conference date: July 23, 2015 @ 8:00 AM Pacific Time
for quarter ending: June 30, 2015 (Q2, second quarter 2015)
Overview: Agenus continued to develop its pipeline candidates.
Basic data (GAAP):
Revenue was $6.4 million, up sequentially from $4.0 million but down from $31 million year-earlier.
Net income was negative $40.4 million, down sequentially from negative $18.7 million, and down from negative $7.8 million year-earlier.
Earnings per share (EPS) were negative $0.53, down sequentially from negative $0.28, and improved from negative $0.12 year-earlier.
In June had announced a one-year continuation of the partnership with Merck for checkpoint modulators (CPMs). First IND for Incyte should be filed this year, and an IND for an Agenus proprietary CPM.
"In July, Agenus announced the acquisition of novel antibodies targeting Carcinoembryonic Antigen Cell Adhesion Molecule 1 (CEACAM1) from Diatheva s.r.l., an Italian biotech company controlled by SOL S.pA."
In April Agenus had acquired the SECANT yeast display platform for antibodies from Celexion.
Evan Ballantyne was hired as CFO.
A public stock offering raised $74.6 million.
The increase in GAAP net loss was a $20.7 million non-cash charge for fair value adjustments to contingent obligations and a $13.2 million charge for Secant yeast platform.
In 2015 Agenus hopes to advance Prophage for newly diagnosed GBM (glioblastoma, a brain cancer) into a Phase 3 tria later this year. Data was presented at ASCO from the Phase 2 trial. Will have discussions with the FDA about trial design and endpoints. Data showed PFS of 27 months and overall survival of 45 months for a significant subset of patients with low monocyte PD-L1. All patient groups showed significant PFS.
Royalties from the GSK malaria vaccine are likely to be modest. A European regulatory decision is expected in 2015.
Agenus made progress in creating 2 CPM antibodies for its deal with Merck.
Agenus may start clinical trials with its own or Incyte-partnered CPMs some time in early 2016, following IND filings with the FDA.
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 $24.8 million. General and administrative expense was $8.0 million. Contingent fair-value adjustment of $6.8 million. Leaving operating income at negative $33.2 million. Other expense was $7.2 million.
Cash and equivalents balance ended at $139.6 million, up sequentially from $79.3 million. This reflects the raising of $74.6 million from the recent common stock offering.
Agenus believes it has sufficient cash to fund operations through mid-2016.
CEACAM-1 product milestone and royalties? Cannot provide those details yet, but are close to industry standards. This is a target where we expect to see additional exciting developments going forward.
CEACAM-1 competition? We expect the field to get increasingly competitive. We think our opportunity was the best we could acquire at this time. One rival antibody is at the very early stage of clinical development.
We still expect the Phase 3 Prophage Glioblastoma trial to be funded by a partner. The process is on track.
Non-cash expenses in the quarter? Net cash burn was $23.6 million for 6 months.
GSK vaccine timeline? GSK expects an EMA decision on malaria this year. WHO also has to approve it, then the individual African countries. That process will take some time.
The shingles trial showed strong efficacy. GSK expects to file next year.
The newly-diagnosed glioblastoma trial will take all comers, but will be stratisfied by PDL-1 levels. Good assays are currently available.
CEACAM-1 is broadly expressed in cancers, but has an unusual interaction path. [listen to call for considerable science detail]
[More science detail on CPMs]
We are interested in having more partners for our world-class antibody discoveries. We are not interested in just providing a service function.
Level of interest by big pharma in glioblastoma vaccine trial? Intense.
Agenus web site
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