Q1 2022 Theratechnologies Inc Earnings Call

Good morning, ladies and gentlemen, and thank you for standing by welcome to <unk> technologies first quarter fiscal year 2022 earnings conference call.

At this time all participants are in a listen only mode.

Following the presentation, we will conduct a question and answer session with analysts instructions will be provided at that time for you to queue up for questions.

Following following the analyst Q&A session Investor wishing to submit a question may do so by clicking on the ask a question link on the website 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 Wednesday April 13, 2022 at 830 am Eastern time, I will now turn the call over to John Malawi lifestyle advisors.

Please go ahead.

Okay.

Thank you and welcome Mr. Paul <unk>, President and Chief Executive Officer of <unk> technologies and Mr. Filip <unk> seen.

Senior Vice President and Chief Financial Officer will be the speakers on today's call. Additionally, Derek technologies has also asked Christiane Marcial eight.

Chief Medical officer to participate on today's call to provide an update in regards to the progress Th 19 O two the company's lead oncology asset.

Now before Paul begins his remarks I've been asked Spike our technologies to read the following messages regarding forward looking statements I would like to remind everyone that various 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 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 you are cautioned not to place undue reliance on them.

Their technology refers current and potential investors to the forward looking information section and it's management discussion and analysis issued.

This morning.

Available on SEDAR at Www Dot C D E R dot com or on Edgar at Www.

<unk> Dot Gov forward looking statements represent their technologies expectations as of April 12, 2022, except as may be required by securities laws.

Tara technologies does not undertake any obligation to update any forward looking statement, whether a result of new information future events or otherwise.

I would now like to turn the conference call over to Paul.

Thanks, John and good morning to everyone joining the call today.

We are well into the new reporting year.

With great installed it's alright.

As you can tell from our excitement during the year end call. We have never been more confident in our recent history and where we are today.

We are leaning into the advantages of our strategic business model consisting of both.

Element pipeline in our commercial truck business.

On this note we have asked this genre Sudan, Alright technologies, Chief Medical officer to join our call today in order to provide a brief but important updates on the significance of the new preclinical th 19 O. Two studies as presented at this year's American Association for Cancer Research annual meeting.

Inc, which took place earlier this week.

Our pipeline across oncology.

Where we are exploring how the peptide drug conjugate asset is potentially a promising new technology, representing a broad range of commercial or <unk>.

Across solid refractory and adding answers for patients with significant unmet needs.

Our phase one study investigating <unk> 19 to a two hour D.

<unk> drug conjugate linked to Docetaxel, a well established and well characterized.

The agent used in the treatment of cancer has been progressing well in the past few weeks.

Currently we have completed the 300 milligram per square meter dosing regimen equivalent to 1.5 times the indicated therapeutic dose of Docetaxel alone or three patients with th 19 O. Two and are nearing the conclusion at this stage of the trial and establishing a recommended phase.

Two dose we expect to have all six stations.

<unk> enrolled by the end of April .

This is significant as the targeted delivery of page 19, or two along with a rapid internalization of the dragon and yourselves could enable the accumulation of 7.5 to 10 times the more toxic agent within cancer cells as compared to the integration of Docetaxel alone.

This increase tumor penetration significantly in specifics in cancer cells is a key differentiator of th 19 into as a therapeutic treatments for cancers.

Now if the absence of dose limiting toxicity or DLT is confirmed at 300 milligram per square meter. This those will become the recommended phase II dose as previously discussed once the recommended phase two dose is established.

Asian of enrollment of the larger open label Basket trial will begin immediately which can potentially starting as early as the end of may.

The basket trial were further assess the safety and Tolerability of Th 19 O two.

In addition, we are confident in the design of the basket trial as it should enable us to show preliminary efficacy in a number of solid tumors in the second half of 2022, given that we have selected cancer types, where in Georgia and in expression is high.

And an amendment to the phase one protocol was submitted to the FDA Duane Halloween solid tumor types hormone positive breast cancer triple negative breast cancer ovarian cancer endometrial cancer melanoma 10 patients per arm with summit.

One additional arm will be added to include fibroid small cell lung prostate and potential other at high sorted and expressing cancers for 15 patients in total for that arent.

We're happy to report that to date. The company has received and responded to questions raised by the FDA and does not expect to receive any additional questions before the April 15 deadline date by which the amendments to the protocol will be deemed accepted and ready to be implemented.

On the partnering front, our licensing development and commercialization rights for Th 19, two in greater China continues and our ongoing with a number of different pharmaceutical and biotech company.

The early signs of Th 19 O. Two music is expected in the second half of 2022 will aid in further supporting conversations around the commercial bad way shouldn't up th 19 O Tuesday rights.

Earlier this week the company presented three posters at the recently attended E. Our annual meeting, including new in people with Th 19 O two preclinical data demonstrating tumor growth inhibition.

Of human cancer stem like cell C. G 133 positive in both triple negative breast and ovarian cancers.

Cancers and lifestyles.

Nitpicking implications in the Arsenal Genesis of cancers, and an important area of investigation and therefore, its sian can provide additional color to what was presented considering the importance and implications.

All the data.

Moving onto a grifter S. V. Now we previously noted our intention to file a supplemental BLA for the <unk> formulation some worn in by the end of the first quarter of calendar 2022.

However, we were recently informed by the sole global supplier of bacterial static water for injection or be Wi Fi.

When she is required for the reconstitution of company's Enphase formulation that is manufacturing facility was recently inspected by the FDA and he is now required to make modifications before resuming manufacturing and shipment August BW and I product.

D. M. D. E also point out would be Bolton, noting the shortage of VW and pie that isn't available to the market.

As a result of this supply chain interruptions, we have decided to pause all external activities related to the company's phase III Nash trial and daily submission of our guests eight formulations and the L. A as.

As you may be aware the phase III Nash trial was underpinned by the use of the companies that they are mornings formulation.

With the manufacturing overhang around B W. F. I, we can no longer reliably comment with certainty as to when we can resume lifecycle management and start that there's some orleans phase III activity as we seek to source BW in mind.

On a positive note we have learned that initial shipments of BWI orange schedule for high priority customers, including hospitals clinics and pharmacies, which may indicate that the situation is on track to get normal.

So as to not punish them for any confusion, we want to note that there is no shortage from water for injection or Wi Fi, which is a different delaware using the reconstitution of our technologies currently marketed or formulations.

Although this unplanned circumstances unfortunate we're still awaiting feedback from the FDA on our protocol Amendment and.

It will be and we'll continue to refine our national development plan by working towards identifying and ideal partner refueling alternative financing that can take the program through its interim analysis and determining that we have a competitive methods a demonstration for when we commercialize the product.

Beyond our pipeline efforts, we are very proud of our commercial business, which reported sales of $70 million in fiscal 2020 , one for which we have great aspirations for in the future.

And to this effect before we go further with today's call we want to reiterate guidance expecting fiscal year 2022 revenue to be in the range of 79 million and 84 million for fiscal 2022 .

This represents growth of the commercial portfolio in the range of 13, and 20% when compared to 2021 .

We are emphasizing 'twenty two 2022 outlook supported by the fact that they continued to experience solid sales growth through advancement of our 2022 operating plants in spite of Q1 being historically, our weakest quarter.

With a grid Gripsack S V commercial sales achieving 35% growth in overall blended commercial sales growing into double digits by 20%. It's early on in the fiscal year. The full onboarding of the newly hired into your own commercial sales force will only serve to reinforce our sales object.

Yes.

As we continue to exist endemic restriction.

It is our expectation that we would be able to deploy the full breadth of our salesforce, enabling increased physician engagement.

One is fully on boarded which should be the case by the end of April .

As this is now an interim option, we expect employee engagement through increased turnover to diminish and allow for the recruitment of top tier talents in the future.

Against this backdrop of continued performance, we're even more convinced that the building of our internal field force at this particular juncture, what's the right call.

For tomorrow with supplemental biologics license application. So it S. BLA was filed with the U S food and drug administration D. M D E and F. 2021 for the company IV push modem administration for the treatment of HIV one.

With the FDA accepting our filing.

We were giving a target action date of October 3rd 2022 in accordance with the prescription drug user fee Act, which is commonly known as a drugs produce a day.

There are technologies in time and are also evaluating an intramuscular mode of administration with regards though within D. G. M. B Dash 302 study.

D. I M formulation, if approved will be a marked improvement in the patient experience.

So in the next few months well before the start of the summer season, you shouldn't be expecting two significant milestones. The first is initiation of part b of the phase one trial of Th 19, two or what we referred to as the basket trial.

And in the full launch of our company field force in support of our year end sales object now.

Now before I turn the call over to Phil who will provide a financial summary of the reporting period before moving to Q&A I would like to introduce our chief Medical officer to discuss the Th 19 O. Two preclinical data that was presented at ACR This year Michelle.

Thank you Paul Hello, and good morning, everyone.

There are technologies attended the ACR 2022 annual meeting and we wanted to share with you. Some of the findings of the three posters that were presented.

It's our belief that the sore command center is an ideal candidate for trafficking peptide conjugate, our PVC specifically to cancer cells.

As background sorts and then receptor expression is both common and high across many known tumor types, but almost absent an LTV issues.

Making it an attractive target for cancer drug development.

Sort of an expression interestingly also increases as a function of tumor grade 124.

And there's typically associated with poor prognosis and decreased survival rates in a number of cancers.

Our sort one positive technology.

In oncology platform, consisting of novel peptides targeting the smart one receptor.

We are currently investigating the exploitation of the sort on function.

With various combinations of Bdcs, which lead to receptor mediated trafficking of wellness Stablish anti cancer agents for example, Docetaxel doxorubicin and Sn 38 that are attached to the novel proprietary peptide.

This approach could potentially decrease the off target up anticancer drugs like cyclotomic cig and.

And increase their biggest thing by increasing their concentration specifically in cancer cells.

A key aspect of this technology has the ability to traffic payloads directly to cancer cells.

We're at the access P. D. C. Bill is released from the peptide to exert its cytotoxic effect, specifically inside the cancer cell sparing normal cells from toxicity.

This is accomplished by the exploitation of the sorts of the receptor native function as a transmembrane scavenger a receptor.

All the import export of large peptides into the cell you have the and those are all lines, there's a mall.

A cellular shower system.

The platform technology allows for versatile and flexible integrated strategies.

Two actually different ratios anticancer drugs.

These exciting new preclinical data presented at ACR demonstrate the significant potential in preclinical studies of our platform technology as a treatment for sorts of <unk> expressing cancers.

Additionally, the promise after technologies Heartland positive technology platform suggests that it can be effective in targeting and trafficking different anti cancer payloads.

As part of our preclinical studies, we investigated cancer stem like cell.

In humans cancer stem cells are an important target and treatment of cancer.

They contribute to the carcinogenic cancer and are typically resistant to conventional treatments such as chemotherapy and radiotherapy.

Moreover, sort climate is also integrated and the formation of Escalade, Janet maybe to restructures.

I want to feed the tumor as they grow and are also associated with cancer of resistance to standard treatments.

From the human cancers.

<unk> sells that.

Bearing this easy 133 are known cancer stem cell Mark.

We demonstrated that th 19 O two peptide centric moves into those tumor cells, yet the sort one receptor function.

Additionally, once inside of the tumor th 19 routinely induces cell death of these cancer stem like cell more effectively than the site with a toxic agent alone in both triple negative breast and ovarian cancers.

These results are very impressive.

Cancer stem cells are known to be resistant to most anti cancer treatment.

And a second poster we have presented the results of the combination of DH 19, O two with carboplatin as compared to paclitaxel or docetaxel or both Hudson combinations in ovarian cancer.

The results clearly demonstrated that th 19 O. Two alone is better than some of the gold standard treatment for ovarian cancer and then the combination of these 19 notes with Carboplatin, Kevin further improve the efficacy of ovarian cancer treatment.

This is the first time, we showed that th 19 O two can be used in a combination treatment.

These results certainly opened the door for treating patients and earlier lines of cancer treatment.

Our third poster presented results showing th 19, nordson demonstrated better and sustained efficacy.

Those is equivalent to the maximum tolerated dose of Docetaxel in human and urine melanoma subcutaneous xenograft models and that the mines prolong survival rate increased 263% in mice treated with th 19 owned.

We were also able to demonstrate that <unk> 19.

Davidson.

The formation of logging the businesses and the B 16 and model across different GH 19 O two regimens.

These insightful new results further confirmed that our sort one positive technology is a novel therapeutic approach to delivery of established anticancer drugs to tumor cells, thereby optimizing our biggest limiting toxicity and improving the paramedic window of the cytotoxic.

Yeah.

It also shows that this platform could be effective in.

In summary resistant cancer as well as against that now opened metastasis.

To summarize the data that was presented at ACR Mark as part of the key differentiators of noble each $19.

First in preclinical work, we have observed enhanced effectiveness of <unk> 19.

Versus docetaxel alone.

Especially in hard to treat refractory cancer.

Second the capacity of the aged 19 to inhibit our nation of B M and growth of cancer stem like cell and in fact be the mechanism of action at play behind those observations.

And lastly, leveraging sort one receptor o'donoghue th 19 O two to target cancer cells with a seven 5% and full concentration of the cytotoxic agents and the cancer cells, while sparing normal cells as those are known to show little or no sort one expression.

Thank you for your time, everyone I will now pass the call to Phillip tariff acknowledging Chief Financial Officer.

Thank you Tom for reviewing the data that we presented this week at ACR and good morning, everyone.

So I'll go through the financials before I turn the call over to the operator for the Q&A session.

Consolidated revenues for the three month period ended February 28, 2022 was $18 6 million compared to $15 4 million.

Same year ago period, representing an increase of 20%.

For the first quarter of fiscal 2022 net sales of a grifter S. V reached 11 7 million compared to $8 7 million in Q1 of last year, representing an increase of three 5%.

Due to the combined effect of a higher number of units sold and a higher net selling price.

In the first quarter of fiscal 'twenty to <unk> net sales amounted to $6 9 million compared to $6 7 million last year, representing an increase of one 6%.

While unit sales were higher in both North America, and Europe revenue growth was impacted by growth by greater rebates, mostly in Europe .

In Q1 2022 cost of goods sold was $4 9 million compared to $4 2 million for the same quarter last year.

The increase in cost of goods sold was mainly due to higher sales accounts.

Cost of sales also includes amortization of $1 2 million.

Related to the repurchase of Arista commercialization rights.

This figure is the same as it was in Q1 2021.

R&D expenses amounted to 8 million for the three months period ended February 28, 2022, compared to $4 9 million for the same year ago period.

This increase was largely due to the higher spending in our oncology programs increased spending in medical and patient education as well as increased medical affairs spending.

In Europe .

Selling expenses amounted to $7 8 million for Q1, 'twenty two compared to $6 2 million for the same period last year, reflecting the addition of key hires in North America and in Europe , as well as greater commercialization activities in both territories.

The amortization of the intangible and tangible asset value for the growth that Antoine <unk> commercialization rights is also included in selling and market development expenses.

Such we recorded an expense of 785000 in Q2 as well as in Q1 of last year and Q1, 'twenty two with it as well as in Q1 of last year.

G&A expenses amounted to $4 $4 million for the first quarter compared to $3 5 million for the first quarter of last year.

The increase in G&A expenses was mainly associated with an overall increase in business activities and increased activity in Europe .

Net finance costs for Q1, 2022 were stable at $1 3 billion.

Net finance costs in the first quarter of 'twenty, two and 'twenty. One included interest of 800 to thousands on the senior convertible notes issued in June 2018.

Net finance costs also include recent expense of 517000 in the first quarter of 'twenty two.

Third to $581000 in the comparable period in 2021.

Given the above increase in revenues greater expenses are greater increases in expense for the three months period ended February 28, 2022 net loss for the period was <unk> 9 million compared to $5 9 million for the same period last year.

In the first quarter of 'twenty, two operating activities used $4 1 billion.

As compared to $1 $9 million in the comparable period of fiscal 2021, primarily due to the increased loss in 2022.

In Q1, 2022 changes in operating assets and liabilities had a positive impact on cash flow of $69000 versus a negative impact of $3 3 million in Q.

One of last year.

This year's changes included a negative impact from higher accounts receivable and from decrease in accounts payable.

And these were offset by positive impacts from lower inventories and lower prepaid expenses and deposits. So we ended the first quarter of fiscal 2022 with $34 $3 million in cash bonds and money market funds.

Second quarter of 2022 is off to a good start and as Paul just mentioned, we were pleased to confirm the guidance for fiscal 'twenty to expecting revenues between 79 and $84 million.

So with that I'll, we'll come back with the final comments, but first we'll open the call to take your questions.

Operator.

Thank you, ladies and gentlemen, if you'd like to ask a question at this time.

First our agenda one key on you touched on the telephone.

Please standby, while we compile the county, Washington.

Our first question coming from the line of Andre Uddin with Mackie Research capital. Your line is open.

Okay. Thank you operator, good morning, Paul Felipe and Christian just I'm looking at Europe , right now where is your main commercial focus.

Terms of countries and also how many reps do you have there.

And sort of what are your plans for those smaller European countries. Thank you.

Well. Thank you for the question. So as you know in Europe , not much can happen.

Before you obtain pricing and reimbursement and that is an endeavor that is a country by country endeavor.

We you know we've been in discussion with.

Many jurisdiction.

We have been able to establish a fairly good price and many small European.

Countries, but in the major countries.

Asides from easily where we negotiated what we believe an acceptable price.

We're still in negotiation and we have to reject the offering from the German government, because we could not accept the price at the wanted.

So put forward for a drug that we consider.

No.

Yes, very very very innovative medicines and what they were offering would not match that positioning, but it's a country by country.

Negotiation, where apparently in domestic negotiation in France things are evolving we believe that you know it's going to slow down as France is going through the first round of second round up your election process. So April will probably not be decisive, but frankly that important.

Country for us because the pool of patients is significant so we'll be updating the market as a.

You know the stories on holding.

And Meanwhile, we have the resources in Europe are very important for global activities and for the preparation of outward and equal programs in oncology. So we have a presence in Europe . We are committed to continuing having a presence in Europe and we're trying to do our best at.

It's time to pull the pricing.

All of that is that matching the innovative nature of <unk>.

Okay that's useful.

You presented some nice preclinical data of teach 19 O two or D. C. R.

Just was wondering if it's possible, but if we're going to see any data at osco.

June thank you.

So Sam.

Great. Thanks for the question are they as we move forward with the first in human at the moment.

Sure.

We have three patient that received a 300, we need to go to the following three patients at 300 and the ask was in June .

<unk> for submission of the abstract work earlier on this year.

Then we wont have any communication that asphalt, but we're all paying as Paul mentioned that towards.

End of this year that we should have an update.

Central activity of the drug in patients.

Okay. That's great. Thank you.

Thank you for your question. Obviously is the reason why we're putting emphasis on what was just presented in New Orleans. This week as it is because we believe that this is very very significant this is preclinical data, but it provides reassurance.

Reassurance for its mechanism of action.

Minus extremely innovative and as we move forward with the basket trial, you know, we'll see what is at play, but I think that what <unk>.

As presented today to date that would be exciting.

Next question.

And our next question coming from the line of Steven Kwok with National Bank. Your line is open.

Hey, guys. Good morning, Thanks for taking my question I'm, just calling in for Andrew and actually most of my questions have been answered between the last questions in the opening remarks I just had one.

So given there have been some shut downs in China is this at all impacting your negotiations and partnership strategy.

No. It is not it's ongoing and quite frankly.

You know how negotiation golf was it that you have a set of companies that are moving faster than others. You don't want to conclude too fast before you'd ask other companies coming in so we had a nice I would say crew or mix.

Our biotech and large pharma that are showing interest and quite frankly, as we get closer to early sign of efficacy and we keep saying that this is what we're going to see as soon or as soon as early on into the basket trial I think the interest is going to increase so quite frankly getting the converse.

Station going getting it under CDA with.

You know many of them will actually be conducive to getting the right partner and the right valuation that this great asset or greater China. So things are moving aspirin to plan when it comes to that.

What anything well no, but the only thing is that we haven't really been getting the feeling from pharmaceutical or biotech companies in China.

There is nothing more than business as usual, so there hasn't really been any impediments to talking to them or anything.

As usual for them.

Okay, great Yeah. Thanks, that's all my questions.

Okay. So we have some some questions here from.

On the webcast.

So this is a question for John what.

<unk> from the in vivo and in vitro research your Skus might have seen in humans. Thus far that would lead you to believe that scientific view of the concept around Sorel and has a target its function.

And how is that playing out in a manner consistent with your previous discoveries.

I think I've got a question, it's a bit premature to talk about the human data, but in terms of what we've seen in vitro.

In in vivo, it's always very impressive it's always very consistent very similar efficacy using cell lines are expressing the sorts of the receptor and what we see is really a significant increase of the concentration of the psychotoxic inside the cancer cells versus the normal cells and as those as that.

Similar to the dose used with Docetaxel in human.

Safety profile is very good and maybe like in terms of efficacy. It's R. R.

Our safety, what we have seen thus far in human and it's more or less similar than what we were expected based on the animal study.

<unk> hundred 20, as we mentioned we've seen some toxicity, which is normal because this is about two times the dose of Docetaxel and that's the reason why now we have decreased 300.

There's a number of patients that received 373 patients where you haven't seen any DLT AR.

And the first cycle and I would like to remind you that the 300 milligram per meter square G.

Th $19 two is the equivalent to one five times the dose that will sit back so and we don't see DLT. That's something impressive in addition based on the.

Based on what we have seen in the animal we have shown before that the concentration of Docetaxel and the cancer cells when administered with each 19 O S.

S. Four five times higher therefore, if we can get one five times the dose.

So the ratio or the accumulation of the cytotoxic inside the cancer cell should be between seven five and at that time. So the program is moving well our expecting that resolved in the near future.

Isn't that correct.

Next question regarding page 19, with two is there a window of opportunity for revenue from Th 19 O. Two that may come with any accelerated approval available with the received fast track designation.

So well. Thank you for the question just it's a good question an interesting one would be trying to address it with the activity that we conducted recently that was really really productive way.

Orchestrated than oncology strategic session and we had you know what.

Few individuals within the company that ended and we had a Mesa Rozenberg. Our advisor we had talked to you about evo that knows obviously the platform extremely well and we had dual arena where scientific.

Remember and we've reviewed all of the data were reviewed where we are with th 19, you'll chew and we reviewed the place that th 19 to chew can play within the Arsenal and the treatment guidelines of different indications, where we know the Sorbonne expression is high and quite frankly.

Lee what we want to do with exactly what your question is about which is can we actually as soon as we see compelling results early sign of efficacy for one of these arms can we turn to <unk> with this fast track designation in say cant, Ken and we assign a lot.

Your trial, so that it could become the pivotal trial Duane indication.

That is not obviously a done deal it's not something that we can forcefully and predict at this time, but is the plan. The plan will be to actually accelerate at least one indication the fastest possible way and keep developing applications. Afterwards, because what you have to understand is there.

Treatment guidelines in oncology rules, and we need to squeeze in somewhere in the treatment guidelines related to cancer therapy for one indication or two indications, but it's one tumor type.

At a time it sounds like you want to provide additional color on this.

Well, that's that's that's the plan so far and again there are many examples in recent years, where drugs were approved with a limited number of patients through the X rays that path with the FDA that again, if we see signs of efficacy in some of those solid tumor we will meet with the FDA and we will.

Try to obtain a lake.

Sign with a limited number of patients to get to the market that's about that's possible.

There's a few questions on the call.

Verification or around where exactly we are.

The enrollment of the <unk>.

Patients on the.

At the 300 milligram dose can you can you just maybe clarify where we are exactly and when we expect that situation to be in.

And so far as it was mentioned before at our three patients now that were treated at the 300 once we lowered that those after the treatment up 420.

We did not observe any DLT within the first cycle. The other patients are being screened and we do think that those three patients will be treated in April as you know, it's sometimes difficult patients who are advanced but we do think that those three patients will be treated in April about three weeks after that the cycle will be completed and.

There are no other ERP and based on the experience with the drug. So park, we're confident that there shouldn't be any D. L. E 300, we will be ready to initiate the basket trial, which would be towards the end of may.

Oh, just clarify the question.

The other question could you. Please clarify whether you are planning.

Whether you're planning for the Nash program to progressive or how you are planning for the Nash program to progress. So so let me summarize the elements here, but I think I touched on this in the speech to date.

We're still awaiting some feedback from agents see when it comes down to the amended protocol that we presented so as you would recall we want to have a formal interim analysis on hard data and.

This amendment was submitted and within the next few weeks, we should have and the feedback from the agency.

We said that we wanted to continue with partnership. So we are also you know.

In conversation with different companies on partnership and we're looking in parallel at you know how we could finance this in a non dilutive way so that we can.

Start and in execute the front part of that trial, all the way to the interim analysis. We also need to start that trial with the F. Eight formulation that is a pre requisite we never wanted to carry on that trial with <unk> Org and you would recall that when we.

Started in our plan, we said that there were three things that were extremely important for us to you know as iron to getting a decent market share once the market will be constituted in years to come first one was to have the right IP protection and in this case the ICU.

<unk> is linked to two things it's linked to the Feight formulations IP that we have in Europe and in North America, but also D. A used patent that we have linking to use up to some orlan and Nash and Apple. So that's important and that doesn't change, but that means that we need to get going.

D F eight formulation.

Part was to continue to have wide support for the mechanism of action and the science behind this morning, and that's exactly what we've done and Theres nothing wrong with that we have Roger if anything our support from K, well afford disarm orly and having a chance to win in Nash and the last part was to say once.

We actually completed the trial and have an indication we need to ensure that we have a mode of administration that will be competitive. So we keep on working on getting a pen or a method of administration that will be competitive that's very very important. So now if you put this all together.

Again, and I want to summarize the amended protocol now and we're still waiting feedback from the agency the financing and the partnership that is still ongoing but what is stalling us now and moving forward in east this issue related to debentures static water and its global shortage.

Got a serious stuff.

And we no longer had visibility unfortunately, but as I indicated in my speech again, I think that some hospitals now are on the priority list and maybe there are some manufacturing batches that are being renewed is slowly, but surely and at one point, we'll be able to source that we'll be able to manufacture ourselves.

And then we'll put it all together with all the other elements to.

Decide what's going to be the plan forward then the timeline associated to a natural fit if you want to say a word on financing just a well there. There's a few questions also on the on.

The mention of the convertible debenture that is still over a year away in terms of maturity, but we are starting to address it.

Blends in with the with the Nash financings as well we've mentioned a number of times before that there is quite a bit of interest.

Or non dilutive financing and so everything is taken into consideration at the same time, you're obviously.

If.

Someone were to come in.

On a non dilutive basis, they will what the.

The convert can be addressed as well so it's one on whole package.

So that's it for the questions Paul.

Summarizing.

Thanks, Ben and thank you John .

And thank you everyone for joining our update call today, we have confirmed early on in this fiscal year that the momentum that was built in <unk> 'twenty 'twenty. One continues to sustain the growth of our commercial business in particular, the reported 35% sales growth in encrypted E. This quarter as well as the.

Blended commercial sales growth, 20% are very good signs where performance through to the remainder of the fiscal year.

In conclusion, we are greatly encouraged by the data that has reviewed on the call today.

On the scientific side the data that was presented at ACR is seen by our technologies as key Differentiators of novel Th 19 O two.

A promising new therapy in solid refractory metastatic cancers.

Firstly in preclinical work, we have observed enhance acted ness of th 19 O two virtuous docetaxel alone, especially in hard to treat refractory cancers.

The capacity of Th 19, new attuned to inhibit formation of asking allogeneic mimicry and growth of cancer stem like cell can in fact be the mechanism of action that played behind those observations in.

And lastly, <unk>.

Leveraging short one receptors allowed th 19, new into the target cancerous cells with a 7.5 to 10 fold concentration of the cytotoxic agent while sparing activities on normal cells as those are known to show little to no short one expression.

Additionally.

It is unfortunate that the supply chain up to necessary manufacturing component has delayed.

As the late development in our Nash program in the near term. However, as Billy has provided us with the opportunity to remain completely focused on the brink of a theory large near term milestones, including the reporting of early signs of efficacy for th 19, or two from the basket trial in the second half of <unk>.

'twenty two.

We will also be able to provide our utmost attention. These fully on boarding of our internal field force, which will contribute to our deliverance of guidance for the year.

Following these two significant upcoming milestones we are taking the utmost care and reviewing our Nash development strategy, including this eking out of the right partners with necessary execution experience to move the programs forward alternative financing options and optimized mode of administration to ensure patient.

Initiation and adherence to our new formulation.

For this we hope that we have been able to share our optimism for 2022, and our progress to date with everyone today.

And as we continue to move forward with both our commercial aspiration and expectations to meet forecasted revenue guidance for the full year as well.

Vince our pipeline across the clinic, while navigating the necessary regulatory channels required to commercialize in advance stage products with a markedly improved formulation and have a great day and I look forward to the next update call. Thank you for attending.

Ladies and gentlemen that does conclude our conference for today. Thank you for your participation you may now disconnect.

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