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.

[Operator Instructions] Please be advised that today’s conference is being recorded. [Operator Instructions] I would now like to turn the call over to Jon Lieber, the U.S.-based CFO of Entera. Please go ahead..

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.

For those of you who have not yet seen it, it is available on the Investor section of our website www.enterabio.com. On our call this morning, we will share with you a business update and review of our financial results, which will be followed by a question-and-answer session.

Before we begin our prepared remarks, I would like to remind you that various statements we make during this call about the Company's future results of operations and financial position, our interpretation of the interim data from the ongoing Phase 2 clinical trial of EB613 and the expected timing of data readouts from the ongoing Phase 2 clinical trial of EB613, our business strategy and plans and objectives for our future operations are considered forward-looking statements within the meaning of the Federal securities laws.

Our forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Specifically, developments related to the COVID-19 pandemic continue to evolve, and the extent to which the pandemic will impact us in the future will depend upon the duration and magnitude of such impact, and on numerous factors that we may not be able to accurately predict.

These risks are described more fully in our SEC filings and are available on the SEC's EDGAR system and on our website. We encourage all investors to read our SEC filings.

All the information we provide in this conference call is provided only as of today and we undertake no obligation to update any forward-looking statements we make on this call on account of new information, future events or otherwise. Finally, please be advised that today's call is being recorded and webcast.

I will now turn the call over to 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.

Based on the three-month interim biochemical marker and safety data from the first 80 subjects randomized, the Phase 2 protocol was amended in third quarter to discontinue the two lower doses of EB613 and add a higher dose, 2.5 mg. After that point, new subjects are randomized either, 1.5 mg, 2.5 mg of EB613 or matching placebo tablets.

In August, we announced the six-month interim biomarker and BMD data from the first 50% of patients in this Phase 2 trial. Art Santora, our Chief Medical Officer will review some of the specifics shortly.

But in summary, the data indicated EB613 has a meaningful and positive impact on lumbar spine BMD in a dose-dependent manner and supported the earlier decision to add the 2.5 mg dose.

These findings are important because increases in lumbar spine BMD have been associated with fracture reduction in patients treated with subcutaneous PTH and a change in lumbar spine BMD is now generally accepted as an endpoint for regulatory approval of novel PTH formulations.

Importantly, the BMD and biochemical marker data reported today do not include data from any subjects in the 2.5 mg treatment arm. We expect to report biomarker data that includes the 2.5 mg dose in the first quarter 2021 and final data from this trial including BMD in the second quarter 2021.

We believe that the data from this trial will be important to the future development of EB613, including the selection of a final dose to move into a Phase 3 study, which assuming positive Phase 2 data, we are targeting to begin in 2022.

We believe the value proposition of EB613 is very strong due to the fact that only a small percentage of patients with osteoporosis are actually treated with subcutaneous PTH or other injected bone building drugs due to cost, convenience and compliance challenges.

The market research we conducted and reported earlier this year points the significant unmet medical need for all therapies that builds bone in this multi-billion dollar osteoporosis market.

Turning to EB612 of hypoparathyroidism, we are focused on optimizing the formulation that we likely move forward subject to funding and Phillip will talk a bit more about EB612 later in this call.

We’ve also continue to support pre-clinical work in a collaboration with Amgen and we are pleased with the progress made to-date and look forward to continuing to support the collaborations in accordance with Amgen’s project plans and objectives.

From a business development perspective, we have increased our expertise to leverage our technology platform and have an ongoing dialogue with several companies that are interested in exploring the use of our oral delivery technology with their injectable product candidates.

While it’s difficult to predict the timing of any collaboration, we are focused on moving some of these conversations into a formal agreement. Operationally, we have continued to carefully monitor our expenses and our current cash on hand is sufficient to support our planned operations into the second quarter of 2021.

Right now, I would turn the call over to Dr. Art Santora, our CMO to discuss our Phase 2 trial of EB613. .

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.

The placebo-adjusted increase was comprised of a mean BMD increase of 1.44% in the 1.5 mg treatment arm, compared to a mean decrease of 0.71% in the placebo arm. An additional analysis of BMD change in all EB613 treatment groups showed a significant dose-dependent trend in the percentage increase in lumbar spine BMD.

Increases in maintenance of BMD are widely accepted by clinicians throughout the world as indicators of an overall improvement of osteoporosis during parathyroid hormone treatment. We look forward to reporting the final BMD data, including data from the 2.5 mg dose group in the second quarter of 2021.

The change in lumbar spine BMD is a recommended Phase 3 study efficacy endpoint for a novel oral PTH 1-34 formulation intended to treat osteoporosis and developed using the FDA’s 505(b)(2) regulatory pathway.

Our fracture endpoint trial is not required because subcutaneous PTH 1-34 generically named Teriparatide for injection has been shown to reduce the risk of fractures.

As expected, in consistent with the published data from studies of subcutaneous Teriparatide, an analysis of BMD of the total femur and femoral neck did not show a physically significant effective treatment with EB613. I will now turn the call over to Dr.

Phillip Schwartz, our President of R&D to share some updates with you on EB612 and our Amgen program. .

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.

We also continue to focus on the development of our platform, as it relates to the evaluation of new APIs, active pharmaceutical ingredients, believe that these efforts have the potential to generate value through either additional validation of our technology platform and/or through potential business development activities.

Of interesting note, Novo Nordisk’s recent acquisition of Emisphere may validate the inherent value of Emisphere developed SNAC and absorption enhancer currently utilized by Entera as part of our drug delivery technology.

As a reminder, SNAC was first patented in 1992 and the extensive development of SNAC by Emisphere recently culminated in the first FDA approval of an oral semaglutide, Rybelsus for the treatment of diabetes. The approval of Rybelsus is helpful to Entera in that SNAC is now in an FDA approved drug product.

Entera has worked for almost a decade on enhancing the utilization of SNAC by adding additional excipient ingredients which are not related to the drug or treatment of disease in order to protect the biologics and other large molecule drugs.

The culmination of this work has resulted in an oral formulation of parathyroid hormone, as well as a technology, which maybe applicable to other drugs in development such as the drug in the Amgen collaboration.

In the process of developing the technology for other molecules that are proprietary to potential partners, we continue to identify enhancements to our existing platform. We look forward to this work potentially leading to additional patents, expansion of our capabilities and additional collaborations with partners.

I’ll now turn the call over to Jon Lieber, our U.S. CFO to cover the financial results. .

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.

General and administrative expense for the nine months ended September 30 was primarily made up of salary and related expenses, including share-based compensation, professional fees, D&O insurance expense and legal fees. Net comprehensive loss was $7.7million or $0.42 per ordinary share basic and diluted for the nine months ended September 30, 2020.

As a reference point, we currently have approximately 18 million primary shares outstanding and 25 million fully diluted shares outstanding.

At September 30, 2020, Entera had cash and cash equivalents of $7.1 million and in our 6-K that we intend to file today, we will report approximately $6.2 million in cash and cash equivalent as of November 9, 2020. Based on current operating plans, we expect our 2020 operating loss to be approximately $11 million.

This is subject to the expected timing of product development programs, including EB613 and subject to any continuing impacts of COVID-19 on our operations. As a result, we currently believe our cash position will fund our operations into the second quarter of 2021. I’ll now turn the call back to Roger for concluding remarks before we go to Q&A..

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

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

Roger, do you want me to take that?.

Yes. Would you, Jon, that’d be great. .

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. .

Thank you. .

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

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. .

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