Agenus Inc. (AGEN)
NASDAQ: AGEN · Real-Time Price · USD
3.900
+0.140 (3.72%)
At close: Apr 24, 2026, 4:00 PM EDT
3.968
+0.068 (1.75%)
After-hours: Apr 24, 2026, 7:47 PM EDT
← View all transcripts

AGM 2018

Jun 20, 2018

Speaker 1

Good day, everyone, and welcome to the Agenus twenty eighteen Annual Meeting of Stockholders. All participants will be in listen only mode. Please note that I would now like to turn the conference over to Doctor. Guerra Armen. Please go ahead.

Speaker 2

Thank you very much. Good afternoon, everyone. I'd like to call thee to order Agenasys Annual Meeting of Stockholders. Participating in the meeting today are our Board of Directors, Brian Corbese, Bill Jordan and Ulf Windberg. I'd like to thank our Board of Directors and each one of you for your time and commitment to Agenus.

I'd also like to thank our shareholders. Amongst you are those who have been with us from the start and who have witnessed the challenges and the transformation of Agenus. Before I start my update, I would like to mention that my remarks will include forward looking statements that are subject to risks, and we refer you to our public filings for more details. We were founded twenty four years ago based on a personalized neoantigen cancer vaccine. Today's Agenus has four technology platforms comprising checkpoint antibodies, neoantigen vaccines, cell therapy and adjuvants.

In the past four years, we have made several acquisitions and built our capabilities, which are now fully integrated. Our innovation engine has produced five INDs in the past eighteen months, six INDs will have been filed by the end of this year and two are slated in the first six months of next year. That is a total of 13 INDs in a span of three years, a remarkable accomplishment by any count, particularly given the highly innovative portfolio of products this roster represents. Yet despite these accomplishments, our stock price has come under substantial pressure because of concerns regarding our ability to finance our extensive pipeline of innovative products. Adding to these concerns has also been delays in delivering on a comprehensive partnership transaction.

While we are working diligently to deliver on these, our stock price is likely to remain under pressure until we close on a substantial partnership and or a cash infusion. Despite our near term challenges, Agenus is positioned to deliver on being a commercial company in the next several years as well as, very importantly, deliver the next major breakthroughs in immuno oncology with first in class antibodies, including bispecifics, cancer therapy, cell therapy, that is, and neoantigen vaccines, all of which are expected to be in the clinic within the next year with first clinical entrant of this group in the fourth quarter of this year. You may be aware that this year, aggregate commercial revenues for antibodies targeting PD-one and CTLA-four are expected to reach $15,000,000,000 Despite the competitive landscape, our foundational antibodies targeting these CTLA-four and PD-one represent a significant commercial opportunity for Agenus and very importantly will also enable the commercialization of our innovative combinations with our novel antibodies in the portfolio. We plan to strategically develop, register and launch our CTLA-four and PD-one antibodies and become a commercial company within the next three years or less. With regards to our clinical stage programs, we have CTLA-four and PD-one in Phase II clinical trials.

We are developing them in combinations with one another for second line cervical cancer. That would be our first potential indication. Our current trial is designed to generate data in 2019 and product registration for both agents as early as in 2020. This year, we launched combination clinical trials of our CTLA-four and PD-one. We have treated more than 100 patients with monotherapy or combinations.

At ASCO, we reported that our CTLA-four and PD-one antibodies have single agent activity and delivered clinical benefit in thirty one and forty two percent of the patients, respectively. This was highlighted at ASCO and was the subject of a recent CBS news story in Miami, although without explicit reference to Agenus. We are developing our combination in patients with second line cervical cancer who have no effective treatments today. Like other virally induced tumors where PD-one is active, we believe that CTLA-four in combination with PD-one will increase response rates and also very importantly, durability of responses. We plan to present an update on our clinical data at a major conference this year.

Delivering a seamless supply of clinical grade material is essential for the success of rapid advancement of our trials. To this end, we have manufactured CTLA-four and PD-one from our in house GMP manufacturing facility in Berkeley, California and delivered pivotal grade material for both CTLA-four and PD-one at commercial scale. Our manufacturing team is also delivering at path breaking speed. Today, we can deliver clinical grade material from research cell bank in six months. This is about two to three times faster than the industry average.

Furthermore, we have delivered registration grade material at commercial scale from technology transfer to our commercial CMO in a record four months. I believe that has never happened before, which is five times faster than the industry standard. Switching gears for the need for innovation to drive next generation breakthrough treatments. Despite the progress we've made in immuno oncology, a substantial number of tumors still escape immune surveillance and patients relapse. Our next wave of antibodies slated to enter the clinic include bispecifics designed to address critical tumor escape mechanisms.

We will be filing, as I mentioned earlier, two INDs in the first for the first in class molecules in the latter half of this year. The first of these molecules depletes regulatory T cells and it does it in the tumor microenvironment. While these regulatory T cells called Tregs have been recognized by immuno oncology experts as critical tumor resistance mechanisms, unfortunately, compounds that selectively eradicate Tregs from the tumor microenvironment do not exist today. We have designed a bispecific molecule that selectively depletes intratumoral Tregs, while sparing important immune regulatory peripheral Tregs and cancer fighting effector T cells. We have shown that our molecule achieves Treg depletion in ways that combination of monotherapies targeting the same receptors do not even when combined.

Secondly, we have developed a second rationally designed bifunctional antibody to combat two prominent resistance pathways for cancer immunotherapy. These resistance pathways are present across a wide range of indications and are associated with poor responses following chemotherapy, targeted therapy as well as checkpoint immunotherapy. Notably, this agent of ours can boost the antitumor activity of a range of tumor infiltrating cell types, including myeloid cells, NK cells, T cells and cancer associated fibroblasts. This bispecific molecule produces superior activity and employs mechanisms that cannot be achieved with the combination of monospecific antibodies against each target. As a result, it has generated significant interest from clinical experts as well as potential partners.

We have agreed not to disclose these targets just yet because of competitive sensitivities and ongoing partnership discussions. We will also be filing INDs for potential best in class checkpoint therapies later this year and early in 2019, including our Fc enhanced CTLA-four and TIGIT antibodies, as well as our conditionally active CD137 antibody. These molecules have been designed to maximize the antitumor response that can be achieved by modulating these targets, while overcoming limitations of current approaches that is improving the immunogenicity and broadening the patient population responsiveness to CTLA-four and TIGIT antagonism and while preventing liver toxicity that may be caused by CD137 agonism. I would like to also emphasize that each one of these molecules stem from Agenus' internal discovery efforts and are reflective of our innovative research engine. We have progressed these molecules from discovery to IND enabling studies under accelerated timelines.

Made possible by our integrated end to end capabilities, including our GMP manufacturing. This again is a remarkable feat for a company of any size. We have also rationally designed our portfolio to optimize combinations opportunities of combinations with our agents, which is essential to produce meaningful benefit to patients. We expect our cell therapy company, AgenTus, to also file its first IND for ATTR therapy next year. I will speak more about our cell therapy company shortly, but I'm delighted that our AgenTus CEO, Bruno Lucidi, is here today.

Partnerships are core to our strategy. We have funded our company successfully through partnerships, and we plan to continue to do so. We are in discussions with various companies related to multi asset deals as well as much larger collaborations. It is also worth noting that we have funded our company without an underwritten public offering in the past three years. We have delivered on our existing partnership programs with Insight and Merck.

We have milestones and we expect additional milestone payments, including some that will be payable this year. As part of our collaboration with Incyte, we have delivered four INDs, which are in the clinic or soon to be in the clinic. What we have delivered comprises a significant part of Incyte's innovative pipeline of immuno oncology candidates. Now switching gears to one of the greatest success stories of recent times, QS-twenty one, which is a key component in the world's most efficacious shingles vaccine, Shingrix, with over ninety seven percent efficacy. Shingrix was approved at the end of last year.

Revenue estimates for this product have been revised three times higher than the previous projections. In fact, GSK's first full year of Shingrix revenues is expected to top $600,000,000 this year. That's its first year. This equates to where Merck's Zostavax was tracking last year after fifteen years on the market. Our QS-twenty one stimulant has received increasing attention as the most potent adjuvant available today.

Our royalty transaction announced earlier this year has additional revenue milestone payments totaling $40,000,000 that are due to Agenus if specific revenue milestones are achieved, which look more probable today than they did just six months ago. The ability of QS-twenty one to strengthen and broaden immune responses also makes it a critical component of our neoantigen cancer vaccine program, which is Autosynvax called ASV amongst us. Autosynvax will be entering the clinic in combination with our own checkpoint antibodies this year. And yes, we are continuing to innovate. I mentioned earlier about our innovation and our innovation research engine, which has delivered our first in class bispecific therapies among others.

Last week, we published a discovery made by our scientists here at Agenus in a high impact journal called Cancer Cell. We discovered a novel mechanism that can enhance the immune activity of cancer fighting antibodies, including anti CTLA-four antigen. Specifically, we have shown that mechanism can improve the way T cells are primed and educated to destroy cancer cells. This finding could change the way modern antibodies are engineered. Importantly, we have applied this technology to our next generation CTLA-four and TIGIT antibodies, which we believe will be best in class molecules.

And as mentioned earlier, we expect to file an IND for our next generation CTLA-four in the third quarter of this year and our TIGIT molecule in early twenty nineteen. Moving beyond antibodies to our innovations in cell therapy. We have seen that cell therapy has shown life saving potential for patients and created significant value for shareholders. Last year, we announced the establishment of our cell therapy company, Agentis. With a dedicated team to advance breakthrough living drugs designed to cure cancer, we announced the appointment of Bruno Lucidi as CEO.

Bruno has more than twenty eight years of drug development and business successes, including helping build companies that have realized over $10,000,000,000 in transaction value. Despite the remarkable success of clinical benefit demonstrated by cell therapies, current approaches have limitations. These include manufacturing and logistical challenges and prohibitive costs of production associated with individualized or autologous therapies. Furthermore, currently approved cell therapies target hematological malignancies, and there's still a very large unmet need to improving responses in solid tumors, which account for more than ninety percent of cancers today. AgenTus has built the technologies and capabilities to overcome the challenges of today's cell therapies.

Earlier this year, Doctor. Andy Hurwitz, who leads preclinical research for AgenTus, presented our TRx platform at the PEGs conference. TRx is a proprietary state of the art discovery platform that we have, which enables the rapid discovery and characterization of T cell receptors, called TCRs, as well as chimeric antigen receptors, called CARs. He also shared preclinical data related to a unique set of neoantigens called phosphopeptide tumor targets. We call them PTTs.

PTTs are shared across most solid and hematological cancers and are proprietary to Agenus and represent a library of approximately 2,000 neoantigen targets. With this powerful drug engine and a suite of novel targets, we believe that our cell therapy approaches have the potential to produce benefit in solid tumors. Further, our differentiated allogeneic cell format is designed to address manufacturing and logistical challenges, scalability, as well as costs. Our core capabilities in bioinformatics, structural and computational biology, molecular and cell biology, and importantly, Agenus' pipeline to rapidly develop first in class combinations provide Agenus with a compelling advantage. Soon, we expect AgenTus to engage in private funding mechanisms followed by a public offering.

I am delighted with our progress over the past twelve months across diverse areas of our business. And we continue to push the limits of excellence in delivering differentiated molecules and combination approaches. We're looking forward to an exceptional year with the following representing a glimpse of our anticipated milestones over the next twelve months. First, we expect to complete accrual of our CTLA-four and PD-one trial in the 2019, results from which we expect to support our path to a BLA filing and our endeavors to develop, register and launch our CTLA-four and PD-one antibodies. Second, we will file six INDs this year, including two first in class bispecific antibodies, our next generation CTLA-four and our personalized neoantigen vaccine.

We will file two additional INDs in the first half of next year. We will initiate combination studies of our proprietary vaccine with our CTLA-four and PD-one antibodies. We will strengthen our balance sheet through corporate partnerships and other transactions. In closing, I want to thank you for your attention here today. Agenus has the team, the capabilities, the intellectual and technological capital and unrivaled innovation and assets to deliver on the next generation immuno oncology breakthroughs and importantly, to deliver for patients.

I'm confident that Agenus combination as well as Agenus combination is the right combination for bringing cancer cures and for maximizing value for shareholders. We have executed with speed and met or exceeded our operational milestones in the past year. This progress will drive value for our company. And now I'd like to introduce you to Karen Valentine, the company's Chief Legal Officer and General Counsel to conduct the formal portion of our meeting. Karen, please.

Speaker 3

Thank you, Garo. Good afternoon, everyone. This meeting was called by the Board of Directors of Agenus on April 1938. I've received an affidavit of distribution from Broadridge Financial Solutions that notice of this meeting was furnished by the company on or about April 2638, to every holder of record of common stock as of April 2438. The Board of Directors has appointed Christine Klaskin as the Inspector of Election for this meeting.

Ms. Klaskin has signed the oath of office, which will be filed with the minutes of this meeting, and she has prepared a report stating that the holders of a majority of the outstanding shares of common stock of the company as of April 2438 are present in person or represented by proxy at this meeting. Therefore, I declare that a quorum is met. We are now ready to proceed with the business of this meeting. Let me briefly describe the voting procedures.

We will vote by proxy and by written ballot. If you have previously turned in your proxy and you do not intend to change your vote, it is not necessary that you complete another proxy or ballot. Your vote will be counted. You are eligible to vote and have not submitted your proxy or if you want to change your vote, please raise your hand now and the Inspector of Elections will distribute to you a blank ballot. It is now 05:27 on June 2038, and the polls for each matter to be voted on at this annual meeting are now open.

Proposal number one. The first item on the agenda is to elect one director to the Board of Directors of the company. The proposal is to elect Wadi Jordan as a Class III director for a term of three years expiring at the twenty twenty one Annual Meeting of Stockholders. The qualifications of Mr. Jordan are described on Page seven of the proxy statement, and the Board of Directors unanimously recommends that the stockholders vote in favor of Mr.

Jordan. Are there any questions concerning the proposal? Anyone who is voting by ballot, please mark your ballot for proposal number one now. Proposal number two. The second item on the agenda is a proposal to approve an amendment to the company's amended and restated 2009 equity incentive plan to increase the number of shares of common stock authorized for issuance under such plan by 9,000,000 shares.

A detailed description of the proposal can be found on Pages 52 to 60 of the proxy statement. And the Board of Directors unanimously recommends that the stockholders vote in favor of this proposal. Are there any questions concerning this proposal? Anyone voting by ballot, please mark your ballot for proposal number two now. Proposal three.

The third item on the agenda is a proposal to approve an amendment to the company's director deferred compensation plan, as amended, to increase the number of shares of common stock authorized for issuance under such plan by 100,000 shares. A detailed description of the proposal can be found on Pages 61 to 63 of the proxy statement, and the Board of Directors unanimously recommends that stockholders vote in favor of this proposal. Are there any questions concerning this proposal? Anyone voting by ballot, please mark your ballot for proposal three now. Proposal four.

The fourth item on the agenda is a proposal to ratify the appointment of KPMG LLP as the company's independent registered public accounting firm for the fiscal year ending December 3138. The detailed description of the appointment of KPMG can be found on Pages 64 through 65 of the proxy statement, And the Board of Directors unanimously recommends that the stockholders vote in favor of this proposal. Are there any questions concerning the proposal? Anyone voting by ballot, please mark your ballot for proposal number four. We will now collect any remaining proxies or ballots in the audience.

Please raise your hand and we'll have them collected and recorded by the Inspector of the Elections. You must submit your ballot to the Inspector of Elections now in order for them to be counted. The Inspector of Elections will not accept ballots, proxies or votes or any changes, revocations submitted after the closing of the polls. It is now 05:30 p. M.

On June 2038, and the polls for the matter to be voted on at this annual meeting are now closed. No additional ballots, proxies or votes and no changes or revocations will be expected accepted. Inspector of Elections, please prepare the report on the results of the voting. The Inspector of Elections has certified that each of the proposals placed before the meeting have been adopted by the requisite votes. I hereby declare that each of the proposals presented at the meeting have been approved by the stockholders.

That now concludes the formal portion of the meeting. I would now like to turn matters back to Doctor. Armen.

Speaker 2

Thank you, Karen. I think that will conclude the formal portion of the meeting.

Speaker 1

And the conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Powered by