conference date: March 3, 2016 @ 8:00 AM Pacific Time
for quarter ending: December 31, 2015 (Q4, fourth quarter 2015)
Overview: Continues to make progress with pipeline, including moving preclinical therapies into clinical trials.
Basic data (GAAP):
Revenue was $7.6 million, up sequentially from $6.8 million and from $1.6 million year-earlier.
Net income was negative $15.7 million, down sequentially from negative $13.1 million, and down from negative $26.0 million year-earlier.
Earnings per share (EPS) were negative $0.18, down sequentially from negative $0.16, and improved from negative $0.41 year-earlier.
No financial guidance.
In 2015 Agenus completed an infrastructure that can rapidly generate new cancer immuno-therapies.
GlaxoSmithKline (GSK) should be filing for approval of its shingles vaccine, which used Agenus QS-21 stimulon, in the second half of 2016. But Agenus already raised money against the potential royalties.
In the second half of 2016 Agenus hopes to advance Prophage for newly diagnosed GBM (glioblastoma, a brain cancer) into a Phase 3 trial. There is very encouraging long-term survival in a group of patients. Agenus hopes to retain U.S. rights while funding the trial or trials with collaborators. Part of the trial will be in combination with a CPM.
Agenus is creating 2 CPM antibodies for its deal with Merck.
Agenus will start clinical trials for AGEN 1884 some time in the first half 2016. This is an anti-CTLA-4 antibody. An IND was submitted in December and approved in January. Believes has two CTLA competitors in trials already.
With partner Incyte (INCY) will start Phase I trial for INCAGN01876, anti-GITR antibody, in first half of 2016. An IND was submitted in December and approved in January. Has competitors, but believes this is a better GITR antibody than competitors. In six other preclinical programs with Incyte.
Agenus plans to initiate a clinical trial for at least one more CPM in 2016, and possibly for more.
Plans initiation of Phase I trial of first ASV vaccine product candidate in the second half of 2016. The ASV program targets cancer neoantigens with an autologous synthetic vaccine approach. This is based on the PhosImmune acquisition made in December.
In December acquired XOMA's antibody manufacturing pilot plant, which should reduce costs of producing antibodies for clinical trials.
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 $18.0 million. General and administrative expense was $8.5 million. Contingent fair-value adjustment benefit of $0.6 million. Leaving operating income at negative $18.1 million. Other expense was $2.5 million.
Cash and equivalents balance ended at $172 million, down sequentially from $199.1.
Agenus believes it has sufficient cash to fund operations for now. Agenus has no plans to raise cash through equity officerings, for now.
AACR abstract titles for your antibodies, what kind of data might be in the abstracts? They give further biochemical and cellular information, not animal data, but there are details that could show how they might be better than competitors.
Prophage, whose CPMs with? We won't have any data from the trials this year. We will do trials with both existing, marketed products and our own candidates. It would be a formal cooperation with the owner of an existing CPM, if we do that.
Prophage study, will it be a registration study? The first combination study showed synergy last year. We have preliminary evidence to be enthusiastic about combinations. The outcomes of a randomized trial will determine whether or not it trial will be registration. We do not have an SPA with the FDA for this trial.
Your anti-CTLA4, how does it differ from others, side effects? 1884 has an FC segment similar to Yervoy but may be more effective as a single agent, the second is more like the AstraZeneca compound, and may be more suitable in combination regimens.
Anti-GITR differentiation from the Merck molecule? Our molecule is likely to be the third one in clinic. We have compared ours to the competitive compounds and believe there are differences that could give ours an advantage.
Is a milestone payment expected from GSK in the second half? Any payment, including milestones, go to Oberland, up till we have repaid them.
CKM1 molecule? We expect a similar mechanism of action to the Merck compound.
LAG3 program? There are many of these immuno-oncology programs that might be flipped to reduce immune responses and the diseases they cause.
Agenus web site
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