at $52.9 million, sequentially from $62.8 million.
Agenus believes it has sufficient cash to fund operations through mid-2015.
Agenus continues to explore possibly working with new licensing partners for QS-21. It is also in active discussions with potential partners for its checkpoint antibodies program.
It seems like everyone is pursuing combinations in some form or another. How does Agenus fit into this bigger picture? At what point will larger players want to pick up your clinical assets? It's complicated. We believe combinations will drive the future of immuno-oncology. We have a full portfolio of checkpoint targets to combine, which is why Merck came to us. We evaluate financial and collaboration options, we are exploring a number of them right now. It has been an extremely active area. No one combination will address every need. In addition to cooperating with other companies, it would be powerful if we could control combinations, not just single agents.
The $2 million GSK milestone payment was booked as revenue in Q2 even though the actual cash came in in Q3.
Shouldn't your cash last longer than mid-2015? That is a very conservative number, based on substantially enhanced activity, in case we don't have a collaborator.
How active is BD (business development) in terms of moving GBM forward? Our 2 top priorities are to move our internal programs to the next level of value creation, which would be clinical trials as early as next year. Engaging with the right corporate partnership is also a priority.
What kinds of cancer indications are most attractive for CPMs? Characterizing patients and immune system monitoring are very important to development. It won't be so much by type of tumor because of mutation burden differences. In some tumors, like colorectal and prostate cancer, high tumor burden does not so far correspond to effectiveness.
Are you looking to develop CPMs for autoimmune diseases? Yes, the flip side is to use some to dampen down immune responses. We are interested in exploring that. We are characterizing antibodies to see which diseases they are effective in treating.
Are you working on any other cancer with a Prophage-like vaccine? We take a tumor sample and create a cell-free vaccine to trigger T-cell response. Any tumor that does not respond to CPMs a single agents might benefit from combination with vaccines. To get approval you would need first to do enough monotherapy to show safety.
Does your platform do biomarker identification? We are building our own capabilities. We are way up the learning curve, we can watch how a patient's immune system responds.
Action by the EMA on GSK's malaria vaccine could happen next year.
Agenus web site
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