On August 3, 2017 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies and cancer vaccines, provided a corporate update and reported financial results for the second quarter ended June 30, 2017 (Press release, Agenus, AUG 3, 2017, View Source [SID1234520012]). Schedule your 30 min Free 1stOncology Demo! "In the second quarter, we advanced our anti-CTLA-4 and anti-PD-1 antibodies in preparation for initiating combination trials in the second half of this year. We also produced GMP grade product in our facilities in Berkeley and selected a commercial supplier for our lead antibodies. In addition, our partnering efforts are maturing and we expect to close on several transactions in the second half of this year," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "We are committed to our path of generating potential first-in-class and best-in-class immuno-oncology agents, and doing so with speed, quality and efficiency."
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Anticipated Milestones for H2 2017:
AGEN1884 (anti-CTLA-4) Phase 1 trial: complete dose-escalation and compile safety and pharmacodynamic data
AGEN2034 (anti-PD-1) Phase 1/2 trial:
Complete dose-escalation for monotherapy, define optimal combination dose and collect safety and receptor occupancy data
Recruit patients with second line cervical cancer
AGEN1884+AGEN2034 Phase 1b trial: commence combination trial
AutoSynVax (neoantigen vaccine): immunological readouts expected in patients with advanced malignancies
Advance our cell therapy spin off efforts
Secure substantial funds from existing agreements and future transactions
Recent Highlights:
AGEN1884 interim data presented at ASCO (Free ASCO Whitepaper):
Safe at doses up to 3 mg/kg
Partial response in a patient with angiosarcoma with 92% reduction in tumor burden at 0.1 mg/kg dose (since ASCO (Free ASCO Whitepaper) this patient has experienced a complete response)
QS-21 Stimulon update:
GSK’s shingles vaccine containing Agenus’ QS-21 Stimulon adjuvant showed strong immunogenicity in patients previously treated with standard of care (Merck’s Zostavax)
U.S. regulatory approval of Shingrix is anticipated in Q4
Manufacturing readiness:
Agenus West successful GMP production of AGEN2034 at 1,000L scale
Selection of CMOs for production of commercial grade material for planned registrational trials
Second Quarter 2017 Financial Results
Cash, cash equivalents and short-term investments were $96.8 million at June 30, 2017 compared to $76.4 million as of December 31, 2016.
For the six months ended June 30, 2017, Agenus reported a net loss of $48.8 million, or $0.51 per share, compared with a net loss for the same period in 2016 of $60.1 million or $0.69 per share. The decrease in net loss for the six months ended June 30, 2017, compared to the net loss for the same period in 2016, was primarily due to the accelerated milestone payment received from Incyte during the first quarter of 2017. Our operating expenses increased $9.2 million over the same period in 2016.
For the second quarter ended June 30, 2017, Agenus reported a net loss of $31.7 million, or $0.32 per share, compared with a net loss for the second quarter of 2016 of $28.3 million, or $0.33 per share. The increase in net loss for the three months ended June 30, 2017, compared to the net loss for the same period in 2016, was primarily due to the later stage advancement of our programs.