Q4 2019 Earnings Call
Continue to standby integration.
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Good morning, and welcome 10 terabyte.
2019 financial and operating results conference call at this time, all participant I notice and all you might have been speaker penetration there will be a question and answer session. That's the question. During this session. You want me to press Star one on your telephone if you acquire any finishes and please press star Yeah, I would not.
And the coffin over to John Me, but do you must be CFO of Integra. Please go ahead.
Thank you and welcome to the call joining me on today's call our Adam Ruby our CEO, Philip Schwartz, our president of warranty and Arthur Centaur our CMO.
A press release announcing in tourist financial and operating results for the fourth quarter and full year ended December 31st when she was issued earlier today.
For those of you what not yet seen it gets a bill that's her section of our website www dot and terror bio dotcom.
Our call. This morning, we will share with you a distance empty and review our financial results, which will be followed by a question answer session.
Before we begin our prepared remarks, I would like to remind you that varies state and she made during this call I thought the company's future results of operations and financial position business strategy and plans and objectives for future operations are considered forward looking statements within the meaning of the federal Securities laws are forward looking statements are based on on current expectations that.
Involve risks changes in circumstances assumptions and uncertainties in particular, the cobot 19 pandemic is rapidly evolving and has created a significant amount of uncertainty extend to which to covert 19 pandemic impacts us will depend on the duration of magnitude of such impact will depend on numerous factors that the company may not be.
People to accurately predict these risks are described more fully in RCC filings are available on the FCC Edgar system and on our website <unk>.
We encourage all investors to read our SEC filings all the information we provided in this conference call subsided only as of today and we undertake no obligation to update any forward looking statements. We make on this call on account new information future events or otherwise finally, please be advised that today's call is being recorded webcast I will now turn.
The call over to Adam Gridley.
Thank you John.
Thanks to everyone for joining the call. This morning, especially given the challenges we're all facing do the spread does cobot 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 patient employees and local communities.
Without creating unnecessary disruptions that accompanies primary goals.
Before moving into our 2019 business update.
And corporate objectives for 2020, I want to thank our employees.
Our investigators and or patients for their support.
And participation in their phase two clinical trial for he be 613 and osteoporosis.
These are clearly unique times, we very much appreciate everyone's continue perseverance and vigilant.
When I joined the company third quarter 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're well positioned financially.
And operationally to achieve a number of important goal this year.
However, we cannot predict the impact of the krona virus outbreak, we'll have our phase two clinical trial.
And our employees.
During 2019, we chose to refocus our effort to where we believe our technology platform will provide patients novel therapeutic options for large disease state.
And create the most value for our shareholders.
To that and we pivoted to focus on he be 613, our orally delivered parathyroid hormone or PTT program and initiated the dose ranging placebo controlled phase two clinical trial and post menopausal women with osteoporosis.
Or loan bone mineral density BMD.
We will discuss the be 613, 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 are approximately 60% of the planned trial.
And until Cobot 19 had been on track to meet the timelines, we established and communicated in 2019.
In September 2019, we also reported positive results from a phase two PK PD study of our second product candidate you'd be six one too.
Are we confirmed that world P.T.H. is effectively delivered into the bloodstream inactivates P.T.H. dependent biological pathways that are inadequately activated in patients with hypoparathyroidism.
In addition to advancing our internal peachy to programs. We also initiated preclinical work on the first molecule covered by our collaboration with Amgen.
We're 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 a 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 come with a final closing in February 2020.
Generated $13.3 million a 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 2021.
And we will continue to explore opportunities to further extend their cash runway in light of the ongoing cobot 19 crisis.
Well 2019 wasn't eventful year upfront and Terra we also established a milestone rich playing 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 tendering 2020, both from a clinical and from a financial perspective.
However, providing timelines today for a 2020 objectives is tricky given the significant ongoing uncertainty related to cope with 19 pandemic.
The extent to which Kogut 19 pandemic in Texas 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 timelines that we described today.
However for context prior to the global outbreak of co. Good 19, we communicated the detailed plan or last quarterly investor call to complete enrollment of the phase two clinical trial for 80 613.
In the first half the 2020.
And finished the trial in the fourth quarter Twentytwenty.
Furthermore, we expected to report the interim three month biomarker data and the second quarter 2020.
With full three and six month B.M.D. data in the third and fourth quarters of Twentytwenty, respectively.
Importantly, we were on track to achieve all of these milestones until the second week of March when certain quarantine steps and restrictions related to Kogan 19 were introduced in Israel.
And now in the United States.
We had been evaluating contingency plans and employing risk mitigation strategies. Each day based on the is really regulations and the Israel Ministry of health guidance on travel restrictions.
Essential health services and quarantine rules.
Along with the rapidly changing guidelines from the conduct of clinical trials.
To that end.
He provide some color on the status of the he be 613 clinical trial and our broader operations.
So we have four investigative sites in Israel, all of which are leading hospitals with patient enrollment fairly distributed across the whole fore sight.
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.
Can't bring all non the central patient visits.
And in some cases rapidly moving resources, and then hospitals to treat cobot 19 cases.
As such we have complied with the Ministry of Health request and a temporary suspended new patient enrollment where until a week ago, we are tracking to enroll to roughly remaining 60 patients.
Over the coming month as originally planned.
Depending on the duration and magnitude of Cobot 19, we do not know how long the suspension will lock.
Now for the roughly 100 patients currently enrolled in the study, we're prioritizing patient care and data collection through the approved means possible by the Ministry of health.
These steps include home health care visit.
Transportation for patients to investigative sites that remain open to sort of existing patients on the 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 still difficult to ascertain the full impact of cobot 19 on our existing patients in our ability to continue their associated data collection.
As well as when we need to be able to restart the enrollment process for new patients.
We anticipate at this time that there may be at least a one quarter delay in completing enrollment if at all and correspondingly our full three month biomarker endpoints.
Six month B.M.D. data may be delayed by at least one quarter.
However, we do currently anticipate that we will meet or timelines for top line data release of the first 50% of patients with their three month biomarker data in the second quarter Twentytwenty.
Which will discuss shortly in more detail.
We will certainly keep everyone updated with any material changes to our timelines 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 five to six weeks.
Before we discuss the importance of the data that we expect to generate from the phase two clinical trial for <unk> 613.
I'd like to quickly remind everyone about the opportunity that exists in the osteoporosis market today.
There's a clear unmet need and osteoporosis due to the fact that only a small percentage of patients with this disease or actually treated.
Due to cost convenient and compliance challenges.
We continue to believe that we can significantly grow the market by offering physician and patient a once daily oral tablet.
That increases bone formation and builds bone math 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 kind of the call over Dr., our 10 Torah, our chief Medical officer to discuss phase two trial for you'd be 613 art.
Thanks, Adam based on the feedback from our meeting with the FDIC November of 2018, we initiated a phase two multi center. This are entering trial will be 613, and approximately 160 osteoporosis patients at four leading osteoporosis centers in Israel in July 29 team.
The trial, which includes a circling treatment period is being conducted to evaluate book the safety of you'd be six searching and to identify the optimal dose that we will select to advance into a single phase three pivotal non inferiority be in vitro versus subcutaneous parathyroid hormone subject to.
Positive phase two data.
There are four arms in the phase three trial of 40 patients each one placebo arm in three different you'd be six searching doses 0.5 milligrams 1.0 milligrams to 1.5 milligrams a world th.
Based on our prior data showing the maximum concentration of P.T.H. and the board.
Sometimes referred to as a C. Max at an average concentration.
Referred to as you see after a dose of you be six searching we believe these doses encompass potential optimal dose equivalent to a 20 microgram injection forteo.
And this trial, we are evaluating the effects of you'd be six searching on bone mineral density or BMD. After six months and multiple biochemical markers, including P. One into a bone formation marker and CTX, a bone resorption marker of both three and six months as well as the standard set of safety.
Vestments.
Specifically the study has two primary endpoints the change in bone formation marker P. One in tea after three months and the change in spine BMD over six months.
Because of the long history of the use of injectable P.T.H. Forteo tradeoffs to persist and the minimum correlation of the improvement in Biomarkers of bone formation rate in BMD.
To treatment of the underlying disease, we didn't terra believed that the biomarker and related BMD data from the trial will be indicative of the potential anti fracture efficacy of you'd be 613.
Furthermore, we believe that data will be important in refining design of the phase three trial and the village views the five Boe far be to regulatory pathway for potential approval in the United States.
Historically forteo in other regions have demonstrated the bone markers and higher bone mineral density are strongly correlated with reduced fracture risk.
Demonstration of BMD and anti fracture I would say usually requires multi year studies of thousands of OSU product patients.
Fortunately there are also a number of well studied biomarkers of bone permission resorption.
There have been demonstrated a strong correlation with improvements in bone mineral density for each class Ross, you persist drugs, including P.T.H. and its analogs.
And our upcoming three months initial biomarker redoubts and 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.
She want empty serum concentration as an indicator of the rate of new bone formation, and typically increases between 50 and 100% after three months in clinical trials and pitch.
CTX serum concentration is an indicator of the rate of old bone resorption biopsy request souls to remove old though.
Teach and analog or osteria anabolic because they stimulate bone formation, especially by few warranty much more than they increase bone resorption, which is measured by CTX. There's a difference between bone formation and bone resorption determines BMD increases.
Other primary endpoint in the phase two study.
For reference several independent clinical trials with additional OSU anabolic osteoporosis treatments have shown that the increases in bone formation relative to bone resorption is more in predictive then an absolute increase in bone formation of the increase in DMD during treatment with TPH.
MPT channels.
We look forward to views initial biomarker reduction in the second quarter of 2020 with the first 50% of patient data available and we plan to provide topline data via a press release and hold a conference call to discuss the results when available.
Assuming a favorable outcome in the current phase two study.
We intend to position he be six searching for a single phase three multi center Noninferiority BMD endpoint trial of 600 to 700 cost to persist patients comparing world. He be 613 with subcutaneous forteo over a six to 12 on treatment period.
We have already received regulatory guidance from the FDA that the Noninferiority margin is expected to be 25% of the effective forteo on BMD.
This is a margin we believe maybe achievable in the study of the size based on prior literature and the anticipated clinical data from the ongoing phase two study.
As part of the development plan for you'd be six searching we've conducted several nonclinical safety assessment studies to support a regulatory filings, including a planned investigational new drug application or I Andy.
Filing with the FDA later this spring.
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We will also be preparing a phase three protocol to position the program for a phase three trial potentially beginning in 2021 or 2022 pending the timing of completion and the successful outcome of the phase two clinical trial.
Funding and the potential collaboration with another company if achieved.
Moving onto our second proprietary program with oral Peachy H E. B 612 for the treatment of the orphan disease hyperparathyroidism.
In September 2019 reported positive results at the 2019 annual meeting of the American Society for bone mineral research that'd be phase two trial of you'd be 612.
The trial evaluated the pharmacokinetic Pharmacodynamic profile E V 612, and 16 patients with multiple doses and dosing regimens of orally delivered you'd be 612 against a single once daily dose of 100 micrograms of no para parathyroid hormone there.
River via subcutaneous injection and this trial you'd be 612 was generally well tolerated and we were able to show a dose dependent pharmacodynamic response.
As an increase in serum calcium.
And active vitamin D and a decrease in phosphate.
In addition, oral P.T.H. reduce yearn calcium loss as demonstrated by and almost 25% reduction and 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 timeline.
Hi, Thank you very much art hi, good morning, everyone. Our collaboration with Amgen for the development of an oral anti inflammatory agent continues to progress.
In late 2019, amtech elected to continue the collaboration which triggered the ongoing financial support for the year Twentytwenty over the last 12 month. 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.
We are pleased with results today.
We believe our technology is performing well in that we have been able to rapidly create different formulations with different PK PD profile to support Amtrust activity.
Turning to other research activities for 2020, we are focused primarily on two objectives.
Development of our platform as it relates to the valuation of new epi cooler active pharmaceutical ingredient and formulation development for E V 612.
We believe that each of these areas has the potential generate value either additional validation of our technology platform.
And or two potential business development activities.
In the area of Apiay or additional drug development.
We continue to evaluate new eight the eyes that can benefit from the application of our technology.
As a reminder, we have a newly developed set of in vitro assays that had an April dust to significantly reduce the initial evaluation time of new Apiay.
To date and Terra has brought several apiay into preclinical animal testing at 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 three to four amino acid peptide two very large proteins with more than 100 kill adult.
We intend to repurchase work and have a goal to build their platform by adding two new target in twentytwenty for potential future development.
In addition to screening the potential molecule based on the attributes that we think with 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 80 612, our product for hyperthyroidism, we intend to conduct additional formulation and development activity to determine inappropriate formulation that will enabled us to prepare for the potential if she initiation in 2021 opened his initial phase to be for phase three clinical trial of either.
Six wells for the treatment of hyperthyroidism.
As a reminder, the clinical trials to support approval product of product to treat hyper parathyroid that's.
Our often small for example, NIPT para the leading injectable was approved on the basis of the single 120 patient phase three clinical trial.
Given the likely sizes the phase three clinical trial.
We believe we could develop and commercialize this on our ROE.
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 Philip.
Besides our Amgen collaboration we continue to explore a variety of co development and collaboration opportunities and Twentytwenty, we have three 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 the structure similar to the Amgen collaboration.
The recent approval of Novo Nordisk oral Semaglutide GLP, one agonist, which utilize the same absorption in hand through that and Terry is.
Has stimulated great interest in our oil large molecule delivery systems.
The approval of Novo's drug not only validates our use of this particular absorption enhancer molecule in other indications.
But also proved that it is possible to get in oral biological drugs approved by the FDA.
Additionally de 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 co develop their molecules, where they are 80 eyes 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 and potential commercial and licensing arrangements around Essex one three.
Given our upcoming phase two readouts in the coming quarters.
And the rather short development pathway to phase three study. We are currently in confidential discussions with several potential commercial partners, who may have interest in working with them from the phase three program.
We are evaluating our opportunities either complete the global registration trial in osteoporosis on her own.
Or delights them just prior to a phase three were 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've started to leverage our vast development and clinical experience into global registration programs.
The osteoporosis market in China. For example is growing rapidly do because an aging population.
No calcium and vitamin D intake and the presence of a number of leading pharmaceutical companies with experience in injectable TPH entering the Chinese market.
We're also conducting diligent with a number of parties in China. Following meetings that JP Morgan to discuss our lead osteoporosis program and potentially new compounds.
Well the Chinese new year end Cobot 19 has had some impact on the momentum in those discussions. We've recently reinvigorated this initiative with additional experts and the Chinese pharmaceutical and financial industry.
Now the case of Japan. We also believe there is strong interest in certain rare indication in renal diseases.
In a strong foundation of companies targeting osteoporosis.
After a number of productive meetings at the soaking opened Japan and the JP Morgan 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 meeting.
However, our momentum continues with virtual Videoconferences. 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 HEICO parathyroid system by utilizing much strong data packages will use for the eye in d. going to the FDA and the United States.
In summary, we have found that our unique technology offerings novel delivery of well established day pie is currently administered by injection.
In a manner that protects and enhances absorption get doesn't modify these apiay may afford to rapid regulatory pathway for leading biotech.
And pharma partners.
Coupled with our deep know, how and rapid development process supported by EUR nine plus years with investment into our formulations in PMC 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 that's sustainable product portfolio for potential partners on a worldwide basis.
At this point I'll turn it over the call Jon Lieber, our U.S. CFO to cover the financial results tongue.
Thank you Adam.
Revenues from your end of December 30, Onest 2019 were 236000 I'm 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 31st 2019 were 11, and a half million dollars and included $7.2 million in research and development expenses and $4.3 million general and administrative expenses.
R&D expense for the year ended December 31st 2019 consisted primarily of headcount related costs costs related to the initiation in contract or be 613 phase two clinical trial and consulting expenses and teach related to the preparation of benign de application for easy 613.
General and administrative expense for the year ended December 31st lien 19 was primarily made up of salary and related expenses include shirts compensation legal and accounting fees and Dino insurance expense.
Net comprehensive loss was 10.8 million and included a gain on the change in fair value or warrant liabilities.
Second diluted loss per ordinary share was 89 cents.
As a reference point, we currently have approximately 18 million primary shares outstanding and 26 million fully diluted shares outstanding.
At December 31st 2019, and turn it had cash cash equivalents or $15.2 million. The December cash balances foods, approximately 0.8 million net of expenses received in February 2020 in connection with final closing of the December 2019 private placement.
And then our 20-F filed today, we reported 13.7 million in cash and cash equivalents hasn't 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 Cobiz 19, we expect our 2020 operating loss to be between 10 and $12 million based on steps already taken to preserve our cash to extend our runway into we have certain stability to the impact of.
Moving 19, our clinical milestones and the overall international markets. We currently believe our current cash position will fund our operations into the second quarter 2021.
I'll now turn the call back to honor for concluding remarks before we go to QNX.
Thanks, John we appreciate everyone's patience and support during these uncertain times 29 team 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 coated 19 challenges.
Both in Israel per ongoing phase two study and on our employees.
And also in the United States, where financial markets obscene considerable disruption.
We will continue to be careful stewards of our human capital.
Financial resources.
And seek to proactively and rapidly pivot in a manner that preserves our product development initiatives.
Advances our business development opportunities.
And positioned us for rapid growth as these uncertainties debate.
Our 2020 milestones for our osteoporosis program continued 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 2020, we do anticipate meeting our original timeline of the three 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 two trial in Israel.
And we'll continue to update our stakeholders as we received material updates, including in our upcoming first quarter 2020 financial results call targeted for mid May of 2020.
Operator, please open applying for questions.
Thank you as a reminder to ask a question you have any cuts that one on your telephone.
Which I had question past the time, Keith please standby mode to compare the candela there.
Our first question comes from Jason Mccarthy with Maxim Group. Your line is kind of orphan.
Hi, Good morning, and this is not going on for Jason help everyone safe and well.
Obviously, given the cobot 19 situation on lot of timelines in trials have been impacted you know there's been a lot of disruption. So I was wondering.
Now I understand timelines may not be Matt and that said I'm, sorry, I missed it but can you remind us again, what catalyst on milestones we might expect in 2020 from Intel right. In addition to the two month biomarker data into Q.
Sure. Thanks Marine 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 three month Biomarkers in the third quarter, and then bone mineral density data in the fourth quarter.
And that was the six month primary endpoint. So we still have plans for the initial three month, the 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've made on enrollment is that were already about 60% enrolled.
So that 50% Mark is still on target obviously, it's hard to predict how long that this temporary suspension will result in but our goal is to hopefully get things. We started in the next couple of months and then we would anticipate if things were pushed out by one quarter. We would still have the pool three month biomarker data Inc.
Completion of the trial this year. So we're still optimistic the investigators and patients on 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 state that not process. So we're still pretty optimistic about 2020. This is still.
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 know you been engaged with a lot of people in other regions could there be any deal announcement 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 we be 613 independent of this most recent delay we think theres a lot of interest given the very short development timeline.
And the ability to run one phase three trial. So we've got very active discussions in China, and Japan looking at Korea and naturally in those regions started to come back on post co bid, we're accelerating or efforts there and naturally we're all getting used to working virtually here in the United States and in Europe in Israel as well.
So I don't anticipate that those activities slowed down and as we think about this time period, where in fact trying to accelerate codes. So that is one of our major focus is right now for that lead program. There is also quite a bit of interest in Hypoparathyroidism program, particularly in Japan, where you have a higher rate of fibroid cancer than other.
Absent and then as we noted Philips been leading a number up 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 noble of course with snack, 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 like.
Turning to accelerate.
Great and one last one for me can you comment on the engine partnership obviously, you can't comment on the does tie good, but perhaps has and elected to select additional program had there been any discussions around that like the to penetrate.
Sure generally speaking, it's too premature for us to comment on that but perhaps fill up our president of R&D can comment on how the overall program is going and give a little bit of color on that Philip.
Yes sure. Thanks, Adam Yes, as the program is moving along we're going into we've done a number of preclinical studies and Amgen has now doing a number of preclinical studies in their hands as well.
Unfortunately recently has been in the news there 1000 Oaks location has has shut down for the moment.
But we hope that it will be coming back up in the near future.
With regards to other amount.
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 a and that would lead obviously to them deciding perhaps that they would like to pursue one of those molecules is that just as a reminder, I'd like to point out that the molecules that Amgen has been interested in that continues to be interested in.
Our not necessarily molecules that are.
That are currently a injectables that they need to convert into.
Oh oral formulations because of the convenience factor or other things Waltham molecules that are injectables do not work is injection. So 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.
It therapeutically effective medication.
So that really why didn't 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 the administration and converting them to another form of administration were 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, Philip So Doreen I think we're very pleased with the progress. Thus far we are just amgen in a couple of months ago and expect that this program will continue Internet stay and we're also looking at ways that weekend incenting 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.
Great. That's helpful. That's that's how funny thing.
Thank you you as well marine.
Thank you as a reminder to ask a question you already in the past, Taiwan and your telephone.
And our next question kind of <unk>.
Pack live in stainless.
Incentive venture partners. Your line is open.
Hey, Adam Thanks for the.
For the follow up.
Could you please discuss the or in any more detail. The two additional molecules that you're thinking about going forward on a year in other words, just what areas of focus therein.
At this juncture those molecules or potentially confidential. However, we can comment Eric on the number of molecules that we've looked at naturally are our product portfolio has utility and molecules up to 150, Kyla Dalton's, we've been looking at a wide range of potentially p. eyes as Phil.
As noted in some cases the aren't just injectables. So in the case apparent thyroid 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 continued to be one area where there.
Be as Injectables that we could then improve the cost compliance and convenience challenges alternately we've looked at other compounds such as growth hormone Weve 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.
Be as question that we always get because can you do monoclonal antibodies were not sure yet, but we're evaluating Matt.
And we continue to look at how we can extend that portfolio.
Thank you.
Thanks, Eric.
Thank you.
I'm not showing any further questions at this time and I like attend hop back all of its Adam get paid for closing remarks.
Thanks, Phil Thanks, everyone for taking the time this morning during our call. We look forward to speaking with you in a couple of weeks he safe and happy good day.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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