conference date: April 28, 2016 @ 8:00 AM Pacific Time
for quarter ending: March 31, 2016 (Q1, first quarter 2016)
Overview: Continues to make progress with pipeline, including moving preclinical therapies into clinical trials.
Basic data (GAAP):
Revenue was $6.0 million, down sequentially from $7.6 million and up from $4.0 million year-earlier.
Net income was negative $31.8 million, down sequentially from negative $15.7 million, and down from negative $18.8 million year-earlier.
Earnings per share (EPS) were negative $0.37, down sequentially from negative $0.18, and down from negative $0.28 year-earlier.
No financial guidance.
CEO Garo Armen stated "During the remainder of 2016, we expect to begin clinical trials for additional checkpoint antibody candidates. Our plans this year and into next include initiating one or more randomized trials with Prophage™, including combination trials with approved and/or experimental immunotherapeutic agents. Within the next 12 months we also plan to initiate a Phase 1 trial of our AutoSynVax™ or ASV™ vaccine, a synthetic autologous vaccine candidate that targets cancer neoantigens."
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 several CPM antibodies for its deal with Merck, which will decide which ones it wants to take into clinical trials. No timing for the decision is available yet.
Agenus initiated a Phase 1 clinical trial for AGEN 1884 in April 2016. This is an anti-CTLA-4 antibody being tested on solid tumors. Preclinical data was presented at AACR in April (American Association for Cancer Research).
AGEN2041, a distinct CTLA-4 antibody, positive data was also presented at AACR.
With partner Incyte (INCY) will start Phase I trial for INCAGN1876, anti-GITR antibody, in first half of 2016. An IND was submitted in December and approved in January. In April preclinical data was presented at AACR.
Another Incyte partnership, INCAGN1949, an OX40 agonist antibody, also presented positive preclinical data at AACR.
Plans initiation of Phase I trial of first ASV vaccine product candidate in the next twelve months. The ASV program targets cancer neoantigens with an autologous synthetic vaccine approach. This is based on the PhosImmune acquisition made in December.
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 $25.0 million. General and administrative expense was $9.2 million. Contingent fair-value adjustment benefit of $0.3 million. Leaving operating income at negative $28.0 million. Other expense was $3.8 million.
Cash and equivalents balance ended at $148.2 million, down sequentially from $172 million.
Agenus believes it has sufficient cash to fund operations for now. Agenus has no plans to raise cash through equity offerings, for now.
OX40 preclinical work, adverse events in animal models? 1949 does not interact with the murine receptors so it is not possible to assess its actual activity. OX40 agonists in general have been relatively well tolerated in mice. The toxicities we have seen in our IND enabling studies look very manageable. It can help fully activate partially activated cells, but it does not indiscriminately activate. The depletion of T-regs is confined to intratumoral cells, so the likelihood that you will have widespread disregulation is very small.
LAG3 program? That is partnered with Incyte for oncology, we are pleased how it is progressing, but generally don't comment on it. Combinations of PD1 and LAG3 may help patients with deeply exhausted T-cells.
Spending guidance for 2016? We expect to have cash into the middle of 2017. We are on budget, but are spending on getting the checkpoint molecules into the clinic.
Not impressed by some of the AACR data (not AGEN's agents). Will you do more preclinical studies before starting with humans? Part of that is identifying the right patients. Part you can learn from animal models. You need to understand the tumor and the state of the immune system, particularly whether it recognizes the cancer as non-self or not. We believe small studies that are intensely investigated are a good way forward for us.
Your neoantigen id process v. startups? We are the original neoepitope company. We use the tools we developed to identify neoepitopes. PhosImmune acquisition has identified a exciting new class of epitopes of unusual sites of phosphorylation. These can be highly patient relevant without being truly individual to each patient.
Prophage glioblastoma (GBM) program? Will start randomized combination trials along with immunoncology agents. There will be an update in Q3 re a registrational trial. In the Phase 2 trial we are now out to about a 29% four-year survival for the PDL1 subgroup. The Celldex trial suggests that you can put pressure on EGF receptor variant 3, but then have antigen escape. Our approach is very distinct because we have multiple neoepitopes.
We remain confident about the CEACAM1 program.
Some phosphorylation patterns, like in leukemia, have patterns that are non-self, but similar across patients, and therefore a good target.
Data from the new Phase 1 trials? They will start at a low dose and escalate. We hope to get an effective dose as soon as possible. Second half of the year or beyond.
Agenus web site
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