Karen Valentine - Vice President and General Counsel
Garo Armen - Chairman and CEO
Agenus Inc. (AGEN) Annual Shareholder Meeting June 12, 2013 5:00 PM ET
Good day ladies and gentlemen and welcome to the Agenus Annual Shareholders Meeting Conference Call. As a reminder, today’s conference is being recorded. At this time, I’d like to turn the conference over to Ms. Karen Valentine please go head miss.
Welcome to (inaudible) Vice President and General Counsel (inaudible) Brian Corvese, Tom Dechaene (inaudible). I have (inaudible) a report stating that the holders of the majority of the outstanding shares of common stock of the company are present in person or are represented by proxy at this meeting and accordingly (inaudible) before proceeding with the formal business of the meeting Dr. Garo Armen our Chairman and CEO would like to share his thoughts with us on the past year and key events to come. But first I would like to note that the following presentation will include forward-looking statements (inaudible) subject to (inaudible) cause actual (inaudible) and a slide under (inaudible) quarterly reports on Form (inaudible) for the quarter ended March 31, 2013 with the company previously filed with the SEC.
I will now transition to Dr. Armen.
Thank you for joining us today. When Agenus was founded in 1994 we made the decision to take the road less travelled when it came to developing new therapies for cancer and infectious diseases. Nearly two decades later this road is the focus of attention for having led to the most important class of therapies for cancer patients in modern times. Of course you know I am speaking about the new and exciting immunotherapeutics. While we are not yet perceived as an important beneficiary of this exciting trend I expect that we will soon be. Our technologies are represented in product candidates which are perceived as important advances by specialists in various cancers and infectious diseases these include our QS-21 adjuvant our Prophage vaccines and HerpV vaccine. Some of the treatment areas include brain cancer, lung cancer, melanoma, genital herpes, shingles, malaria and tuberculosis. Being a pioneer is seldom easy through our travels over 20 years and despite many obstacles and some detractors we have strengthened our resolve that immunotherapy will lead the way to a new generation of drugs that will dramatically improve the way patients are treated both in terms of disease outcomes and quality of life, this last item is not trivial, as many years a patient experiences with our treatments reinforces the fact that quality of life is every bit as important as quantity of life. Building on the Heat Shock Protein technology platform we were founded upon we have broadened our exposure to the course of opportunistic transactions such the acquisition of our Aquila Biopharmaceuticals in 2000. This acquisition brought us the QS-21 stimulon adjuvant that is now used in 19 clinical trials, going forward we will continue to seek our strategic assets to broaden our exposure to immunology and cancer treatments.
More recently the exciting clinical data reported at ASCO with several experimental immunotherapeutics across multiple cancers has substantially increased conviction that immunotherapy will play a critical role in the treatment of diseases going forward. On nearly every level through our progress over the last year I believe that Agenus is being positioned to deliver benefit to patients and well deserved value to its shareholders, on this note, very recently, we retired our outstanding 39 million, 8% senior secured convertible notes which would have come due in 2014, our current debt is now 10 million, which is clearly much more manageable.
Last year we were able to significantly increase our cash position with non-dilutive sources such as the expanded agreement with GSK and the sale of a non-strategic asset, this year we continue to work on non-dilutive opportunities to raise additional cash.
On the clinical front we made significant progress with our internal programs and our partners have advanced their lead programs such that they expect pivotal Phase 3 data readouts within the next several months. Here are a few specific updates on the clinical front, data presented at the 2012 American Association of Neurological Surgeons Annual Scientific Meeting, showed over 40 Prophage treated patients who had recurrent GBM, lived significantly longer than 86 consecutive patients not enrolled in the clinical trial, but treated with alternative therapies during the same study period, at this year's meeting positive preliminary data from 46 patient single armed Phase 2 trial of Prophage with newly diagnosed GBM showed patients treated with Prophage and the standard of care had a median progression free survival of 17 months, which is a 146% increase compared to progression free survival reported with the standard of care alone, median overall survival which is the primary end point for the trial was 23.3 months compared to 14.6 for the standard of care. The majority of enrolled patients in the trial are still being followed and data will continue to mature, we are currently assessing our pathway forward for a potential Phase 3 study.
Last year, the National Cancer Institute selected our Prophage vaccine for a randomized light scale study with Avastin for Recurrent Glioblastoma, the NCI selection of the study was a direct result of the data presented at the AANS in 2012, as well as previously reported data of course. I am very pleased to report that during May of this year this trial was initiated with much excitement by the participating clinicians. The trial is in process of enrolling now 222 patients, I am proud to say that this is the largest vaccine trial ever funded by the NCI in brain tumors and the largest cancer vaccine study ever conducted in combination with Avastin.
Additionally, a Phase 1 managed group of each data in recurrent GBM was published last year in clinical cancer research. This year we anticipate that the final study report for the Phase 2 trial of Prophage in recurrent GBM will be published in a peer-reviewed scientific journal.
Moving along to infectious diseases therapy, our HerpV is currently the most clinically advanced vaccine for the treatment of Genital Herpes. Last October, we begin enrollment and in February of 2013, we completed patient screening of this Phase 2 randomized double blind multi cancer study.
HerpV is recombinant off-the-shelf therapeutic vaccine candidate. I would like to note that HerpV in addition to utilizing our HSB technology also contains our QS-21 Stimulon adjuvant. We're expecting initial results during the fourth quarter of this year, it is estimated that over 16 million Americans and Europeans are carrying the Herpes Simplex Virus-2 which makes it a major human pathogen.
In addition to progress with internal programs, our corporate partners have also delivered solid progress in advancing development of our QS-21 Stimulon adjuvant containing products. In total, there are now 19 clinical programs and 13 preclinical candidates that contain QS-21 Stimulon.
All of these programs four are in Phase 3 development pursued by GlaxoSmithKline. Later this year and into next, we look forward to pivotal data readouts of the two Phase 3 MAGE-A3 cancer immunotherapeutic, one for Melanoma and the other for non-small cell lung cancer. The Melanoma Phase 3 data is anticipated during the second half of this year and non-small cell lung cancer study is expected to readout around the end of this year.
We believe QS-21 is critical for the performance of new generation of GSK vaccine. As such, we expect QS-21 to be one of the key drivers of GSK’s existing as well as new line up of vaccine. Further underscoring the importance of QS-21 Stimulon and our belief that adjuvants are a critical component of success of vaccines, we are working on an exciting program that is in early development but has the potential to add significant value to our company. This is our next generation QS-21 Stimulon platform. We look forward to sharing more about this program with you as it advances.
It takes courage, creativity and determination to take the road less traveled but the rewards whether measured by the difference we make and how patients are treated, the jobs we create and maintain, the value delivered to our stakeholders and many other benefits more than justify the journey. Importantly, Agenus is no longer traveling this path alone, as evidence at ASCO 2013, there is now a growing conviction amongst people including clinicians, patients, journalist and the investment community that recent breakthroughs and continuing advances representing new promising paradigm to treat cancers and possibly many other diseases in ways that conventional drugs cannot.
We believe that our technologies will play a key role in this growing and exciting field. One thing I feel absolutely excited the next year, before our next Annual Meeting, we anticipate reporting results of key programs of both of our internal and external development initiatives these include Phase 2 results from our HerpV program later this year. Our Prophage newly diagnosed GBM program results and pivotal trial readouts from GSK’s MAGE-A3 in both melanoma and non-small cell lung cancer.
We also anticipate there will be additional QS-21 Stimulon programs that will advance in the clinic and advance into the clinic. Accordingly, it is with great pride and enthusiasm that I look forward to addressing each of your next year, thank you for your continued support and interest in Agenus. I would now conclude my remarks and turn the meeting to Karen Valentine for the formal part of the meeting.
Thank you. We’re now ready to proceed with the formal business of the meeting. I will explain the items on the agenda and call for a discussion and vote. After all the items have been called and voted on we will close the poll and I will tally all ballots and report the results of the voting before we adjourn.
The first item on the agenda is to elect two directors to the board of directors of the company. The proposed resolution is as follows: To elect Brian Corvese and Timothy R. Wright to serve as directors of the company until the annual meeting of the stockholders in 2016 and until the (inaudible) successors are elected and qualified or into their earlier (inaudible) or removal. The qualifications of the nominees are described on pages six and seven of the proxy statements. Do I have a motion for this resolution? Do I have a second? Is there any discussion? The poll for this matter is now closed.
The second item on the agenda is a proposal to approve an amendment for the company’s 2009 equity incentive plan. The proposed resolution is as follows: To approve an amendment to the company’s 2009 equity incentive plan as amended as described in the company’s proxy statement mailed to the company’s stockholders on or about April 23, 2013. The detailed description of the amendment to the company’s 2009 equity incentive plan can be found on pages 46 through 52 of the proxy statement, this resolution.
Second, is for any discussion the poll for this matter now closed. The third item on the agenda is a proposal to ratify the appointment of KPMG LLP is our independent registered public accounting firm for 2013. The proposed resolution is as follows: To ratify the appointment of KPMG LLP as the company’s independent registered public accounting firm for fiscal year ending December 31, 2013 as described in the company’s proxy statement mailed to the company’s stockholders on or about April 23, 2013. The detailed description of the appointment of the KPMG can be found on pages 53 and 54 of the proxy statements.
Do I have a motion for this resolution? Do I have a second? Is there any discussion? The pole for this matter is now closed. In my capacity as inspector of election I have certified that the proposals placed before the meeting has been adopted by the requisite (inaudible). That concludes the formal portion of the meeting. Do I have a motion to adjourn the meeting? Do I have a second? All those in favor of adjournment please say I, all are closed, please say no. The meeting is formally adjourned, thank you.
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