Q4 2019 Earnings Call
And welcome to the protagonists therapeutics year end 2019 update call.
Please note that today's conference is being recorded at this time I like to introduce Dan how Kaufman.
Protagonist, Chief Financial Officer. Please.
Please go ahead.
Thank you operator, good afternoon, everyone.
Please note that a replay of today's call will be available at the Investor section on our website at protagonist dashing Dot com.
Before we begin I'd like to remind you that today's discussion will include statements about the company's future expectations plans and prospects to constitute forward looking statements for the purposes of the safe Harbor.
Arbor provisions.
The private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by these forward looking statements as a result, the various important factors, including those discussed in the risk factor section of our quarterly and annual reports on forms 10-Q, when 10-K, which are in filed.
Yes, you see.
What do you mean may elect to update these forward looking statements at some point in the future. We specifically disclaim any obligation to do so even if our views changed.
With that I will now turn the call over to the Nashville, President and CEO to provide an update on the company's progress to date.
Thanks.
Good afternoon, everyone and thank you all for joining us today.
On today's call I would like to be fleet of deal that you my soul of the past year.
We had over time state does.
Satellite aptly a review of all the goals for the 2020.
Following this.
So what do you Don cattle telephone CFO will reveal a financial results and then leave it open up the called into question.
Also present for the call today, our somebody else sex Chief Medical Officer.
David Lewis, Chief Scientific officer, and hate about Andy.
So the.
But chief development Officer, and they will also be available to address any question.
[music].
We started last steel that.
Three assets in different stages of clinical development.
A value partnership 50 Ensign.
And I guess, then wait to fund our operations to the.
<unk> 2020.
Getting the 29 Tim.
Progressed and position this three assets.
Right up to six different disease indication.
Made significant progress in an expanded the and some collaboration.
Expanded and strengthened the.
Steve.
And extended the cash Sunday by and Additionally, through the end up 2021.
As a quick reminder.
Yes, that's in development have been discuss what are the use of other technology platform.
So to summarize the current status we have preclinical assets.
That.
Six clinical proof of concept or feel see studies each in a different indication.
And gashes conveyed to the end of 2021.
That enables us to reach a conclusion you definitely when go no go decision someday studies at various different time point, so up 22.
20 and 2021.
Now I would like to provide details on the status of this the asset BTD 350, 200 and be a night for three and various clinical studies these assets and what to expect over the course of Twentytwenty.
As.
You bet equal.
Yes, that's falling two broad categories up disease.
We didn't get 300 far better yes blood disorders.
Many off each other rare disease, and BT <unk> 200, and see a nine full it could he fought in such a positive as is our IBT.
So let's.
Indeed, 300 peptide might it take up the nature of them on Hep side in that so that's a master regulated off I'm hobbyist Stacy some distribution.
This is our most advanced asset and the year twentytwenty going to be dominated by the outcome of various clinical b or C studies that are correct.
Currently in progress with 300.
We are pursuing P.D. 300 in four different indications.
Be done pellets email or beat up how well the sites email that out or BV. How do you did he came up with them with Eutelsat chats and an investigator sponsored study in Myelodysplastic.
Well the Mds.
These are all open label proof of concept studies and the matched up Jeff do for 2020 is to pick up our fourth clinical indications for 5300 that'd be can progress towards the pivotal study in twentytwenty well.
Got it prioritization that.
She thinks choice of the fullest syndication it'd be based on three important factor.
Strands of the clinical data.
Regulatory path forward and commercial opportunity assessment.
Yeah very encouraged by the progress we have made so far with BTG 300.
Let 29 theme, we gained very useful insights into the pharmacodynamic effects of 300, but they eliminated is that some of the ongoing transcend study in beta thalassemia, a rare disease caused by ineffective erythropoiesis and characterized by chronic anemia, and I and overloading the body.
Did you bought it doesn't relate to that exposure, then pharmacodynamic responses, namely the touch sensing see it I end and transferred and saturation or TCEP levels from the transfusion dependent population I'm up the study.
This preliminary results for why did the very first heavy does also.
The fact somebody did 300 patients who have highly elevated level itself I didn't the body.
And it and cut aged and guided us to what is continuing to study with a 40 milligrams twice weekly dosing regimen.
B D 300, well, it's also found to be bad told that it did and systemic.
Let's see wenzler, mostly mild to moderate instead, we already.
It's the last but not those are the let Ted and did not prevent dose escalation in the study.
The beat up how study is progressing as planned in the transfusion dependent population and we expect to reach definite do conclusions they see us some the study.
Another strong outcome from the preliminary pharmacodynamically cells of the transcend beat up have study was that it for a wide it stronger rationale for potential utility up 300, and other blood disorders directly dependent on disruption enough not I'm balancing the body.
Specifically be referring to.
40 sites email that up a rare disease off my other proliferative neoplastic disorder characterized by all the production operator, let's south and how did that he came up but I must tell us is a disease caused by the absence, but the efficiency of the automotive upside in into human body.
Therefore, we have entered the ethically.
Okay and tuning that other plants of conducting clinical study you will see studies for 300, not only in be it up but also NPV of that Chad the objective of making did that they're going to say something 2020.
All three open label studies that ongoing and be plan to shed a lot of findings went.
I mean, each conclusions from its study getting different time stuff 2020.
As mentioned previously about called intent here is to pick the first indication they see a four digit 300 that can be progress towards a pivotal study in 2021.
Now, let's switch gears.
<unk> talk about whatever I B D S that stopping the ensign collaboration asset BT <unk> 200 also known as JNJ 67864 0.38.
As a reminder, digital Hyundai does an orderly delever gut, let's stick that peptide that thought of gets the I was 23 pathway.
A biologic capacity validated by road injectable anti body drops on the market today.
Specifically, yes, and injectable anti body to that's stelara targets. The out it's a lot of 23 pathway and is approved for I'd be D.
Last year in Maine, the announced the proposals.
I'll be de 200 into a phase two clinical proof of concept study in catalyst is is the bigger off at 25 million milestone payment some jaeson to protagonist and the expansion of the collaboration equity man to include New second generation, Although I 23. This after.
Antagonists.
[laughter] BT <unk> 200 face stupid on studies is ongoing and they expect studies of some this study in the first half of 2021.
I want to research collaborations with efforts with the and send are progressing extremely well and in Genuity up this year the announced the nomination off a second generation.
Some development can do that further demonstrating the continued utility off our platform.
And it also resulted in a 5 billion milestone payment from Johnson.
We look forward to what came at the end send to explode the full potential clinical utility, although I have 23 receptor antagonists.
No.
Finally, let's talk about our second I'd be D.S. that'd be a knife <unk> pretty adept restricted autoliv dealer peptide that thought of gets out of stuff or be doesn't have any took that.
This biological target has been validated by the injectable anti bodies and Ti Vo from Takeda.
Last year, we completed.
Phase one studies will be a nice <unk> three in healthy volunteers and demonstrate its a beat our target then gets bad income bodies into its first generation.
[laughter] diabetes you 100.
Did that he loves this study what is shared as an order presentation at the 2019.
Digestive disease week or de de Dup, Liquent photo and video.
We remain on track to initiate a phase two study with nine four to three in patients with ulcerative colitis and the second quarter of they see a and anticipate topline ethical cities. That's from this study in the second half off 2021.
The fourth.
Based on building in this study, but why does the optionality $20 million draw based on defense up all that got in depth facilities.
We are highly enthusiastic about the future prospects Sofia nicely.
This candidate is wholly owned by protagonist and it is an oral.
They stuff I'm supposed to be tough seven interplaying, we're just starting out to people in up the safest most specific and validated IBT targets being an older legend via 943 has the potential to play a central role in the new IB deeply met paradigm shifting towards older Agence and.
Sure happy in the future.
So in summary, we are very blessed to have made great progress in 2019 and set the stage for further development of three different clinical assets in six different clinical update you will see studies in six different diseases, and making it actually running from.
And all of this theater indexed.
29 didn't close awfully, where do we took the opportunity to expand and strengthen the protagonist stem and be able to continue to do so going forward.
Our priorities for Twentytwenty include the following.
One evaluating the EPS I didn't buy metric we.
Did you 300, and multiple indications and selecting the first indication they see a for conducting a pivotal study in 2021 to working with how about partner Jaeson do continue phase two development of speed did you see hundred in Crohns disease as well as just the wedding and developing second generation.
Well I 23 receptor antagonist under the collaboration and qualifying for milestones based on progress and performance and finally number three advancing be a nine fold. It pretty you know phase two study and that's what I do collective.
Yeah, Fox should I still have adequate financial resources through.
Yeah, that's 2021, which should enable us to reach definitive conclusions from all the ongoing clinical proof of concept studies.
Finally, we have selective about and mindful of the potential impact that that eastern Catarina wireless outbreak would have on about local operations and global activities.
As of now about guidance, some specific object dues and the corresponding timelines remains unchanged.
That I've been out on the call over to dawn duty view about fourth quarter, and yet and financial they some dawn.
Thank you Dinesh.
The press release, we issued today provides.
For a fourth quarter and full year 2019 results rather than repeat the details included in that really sure. My comments will center on a few of the highlights.
We're taking this reported a net losses 77.2 million for the full year of 2019 compared to net loss of 38.9 million for 2008.
As and reported a net loss of 17.5 million for the fourth quarter 2019 in comparison to a net loss of 13.9 million for the fourth or 2018.
[noise] or license and collaboration revenue booked for the full year of 2019 was <unk> point 2 billion as compared to 30.9 billion for the full.
For 2018.
The company did recognize 9.6 million of license and collaboration revenue for the full year of 2019, which was then offset by the onetime cumulative adjustment related to the application of revenue recognition principles. Following the May Amendment May 2019 amendment or the Ensign biotech agreement the Henry.
The revenue recognition by 9.4 million for the year and thus resulted in the net reported revenue were <unk> point Twomillion for the full year 2019.
License and collaboration revenue was 2.7 million for the fourth quarter 2019, compared to 2.4 billion for the same period in 2018.
[noise] research.
Development expenses were 65 million for the full year or 2019 compared to 59.5 million for the full year of 2018.
And R&D expenses were 15.9 million for the fourth quarter 2018, that's compared to 14.2 million for the fourth quarter 2018.
For Gen one.
And administrative expenses for the full year 2019 were 15.7 million compared to 13.7 million for the for full year of 2018 energy in expenses were 4.1 million for the fourth quarter 2019, as compared to 3.5 billion for the fourth quarter 2018.
Protect us.
We ended 2019 with 133 million in cash cash equivalents and marketable securities and 10 million outstanding under our debt facility.
The company forecasted cash cash equivalents in marketable securities along with access to our debt facility will be sufficient to fund plant operating and capital expenditures through year end.
2021.
I'll now open the call for questions operator, [laughter]. Thank you as a reminder to ask a question do you need to press star one on your telephone.
To address your question press the pound key.
Please standby when we compare the community roster.
And our first question.
I will come from nine of Chrismer, Christopher MRI from Nomura.
To begin.
Hey, good afternoon. Thank you for take question congrats on a quarter. So we're looking forward to several data read out. It seems I was wondering though you know if you could comment on on the most recent one.
With respect.
It could be TG 300, I noticed in your prepared remarks on you talked about.
I suppose transfusion dependent patients would be the towel.
And your work and then Halloween is where are you continuing to explore the opportunity for 300 in patients with Uh huh.
With hotel transfusion dependent.
That's a follow up thank you.
So yeah sure a great. Thanks for the question as of today, we are pursuing both the transfusion dependent and the non transfusion dependent to populations in the study.
D and a as you well know they.
Entity population that draws meant is up but I think doubly slow on that has been the same observation with other drugs that have traveled on this about before.
Okay, Great and then just a follow up.
300, maybe you know as you think about these multiple potential paths to registration P. H age.
<unk> Sal.
Could you imagine.
Bringing the drug ordered and.
Multiple indications.
In registration trials in Oh, 2021, you know I mean, do you have the capacity internally and otherwise I'm to help execute on that supposing core presuming success in each of those and then secondarily I understand that you know you.
The find those.
In beta Sal for 300, but.
Could you maybe talk about how that does might or might not relate to the doses of 300 NPV for each age and then finally do you believe that you've sort of at least identified the upper and lower balance of the dose 300.
Such that you can make some educated guesses about P.H. dose there will be effective going forward. Thank you.
No I think those out all.
The excellent questions and though I'll, let me go through them one at the time. So in terms of the question off you know one indication on multiple indicates.
Hey sense to pursue.
Our focus right now is to pick the first indication for pivotal study and and to clarify that's the first indication not necessarily the only indication so that down the road.
Depending on multiple factors will be more then keen to pursue multiple indications.
So that will really then define the total expand at school bus the drought once it reaches the market.
The second point is Oh, you know they quote unquote effect do you does that.
Gave us the desirable pharmacodynamic effect, some beat up how how does that so the guide that those they saw the dosing regiments, they know that indications.
As you might recall the also declared like what are the baseline feed 'em eye on our piece that they let us in different patient populations.
And what that dictates is that the iron ore body that demand is different in different indications. Some logic would dictate that up the effective doses would be different for different indications notwithstanding south that the transfusion dependent beta pallets population is the most demanding.
One.
TCEP, let us at baseline anywhere from 8200% so the anticipated in theory and logically that the effective dose this could be the same or low letting other indications and so in terms of the upper boundaries and lower boundary as you know my guess would be we have gone up.
Two as high as 80 Meg.
Finally, our of 40, it makes twice weekly dosing.
In the sense isn't dependent beat that Palin populations other safety.
Got what age will allow us to go high at if necessary. So that's got up but boundary and the lower boundary could be anybody's guess.
Great. Thank you very much I'll jump back into queue.
Thank you and our next question was off line of Joseph Schwartz from SVB Leerink you may begin.
Hi, I'm jewelry park dialing in for John. Thank you for taking your question I guess my first question I'm is often PTT three.
Well, that's just wondering if you could provide some color on how and when you plan to transcend.
I know that you previously guided to transcend data on one Q. So I was just wondering.
I would be able to see that.
Right So last year, when we shed the preliminary.
Reserves, mainly the pharmaco dynamic or read out some that transcends study at that time, you clarified that you know oh, the ultimate data, including the clinical they respond does meaning the effect sudden on plenty classic see that is something or b.
I would share sometime in 2020 and.
The reason for choosing such a broad timeline is that we would want those shattered data for each trial for each indication as then van will reach a point tough or some form conclusions.
Okay, great. Thank you.
My next question has to do with a 943 from your preclinical and healthy volunteer studies on how much of an improvement over PD 100 could we backed with TPG 943 in your upcoming phase two trial.
You know is there any color.
Regarding the trial design.
Yeah, I know the those that again bullet excellent question. So.
Nine fold three was consistently superior to 100 by all pre clinical measures.
And in the Phase one study in healthy volunteers, which enabled us to do a side by side companies and that's wonderful.
With 180 that you know human setting what can be found is like roughly speaking one could claim that's nine for free is two fold more effective than it did.
100, and what we mean by that is that the effect on the pharmaco dynamic that to get out. So you know blood receptor occupancy that to be saw with a particular doze off BTG 100, let's say at a 900 and make those VIBATIV, but it to what you and.
Exit that level off effect at sea times, lower bills being mindful treat specifically the 300 milligram dose.
And in terms of the next study the phase two study would be a 943, we look forward to providing more guidance.
So on that in in the second quarter of the theater, but as you can imagine I'll be how already achieved a matched up that object to oh, what here that is battling the concept often oral GLP strict did I was helpful or be does have an integral then block or with other previous.
[noise] peptide BT to 100, so be it the clinical proof of concept in hand, we are feeling very confident and that's why we will be conducting a fairly oh well rounded phase two study it will have the typical alamance off you know a high dose.
No. It does a placebo arm up enough number of patients so that they can get statistical significance in a meaningful way. The typical induction period, followed by long term extension and so on and so forth, but as I mentioned before then shed more details in the coming month.
Okay and that's just.
One more question if I could just squeeze it in a given the competition.
The trial.
Wondering what steps you're taking to ensure you remain on track.
You have 21 right now.
Yes, I mean, clearly that is a competition for the you see patient population, but we believe that our drug Oh.
Offer somebody fine advantageous number one this is up at all when target.
Number two the GE I'd stick that approach is up at all one one through other previous molecule, but did you 100 number three this is an older approach. So when you combine all these elements.
And of course, the at all so they're not you know offered a longtime extensions or so when you add all these up they believed that the a a feeling a fairly confident about the proper kind off and broadband so that the hope to stop the study in the second carved out of the.
And we anticipate clinical readouts in the second half of 2021.
Okay, great. Thank you.
Thank you next question will come from line of George former from BMO capital markets, maybe get.
Hi, Thanks for taking my question Dinesh we talk to.
The past about further exploration.
On the 80 make dose.
For P.G. 300, I noticed that in your prepared remarks, you seem to be kind of stopping at 40 makes twice weekly, which equals 80 per week, but should we expect a anything.
Above that or do you think you found your does.
It's it's a fairly good question.
A slightly ticky when I would say what I would maintain for that is that for now is that'd be a continuing stadiums automatically teller.
40 bags twice weekly dosing and ER and the proper time, we intend to shattered the data that to be get from the current study.
Okay, now, having said that though based on the safety bad I mean, it does that is nothing that is stopping does some going too.
Got it goes live and Sam I, just wanted to mention them as Dennis mentioned earlier, the only place where we'd be thinking about that currently use in beta thalassemia because as he mentioned earlier, we believe that the dose required looks like it's dependent on the island status and there's nothing we're treating it has a higher iron overload and.
Infusion dependent beta though.
Okay, and then what do you need to see from the from the base without.
Study to.
To make it as a candidate indication moving forward you, if p. fad or iron level sufficient or do you need to see some impact on transfusion dependent fees.
Yeah, they would definitely want to see a impact on transfusion burden because at the end up the day that is what matters at the Layla if a patient then practicing physicians right. So does the definition that we have now.
For our clinical this fond of saying this study is up.
20% reduction in transfusion burden over at an eight week time period, having said that in the same but at what I would also add is like you know just an eight week time video doesn't.
Create a drug in itself so they would want to.
See continued and prolonged observation.
The effect on transfusion burden to make it a strong candidates.
Okay, and then I question on 943 can you Mark a little bit on on what lessons you've learned from the P. TG 100 study that you're applying to for a successful outcome potential successful outcome and yet.
943 study.
Yes, certainly I I mean that have been a a several licensing away and as you recall.
The the place where we kinda for taken by surprise or was the.
That's the densely high placebo effect in the initial futility laid out up since then the or even for a period you 100. They did w. They just then be went to.
Another Seattle, namely at all about ER and finally, they've got the data that can be found to be.
Very convincing so all those XP didn't say send observations how ban not taken into consideration or as they move or thought about a bit be a nine for three and the other thing I would add also is that you know the odd in into bed dialogues with the cable was the IB DKL.
He is such a great community a everybody is very simple to and vetting guiding and now we have a different clinical team also in place. So I'll do you believe we have taken.
I'll.
Very extensive measure stool and shower.
An uninterrupted.
Pardon me a lot of what vis 943.
Okay, great. Thanks very much.
Thank you and our next question I'm comfortable and Douglas fell from H.C. Wainwright you may begin.
Hi, good afternoon, thanks for taking the questions just maybe following up.
I'm not one question on non 43.
Dinesh as you're given the fact that you had such strong evidence from the prior phase two study for TG 100 in terms that sort of proof of concept for proof of mechanism.
Are you trying to answer your first question.
At this stage two study for Pierre.
43 in terms of sort of what you're trying to establish as you move into say it you're potentially into phase three thank you.
Yeah, No certainly that's it that's a very good question and and ER as a as I mentioned.
The.
Wanted to make the upcoming phase two study as infant made to assess as possible and or the idea of what he said it would be that let's get that enough information. So that it potentially gives us a ready to get an opportunity to the past thought a pivotal study.
After this particular faced a study and a pretty sun and in the coming month definitely in the second quarter. The we'll be sharing more details about other clinical trial design.
And then you know in terms of dosing and the potency I mean do you see the.
Each year.
Able to retrieve sort of strong efficacy at a lower dose or do you really want to try to.
Correct.
That's great efficacy as possible.
Yeah Fantastic a a question so so.
We would want to do book and that is why on purpose.
They are choosing the load those at a high does so a good efficacy at low does.
And very good efficacy hopefully at high hurdles that gonna do they intent.
Okay, great. Thank you.
Thank you and our next question comes Leno, Adam Walsh from Stifel. You may begin.
Well you guys. Thanks for taking my questions. My first one is just on sequencing of clinical data read outs for the 300 product. This year you know we we've been over that these are open label trial. So there's the opportunity to kinda present data can you just outline for us for each of the trials one of the minimal kinda clinical thresholds in your mind.
That are there for the potential for you to announce some kind of Ah data read from each of the trials. Thanks.
Thanks.
So as we said earlier the threshold is where we made a decision it's worth going forward into registration start program. So that's we're looking for a that level of certainty.
To make an announcement, we will look for updates throughout the year on all of our programs were 300 at various medical meetings that are appropriate, but our central goal is to do fine.
Data that would indicate that we have an indication to pursue and make that data available to back up drug research.
That's okay and.
Oh I would also add is that Oh, you know at one level clearly they started firstly the beat up have studied then BV and then etch, but for all practical purposes.
One way to look at this is like all the studies that only a caught that apart from each.
Each other and what I mean by that is like for the beat up have studied for example, even though they started early last year. It's only higher goes is that like effective doses, which happened in the second half of the a and then in Q3 off last year, Vietnam see initiation of the BV.
They and early this year Vietnam see initiation of the at Chats study and then as Sam pointed out early on we believe that theoretically logically other <unk>.
Bills burden is probably going to be the highest in the beat up how transfusion dependent population based on the see it I'm.
As being the maximum or whether that so when you combine all these factors. It said that really big M. say, a delicate grace amongst all those different studies and the that is why be up you know continue to emphasize that we will make the data available as then.
When it reaches a certain level off certainty, but behind all this the go to object to is still and they cannot emphasize this enough is still just big the four syndication not the only but the first indication what a pivotal study going into 2021.
We've also said repetitive.
The only other than that I know you know this to be true that just because we say it's going to be in 2021 should not assume it's gonna be December to your point. These are open label studies, we can read certainty at any time. So that's why we've kind of left it open ended.
That's really helpful and then on the dosing question that came.
Up earlier, you know in the or in the phase two transfusion dependent beta thal patients. When you use. The 40 makes twice weekly you know you did see kind of a more sustained and significant reduction in T. said and I'm. Just curious I mean I understand why you know you might be able to.
Go with a lower dose in the other indications, but what about the twice weekly have you thought about maybe 20 twice weekly or 40 twice weekly for the other indications in other words, you know can you very the dosing regimen in those other indications to maybe get a more sustained response.
By using it twice weekly have you thought about.
But.
Yeah. So obviously isn't just about all development programs our goal will be due to give the lowest goes with the least frequency as possible it's necessary to achieve the African says we want to achieve so that being said or you know, we'll let the data speak for itself, but our goal will be to try and make the regimens.
In Europe as possible, but for all practical purposes as they study is this is the designed in such a way that did allows front the flexibility off more frequent dosing got less frequent dosing.
Okay. That's helpful. And then one final one quickly on 943.
Can you comment on a if you know anything about it more think is developing a kind of a competitive oral a alpha for beta said seven a integration competitor and I'm just curious they only have really some early data and often times you know competition is the best form of flattery, but.
Can you comment on your thoughts on the competition with the data we have at this point. Thanks.
No I think no let up all our job is to they they fully of AD off what else is going on and the understand Murphy express and and and up but do you make it a point not.
To.
Make any formal comments on or other drugs that I didn't development.
Understood. Thank you.
Thank you.
And I'm not showing any further questions at this time I like to turn the call back over to diminish but tell for any closing.
Remarks.
Thank you.
We are highly encouraged by other progress to date and look forward to multiple data driven to say something twentytwenty.
We would like to think protagonist shareholders, who support our efforts the patients who participate in other studies and then.
Left to get us to support this studies.
Finally, we are very proud off and thankful to all that highly dedicated team of perfectionist employees, one thats, what ready passionately and diligently to make all this possible.
Thank you all for joining us today operator.
Ladies and gentlemen.
This concludes todays conference call. Thank you for participating you may now disconnect.
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