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spk03: Greetings and welcome to the Interrobio fourth quarter and year-end 2021 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the call over to Ramesh Ratan, Chief Financial Officer. Thank you. You may begin.
spk07: Good morning and welcome to the call. Joining me on today's call are Scott Johns, our CEO, Arthur Santora, our chief medical officer, and Philip Schwartz, our founder and president of R&D. A press release announcing NTERRA's financial and operating results for the full year ended December 31, 2021, was issued this morning. For those of you who have not yet seen it, it's available on the investor section of our website, www.nterrabio.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'd like to remind you that various statements we make during this call about the company's future results of operation and financial position, our importation of data from the recently completed phase two 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 expectation 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 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 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 on this conference is provided only as of today and undertake no obligation update any forward-looking statements you make on this call and 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 Sviraj Jamas.
spk06: Thank you, Ramesh. And thanks to everyone for joining the call this morning. I joined Interra because of the promise of the company's validated technology platform that enables the oral delivery of protein therapeutics and the talented, dedicated, and hardworking team. We have hit several key milestones that have generated value for our shareholders and confirmed my confidence in our team and technology and believe we are on the path to creating a very valuable business. In the second quarter of 2021, we reported the ultimate in scientific validation that our Phase II clinical study of EB613, our oral PTH product for the treatment of osteoporosis, met its primary and key secondary endpoints. There is a linear and statistically significant dose response for PTH dose and the key anabolic biochemical markers P1NP and osteocalcin with a p-value of less than 0.001. and bone mineral density, the clinical marker of bone mass and strength. The three-month biomarker results were accepted and presented at the leading clinical bone disease conference, the ASBMR, last October 2021. Our six-month bone mineral density results were accepted and presented by our chief medical officer, Art Santora, as a prestigious late-breaker oral presentation. also at ASPMR. This is important peer-reviewed presentation of our studies. I believe these data will support business development efforts and will generate future value through strategic collaborations and partnerships. Separately, the data from our Phase IIa study of EB61T in hyperparathyroidism patients was published in the Journal of Bone Mineral Research. We are focused on leveraging the platform technology to create additional value either through proprietary products such as EB613 and EB612 that can be developed either by Ontario alone or in collaboration with a partner or applying our technology to another company's compound such as what we are doing in our collaboration with Amgen. In addition to our expanding internal pipeline as part of our business development efforts, we have signed material transfer agreements with multiple biopharma companies to demonstrate the feasibility of Interis platform for oral delivery of various proprietary target compounds. These options potentially enable multiple partnering opportunities that can generate non-dilutive funding, news flow, and allow the company to share in the future value of multiple dearest assets. 2021 was definitely a year of execution. We ended 2021 with a successful end of phase two meeting with the FDA where we reviewed the phase two osteoporosis data, proposed phase three protocol, and other requirements for an NDA submission. The meeting was positive and confirmed the use of bone mineral density as a primary phase three endpoint. We are incorporating input from the FDA into the phase three study design and we are projecting a second half of 2022 start of the Phase III study. We strengthened our balance sheet, and I am pleased to report $24.9 million at year-end 2021. I'd like to give you a snapshot of why we think EB613 is a tremendous opportunity in the osteoporosis market. EB613 is an oral formulation of human parathyroid hormone 1234, or PTH. and is positioned to be the first oral, once-a-day, bone-building osteoanabolic product to treat osteoporosis patients. The successful Phase II study has brought EB613 one step closer to potentially becoming available to the estimated 200 million people affected by osteoporosis worldwide. In the U.S. alone, 54 million Americans have osteoporosis or low bone mass, which places them at an increased risk for developing osteoporosis. One in two women and one in four men over 50 years of age will break a bone due to osteoporosis. In a therapeutic market this large, estimated at over $7 billion annually today, surprisingly, there are only three effective bone-building treatments available. They are proteo or teraparatide, tymlos, abaloparatide, and a vanity, dromososumab. All three are injectables. This may be one reason why less than 5% of people living with osteoporosis are treated with anabolic drugs. These injectables are also quite pricey at a cost of between $20,000 and $35,000 per year in the U.S. We believe that a safe and effective oral bone-building drug like EB613 may significantly expand the number of patients being treated. More than 90% of all osteoporosis patients who are taking any form of pharmaceutical are being treated with an oral agent. An oral bone-building agent may not only get conversions from current injectable drugs, but may also attract many new patients currently not receiving any treatment. This assumption was borne out in a research study we commissioned with an independent market research firm which found that patients, physicians, payers, and providers are seeking more cost-effective oral solutions. Aside from the more patient-friendly oral delivery as an oral drug, EB-613 can be far more cost-effective than injectables. We believe Enterra has a multi-billion dollar opportunity here by treating new patients at high risk of fracture. We estimate there is a realizable opportunity for a 10% or greater market penetration for both treated and currently untreated patients. Even at a discount to current injectable therapies, this should translate to a potential multi-billion dollar market opportunity. I will now turn it over to Philip to review EB612, additional progress with our platform, and various business development activities.
spk04: Thank you, Spiros, and good morning, everyone. First of all, we are announcing today that Interra has engaged a highly accomplished and experienced investment bank, Torea, to support our strategic partnering efforts for our lead asset, EB613, in osteoporosis. Since its founding in 2007, Torea has closed on over $100 billion in strategic transactions. Needless to say, we are thrilled to be partnering with such a superb team for our lead asset in osteoporosis. a multi-billion dollar market with immense growth potential. I would now like to provide you with a brief update on EB612, our orally delivered PTH for the treatment of the orphan disease hypoparathyroidism. Hypoparathyroid patients are plagued with low serum calcium and numerous other acute and long-term sequelae. We are developing EB612 to be used as a first-line hormone therapy that would be applicable to patients with different levels of disease severity and are excited by the recent publication of our Phase IIa data in the Journal of Bone Mineral Research, a leading peer-reviewed journal. EB612, when added to the standard of care, led to a statistically significant decline in supplemental calcium usage a lowering of excess serum phosphate, and a significantly improved quality of life. All of these are key endpoints in past hyperparathyroid studies. There is significant unmet need in the treatment of hyperparathyroidism, and we believe that an oral PTH will have an improved efficacy, improved compliance, and treatment which will be far more customizable for this very heterogeneous disease population. especially as compared to the currently available daily injectable alternative. We now have an improved formulation of VB612 that offers a PK profile better tailored for this indication. We have tested this formulation in preclinical studies and will be evaluating this formulation in healthy volunteers in a study in 2022. If the improved profile is as expected, we intend to discuss and finalize our design for a single Phase 2b3 pivotal study with the FDA. Net para, injectable PTH1 to 84, was originally approved for the orphan indication of hyperparathyroidism with just one 124-patient Phase 2b3 study of six-month duration. We currently have strong interest from a number of potential partners to co-develop EV612, and we anticipate financing EV612's development through such collaborations. We continue to make progress in our partnering our oral delivery platform to assist other companies in developing their internal pipeline of biologic and large molecule therapeutics. 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 currently in its third year. Amgen has completed several preclinical studies that have included the evaluation of different formulations of their drug with our platform, and Amgen is pleased with the results. As reported in our financials, Antero receives annual research funding from Amgen that covers all expenses, including employee costs. Additionally, we have now demonstrated that our platform works to orally deliver another peptide with a significant potential, GLP-2. The only GLP-2 analog currently on the market, tetaglutide, was approved in 2012 as a once-daily injection for the treatment of short bowel syndrome. GATEX, the GLP-2 analog, registered global sales of over $600 million in 2020. In preclinical models, Entera's oral formulation of a GLP-2 analog has shown a comparable pharmacokinetic profile to the subcutaneous injection, and we strongly believe in the viability of this oral formulation. In addition to GLP-2, Entera has tested more than 12 undisclosed large molecule biologic therapies, both generic and proprietary ones from other pharmaceutical companies, in preclinical animal models. These data have improved our understanding of this technology as well as validated our ability to work with a variety of different large molecule therapies. As a leader in the oral delivery of large molecules and peptides, Entera further advanced its platform technology in 2021 by identifying potential new treatment indications, filing new patents, and receiving a foundational patent in the European Union representing new intellectual property with an extended patent life. Interra's platform technology continues to gain recognition for its application in transforming injectable biologics into oral pills. A study in collaboration with researchers at the University of East Anglia in the United Kingdom describing the platform's dual mechanism of action was published in the peer-reviewed International Journal of Pharmaceutics at in October 2021. Additionally, new data were announced suggesting Interra's platform orally delivers human growth hormone, shared in a poster presentation at the 31st Annual European Pharma Congress in London in 2021. From a business development perspective, we have increased our efforts to leverage our technology platform and have ongoing dialogues with several companies that are exploring the use of our old delivery platform with their injectable product candidates. We also continue to focus on the development of our platform as it relates to the evaluation of new APIs and believe that these efforts have the potential to generate value through either additional validation of our technology platform and or potential business development activities. Given the significant increase in active material transfer agreements that we have executed, we believe that some of these will result in more extensive long-term collaborations and licensing transactions. I now turn it over to Ramesh, our Chief Financial Officer for the United States.
spk07: Thank you, Philip. Revenues for the year ended December 31, 2021 for $571,000 as compared to 365,000 for the year ended December 31st, 2020. For 2021 and 2020, the majority of our revenues were attributable to research and development or R&D services provided to Amgen under the Amgen Agreement and other MTA agreements. The cost of revenues for the year ended December 31st, 2021 and December 31st, 2020 were 373,000 and 300,000 respectively and were comprised of salaries and related expenses in connection with R&D services provided to Amgen and other MTA agreements. Total operating expenses for the year ended December 31st, 2021 were 12.4 million and included 6.7 million in research and development expenses and 5.7 million in general and administrative expenses. Total operating expenses for the year ended December 31st, 2020 were $11.2 million and included $6.4 million in research and development and $4.8 million in general and administrative expenses. Research and development expense for the year ended December 31st, 2021 consisted primarily of headcount related costs and external costs related to the conduct of recently completed EB613 Phase II clinical trial. General and administrative expense for the year ended December 31st, 2020 were primarily made up of salary and related expenses, including share-based compensation, professional fees, DNO insurance, and legal fees. Net loss for the year ended December 31st, 2021 was $12.2 million or $0.47 per ordinary share. For the year ended December 31st, 2020, The net loss was $11.2 million or $0.67 per ordinary share diluted. As of December 31st, 2021, Interra had cash and cash equivalents of $24.9 million. And in our 10K that we filed today, we will report approximately $21.7 million in cash and cash equivalents as of March 1st, 2022. Based on current operating plans, we expect our cash position will be sufficient to fund our operations into the fourth quarter of 2022. I'll now turn the call back to Spiros for concluding remarks before we go to Q&A.
spk06: Thanks, Ramesh. The successful completion of the Phase II osteoporosis study was a major milestone given the extraordinary challenges related to the COVID-19 pandemic. And I want to thank the patients investigators, consultants, and the entire Interra team for their hard work and persistence in rigorously executing this clinical study. I also want to thank our shareholders and directors and consultants for their support of Interra's mission. 2021 was an extraordinary execution year. With our lead program progressing to phase three for this multi-billion dollar market, We expect 2022 will also be a year of execution and meaningful deals. We're off to a good start this year with a key patent filing and numerous business development and strategic partnering discussions. And Terra is entering very exciting times with many big catalysts in the coming year. Thanks to everyone for taking the time this morning listening to our review of operations. We look forward to providing you with regular updates on our progress in the coming months. Have a good day. We will now take questions.
spk03: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for your questions. Our first questions come from the line of Kalpit Patel with B. Riley. Please proceed with your questions.
spk05: Yes, hi, good morning. Thanks for taking our questions. Spiros, first, can you confirm... that you will be titrating to the 2.5 milligram dose of EB613 in the upcoming phase three. And then if you are titrating, can you give us additional color on perhaps how you're designing this trial to mitigate any risks for not showing non-inferiority against Forteo? I know there were some differences in efficacy between the titrated and non-titrated dosing groups in the phase two. So are there any, you know, certain steps that you might be taking to offset these efficacy differences, you know, potentially in the phase three?
spk06: Yeah, hi. Thanks for your question. Yeah, so in terms of the titration regimen, yeah, we've really tried to learn as much as we can from the phase two and apply that to the phase three study to sort of de-risk the the impact of the titration. So the phase two study, as you know, titrated over a very prolonged period, over two months, to go from the 1.5 milligram dose up to the 2.5 milligram dose. And it took us two months to get to the 2.5 milligram dose. And then it was only for the four months out of the six that patients were on the maximal 2.5 milligram dose. And so what we're instituting in the phase three study, we're still doing the same titration, going from 1.5 to the 2.5 milligram dose, but we're going to institute a more accelerated titration just over two weeks versus the two months in the phase two study. And so based on our review of the PK data and our phase two results, we feel that that titration will achieve what we need. The other good thing about the titration, as we saw in our phase two study, that in the titrated group, only one patient dropped out. So there was a very high retention, about over 90% of patients that were titrated up to 2.5 milligrams remained in the study, which was a very good sign of the tolerability. for those patients, even though they were at the 2.5 milligram dose for the full course of the study. And then one other element is that the phase three study is a 12-month study. And so patients will be on the full 2.5 milligram dose for essentially the entire 12-month period and having this very rapid titration up to the 2.5 milligram dose. Does that go? Okay.
spk05: Sorry, go ahead.
spk06: No, go ahead.
spk05: No, I think that's very helpful. I was going to ask, what's the status of the phase three? Are there any additional gating factors before you actually commence the trial? I think previously you guided to initiate in third quarter of this year. Is it still fair to assume that those timelines remain on track?
spk06: Yeah, sure. Yeah, the timelines that we were guiding to, so second half of this year. So it could be a third quarter or fourth quarter, but definitely for the second half of this year. And some of the activities are going on. I mean, we've signed up the CRO that is going to be working with us on the study. We're very busy in sort of identifying sites and on the operational side. and getting that aspect of the study operations were going up, up and running. Then we also, there are some refinements to the protocol that based on our end of phase three meeting with FDA, FDA has made some very useful suggestions for the study design, which I think would improve the phase three study. And so we're going through the process of updating the phase three protocol. And once that we have the final phase three protocol, Obviously, we'll be going with that, and we will update the market when we have the final phase three protocol. And we're still assuming about between 600 to 800 patients is still the current assumption for the phase three study.
spk05: Okay, fair enough. And how should we think about, you know, business development opportunities for 613? I think you mentioned some interest for 612. But what about, you know, the LEAD program? There was some regional interest that you mentioned in the past for 613. Are those conversations still ongoing?
spk06: Oh, yes. Very much ongoing. There's significant regional, especially Asian interest for Ultraversus, a very large market. And those discussions are progressing extremely well. And, you know, we've also, as we announced today, we've recruited Torea Capital to work with us on the partnering, global partnering for our Ultraversus asset. We think That will put us in the best position to get to really have the best partnership for our program, and that will really ultimately help us get to the finish line of an approved product globally. And so we're really excited about Torea coming on board, and they're obviously helping a lot in the strategic alliance and partnering efforts. There's also substantial interest, as Philip mentioned, on funding. Our hyperparathyroidism asset, there's a lot of companies with presence in the orphan disease space have a lot of interest. And there's a high possibility of a collaboration in that space as well.
spk05: Okay. And one final question, Spiros. Is the GLP-2 program the next step? you know, program that we should expect you to enter into the clinic? How should we think about timelines for advancement on this one?
spk06: Yeah. We will be sort of announcing or having another sort of investor day to discuss our platform and our next, what next API we will select. We're going through, we've put together a very seasoned scientific advisory committee that is helping us select our next API that offers the best potential between our platform and the properties of the API. So it may be GLP-2, but there are some other also very exciting possibilities. There are other GLPs that also offer maybe even bigger potential and a much bigger commercial opportunity. And so we're going through that process of prioritizing which one which next API we will select for our next program. So expect of an update probably in the first half of this year where we will update our investors and the market.
spk05: All right. Thanks very much, Spiros. Thanks for taking the questions. Thanks, Alfred.
spk03: Thank you. As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. Our next questions come from the line of Nathan Weinstein with Aegis Capital. Please proceed with your questions.
spk01: Thank you, and good morning, Spiros, and to the entire team, congrats on the progress with the business in so many different areas. I guess just a couple questions for me. Firstly, the revenue line continues to tick higher. Do you think you could make any directional comments on where that could go, and then does that include both the Amgen and new partnerships as well? Okay.
spk06: Yeah, great. Hi, Nathan. Yeah, great question. Yeah, good catch there on our revenue line. Yeah, it's kicking in the right direction, and that is, you know, the bulk of the revenues are from Amgen's payments to Interra. You know, Amgen covers all Interra costs related to the Amgen collaboration, so there's no sort of funding that Interra contributes towards that partnership. It is all covered by by Amgen, but we have also been getting a number of new material transfer agreements, which are funded by the companies that we negotiate with. So those companies are paying us to do these initial feasibility studies. And so there is that uptick in revenues also related to the higher number of MTAs that we've signed. We're getting that initial MTA funding. And so that is a good kind of... It's a good market. I would say that we expect to be entering into a next large collaboration this year on a new program, very similar to Amgen that's very de-risked, but that will provide significant funding to Interra.
spk01: Great, thank you, Severos. And just one question here on EB613. In the studies to date, could you just remind us what, if any, background therapies patients were on and then what might be allowed or not in the Phase III study?
spk06: Yeah, there were no, I believe the patients could not be on any anabolic drugs for a number of years before, for quite a long period before they were enrolled. in the study, and it's the same as the case for the Phase III. I'll ask Art Santora, chief medical officer, to just add a little more information on what background therapies patients were on or not on the Phase II, and then also how we're handling that for the Phase III. Art, if you could provide that.
spk02: Yeah, sure. All the patients had nutritional support in terms of supplemental dietary calcium if they needed it and a standard dose of vitamin D3. That's the nutrient vitamin D3, not an activated analog. And as Bear pointed out, patients couldn't have been on active therapy at the time they started this study. However, use of, say, bisphosphonates, as long as it was a number of years in the past, was allowed. And that's a very common situation we run into clinically. no immediate transitions from a bisphosphonate to EBPO5 would be allowed. The same would be in phase three. These would be a very similar population who would be candidates for an osteoanabolic that's currently approved, and they wouldn't be transitioning directly from a prior therapy like bisphosphonate or denosumab to the intervention in the trial. There'd be a gap of Probably in the order of two to three years, depending on the drug.
spk01: Okay. Okay, fine. So thank you for the detail there. And I think that's it for me for now. And congrats again on the progress. It's nice to see you guys developing the businesses so much. Thanks, Nathan.
spk03: Thank you. As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. There are no further questions at this time. I would now like to turn the call back over to Spiros Jamas for any closing comments.
spk06: Good morning, everyone. Thank you so much for calling in for our earnings call. As you can see, we're really on the verge of some big catalysts for Interra, for expanding Interra's business and using our platform as a huge value driver that I always really believed can can become. We have some very solid clinical milestones this year with progression to phase three. And we'll be keeping you updated on both our lead program but also our expanding opportunities with our platform. So thank you very much. Have a good day.
spk03: This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.
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