Q3 2021 Theratechnologies Inc Earnings Call
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Today's conference is scheduled to begin shortly please continue to standby and thank you for your patience.
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Good morning, ladies and gentlemen, and thank you for standing by welcome to Sara Technology's third quarter fiscal year 2021 earnings call. At this time all participants are in a listen only mode. Following the presentation. We will conduct a question and answer session and instructions will be provided at that time for you to queue up for questions. In addition questions.
We'll be.
We will be able to be submitted in written form via the webcast platform.
If anyone has any technical difficulties here in the prepared remarks or during the Q&A portion of the call. Please press the star key followed by zero for operator assistance at any time.
I would now like to remind everyone that this conference call is being recorded today Wednesday October 13th 2021 at 830, a M eastern time.
I will now turn the call over to their technologies head of Investor Relations Leah Gibson Ms. Gibson. Please go ahead.
Thank you Catherine and welcome everyone Mr.
Mr Pollack, President and Chief Executive Officer of their technology and Mr. Collected book Senior Vice President and Chief Financial Officer will be the speakers on today's call a Q&A session will follow their prepared remark.
Before we begin I would like to remind everyone that there are technologies remarks today contain forward looking statements about its current and future plans expectations and intentions results levels of activity performance goals or achievements or other future events and developments.
In preparing these forward looking statements several assumptions were made by their technologies and there are risks that actual results obtained by the company will differ materially from those statements.
As a result, the company cannot guarantee that any forward looking statement will materialize and you're cautioned not to place undue reliance on them.
There are technologies refers current and potential investors to the forward looking information section of its management's discussion and analysis issued this morning available at SEDAR Dot com and on Edgar at SEC Dot Gov.
Forward looking statements represent their technologies expectations as of October 13th 2021.
Except for that which is required by securities laws, They're technologies does not undertake any obligation to update any forward looking statement, whether as a result of new information future events or otherwise.
I would now like to turn the call over to Paul Paul.
Thank you Leah good morning, everyone and thank you for being with us today.
I'm very pleased to provide an update on where some of our technology and in our effort to build upon the clear and strong operational results that have been achieved in fiscal 2020 one thus far.
At the beginning of the fiscal year, we set forth a logical strategic plan to lead the company towards inevitable growth and transformation in our commercial and investigational pipeline.
As we move well into the back half of our fiscal year.
Are beginning to show through.
We're continuing to further unlock the unrealized value held in our commercial business through product lifecycle management and innovation, while at the same time building on the vital body.
On Sept work needed to advance the promising therapeutic potential of our investigational oncology portfolio and phase III development program in Nash.
Do this and we are extremely excited about the progress made in the phase one study evaluating our novel peptide drug conjugate th 19 don't you.
For the treatment of sourcing and positive answers.
As you recall, we received fast track designation from the FDA in January 2021 recognized named G..18, 19 months when our fourth one positive technology as a broadly applicable cancer agnostic treatment for patients with sort of <unk> expressing solid tumors.
This morning, we provided an interim update noting that to date, we have several patients in part a of the study with some participants receiving more news to act.
You gave us with GH 19 would you then be indicated knows them don't get back a little Additionally, patients that received up to 300 milligram per square meter of Th 19, O two which is equivalent to approximately 1.5 times dedicated therapeutic dose of docetaxel have not experienced.
Any grade two adverse events.
The last patient that was dosed in the trial and received 420 milligram per square meter of Th 19 O two or approximately two times. The indicated those are those at XL and a desk level the patient experienced grade four neutropenia.
We are now awaiting all safety information to come in so we may access the next dosing level and pursue this study as pretty approved protocol design.
As a reminder, arent doing escalation study of the phase one trial is primarily mix with avnet, a maximum tolerated dose.
While we have not yet identified what the maximum tolerated dose will be.
What we have observed thus far is very encouraging because it seems that page 19, new to eat better tolerated than docetaxel alone.
Furthermore, in our preclinical work, we have demonstrated that th 19, who can potentially penetrating answer so far more effectively than docetaxel alone and increase the concentration of those sit back how specifically where it counts in the cancer itself.
Th 19 induced targeting just worth one receptor, which is a very prominent receptor in many solid tumors.
In terms of next steps for this program, we will plan to providing another update of the phase <unk> study. When we have reached the maximum tolerated dose of <unk> 19 of June at which time, we may have early signs of efficacy data to report.
We continue to expect initiating the part D basket trial in the U S and Europe in early 2022.
As one of the only biotech companies currently targeting <unk>, one receptor into treating lung cancer. We are fully committed to this journey, our pioneering a novel and potentially transformational treatment to a broad class up hard to treat cancers. Therefore, we're taking the same approach to garden ring scientific support for it.
This program as we did for our Phase III program in Nash.
Aligned with this strategy how long is the appointment of Doctor made a rough Hamburg has a scientific advisor in four hours sort one positive technology oncology platform we.
Very excited to have made that as part of our team as he brings more than 30 years' experience across government academia and the biopharmaceutical industry. Most recently, serving as Chief Medical Officer advisor before his retirement earlier this year, where I had the opportunity to work with them.
During his time at Pfizer as CMO the company initiated completed and obtain emergency use authorization rich COVID-19 vaccine and obtain regulatory approval for <unk>.
New cancer medicines mace.
<unk> will no doubt be an important advisor technology as we advance our rock algae platform development and toward approval.
We are also looking at additional opportunities to extend our regulatory and commercial skills for teach 19 hold true in other geographies.
Currently we are exploring potential collaborations and alliances with China based organization. So we've got to wait th 19 O. Two in patients in greater China that are suffering from sourcing and expressing cancers.
By gaining the support and scientific expertise is a locally based organization to help us develop th 19 O two where are better positioning ourselves to bring this potential treatment to patients faster and more effectively which is at the foundation of our oncology strategy.
As we think about the future objectives of our resorts one positive technology platform. There are a number of additional value driving opportunities that we will work toward included.
Waiting different dosing schedules, such as weekly or intermittently.
Potentially increase the therapeutic window in terms of safety and ethics.
Exploring the possibility of congregating with different anti cancer agents, including cytotoxic like Sn 38, and I wrote to Ken <unk> and evaluating synergistic partnerships and finally exploring rational combinations with other cancer treatments.
Especially immunotherapies.
But for the near term, we remain focused and committed to completing our first one phase one trial as quickly as possible.
Turning to our phase III program in Nash the company continues to evaluate our options to most effectively execute the phase III clinical trial of the summer and into the treatment of Nash.
Which includes seeking a potential partner.
As we announced in our last earnings call and external U S. Based Biopharma advisory firm was retained with this in identifying a potential partnership for this program and we also explore other opportunities to initiate the trial in a timely manner.
In support of these initiatives, we recently hosted a virtual Nash webinar, featuring Doctor Rohit Mamba, Stephen Harrison and Steve Green Spoon warranty opinion leaders in hematology endocrinology in Nash.
The event provided a deep dive into our innovative approach to treating Nash and for Marlin and also demonstrated the distinct to support. This program has from these leading disease and industry experts.
We look forward to updating you on the advancement of our Nash program soon.
Moving on to the commercial side, we're happy to report on the uptick in activity and demand for a Swift N V for the treatment of life with history.
While the Covid pandemic was an unfortunate.
Foreseeable event, which has no doubt materially impacted most of the health care industry. We wanted to note that in many ways dependent makes transformational pressures have only accelerated the healthcare industries need to move toward digital talent, which has been an ongoing presence in house here for the past decade.
Engagement between Hcp's into patient care journey have increasingly shifted towards new behavioral patterns that are largely driven by a need for better technology and immediate access to HCP.
When I came onboard as our technologies, we made the conscious decision to move the company towards this pack and coincidentally at the start of the pandemic.
Since then we have challenged the fundamentals of our business.
Developing a mature business acumen, which includes a more focused field force.
And Digitalized training and product education tools and have ultimately created a solid go to market model.
As a result sales increased nearly 30% in the third quarter over 2021.
Over last year supported by 65, increasing a grifter sbcs and the improvement in a grifter sbcs as a direct result of a return to some face to face meetings and graders and more efficient digital campaigning tasteful irrigation, which also led to a 40% increase in new prescribers during the quarter.
Based on this momentum we believe we have begun to revert back to a pre COVID-19 sales environment, but with a much better level of a cross functional team execution.
Creating a springboard for growth for our approved medicines.
In terms of market expansion in HIV beyond our existing markets. We have also made progress toward securing pricing and reimbursement agreements with regards to in several countries outside of the U S, including easily most recently, which is an integral part of our <unk> growth strategy spin.
<unk> to our progress in the Italian market for our technologies and the Italian Medicines Agency recently reached a reimbursement agreement with regards though and we expect that this medicine will become commercially available to all eligible patients in each of them by the end of fiscal year 2021.
Our lifecycle management strategy with regards to is also progressing nicely. Most recently, we announced results before the DMV Dash 302 study evaluating an IV push mode of administration Ultra Garceau with HIV one patient.
If in journal study achieved consistent and statistically significant results demonstrating that there was no different state pharmacokinetic between the IV push and the current IV infusion motive administration.
More convenient IV push motive increasingly parties only two quick infusions per month offering patients a rapid infusion time, thereby potentially increasing patient compliance and allowing patients to benefit from long acting protection against HIV. One when with regards there was administered with other anti retrovirals.
Based on the results of the IV push study we plan to file.
U S BLA with the FDA. During this quarter. In addition patient screening to evaluate an intramuscular or I am method of administration with regards though is also planned to begin this quarter.
Further supporting our growth strategy sports bars, but with our plan to initiate a post authorization study named as regards the promise trial.
We'll evaluate the real world long term efficacy and safety for Barnwell in combination with other anti Retrovirals. This study is expected to enroll patients in the EU. During this quarter on a similar study will be initiating in the U S. In the first quarter of 2020.
Enhancing our portfolio of real world evidence with regard as it will.
We will provide a review of course with additional and important market data to support their discussions with patients nhcd's.
Based on todays business update it is clear to see that we are proceeding as plan and executing against the goals that we have rolled out at the beginning of this year.
In oncology, we are extremely pleased and encouraged by deep early indication.
The phase one study.
Study in th 19 of which who have demonstrated and look forward to both interim and full data readout in this program over the next several quarters.
We're also encouraged by the current commercial landscape.
Has begun to show signs of recovery and expanding market penetration as we continue to unlock the intrinsic value of half an hour a drift up as the interim garzone medicines for HIV.
And we continue to work hard.
Average less leads we evaluate opportunities to most effectively execute our ready to proceed phase III program in Nash and advance this exciting program toward a potential approval.
That I will turn the call over to Filip, who will provide the Q3 financial summary.
Thank you Paul and good morning, everyone.
Their technology is posted strong overall results for the third quarter of 2021, registering a 27% growth over the same period in 2020.
We recorded sales of $26.0 million.
<unk> and $52.0 million.
The first nine months of the year sales.
Sales of the group performed well as the effects of the pandemic are showing signs of wearing off.
We recorded sales of $13.0 million or a drift up in the third quarter up 64% same period last year period, which had been negatively affected by the transition to a grifter SV from the original version.
Sales of <unk> over the quarter were down seven 8% compared to last year and came in at $12.0 million.
As mentioned in the past regarding new prescriptions have been more impacted by Covid.
Patients have been more reluctant to visit healthcare facilities sales were also impacted by the entry of a new competitor in the multi drug resistant market.
We are encouraged by the new prescription numbers, you're seeing since the start of the fourth quarter.
Cost of goods sold in the third quarter of 2021 amounted to $7.0 million.
Down slightly from $10.0 million for the same quarter last year. This is due in large part to a higher proportion of sales to be grifter, which carries a lower cost of goods sold and the lower cost of goods sold for Horizontals, which decreased from 50% to 62% to 52% <unk>.
The third quarter of last year.
As we advance the development of our sort one positive technology in oncology with the initiation of our phase one trial for <unk>. Thank you.
And we continue to get ready for the launch of our phase III trial or test tomorrow at Nash R&D expenses are increasing.
In Q3 of 2021, they stood at $11.0 million compared.
Compared to $6.0 million for the same quarter last year.
R&D expenses also included expenses related to the medical science liaison team and medical education activities in the U S and in Europe, as well as a development.
Organization of the group and the multi dose pen injector.
Okay.
Selling expenses in the third quarter of.
Turning 21 were up 9% standing at seven 7 million compared to $7 million for the same period last year.
This is mainly associated with increased activities in Europe, as we gear up for a number of country launches in the upcoming quarters.
G&A expenses grew to $9.0 million in the third quarter of 2021 compared to $9.0 million for the.
The same quarter last year.
Increase in G&A expenses was mainly associated with an overall increase in business activities senior hires to support our sales activities in the U S.
And head office functions as well as increased activity in Europe.
In Q3, and 2021 net finance costs amounted to $5.0 million.
Compared to $799000 in Q3 of 2020.
Finance costs, mostly represented interest on our senior convertible notes issued in 2018, and a foreign currency loss as opposed to a foreign currency gain in the third quarter 'twenty.
For the third quarter of 2021, we recorded a net loss of $14.0 million.
Or <unk> 10 per share compared to a net loss of $14.0 million or <unk> <unk> per share for the same period last year.
During our third quarter of 2021, our operations, including working capital variations.
$4.0 million, which includes the positive impact of $5.0 million from changes in operating assets and liabilities.
Our financial position remains strong with $57.0 million in cash bonds at the end of the third quarter.
I will now turn the call back to Paul for some closing remarks.
Thank you Phillip from a commercial perspective, we're very pleased with the improvements made since the beginning of 2021 and we're optimistic for future growth based on our third quarter results.
In terms of our operational and pipeline performance, we've had three quarters of solid progress, but have been transformational for the organization.
Looking ahead, we remain committed to building out our clinical and commercial assets and achieving that equation, where the company is much better aligned with the opportunities ahead of us.
Look forward to continuing to report positive progress that the team that there are technologies has worked so hard to achieve.
With that we will now open the call up to questions from the audience. As a reminder, questions can be submitted in written form via the webcast platform. We will also take analyst questions via the conference call line.
Operator.
Thank you to ask a question over the phone you will need to press star one on your telephone.
To withdraw your question press the pound key.
And our first question over the phone comes from Andre <unk> with research capital line is open.
Good morning, Paul Philippe and Krishna.
Just had a couple of questions in terms of.
For cars or I was just hoping you could elaborate a little bit more on the pricing of it in the EU.
And also with the U S for cars or competitors.
In terms of the competitive are there.
Thank you Andrew for your questions.
Well we are we.
We have achieved a very solid price you need to lean in our negotiation.
The price is not public at this time I don't believe it is.
However, we're very pleased with this because it's going to be an anchor point in Europe. So this is a good start for us we're happy and actually they negotiation you need somebody with a pretty stunning because.
Right.
Covid environment over there is loan.
Only God knows how much do we are affected by that we ended up ahead of schedule and.
Heating pricing and reimbursement and as I said, that's a pretty solid anchor point that will be very important for the rest of Europe in our negotiation.
When it comes down to recoup yet recoup yet is a competitor of ours to what you said.
It has made some significant inroads in the U S based on their sales force presence and also the trial that they had that was significantly large and ended up creating a bolus of patients for them at the beginning.
I remain optimistic that the.
<unk> is going to help us expand and extend that segments of multi drug resistance and I think that we're trying to find a way to continue to be relevant and I'm very optimistic about the future. John do you want quite a few things.
One thing I would add Paul is that we do see a shift in the MBR market.
Long acting and as you as you know with regards though is a FERC long acting agent and so.
More long acting agents come out I think that we're going to see.
More interest and more movement in that direction, but the landscape in a multi drug resistant HIV space is changing and there are.
Our competitors that are coming out that are can impact that.
Thank you for your question. Okay. Thank you and then just in terms of the Canadian market do you have any foreseeable plan there for.
Partnerships or launches if you could elaborate a little bit on that and then.
If you could just also give us a bit of a business development update as well in terms of out licensing and in licensing.
It would be great. Thanks.
Thank you.
Ill turn to you for the BD in a moment when it comes to the Canadian market.
<unk> is approved here, but its only its previous our formulation and since you know that we have DSV, but we are committed to shifting and transitioning to the ethane.
More convenient.
Motive administration next year, that's probably where we're going to kind of recap our planned for Canada.
We're not turning over back to Canada.
Our priority at the moment.
And when it comes down to clinical development, we'll see at what stage, we want to have or not some Canadian centers involved in our programs, but we are well grounded in Canada, and we'll continue to look for opportunities.
<unk> development.
As al mentioned on the on the Nash program. The outreach is continuing and we have had some discussions with potential partners, but there is no real update.
At this point.
On the oncology we've had some.
We hired.
And adviser as well for greater China, We have received some inbound interest from Chinese companies and we decided to.
Go out.
Broader than just dealing with one or two and so we've initiated a process of portable process theres quite a bit of interest.
In China for the oncology platform again very early to report anything substantial but.
Sure.
Frankly pretty encouraged with.
With the interest that we've seen.
On the in licensing side, it's a little it's a little.
Less active although we have been approached with some very interesting earlier stage projects. So we're not quite ready to discuss that.
But there is.
One of the plans that we have is through access.
As a catalyst research.
Done here in Quebec, and in addition to.
Licensing other technologies.
And I think we're starting to have.
Pretty good name out here. So we're having we're seeing some very interesting science copper way.
Great. Thank you.
Thank you we have a question from airports Nash with Canaccord Genuity. Your line is open hi, good.
Good morning, guys. Thanks for taking my question.
Wanted to just ask I guess my first question is just one.
Model housekeeping filled.
Philip I know you mentioned with regards to the increase in R&D. There were several things in there obviously is sort of in one and then the pen injector.
We look at things like dependent injectors kind of a one off one and done type thing.
Obviously as you guys are now starting to ramp up with the oncology side of things. The number we saw in the third quarter is that a pretty reasonable run rate, we should expect over the next.
Next quarter and then the rest of next year or.
Or should we expect it to be variable.
Yes, I think it's a good indicator as you said some of these projects will will go away, but we have more like Paul mentioned, the promise trial, which will start in the EU.
In north.
Erika as well, so I guess that level is.
Sustainable even though there are some projects that will be falling off activity and activity should be ramping up in the oncology program as well because as you know we've been we've been enrolled.
Enrolling patients one by one and as we move deeper in the phase one.
Enrolling.
A three by three and then when the expansion trial Covid. It's it's 40 patients. So next year should be to ramp up on the oncology program.
Okay. That's helpful. Thank you and then just with regards to the to the promise studies.
Which I think makes a lot of sense I guess my question is was this more driven internally by you guys to try to.
Help further educate physicians or were you actually getting the feed push from physicians to better understand.
How they would incorporate triggers though for those multi drug resistant patients.
Thank you Edward and it sounds to provide additional color, but you should know that first of all this isn't the obligations. We have in Europe comes with the approval, we got to get going with a post marketing surveillance trial, but in my experience from a strategic point of view. This is great stuff because you.
You actually give a chance to a lot of kols to develop hands on experience and I think this is going to be a strategic activity for us in the upcoming years with regards though and our commitment is.
It sounds you want to add anything this is a very very good tool par clinical team.
As Paul mentioned for Europe. It was requested by <unk> and in the U S. We decided to implement the steady with a slight change.
We'll do retrospective data entry and the patients that have been treated so far.
This is a good tool to interact with our positions and hopefully in the near term the near future maybe in a year from now we'll be able to start reporting good long term safety and efficacy data.
So a good tool to interact with the physician and potentially put publication of our product.
Got it.
So much I appreciate it.
Thank you Edward.
Again, if you would like to ask a question press. The Star then the one key on your Touchtone telephone we have a question from Andre <unk> Leno with National Bank. Your line is open.
Hey, good morning, Thanks for taking my questions.
Starting with Trocar. So I was wondering if you guys could talk a little bit on the tail from the breakdown of that decline.
We saw there.
There was a coffee.
Related.
Even last year right. So is it safe to assume that most of the decline you saw this quarter is because of the competition.
Well.
Thank you for the question I think we said in previous quarters, and we haven't changed our remind that you know what that.
That was a multi factor playing out.
<unk> is an IV infusion patients were asked to stay home do you needed to go to the clinic to the hospital at a time, where physicians were telling them to stay at home.
So that impacted obviously us capturing new patients, putting new patients on therapy and at the same time record via came out in <unk>.
Pill mode, and although we absolutely believe that VIP is more pills and patients are facing deal fatigue. So its directionally correct, but for a short period of time, it was kind of favorable to them and unfavorable to us I think that now we see the situation changing a bit and as I said before what is.
Absolutely important to me is that we team up in a way to make sure that the segment the multi drug.
Resistance segment is opening up so that we can both of us benefit from doctors being less lenient when it comes down to the viral load on treat it and that they go about treating it John do you want to add anything.
I think thats it Paul I mean, Covid has certainly had a major effect on any IV drug.
There was many emphasis in other disease states like oncology, where there was a shift to oral agents and so.
I think we were impacted by that certainly, but as Paul said we.
<unk> had a new competitor launch and that has also had an impact.
Okay, Okay, great yeah, thanks for the color.
The other question with regards to see if he can talk a little bit about the cadence of new reimbursement plans in Europe. I mean, there are several other factors I think that.
You've talked before to potentially targets at France, Spain, UK any color you can give you there.
Yes.
Okay.
Yeah.
But I was wondering about the reimbursement.
That's of launches in Europe, what we're seeing okay, well I mean as you know we've got some cohorts in some countries now in France in particular, where.
We are under <unk> so.
The temporary authorization if the patients are reimbursed.
At full price and Meanwhile, we're doing the pricing negotiation with the government as one of our major country over there, but as I said before you know in the midst of the pandemic, we were able to accelerate negotiation and each of them and they came out with as showing leadership, we have many kols on the.
<unk> that are coming forward and ended up being.
Big advocates for us too.
Get reimbursement so that will be published in the next couple of weeks and we believe that we're going to have by the end of this year reimbursement and therefore, we will start our activities underground now most of the other countries will unfold and early in mid 2022, so organic gearing up now.
Now to really capitalize on this situation and again I think that in Europe. We are ahead of Columbia and in many countries and the market dynamics are different I think the key well in Europe are playing a much bigger role as opposed to.
The HIV providers in the U S. So the goto market model may be different and may not require that we deployed a huge amount of resources to actually get that going with <unk>.
Our commercial model.
Okay, great. Thank you for the color. My next question just on the key.
Each at $19 two.
I was wonder if you guys can comment a bit in terms of if the if you saw the great for SCE on the 400 milligram dose would that suggest that that that could be the MTBE.
Or is it more work that you need to do there or do you need to see another S. A is that those groups to make that call.
Yes, absolutely.
We're not there yet with the with the MTBE the way. It works is even like what you need to see is what we call a dose limiting toxicity and what we have seen so far is the neutropenia without fever of airports is not yet the DLP that once we reach in like a grade two adverse events, we need to enroll more patients at.
That those level and once we do we have.
A total of three patients treated at that dose level, we decided if we can continue to increase or if we remain at the same dose.
Lower dose than what I can say about this phase one trial at the moment. It is really what we have what we were expecting from the animal data that we are now at those levels that are in the range of about two times docetaxel.
Dose based on a 300 without grade two adverse events, which means that we can administer up to one five times the dose of Docetaxel when conjugated with deep on th 19, O do without having any adverse events than we're getting close to the MTV.
That's the dose that we're expecting based on the animal model, we need few more patients to be able to define our MTV, but it doesn't mean that in terms of efficacy that it's Glenn.
<unk> efficacy at lower doses than we are on track. We continue MTV, we should probably reached MTV towards hopefully the end of this year and after that we'll be able to initiate our basket trial beginning of 2020.
It's got to be clear to everyone. This morning that all of this is directionally correct and quite frankly, we're very proud of where we are because it's a very least one five times the dose of docetaxel and that we're able to carry without significant side effects. So.
We haven't reached the maximum tolerated dose and was zero on this and it's very important that we carry on the dose escalation to find out what that is which is going to inform the part b of that phase one trial, but for now what we see is very encouraging I'm going to say that again, because we can it seems good.
If more of those effects out better tolerated.
And it is directionally very exciting and hopefully that is going to translate to the efficacy. We saw in the animal model once we get further down into trial.
Okay great.
One more question there I don't know if you have the data on it yet or even wanted to disclose at this point, but was there any difference in the circulating expression between the patients that you.
Treat it in terms of how they respond to the different doses.
Oh.
At the moment.
Mentioned before we're in discussion with the FDA, we are not selecting patients based on the express the sourcing et cetera.
It's normal that was requested by the FDA, because we need to SaaS eventually what will be the level the resorts and receptor like the association between the receptor <unk>.
On the other hand, we are collecting the information we will do this painting with even though it's still chemistry test and we will have the information at the end of the MTV.
There are some patients that are responding or surprising we'll be able to see if there's a correlation with the expression of the receptor of those patients are not selected the expression of the receptor and Thats, what we will do as well in the basket trial. It is very important to be able to determine what level of expression of the receptor is needed to show efficacy.
Thanks again this is a key key key facts to understand the patient in the dose escalation. All comers are not selected based on their level of <unk> expression. That's very important that people understand that we take all comers people that are at the end of the line when it comes down to their own treatment.
And therefore, they are the patients that we're treating.
With the <unk> and any additional questions.
No no that's it that's great color actually thank you very much.
Thank you and there are no other questions on the phone line.
Okay. So there are there are quite a few questions.
On the webcast and most of them are related to the timing.
Yes.
The phase one trial, so I think they have been addressed but there's one here that I will ask.
<unk> was the one great for SAE, the only one seat so far in the trial any reason why the trial seems to be a little behind schedule.
Well, yes. This is the first time that we're seeing what we call an discrepancy grade four neutropenia, but its a great person fast and it's the first time that we see great two adverse events since the initiation of the trial and as you remember we started with 30 milligram per day.
Square and this is what we.
Like we're able to increase double the dose with one additional basin only one patient per dose as per the protocol. Once we reach the 200 milligram once a coupon xg escalation dose deem that it's no longer a doubling that those but it is done because we know that we're getting closer to some toxicity and we don't want to double the dose.
Anymore, but as I said before we're very happy that we reached is also a part for the 20 milligram per meter square. It shows that we can get more docetaxel with th 19 LG.
And those effects are about and if you remember from the animal data, we always mentioned that in the presence of the sorts of the receptor.
Looks like there are more drugs that entered against yourself and the noncancerous cells that if we give one five times the dose of Docetaxel and therefore drive entry into cancer. So hopefully that will have an impact on the efficacy in terms of the timing where write off.
<unk> are given every three weeks, but to recruit the following base and we need to have all of the safety data.
The airport and it will take probably four to five weeks.
Between each patient and I must say that at the moment, we're right on target.
Probably even ire to some extent what the 420 background and now we will decide once we have all of the information and safety, which will be the next dose forward to following patients and if we need to enroll more patients at the following numbers.
Okay.
Okay, well. Thank you very much for your questions. Andy enthusiasm. This morning, I, just want to wrap up and saying that first of all we had a solid quarter from a revenue point of view. This is a really really exciting to us coming out of the COVID-19 being able to deploy resources in an effective manner.
Very enthusiastic about the.
The progress of Th 19 O two.
This is very exciting we carry on we're not behind we're where we thought we would be and this.
Early report tells us that it seems like our th 19 O. Two is better tolerated than Docetaxel alone. This is directionally correct very excited and we're still committed to the Nash trial. We've said many many times that we're looking for a partner we are in discussion we'd want to see if there are some partners.
Available, where there would be a good fit from a capability and Resourcing point of view and we're committed to the trial. So if we don't want client of ours and it will find alternate way responsible way for our shareholders to finance. This trial, we are sitting on a phase III ready to go program in Nash, It's one of the highest unmet medical need.
<unk>.
Area and I don't see why it would sit on it and we're committed to finding a way to put that in the clinic. So again. Thank thank you very much for attending today and looking forward to it.
Next update at the next quarterly report Thank you again.
This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
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Good morning, ladies and gentlemen, and thank you for standing by and welcome to third Technology's third quarter fiscal year 2021 earnings call. At this time all participants are in a listen only mode. Following the presentation. We will conduct a question and answer session and instructions will be provided at that time for you to queue up for questions. In addition questions.
It will be.
We'll be able to be submitted in written form via the webcast platform.
If anyone has any technical difficulties here in the prepared remarks or during the Q&A portion of the call. Please press the star key followed by zero for operator assistance at any time.
I would now like to remind everyone that this conference call is being recorded today Wednesday October 13th 2021 at 830, a M eastern time.
I will now turn the call over to their technology as head of Investor Relations Lee Gibson Ms. Gibson. Please go ahead.
Thank you Catherine and welcome everyone Mr.
Mr Pollack, President and Chief Executive Officer of their technology and Mr. Collector book, Senior Vice President and Chief Financial Officer will be the speakers on today's call a Q&A session will follow their prepared remark.
Before we begin I would like to remind everyone that there are technologies remarks today contain forward looking statements about its current and future plans.
<unk> and intentions results levels of activity performance goals or achievements or other future events and developments.
In preparing these forward looking statements several assumptions were made by their technologies and there are risks that actual results obtained by the company will differ materially from those statements.
As a result, the company cannot guarantee that any forward looking statement will materialize and you're cautioned not to place undue reliance on them.
There are technologies refers current and potential investors to the forward looking information section of its management's discussion and analysis issued this morning available at SEDAR Dot com and on Edgar at SEC Dot Gov.
Forward looking statements represent their technologies expectations as of October 13th 2021.
Except for that which is required by securities laws, They're technologies does not undertake any obligation to update any forward looking statement, whether as a result of new information future events or otherwise.
I would now like to turn the call over to Paul Paul.
Thank you Leah good morning, everyone and thank you for being with us today.
I'm very pleased to provide an update on where technology and in our effort to build upon the clear and strong operational results have been achieved.
In fiscal 2020, one thus far.
At the beginning of the fiscal year, we set forth a logical strategic plan to lead the company to word inevitable growth and transformation in our commercial and investigational pipeline.
As we move well into the back half of our fiscal year and efforts are beginning to show through.
We're continuing to further unlock the unrealized value held in our commercial business through product lifecycle management and emulation.
At the same time building on the vital quality of proof of concept work needed to advance the promising therapeutic potential of our investigational oncology portfolio and phase III development program in Nash.
Due to this and we are extremely excited about the progress made in the phase one study evaluating our novel peptide drug conjugate th 19, what you for the treatment of sorts in any positive answers.
You'll recall, we received fast track designation from the FDA in January 2021.
Recognizing the th 19, when she went our source one positive technology as a broadly applicable cancer agnostic treatment for patients with sort them and expressing solid tumors.
This morning, we provided an interim safety, noting that to date, we have several patients in part a of the study with some participants receiving more notice. It at one time you gave it to GH 19 on June 10.
Then he indicated no no don't get back a little.
Additionally, patients that have received up to 300 milligram per square meter of Th 19, O two which is equivalent to approximately one five times dedicated therapeutic doses. There was in fact have not experienced any grade two adverse events.
The last patient that was dosed into trial received 420 milligram per square meter of Th 19, O two or approximately two times be indicated there was a dose at XL and at that level the patient experienced grade four neutropenia.
We are now awaiting all safety information to come in so we may access the next dosing level and pursue this study as Bertie approved protocol design.
As a reminder, a dose escalation study of the phase one trial is primarily mess with avnet and maximum tolerated dose.
While we have not yet identified what the maximum tolerated dose will be.
What we have observed thus far is very encouraging because it seems that the age 90, new two is better tolerated than docetaxel alone.
Furthermore, in our preclinical work, we have demonstrated that th 19, and potentially penetrated answers now far more effectively than docetaxel alone and increase the concentration of those it back how specifically where it counts in the cancer itself.
Th 19 Jewish targeting this worth one receptor, which is a very prominent receptor in many solid tumors.
In terms of next steps for this program, we will plan to provide another update of the phase one or eight study when we have reached the maximum tolerated dose of th 19 O. Two at which time, we may have early signs of efficacy data to report.
We continue to expect initiating the part D basket trial in the U S and Europe in early 2022.
As one of the only biotech companies currently targeting towards one week after in the treatment of cancer. We are fully committed to this journey, our pioneering a novel and potentially transformational treatment to a broad class of hard to treat cancers. Therefore, we're taking the same approach to garden ring scientific support for it.
This program as we did for our Phase III program in Nash.
Along with this strategy along with the appointment of Doctor made a rough Hamburg has a scientific advisor in four hours sort one positive technology oncology platform. We are very excited to have made that as part of our team as he brings more than 30 years' experience across government academia and the biopharmaceutical industry.
Most recently, serving as Chief Medical Officer advisor before his retirement earlier this year, where I had the opportunity to work with them.
During his time at Pfizer as CMO the company initiated completed and obtain emergency use authorization rates COVID-19 vaccine and obtain regulatory approval for a new cancer medicines mace.
<unk> will no doubt be an important advisor.
<unk> as we advance of oncology platform through development and toward approval we are.
We're also looking at additional opportunities to extend our regulatory and commercial installed our th 19 O. Two in other geographies. Currently we are exploring potential collaborations and alliances with China based organization. So we've got to wait th 19 O. Two in patients in greater China that are suffering from <unk> expressing cancers.
By gaining the support and scientific expertise is a locally based organization to help us develop th 19 O two where are better positioning ourselves to bring this potential treatment to patients faster and more effectively which is at the foundation of our oncology strategy.
As we think about the future objectives of our resorts one positive technology platform. There are a number of additional value driving opportunities that we will work toward included evaluating different dosing schedules, such as weekly or intermittently.
Pension increase the therapeutic window in terms of safety and efficacy.
Exploring the possibility of conjugated with different anti cancer agents, including cytotoxic like Sn 38, and I remember again N T I when evaluating synergistic partnerships and finally exploring rational combinations with other cancer treatments, especially in Europe.
On therapies.
But for the near term, we remain focused and committed to completing our first one phase one trial as quickly as possible.
Turning to our phase III program in Nash the company continues to evaluate our options to most effectively execute the phase III clinical trial of the summer and into the treatment of Nash, which includes seeking a potential partner.
As we announced in our last earnings call and external U S. Based Biopharma advisory firm was retained to assist in identifying a potential partnership for this program and we also explore other opportunities to initiate the trial in a timely manner.
In support of these initiatives, we recently hosted a virtual Nash webinar, featuring Doctor Rohit Mamba, Stephen Harrison and Steve Greensboro, and warranty opinion leaders in EBITA allergy endocrinology in Nash.
The event provided a deep dive into our innovative approach to treating Nash into some marlin and also demonstrated the distinct to support. This program has from these leading disease and industry experts.
We look forward to updating you on the advancement of our Nash program soon.
Moving on to the commercial side, we're happy to report on the uptick in activity and demand for acreage that <unk> for the treatment of <unk> District.
While the Covid pandemic was an unfortunate.
Foreseeable event, which has no doubt materially impacted most of the healthcare industry, we want to know that in many ways. The pandemic transformational pressures have only accelerated the healthcare industries need to move towards digital talent, which has been an ongoing presence in house here for the past decade.
Engagement between Hcp's and the patient care journey have increasingly shifted towards new behavioral patterns that are largely driven by a need for better technology and immediate access to HCP.
When I came on board as our technologies, we made the conscious decision to move the company towards this pack and coincidentally at the start of the pandemic.
Since then we have challenged the fundamentals of our business.
Developing a mature business acumen, which includes our more focused field force.
And Digitalized training and product education tools and have ultimately created a solid go to market model.
As a result sales increased nearly 30% in the third quarter over 2021.
Over last year supported by 65, increasing a grifter sbcs and the improvement in a grifter sbcs as a direct result of a return to some face to face meetings and graders and more efficient digital campaigning take on education, which also led to a 40% increase in new prescribers during the quarter.
Based on this momentum we believe we have begun to revert back to a pre COVID-19 sales environment.
With a much better level of cross functional team execution.
Creating a springboard for growth for our approved medicines.
In terms of market expansion in HIV beyond our existing markets. We have also made progress toward securing pricing and reimbursement agreements with regards to in several countries outside of the U S, including easily most recently, which is an integral part of our <unk> growth strategy spin.
<unk> to our progress in the Italian market.
<unk> in the Italian medicines agency recently reached a reimbursement agreement with regards though and we expect that this medicine will become commercially available to all eligible patients can easily by the end of our fiscal year 2021.
Our lifecycle management strategy with regards to is also progressing nicely. Most recently, we announced results before the GE <unk> Dash 302 study evaluating an IV push mode of administration of <unk> in HIV one patient.
Journal study achieved consistent and statistically significant results demonstrating that there was no difference with pharmacokinetic between the IV push and the current IV infusion motive administration.
Just more convenient IV push motive industry requires only two quick infusions per month offering patients a rapid infusion time, thereby potentially increasing patient compliance and allowing patients to benefit from long acting protection against HIV, one when with regards though is administered with other anti retrovirals.
<unk>.
Based on the results of the IV push study we plan to file an S BLA with the FDA during this quarter.
In addition, patient screening to evaluate an intramuscular or methods of administration of <unk> is also planned to begin this quarter.
Further supporting our growth strategy sports bars, but with our plan to initiate a post authorization studies named as regards the promise trial.
And we'll evaluate the real world long term efficacy and safety for Barnwell in combination with other anti Retrovirals. This study is expected to enroll patients in the EU. During this quarter well a similar study will be initiating in the U S. In the first quarter of 2020.
Enhancing our portfolio of real world evidence for <unk>.
We will provide a real force with additional and important market data to support their discussions with patients in HCV.
Based on todays business update it is clear to see that we are proceeding as plan and executing against the goals that we have rolled out at the beginning of this year.
In oncology, we are extremely pleased and encouraged by the early indication.
The phase one study in Th 19, two have demonstrated and look forward to both interim and full data readout in this program over the next several quarters.
We're also encouraged by the current commercial landscape that has begun to show signs of recovery and expanding market penetration as we continue to unlock the intrinsic value without an hour a drifter SDN <unk> medicines for HIV.
And we continue to work.
Average Leslie to evaluate opportunities to most effectively execute our ready to proceed phase III program in Nash and advance this exciting program toward a potential approval.
That I will turn the call over to Filip, who will provide the Q3 financial summary.
Thank you Paul and good morning, everyone.
There are technologies posted strong overall results for the third quarter of 2021, registering a 27% growth over the same period in 2020.
We recorded sales of $26.0 million.
<unk> and $52.0 million.
The first nine months of the year sales and recruiter performed well as the effects of the pandemic are showing signs of wearing off.
We recorded sales of $13.0 million or a drift up in the third quarter up 64% same period last year periods, which had been negatively affected by the transition to a grifter SV from the original version.
Sales of <unk> over the quarter were down seven 8% compared to last year and came in at $12.0 million.
As mentioned in the past regarding new prescriptions have been more impacted by Covid as <unk>.
Patients have been more reluctant to visit healthcare facilities.
<unk> were also impacted by the entry of a new competitor.
Multi drug resistant market.
We are encouraged by the new prescription numbers you see since the start of the poor fourth quarter.
Cost of goods sold in the third quarter of 2021 amounted to $7.0 million.
Down slightly from $10.0 million for the same quarter last year. This is due in large part to a higher proportion of sales being rooftop, which carries a lower cost of goods sold and a lower cost of goods sold for horizontals, which decreased from 50% to 62% to 52% during.
The third quarter of last year.
As we advance the development of our sort what positive technology in oncology with the initiation of our phase one trial for ph type two and we continue to get ready for the launch of our phase III trial or test tomorrow in Nash R&D expenses are increasing.
In Q3 of 2021 stood at $11.0 million.
Compared to $6.0 million for the same quarter last year.
R&D expenses also included expenses related to the medical science liaison team and medical education activities in the U S and in Europe as well as the development of the.
Organization of the group and.
And the multi dose pen injector.
Yeah.
Selling expenses in the third quarter of 2021 were up 9% standing at seven 7 million compared to $7 million.
For the same period last year.
This is mainly associated with increased activities in Europe, as we gear up for a number of country launches in the upcoming quarters.
G&A expenses grew to $9.0 million for the third quarter of 2021 compared to $9.0 million.
In the same quarter last year.
Decrease in G&A expenses was mainly associated with an overall increase in business activities senior hires to support our sales activities in the U S.
And head office functions as well as increased activity in Europe.
In Q3 of 2021, net finance costs amounted to $5.0 million.
Compared to $799000 in Q3 of 2020.
Finance costs, mostly represented interest on our senior convertible notes issued in 2000, AP and a foreign currency loss as opposed to a foreign currency gain in the third quarter.
For the third quarter of 2021, we recorded a net loss of $14.0 million.
Or <unk> 10 per share compared to a net loss of $14.0 million or <unk> <unk> per share for the same period last year.
During our third quarter of 2021, our operations, including working capital variations.
$4.0 million, which includes a positive impact of $5.0 million from changes in operating assets and liabilities.
Our financial position remains strong with $57.0 million in cash bonds at the end of the third quarter.
I will now turn the call back to Paul for some closing remarks.
Thank you.
From a commercial perspective, we're very pleased with the improvements made since the beginning of 2021 and we're optimistic for future growth based on our third quarter results.
In terms of our operational and pipeline performance, we've had three quarters of solid progress, but have been transformational for the organization.
Looking ahead, we remain committed to building out our clinical and commercial assets and achieving a valuation for the company is much better aligned with the opportunities ahead of us.
Look forward to continuing to report positive progress that the team is there are technologies has worked so hard to achieve.
With that we will now open the call up to questions from the audience. As a reminder, questions can be submitted in written form via the webcast platform. We will also take analyst questions via the conference call line.
Operator.
Thank you to ask a question over the phone you will need to press star one on your telephone.
To withdraw your question press the pound key.
And our first question over the phone comes from Andre <unk> with research capital. Your line is open.
Good morning, Paul Philippe Krishna.
Just had a couple of questions in terms of.
For <unk> I was just hoping you could elaborate a little bit more on the pricing of it in the EU.
And also with the U S triggers or competitors.
In terms of the competitive are there.
Thank you Andrew for your questions.
Well, we we.
We have achieved a very solid price immediately in our negotiation.
The price is not public at this time I don't believe it is.
However, we're very pleased with this because it's going to be an anchor point in Europe. So this is a good start for us, we're happy and actually the negotiation in each of the west pretty stunning because.
Despite the COVID-19 environment over there.
Only God knows how much do we are affected by that we ended up ahead of schedule and in.
Negotiating pricing and reimbursement and as I said at the pretty solid anchor point that will be very important for the rest of Europe in our negotiation.
When it comes down to <unk> <unk> is a competitor to <unk>. So as you said.
It has made some significant inroads in the U S based on their Salesforce present, and also the trial that they had that was significantly large ended up creating a bolus of patients for them at the beginning but I remain optimistic that <unk> is going to help us expand and extend that.
<unk> of multi drug resistance and I think that we're trying to find a way to continue to be relevant and I'm very optimistic about the future of John do you want to wait a few things.
The only I would add Paul is that we do see a shift in the MTR market to long acting and that as you as you know with regards though as the first long acting agent and so.
More long acting agents come out I think that we're going to see.
More interest and more movement in that direction, but the landscape in a multi drug resistant HRD space is changing and there are.
Competitors that are coming out that are going to impact that.
Thank you for your question. Okay. Thank you and then just in terms of the Canadian market do you have any foreseeable plans there for partnerships or launches if you could elaborate a little bit on that and then.
If you could just also give us a bit of a business development update as well in terms of out licensing and in licensing that'd be great. Thanks.
Thank you Philippe.
Philip I'll turn to you for the BD in a moment when it comes to the Canadian market.
Great days approved here, but its only its previous our formulation and since you know that we have DSV, but we are committed to shifting and transitioning to a more convenient.
Motive administration next year, that's probably where we're going to kind of recap our planned for Canada.
We're not turning over back to Canada, but it's just not our priority at the moment.
And when it comes down to the clinical development, we'll see at what stage, we want to have or not some Canadian centers involved in our programs, but we are well grounded in Canada, and we'll continue to look for opportunities for business development.
As Paul mentioned on the on the Nash program. The outreach is continuing and we have had some discussions with potential partners, but there's no real update.
At this point.
On the oncology we've had some.
We hired.
Advisor as well for greater China, we have received some inbound interest from Chinese companies and we decided to.
Go out.
Each broader than just dealing with one or two and so we've initiated a process of formal process theres quite a bit of interest.
In China for the oncology platform again very early to report anything substantial but.
Sure.
Frankly pretty encouraged with.
With the interest that we've seen.
On the in licensing side, it's a little it's a little.
Less active although we have been approached with some very interesting earlier stage projects. So we're not quite ready to discuss that.
But there is.
One of the plans that we have is through access.
As a catalyst research that's being done here in Quebec and in addition.
Licensing other technologies.
And I think we're starting to have.
Pretty good name out here. So we're having a we're seeing some very interesting science copper way.
Great. Thank you.
Thank you we have a question from Edward Nash with Canaccord Genuity. Your line is open.
Hi, Good morning, guys. Thanks for taking my question.
To just add so I guess my first question is just one.
Model housekeeping.
Philip I know you mentioned with regards to the increase in R&D. There were several things in there obviously is sort of in one and then the pen injector.
I look at things like dependent injectors kind of a one off one and done type thing.
But obviously as you guys are now starting to ramp up with the oncology side of things. The number we saw in the third quarter is that a pretty reasonable run rate, we should expect over the next.
Next quarter and then the rest of next year or.
Or should we expect it to be variable.
Yes, I think it's a good indicator as you said some of these projects will will go away, but we have more like Paul mentioned, the promise trial, which will start in the EU.
In North America, as well, so I guess that level is.
He is sustainable even though there are some projects that will be falling off activity and activity should be ramping up in the oncology program as well because as you know we've been we've been enrolling.
Enrolling patients one by one and as we move deeper in the phase one.
Enrolling.
A three by three and then when the expansion trial comes it hits 40 patients. So next year should be a ramp up on the oncology program.
Okay. That's helpful. Thank you and then just with regards to the promise studies.
Which I think makes a lot of sense I guess my question is was this more driven internally by you guys to try to.
Further educate physicians or are you actually getting the feed push from physicians to better understand.
How they would incorporate regards though for those multi drug resistant patients.
Thank you Edward and it sounds to provide additional color, but you should know that first of all this is an obligation we have in Europe that comes with the approval, we got to get going with a post marketing surveillance trial, but in my experience from a strategic point of view. This is great stuff because you.
You actually give a chance to a lot of kols to develop hands on experience and I think this is going to be a strategic activity for us in the upcoming years with regards though and our commitment is big it sounds you want to add anything yeah.
This is a very very a toolbar clinical team.
You mentioned for Europe. It was requested by <unk> and in the U S. We decided to amend the study with a slight change we will do retrospective data entry and the patients that have been treated so far again. This is a good tool to interact with our positions and hopefully in the near future in the near future maybe in a year from now we'll be able to historic report.
Being good long term safety and efficacy data and.
It's a good tool to interact with the physician potentially publication of our products.
Got it thanks, so much I appreciate it.
Thank you Edward.
Yeah.
Again, if you would like to ask a question press. The Star then the one key on your Touchtone telephone we have a question from Andre <unk> Leno with National Bank. Your line is open.
Hey, good morning, Thanks for taking my questions.
I'll start with Trocar. So I was wondering if you guys could talk a little bit on the tail from the breakdown of that decline.
We saw there was a coffee.
<unk> drops even last year right. So is it safe to assume that most of the decline you saw this quarter is because of the competition.
Well I think thank you for the question I think we said in previous quarters, and we haven't changed our mind that you know what.
That was a multi factor playing out <unk> is an IV infusion patients were asked to stay home do you needed to go to the clinic or the hospital at a time, where physicians were telling them to stay home.
So that impacted obviously us capturing new patients, putting new patients on therapy and at the same time record via came out and it tailed mode and although we absolutely believe that VIP is more pills and patients are facing bill fatigue, so its directionally correct, but.
For a short period of time, it was kind of favorable to them and unfavorable to us I think that now we see the situation changing a bit and as I said before what is absolutely important to me is that we team up in a way to make sure that the segment the multi drug resistance.
Our resistance segment is opening up so that we can both of us benefit from doctors being less lenient when it comes down to the viral load on treated and that they go about treating it John do you want to add anything.
I think thats it Paul I mean, Covid certainly had a major effect on any IV drug.
There was many instances in other disease states like oncology, where there was a shift to oral agents and so.
I think we were impacted by that certainly, but as Paul said.
<unk> had a new competitor launches and that has also had an impact.
Okay, Okay, great yeah, thanks for the color.
The other question with regards to see if he can talk a little bit about the cadence of new reimbursement plans in Europe. I mean, there are several other countries I think.
You've talked before to potentially targets at the Paas, Spain UK any color you can give you there it becomes a part of life.
Okay.
But I'm wondering about the reimbursement and the successive launches in Europe, what we're seeing okay, well I mean as you know we've got some cohorts in some countries now in France in particular, where.
We are under HEU so.
A temporary authorization and the patients are reimbursed.
At full price and Meanwhile, we're doing the pricing in negotiation with the government one of our major country over there, but as I said before in the midst of the pandemic, we were able to accelerate negotiation and easily and Italia. It came out as showing leadership, we have many kols.
<unk> that are coming forward and ended up being.
Big advocates for us to get reimbursement so that will be published in the next couple of weeks and we believe that we're going to have by the end of this year reimbursement and therefore, we will start our activities underground now most of the other countries will unfold in early and mid 2020.
You too so organic gearing up now to really capitalize on this situation and again I think that in Europe. We are ahead of <unk> and in many countries.
And the market dynamics are different I think the key <unk> in Europe are playing a much bigger role as opposed to.
The HIV providers in the U S. So the goto market model may be different and may not require that we deployed a huge amount of resources to actually get that going with <unk>.
Our commercial model.
Okay Great. Thank you My next question is key.
Each at $19 two.
I was wonder if you guys can comment a bit in terms of if the if you saw the great for SCE on the 400 milligram dose would that suggest that that that could be the MTT.
Or is it more work that you need to do there or do you need to see another essay is that those groups to make that call.
Yes, absolutely well because we're.
We're not there yet with the with the MTBE the way. It works is even like what do you need to see is what we call a dose limiting toxicity and what we have seen so far is the neutropenia without fever airports is not yet the DLP that once we reach in like a grade two adverse events, we need to enroll more patients at.
That those level and once we treat.
A total of three patients treated at that dose level, we decided if we can continue to increase or if we remain at the same dose cohort or those then what I can say about this phase one trials at the moment. It is really what we have what we were expecting from the animal data that we are than we are now at those levels that are in.
The range of about two times Docetaxel.
We have dose based on a 300 without grade two adverse events, which means that we can administer up to one five times the dose of Docetaxel when conjugated with th.
Th 19 O do without having any adverse events then.
We're getting close to the MTV.
The dose that we're expecting based on the animal model, we need few more patients to be able to define a NPV, but it doesn't mean that in terms of efficacy.
Show efficacy at lower doses than we are on track. We continue MPD, we should probably reached MTV towards hopefully the end of this year and after that we'll be able to initiate our basket trial beginning of 2020.
Thank you it's got to be clear to everyone. This morning that all of this is directionally correct and quite frankly, we're very proud of where we are because it's a very least one five times.
The dose of Docetaxel that we're able to carry without significant side effects.
We haven't reached the maximum tolerated dose and was zero on this and it's very important that we carry on the dose escalation to find out what that is which is going to inform the part b of that phase one trial, but for now what we see is very encouraging I'm going to say that again, because we can it seems good.
More of those effects out better tolerated.
And it is directionally very exciting and hopefully that is going to translate to the efficacy. We saw in the animal model once we get further down into trial.
Okay great.
Laura.
I don't know if you have the data on it yet or even wanted to disclose at this point, but was there any difference in the circulating expression between the patients that you.
Treat it in terms of how they respond to the different doses.
Oh.
Oh.
At the moment.
I mentioned before we are discussing with the FDA, we are not selecting patients based on the xpress absorption et cetera.
It is normal that was requested by the FDA, because we need to assess eventually what will be the level.
And receptor like the association between the receptor <unk>.
On the other hand, we are collecting the information we will do the spending with the even though it's still chemistry and we will have the information at the end of the MTBE. If there are some patients that are responding or surprising we'll be able to see if there is a correlation with the expression of the receptor of those patients are not selected the expression of <unk>.
Receptors and Thats, what we will do as well in the basket trial, it's very important to be able to determine what level of expression of the receptor is needed to show efficacy. Thanks again. This is a key fact to understand the patient in the dose escalation are all comers are not selected based.
On their level of <unk> expression, that's very important that people understand that we take all comers people that are at the end of the line when it comes down to their own treatment and therefore, they are the patients that we're treating.
With the <unk> and any additional questions.
No no that's great color actually thank you very much.
Thank you and there are no other questions on the phone lines.
Okay. So there are there are quite a few questions on the on the webcast and most of them are related to the timing of the.
<unk>.
The phase one trial, so I think they have been addressed but there's one here that I will ask.
<unk> was the one great for SAE the only one seat so far trial any reason why the trial seems to be a little behind schedule.
Yes. This is the first time that we're seeing what we call them discrepancy grade four neutropenia, but its a grade two adverse events and it's the first time that we see great to adverse events since the initiation of the trial and as you remember we started with 30 milligrams per day.
Square and this is what we.
Like we're able to increase double the dose with one additional basin only one patient for goes as per the protocol once we reach the 200 milligram.
Next she escalation dose deem that it's no longer doubling that those but it is done because we know that we're getting closer some toxicity and we don't want to double that those anymore, but as I said before we're very happy that we reached is also a partner then 20 milligrams per meter square. It shows that we can get more docetaxel with th 19 LG.
Then those effects of adults and if you remember from the animal data, we always mentioned that in the presence of the sportsman receptor. It looks like there are more drugs that entered against yourself and the noncancerous cells that if we give one five times the dose of Docetaxel and Theres more direct entry to cancer cell hopefully.
We will have an impact on the efficacy in terms of the timing were right off the <unk>.
<unk> are given every three weeks, but to recruit the borrowing base and we need to have all of the safety data that will be quite carefully and it will take probably four to five weeks between each patient and I must say that at the moment, we're right on target.
Probably even ire to some extent with a 420 background and now we will decide once we have all of the information and safety, which will be the next dose forward to following patients and if we need to enroll more patients at the following doses.
Okay.
Okay, well. Thank you very much for your questions. Andy enthusiasm. This morning, I, just want to wrap up and saying that first of all we had a solid quarter from a revenue point of view. This is a really really exciting to us coming out of the COVID-19 being able to deploy resources in an effective manner.
Very enthusiastic about the.
The progress of Th 19 O two and this is very exciting we carry on we're not behind where we thought we would be and this.
Early report tells us that it seems like our th 19 year two is better tolerated than Docetaxel alone. This is directionally correct very excited and we're still committed to the Nash trial as we've said many many times that we're looking for a partner we are in discussion we want to see if there are some partners.
Available, where there would be a good fit from a capability and Resourcing point of view and we're committed to the trial. So if we don't apply an apartment will find alternate way responsible way for our shareholders to finance. This trial, we are sitting on a phase III ready to go program in Nash, It's one of the highest unmet medical need.
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Area and I don't see why we would sit on it. So we're committed to finding a way to put that in the clinic. So again. Thank thank you very much for attending today and looking forward to.
Next update at the next quarterly report Thank you again.
This concludes today's conference call. Thank you for participating you may now disconnect.