Entera Bio Ltd.
Q3 2020 Earnings Call Transcript

Published: 19 Nov 2020

[Operator:]

Good morning, and welcome to Entera Bio's Conference Call to discuss the Financial and Operating Results from the Third Quarter of 2020. At this time, all participants lines are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. Please be advised that today’s conference is being recorded. I would now like to turn the call over to Jon Lieber, the U.S.-based CFO of Entera. Please go ahead.

[Jon Lieber:]

Thank you, and welcome to the call. Joining me on today's call are Roger Garceau, Interim CEO; Philip Schwartz, our President of R&D; and Arthur Santora, our Chief Medical Officer. A press release announcing Entera’s financial and operating results for the quarter and nine months ended September 30, 2020 was issued earlier today.

[Roger Garceau:]

Thank you, Jon, and thanks to everyone for joining this call this morning. The completion of enrollment of our Phase 2 Clinical Trial of EB613 is a major milestone for Entera, especially, given the extraordinary challenges related to the COVID-19 pandemic. It is also an important step forward as we progress toward a pivotal Phase 3 clinical trial. I’d like to thank the patients for their participation and the sites and the investigators for their efforts to both enroll and follow-up these patients in the trial. I also like to thank the entire Entera team for their work and hard focus to support the sites in the enrollment and follow-up today and faced with the many challenges related to COVID-19. As a reminder, the Phase 2 clinical trial is a dose-ranging, placebo-controlled study in postmenopausal female subjects with osteoporosis or low bone density or BMD. This trial is being conducted at four leading medical centers in Israel and had an initial target enrollment of 160 with the final enrollment being 161 patients.

[Arthur Santora:]

Thanks Roger. I’d like to personally add my thanks to the patients, investigators and their study site staff and the team at Entera Bio for completing the enrollment amidst the COVID-19 epidemic. As a reminder, the trial was designed to evaluate the impact of different doses of EB613 on biomarkers of bone activity after 3 and 6 months of treatment and on BMD or bone marrow density after six months of treatment. Subjects were initially randomized to receive either placebo or one of three doses of EB613, 0.5 mg, 1.0 mg, and 1.5 mg. After the evaluation of the interim three months biomarker data that indicated that the maximum efficacious dose had not yet been achieved, we amended the protocol to discontinue additional enrollment of the 0.5 mg and 1.0 mg dose groups and add a new higher 2.5 mg dose group. After the protocol amendment, the final 60 subjects randomized to receive placebo, 1.5 mg or 2.5 mg of EB613. The goal for the new 2.5 mg group was 36 subjects with slightly fewer subjects in each of the lower dose groups. The total number of subjects randomized was 161 and the final numbers in each group will be known once we break the blind in the second quarter of 2021. Subject follow-up in the Phase 2 trial remains strong with approximately 86 subjects having already completed their six months visit. In addition, there have been no serious drug-related adverse events in the trial. Finally, demographics of subjects in this trial are generally consistent with other previously reported osteoporosis trials in postmenopausal women. Based on the three months biomarker data generated in the trial, EB613, our orally delivered human PTH 1-34 has a biomarker profile that differs from injectable PTH 1-34 and we expect the final biomarker data in the first quarter of 2021. More importantly, when we looked the impacts of EB613 on BMD, based on the six months BMD data, EB613 generated a mean placebo-adjusted increase in lumbar spine bone marrow density of 2.15%, physical test or difference P value is 0.08 for the 14 subjects in the 1.5 mg treatment arm as compared to the 16 subjects in the placebo arm.

[Phillip Schwartz:]

Thank you very much, Art, and good morning, everyone. I would like to provide you with a brief update on EB612, our orally delivered product candidate for the treatment of the orphan disease hypoparathyroidism. As a reminder, our goal is to treat patients’ acute symptoms while normalizing serum and urine calcium levels to minimize the adverse events of long-term calcium supplements and active vitamin D use. We are developing EB612 to be used as a first-line therapy that would be applicable to patients with different levels of disease severity. We have continued to conduct additional formulation work on EB612 including the identification of enhancements that we are evaluating in preclinical models. To-date, we have identified two technological enhancements, which if successful, could provide the support to advance this program into a potential Phase 2b or Phase 3 clinical trial in 2021 or 2022. Our collaboration with Amgen for the development of an oral anti-inflammatory agent has continued and we are pleased with the progress we have made to-date. We are continuing to support the collaboration and Amgen has completed several preclinical studies that have included the evaluation of different formulations of their drug.

[Jon Lieber:]

Thanks, Phillip. Revenues for the nine months ended September 30, 2020 were $144,000, as compared to $134,000 in the first nine months of 2019 with revenues in both years attributable to the R&D services provided to Amgen. The cost of revenues for the nine months ended September 30, 2020 and 2019 were $104,000 and $102,000, respectively, and were comprised of salaries and related expenses in connection with the R&D services provided to Amgen. Total operating expenses for the nine months ended September 30, 2020 were $8.9 million and included $5.2 million in research and development expenses, and $3.7 million in general and administrative expenses. Research and development expense for the nine months ended September 30, 2020 consisted primarily of headcount-related cost, external cost related to the conduct of the EB613 Phase 2 clinical trial, and consulting expenses and fees paid related to the preparation of a potential IND application for EB613.

[Roger Garceau:]

Thank you, Jon. We are pleased that we are able to complete enrollment in the Phase 2 clinical trial EB613, despite the significant challenges resulting from COVID-19 pandemic and look forward to reporting out additional data from this trial in the first and second quarters of 2021. The market opportunity and the need for better therapies in a convenient oral form is substantial. We believe our technology platform offers several benefits to potential collaborators that have expressed interest in our patent protected platform, which both delivers and protects macro molecules. We remain committed to opportunistically advancing those programs, while protecting our financial resources with the goal of advancing EB613 into a Phase 3 program. This ends our formal presentation today. Operator, please open the line for questions.

[Operator:]

Our first question comes from the line of Dan Michael, private investor. Please go ahead.

[Unidentified Analyst:]

Do you have any plans in place to extend your cash runway?

[Jon Lieber:]

Roger, do you want me to take that?

[Roger Garceau:]

Yes. Would you, Jon, that’d be great.

[Jon Lieber:]

Yes. Sure. So, thanks for the question. So, as Roger said, we have enough cash to get ourselves into the second quarter of next year and that of course does get us to what we think is going to be a very important milestone for the company, which are data we think from the Phase 2 EB613 trial. There are lots of opportunities coming to raise additional capital and we are certainly evaluating all those, some of them include things like business development activities, et cetera. And while those are – the timing of those are certainly hard to predict. We hope that some of – some capital can come from things such as business development collaborations, et cetera. So, we do – we are certainly evaluating a number of different strategies to put more capital on the balance sheet and we’ll provide updates as we have more information.

[Unidentified Analyst:]

Thank you.

[Operator:]

Thank you. There are no further questions at this time. I would now turn the call back to Roger Garceau for closing remarks.

[Roger Garceau:]

Thanks, everyone for taking the time this morning to join our call. We look forward to providing you an update, once we have any additional information report. Have a great day, everyone. Thank you again.

[Operator:]

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.