Entera Bio Ltd. (ENTX) Earnings Call Transcript & Summary

Good morning, and welcome to Entera Bio's 2019 Financial and Operating Results Conference Call. [Operator Instructions] I would now like to hand the conference 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 Adam Gridley, our CEO; and Phillip Schwartz, our President of R&D; and Arthur Santora, our CMO. A press release announcing Entera's financial and operating results for the fourth quarter and full year ended December 31, 2019, was issued earlier today. For those of you who have not yet seen it, it's available in the Investors section of our website, www.enterabio.com. On our call this morning, we will share with you a business update and review 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, 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 on current expectations that involve risks, changes in circumstances, assumptions and uncertainties. In particular, the COVID-19 pandemic is rapidly evolving and has created a significant amount of uncertainty. The extent to which the COVID-19 pandemic impacts us will depend on the duration and magnitude of such impact, and will depend on numerous factors that the company 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 of the information we've provided in this conference call is provided only as of today, and we undertake no obligation to update any forward-looking statements we may 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 Adam Gridley.

Thank you, Jon, and thanks to everyone for joining the call this morning, especially given the challenges we are all facing due to the spread of COVID-19. We've been rapidly evolving our plans to address the changing government regulations and the spread of the virus around the world. Our priority today is to protect the health of our patients, employees and local communities, without creating unnecessary disruptions into the company's primary goals. Before moving into our 2019 business update and corporate objectives for 2020, I want to thank our employees, our investigators and our patients for their support, and participation in our Phase II clinical trial for EB613 in osteoporosis. These are clearly unique times, and we very much appreciate everyone's continued perseverance and vigilance. When I joined the company in the third quarter of 2019, we committed to our stakeholders that we would be myopically focused on the execution of our most important business objectives, and I believe we are well-positioned financially and operationally to achieve a number of important goals this year. However, we cannot predict the impact of the coronavirus outbreak will have on our Phase II clinical trial and our employees. During 2019, we chose to refocus our efforts where we believe our technology platform will provide patients novel therapeutic options for large disease states and create the most value for our shareholders. To that end, we pivoted to focus on EB613, our orally-delivered parathyroid hormone, or PTH program, and initiated a dose-ranging, placebo-controlled Phase II clinical trial in postmenopausal women with osteoporosis or low bone mineral density, BMD. We will discuss EB613 and the data we expect to generate in more detail later on the call. But I'm pleased to say that as of today, we've enrolled 98 patients or approximately 60% of the planned trial, and until COVID-19 had been on track to meet the time lines we established and communicated in 2019. In September 2019, we also reported positive results from a Phase II PK/PD study of our second product candidate, EB612, where we confirmed that oral PTH is effectively delivered into the bloodstream, and activates PTH-dependent biological pathways that are inadequately activated in patients with hypoparathyroidism. In addition to advancing our internal PTH programs, we also initiated preclinical work on the first molecule covered by our collaboration with Amgen. We are pleased with the progress we have made, and are working with Amgen to move the R&D program forward in accordance with Amgen's project plan and objectives. On the corporate side, we expanded and enhanced our executive team and Board of Directors and established the new U.S. headquarters just outside of Boston. Our new executives and board members have significant experience in business development, and capital raising in the Life Sciences sector. We were heartened by the broad investor interest in our 2019 $14.3 million private placement, that went to final closing in February 2020, generated $13.3 million in net proceeds. Importantly, and based on our current operating plan, we believe we have ample funding in place to support our operations into the second quarter of 2021. And we will continue to explore opportunities to further extend our cash runway in light of the ongoing COVID-19 crisis. While 2019 was an eventful year for Entera, we also established a milestone-rich plan in 2020 for our lead programs, and generated significant investor interest in supporting the advancement of these 2020 objectives. As such, we believe we are extremely well-positioned entering 2020, both from a clinical and from a financial perspective, however, providing time lines today for our 2020 objectives is tricky, given the significant ongoing uncertainty related to the COVID-19 pandemic. The extent to which COVID-19 pandemic impacts us will depend on the duration and the magnitude of such impact, and will depend on numerous factors that the company may not be able to accurately predict. As a result, we cannot guarantee any of the time lines that we describe today. However, for context, prior to the global outbreak of COVID-19, we had communicated a detailed plan in our last quarterly investor call to complete enrollment of the Phase II clinical trial for EB613 in the first half of 2020 and finish the trial in the fourth quarter of 2020. Furthermore, we expected to report the interim 3-month biomarker data in the second quarter of 2020 with full 3 and 6-month BMD data in the third and fourth quarters of 2020, respectively. Importantly, we are on track to achieve all of these milestones until the second week of March, when certain quarantine steps and restrictions related in '19 were introduced in Israel and now in the United States. We have been evaluating contingency plans and employing risk mitigation strategies each day based on the Israeli regulations. And the Israel Ministry of Health guidance on travel restrictions, essential health services and quarantine rules, along with the rapidly changing guidelines for the conduct of clinical trials. To that end, let me provide some color on the status of the EB613 clinical trial and our broader operations. So we have 4 investigative sites in Israel, all of which are leading hospitals with patient enrollment fairly distributed across all 4 sites. The investigators, study coordinators and patients have continued to demonstrate enthusiasm to complete their treatment, or in the case of new patients, we have an active and growing backlog of patients to be screened, and potentially randomized that would have allowed us to continue enrollment per our original plan. Based on government and institutional directives implemented over the last several days, each of the sites are temporarily suspending on-site visits for monitors, canceling all nonessential patient visits, and in some cases, rapidly moving resources within hospitals to treat COVID-19 cases. As such, we have complied with the Ministry of Health's request and have temporarily suspended new patient enrollment, where until a week ago, we were tracking to enroll the roughly remaining 60 patients over the coming months as originally planned. Depending on the duration and magnitude of COVID-19, we do not know how long the suspension will last. Now for the roughly 100 patients currently enrolled in the study, we are prioritizing patient care and data collection through the approved means possible by the Ministry of Health. These steps include home health care visits, transportation for patients to investigative sites that remain open to serve existing patients on a limited basis, remote monitoring and courier services to ensure patients can stay on study drug, and we can collect as much data as is feasible. All steps are also documented, and within the emergency guidelines permitted by the Ministry of Health. At this juncture, it's still difficult to ascertain the full impact of COVID-19 on our existing patients and our ability to continue their associated data collection. As well as when we may be able to restart the enrollment process for new patients. We anticipate at this time that there may be at least a 1 quarter delay in completing enrollment, if at all, and correspondingly, our full 3-month biomarker endpoint, and 6-month BMD data may be delayed by at least 1 quarter. However, we do currently anticipate that we will meet our time lines for top line data release of the first 50% of patients with their 3-month biomarker data in the second quarter of 2020, which we'll discuss shortly in more detail. We will certainly keep everyone updated with any material changes to our time lines and data expectations as new information becomes available, or at the latest, in our next quarterly financial results call, which is anticipated to be in the next 5 to 6 weeks. Before we discuss the importance of the data that we expect to generate from the Phase II clinical trial for EB613, I'd like to quickly remind everyone about the opportunity that exists in the osteoporosis market today. There's a clear unmet need in osteoporosis due to the fact that only a small percentage of patients with this disease are actually treated due to cost, convenience and compliance challenges. We continue to believe that we can significantly grow the market by offering physician and patients a once-daily oral tablet that increases bone formation and builds bone mass, as an alternative to the currently available injectable anabolic drugs that are both expensive to manufacture, costly to the patient and health care system and inconvenient. I'd like to now turn the call over to Dr. Art Santora, our Chief Medical Officer, to discuss the Phase II trial for EB613. Art?

Thanks, Adam. Based on the feedback from our meeting with the FDA in November of 2018, we initiated a Phase II multicenter dose-ranging trial of EB613 in approximately 160 osteoporosis patients at 4 leading osteoporosis centers in Israel in July 2019. The trial, which includes a 6-month treatment period, is being conducted to evaluate both the safety of EB613, and to identify the optimal dose that we will select to advance into a single Phase III pivotal noninferiority BMD trial versus subcutaneous parathyroid hormone, subject to positive Phase II data. There are 4 arms in the Phase II trial of 40 patients each, 1 placebo arm and 3 different EB613 doses, 0.5 milligrams, 1.0 milligrams and 1.5 milligrams of oral PTH. Based on our prior data showing the maximal concentration of PTH in the blood, sometimes referred to as a Cmax, and an average concentration referred to as AUC, after a dose of EB613, we believe these doses encompass potential optimal dose equivalent to a 20-microgram injection of FORTEO. In this trial, we are evaluating the effects of EB613 on bone marrow density, or BMD after 6 months, and multiple biochemical markers, including P1NP, a bone formation marker in CTx, a bone resorption marker at both 3 and 6 months as well as a standard set of safety assessments. Specifically, the study has 2 primary endpoints, the change in bone formation marker P1NP after 3 months, and the change in spine BMD over 6 months. Because of the long history of the use of injectable PTH, FORTEO, to treat osteoporosis and a non-correlation of the improvement in biomarkers of bone formation rate in BMD to treatment of the underlying disease, we at Entera, believe that the biomarker and related BMD data from the trial will be indicative of the potential anti-fracture efficacy of EB613. Furthermore, we believe the data will be important in refining the design of the Phase III trial and the ability to use the 505(b)(2) regulatory pathway for potential approval in the United States. Historically, FORTEO and other agents have demonstrated that bone markers and higher bone mineral density are strongly correlated with reduced fracture risk. Demonstration of BMD and anti-fracture efficacy usually requires multiyear studies of thousands of osteoporotic patients. Fortunately, there are also a number of well-studied biomarkers of information and resorption that have demonstrated a strong correlation with improvements in bone mineral density for each class of osteoporosis drugs, including PTH and its analogs. In our upcoming 3-month initial biomarker readouts in the first 80 patients enrolled in the second quarter of 2020, we will be analyzing the following biomarkers, and I will now explain their potential importance. P1NP serum concentration is an indicator of the rate of new bone formation, and typically increases between 50% and 100% after 3 months in clinical trials in PTH. CTx serum concentration is an indicator of the rate of old bone resorption by osteoclast, the cells that remove old bone. PTH and analogs are osteoanabolic because they stimulate bone formation as measured by P1NP much more than the increased bone resorption, which is measured by CTx. It is the difference between bone formation and bone resorption that determines BMD increases, our other primary endpoint in the Phase II study. For reference, several independent clinical trials with additional osteoanabolic osteoporosis treatments have shown that the increases in bone formation relative to bone resorption is more predictive than an absolute increase in bone formation of the increase in BMD during treatment with PTH and PTH analogs. We look forward to these initial biomarker readouts in the second quarter of 2020 with the first 50% of patients' data available, and we plan to provide top line data via a press release and hold a conference call to discuss the results when available. Assuming a favorable outcome in the current Phase II study, we intend to position EB613 for a single Phase III multicenter noninferiority BMD endpoint trial of 600 to 700 osteoporosis patients comparing oral EB613 with subcutaneous FORTEO over a 6 to 12-month treatment period. We have already received regulatory guidance from the FDA that the non-inferiority margin is expected to be 25% of the effect of FORTEO on BMD. This is a margin we believe may be achievable in a study of the size based on prior literature and the anticipated clinical data from the ongoing Phase II study. As part of the development plan for EB613, we have conducted several nonclinical safety assessment studies to support our regulatory filings, including a planned investigational new drug application, or IND, filing with the FDA later this spring to conduct our initial U.S. clinical pharmacology/pharmacokinetic study. We'll also be preparing a Phase III protocol to position the program for a Phase III trial potentially beginning in 2021 or 2022, pending the timing of completion and the successful outcome of the Phase II clinical trial, funding, and a potential collaboration with another company, if achieved. Moving on to our second proprietary program with oral PTH EB612 for the treatment of the orphan disease hypoparathyroidism. In September of 2019, we reported positive results at the 2019 Annual Meeting of the American Society for Bone and Marrow Research and the Phase II trial of EB612. The trial evaluated the pharmacokinetic/pharmacodynamic profile of EB612 in 16 patients with multiple doses and dosing regimens of orally-delivered EB612 against a single once-daily dose of 100 micrograms of Natpara, parathyroid hormone, delivered via subcutaneous injection. In this trial, EB612 was generally well-tolerated and we were able to show a dose-dependent pharmacodynamic response with an increase in serum calcium and active vitamin D and a decrease in phosphate. In addition, oral PTH reduced urine calcium loss as demonstrated by an almost 25% reduction in 24-hour urinary calcium excretion. I'll now turn to Dr. Phillip Schwartz, our President of R&D, who will provide an update on our product development efforts and time line.

Thank you very much, Art. Good morning, everyone. Our collaboration with Amgen for the development of an oral anti-inflammatory agent continues to progress. In late 2019, Amgen elected to continue the collaboration, which triggered the ongoing financial support for the year 2020. Over the last 12 months, the teams have been working well together and Amgen has completed several studies that have included the evaluation of different formulations we have provided to Amgen, and we are pleased with the results to date. We believe our technology is performing well and that we have been able to rapidly create different formulations with different PK/PD profiles to support Amgen's activity. Turning to other research activities for 2020. We are focused primarily on 2 objectives: the development of our platform as it relates to the evaluation of new APIs or Active Pharmaceutical Ingredients and formulation development for EB612. We believe that each of these areas has the potential to generate value through either additional validation of our technology platform and/or through potential business development activities. In the area of API or additional drug development, we continue to evaluate new APIs that can benefit from the application of our technology. As a reminder, we have a newly-developed set of in vitro assays that have enabled us to significantly reduce the initial evaluation time of new APIs. To date, Entera has brought several APIs into preclinical animal testing and preliminary proof-of-concept data. And this data indicates that we can work with a variety of large molecule drugs, ranging in size from small 3 to 4 amino acid peptides to very large proteins with more than 100 kilodaltons. We intend to leverage this work and have a goal to build our platform by adding 2 new targets in 2020 for potential future development. In addition to screening the potential molecules based on the attributes that we think would lend themselves to our technology, we will also be evaluating candidates based on criteria, including market size, unmet need and the overall development and regulatory pathway. With respect to EB612, our product for hypoparathyroidism, we intend to conduct additional formulation and development activity to determine an appropriate formulation that will enable us to prepare for the potential initiation in 2021 of an additional Phase IIb or Phase III clinical trial of EB612 for the treatment of hypoparathyroidism. As a reminder, the clinical trials to support approval products -- of products to treat hypoparathyroidism are often small. For example, Natpara, the leading injectable, was approved on the basis of a single 120-patient Phase III clinical trial. Given the likely size of the Phase III clinical trial, we believe we could develop and commercialize this on our own, but we also believe that we should evaluate collaborations that leverage our existing resources. I'll now turn it back to Adam to provide an update on our business development opportunity.

Thanks, Phillip. Besides our Amgen collaboration, we continue to explore a variety of co-development and collaboration opportunities. In 2020, we have 3 initiatives. Our first priority is to work with companies seeking to leverage our development and delivery capabilities to work with their internally developed compounds and injectables, perhaps in a structure similar to the Amgen collaboration. The recent approval of Novo Nordisk's oral semaglutide GLP-1 agonist, which utilize the same absorption enhancer that Entera uses, has stimulated great interest in our oral large molecule delivery systems. The approval of Novo's drug not only validates our use of this particular absorption enhancer molecule and other indications, but also proves that it is possible to get an oral biological drug approved by the FDA. Additionally, the Novo approval has the potential to ease our regulatory processes and has resulted in a substantial increase in the number of detailed discussions with several additional companies seeking to codevelop their molecules or their APIs as oral therapies. Given the very tunable nature of our technology through the synergistic combination of absorption enhancers and protease inhibitors, many companies have approached us to help solve their drug delivery problems. We believe our unique capabilities of reducing variability and increasing bioavailability offers distinct advantages versus other oral delivery technologies. Our second business development initiative is the initial efforts in potential commercial and licensing arrangements around EB613. Given our upcoming Phase II readouts in the coming quarters and the rather short development pathway to a Phase III study, we are currently in confidential discussions with several potential commercial partners who may have interest in working with us on the Phase III program. We're evaluating our opportunities to either complete the global registration trial in osteoporosis on our own, or license this prior to a Phase III where leading pharmaceutical companies may be interested in conducting the trial on their own with their own key opinion leaders. Thirdly, our efforts in China and Japan are progressing with strong interest in both regions regarding potential collaboration opportunities. As a reminder, due to recent changes with both the FDA and global registration pathways, we have started to leverage our vast development and clinical experience into global registration programs. The osteoporosis market in China, for example, is growing rapidly due to an aging population, low calcium and vitamin D intake, and the presence of a number of leading pharmaceutical companies with experience in injectable PTH entering the Chinese market. We're also conducting diligence with a number of parties in China following meetings with JPMorgan to discuss our lead osteoporosis program and potentially new compounds. While the Chinese New Year and COVID-19 has had some impact on the momentum in those discussions, we've recently reinvigorated this initiative with additional experts in the Chinese pharmaceutical and financial industry. Now in the case of Japan, we also believe there is strong interest in certain rare endocrine and renal diseases and a strong foundation of companies targeting osteoporosis. After a number of productive meetings at the Supanova Japan and the JPMorgan conferences, we recently engaged one of the preeminent Japan market business development consultants to assist with our partnering efforts. Until the recently canceled BIO Asia Conference in Japan, we are engaged in multiple discussions and partnering meetings. However, our momentum continues with virtual video conferences during this period of travel restrictions, and we continue to work closely with a number of potential collaborators regarding these opportunities. We are, in parallel, exploring the opportunity to seek orphan drug status in Japan and hypoparathyroidism by utilizing much of the strong data packages we'll use for the IND going to the FDA in the United States. In summary, we have found that our unique technology offerings, novel delivery of well-established APIs currently administered by injection in a manner that protects and enhances absorption, yet doesn't modify these APIs, may afford a rapid regulatory pathway for leading biotech and pharma partners. Coupled with our deep know-how and rapid development process supported by our 9-plus years of investment into our formulations and CMC programs, we can also offer a tablet that could be made for a fraction of the cost of injectables. Finally, our strong IP position provides an attractive, cost-effective yet sustainable product portfolio for potential partners on a worldwide basis. At this point, I'll turn over the call to Jon Lieber, our U.S. CFO, to cover the financial results. Jon?

Thank you, Adam. Revenues for the year ended December 31, 2019, were $236,000 and were attributable to R&D services provided to Amgen as part of the collaboration. The cost of revenue includes direct salaries and related pass-through costs. Total operating expenses for the year ended December 31, 2019, were $11.5 million and included $7.2 million in research and development expenses and $4.3 million in general and administrative expenses. R&D expense for the year ended December 31, 2019, consisted primarily of headcount-related costs, costs related to the initiation and conduct of the EB613 Phase II clinical trial and consulting expenses and fees related to the preparation of an IND application for EB613. General and administrative expense for the year ended December 31, 2019, was primarily made up of salary and related expenses, including share-based compensation, legal and accounting fees and D&O insurance expense. Net comprehensive loss was $10.8 million and included a gain on the change in fair value of warrant liabilities. Basic and diluted loss per ordinary share was $0.89. As a reference point, we currently have approximately 18 million primary shares outstanding and 26 million fully diluted shares outstanding. At December 31, 2019, Entera had cash and cash equivalents of $15.2 million. The December cash balance excludes approximately $0.8 million net of expenses received in February 2020 in connection with the final closing of the December 2019 private placement. And in our 20-F filed today, we reported $13.7 million in cash and cash equivalents as of March 16, 2020. Based on current operating plans and the expected timing of product development programs and subject to the impact on our operations of COVID-19, we expect our 2020 operating loss to be between $10 million and $12 million based on steps already taken to preserve our cash to extend our runway until we have further visibility to the impact of COVID-19 on our clinical milestones and the overall financial markets. We currently believe our current cash position will fund our operations into the second quarter of 2021. I'll now turn the call back to Adam for concluding remarks before we go to Q&A.

Thanks, Jon. We appreciate everyone's patience and support during these uncertain times. 2019 was a year of transition and execution, and we ended the year in a very strong financial position with substantial value-creating milestones coming in 2020. We continue to have conviction regarding our long-term development strategies, yet we are mindful on the rapidly evolving COVID-19 challenges, both in Israel for our ongoing Phase II study and on our employees. And also in the United States, where financial markets have seen considerable disruption. We will continue to be careful stewards of our human capital, our financial resources, and seek to proactively and rapidly pivot in a manner that preserves our product development initiatives, advances our business development opportunities and positions us for rapid growth as these uncertainties abate. Our 2020 milestones for our osteoporosis program continue to be our first priority. And while our current estimates assume a delay in completing full enrollment of patients into at least the third quarter of 2020, we do anticipate meeting our original time line of the 3-month biomarker data for the first 50% of patients in the second quarter of this year. We also anticipate that we will have additional visibility to the impact on the continued enrollment of the Phase II trial in Israel. And we'll continue to update our stakeholders as we receive material updates, including in our upcoming first quarter 2020 financial results call targeted for mid-May of 2020. Operator, please open up the line for questions.

[Operator Instructions] Our first question comes from Jason McCarthy with Maxim Group.

This is Naureen on for Jason. I hope everyone is safe and well. Obviously, given the COVID-19 situation, a lot of time lines and trials have been impacted. There have been a lot of disruptions. So I was wondering, I understand time lines may not be met, and that said, I'm sorry, I missed it. But can you remind us again what catalysts or milestones we might expect in 2020 from Entera in addition to the 3-month biomarker data in 2Q?

Sure. Thanks, Naureen. Appreciate the question. And indeed, we still have a plan for a milestone-rich 2020. The original plan had contemplated the first biomarkers in the second quarter, the full 3-month biomarkers in the third quarter and then bone mineral density data in the fourth quarter, and that was the 6-month primary endpoint. So we still have plans for the initial 3-month interim biomarker data, which is one of the primary endpoints. And that will be in the second quarter, so sometime in the next couple of months. The benefit of the great progress we made on enrollment is that we're already about 60% enrolled. And so that 50% mark is still on target. Obviously, it's hard to predict how long this temporary suspension will result in, but our goal is to hopefully get things restarted in the next couple of months. And then we would anticipate if things were pushed out by 1 quarter, we would still have the full 3-month biomarker data and completion of the trial this year. So we're still optimistic. The investigators and patients are quite enthusiastic and indeed still trying to enroll. However, we are going to comply with the Ministry of Health requirements in Israel, and make sure that our patients are safe in that process. So we're still pretty optimistic about 2020. This is still a very considerable data set that we'll be reporting, and expect to be bringing that forward to our investors soon.

Great. That's helpful. And could -- you've been engaged with a lot of people in other regions, could there be any BD announcements this year?

It's hard to predict exactly when those would be announced, but indeed, that is part of our significant strategy in a number of a couple of areas. So first, of course, is the lead program, so EB613. Independent of this most recent delay, we think there's a lot of interest given the very short development time line and the ability to run 1 Phase III trial. So we've got very active discussions in China, in Japan, looking at Korea. And naturally, as those regions start to come back on post-COVID, we're accelerating our efforts there. And actually, we're all getting used to working virtually here in the United States and in Europe and Israel as well. So I don't anticipate that those activities slow down. And as we think about this time period, we're in fact, trying to accelerate those. So that is one of our major focuses right now for that lead program. There's also quite a bit of interest in hypoparathyroidism program, particularly in Japan, where you have a higher rate of thyroid cancer than other regions. And then as we noted, Phillip's been leading a number of our R&D initiatives to look at new compounds, very similar to the original Amgen deal that we did where we were looking at completely new compounds outside of parathyroid hormone. And the recent approval by Novo, of course, with SNAC, which is a similar absorption enhancer, I think, has led to a lot of interest. So we continue to accelerate on each of those. We think that's an important part of our overall value creation initiative. And would anticipate that over the next couple of months, even though we're virtual, those activities are likely to accelerate.

Great. And one last one for me. Can you comment on the Amgen partnership? Obviously, you can't comment on the drug target, but perhaps has Amgen elected to select additional programs? Have there been any discussions around that? Or is it too premature?

Sure. Generally speaking, it's too premature for us to comment on that. But perhaps, Phillip, our President of R&D, can comment on how the overall program is going and give a little bit of color on that. Phillip?

Yes, sure. Thanks, Adam. Yes, the program is moving along. We're going into -- we've done a number of preclinical studies. And Amgen is now doing a number of preclinical studies in their hands as well. Unfortunately, recently, as has been in the news, their Thousand Oaks location has shutdown for the moment, but we hope that it will be coming back up in the near future. With regards to other molecules, we have discussed other molecules, and we continue to have very active conversations regarding other molecules as well. And sometime in the future, perhaps we'll try to test out some of those molecules. And that would lead, obviously, to them deciding perhaps that they would like to pursue one of those molecules with that. Just as a reminder, I'd like to point out that the molecules that Amgen has been interested in and continues to be interested in, are not necessarily molecules that are currently injectables that they need to convert into oral formulations because of the convenience factor, other things, often molecules that are injectables do not work as injections, and therefore, it can take a molecule, which previously was not useful as an injection or not therapeutically effective, and turn it into a therapeutically effective medication. So that really widens the field, especially when the failure in drug development is so frequent and very, very few molecules actually make it to the market. By offering another chance for people to take molecules, which may not work with one form of administration and converting them to another form of administration, we're actually giving companies a second chance to try to use molecules, which may be very effective in the target but can't be administered as an injection. Adam, do you want to go on?

Thanks, Phillip. So Naureen, I think we're very pleased with the progress thus far. We were just at Amgen a couple of months ago and expect that this program will continue. And understand, we're also looking at ways that we can incent and create data to be able to look at new compounds. So very excited about that, and we think that, that potentially broadens the opportunity for other partners as well.

[Operator Instructions] And our next question comes from Eric Rubenstein with Intuitive Venture Partners.

Adam, could you please discuss the -- or in any more detail the 2 additional molecules that you're thinking about going forward on? In other words, just what areas of focus they are in?

At this juncture, those molecules are potentially confidential. However, we can comment, Eric, on the number of molecules that we've looked at. Naturally, our product portfolio has utility and molecules up to 150 kilodaltons. We've been looking at a wide range of potential APIs. As Phillip noted, in some cases, they aren't just injectables. So in the case of parathyroid hormone, our lead program, we're taking a well-known injectable, otherwise known as FORTEO. And we believe that we can convert that into an oral pill with all of the efficacy and safety benefits, but at a fraction of the cost. So those continue to be one area where there are obvious injectables that we could then improve the cost compliance and convenience challenges. Alternately, we've looked at other compounds such as growth hormone. We've naturally started to look at other areas in other therapeutic spots outside of the anti-inflammatory space. And in many cases, folks are coming to us. The obvious question that we always get is, can we do monoclonal antibodies? We're not sure yet, but we're evaluating that. And we continue to look at how we can extend that portfolio.

I'm not showing any further questions at this time. I would now like to turn the call back over to Adam Gridley for closing remarks.

Thanks, Joel. Thanks to everyone for taking the time this morning to join our call. We look forward to speaking with you in a couple of weeks. Be safe, and have a good day.

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