Q4 2021 Theratechnologies Inc Earnings Call
Ladies and gentlemen, please remain on your lines. Your conference call will begin momentarily. Once again. Please remain on your lines of your conference call will begin momentarily. Thank you for standing by.
[music].
Okay.
Good morning, ladies and gentlemen, and thank you for standing by welcome.
Welcome to their technologies fourth quarter and annual fiscal year 2021 earnings call.
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Following the presentation, we will conduct a question and answer session with the analysts.
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I would like to remind everyone that this conference call is being recorded today Thursday February 24th 2022 at 830, a M eastern time.
I will now turn the call over to John Mulally lifestyle advisors. Mr. Mulally. Please go ahead.
Thank you and welcome Mr. Paul was Beck, President and Chief Executive Officer of <unk> technologies and Mr. Felipe give Beck senior Vice President and Chief Financial Officer, who will be the speakers on today's call before Paul begins his remarks I've been asked by <unk> technologies to read the following message regarding forward looking statements.
We'd like to remind everyone that Derek technology 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 or developments in preparing these forward looking statements. Several assumptions were made by therapy technologies and there are at risk.
That results actually obtained by the company will differ materially from those statements as a consequence the company cannot guarantee that any forward looking statement will materialize and you are cautioned not to place undue reliance on them.
<unk> technologies refers current and potential investors to the forward looking information section of its management's discussion and analysis issued in this morning's issued this morning available on SEDAR at Www Dot SEDAR dot com and on Edgar at Www Dot SEC Dot Gov.
Forward looking statements represent their technologies expectations as of February 23, 2022, except as may be required by securities laws. There are technologies that <unk> 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 conference.
Over to Paul.
Thanks, John and good morning to everyone joining the call today.
I wish you a warm welcome and to express our thanks for taking part in <unk> journey.
This has been an incredible year of milestone achievements. In addition to the progress made in support of our commercial franchises.
We want to focus your attention on four key updates, which we believe are the major drivers and propelling our success in the new year.
The drivers include the build out of our own commercial sales and medical teams. Our full year 2021 results, particularly our second half performance versus that of the first half.
Data for our lead oncology asset <unk> hundred 19 in June and the progress in our Nash program.
As we also need drawn here to the close of Q1 of our new fiscal year, we carry with us the full momentum.
As for successful quarters of progress.
What stands out the most about their technology is just how differentiated we are and being an early stage biotech as we possess both late and early stage assets.
Moreover, in addition to our pipeline development. We're also a drug company with mature commercial brands and a strong strategy to grow our franchises for years to come.
Im mentioning this now since we have recently announced the strengthening of our global commercial capabilities through the launch of an internal appeal for us our commercial business has reached critical mass and we look forward to kick start in our new stage of growth with this initiative at.
At present, we are finalizing our employment offers to top performers at the current field force, who will be joining the company from our partner contract sales organization.
This will be an addition to the hiring of new experienced sales representatives in order to create a truly competitive field force.
We do believe this will ultimately lead to superior performance and faster growth part of our commercial portfolio.
In parallel to this push to better serve our patients and healthcare providers. We're also strengthening our medical affairs team.
We fully expect the expansion of our disease awareness initiatives ramp up knowledge of this therapeutic field, we are invested in across the patient and provider landscape.
For example, we expect our promise trial in North America, and Europe for Tomorrow.
<unk> study for the <unk> will contribute to helping healthcare providers identify patients in the diseases that we treat.
In building a real world evidence where assets, we are reinforcing the value they provide to patients and encouraging them to start and stay on therapy.
We are optimistic for what lies ahead in the new year, coupled by positive post COVID-19 momentum, especially now that face to face meetings have resumed across most states.
In making the decision to transition from a contract field force model. The one stat by Tara technologies employees, we are confident that the hiring of our own scene.
Signup and medical affairs teams will significantly improve the important task of engagement with our customers.
Believes that both recruitment and retention of top talent will also improve as we begin this new chapter of the company's corporate development.
In summary on this topic as our new sales and medical affairs colleagues are integrated into the whole I would like to express our delighted we are to welcome. These key members of our contract field force into the thorough technologies family.
While 2021 overall growth was five 7% the second half grew 10% compared to just 1% in the first half versus 2020.
In addition, new patient enrollment across our franchises grew up length of 24% in the second half of the year as compared to the same year ago period.
This is a very good sign that with post Covid promotion, we are gaining traction in the marketplace.
Growing revenues and the execution of our commercial strategy and in the year remains a high priority as we move swiftly to catch up with demand for <unk> in patients with unmet needs.
As a side note capital access is very difficult in the current volatile biotech mark.
However, revenues from our commercial business serves to support and Derisk our pipeline development.
This relative advantage of being a revenue generating enterprise.
Is that our commercial business allows us to be more selective and our capital allocation choices.
On the clinical trial, we are happy to report that our oncology program is close very close to establishing the maximum tolerated dose or MTV and to initiating the part b of the phase one trial of <unk> hundred 19 <unk>.
We are now in the final stages of Th 19, new juice.
As one part a dose escalation study evaluating our lead investigational peptide drug conjugate penetrate many of <unk> positive cancers.
In total for patients in the trial had been administered significant doses up th 19, <unk> 420 milligram per square meter equivalent to nearly two times the indicated therapeutic dose of Docetaxel.
To date, we have observed a dose limiting toxicity or DLT in one patient.
<unk> of our grade four neutropenia lasting more than seven days as well as other adverse events after more than one cycle at 420 milligram per square meter.
As a result, we have decided to pursue this study at a lower dose of 300 milligram per square meter or approximately one five times the usual dose of Docetaxel.
We currently are enrolling patients at this lower dose to confirm the absence of the <unk>.
Following the first cycle once <unk> been establishing a study protocol allows for immediate initiation of enrollment of the larger open label basket trial the.
The basket trial will further assess the safety and Tolerability of <unk>.
Additionally, the preliminary anti tumor activity of <unk> thousand 19 until will be evaluated for all patient aspirin to response evaluation criteria in solid tumors.
Based on additional research we have conducted on <unk>. One receptor we have submitted an amendment to the phase one protocol to the FDA to include the following solid tumor types.
<unk> positive breast cancer triple negative breast cancer ovarian cancer, endometrial cancer and melanoma with approximately 10 patients per tumor type.
In addition, one arm will be added to include a mix of tumor types, including finally small cell lung prostate and potential under our highest short jillian expressing cancers with 15 patients in total.
The original trial design consisted of 40 patients across a selection of solid tumors, including colorectal and pancreatic cancers and our plan now is to enroll a total of approximately 70 patients in the basket trial in order to evaluate the potential anti tumor activity of <unk> 19 in Q.
As previously mentioned were also exploring the possibility of out licensing development and commercialization rights for Th 19, new tools in greater China. We are very pleased to report that there has been solid interest on the part of Chinese companies and that discussions are ongoing with a number of different pharmaceutical and <unk>.
Tech companies.
In addition to the geographic exposure gained from these dialogues. We're also in the exploratory talks with companies seeking to leverage our peptide as a carrier to target cancer cells <unk> one receptors looks.
Looking at the potential of <unk> internal development out licensing and partnering opportunities. We are optimistic in our approach to managing the development of <unk> 92 for the treatment of solid metastatic and refractory cancers, both in the near and medium term.
Moving onto our dash update you.
You may have recently seen in the news that a company with interest in Nash published very interesting data.
The investment community subsequently reacted very favorably.
Based on this and other recent data published in the area of Nashville in Nash, we are seeing renewed interest and believe more than ever and the prospects for just some warning as the treatment for Nash as a treatment for Nash as experts continued to gain awareness of the <unk> as a nash treatment option.
While we continue to see partnering and non diluted financing options are phase III Nash program.
The company will segment in the upcoming days, an amended protocol to establish an interim analysis are primary end points.
The new trial design will include a seamless phase <unk> III study, where the first 350.
Planned total 1094 patient data will be analyzed by a data monitoring committee in order to assess the efficacy of <unk> on a smaller subset of patients.
A decision we will then be made to proceed with the studies remainder of the plan totaled 1094 patients. While this doesn't change the total number of patients required to seek accelerated FDA approval of <unk> for the treatment of general Nash It will serve as a substantial derisking event.
And we will inform the continuation of enrollment, while providing an indication of benefits to patients.
In the meantime, we continue to seek an ideal partner with both the credibility and capability to assist us with the Nash program going forward.
And in covering all basis, we're also seeking financing alternatives to execute the trial up to the interim analysis on our own.
Before I turn the call over to Phillip I wanted to note that our objectives for fiscal 2020 to remain crystal clear from a development perspective. We're also continuing our line extension efforts to further develop the benefits or convenience of our products, which includes new formulations and motive administration in <unk>.
Total our program management strategy is to develop the complete portfolio of assets with clear immediate near term medium and long term catalysts that will benefit not only patients unmet needs provide entry and exit opportunities for investors alike.
With this I would like to turn the call over to Phil who will provide a financial summary for the reporting period before moving to Q&A.
Thanks, Paul Good morning, everyone.
Consolidated revenues for the fourth quarter of our fiscal year 2021 were $18 8 million.
Down one 9% versus Q4 of 2020 as I will explain later our topline for the quarter was affected by a provision we are taking related to potential clawbacks in France, and which are directly related to our ongoing negotiations with the government for the reimbursement hub for <unk>.
We are however, pleased to report that revenues of our Grifter SC were $12 $7 million. This quarter up 18, 6% from the same period of last year.
Increased sales of <unk> as we were the result of a higher unit.
Unit sales.
And our net selling price mostly.
The result of a combination of a higher gross selling price and lower rebates charge backs from government payers in the U S.
<unk> revenues were $6 million during the quarter down from $8 4 million in the same period of 2020.
Unit sales were down 7% year over year and were mostly affected by lower new patient starts during the COVID-19 pandemic.
We aren't currently seeing clinics reopen.
To face meeting with physicians increased as a result of the general reopening of the economy. We are confident that <unk> unit sales will start growing again in 2022, even if the recent short term lockdowns related to the Omicron Berry has affected the market in December to January .
Bigger impact with regards to revenues was related to a provision we needed to take in anticipation of clawbacks related to early sales.
<unk> in France.
This provision is mostly related to the anticipated price to be negotiated with the French government, which is being affected by the agreed price of a competing drug.
Negotiations with the French government continue we believe we will be able to conclude these negotiations shortly.
As our first quarter within the next few days I can report that reversal unit sales have resumed growing after a difficult few quarters and that the Griffith Z unit sales have grown in the 20% range from Q1 2020 to Q1 2021.
So with this in mind, we are announcing our revenue guidance for fiscal 2022. This morning are expecting sales revenue of between 79 and 84 billion.
Cost of sales in Q4, 2021 was relatively stable at $6 4 million compared to $6 7 million for the same quarter last year. The decrease is mostly due to production related costs, which were incurred in 2020, but not in 2021.
R&D expenses amounted to $8 7 million in Q4 compared to $6 8 million for the same quarter last year. This increase is largely due to higher spending in our oncology program, including the phase one trial and the Nash III Nash phase III preparations.
Increased spending in medical and patient education, as well as higher medical affairs initiatives in Europe .
For the three month period ended November 32021, selling expenses amounted to $8 2 million compared to $6 $5 million in the same period last year.
Increase in selling expenses is largely associated with the addition of senior personnel in North America to build a stronger sales organization as well as increased activities in Europe .
Ahead of the launch of <unk> in key markets.
G&A expenses amounted to $3 9 million in Q4 of 2021 up slightly from $3 3 million in Q4 2020.
The increase was mainly attributable to the overall increase in business activity and increased activity in Europe .
In Q4, 2021, net finance costs were $1 8 million compared.
Compared to $1 $4 million in finance costs.
In Q4 2020.
As previously stated net finance costs comprised of interest on the convertible notes foreign exchange variation as well as accretion expense and are offset by interest earned on our cash balance.
For the fourth quarter of 2021, we recorded a negative EBITDA of $5 5 million compared.
Compared to negative $1 4 million last year.
Difference is mainly due to the higher net loss during the quarter.
So reflecting the impact of the capital raise during Q1 of 2021, we ended the year with cash cash equivalents of 40.
$4 million.
So Paul will be back for final comments, but first we will open the call to take your questions.
Thank you.
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Our first question comes from the line of Andre Uden with Mackie research.
Good morning Felipe Krishna.
A few questions.
When do you think we would see some phase one now.
19 O two safety data and when do you think you would also start the phase three Nash trial.
Okay. So thank you for your question Th $19 two as we said.
Is about to finalize its maximum tolerated dose and the basket trial I think it's going to be following right. After it sounds you want to provide additional color to that.
What we mentioned is that we have seen some <unk> 420 milligram per meter square.
Due to those to 300 milligram per meter square, which is one five times the dose.
Docetaxel, given where administered alone and this is a very good those and now we are proceeding with the study enrolling three basins looking at the Lpns. Following three patients after thats, what will be ready to open the basket trial at this stage based on the data that we have nothing.
Expecting any DLP.
That will be known in the next two or three months.
When it comes to your second question. The Nash, we are about to file the amended protocol with the FDA.
We expect 30 to 40 day response from them and following that we will have pretty much everything that is needed for us to actually.
A refi of our plan forward, but this is a major decision that we've made and that we are announcing today because.
Doing so will allow us <unk>.
350 patients have been treated to have hard endpoint data, which is very very significant and being able to go with the phase <unk>.
Three slash III seamless protocol allows us to carry on with the recruitment of patients and therefore, not waste time. So I think we're going step wise now first to confirm that this amended protocol is fine with the FDA second ensure that we can finance one way or another either through <unk>.
<unk>.
Or other financial means support at the beginning of the trial.
And we will certainly get back to you as soon as we have a final decision made when it comes to that.
Okay. That's great just a couple of other questions.
I was just wondering if there are any synergies with <unk>.
Based on what we're seeing at the crop.
<unk>.
Here.
Yes.
So what we are.
<unk> bank at the moment you have shown in our pivotal trial with a 40 basis yet combination.
<unk> and <unk> and even if those are the two only fully active agent we can control the viable it becomes undetectable and we see that that combination is more and more use of the market. You also work with scientists at are assessing the synergy or additive effect of different drug in vitro models and those data will be.
<unk> most likely later this year.
At the moment, what I can say is that the turn cold yet we see additive effect, which is very very good.
Okay, and just one last one here just.
There was an independent Italian study last year, showing about levels predicted COVID-19 ICU admission.
Just wondering if there are any studies looking at a director for this and is there any off label use going on for <unk> in this indication.
Yes.
A very good question and this was a very nice observation in this there's detailing and steady but there were other also use study looking at making debate between.
A significant amount of fat and more severe symptoms of Covid and what we've done it's really showing that that is not only cosmetic and needs to be treated and physician need to tackle that and what we did the medical team was able to talk about these data. These data were very well received it was also included our steeper pre.
Graham and the physician RCM program, we're able to talk about this then that's something which is important and it shows that.
Our assets in the HIV patient population, but that in fact.
Should be treated and making sure that is reducing the maxim. Thank you can tell you. It's further reinforces the fact that <unk>.
Or like what district feeds a serious medical condition. So we're using the bulk of evidence in the continuing medical education.
And we think that.
More and more doctors will see for themselves that we are the only solution to treat like with district in HIV patients.
Okay, that's great thanks very much.
Hi, Jonathan.
Thank you.
Question comes from the line of <unk> Leno with National Bank.
Hi, good morning, Thanks for taking my questions.
For me, but I'll start with the first one for Paul perhaps.
Question is on the sales force what is the rationale for it.
Elisa into Salesforce and what do you plan to achieve that you are not achieving towards the CSO.
While any one and.
In business will tell you that contract sales organizations are fine, but normally you use a contract sales force for only a period of time.
Either be before you transition to something else or because you have a new indication that you want to add a surge that is not permanent in the type of activities that you want to have for the long run. So our rationale was if we want to beat the competition. If we want to be relevant we want to actually produce the type of <unk>.
Growth that we wanted to set for ourselves we need to have a theory and gauge very competent very relevant CF for us and I think that we wanted to see if we could move these products before initiating.
The transition because this is a significant endeavor and as I have highlighted in his speech. We were extremely pleased with the results. We got in terms of new prescriptions, new enrollments in the latter part of the year last year as soon as we could execute on our strategies and tactics when it comes down to and track team face to face.
Physicians, so that was a trigger and what we foresee is more effectiveness salesforce effectiveness more synergy with the medical field a team and all of that together will actually I think triggers superior engagement and superior results. John do you want to add a few things.
Yes, I mean as with any any product I mean, having a highly engaged salesforce is absolutely critical and where the contract Salesforce I think there is some inherent limitations one we had a fairly high turnover rate and due to the nature of these.
The contract could be somewhat transitory and having our own people is going to be.
Significantly be a significant benefit to these products. We also hired a VP of sales last year that has significant experience in HIV. So we're in the process of building the capabilities of this sales force them and we think thats going to really pay big dividends in the coming months.
Okay, Great that is great color and one more follow up on that.
What would be the cost bump initially.
What kind of ROI are you targeting any timelines again.
As you can to achieve it that that ROI with the entire lifestyle of course.
Got it.
Andrey.
While the cost is pretty much cost neutral because we did pay <unk>.
The management fee, just sending us to manage our operations. So we're no longer paying that we do have to hire some more support staff, but the cost and generally is neutral it really is for the engagement the lower turnover and the.
The recruitment of top performers so on a cost basis, it's pretty neutral.
But it's really on the operations.
Where the impact is Betsy.
Great. Thank you very much for that.
Question I have one trocar. So first if you can quantify.
Quantify what the claw back provision with regards to what this quarter just for modeling purposes and the other question with regards so if you can give an update where you would have gained reimbursement in Europe and what other countries are you targeting there.
Well the situation in Europe is one country at a time as you know, we got an indication for being able to commercialize buying from EMA, a while ago, but the negotiation is country by country.
Got some countries now where we have.
Been able to negotiate a good price and no cap when it comes down to a total number of patients that we can recruit.
Some other countries, where we have a good price.
Have a cap and there are some other countries in Europe as you may imagine, where it's a direct relationship between pricing and volume and for those we are extremely.
Careful before accepting an offering that would not allow us to actually promote for the long run based on the fact that we would not be able.
To read the benefits of our investments. So we are negotiating with many countries all the countries in Europe for which we have approvals are in scope incidentally, we just negotiated a good price in Israel recently.
And we will continue in smaller countries like Austria and Norway.
But the main countries for us in Europe .
Probably France.
We find that there's a significant potential in Italy, where we secured a price earlier.
Last year at the end of 2021, and we also have a great deal of expectation for a country like Portugal and that is a small country, but that carries a fair amount of HIV one patients, Spain is in scope UK and scope and it's one country at a time as I said based on their way of.
Heating so we have to be customer facing customer focused and it's one country at a time and.
We'll let you know.
Enzo, Indiana, but to answer your questions.
The countries are in scope, we just need to do with the right negotiation and get out of the negotiation in a way where we could actually havent go to market model that makes sense for us.
Now I think your second question had to do with <unk> potential claw back is that is that what I heard.
That's one.
Andrew we're not announcing.
The exact size of the.
The provision we are still in negotiation with the French government. So we want to keep that private for now.
What I can say is that we would have shown growth on the top line overall for the quarter, if we hadn't added so.
That's all we're going to say right now.
That's good color as to color. Thank you.
Just a couple quick ones for me on the development product that I will turn it over the line, but on the Nash. The modified protocol is this in response to any feedback that received are in discussion with potential partners or is it an internally developed strategy.
Well.
It's two fold I guess.
We've been doing a fair bit of analysis to compare the benefits of doing a phase II B and then a phase III trial and quite frankly, a phase <unk> trial would be very similar to.
Doing this interim analysis, we want to embed in our phase III protocol. So we believe that we are good to go and the agency believes that a long time ago, because they gave us.
Studying the proceeds letter, but at the same time.
Jumping off the study and smaller bids from the financial point of view makes a great deal of sense and being able to have hard endpoint analysis. After the first 350 patients are treated makes also a lot of sense from both a science and a financing point of view so.
We think that providing that agencies find with this approach which is called seem less.
Type of approach our protocol I think we are going to have all the cards on the table for us to make a final decision just how do you want to add to this.
Okay, great. Thank you and then.
Once again on the oncology team.
Page two of the out license in China.
This is a strategy.
You're going to get something on the table at this point or would you wait until you have established the MTBE and have some indication of activity from the basket trial.
Well thanks for the question I'll, let <unk> answer that question is we are in negotiation when many companies some of them.
Are very happy with what <unk> seen and already we have terms some others. It may actually turn to we want to see more what can we say I think the overall.
The objective here was to.
Get a Chinese partner, because we're not going to develop it ourselves for the Chinese market. So we wanted to someone to get involved as early as possible and as much as possible of parallel development track and so obviously we contacted.
The 100 companies and some of them said, we'd rather wait for the phase one data, but some of them are willing to take the risk. So we don't see why we should wait because there will be milestones associated to Enbridge every regulatory development.
Hurdle that we go through so.
Really what we wanted to achieve was have someone.
As early as possible into development, so that they could help us spring on a forward on a global basis.
So in general this is a value generating strategy that we want to put forward.
That's great color. Thank you very much.
Thanks for your question.
Thank you and I'm showing no further questions.
Okay. So it will take a few questions from the.
The web platform.
And Theres quite a few on <unk>.
Apology trial in terms of the selection of Dubuque cancers that will be putting into the phase one b trial, all reading paraphrase a few of them.
So can you. Please clarify the phase one beat cancer types and what informed the decision to add more.
Tight and to draw pancreatic and colorectal.
And was that was it something that was seen in the trial or other work that you did.
Well. Thank you for the question. This is an important announcement that we've made today and I wouldn't like anybody to actually see this as a drop of colorectal pancreatic and you should see it the other way around what we've done is that we are optimizing our basket trial to see early sign of efficacy based on this.
<unk> one work that we've done to measure the expression of that receptor just sound do you want to say more.
Randy.
If you remember the protocol.
The minutes with the FDA and completed them.
More than a year and a half ago, but since then we've done many many analysis in different tumor types and what we have seen is that that sector is significantly express and the large number of patients and all of the cancers that we've selected for the phase one and that's all set it's a better chance to.
Signs of efficacy, but it's also a better chance to have a fast track to the FDA without the diagnostic test and Thats the goal at the moment and.
And maybe just for colorectal cancer or pancreatic cancer, we have seen some expression, but it's only the lower percentage of patients eventually with the diagnostic test that would work as well, but the initial goal.
As the market.
Cancer types of are expressing the motions.
So this is a very important point in today's conversation we are just.
Highlighting some we're integrating some new learnings into our protocols. So that we increase our chance of winning and driving an indication as fast as possible.
And maybe just to close on that we are.
Planning to either published or presented their results from the <unk>.
Sort of in work that we've been doing.
So do you expect a <unk> 19 to <unk>.
These were all <unk> four expressing solid tumors.
Or will they be a phase II phase III offer each cancer type.
So Sam.
This is a very good question.
Well it depends on what we see in our basket trial.
At the moment, most capable off tumor type by tumor type.
If we see more efficacy in one tumor type we might change that approach because it will be faster to market.
If we see similar efficacy in many different tumor there could be a kind of a basket approach as well, but I think that will most likely be one type of cancer in a fast track.
Okay.
<unk> again, how serious where the adverse events.
In the cycle.
After the initial cycle.
Yes, what we've seen is our adverse events are linked to when you gave higher dose of Docetaxel at some points you cannot reach or go higher to a certain level and what you see what those attacks on what we've seen the same after two or three cycles that can be signs of neurotoxicity that seen with those attacks.
Scene also some signs.
Visual acuity seen one dose it thanks, Hal and some fatigue.
We have a regular discussion with all of the investigator taking part in this study and based on that observation, we decided to go to the 300 milligram per meter square, we think that even if it's at one five times that doesn't have those effects out it will be much better tolerated and it will be able to give way more cycle after three months.
Which is the objective in treating cancer patients.
A question here will you be looking at other applications for the <unk> one receptor outside of oncology.
So thanks for the question, we know that there could be some other applications based on short corn expressions in other parts of the body, but quite frankly, we've got our hands full now with <unk> expression.
Apology and its potential.
You also heard that some companies have.
Shown interest in our peptide as a carrier to get to the cancer cells and we'll have to do a fair bit of education on this fourth one receptor as we get into the.
The basket trial, so that people can understand how it works and why do we have identified this and treat the cancer cells. While the vast majority of companies have not so we've got to be very very prudent Gary the way that we spread ourselves and Dr. Many additional applications.
Answer, but this is not part of our.
Journey at this time.
Okay.
Long will it take to confirm safety at the 300 milligram level did you gave a timeline.
The way the protocol is set as we recruit three patients.
We need to hold them for three weeks. If there is no DLT window can go to the next three patient pull them for three weeks. After we will be ready toward a basket trial I think the one thing that we have to be careful in terms of timeline sometime we havent basin that was almost ready to start and there is a significant progression of the condition and the patient has to be excluded from the trial that there could be a bit more.
And recruiting patients, but I think within the next two to three months.
We should be able to confirm for moving ahead with the basket trial.
I want people to understand thank you can assume that the dose escalation. Unfortunately is not always a straight line.
And it could it could mean, sometimes that you go one step forward to have one step backward.
And it looks like now we are really at the end of this process and we need to confirm with just.
Highlighted in the next couple of weeks and as soon as that confirmation is done we'll actually start.
Opening up at a different pace.
Towards the basket trial.
So last question on oncology any upcoming conference presentations on cancer.
Im going to answer that.
We can't really answer, but we will tell you that ACR is coming up in <unk> is coming up in June as well so.
That's all we can say on that for now.
There's a question on the on the estimated cost of pursuing the first 360 patients.
Nash and we're still working with our CRM on determining the exact cost, but it should be.
$50 million range.
So about a third of the overall cost and or a third of the patients.
And there's a question on the impact again.
Again on the cost impact on the sales force transition as we said there are a little bit of some upfront.
Cost to set it up but on a go forward basis, it should be a cost neutral.
So that confirms the concludes the Q&A session. So I'll hand, it back over to al for closing remarks.
Well, thank you to everyone, who joined our call today, and we hope that we have clearly articulated at the four main drivers of Claret Technologies' 2022 strategic operating plan.
Our marching orders are rather clear and focused on these drivers which includes firstly the rollout of our newly established internal sales and medical field force in support of our franchise activities.
We believe our internal field force will allow the company to be even more competitive in 2022 and beyond as we flex our superior ability to connect and engage with patients and providers in order to improve therapeutic outcomes.
From a financial metric perspective, it is our intent to build upon the momentum of the second half of fiscal 2021 and are targeting from 13% to 20% growth in our commercial portfolio now that face to face activities have mostly resumed the continued commercial success of our brand is a strategic.
Chick imperative and at the core of maintaining a fundamentally strong balance sheet as well as working capital to fund activities.
Third we will continue to advance development of our oncology pipeline and the development of th $19 two for the treatment of solid <unk>.
Ed again refractory cancers in tandem to this R&D effort, we are exploring outlined sensing developments for th 19, two in greater China and.
In addition to partnership with other pharma and biotech companies, who are interested in our peptide as a carrier to target cancer cells through <unk> one receptors.
Lastly, we will continue to advance our phase III Nash program.
Partnering discussions around Nash carried over from 2021, RSV continuing while we seek non diluted financing financing options for the program having filed an amended protocol with the FDA. We are moving the program forward, which will carry significantly derisk development profile by assessing.
The efficacy of <unk> on a much smaller subset of patients I would like to reiterate that we believe these driving forces will allow the company to be even more competitive in 2022 and unlike in majority of early stage biopharmaceutical companies.
<unk> commercial business vastly differentiates ourself as we continue to work on our development pipeline of late and early stage asset spread across several indications.
And with that thank you everyone for joining our fiscal review of the period. We look forward to the next set of quarterly financial and milestone updates as our story progresses.
Have a great day everyone.
This concludes today's conference call. Thank you for participating and you may now disconnect.
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Good morning, ladies and gentlemen, and thank you for standing by.
Come to their technologies fourth quarter and annual 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 with the analysts.
Instructions will be provided at that time for you to queue up for questions.
Following the analyst Q&A session investors wishing to submit a question may do so by clicking on the ask a question link on the webcast platform.
If anyone has any difficulties hearing the conference. Please press the star key followed by zero for operator assistance at any time.
I would like to remind everyone that this conference call is being recorded today Thursday February 24th 2022 at 830, a M eastern time.
I will now turn the call over to John Mullally lifestyle advisors. Mr. Mulally. Please go ahead.
Thank you and welcome Mr. Paul <unk>, President and Chief Executive Officer of <unk> technologies and Mr. Felipe give back senior Vice President and Chief Financial Officer, who will be the speakers on today's call before Paul begins his remarks I've been asked by <unk> technologies to read the following message regarding forward looking statements.
I'd like to remind everyone that <unk> technology remarks today contain forward looking statements about its current and future plans expectations and intentions results levels of activity performance.
Our achievements or other future events or developments in preparing these forward looking statements. Several assumptions were made by <unk> technologies and there are risks that results actually obtained by the company will differ materially from those statements as a consequence, the company cannot guarantee that any forward looking statement will materialize and Europe .
Cautioned not to place undue reliance on them.
Ferrous technologies refers current and potential investors to the forward looking information section of its management discussion and analysis issued in this morning's issues. This morning available on SEDAR at Www Dot SEDAR dot com and on Edgar at Www Dot SEC Dot Gov.
Forward looking statements represent their technologies expectations as of February 23, 2022, except as may be required by securities laws. There are 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 conference.
<unk> over to Paul.
Thanks, John and good morning to everyone joining the call today.