Sesen Bio, Inc.
Q3 2015 Earnings Call Transcript

Published: 4 Nov 2015

[Operator:]

Welcome to Eleven Biotherapeutics Third Quarter 2015 Financial Results Conference Call. At this time all participants are in a listen-only mode. This call is being webcast live on the Investors and Media section of Eleven’s website at elevenbio.com. This call is the property of Eleven Biotherapeutics and recordings, reproduction or transmission of this call without the express written consent of Eleven Biotherapeutics is strictly prohibited. As a reminder today’s call is being recorded. I would now like to introduce Leah Monteiro, Corporate Communications Manager of Eleven Biotherapeutics.

[Leah Monteiro:]

Thank you. Good morning. The press release of our third quarter 2015 financial results became available at 7

[Dr. Abbie Celniker:]

Thank you, Leah, and good morning, everyone. Last quarter was highly productive for the Eleven team, as we continue to make important progress with our product pipeline. We continue to focus our efforts on the development of Isunakinra also known as EBI-005 for the treatment of moderate to severe allergic conjunctivitis and EBI-031, our pre-clinical anti-IL-6 antibody for the treatment of diabetic macular edema and uveitis. We will begin by discussing our Phase 3 program studying isunakinra in allergic conjunctivitis. The name isunakinra was recently granted to us as the international non-proprietary name for our topical, novel Interleukin-1 or IL-1 receptor blocker EBI-005. Last month, we announced that we completed the enrollment of our first Phase 3 study of isunakinra in patients with moderate-to-severe allergic conjunctivitis. Allergic conjunctivitis ranges in clinical severity from relatively mild common form to more severe forms that can cause impaired vision and even in the most severe cases blindness. Of the approximately 11 million patients that we believe seek treatment for allergic conjunctivitis in the United States, we estimate that about half of the patient may not be well treated by the current standard of care. These are patients who follow on to the more moderate-to-severe end of this disease spectrum. Based on our market research, approximately 4 million of these patients have moderate allergic conjunctivitis and approximately 1.8 million have severe allergic conjunctivitis and often wind up having to be treated with steroids that we know can be associated with sight threatening toxicities such as cataract formation, infection and intra-ocular pressure increases which can lead to glaucoma. There is a clear and compelling need among patients and providers for a new, safer non-steroidal treatment. Our first pivotal Phase 3 study in allergic conjunctivitis is designed to evaluate the safety and efficacy of isunakinra in patients with moderate-to-severe allergic conjunctivitis over a four week period in an environmental setting. To expand to a global registration program, we know studies in an environmental setting are required. The EMA does not accept challenge model. Using the environmental setting, also support the study of patients in the late phase response where we expect isunakinra will continue to work well. The only improved topical steroid used to treat this patient population [ARB] [ph] was approved based on the use of the environmental setting. Topline results from this pivotal study are expected in the first quarter of 2016. Our primary endpoint is ocular itching and the secondary endpoint include ocular tearing, total nasal symptoms and conjunctival redness. If results are favorable, we intend to initiate the second Phase 3 study in the second half of 2016 and hope to file a BLA by the end of 2017. We are also conducting a truncated safety study evaluating isunakinra in dry eye patients and expect to have data available in the first quarter of 2016. In this truncated study, subjects were randomized for treatment with Isunakinra or placebo for either three months or in some cases six months. We plan to continue discussions with regulatory authorities regarding our ability to utilize the data from this safety study, along with the data from other studies with Isunakinra and patients with dry disease to support our overall allergic conjunctivitis development program. Next week, I look forward to speaking at the Ophthalmology Innovation Summit at the American Academy of Ophthalmology Conference in Las Vegas. My presentation will highlight Isunakinra, as we have discussed today and also EBI-031. EBI-031 is a novel anti IL-6 antibody for the treatment of back of the eye diseases such as diabetic macular edema and uveitis. Based on our pharmacokinetic modeling, we believe that the potency and intravitreal retention time of EB1-031 may result in the need for less frequent intravitreal injections relative to the current standard of care therapies for the treatment of diabetic macular edema. We are focused on filing an IND in the first half of 2016 to initiate the clinical development of EB1-031 in diabetic macular edema. Diabetic macular edema or DME is characterized by an abnormal accumulation of fluid in the macula, the portion of the retina that provides the clearest and most detailed vision, due to leakage from blood vessels in the retina. According to the American Diabetes Association, DME is one of the most common causes of vision loss in the U.S., affecting an estimated 750,000 patients. Uveitis is a heterogeneous group of ocular conditions that are characterized by inflammation inside and can also be sight threatening. We are particularly enthusiastic about this program, given recent studies with a systematic IL-6 receptor antibody, providing clinical validation of IL-6 as a target in the macular edema associated with uveitis. And we believe that our differentiated intravitreal delivery approach positions us to deliver novel medicine with longer retention times than the currently available therapies. Recently, we are pleased to have our Chief Scientific Officer, Eric Furfine, present at the International Ocular Inflammation Society or IOIS, regarding further characterization of EB1-031. One of Eleven scientists, [Wanka Wayne] [ph] also presented at the 2nd Technology Transfer for Biologics Meeting, reflecting on the rapid transitions that we have taken to progress EBI-031 to the clinic. Additionally, we continue to utilize our AMP-Rx platform to engineer treatments with extended residence time in the eye and are exploring a number of understood and validated targets, including bad jobs. We are very excited about the potential of our novel drug candidates for the treatment of ocular inflammation and the power of our protein engineering platform and look forward to continuing to update you on our progress. With that, I will now turn the call over to John McCabe to provide a review of the financial results for the quarter.

[John McCabe:]

Thank you, Abbie, and good morning to all. Early this morning, we issued a press release detailing our financial results for the third quarter of 2015. I will review the financial highlights first and then speak to our cash position and our financial guidance. For the third quarter of 2015, we reported the net loss of approximately $9.7 million compared to a net loss of $10.7 million for the same quarter in 2014. Revenue for the third quarter of 2015 was approximately $67,000 compared to $539,000 for the same quarter in 2014. Research and development expenses for the third quarter of 2015 were $6.7 million compared to $8.9 million for the same period in 2014, a decrease primarily driven by lower Isunakinra-related development expenses. General and administrative expenses for the third quarter of 2015 were $2.7 million compared to $2.3 million for the same period in 2014. We ended this quarter with $46.4 million in cash and cash equivalents. Based on current operating plans, we believe that we have sufficient cash and cash equivalents to fund our operating expenses, debt service obligations and capital expenditure requirements into the second half of 2016, during which time we expect to have data from our allergic conjunctivitis trial and to file our IND for EBI-031. With that, we can open up the call for questions. Operator?

[Operator:]

[Operator Instructions] Our first question comes from Jason Gerberry from Leerink Partners. Your line is open.

[Unidentified Analyst:]

This is [indiscernible] filling in for Jason. Just had a couple of questions. First, are there any -- so you mentioned this truncated study for EBI-005, are there any data readouts from this -- the current Phase 3 that may create a lag and being able to actually announce data for this Phase 3, or is there anything that we can expect in terms of this truncated study or anything out that may create a lag in the data readout? And the second question I have is around EBI-031, if -- can you give a little bit more in terms of the timeline, if we can expect or when we could expect maybe Phase 1 for that study to begin?

[Dr. Abbie Celniker:]

Yeah. So thanks for the question. Regarding the truncated safety study, there is nothing about that study that would impact or readout for the Phase 3 study in allergic conjunctivitis. I think, as we mentioned previously, we do expect the data from the truncated safety study to be supportive of our general allergic conjunctivitis filing and we’ve initiated discussions with the FDA about that. But we don’t see the two studies linked in anyway with regard to the timelines we are reporting out of the Phase 3 allergic conjunctivitis data. And regarding EBI-031 and the timeline for moving into the clinic, as we stated, we plan to file our IND in the first half of the year and then provide a favorable reviews, we would then rapidly progress into our Phase 1 studies immediately after filing the IND and getting feedback from the FDA, given the normal review time that we understand are 30-day timeline. So we’re anxious about being able to move that forward, unless there is any issues unforeseen to it at this point in time. Our progression to the clinic should be rapidly after the filing of the IND.

[Unidentified Analyst:]

Great. Thank you.

[Operator:]

All questions have been answered, Dr. Celniker.

[Dr. Abbie Celniker:]

All right. Thank you once again everybody for your participation and you may now disconnect. Everyone have a great day.