Sesen Bio, Inc.
Q2 2017 Earnings Call Transcript

Published: 14 Aug 2017

[Operator:]

Good morning, and welcome to the Eleven Biotherapeutics Second Quarter 2017 Financial Results Conference Call. [Operator Instructions]. Please be advised that this call is being recorded at the company's request. At this time, I'd like to turn the call over to Michael Schaffzin from Stern Investor Relations. Please proceed.

[Michael Schaffzin:]

Thank you, Operator. Good morning, and welcome to Eleven's Second 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. Greg Adams, Chief Scientific Officer; and Art DeCillis, Chief Medical 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 factor 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. The second quarter was a very exciting period for Eleven Bio, especially with respect to driving forward development of our lead product, Vicinium. As a reminder, Vicinium is in a Phase III registration trial for the treatment of non-muscle invasive bladder cancer, or NMIBC. Vicinium is the lead program based on our targeted protein therapeutics, or TPT, platform. TPTs are fully biologic, single protein molecules that are based on the same concept of an ADC, or an antibody drug conjugate, a front-end molecule that selectively binds the cancer cells, is internalized and kills the cancer cells. We believe our TPTs are designed to improve upon some of the challenges that ADC has faced, specifically promoting an antitumor immune responses, delivering better tumor penetration and utilizing an improved payload, capable of killing both rapidly replicating cells, but also quiescent cells, all while leveraging a stable single protein structure to improve on safety and tolerability. Vicinium is locally administered single protein anti-EpCAM antibody fragment genetically fused with Pseudomonas Exotoxin A, or ETA. ETA is a potent cytotoxic payload, is administered directly into the bladder, where it selectively bonds the EpCAM on tumor cells. Vicinium is then internalized into these cells. Once released inside the tumor cells, ETA interrupts protein synthesis, leading to cell death. Importantly, our data demonstrated that EpCAM is overexpressed to more than 98% of non-muscle invasive bladder cancers and has little to no expression on normal bladder cancer cells. We believe NMIBC is a perfect setting for our TPT product candidate. Our Phase III registration trial is a single arm study in patients who have previously received 2 courses of BCG and whose disease is now BCG-unresponsive. The trial's primary endpoint is a complete response in patients with carcinoma in situ, or CIS. Importantly, our Phase III trial design is supported by recently published FDA draft guidance on drug development in non-muscle invasive bladder cancer, which states that a single arm clinical trial with a complete response rate as the primary endpoint can provide sufficient evidence of effectiveness to support a marketing application. We completed 2 very significant milestones in this quarter with respect to our Vicinium program. First, we announced that our independent Safety -- Data Safety Monitoring Board, DSMB, had previously only reviewed safety data from our Phase III registration trial. But in June, they undertook their first review of preliminary efficacy in conjunction with safety data and recommended that the trial continue without modification. Patients with BCG-unresponsive non-muscle invasive bladder cancer had limited therapeutic options and frequently require cystectomies to prevent disease progression. Bladder removal, however, is a serious life-altering surgery associated with significant morbidity and mortality. We consider the results of the DSMB review to be a very significant step as they suggest Vicinium may offer patients a positive nonsurgical benefit risk profile versus the standard of care. We expect to complete enrollment in our Phase III trial in Q1 2018 and announce 3-month top line data mid-2018 and 12-month data in the second quarter of 2019. Excitedly in this quarter, we also announced that we signed a cooperative research and development agreement, or CRADA, in June with the National Cancer Institute, or NCI, for our first combination trial, Vicinium in the immuno-oncology space. We're very excited about this collaboration. The NCI will evaluate Vicinium in combination with AstraZeneca's PD-L1 checkpoint inhibitor, Imfinzi, also known as durvalumab, for the treatment of non-muscle invasive bladder cancer. Under the terms of the CRADA, principal investigator Dr. Piyush Agarwal of the NCI Center for Cancer Research's Urologic Oncology branch, will conduct a Phase I study in patients with high-grade non-muscle invasive bladder cancer to evaluate the safety, efficacy and biological correlates of the Vicinium and durvalumab combination therapeutic strategy. Patients will be evaluated for responses and recurrence throughout the study. We look forward to updating you on this trial. The decision to pursue development of Vicinium in combination with check -- a checkpoint inhibitor was based on our compelling preclinical research, which suggests that cancer cells treated with VB4-845, the active pharmaceutical ingredient used to formulate Vicinium, can undergo immunogenic cell death, or ICD. ICD is known to stimulate host immune responses against cancer. This supports the hypothesis that our TPTs not only kill cancer cells, but also induce a host immune cell-mediated antitumor response. Given these exciting developments, and our real enthusiasm for the potential of Vicinium, we have decided to prioritize and -- our resources to focus on the rapid development of our Phase III registration trial of Vicinium. Therefore, we are temporarily pausing ongoing development of our earlier-stage assets, Proxinium, for the treatment of squamous cell carcinoma of the head and neck, and VB6-845d, our lead systemically administered compound. We do look forward to advancing our earlier, exciting -- advancing our earlier clinical pipeline at the appropriate time in the future. Quickly on the corporate side, we continue to strategically expand our scientific team to ensure execution of our ongoing clinical activities. To that end, we are pleased to welcome David Brooks as Senior VP of Clinical Development in May. David brings substantial experience leading oncology development programs and setting clinical strategy for assets entering testing as both direct antitumor and in combination therapies. In fact, David led one arm of an innovative immunotherapeutic multi-agent basket trial for muscle invasive bladder in the past. We are thrilled to have him on board. With that, I'll pass the call over to John.

[John McCabe:]

Thank you, Steve, and good morning to all. For the second quarter of 2017, we reported a net loss of approximately $7.3 million, or $0.30 per share, compared to a net loss of $6.5 million, or $0.33 per share, for the same quarter last year. Eleven did not record any revenue in the second quarter of 2017 compared to $0.3 million for the same period last year. This decrease was due to the termination of Eleven's collaboration agreement with Thrombogenics N.V. in June of 2016. Research and development expenses for the second quarter of 2017 were $2.9 million compared to $3.3 million for the same period in 2016. This decrease was due to a reduction in EBI-031 development expenses, partially offset by increases in Vicinium-related development expenses. General and administrative expenses were $2.2 million for the second quarter of 2017 compared to $3.5 million for the same period in 2016. This decrease was primarily due to a reduction in professional fees. Cash and cash equivalents were $15.8 million at the end of the second quarter of 2017. Based on current operating plans, we believe that we have sufficient cash and cash equivalents to fund our operating expenses into early 2018. I'll now turn the call back over to Steve for concluding remarks. Steve?

[Stephen Hurly:]

Thank you, John. Looking ahead, we expect the remainder of 2017 to be busy and productive for Eleven. We're working hard to advance our Phase III registration and clinical trial of Vicinium and expect again to complete enrollment in the first quarter of next year. Report top line 3-month data mid-2018, and report the 12-month data in second quarter '19. We look forward to updating you in the near future. With that, I'd like to open the call up to any questions. Operator?

[Stephen Hurly:]

Thank you, Operator. Thank you, everybody, for joining us on the call today. We look forward to updating you again soon.

[Operator:]

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