Sesen Bio, Inc.
Q1 2017 Earnings Call Transcript

Published: 8 May 2017

[Operator:]

Good morning and welcome to the Eleven Biotherapeutics First Quarter 2017 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up for your questions. Please be advised that the call is being recorded at the Company's request. At this time, I'd like to turn the call over to Mr. Michael Schaffzin from Stern Investor Relations. Pleased proceed.

[Michael Schaffzin:]

Thank you, Operator. Good morning and welcome to Eleven's First Quarter 2017 Financial Results Conference Call. Earlier this morning, we issued our financial results and corporate highlights press release which is available at www.elevenbio.com. Today, on our call, Stephen Hurly, President and CEO, will provide an overview and update on Eleven and its TPT platform; John McCabe, Chief Financial Officer, will review the financial results. And then, we will open up the call for your questions; Art DeCillis, Chief Medical Officer; and Glen MacDonald, Chief Technology Officer are also available for Q&A. Before we begin, I would like to caution you that during today's conference call, we will be making forward-looking statements regarding future events or the future performance of the Company, including statements about possible future developments regarding clinical, regulatory, commercial, financial and strategic matters. Actual events or results of course could differ materially. We also refer you to the risk factors section of our annual report on Form 10-K, quarterly reports on Form 10-Q and other reports filed with the Securities and Exchange Commission. With that, let me pass the call over to Steve.

[Stephen Hurly:]

Thank you, Michael, and thank you, everyone, for joining us today. As many of you know, Eleven acquired Viventia Bio back in September 2016. That created a late-staged oncology company, focused on developing targeted protein therapeutics or TPTs that are designed specifically to improve upon and overcome the challenges of existing therapeutic options. TPTs are fully biologic, single protein molecules that are built by generally fusing a tumor-targeting antibody fragment to a cytotoxic or cell killing protein. Our TPT platform emerged from the original concept of a smart missile, a front-end navigating molecule that selectively binds to an antigen or reception that's over-expressed on cancer cells. These binding targets are chosen not just for their selectivity of the cancer, but also for their internalization properties. Once our agent binds to its target, it is internalized into the cancer cell where cytotoxic protein is released, driving targeted cancer cell death. Now for an update on the first quarter 2017 progress. We made meaningful advances across our pipeline of rationally designed TPTs including advancing our Phase 3 registration trial of Vicinium and continuing development efforts with Proxinium. In addition, at the American Association for Cancer Research or AACR annual meeting in April, we presented new preclinical data which supports our belief that our TPTs not only directly kill tumor cells, but also operate via second mechanism of action - the induction of a host-immune cell mediated anti-tumor response. This suggest our compounds are not only differentiated from existing treatments, but they may have real synergy with checkpoint inhibitors and other immuno-oncology compounds. Specifically in preclinical studies presented at AACR, VB4-845, the active pharmaceutical ingredient used to formulate our two lead TPTs for Vicinium and Proxinium infused the expression of HMGB1. HMGB1 is one of three damage-associated molecular patterns or DAMPs, indicative of immunogenic cell death. This type of cell death is recognized by immunologists to actively engage the host immune system and promote anti-tumor immune responses. This is especially meaningful because it builds on our prior research in which we observed two other DAMP markers, cell surfaced expression of calreticulin and extracellular release of ATP following treatment with VB4-845. The induction of these three DAMPs that comprise the hallmark of immunogenic cell death strongly suggests our TPTs are capable-inducing host anti-tumor immune responses that can promote the function of immuno-oncology agents like checkpoint inhibitors. This was even further supported in preclinical data. We used patient-derived tumor xenograph bearing mice reconstituted with human immune system to assess the combination of intratumoral injection of VB4-845 with anti PD1 checkpoint inhibitor development. VB4-845 suppressed the growth of injected tumors while Nivolumab alone had little effect. Growth delay of contralateral non-injected tumors in the same animals was more pronounced with the combination of VB4-845 and Nivolumab than either agent alone. This data suggest that VB4-845 killing of tumor cells could facilitate and augment anti-tumor activity of checkpoint inhibitors. This data has important implications for our clinical development strategy. Based on these results, we're exploring our lead TPTs and build monotherapies as well as combination agents. We're currently developing our lead drug Vicinium as a monotherapy for the treatment of non-muscle invasive bladder cancer. Vicinium is a locally-administered single protein anti EpCAM antibody fragment genetically fused with Pseudomonas Exotocin A or EGA, a potent cytotoxic paylod. Vicinium is administered directly into the bladder where it seeks out the cancer tissue. After binding to EpCAM on cancer cells, Vicinium is internalized into these cells where it releases ETA. ETA in turn interrupts protein synthesis and drive cell death. Importantly, EpCAM is over-expressed or is expressed in more than 98% of high grade non-muscle invasive bladder cancer and is minimal to no expression or normal bladder cancer. Vicinium is currently in a Phase 3 registration clinical trial for non-muscle invasive bladder cancer. Bladder cancer affects over 79,000 new patients in the U.S. annually, with non-muscle invasive bladder cancer making up 70% to 80% of all bladder cancer and carrying high per patient cost. There have been no major advances in this space for over four decades. The first line standard of therapy BCG, which is initially very effective but offer some significant failure rates. Upon relapse, unfortunately there are no good alternatives and patients typically undergo bladder removal, a major surgery or significant risk of complications, routine hospital stays, post-surgery and a major impact on quality of life. As a reminder in a Phase 2 study, Vicinium showed promising safety and efficacy in 46 post BCG refractory or intolerant Carcinoma in situ or CIS patients. The study had two arms

[John McCabe:]

Thank you, Steve, and good morning to everyone. For the first quarter of 2017, we reported a net loss of approximately $6.1 million or $0.25 per share, compared to a net loss of $7.6 million or $0.39 per share for the same quarter last year. Total revenue for the first quarter of 2017 was $0.4 million, compared to $0.2 million for the same period last year. This increase was related to revenue recognized under our license agreement with Roche. Research and development expenses for the first quarter of 2017 were $2.9 million, compared to $4.6 million for the same period in 2016. This decrease was primarily due to a reduction in [indiscernible] and EBI-031 related development expenses, partially offset by an increase in Vicinium-related development expenses. General and administrative expenses for the first quarter of 2017 were relatively flat at $2.2 million, compared to $2.1 million for the same period in 2016. Cash and cash equivalents were $20.3 million at the end of the first quarter of 2017. Based on our current operating plans, we believe that we have sufficient cash and cash equivalents defined our operating expenses into early 2018. Now I'll turn the call back over to Steve for concluding remarks. Steve?

[Stephen Hurly:]

Thanks, John. I'd like to take a brief moment the recap the key program milestones we anticipate for the remainder of the year which will continue to enhance our pipeline forward. Starting with the lead product Vicinium. Later this year we expect to complete enrollment in our Phase 3 registration clinical trial for BCG refractory or relapsed high grade non-muscle invasive bladder cancer patients and expect to have top line data in 2018. For Proxinium, we plan to initiate a Phase 1/2A trial, clinical trial in combination with checkpoint inhibitors in the second half of the year in head and neck cancer; and finally in our earlier stage pipeline, we plan to finalize preclinical development later this year and file an IND for the first de-immunized systemically-administered TPT VB6-845d in the first quarter of 2018. Taken together, we believe these programs have the potential to bring meaningful new treatment options to patients and we're excited to continue advancing them through development. We look forward to updating you further as we continue to progress. With that, I'd like to thank you all for your time and open up the call to any questions. Operator?

[Stephen Hurly:]

Thank you, Operator. And again, I'd like to -- on behalf of the entire team at Eleven, thank you all for your time. We look forward to continue to providing you updates as we progress in our clinical development and balance of this year. Thank you again. Bye, bye.

[Operator:]

Ladies and gentlemen, this concludes today's program. Thank you once again for your participation. You may now disconnect. Everyone, have a great day.