conference date: April 23, 2015 @ 8:00 AM Pacific Time
for quarter ending: March 31, 2015 (Q1, first quarter 2015)
Overview: Agenus continued to develop its pipeline candidates and enroll partners, with the Incyte deal in Q1 as the most resent example.
Basic data (GAAP):
Revenue was $4.0 million, up sequentially from $1.6 million and up from $0.7 million year-earlier.
Net income was negative $18.7 million, down sequentially from negative $26.0 million, and down from negative $0.4 million year-earlier.
Earnings per share (EPS) were negative $0.28, down sequentially from negative $0.41, and improved from negative $0.01 year-earlier.
In the quarter Agenus formed a collaboration with Incyte to develop cancer CPMs (checkpoint modulators). Agenus received a $60 million upfront payment including a $35 million equity investment by Incyte. Initial focus is on GITR, OX40, LAG-3, and TIM-3. Agenus and Incyte will share development costs and profits for GITR and OX40. Incyte will fund LAG-3 and TIM-3, and Agenus will be eligible for royalties if the programs are successful.
Agenus bought Celexion's SECANT yeast display platform to create novel, full-length human antibodies, and other related Celexion biotechnology.
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.
In December Agenus reported that partner GlaxoSmithKline's Phase 3 shingles trial, which had SQ-21 Stimulon as a component, reported "remarkably" positive results, a 97% reduction in risk of shingles. Full results will be published and presented later this year. Royalty payments are potentially significant.
In 2015 Agenus hopes to advance Prophage for GBM (glioblastoma, a brain cancer) into a Phase 3 trial, following the official publication of Phase 2 data and discussions with the FDA about trial design and endpoints. There is heightened interest in Prophage from potential partners due to the increasing belief that vaccines may be combined with CPMs to increase effectiveness.
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 $9.2 million. General and administrative expense was $5.5 million. Contingent fair-value adjustment of $7.5 million. Leaving operating income at negative $18.7 million. Other expense was near zero.
Included in GAAP net income was $7.5 million in non-cash charges.
Cash and equivalents balance ended at $79.3 million, sequentially from $40.2 million due to the Incyte payment and investment. Cash burn in the quarter was $10.7 million.
Agenus believes it has sufficient cash to fund operations through mid-2016.
Agenus continues to explore possibly working with new licensing partners for QS-21.
On May 14, 2015 Agenus will hold its R&D analyst day.
Prophage thoughts on partnering? We are looking at all options. There is a high level of commitment to take Prophage into Phase 3. There should be an update within a few months. We could do some pilot work with CPMs that are already approved, or with our own CPMs.
SECANT platform benefits? It is a yeast-based display platform using full length antibodies that can easily separated from the yeast. Our own platform displays on mammal cells, and requires more time to separate the antibodies, but produces superior antibodies. So we can do rapid probing with SECANT and then optimize on Retrocyte display.
In addition to the 6 programs that we have discussed with the public, we have a half-dozen CPMs that we have developed but not announced.
We are looking at a multiple myeloma vaccine using techniques similar to what we used for Prophage.
Will the data you present on Prophage include immune response stratification data? On May 13 the ASCO embargo will be lifted on Prophage. There will be data released on the interplay between immune data and the status of patients. We believe there is an approach to stratification that would help us design a successful trial.
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