Garo Armen
Analyst · JMP Securities. Your line is open
Thank you, Michelle, and thank you all for joining us this morning. In 2015, we reached a number of important milestones in pursuit of our mission of curing cancer with immuno-oncology treatments. We started the year entering into a global oncology collaboration with Incyte Corporation. We extended our existing oncology collaboration with Merck. We made several strategic acquisitions, advanced our pre-clinical programs, leading up to the successful filings of two INDs for checkpoint modulator programs; make progress with our lead clinical vaccine program, and also very importantly, substantially strengthened our balance sheet closing the year with $172 million in cash. In 2015, we made a series of strategic acquisitions that helped us build a vertically integrated company with an internal engine that enables us to rapidly discover and optimize antibody candidates, develop best-in-class cell line and to manufacture our own immunotherapies faster, more cost effectively and under GMP conditions. Our greatest asset, however, is our intellectual capital, comprised of an exceptional team of immunologist, molecular biologist, translational biologist, computational chemists, and structural chemists. We believe a multi-disciplinary approach is critical because the future of cancer therapy will be based on the ability to identify subpopulations of patients that are likely to best respond to specific immuno-oncology agents or combinations of agents. This will also require a wider use of biomarkers to determine the best combinations of immuno-oncology treatments including antibodies, vaccines, and adjuvants, as well as cell therapy. At Agenus, we believe that we are uniquely positioned in the immuno-oncology landscape by having assembled the critical parts for what we would consider the future of the immuno-oncology ecosystem. I’m now going to briefly expand on several of our corporate achievements during the quarter and the year. And then Dr. Robert Stein, our President of R&D, will provide an update on our clinical and pre-clinical development activity. As I mentioned earlier, we began last year with an alliance with Incyte Corporation to discover and develop novel antibodies using Agenus’s state-of-the-art discovery platforms. The alliance focuses initially on the development of checkpoint modulator antibodies directed against four key immune checkpoint targets: GITR, OX40, LAG-3 and TIM-3. Agenus and Incyte share all costs and profits for the GITR and OX40 antibody programs on a 50:50 basis with Agenus eligible for milestones. TIM-3 and LAG-3 are royalty bearing programs to be funded by Incyte entirely with Agenus eligible for milestones and royalties. Agenus received $60 million upfront payment comprised of $25 million in technology and program access fee, plus $35 million in equity investment. We are eligible to receive up to $350 million in development, regulatory, and commercial milestones for the four lead programs. During 2015, we made considerable progress in our work with Incyte and are very pleased that we’ve expanded our alliance later in the year to include three additional undisclosed checkpoint targets. Dr. Stein will provide further updates on the progress we’ve made with Incyte later on, including the first successful IND filing and the FDA clearance of the first immuno-oncology candidate under this alliance. In addition, we are also very pleased to start 2016 with the clearance by the U.S. Food and Drug Administration of our investigation of new drug application for AGEN1884, an antibody that binds to the clinically and commercially validated immune checkpoint targets CTLA-4. We own the rights to our CTLA-4 antagonist. Last summer, our academic collaborators at Northwestern University, led by Dr. Orin Bloch, presented updated positive results from the Phase 2 study of our autologous cancer vaccine, Prophage. This was done at an oral session at ASCO. The results showed that the newly diagnosed glioblastoma patients, treated with Prophage plus standard of care, experienced substantially longer progression-free survival and median overall survival compared to historical controls alone. Among our plans for the year or to start well-controlled randomized trials in GBM, including studies for Prophage in combination with SCPM or checkpoint modulator in GBM. Dr. Stein will elaborate on our plans for Prophage later on in this call as well. On the financial front, in 2015, we significantly strengthened our cash position through our partnership with Incyte, a public stock offering and a non-dilutive royalty transaction. Together these transactions highlight our ability to execute on a variety of financial opportunities. The capital provides financial flexibility to advance our proprietary and partnered pipeline programs and also allowed us to make value enhancing strategic acquisitions, which put us in a very unique position with the opportunity to pursue our objectives with greater flexibility, speed, and efficiency. The non-dilutive royalty transaction with the investor group led by Oberland Capital Management wrote in $100 million of non-dilutive capital under this agreement, the investor group Oberland Capital obtained the right to received 100% of Agenus’s rights to the worldwide royalties on sales of GlaxoSmithKline’s shingles and malaria prophylactic vaccines that contain QS-21 adjuvant. This financing also allows us to retain any upside from the vaccine royalties remaining after the Oberland returns are satisfied. We expect our partner GSK to submit an application for regulatory approval of the shingles vaccine in the second half of this year. In May of 2015, we also raised approximately $75 million through the sale of common stock in a public offering led by Jefferies and William Blair and with joint book-running managers led by Oppenheimer acting as co-manager. In two 2015, we made several strategic technology acquisitions. Through these acquisitions, we’ve built a state-of-the-art engine for sustainable innovation. I want to highlight two important acquisitions that I believe could bring us both short-term and long-term benefits. Late in the year, we acquired a closely held private biotech company called PhosImmune, expanding our vaccine approach to cancer neoantigens. Neoantigens represents an important new field of research for cancer vaccines. PhosImmune discovered an extensive novel portfolio of cancer neoantigens based on aberrant phosphorylation of proteins. Our acquisition of PhosImmune provides us with the unique potential to accelerate the development of novel off the shelf and personalized cancer vaccines based on immunogenic phosphopeptide and also may synergize with our AutoSynVax vaccine platform for targeting mutation-based patient-specific tumor neoantigens. I would also like to highlight briefly our acquisition of an antibody pilot production facility from XOMA Corporation. This pilot plant will enable Agenus to meet its growing GMP antibody production requirements for clinical development through proof-of-concept studies. The facility should reduce our dependence on outside contract manufacturing organizations. These advantages should be especially significant in light of the fact that we have one of the deepest and broadest portfolios of antibody drug candidates in the immuno-oncology’s subsector of the biotechnology industry. Finally, we continue to strengthen our management and scientific teams. In addition to bringing our Board key scientific talents through the year some of whom you’ve heard from our two Analyst Day events last year. We appointed Evan Ballantyne, as the company’s Chief Financial Officer. Evan brings more than three decades of financial and operational experience to Agenus having been CFO of Synthetic Biologics of Clinical Data Inc among other leadership role. With that, I will return the call to Bob Stein, President of R&D, for an update on our clinical and pre-clinical programs and I will come back to give some closing remarks. Bob?