Q3 2020 Entera Bio Ltd Earnings Call
We also continue to focus on the development of our platform as it relates to the evaluation of new API.
Active pharmaceutical ingredient and believe that these efforts have the potential to generate value through either additional validation of our technology platform and or through potential business development activity of interesting note. Novo nordisk's recent acquisition of atmosphere May validate the inherent value of emisphere developed snack and absorption enhancer currently utilized by antara as part of our drug delivery technology.
As a reminder snack was first patented in 1992 and the extent of development of snack by emisphere recently culminated in the first FDA approval of an oral surgeon blue type of service for the treatment of diabetes. The approval of our Bell system is helpful to enter in That Snack is now in an FDA-approved drug products and Tara has worked for almost a decade on enhancing the utilization of snack by adding additional excipient ingredients which are not related to the drug or treatment of disease in order to protect biologics and other large molecule truck.
The culmination of this work has resulted in an oral formulation of parathyroid hormone as well as a technology which may be applicable to other drugs and development such as the drug in the lounge in 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 work potentially leading to additional patent expansion of our capability and additional collaborations with Partners. I'll now turn the call over to John Lieber are U SEF to cover with financial results.
Thanks a lot.
Revenues for the nine months ended September 30th 2020 were one hundred and forty four thousand dollars as compared to $134,000 in the first nine months of 2019 with revenues in both attributable to the R&D Services provided to amja the cost of revenues for the nine months ended September 30th, 2020 and 2019 or $104,000 and $102,000 respectively and we're comprise the salaries and related expenses in connection with the R&D Services provided to Amgen.
Thank you for calling of the Conferencing Center. If you do not anticipate asking a question via the phone you can alternatively access the call audio via the webcast link provided in a press release or on the IR Web site a conference coordinator will be with you momentarily. Thank you.
Total operating expenses for the nine months ended September 30th 2020 with 8.9 million and included five point two million in research and development expenses and three point seven million in general and administrative expenses.
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Research and development expense for the nine months ended September 30th, 2020 consisted primarily of headcount related costs external costs related to the conduct of the V6 3.0 trial wage expenses and fees paid related to the preparation of a potential IND application for e d 613 General and administrative expense for the nine months ended. September Thirty was primarily made up of Bowery and related expenses, including share-based compensation professional fees theater Insurance expense and legal fees.
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Comprehensive loss is seven point seven million dollars for 42 cents per ordinary share basic and diluted for the nine months ended September 30th 2020 as a reference point. We currently have approximately 18,000 primary shares outstanding and twenty five million fully diluted shares updated at September 30th, 2020 and turn on cash and cash equivalents of 7.1 million in our in our 6K that we need to file today. We will report approximately 6.2 million in cash and cash equivalents as of November 9th 2020 based on current operating plans. We expect our 2020 operating loss to be approximately eleven million dollars.
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Well the the press star one of your telephone leads.
Please be advised of today's conference is being recorded.
Have you Arnie for the assistance Please press star zero on.
Now I'd like to turn the call over the Jon Lieber you.
With the CFO of the Terror. Please go ahead.
Yeah.
Thank you and welcome to the call.
Yeah.
The only me on today's call are Roger Garceau, our interim CEO Phil.
This is subject to the expected timing of product development programs, including e b613 and subject to any continuing impact of COVID-19 on our operations as a result. We currently believe our cash position under operations into the second quarter of 2021. And now turn the call back to Rodger for concluding remarks before we go to Q&A.
Look Schwartz, our president of R&D, and Arthur Centaur, our Chief Medical Officer.
The press release announcing interest financial and operating results for the quarter and nine months ended September Thirtyth 2020 was issued earlier today.
For those of you who have not yet seen the it's available on the investors section of our website www dot and terabyte of Dot com.
Thank you, John.
On our call. This morning, we will share with you the business update and review of our financial results, which will be followed by a question and answer session. The.
We are pleased that we're able to complete enrollment in the phase 2 clinical trial every six months despite the significant challenges resulting from the COVID-19 and Democrats and the forward to reporting additional damage on this trial and the first and second quarters of 2021.
Before we begin our prepared remarks, I would like to remind you. The 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 two clinical trial of VB six routine and the expected timing of data readouts from the ongoing phase two clinical trial of GBP 613, our business strategy and plans and objectives.
The market opportunity and the need for better Therapies in a convenient oil form is substantial.
We believe our technology platform offers several benefits of potential collaborators that have expressed interest in our patent-protected platform, which both delivers and protects macromolecules.
Interest for our future operations are considered forward looking statements within the meaning of the federal Securities laws. Our forward looking statements are based on 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.
We remain committed to happen to this quickly advancing those programs while protecting our financial resources with the goal of advancing CB 600 need to a phase 3 Program.
Depends our formal presentation today.
For you, he's open the line for questions.
Impact us in the future will depend on 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 interest SEC filings and are available on the Fccs Edgar system and on our web site. We encourage all investors to read our SEC filings all of the information we provide on this conference call.
Thank you. As a reminder to ask the question. You would need to press star then one of your telephone to withdraw your question, please press the pound key, please standby once compiled the Q&A roster.
The provide the only as of today and we undertake no obligation to update any forward looking statements. We make on this call and the kind of new information future events or otherwise finally, please be advised of today's call is being recorded and webcast I will now turn the call over to Roger car sales.
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?
Thank you John the.
Thanks to everyone for joining this call this morning.
The completion of enrollment of our phase two clinical trial of you'd be 603 is the major milestone from Tara.
Rodger do you want me to take that? Yeah, would you down that be great? Yes. Sure. So thanks for the question. So it's Rodger said we have enough cash to get ourselves into the second quarter of 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 which are data. We think from the phase to be 613 trial. There are lots of opportunities coming to raise to raise additional capital and you know, we're certainly evaluating although some of them include things like Business Development activities Etc and watch those are the timing of those are certainly hard to predict. You know, we hope that some of some Capital can come from things such as business development collaborations Etc. So we do we are certainly evaluate a number of different strategies to put more capital on the balance sheet and will provide updates as we have more information. Thank you.
Especially given the extraordinary challenges related to the club the 19 pandemic.
It is also an important step forward as the progress toward a pivotal phase three clinical trial.
I'd like to thank the patients for the participation and the sites and the investigators for their efforts to both the role and follow up these patients in the trial.
I'd also like to thank the entire entire team for their work and hard focus to support the sites and the enrollment and follow up today when faced with the many challenges related to code the 19.
As a reminder of the phase two clinical trials the dose ranging placebo controlled study in post menopausal of female subjects with adjusted grosses are low bone density or BMD the.
Cash being conducted the four leading medical centers in Israel and had an initial target of 160 patients with the final enrollment being quite at the 61 basis.
Based on the three month income biochemical marker and safety data from the first 80 subject randomized the phase two protocol was amended in the third quarter to discontinue the two lower doses of 86 Centsthree.
Thank you.
There are no further questions at this time. I would now turn the call back to article so for closing remarks.
And at a higher dose of 2.5 milligram.
After that point, new subjects were randomized to receive either 1.5 milligram 2.5 milligrams of GBP 603 or matching placebo tablets.
Thanks everyone for taking the time this morning to join our call the forward to providing you an update once we have additional information report. Have a great day everyone. Thank you again.
In August we announced the six month in from biomarker and BMD data from the first 50% of patients in the space who trial.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
Our centura, our Chief Medical Officer for review of some of the specific shortly.
But in summary, the data indicated EBIT six months three has a meaningful and positive impact on lumber spine BMD in a dose dependent manner and supported the early of decision to add the 2.5 milligram dose.
These findings are important because the increases in lumber spine BMD has been associated with fracture reduction in patients treated with subcutaneous BTK and a change in lumbar spine. BMD is now generally accepted as an endpoint for regulatory approval of novel PGM formulations.
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Importantly, the BMD and biochemical marker data reported to date do not include data from any subjects in the 2.5 milligram treatment arm.
We expect to report biomarker data that includes the 2.5 milligram dose in the first quarter 21 and final data from this trial, including BMD in the second quarter of 21.
We believe that the data from this trial will be important to the future development 86 cents range, including the selection of the final dose to moving to a phase three study, which.
Which assuming positive phase two data we are targeting to begin in 2022.
We believe the value proposition of EBIT declined three is very strong due to the fact, the only a small percentage of patients with lots of grosses are actually treated with subcutaneous dth or other injected bone building drugs due to cost convenience the compliance challenges.
The market research, we conducted and reported.
Earlier this year points, the significant unmet medical need for oral therapy at build phone and this multibillion dollar as the occurrences market.
Turning to E. B six went to the Hypoparathyroidism, we are focused on optimizing the formulation that we'd like to move forward subject of funding and Philip will talk a bit more about the vsix on to later in this call.
We've also continued to support preclinical work and the collaboration with Amgen and.
We are pleased with the progress made to date and look forward to continuing support the collaboration in accordance with answers project plans and objectives.
From a business development perspective, we have increased our efforts to leverage our technology platform and have an ongoing dialogue with several companies that are interested in exploring the use of our oil delivery technology with their injectable product candidates.
Well, 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 the carefully monitor our expenses than our current cash on hand is sufficient to support our planned operations into the second quarter of 2021.
Let's now turn the call over to debt to our centura, our CMO to discuss the phase two trial of VB six on three.
Thanks Roger.
I would like to personally add my thanks to the patients investigators in the study site staff.
And the team, but in terms of bio for completing the enrollment amidst the current lighting epidemic.
As a reminder, the trial was designed to evaluate the impact of different doses of PV 613.
Biomarkers of bone activity after three to six months of treatment and on BMD or bone mineral density after six months of treatment.
Subjects were initially randomized to receive either placebo or one of the three doses of the B 613, Seer reported five kilograms of 1.0 milligrams and 1.5 milligrams.
After the evaluation of the interim three months biomarker data the indicated that the maximum efficacious dose, but not yet for the achieved we amended the protocol to discontinue additional enrollment of the 0.5 and 1.0 milligram dose groups and to add a new hire 2.5 milligram dose.
Yeah.
After the protocol Amendment. The final 60 subjects were randomized to receive from placebo 1.5 milligrams or 2.5 milligrams of each of you 613.
The goal for the New 2.5 milligram group was 36 subjects were 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.
Subjects follow up in the phase two trial remains strong with approximately 86 subjects the.
Being 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 endorsement of calls a woman.
Based on the three month biomarker data generated in the trial.
He be 613 are orally delivered human PK twond of 34.
As a biomarker profile it differs from injectable PCH one of the 34 and we expect the final biomarker data in the first quarter of 2021.
More importantly, when we looked at the impact of VB six searching on DMD.
Based on the six month BMD data, if you 613 generated a mean placebo adjusted the increase in lumbar spine bone mineral density of 2.15%.
Fiscal tests or difference P value. The 0.08 for the 14 subjects in the 1.5 milligram 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 milligram treatment arm compared to a mean decrease of 0.71% in the placebo arm.
An additional analysis of BMD change in all the B 613 treatment groups showed a significant dose dependent trend from the percentage increase in lumbar spine BMT.
Increases in and maintenance of the MD are widely accepted by clinicians throughout the world as indicators of an overall improvement of osteopetrosis during parathyroid hormone treatment.
Look forward to reporting the final BMG data, including data from the 2.5 milligram dose group in the second quarter of 2021.
The change of the lumbar spine DMD is the recommended phase three study efficacy endpoint for a novel oral PDH one to 34 formulation intended to treat osteoporosis.
And developed using the F.T. ace five five be true regulatory pathway.
Our fracture important trial is not required.
Because subcutaneous P.T.H. warned of 34 generically named Teriparatide for injection has been shown to reduce the risk of fractures.
As expected and consistent with the published data from the studies of subcutaneous to repair the tide and the.
The analysis of BMD of the total femur and from elect to not sure we specifically significant effect to treatment with either the 613.
I will now turn the call over true Dr., Philip Schwartz, our president of R&D to share some updates with you on the 612 and our Amgen program.
Thank you very much art that day.
Good morning, everyone I would like to provide you with a brief update any of these 612 or lead the delivered product candidate for the treatment of the orphan disease hyperthyroidism.
As a reminder of our goal is to treat patients acute symptoms from normalizing serum and urine calcium levels. The minimize the adverse events of long term serum calcium supplement an act of vitamin D use weird.
We are developing EPS six wells 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 I need the 612, 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 support to advance this program into a potential phase to pay for phase three 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 simple preclinical studies that have included the evaluation of different formulations of their truck.
We also continue to focus on the development of our platform as it relates to the valuation of newly <unk>.
Active pharmaceutical ingredient and believe that these efforts has the potential to generate value through either additional validation of our technology platform.
And or through potential business development activities.
Of interesting though.
The open or discs recent acquisition of atmosphere may validate the inherent value of Emmis fair developed stack and the absorption enhancer currently utilized EBIT by Antero as part of our drug delivery technology.
As a reminder, snack was first patented in 1992 and the extensive development of snack by Emmis here recently culminated in the first after the approval of an oral semaglutide of.
Relative.
For the treatment of diabetes.
The approval of our Bell says is helpful to interest in that staff is now in an FD approved drug product.
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The additional excipients ingredients, which are not related to the drug or treatment of disease.
In order to protect the biologics and other large molecule trucks.
The combination of this work has resulted in an oral formulation of parathyroid hormone as well as a technology, which may be 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 patent the expansion of our capabilities and the additional collaborations with partners.
I'll now turn the call over to Jon Lieber, our U.S. CFO to cover the financial results.
Thanks Philip.
Revenues for the nine months ended September 30 of 2020 or $144000 as compared to $134000 from the first line lots 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 Thirtyth 2020.
And 2019 per 104000, and the 102000, respectively and were comprised of salaries and related expenses in connection with the R&D services provide the two amgen.
Total operating expenses for the nine months ended September Thirtyth 2020 were 8.9 million and included 5.2 million of research and development expenses of $3.7 million in general and administrative expenses.
Research and development expense for the nine months ended September Thirtyth 2020 consisted primarily of head count related costs external costs related to the conduct of the B 613 phase two clinical trial and consulting expenses and fees paid related to the preparation of the potential I and the application for E. B 613.
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. The you know insurance expense and legal fees.
Net comprehensive loss of $7.7 million from of 42 cents per ordinary share of basic and diluted for the nine months ended September Thirtyth 2020.
As a reference point, we currently have approximately 18 million primary shares outstanding and 25 million fully diluted shares outstanding.
At September Thirtyth, 2020, and current cash and cash equivalents of 7.1 million and our in our 6K that we intend to file today, We will report approximately 6.2 million in cash and cash equivalents as of November nine 2020.
Based on current operating plans, we expect our 2020 operating loss to be approximately $11 million.
Just the subject to the expected timing of product development programs, including the the 613 and subject to any continuing impact 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 culinary.
Thank you John.
We are pleased that we were able to complete enrollment in the phase two clinical trial ex history. Despite the significant challenges, resulting from the cold the 19 pandemic and the 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 and the convene oil farm is substantial.
We believe our technology platform offers several benefits of potential collaborators that have expressed interest in our patent protected platform, which both delivers and per tax after molecules.
We remain committed to opportunistically advancing those programs, while protecting our financial resources with the goal of advancing CTP 603 into a phase three program.
This ends our formal presentation today.
Operator, please open the line for questions.
Thank you.
As a reminder to ask the question you need the press Star then one of your telephone to withdraw your question. Please press the pound key please stand by while we compile the culinary roster.
Our first question comes from the line of Dan Michael <unk> Private Investor. Please go ahead.
Q of any plans in place to extend your cash runway.
Roger do you want me to take that yes.
Would you Don that'd be great.
Yes sure. So thanks for the question.
So as Roger said, we have enough cash to get ourselves.
In the second quarter of the of next year.
And that of course does get us to where we think is going to be a very important milestone for the company which are.
Which are data we think from the phase two he be six went to trial.
There are lots of opportunities coming to raise to raise additional capital and you know we're 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 the 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.
Okay.
Thank you.
Thank you.
There are no further questions at this time I would now turn the call batch of logic also for closing remarks.
Thanks, everyone for taking the time this morning to join the call.
We look forward to providing you an update once we have additional information to 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.
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