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

Hello, everyone, and welcome to Entera Bio's Investor Conference Call today to discuss the company's results from the successfully concluded Phase II clinical trial of its drug candidate EB613 for the treatment of osteoporosis. Joining us on the call today are Dr. Liana Tripto-Shkolnik, an osteoporosis expert and principal investigator of Entera's Phase II study, and Entera's executive management team, including CEO, Spiros Jamas; Phillip Schwartz, the President of R&D; Art Santora, the Chief Medical Officer; and U.S.-based CFO, Ramesh Ratan. Spiros Jamas will open the call with an overview of the Phase II results, followed by Dr. Tripto-Shkolnik, who will provide context on the results of the study and the significance of an oral drug to treat osteoporosis. [Operator Instructions] Please be advised that today's may be recorded. [Operator Instructions] I will now turn the call over to Ramesh Ratan for the safe harbor statement.

On our call this morning, we will share with you the results of the EB613 Phase II study that was announced in a press release on June 23, 2021. The press release is available on the Investors section of our website www.enterabio.com. The presentation 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, financial position and interpretation by the company of the recently completed EB613 Phase II clinical data as well as the safety, probability, and comparability of EB613 relative to currently available injectable therapeutics may not be supported by subsequent pivotal trials and could be subject to different interpretation by the FDA. Also, 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, especially in 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 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'll now turn the call over to Spiros.

Thank you, everyone, for joining us today. I'd also like to thank Dr. Tripto-Shkolnik for joining us to add a clinician's perspective on EB613 in osteoporosis. We truly appreciate all her hard work and dedication to the study and making it a success despite all the COVID-19 challenges. We know it wasn't easy. Before we get into the review of the clinical results, I'd like to give you a snapshot of why we think EB613 is a tremendous opportunity in the osteoporosis market. As most of you know on the call today, EB613 is an oral formulation of human parathyroid hormone 1-34, or PTH, and is positioned to be the first oral bone building or anabolic product to treat osteoporosis patients. This 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. 1 in 2 women and 1 in 4 men over 50 years of age will break a bone due to osteoporosis. In a therapeutic market this large and estimated at $4 billion annually today, surprisingly, there are only 3 effective bone-building treatments available. FORTEO or teriparatide, Tymlos or abaloparatide and Evenity or romosozumab, and all 3 are injectables. This may be one reason why only 5% of people living with osteoporosis are treated. These injectables are also quite pricey at a cost of $20,000 to $30,000 per year in the United States. We believe that a safe and effective oral bone-building drug like EB613 may significantly increase the treatment market. 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 solutions. Aside from the more patient-friendly oral delivery as an oral drug, EB613 can be far more cost-effective than injectables. We believe Entera has a multibillion-dollar opportunity here by treating new patients who currently are not on either of these injectables. We estimate there is a sizable opportunity or 10% market penetration with patients currently untreated, and at a cost that is 25% of today's injectable price, which translates into over $20 billion, plus the potential to take share from the 50,000 patients treated with injectables today. Our Phase II clinical trial of EB613 was a 6-month double-blind dose ranging placebo-controlled study in 161 postmenopausal female subjects with osteoporosis or with low bone mineral density. The study was conducted at 4 leading medical centers in Israel to evaluate the safety and efficacy of varying doses of EB613. One of these 4 sites was the Sheba Medical Center's Division of Endocrinology, Diabetes and Metabolism in Tel Aviv. For the third year now, Newsweek ranked the Sheba Medical Center as one of the world's top 10 hospitals. The most important BMD endpoint, change in lumbar spine BMD after 6 months was met. Subjects receiving the 2.5 milligram dose of EB613 showed significant dose-related increases in BMD at the lumbar spine, total hip and femoral neck. At 6 months, lumbar spine BMD increased by 3.78% as compared to placebo with a p-value of less than 0.008. The study's primary efficacy endpoint, a statistically significant increase in P1NP at 3 months was also achieved. EB613 exhibited an excellent safety profile with no drug-related serious adverse events. I want to highlight 2 pieces of data that point to the performance of Entera's platform to deliver a peptide orally and achieving a controlled biologic effect. There was a significant dose response for the PTH dose in EB613 and the increase in lumbar spine BMD with a p-value of less than 0.0001. Also, there was a significant dose response for the PTH dose in EB613 and the increase in month 1 P1NP with a p-value of less than 0.0001. We look forward to an end of Phase II meeting with the FDA to review these data and discuss EB613's development program. With the FDA's agreement, we plan to conduct a single pivotal 1-year Phase III study comparing changes in lumbar spine BMD in patients treated with oral EB613 versus treatment with FORTEO injections as for the 505(b)(2) partly. In this noninferiority study, we would evaluate EB613's effect on spine BMD to be within 25% of FORTEO's or greater. I'd like to point out that increases in lumbar spine BMD versus placebo observed at 6 months in previous FORTEO studies conducted with patient populations similar to that of our Phase II study are in the 3.9% range. As a point of comparison, I'll reiterate that in our Phase II study, oral EB613 2.5 milligrams daily increased lumbar spine BMD by 3.78% compared to placebo. Similar to FORTEO, we expect that the increase in lumbar spine BMD seen with EB613 will continue to increase from 6 months to 12 months. Furthermore, EB613 had a significant impact in both femoral neck and total hip BMD at 6 months. In contrast, significant increases in BMD of the femoral neck and total hip are usually not observed with FORTEO treatment at 6 months. At this point, I will turn the call over to Dr. Tripto-Shkolnik. Dr. Tripto-Shkolnik has been in the field of endocrinology and mineral and bone metabolism for the past 15 years. Her prior and current positions enable her a broad perspective on patient care in the field of osteoporosis, both as a consultant to primary care physician and as a leading bone specialist in a tertiary care facility. Dr. Tripto-Shkolnik is currently Deputy Director of Division of Endocrinology, Diabetes and Metabolism at the Sheba Medical Center. Dr. Tripto-Shkolnik leads the osteoporosis clinic at Sheba, which sees a few thousand patients a year. She is also a lecturer at the Tel Aviv Medical School. Dr. Tripto-Shkolnik has served as a PI in several studies in the field of osteoporosis, including anabolic treatments, novel technologies, rare bone diseases and more. Following her comments, we will open the call to Q&A.

Hello, and thank you for the invitation to discuss the results of the Phase II EB613 study. As a PI at the Sheba Medical Center site, I have enrolled 49 patients in the study. The enthusiasm of the patients to participate was exceptionally impressive despite their awareness of the relatively short exposure to the medication and existence of the placebo arm. Moreover, twice as much, 99 patients, were screened and interested in participation if only their bone mineral density was in the range defined by an inclusion criteria. I think that the option to receive an anabolic bone-forming agent was crucial in the informed consent process for most of the participants. Despite various restrictions and concerns due to the COVID-19 pandemic, patients were still interested in participating in the study. The unique place of anabolic treatment for osteoporosis care has become evident 2 decades ago with the publication of the pivotal teriparatide study. At the beginning, teriparatide was mostly reserved as a second-line treatment for high-risk patients who failed on the initial first-line medication. During the last years, it has become evident from several studies that a bone-forming treatment as a first-line medication followed by an antiresorptive is a more efficient approach. Current guidelines support this sequence in high-risk patients, and it is becoming state-of-the-art approach. In these circumstances, there is an obvious clinical need and potentially a large market for an oral anabolic drug for osteoporosis. Among several thousand osteoporosis patients seen annually in our high-volume tertiary care facility, many have intermediate or high fracture risk and, as such, are offered an anabolic option. In many cases, one of the barriers for patient acceptance of the recommended treatment is a need to inject it daily. An oral anabolic medication is therefore an exciting possibility. Back to the study results, aside for the statistically significant 3.78% increase in lumbar spine bone mineral density, BMD, I believe that the improvements seen in the femoral neck and total hip BMD of 2.76% p-value of less than 0.002 versus placebo and 1.84% p-value of less than 0.02 versus placebo with 2.5 milligrams EB613 are clinically relevant. The lumbar spine results are in line with the observed BMD increment in the FORTEO studies at 6 months. We did observe side effects with a high dose of the study medication, quite similar to the lightheadedness with the company's first doses of FORTEO. Frankly speaking, we were in a way happy to observe this resemblance, supporting our confidence that the oral medication is similar to the injectable. The titration to the 2.5 milligram dose went smoothly for most patients and indeed led to fewer dropouts. In conclusion, I look forward to continuing to collaborate with Entera Bio on EB613 and to being one of the PIs in sites in the company's Phase III study. Thank you.

[Operator Instructions] Our first question comes from the line of Kalpit Patel from B. Riley.

Congrats on clearing the Phase II endpoints. I guess the first one regarding the pharmacokinetic variability for 613. I know in the past, you've shown that 613 is comparable in terms of PK variability to the injectable version of FORTEO in healthy volunteers. And I'm curious to learn how that's trending specifically in the 2.5 milligram dosing group. Maybe some insight on the intra and inter patient variability would be useful. And then in your prior communication with the regulators, can you comment on any feedback that you may have received with respect to this topic?

Yes. Kalpit, thank you very much for your question on the PK variability in the PK -- our earlier PK results. I'll turn it over to Phillip, to just give a perspective on what we're seeing on PK.

Thanks very much, Spiros. Yes, in regards to PK in this clinical -- in this Phase II clinical study, in order to do a full PK analysis, you would have to have the person staying at the clinic for many hours. And there's limitations of how much blood you can take on a 6-month study like this, where we were unable to perform a full PK analysis on this population. We only have the particular time points involved. So we can't give you a full PK analysis in terms of variability to treat the doses. I can tell you that in almost 100 different healthy volunteers as well as many patients that we've done full PK analysis, typically, the variability between doses in terms of interpatient and intrapatient variability was somewhere between 60% and 75% on average, with the oral PTH. And that compares quite favorably with the variability that's observed with FORTEO. Inherently, you always like to see little variability in an oral formulation than we would in an injection regardless of the molecule involved even from a small molecule. So the amount of variability that we achieved is really an incredible accomplishment, especially when compared to the variability of other oral formulations of PTH, which have been tried in the market previously by both Human Genome GSK and by Novartis. In answer to your second question, regarding the FDA -- the agency's stand on the PK variability, I think that, in general, in our pre-IND meeting and we met some face-to-face, first of all, I've written correspondence as they were not concerned at all about the variability that I think and then -- and no correspondence with us. They actually were quite impressed with the viability and commented on how well controlled we get. So I think that the variability is very, very well controlled for this whole formulation. And I believe also that, that is really reflected very much in the statistical analysis and the very, very low p-values that we had, which was incredible, ps of less than [ 0.001 ] or [ 0.0001 ] dose response for this -- to the drug. That's very rare that you see that unless you're getting a very, very consistent dose into the bloodstream. Does that answer your question? Or do you have a follow-up?

Yes. No, that was super helpful. I know you guided to present additional details at an upcoming medical conference. But maybe at a high level, how compliant were the enrolled patients in that 2.5 milligram group? And then do you have a preliminary picture of how the compliance fares relative to what you would expect with an injectable PTH?

Right. So there are 2 different levels of compliance in terms of people taking the medication, at least at high amount. I don't know the exact data to various clinical trials for FORTEO, I'd have to look back and look that up. But our compliance was extremely high. Obviously, it's very easy to take pills. And the only reason that someone would not take the pill is to very few adverse events related to taking the pill or just because they would forget. They are supposed to take the pill early in the morning on an empty stomach and that is what they did. So the compliance was very high. And that's what I can say about the plan. And I'm sorry, the second -- there was a second question that I missed.

No, I think you addressed it. I was just asking on how it fares to -- relative to FORTEO. That's it. Maybe...

Yes. The compliance is at least as good as FORTEO's. And I would say that the 2.5-milligram group did not have different compliance from the lower dose groups [ to have significant effect ].

Okay. And then you reported a placebo-adjusted increase in lumbar spine BMD at month 6. Can you provide some color on what the placebo response was in the 2.5-milligram group and how that compares with what we typically see in other trials?

Yes. I don't think there's a -- minus is durable. Go ahead, Spiros, I'm sorry.

No, go ahead, Phillip.

Yes. So it was minus 0.16%, which was a typical study. This is the milder population that we had, which means that our effect would be -- expected to be greater in a more severe population. So the more severe the population, the greater the effect of the drug generally speaking this clinical trial. And the placebo was only minus 0.16%. So the placebo adjustment did not have a very big impact on the number that you see. That's actually the absolute number is also very, very significant as well. Just to give you an idea, often the placebo in these groups would be minus 0.5%, 0.6%, a much more significant drop because they're more severe populations generally.

Okay. One final question from me. Are you actively engaged in exploring any co-development opportunities for 613 now that you have good results in hand. Or is the Phase III likely shaping to be a sole operation?

Yes. Thanks, Kalpit. Yes, we are -- I mean we're pursuing aggressively to complete our end of Phase II meeting with FDA. So that we can have our final agreement on exactly what the details of the Phase III design, the number of patients so that we can really be planning to move that forward. And operationally, we're pushing to move that forward as a sort of -- we don't -- some of the -- our time lines with initiating Phase III in early next year. But at the same time, yes, we are in multiple discussions. I mean osteoporosis is a global market and indication. And I think Entera would be better served with -- entering into some strategic partnerships on the asset. And so -- yes, and this data is going to be very helpful in allowing us to continue those discussions.

Okay. Congrats on the data again.

Our next question comes from the line of Jason McCarthy from Maxim Group.

A lot of the clinical questions were kind of asked and answered already. Could you just maybe give us a sense of what you think the size of a Phase III trial for a 1 year or 6 months -- or for a BMD endpoint could look like and what the estimated cost? I know there was a question about potential co-development, but until there's a partnership, the assumption is that it's a go-it-alone in Phase III. What do you think that trial could cost?

Yes. Thanks, Jason. Yes, so in terms of the size of the study, I mean, we've guided to a range right now. We expect the study to be between 600 and 800 patients total. And there will be -- with 2 groups, the 2.5 EB613 and FORTEO and a head-to-head comparison. We are -- sort of now that we have our actual results, we're going to fine-tune our assumptions for the Phase III. And so that may change the total sample size for the Phase III. And as soon as we have that, we'll update the market on what we -- what the final design and what we're going to be proposing to the FDA. And so that's kind of where we are with the study size. I mean in terms of the study of that size, again, sort of fine-tuning our estimates for a study of that size, but that would be somewhere in the range of 30 million fully outsourced study with an international CRO. But again, those are things that we're working on in our budget.

Right. Can you just talk a little bit about the bone marker ratios, P1NP and the CTX. Those are important in the prior data updates and you just put out good biomarker data in the spring. And making comparisons between FORTEO or Prolia, those ratios are different. But when you have a ratio that seems to be defined for one drug like yours, we can almost make predictions or even handicaps in a way, if you would, what the BMD change could be. So, again, can you talk a little bit about that? And would you include a bone marker analysis like that potentially as an interim analysis in your next trial?

Yes. I mean we may include a biomarker analysis. But just to go back, I mean, to remind everyone we saw at our month 3 endpoint -- month 3 readout of the study, we saw significant increases in the high dose group at month 3 for the P1NP biomarker and osteocalcin. And at the same time -- and those are sort of correlate with increasing bones mass. And we had significant reductions in CTX. And I think that's the point that Jason is pointing out. But by having this sort of dual benefit of a triggering -- increasing bone mass, but also reducing sort of bone results, and so with the CTX biomarker. So it was nice that the CTX was significantly reduced at month 3. We are currently -- obviously, as you can imagine, there's a lot of -- we're looking at the correlations of the biomarkers with the BMD end points and that could be the subject of subsequent publications and presentations on our data. But yes, that's a very important point, Jason, in terms of the profile that we see. I mean anything else on the biomarkers, Phillip, you want to add?

Yes. No. Thanks, Jason. No, I would say I agree 100% with what Spiros said.In addition to that, I'd like to point out that both FORTEO and/or abaloparatide, there is a significant [ live ] in CTX, meaning CTX is a much more robust or stronger breakdown of bone to put it in simple terms as compared to the ability of P1NP to build bone. So when you have a drop in CTX, that almost can have a greater impact on the increase in bone density as long as you have P1NP as well, which is the pattern that you see more so with a romosozumab where you have both a significant increase in P1NP and a decrease in CTX and romosozumab is perhaps one of the strongest agents in terms of building bone mineral density. So I think we have a pattern that's more similar for romosozumab, obviously, not as strong as romosozumab but near similar to romosozumab, and I think that, that theoretically could favor us better. Obviously, you'll have to go and explore that data definitively as we go on into the next study.

Our next question comes from the line of Nathan Weinstein from Aegis Capital.

I just had a couple of questions. Obviously, fresh off the Phase II, really nice data. And just curious what the awareness is of the EB613 program among medical practitioners and sort of what steps would you take why you're still in development to sort of raise the awareness profile.

Yes. Thanks, Nathan. Are you talking about -- I mean we will be -- we plan to very aggressively present our data at medical and clinical conferences. We have submitted our first abstract on the biomarker results to a major bone -- annual bone meeting. We'll be very quickly submitting an abstract on the final BMD data. And we look to sort of be presenting and discussing these data at multiple sort of conferences to sort of build awareness of this -- the product and its profile.

That's helpful. And just another question. The trial really does a lot in my opinion, to confirm the power of Entera's oral drug delivery technology. So -- how do you -- how have the discussions with partners gone after this data? Has it accelerated those conversations or added additional potential partnership conversations maybe for other APIs?

Yes, sure. Thanks, Nathan. Yes, I mean, as I've said also, joining Entera, I mean one of the things that struck me about the data I was seeing about this platform was the dose response kind of relationship that it was achieving not only in animals but also in humans. And now seeing that this is holding really true with multiple sort of clinical and biomarker endpoints, I think, speaks to the power of this platform to very -- in a very controlled fashion, deliver peptide or protein. And, yes, so having this data now, it's obviously -- it strengthens our negotiating position, but also we are very aggressively pursuing additional partnerships for matching the entire platform with other proprietary peptides and proteins that could benefit from oral delivery or could get a new patent life on oral delivery. And obviously, we'll be updating the market as we sort of reach those -- some new arrangements. But I think what the data we have today just strengthens our hand on the value of this platform.

Congrats to you and your team again for the successful and the nice results on the Phase II.

Our next question comes from the line of Shekhar Basu from Basu Capital.

Can I just understand that the -- has a carcinogenicity study been done, the long-term talks? And secondly, is the FORTEO studies, were they a 1-year study? Was it a longer study for the FDA to see durability of the fracture rates?

Thanks, Shekhar. Yes. Phillip, do you want to touch on the toxicology and what we're doing there with regard to FORTEO?

Sure, sure. Thanks, Shekhar. In terms of the toxicology, we're doing a full toxicology program. We're almost done with our 9 months nonhuman primate. Thus far, the -- all of the primates are doing great, everyone's healthy, and we have not seen any significant adverse event. We also have, obviously, the 6 month [ bovine ] studies as for those [indiscernible] studies. Regarding carcinogenicity, we are not worried about that. Actually, PTH has been shown to be extremely safe. And most recently, I believe we have the black box warning removed for the risk of osteosarcoma. This is after many millions of years -- patient years of data showing that there is no increased risk in humans or in any other animal with the exception of [ bovines ] at this point in time would be [indiscernible] in terms of an increase of osteosarcoma related to PTH. So I do not believe that will be a concern of the agency. And they have not mentioned that it was a concern of theirs. So thus far, I think the bottom line is that we're doing the full safety toxicology profile as would be expected for the drug. And thus far, we have not seen any signals which would preclude us from doing [ a new study ] to the market. As regards to your second question in terms of the length of the study. Currently, we've received guidance from the FDA that this could be submitted under the 505(b)(2) pathway. Under that pathway, the FDA has defined that it would be a noninferiority comparison to FORTEO in terms of the reference drug. That comparison relies on bone mineral density and not on fracture rates. Therefore, you would not be obliged to do a fracture study and 1 pivotal study in Phase III showing that we're noninferior to FORTEO, the reference drug, but would be sufficient based on the FDA guidelines in order to receive approval for this. Therefore, a 1-year BMD study is what we were given guidance to. Obviously, we will get final clarity on that at our end of Phase II meeting, particular our [ exact rate ], the size of the study would be and how we would have to power those endpoints. But at present, actually even initially we even -- they even mentioned that it was impossible for us with a 6-month study but we feel quite comfortable and quite confident that the agencies will agree that a 1-year study concerning bone mineral density in a FORTEO and a EB613 population will be sufficient for a clinical.

Our next question comes from the line of [ Clay Weber ] from [ Libre ] Family Office.

Can you hear me?

Yes.

I appreciate the presentation. One question is the anticipated application of this to patients down the road once it's commercialized, hopefully, is this a drug that people would theoretically be on a daily basis or a weekly basis for years and years and years? Is this -- or is it anticipated that you'd cycle on and off of this medication? I just -- trying to get a feel of how this actually works in a patient population once you get through your trials?

Yes. Thanks. I mean this is a once-a-day oral medication. And, I mean, similar -- FORTEO is a once-a-day subcutaneous injection. And, I mean, sometimes patients do cycle on and off to vary the medications that they are on. But I mean, typically, they are on for a significant period of time. And if -- I mean could I call on Art Santora to provide some color on this as well. Art?

Yes, certainly, I'd be glad to. Actually, as Dr. Tripto or Professor, I should say, Tripto-Shkolnik pointed out, typically, FORTEO is given in a cyclic fashion, meaning patients are treated for a year, possibly 2 years, and then they will switch to another drug that -- for example, like oral alendronate, historically called Fosamax or zoledronic acid, reclass to Prolia. These drugs inhibit bone resorption. But it's given, for a period of time, that is parathyroid hormone or oral PTH in the real world and then patients will be cycled on to another bone resorption inhibitor. Now there is the potential for a second course down the road. These anabolics work quite well and sometimes there isn't a need for a second course. Does that answer your question?

Yes, very much. That's a very good answer. On the subject of statistical significance, I don't want to get very technical and deep in the numbers. But just from the summary that you gave, it sounds like the level of statistical significance was way, way, way beyond the margin or multiples of what would be deemed sufficient or acceptable to the FDA. I mean it sounds like you were, in some instances, maybe 10x or greater, more statistically significant than would be required to move forward. Is that a reasonable summary?

Yes, although getting into details to fiscal discussion is...

Yes. No, no, I don't want to go deep. I just want to get just a general feel for it. And then the last question is, and I'm sure you've spoken to this before, but aware of the oral drug delivery technology of the company that's in theory, going to be applied to lots of different medications down the road. In this case, this particular agent, EB613, is actually Entera's own drug. And while very similar to the injectable FORTEO, it's a different enough drug that it's actually a drug that, if you will, you own and you have patent protection for. And it's not a case of you applying your technology to some other company's drug, correct? And I just wonder how...

That's correct.

Yes. And so there was, I guess, enough difference between FORTEO and this particular agent that this is something that you received recent patent protection for. I just wanted to get a feel for kind of the company's ownership and protection as it relates to this wonderful sounding agent.

Yes. No, thanks. Those were great questions. So first of all on EB613, which is the osteoporosis product, that is a formulation of 3 components that we've described in our sort of platform. It's an absorption enhancer called SNAC and a protease inhibitor called SBTI. Those are the key proprietary components of our formulation, and then the active component which is PTH. And we have patents issued now covering -- protecting the use of PTH in our proprietary sort of formulation. So that protects the use of EB613 in the treatment of osteoporosis. And here -- but we've also shown that we can use this platform to deliver other proteins and peptides and one was recently -- we announced some data on GLP-2. So we will be constantly adding to our patent portfolio of patents where we're applying our platform to other actors. Now a different aspect of your question is also we can go after molecules that are going off patent or have patent already and then we apply our proprietary platform. A different way for the [ rest ] where we can apply our platform is with the company's proprietary compound or molecule. And this is the case of -- we have a collaboration with Amgen that's now in its third year. Amgen is working with Entera to develop an oral formulation of an Amgen molecule, it's a proprietary Amgen molecule where they want to develop an oral formulation. So that, again, that's a different way of partnering on something that is proprietary to the third company, the third party. And -- but that's allowed us to enter into a very nice deal. It was about $270 million in cash milestones that would flow to Entera as this program progresses. There's also royalties on sales of the ultimate product. So we have received ourselves -- there are opportunities for us to collaborate with or go after products that have already lost patent protection, but because of the use of our platform that gives us a level of intellectual property or in the case of the Amgen collaboration, it's a proprietary molecule that the third party is working on. Did that answer your question?

Yes, that's helpful. I'm just trying to look down the road in a very general sense. I initially viewed Entera as a company that was largely going to be getting licensing fees from your technology being applied to injectable drugs that were patented and owned by other companies. But now it appears, not just because of the osteoporosis, whether the peers, whether you're -- in the instance that you're targeting off-patent large molecule drugs, for instance, you could actually have more of your own drug portfolio yourself and be getting the actual economic rewards from having your own drug suite in addition to the licensing fees of applying this to other company's drugs. So it's just -- it's seeming like that may become a very big part of your business, that is your own portfolio.

Yes. No, that's a very good comment. And yes, we see that as well. And I mean one thing we are exploring -- we have generated a lot of recent data using our platform to deliver different classes of molecules orally. And so we could be prioritizing a specific molecule for -- to generate our next -- the next wholly-owned program for it so that some of the internal loss of prioritization that is going on right now.

[Operator Instructions] Our next question comes from the line of [ John Lennon ] from ITF Investments.

Obviously, congratulations on this huge opportunity that you have ahead of you. Regards to the Phase III process, we see that you got a lot of cash burn going on. Do you foresee that cash burn increasing over the next 6 months to gear up to afford the Phase III financial burden that sometimes that is for companies.

Yes. Thanks, [ John ]. And yes, so in terms of the, yes, our burn and our cash position, we announced at the end of our Q1 results that we had $15 million of cash in the bank. And that funds the company to Q2 through next year of 2022. So we have over 1 year of cash. And -- but that assumes that we will be comparing the initial cost of the Phase III because some of those we have -- some of the CMC-related costs on manufacturing the clinical product, we have to stop it now. So that is assuming some level of the Phase III expenditures already in those costs.

And I'm not showing any further questions at this time. I'd like to hand the program back to management for any further remarks.

Yes. Thank you, everyone, for dialing in and getting some great questions. I mean, obviously, for me being at Entera now for 6 months, what's remarkable is that we are on the path that the company had set earlier in terms of having a 505(b)(2)-ready sort of program for a very large market for the treatment of osteoporosis with some really nice clinical data. Again, as I've commented, I've never seen sort of the kind of dose response data that Entera is seeing on the use of its platform. So it's sort of all systems go to finishing the Phase III design and interacting with the FDA and moving the program forward and additional partnerships. So really thank you, everyone, for your attention. And we look forward to reporting additional progress in the coming months.

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.

Thank you.