11/10/2021

speaker
Ryan
Investor Relations

2021, which was filed with the SEC as well as in subsequent reports, including our current reports on Form 8K. The company disclaims any obligation to update or revise any forward-looking statements, except as required by law. Michelle will start today's call by sharing with you the significant progress our team here at ITS has made the past quarter. They'll recap our corporate strategy and provide an overview of our robust clinical development plans for our pipeline programs. And then our Chief Medical Officer, Joe Lager, will provide a more detailed update on our clinical programs. We'll wrap up our comments with our CFO, Matthew Gall, who will provide an update on our financial status, followed by Michelle's closing remarks. We'll then open the line for the Q&A session. With that, I will hand it over to Michelle.

speaker
Michelle
Chief Executive Officer

Thank you, Ryan. Hello, everyone. Thanks for joining us for our third quarter 2021 earnings call. At ITOS, our team is dedicated to understanding the biology of the tumor microenvironment. We use that deep understanding to design what we believe are best-in-class assets to harness the immune system to help patients with cancer live longer and better lives. We are continuing to progress our three clinical programs in West 448, an anti-digit antibody which we partner with GlaxoSmithKline to jointly develop and commercialize and our own selective A2A inhibitor. Both of these therapies have demonstrated single agent efficacy and excellent safety profile. And both targets are simply the risk to our own data as well as external randomized data. We are really excited by these programs and their potential to significantly impact patients' lives. This is what drives us here at ITOS every day. Let's start by discussing our strategic collaboration with GlaxoSmithKline on our anti-digit antibody EOS448. This collaboration is an opportunity to accelerate and expand the development plan of EOS448. In the third quarter of 2021, we closed the co-development and co-commercialization collaboration agreement and received $625 million upfront payment. Beyond the upfront payment, we are eligible to receive up to $1.45 billion in additional development and commercial milestones payments should the program achieve certain milestones. This partnership validates our view that TIGIT is the most promising new target in the coming generation of new IO therapies, and that EOS448 has real potential to be differentiated relative to the other assets in the class. The GSK partnership has brought enormous value to ITOS in many ways. To highlight a couple, This partnership brings together the best-in-class expertise, capabilities, and portfolio of the two companies and enables us together to pursue novel combinations, including combinations in the CIGIC CD226 axis, in ways no other company can. As an example, we will be evaluating the combination of GSK-Accour and GPD-1, Jan Parly, or Tostarima. with both of our highly differentiated clinical stage candidates, EOS448 and Inifadimelt. This is just one of the many unique combinations we have available to explore. the structure of this partnership provides strategic flexibility as we aim to become an industry leader in the immunology space through significant upfront cash, 60-40 shilling of the government cost, and the 50-50 profit share and co-commercialization rights in the U.S. Now, turning to Inipa Demand, our clinical stage program targeting adult and women immunosuppression. We note, with interest, the positive data that has recently been reported in the MTCD73 therapeutic. This data continues to validate our enthusiasm for this pathway and target. Based on our unique understanding of the specific conditions within the tumor microenvironment, ITS scientists thoughtfully designed imipalimum to selectively and potently inhibit the A2A receptor in the specific conditions of the tumor microenvironment. These two programs are just the beginning of what we are working on at ICS. Our scientists continue to innovate and we have a range of diverse and exciting programs focused on further harnessing the power of the immune system to tackle cancer. As previously guided, we nominated an additional therapeutic candidate targeting new mechanisms in the adenine pathway for IMD in adenine studies. This is a trust-in-class program against a new target identified by our in-house synthesis team demonstrating our capabilities in higher discovery. And we continue to capitalize on our demonstrated track record of success in building a differentiated in-ecology pipeline. In summary, our progress through 2021 has laid the groundwork for our robust clinical development plan. With expansion underway for both our clinical programs, we have demonstrated our ability to construct scientific innovation into clinical programs with the potential to improve outcomes for people who have cancer. We have leveraged our deep understanding of cancer immunology and immunosuppressive pathway to build our pipeline and, outside the partnership, we will provide us with additional opportunities. We are now focused on the execution of our clinical trials, delivering on the promise we have made to our patients with advanced cancer. With that, I will hand it over to Joe Leger, our Chief Medical Officer, to provide further details on the significant progress that we have made and where we are with these exciting contacts.

speaker
Joe Lager
Chief Medical Officer

Thanks, Michel. I'll begin with key updates on our anti-tuget antibody, EOS-448. EOS-448 has the potential to achieve significant anti-tumor immune response through a multifaceted mechanism. The antibody blocks the binding of TIGET to its ligand, resulting in the immune-mediated killing of tumor cells by T cells and NK cells. It also engages the FC gamma receptor, further promoting anti-tumor immune response through the release of pro-inflammatory cytokines and chemokines and the activation of antigen-presenting cells. Also, the antibody causes depletion of immunosuppressive Tregs and exhausted T cells, cells that are known to dampen the immune response. We are pursuing a clinical development plan based on this multifaceted mechanism of action of EOS-448, which is focused on the indications and combinations where we see the greatest potential to benefit patients. Given the encouraging monotherapy data we presented earlier this year, we are progressing the next set of trials for this program. We are pleased to share that we have initiated dosing in two combination cohorts in patients with solid tumors in our Phase 1-2 clinical trial of ES-448. The first in combination with Pembrolizumab and the second in combination with Inupiatinib. As a reminder, We had planned to initiate this combination study with Pembrolizumab prior to entering into the collaboration with GSK, and both parties agreed that it made sense to generate data on this combination. This will inform our clinical strategy with Dostralumab. Over the next several months, we will initiate additional studies exploring the safety and efficacy of EOS-448. This will include the combination with GSK's approved anti-PD-1, Dostarlamab. We will also evaluate EOS-448 in monotherapy and in combination with Bristol-Myers Squibb's Ibergamide in multiple myeloma. We look forward to providing updates on the clinical development plan for EOS-448 as we progress. Turning to independence, we have a unique drug candidate in three ways. First, unlike the other adenosine receptor antagonists, Inipediment was designed to inhibit the A2A receptor in the high concentrations of adenosine found within tumors. Second, Inipediment was designed to be highly selective for the A2A receptor, which plays a key role in regulating adenosine's immunosuppressive effects within the tumor. And third, inattachment does not penetrate the central nervous system, reducing the potential for off-target safety effects and improving its therapeutic index. We continue to make significant progress in our clinical development and have several updates to share. We have completed enrollment in the initial evaluation of inipediment in combination with chemotherapy and with pembrolizumab and have found a profile that supports future development. We have also completed enrollment in the cohort exploring inipediment and monotherapy in castrate-resistant prostate cancer and have initiated an expansion of the combination of inipediment with pembrolizumab in PD-1-resistant melanoma. Finally, as we mentioned earlier, while discussing the updates on EOS448, we have initiated the evaluation of the combination of inopatinib with EOS448, and we'll also be evaluating the triple combination of EOS448 with inopatinib and GSK's dosterolimab. In addition, we are building on the identification of potential patient selection biomarkers identified in our monotherapy study. and plan to open a new cohort in our ongoing phase one to a trial in patients with high biomarker expression. Our initial trial is a rich source of translational data that we continue to use to optimize the independent clinical development program to evaluate independent in the patients and tumor types most likely to benefit from treatment. With the data we already have in hand, and that we are generating an ongoing study, and validation from other approaches in the adenosine pathway, we are initiating the next phase of development. We will have data in several indications and combinations that we expect will provide many attractive options as we move into the randomized controlled setting. I will now hand the call over to Matthew Gall, our Chief Financial Officer.

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