Carisma Therapeutics Inc (CARM) 2015 Q3 法說會逐字稿

Welcome to Eleven Biotherapeutics' third-quarter 2015 financial results conference call. (Operator Instructions) This call is being webcast live on the Investors & 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.

Thank you. Good morning. The press release with our third-quarter 2015 financial results became available at 7:30 AM Eastern Time today. It can be found on the Investor & Media section of our website at ElevenBio.com.

Before we begin I will read Eleven Biotherapeutics' Safe Harbor notice regarding forward-looking statements. During today's call we may make forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These may include statements about our future expectations, plans, and prospects, clinical development and regulatory timelines, the potential success of our product candidates, financial projections, projections for 2015/2016 milestones; and upcoming events and presentations. Actual results may differ materially from those indicated by these statements as a result of various important factors including those discussed in the Risk Factors section in our annual report on Form 10-K, our quarterly report on Form 10-Q, and other reports filed with the Securities and Exchange Commission.

Any forward-looking statements represent our views as of today only and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change.

During today's call, Dr. Abbie Celniker, our President and Chief Executive Officer, will discuss recent Company highlights and the progress of our development programs and product pipeline. Following Abbie, John McCabe, our Senior Vice President of Finance, will review financial results for the third quarter of 2015. For Q&A, Dr. Michael Goldstein, our Chief Medical Officer, will also be joining us.

I'd like to turn the call over to Abbie Celniker.

Thank you, Leah, and good morning, everyone. Last quarter was highly productive for the Eleven team as we continued 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 preclinical 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 nonproprietary 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 forms 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 these patients may not be well treated by the current standard of care. These are patients who fall onto 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 intraocular pressure increases which can lead to glaucoma. There is a clear and compelling need among patients and providers for a new, safer, nonsteroidal 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 the environmental setting are required. The EMA does not accept challenge models.

Using the environmental study also supports the study of patients in the late-phase response, where we expect isunakinra will continue to work well. The only approved topical steroid used to treat this patient population, Alrex, was approved based on the use of the environmental setting.

Top-line results from this pivotal study are expected in the first quarter of 2016. Our primary endpoint is ocular itching; and the secondary endpoints 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 about 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 in patients with dry eye 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 EBI-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 EBI-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 US, affecting an estimated 750,000 patients.

Uveitis is a heterogeneous group of ocular conditions that are characterized by inflammation inside the eye and can also be sight-threatening. We are particularly enthusiastic about this program given recent studies with a systemic IL-6 receptor antibody providing clinical validation of IL-6 as a target in the macular edema associated with uveitis. We believe that our differentiated intravitreal delivery approach positions us to deliver novel medicine with longer retention time than the currently available therapies.

Recently, we were pleased to have our Chief Scientific Officer, Eric Furfine, present at the International Ocular Inflammation Society, or IOIS, regarding further characterization of EBI-031. One of Eleven's scientists, Blanca Lain, also presented at the second 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 VEGF. 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'll now turn the call over to John McCabe to provide a review of the financial results for the quarter.

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'll review the financial highlights first and then speak to our cash position and our financial guidance. For the third quarter of 2015, we reported a 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 Instructions) Jason Gerberry, Leerink Partners.

Hi. This is [Edsir Darupe] filling in for Jason. Just had a couple of questions.

First, are there any -- so you mention this truncated study for EBI-005. Are there any data readouts from the current Phase 3 that may create a lag in 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 else that may create a lag in the data readout?

And the second question I have is around EBI-031. 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?

Yes. Thanks for the question. Regarding the truncated safety study, there's nothing about that study that would impact the readout for the Phase 3 study in allergic conjunctivitis. I think as we've 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 any way with regard to the timelines for reporting out 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, provided 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 or a 30-day timeline. So we're anxious about being able to move that forward. Unless there's any issues unforeseen to us at this point in time, our progression to the clinic should be rapidly after the filing of the IND.

Great, thank you.

All questions have been answered, Dr. Celniker.

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