Q3 2019 Earnings Call
Good morning, ladies and gentlemen, thank you for standing by and welcome to your Gen Pharma third quarter 2019 financial myself and business update conference call. It is now my pleasure to turn the call. Okay. That's held senior director of Investor Relations for your Gen pharma.
Please go ahead.
Thank you operator, good morning, everyone and welcome to Yergin pharma third quarter 2019, <unk> financial results I'm business update conference call.
Good morning, we issued a press release, providing an overview of our recent corporate highlights and financial results for the quarter Ambac Pember cardiac 2019 a.
The press release can be accessed coming back for a portion of our website and back for Dr done Dot com.
Joining me on the call today, our members <unk>, President and Chief Executive Officer, Dr., Mark Schoenebaum, Chief Medical Officer, and Peter Fine Chair Chief Financial Officer.
Joining us for you and I of course, another call well be Stephen Mellanox, Chief operating officer, and justify senior Vice President of commercial.
Larry will provide a summary of our recent corporate development I'm, Mark will share clinical development and regulatory epic.
Peter will then provide an overview of our financial highlights for the third quarter 2019, before we open up the call for questions.
As a reminder, during today's call, we well be making certain important button the.
Barrier for Mark that we make during the call about the company's future expectations plans and prospects constitute forward looking statements for purposes of the Safe Harbor provisions under the private Securities Litigation Reform Act of 1995.
Actual results may differ materially American dictated by these forward looking statements ever thought the various important factors, including those discussed and a risk factor section of the Oregon Farmer quarterly report on Form 10-Q filed with the FCC. This morning, and other filings that your Atlantic City AFDC from time to time.
We encourage all investors to read the company's quarterly report on Form 10-Q , and the company's other SEC filings.
These documents are available under the FCC filing section at the Investor page of the urgent website at Investor thought yard Gen Dot com.
In addition, all information we provide on this conference call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.
While we may elect to update these forward looking statements at some point on future. We undertake no obligation to update any forward looking statements. We may make on this call on account of new information future events or otherwise.
I'll now turn the call over to list.
Thank you Kate good morning, everyone and thank you for joining our call. This morning.
Just like to start by acknowledging the announcement that came out yesterday on our licensing agreement with a Gina and I'll comment about that in a moment.
But I want to open today's call within use that we have completed the submission of our rolling new drug application, our India to the FDA for I lead product candidate you D N whenever one for the treatment of low grade upper track. Your failure all cancer are low grade you to you see.
The FDA has a 60 day filing review period to determine whether they in D.A. submission is complete and the company will communicate the FDIC decision by year end.
Your Jan one or one is eligible for priority review and we anticipate a six month review and put to bed, but do per day.
To that in commercial preparations are on track to support a planned approval and launch and the first half of 2020 .
If approved you Dan why no one will be the first drug for the treatment of low grade UTI, you see and represents a significant advance for the approximately 6000 patients who may be eligible for the treatment with UGI and want to one.
We're working closely with the FDA and have a high level of engagement thus far.
Your turn to recently presented data from a final analysis of the primary endpoint for my pivotal phase three Olympus clinical trial, and Mark will discuss in more detail in a few minutes.
We remain very excited by the complete response rate and more importantly by the strong six and 12 month durability.
We are assembling an experienced commercial team and developed a strong branding and plan to ensure a rapid uptake and adoption.
2019 has been a busy year for this team as they have gathered intelligence and built programs to ensure the seamless integration into the urology practice.
As a reminder, we're planning for a nimble south fourth of approximately 50 representative to cover 90% of the pace of potential and we believe that this fourth we'll be able to swiftly and effectively reach our target urology practices.
The management team is onboard and we eagerly anticipate the start of the complete team in January in.
In addition to the South wraps, we will have a small team up nurse educators to provide training and support around installation as well as filled reimbursement managers to ensure access and reimbursement.
Earlier in 2019, we hired a team Fms sales, we have appropriately engaged with physicians interested in learning more about your agenda and our technology.
Additionally, we launched an educational campaign to establish the unmet need and low grade UTI, you see filling a void among all stakeholders, including clinicians and patients.
Based on recent market research, we have learned that 88% of urologist desire, a new and differentiated treatment option for their patients.
Current awareness and beauty and want to one is 70% up from 13% a year ago.
As we navigate the water access and reimbursement we're pleased with the recent progress as CMS to move to a quarterly review for permanent J codes and are hopeful that this will be enacted prior to our approval.
Regardless, we have developed access programs to support offices and patients and assure that any patient and needed by medicine will be able to access it.
We will be prepare for a successful launch by January and our team is looking forward to bring in Eugene and want to wind to patients and physicians.
Beyond our lead product therapy were accelerating development, our next potentially transformative candidate UGI and window to for the treatment of patients with intermediate risk low grade non muscle invasive bladder cancer. We were pleased to recently share positive complete response data on over half of that.
Patients from the phase to be Optima study.
In the interim analysis, we observed a complete response rate of 63% with 20-F 32 patients achieving a CR.
We completed enrollment of the phase to be optimized to trial ahead of schedule and we'll continue to follow these patients with an intent to report durability data at appropriate intervals.
Mark will talk more about the significance of this data to this large patient population of approximately 80000 patients.
But it's important to note that patients with intermediate risk low grade non muscle invasive bladder cancer have no treatment options aside from repetitive surgical resection via a transfer rate, they're all resection of bladder tumor our two you RB team.
Following the interim look at the date or we are requesting a meeting with the agency in the first quarter of 2020 to discuss our registrational path for UGI and window to.
Based on previous discussions with the FDA, we are preparing a protocol for a head to head study of using in one or two versus TR beauty with a recurrent free time as their primary endpoint.
As a leader in the low grade space, we are focused on delivering UGI and one on one end UGI and one or two to patients who are in need of innovative non surgical options.
We believe that that peak revenue potential of these products along could be greater than $1 billion, providing a strong foundation to build a long term sustainable growth business.
As a natural progression of our pipeline, we're very excited to announce the exclusive worldwide license agreement with the genus to develop and commercialize Salmonella Mab AG and.
18, 84, an anti CD lay for anti body in combination with UGI and to a one for the treatment of urinary tract cancer is VR intervest goal delivery.
Seller Perla Mab is currently being evaluated by edginess as a monotherapy and PD one refractory patients.
The initial indication for development will be high grade non muscle invasive bladder cancer supported by the encouraging preclinical data we recently shared.
This agreement with Ajay a GNS built upon our leadership in neuro oncology and leveraging the expertise and capabilities, we have built with UGI and want to one and UGI and Oneto too.
We are preparing for success in a position of strength today as a result of extensive planning and diligent efforts across our nimble company.
With completion of the NDA submission recent data updates and the license agreement we have taken a major step forward in our mission to bring patients unique solutions that overcome barriers to treat specialty cancers and neurologic diseases.
I'd now like to turn the call over to Mark who will discuss our clinical development programs and more detail Mark.
Thank you Liz starting with UGI and want to one final analysis of the primary endpoint for our pivotal phase three Olympus trial demonstrated a 59% complete response rate in patients with low grade year to see which was consistent with our previously presented results.
Durability of response was estimated by Kaplan Meier to be 89% six months and 84% at 12 months after primary disease devaluation.
Maybe the median time to recurrence was 13 months and 34 of the 71 patients treated in the study were initially characterized by the treating physician as having endoscopic we unresectable tumor.
These are the patients who according to the standard here would be candidates for immediate QB removal.
Were 41 patients who will then follow up which is still ongoing.
The most common treatment emergent adverse events included ureter will stenosis urinary tract infection premature flank pain nausea, this urea renal impairment and vomiting. The majority of these were characterized as mild to moderate in severity and transient.
These adverse events are familiar to urologist, given the disease being treated and the instruments utilized.
We have been frequently asked about the potential to retreat patients would you gn one or one.
To that end, we have initiated a retreatment protocol as an extension to the Olympus trial and this study is ongoing.
Looking at UGI in one or two we're very encouraged by the initial CR data from the seems to be optima two trial in patients with intermediate risk low grade non muscle invasive bladder cancer.
And this cohort of 32 patients 63% were 20 patients achieved a complete response.
In the interim analysis, the most common treatment emergent adverse events observed work this urea frequency of urination city premature and urinary tract infection.
The majority of or mild or moderate and transient.
It's important to highlight the intermediate risk low grade non muscle invasive bladder cancer is emerging as a specific clinical entity characterized by frequent recurrence it is difficult, but difficult to control using standard care interventions.
Intermediate risk disease has a number of distinguishing features including multi for calorie, we're tumors greater than three centimeters and rapid rates of recurrence.
Contemporary standard of care for these patients is repetitive to you RBC.
Few patients in the year in the US received arguments introductions will chemotherapy.
The end result is a population of patients perhaps as many as 80000 annually who work in signs to chronic surgical intervention to managed care bladder cancer.
Based on the data observed in the interim analysis, we believe your June one or two has the potential to have an immediate impact and provide these patients with a first line non surgical auction for the treatment of chronic relapse.
We plan to review trial design options for a pivotal phase three trial of you, Jim one or two with the FDA in the near future.
As you read in the release and leaves mentioned, we are excited to add an MPC delay for antibody to our portfolio to starting in combination with huge year, two or one our TLR seven eight agonist in high grade non muscle invasive bladder cancer based on encouraging preclinical data we shared and.
September .
We're currently designing phase one clinical trials for patients with high grade non muscle invasive bladder cancer and will provide further details on this program at a later date.
As a practicing urologist to extend his career treating patients with urinary tract cancers. It is exciting to be part.
Have a program, bringing novel therapies to patients who have seen little innovation in the past 20 years, our portfolio of UGI and want to one you Gen one or two and the combination of Eugene Chew or one with zeller for when that establishes euro Gen. As a leader in Urologic cancers, and with that I would like to.
Turn to call over to Peter who will discuss the financials.
Thank you Mark and good morning to everyone on today's call Jurrjens, well capitalized to advance our clinical development programs.
As well as our commercial planning efforts in preparation for a potential us approval and launch.
And 101 in 2020.
We closed the third quarter of 2019 with $221.7 million.
Cash cash equivalents in marketable securities.
For the third quarter in the nine months ended September Thirtyth 2019, we reported net loss of 22.3 million or one dollar in six cents per share.
And 66.2 million or $3.25 per share respectively.
This compares to net losses of approximately 20.5 million.
Or $1.28 cents per share.
And 51.9 million or $3.30 per share for the same periods in 2018.
The net losses for the third quarter in the nine months ended September Thirtyth 2019 includes 7.2 million and 21.9 million, respectively, and noncash stock based compensation expense.
Research and development expenses for the third quarter in nine months ended September Thirtyth 2019 were.
5.5 million.
And 29.2 million respectively.
Compared to 9.6 million and 25.5 million for the same periods ended September Thirtyth 2018.
And included.
6.4 million and 9.1 million and noncash stock based compensation expense respectively.
Excluding stock based compensation expense.
The year on year increase from 2018 to 2019 was attributable mainly to costs associated with you Jan one on one phase III clinical trial.
Increased clinical activity for you Gen, one or two phase Twob clinical trial, and an increase of head count and related costs supporting increased clinical trial activities.
General and administrative expenses for the third quarter in nine months ended September Thirtyth 2019 were.
14 million and 40.5 million respectively.
As compared to 10.7 million and 27 million for the same period in 2018.
And includes $15.5 million, and 12.7 million and noncash stock based compensation expenses, respectively.
The increase from 2018 to 2019 was attributable mainly to increase and personnel and related costs to support our growing business.
An increase in commercialization infrastructure and services.
And an increase in consulting and other outside fees as well as an increase in stock based compensation expense.
As of September Thirtyth 2019, we had approximately 20.9 million ordinary shares outstanding.
Including the recently announced genus deal.
The company is still on track to end the year with a net loss for the year in a range of 102 $110 million.
Which is expected to include noncash stock based compensation expense.
In a range of $20 million to $30 million subject.
To market conditions.
Based on our current plans, we still project our cash balance carry us through a successful launch of you Jan 101, and well into 2021.
With that operator, I would like to turn the call over for questions.
Thank you.
We will now begin the question and answer session. If you have a question. Please press Star then one on your Touchtone phone if you wish to be removed from the Q. Please first upon the hash key.
You are using a speaker phone you may need to pick up the handset first before passing the numbers. Once again if you have a question. Please press Star then one on your Touchtone phone.
And our first question comes from Eric Joseph from JP Morgan. Please go ahead.
Hi, Eric.
Hey, good morning disciplines Turner on for Eric. Thank you for taking my question just.
Heading into the at the meeting and once you 20 to discuss the pivotal phase three one or two study.
I'm, just hoping to elaborate on the choice of recurrence free time as the primary endpoint instead of six or 12 months CR rates and whether you'd sets for both non inferiority or superiority to Turkey and then Additionally would you plan to enroll patients who are treatment naive or would you also include patients who have relapse poster. Thank you.
So great questions.
You know we share the data from one of two as soon as we actually had the data available.
So right now we're in the process of of putting together our AR.
Report that we need to send down to the agency prior to requesting a meeting so.
That's that's happening right now we expect we expect that in the next week to be able to us and our request down to the agency.
I think it's important to note a couple of things one we actually met with the agency over a year ago before we started.
In one or two and the agency the direction from the agency has been around that we can do a head to head study versus TRP team.
To your point it will be recurrent freight.
Overall, so it is about time, it's not about CR rate that was always the discussion with the agency and.
No I think there's been some some mis and understanding about that but it would be.
Recurrence free time frame so.
Time to recurrence, so we believe given that and the the high recurrence rate of the patients who have this intermediate risk.
We have a very high probability of success of a superiority study, but we also will make sure that this study is becomes both as superiority in a non inferiority that allow us to shots on goal to get an approval from the FDA. So to answer your questions. Yes, we expect to go down.
Depends on when the agency gives us a meeting we expected to be.
The first half of.
The first quarter.
We are already the protocol is is close to being finalized when we send the briefing documents down to the FDA will have our proposed protocol, which will be a head to head steady against T. RBC.
With the.
With the endpoint being being recurrence free endpoint so.
We will enroll both.
We will allow enrollment of both naive and recurrent patients.
Just for your information about 80% of patients in the one or two study where recurrent patients, but we did have about 20% patients naive said we would allow.
Allow that as well so I think that captured all of your questions, but if it didn't please let me now so thank you.
No thats great. Thank you so much.
Our next question comes from Derrick Gilat from Stifel. Please go ahead.
Hey, Thanks, guys. This is Dan Entre Derek Thanks for taking my call.
Just wondering if you can share some thoughts on what stood out to about 1884, and then was anything else.
Thanks.
I didn't catch the first part what about 184 I heard the second part was anything else considered but what was the first question.
Yes, what if you can share some thoughts about what.
Stood out to you.
About one eight a. for.
Yes, I think we we spent a lot of time and we did look at many options and different types of partnership arrangements and different access, but we felt like the genus when a day for compound allowed us to on the detail a four within our portfolio.
And that was in a that was something that we were very interested in them so being able to.
To manage and lead both the development and commercialization actually on that in this space that local delivery in euro oncology. We thought was really important from a lot of due diligence as you can imagine.
With the with the molecule may feel very comfortable and with that between our.
Internal team and external advisers.
We believe the molecule as a great molecule, we believe Evan long experience I think everybody does a detailed before.
And I.
I think we all understand that detailed before it is a great.
Medicine for patients, but systemic delivery of it also has some side effects that has has unfortunately calls either dose limiting toxicities that patients are patients not able to take the medicine. So we felt like and again, our advisors that that a local delivery of assi tally for.
In this context.
Great option for patients and we believe we can.
And we can get a great good effect.
Dose with with detailed before without some of the systemic side effects that you took typically see with four so sure we did diligence around across the board on everything that was out there.
Dumb and came to the conclusion that it was a great fit for us and I just want to comment that Egina team has been great to work with.
We see them also as a as a good partner and we're excited to bring this to this into our pipeline and.
In into development for patients.
Okay, great. Thanks for the answer.
Thank you.
Our next question comes from Ron Savoured, you from H.C. Wainwright. Please go ahead.
Hi, Thanks, very much for taking my questions.
So just wanted to clarify when you think you might get potential additional certification from CMS once UGI on one or one has been approved in other words, you know the timing of the Assignation for example of a J code.
So typically what happens as you know with.
With CMS they use to do it just once a year and they've moved they actually are are officially trying to formalize quarterly review.
Although we know that they have already actually done quarterly reviews on some medicines that have been approved.
So.
Typically they would look at that once a quarter that we would expect six months.
To be on the conservative side, frankly that we should be able to get a permanent J code within six months, having said that I think it's also a really important to note ingest also on the line. If you have any further questions about this but that because these.
Procedures are done in the institution or in the surgery Center. They are also eligible for a C code.
And we will be able to get a permanent C code.
Within the first three to six months so.
Yes, basically conservatively, saying that within six months, we would be able to have a permanent C code and arent J code Forum for UGI and one Edwin.
So this is just to clarify within three to six months of approval.
Yes, correct.
Okay, and then with respect to the broader Olympus study data sets have you received any additional feedback from potential utilizing physicians regarding specifically the safety profile of UGI and want to one.
Mark do you want to comment on that actually what we received is more positive feedback that in fact, the ease that were reported or expected in the context of treating this disease with contemporary technology. So what we've heard from doctors is that in fact this is exactly what they would expect and none of the.
Versus events reported would represent a barrier to utilization.
Okay, Great and then.
With respect to the Agenuss molecule, how you plan to deploy going forward I just wondered if you could give us some additional granularity on how you're thinking about deploying this checkpoint inhibitor in the context of urothelial cancer beyond potentially combination with easier to a warm and also if you could comment.
On the relative positioning.
Youre already oncology relative to the systemic administration of checkpoint inhibitors like for example, the Nivo plus combinations.
Your your general.
Your general answer thanks.
Yes, sure Mark just want to talk about what our plans are initially with HM Eighteeneight for them. We can talk more broadly about your question sure. The first approach. Obviously this is this is pretty well known from things that lives is already announced is too is to deal with the problem of high grade non muscle invasive disease.
Which represents a real conundrum for physicians, particularly those patients to recur will demonstrate refractory.
Behavior in the presence of BCG, which is the standard care for this group. So our first approach has to deal with that unmet medical need and so we will be working on the combination we reported on in our recent Investor day.
Because we have very strong reproducible preclinical information that suggested the combination of one of two.
Due to a one.
18 for like molecules nearing setting are very potent and actually prolonged survival in the model system. So thats, our that's our first.
Yeah.
To advance this program.
And I think beyond that we actually don't have concrete plans about where we will take it but we thought it was important to have the ability to given the data with.
With UGI into a one our TLR seven eight agonist in combination with the details before we think that there is potential applicability beyond high grade non muscle invasive bladder cancer and to your question around the competitive landscape. This is a very different approach to anything that's out there today right. There are a lot.
Got a systemic PD one checkpoint inhibitor.
Study is happening in this space, but.
We are the only once that we'll be looking at this delivery mechanism for both TLR seven eight.
In combination with detailed before and just to be a.
A little bit more finer on the point. Our plan is is that we would use our RTL proprietary technology, but see tally for and then the tail our seven eight would be just.
And installation so we have the ability to utilize our technology that no one else actually has access to that we think that you. This is a unique approach for the not high grade non muscle invasive bladder cancer and that we will have the R&D team looking beyond that but thats, where we have our data today and we'll look to see if there are other.
Applications outside of that.
And then just as a classic Torrey point based on what we're just saying Liz.
To what extent do you have a privileged intellectual property position with respect to the principle of localized delivery of that type of utility for or checkpoint inhibitor as at where whether.
In combination with our drug liking the tier two or one or just directly.
Yes, so our our patent family is within our R&D Jal technology, So clearly that Kelly for in combination with our technology is something that we will continue to protect from a patent standpoint and.
Where were able to tick tick to continue to broaden that we will but today our patent protection is really on our Jal and.
So its 2031 to 2033.
We have a nice.
Nice ability to protect that going forward.
Thank you very much.
Thank you.
Our next question comes from Boris Peaker from Cowen. Please go ahead.
Good morning.
My first question I was on the planned phase three study of one or two I'm. Just curious if we assume that we'll be using turbot as a control which is kind of the current base case assumption what do you anticipate the CRM to being that control arm.
Mark would you like to talk about that sure.
As we've talked about before this is a group of people have a very high rate of recurrences year and so we would expect based on published literature and also are internal experience than in the control group.
The recurrence rate to be there would be somewhere between.
50, and is high as 80%. So it's a group of people, who we would largely expect to recur given their treatment with the standard of care.
But I think the question was really around that ever as vector question bar. If it wasn't really around initial CR well, that's how it's going to say this initial CR and then there's 12 months durability, so kind of want to I want to both.
Sorry, Okay, well so as you as was mentioned earlier the focus of the trial will be on on durability, but with respect to see our I think it's important that step back and think about one other piece of information that doesn't get widely discussed in these conversations which is.
That although trends resection is considered the gold standard for of the primary treatment of this the CR rate is in fact, not 100%. So we would expect based on published literature with for example, augmented.
Trends with resection technology.
This year, we would probably be somewhere in the order of 80%.
Because we know that there is a stable recurrence rate with white light cystoscopy is used during trans research for the control group. So I think you need to think about that we think about what the results would look like Ruby quote unquote experimental or clinical trials.
Yes, I just want to know.
The focus on CR is not the focus right, it's not with Eugene I mean, it's important the initial CR, but even with GM one on one UGI and one of two if you can't get that durability of response. So if you get if you go limited TRP team, even if it's 100%, which we know it's not we know it's closer to.
80%.
If their patient is back and three month the initial CR, it's not very helpful right and so.
The reason that this patient population has such a high unmet need is because unfortunately, they require very quickly and very often.
And yes, we know from again as Mark said from the literature as well as the physicians that we've spoken to that everyone has those patients and this is an elderly patient and at some point just you're you're doing more harm and good by continuing to to have these repetitive tiara bts. So.
The good news is is that both the E Bay and the way have come up with very specific guidelines as to who these patients are so you can identify them upfront, they're likely to recur, but then again as I mentioned before the majority of our patients that are study where recurrent patients.
Patient comes in they require three to six months later and that that is likely to be the majority of our patients, which frankly is the biggest patient population because thats, where the prevalent pool that may incentive pool of this patient population.
Great and my last question as you've mentioned in the past the potential path forward with a single arm study design.
For bladder cancer is that still a possibility could you just comment on that.
Well I think thats the conversation we want to have the agency REIT and frankly, I think probably did not do a good enough job, having everybody understand that we know from the agency already in our discussions that we can do a head to head varsity RBC.
We can do that we're writing the protocol were protocols on with finalized again, we're requesting and meeting with the FDA. We felt very strongly there won't be any issues with that the question that we had is given that results are much stronger than we expected them to be and we'll see how that plays out of the next few months if they maintain if we.
Have a good durability and weve than we would want to talk to the agency to see if theres a faster path to making that's available to patients whether it's a single arm study with a control real world evidence study or whatever it might be but we would want want to do that but but we're not going to delayed the start of our head to head start.
But we do want to have that conversation with agency you never know, we think that the likelihood based on the conversation we've had with them that path. They want to stay ahead to had study I think that they also don't really understand we needed educate them around this intermediate risk patients, which has a patient that has a high high probability.
The recurrence and likely recurs within a few months. So we want to have that conversation with them. So is there is there an opportunity sure. There is but what do we know that we can do is a head to head study with RBC and Thats what were moving forward with.
Great. Thanks for taking my questions.
Thanks, Thanks for us.
Our next question comes from Lynn Leland Gershell from Oppenheimer. Please go ahead.
Good morning, all thanks.
Taking my question also couple of questions on on one or two I guess for remark.
If if you could tell us what you may think the required sample size might be.
For the head to head study in terms of number of patients needs to be adequately powered.
For that that endpoint and also if you may have any further clarity on when we might see the next reveal on the current optimal study and I will follow.
So I think the that the answer to the first question is we're still working on it liz's.
Really emphasize the fact, we are coming down the final stretchered working on that protocol obviously.
Trying to balance Noninferiority superiority trial designs as the APAC power. So we know that this is going to be a trial that is going to evolve hundreds of patients. The question is specifically, how many and we're working on that now and I think we'll have more clarity on that once we've had our opportunity to finalize the design and then talk the agency that's probably about as much as I can say.
And then in terms of the additional.
Information about optima too I think I have to defer to lose on timing, but we are advancing that program. We know that we're going to have a lot more data.
On the.
Your ability of that cohort.
In the.
First half of 2020.
Thats I mean, I think what we'll do as well see how the data plays out and when we felt like we have enough data that is meaningful.
Data that we won't be shy about sharing it when that but we want to make sure that when we do we have enough enough that make it relevant.
Okay.
Thank you and then one question on one or one as we look toward.
Commercial next year.
In addition to two modeling.
Vince floor for selling in terms of Salesforce and infrastructure also wanted to.
Two.
Sure and any commentary you mean.
Other expenses that may relate to logistics, given the nature of the product mixing requirements.
So thanks.
Yes.
Just answered I know, Jeff on the line, but since you are really specifically asking about expenses and then Peter can comment of has any other questions. We do have obviously expenses and within our supply chain right. So.
As we've talked about before a very key strategy for us is ensuring that ease of use.
Which means that it will that our supply chain will require us to go to a specialty distributor and then to a mixing partner which is fairly typical for.
For this this these types of products and so all of those would be included in our cost of goods and so.
We are looking at to have that so it's a big part of our strategy.
I wouldn't say, it's like overly expensive, it's it's very reasonably priced to be able to do it makes a lot of sense. Because again, we think that keyed up early adoption and quick adoption wellbeing, making it as easy as possible on the physicians.
Alright, Thank you for taking my questions.
Great. Thank thank you.
Our next question comes from Chris Howard Chen from Jefferies. Please go ahead.
Hi, good morning, everyone and thanks for taking the questions. This is solid and here for Chris.
The third question that I had was really a clarifying what on your comments for the water to put little on did you say the you were trying to make it both a non inferior and superiority study and if so could you. Please.
Comment on how that would work.
Let's start there.
So, yes, what I, what I did say that I did say that we would want the ability to be able to have.
Both at superiority and in Noninferiority standpoint, if you endpoint I'm sorry, if you and this has happened many many times in the past, but it's basically when you when you look at it and when you do review of the data and if the data is this is a time bound as we've talked a lot about.
So the longer that you follow these patients the more likely we are to be superior and our case and but you can get to a point, where if you want to look at similar recurrence free rate you could potentially have a claim of noninferiority. So it's.
It's easy to design a study when they have been done many times, where you have both superiority and then are able to follow for.
For a non at non inferiority. So likely you would have quote on quote a noninferiority earlier and as superiority later, but on.
We just we want to make sure again that we cover all of our basis, having said that.
We feel pretty strongly that we're going to get to have a superiority right. We've seen the data usage, we shared with you the data the durability. It looks good and if that holds up than we think that is very high likelihood that well have a superiority study.
Again, I guess another point just to add on that is if you have noninferiority from an efficacy standpoint clearly.
Management and that the Carla associated with that actually having multiple to you RB teens is another area in which we believe that we will have a benefit versus current standard of care. So I hope that's helpful.
Yes, thats very helpful but.
The one remaining question I have as it relates to that is that if you are open to the possibility of both does that mean that youre trying to enroll Ford Noninferiority. So I guess those things are you trying to enroll the larger patient population.
Versus what you would need super for superiority superiority trial.
We haven't seen that data the numbers yet so we'll have to make that decision. The meant that the team is finalizing the protocol.
Working with a couple of external statisticians that will make sure that we understand exactly what.
What we need so that will it will be dependent on the number of patients to your point.
Got it. Thank you and the last question that I had was on the one on one virtualization. Thanks for providing all the color earlier, but I kind of wanted to know.
Where the remaining steps to get prepared for this commercial launch you said you're going to be prepared by.
Very early next year, so I'm curious to know what the last remaining sets Sir.
Sure absolutely and we have depo values on the line on his our head of commercial so Jeff can you take that question. Please.
Sure.
So as we've alluded to earlier, we will have the field force hired by early mid January so thats a step once we bring them onboard bill go through training.
Ground on the disease once we have a label will be a final training.
With regards to to the label well there.
When they brought on they'll also do some profiling.
So they'll call on the various accounts understand the logistics how things work.
So we're able to if approved.
Immediately begin to promote the product.
Enter into the practice and as another option for patients.
We also as right now from a marketing standpoint, we're finalizing our our messaging campaign.
Getting we're getting pieces ready or journal adds that that if approved will say now approved everything will be in play from a market access standpoint, we've already Susan the hub.
We'll be.
How the customer provider ordered the product.
So the hub is already chosen as well as our yell at our specialty.
Distributor so those those are all in place now.
And one as we move closer to launch.
We'll be able to.
Like I said.
If I want to prove to be able to take an order up through the hub and get it into or get it to the providers.
Great. Thank you so much.
Yes.
Thank you.
I'm showing no further questions at this time I'll now turn the call back over to your Jets, President and CEO Liz Barrett for closing remarks.
So thank you operator, and thanks, everybody for the questions I think it's a very exciting time as Dom as you've heard.
This morning, and in our announcement yesterday I think with the addition of the detailed before Janus 184 to our pipeline you can see that were really covering the gamut of Bureau oncology, we've got UGI and want to one now we have filed expectation it to launch midyear next year you GM one.
Two which will go into a pivotal study next year and the now with the addition will be will begin to to advance UGI and two I want our retail our seven eight agonists in combination with local delivery FC Taylor before and high grade disease. So an exciting time for us and noted in nice complimentary pipeline to move forward. So again we.
Couldn't be more excited as we grow our position as a leader in neuro oncology and build value for both our shareholders and importantly, bring new innovative unique treatments to options to these patients in areas of high unmet needs. So we'll continue to update you as milestones.
Come through for the remainder this year and into next year and we thank you for joining our call on your continued interest in your Jim you can disconnect now operator, thanks, everyone.
Thank you ladies and gentlemen, you may now disconnect.
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