Q1 2022 Urogen Pharma Ltd Earnings Call
[music].
Good morning, ladies and gentlemen, thank you for standing.
By and welcome to Euro Genpharm Best first quarter 2022 financial results and business update conference call. It is now my pleasure to turn the call over to visit Barone Senior director of Investor Relations for Euro Jed Pharma. Please go ahead.
Thank you operator, good morning, everyone and welcome to Euro Genpharm, its first quarter 2022 financial results and business update conference call.
Earlier. This morning, we issued a press release, providing an overview of our recent corporate highlights and financial results for the quarter ended March 31 2022.
The press release can be accessed on the investors portion of our website at investors thought euro Gen Dot com.
Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Dr. Mark Schoenberg, Chief Medical Officer, Jeff BOVA, Chief Commercial Officer, and Don Kim Chief Financial Officer.
During today's call, we will be making certain forward looking statements.
These may include statements regarding our ongoing commercialization activities relating to gel midol ongoing and planned clinical trials commercial and clinical milestones in the year ahead.
Potential U T N one zero to transform the treatment paradigm as the first viable nonsurgical alternative for low grade intermediate risk and then he see potential.
Potential future commercialization activities for U T. N 102, if approved Ada presentations regulatory filings future research and development efforts, our goal potentially reaching cash flow breakeven by 2025, and 2022 financial guidance among other things.
These forward looking statements are based on current information assumptions and expectations that are subject to change.
A description of potential risks can be found in our earnings press release and latest SEC disclosure documents, including under the risk factors heading of our quarterly report on Form 10-Q for the quarter ended March 31, 2022 filed today.
Are cautioned not to place undue reliance on these forward looking statements and euro Gen disclaims any obligation to update these statements I will now turn the call over to Liz Liz.
Thank you Vincent and thank you to everyone. Joining us today your agenda remains focused on developing novel therapies for your old failure on specialty cancer with the goal of fundamentally transforming the treatment paradigm, but what we believe is a largely underserved patient population.
During the first quarter, we continued to make important progress toward achieving this goal while setting the stage for several meaningful commercial and clinical milestones and a year ahead.
Patient access and awareness continue to drive adoption of job by that team.
Net sales in Q1 were $13 $6 million in line with our expectations and representing an 81% increase over the first quarter of 2021.
Jeff will provide more detail on our commercial efforts and remain optimistic about our ability to accelerate growth during the remainder of 2022 and.
In March we held our first ever in person National sales meeting I'm pleased to say it was a great event, giving the commercial organization and opportunity to come together exchange ideas and best practices and take actionable learnings into the field with a common goal of ensuring that all appropriate patients have access to jump Idaho.
The Yanzhou Midol, we made significant progress in the clinic advancing our lead development program you Jan one O two and initiating a first in human study at EOG and three O. One expanding our clinical focus to include immuno therapies for the treatment of high grade disease.
Turning first to U G M. One O two which aims to address a major unmet need and low grade intermediate risk non Muslim base of bladder cancer, an indication and Pat impacting about 80000 patients in the United States each year.
During the first quarter, we began dosing patients in our single arm open label Phase III envision pivotal trial IBU Jan one O two.
We believe in vision has a high probability of technical and regulatory success, given its streamlined design and encouraging results from the previously completed phase <unk> Optima two study.
We anticipate completing enrollment by the end of 2022 and following patients for durability durability and assuming positive findings submit an NDA for approval in 2024.
Importantly, U G M. One O two if approved would share our prescriber base with Yamato, allowing for an efficient and expedient product launch within our established commercial organization.
We continue to believe Yamato and Eugene one O two together represent well over a billion dollar revenue opportunity for you or Jim and then initiation of our phase III envision pivotal study of U G M window to moved us closer to realizing the full potential of this innovative investigational therapy.
I'm pleased to announce that last month, we initiated a novel multi arm phase one clinical trial intended to evaluate the safety and Tolerability of Eugene and three O. One as monotherapy and in combination with other chemotherapy and immuno modulator as our first immunotherapy investigational candidate.
And she did intended to treat patients with high grade disease, which remains a high unmet need Mark will provide additional details regarding our phase one study. It represents a unique approach to treating high grade non muscle invasive bladder cancer.
With the closing of an up to $100 million term loan facility with funds managed by Pharmacon advisors earlier. This year, we took important steps to significantly strengthen our balance sheet. This.
This capital gives us the financial flexibility to continue expanding our commercial and development effort.
Based on our current financial projections, we believe we have the tools needed to reach cash flow breakeven by 2025.
At your agenda, our mission is to build and commercialize a strong portfolio of innovative therapies with the potential to meaningfully advance the standard of care and your logic and specialty oncology away from repetitive surgeries and disease management 10, minimally invasive therapy there.
There are pudic ablation of tumors and locally administered immunotherapy approaches.
We expect 'twenty to 2022 to be a pivotal year for our company.
As we aim to accelerate growth and create meaningful value for our patients and shareholders. We remain focused on several key deliverables, which we believe are critical to our success this year.
We are on track to achieve our guided full year revenue range of 70 to 80 million in total jump Idaho met cells.
We expect to fully enroll our ongoing phase III envision pivotal trial, bringing us closer to an NDA submission in 2024.
The initiation of a novel multi arm phase one clinical trial of <unk> 301, our anti <unk> four antibody, we expanded our clinical development focus to include Immunotherapies for the treatment of high grade disease.
And perhaps most importantly, we believe we have the tools and sufficient capital to support our business through cash flow breakeven I'm extremely proud of the progress we continue to make toward our goal of bringing novel solutions to patients that deserve better with that I'll turn the call over to Mark to discuss our recent clinical and development update.
Mark.
Thank you Liz.
As long as noted the first quarter was one of the meaningful progress in the clinic as we made important advances we go through our late and early stage development programs.
During the first quarter, we announced the initiation of our pivotal phase III envision clinical trial, that's it for me.
Minder envision is designed as a single arm multinational multicenter study evaluating the efficacy and safety of <unk> in one or two primary chemo ablative therapy in patients with low grade intermediate risk non muscle invasive bladder cancer.
<unk> is expected to enroll approximately 220 patients across 90 clinical sites, who received six once weekly interruptible installations WGN wanted to.
The primary endpoint will evaluate the complete response rate at three months after first installation and the key secondary endpoint will evaluate durability over time with patients who achieve a complete response at the three month assessment, we remain very optimistic about the design of the envision trial and the clinical potential of Eugene one or two.
For several reasons first envisioned shares a similar design, where previously completed phase <unk> Optima II study, which also enrolled patients with recurrent low grade intermediate risk in B C.
But to show the complete response rate of 65% and the <unk>.
The ability of remaining in complete response with 12 months of 72.5% by Kaplan Meier analysis.
Earlier this year, we began treating patients with the goal of completing enrollment before the end of 2022 I'm pleased to report we remain on track to achieve this milestone positioning us to submit an NDA for approval in 2024 subject to positive results from the trial.
Well envision remains our top priority for Aegean them, one or two we also continued to advance the single arm at home installation feasibility study for you Jan one or two we believe establishing a precedent for a convenient at home solution is a groundbreaking step in facilitating access to cure.
Dressing quality of life issues that many elderly patient space with the current standard of care.
A total of 10 patients who were expected to enroll and complete the study this year.
Like Joe Mundo for low grade you can see we believe you Jan one or two is innovative advancing patient care, we could positively transformed the treatment paradigm as the first viable nonsurgical alternative for low grade intermediate risk and it might be seen.
I'm also pleased to provide an update on <unk> 301, our immunotherapy program in development to treat high grade disease, Eugene 301, as our in licensed Mtc till a formula body for intramuscular administration the.
Archie gel in development for the use as monotherapy and in combination with other immuno modulator and chemo therapies to treat high grade and it might be cheap.
Earlier this year, we announced the FDA clearance southern I N D applications supporting human clinical trials with Eugene in 301.
I'm pleased to report that at this time, we have commenced our planned phase <unk> clinical trial of UGI on 301.
The ongoing phase one study will evaluate the safety and Tolerability of interim vesicle Eugene in 301.
Mono therapy and in combination with other immuno modulators, including Eugene two of one our proprietary pier one seven agonist as well as other potential chemotherapy and immuno therapies and patients with recurrent N B C.
This study will also seek to establish the recommended phase two dose of Eugene in 301, both as monotherapy and in combination therapy.
Importantly, this study will utilize a novel Master protocol design that we believe provides for a more efficient and streamlined development program since it affords us the flexibility to evaluate multiple combinations in parallel that was good.
Study progresses, we anticipate the first arm of the phase one study evaluating for Gen 301, as monotherapy will take approximately 12 months to complete.
We continue to view Eugene in 301 is a fundamental checkpoint inhibitor.
And the cornerstone of a variety of potential combination therapies targeting high grade cancers.
<unk> of high grade and there might be still remains a high unmet need, particularly post BCG and given current supply limitations.
Few options for these patients and we believe we have a unique approach with combination therapy that can provide incremental benefit to currently approved and investigational medicines. We believe intramuscular administration of immuno therapies utilizing our T. Gel technology provides us with a host of new opportunities to evaluate a variety of novel immuno.
Modulus, where drug combinations that may advance care across multiple clinical indications and urologic and specialty cancers. As this program advances we will continue our efforts to identify evaluate and prioritize therapies that may be synergistic with our proprietary technology with the goal of advancing here across your appeal.
Wheel and specialty cancers.
With that I'd like to turn the call over to Jeff to provide a commercial update Jeff.
Thank you Mark I'm pleased to provide you with an update of our ongoing commercial rollout of Jo Malone as Louis noted revenues for the quarter were $13 6 million down sequentially from a record fourth quarter 2021 sales, but much stronger when compared to the same period last year.
As discussed during our call we expected an element of seasonal softness heading into the first quarter, which we attribute to the deductible resets typically seen at the start of the year as well as some stocking that typically happens at year end.
Importantly in light of our expectations for the remainder of the year. We remain on track to meet full revenue guidance of 70 to 80 million in total Joe Murdo net sales.
We attribute this confidence to encouraging trends in patient uptake activated sites and repeat prescribers. We also saw an uptick in the number of bulk orders for gel motto, which we view as an indicator of a positive treatment experience from the perspective of both physicians and patients.
We're optimistic these trends may suggest that we're moving towards a more normal launch environment compared to when we launched <unk> in mid 2020.
With our field force now primarily interacting with physicians in person, we're getting the high contact engagement with the accounts that we previously emphasized as a critical component for <unk> success is a buy and bill drug.
And while our key metrics continue to suggest growing enthusiasm and adoption for <unk> in both new and repeat prescribers. We believe we're well positioned to generate additional momentum in the field by going deeper into the existing accounts to identify new patients, while continuing to instill reimbursement confidence.
Our field reimbursement team continues to do an excellent job of educating and supporting accounts to facilitate a smooth and seamless reimbursement process.
The result of which is greater patient access to gel motto across all payer channels and a growing base of successful reimbursements.
I am pleased to report that to date, our metrics indicate payer coverage of gel Murdo, you know, 100% of Medicare fee for service claims, 98% of managed Medicare claims and 97% of commercial plan claims.
During her remarks, Liz mentioned, our inaugural in person national sales.
And I'd like to spend a moment sharing some of the key takeaways from that event.
The National sales meeting was held in March in New Orleans, and represented a very important milestone for euro again since it was the first time since Joe Mottos launch at every level of our commercial organization was able to come together in person to meet exchange ideas and best practices and strengthen connections as a team.
At the meeting we rolled out enhanced messaging and data driven sales resources based on the feedback from health care professionals and from our field team.
We expect these new resources to improve our team's ability to effectively engage with new and existing accounts in the field to further drive appropriate adoption and patient penetration.
Additionally, we recognized our top territory performers. These top colleagues have demonstrated in their respective accounts that the opportunity does exist once physicians embrace yamato as the standard of care.
Our goal is to replicate this across the country, which will result in strong growth and meaningful penetration and adoption.
From a medical affairs perspective, we continue to make progress with you track or Joe Midol registry.
During the first quarter, we continued implementing our phased launch of the registry, which is expected to provide insights into the real world outcomes of U T. You see patients treated with Joe model and evaluate its use in clinical practice in the U S.
The registry is also designed to accrue data to answer specific questions, we receive which were not answered or only partially answered by the Olympus trial and may include use of Joe Murdo, you read or only tumors partial responders and re treatment amongst others.
We're particularly interested to learn more about Joe my those potential utility as multi dose adjuvant therapy. After endoscopic resection as this was not evaluated in clinical trials.
We look forward to sharing additional details at the appropriate time.
I am pleased to report we expanded the pilot named patient program to a total of four international patients who have received jail murdo on a named patient basis in both Israel and Australia.
As we return to normal in person meetings, we look forward to having a major presence at the key urology conferences, including the American Urological Association, where a UA, which will be held from may 13th through May 16th in New Orleans and is the largest medical conference in the urology space.
<unk> will be an in person meeting this year and will allow your gin to meet with physicians and provide education on Joe motto and our pipeline programs.
We will have both a virtual and in person booths, including an interactive patient builder and demonstrations on how our innovative hydrogel technology is advancing care in euro oncology.
We will also have a product theater with Doctor Jennifer Linehan focused on household might've, what's helping to transform the treatment paradigm in low grade you Tuc moving away from previous surgical treatments to the first drug therapy of its kind.
With that I'd like to turn the call over to Don for a review of the financials Don.
Thank you, Jeff and thank you to everyone. Joining today's call I'm pleased to be with you today to review our financial results for the first quarter ended March 31st 2022.
Cumulus and recorded a net product sales will continue to Michael for the first quarter over 2022 or approximately a third pinpoint to $6 million.
This compares to seven point to $5 million in the fourth quarter of 2021.
Cost of revenues for the first quarter over 'twenty 'twenty tool was approximately one point to $5 million, resulting in a gross margin of 89% compared to gross margin of 88% in the first quarter over 2021.
Research and development expenses for the first quarter ended March 31st 2022, or 12 points of $7 million compared to 10 point to $5 million for the same period in 2021.
R&D expenses include the $726000 and one point to $1 billion in noncash share based compensation expense for the first quarters of 2022 and 2021, respectively.
The increase in R&D expense in 'twenty to 'twenty two is related to the ongoing phase III envision study overuse and whatnot tool, which was initiated in the first quarter of 2022.
Selling general and administrative expenses for the first quarter ended March 31, 2022, or 21 point to $3 million compared to $22.2 million for the first quarter.
2021.
Selling general and administrative expenses include $2 $2 million and five point to $1 billion of noncash share based compensation expense for the first quarters, all the 'twenty to 'twenty two and.
And 2021 respectively.
For the first quarter ended March 31, 2022 reported financing expense related to the prepaid forward obligation to RTW, you'll invest month was $5 $8 million.
The transaction closed in May of 2021, there was no such expense in the first quarter over 2021.
For the first quarter ended March 31st 2022, we reported a net loss of 28 point to $4 million or $1 25 per share. This compares to.
$25 $9 million or $1.17 per share in the first quarter of 2021.
Net loss for the first quarter over 'twenty 'twenty. Two includes two point the $9 million in noncash share based compensation expense compared to a six point to $2 million in noncash share based compensation expense in the first quarter of 'twenty or 'twenty one.
We closed the quarter with 137 point, the $1 billion in cash cash equivalents and marketable securities.
During the first quarter, we took important steps to further strengthen our balance sheet in support of our commercial and clinical development activities.
We believe the closing of the up to $100 million homeland personal piece with the funds managed by Pharmacon advisors has insulated us from what is currently a challenging kept our marketing vitamins.
With our fortify the finance our fleet, we remain focused on commercial growth and execution in the clinic and based on our current revenue projections and financial mothers, our current financial position and available tourists provides us with what we believe will be sufficient runway to achieve cash flow breakeven by 'twenty two.
25.
Turning to our financial guidance for 2022, we'd reiterate anticipated full year 2022, net product revenues from Jeremiah ought to be in the range of $70 million to $80 million, representing a 46% to 67% increase over 2020 one.
We anticipate that our full year 2020 operating expenses to be in the range of $1 $40 million to $160 million, including noncash share based compensation expenses.
$10 million to $16 million subject to market conditions.
Lastly, we anticipate the full year 2022 non cash financing expenses related to the prepaid forward obligation to RTW investment in the range of $22 million to $26 million well reach an estimated nine point to want to pinpoint to $4 million will be paid in cash with that.
I'd like to come to court or like a question operator.
Certainly ladies and gentlemen, if you have a question at this time. Please press Star then one near Touchtone telephone. If your question has been answered and you'd like to remove yourself from the queue. Please press the pound key.
Our first question comes from the line of ramps over Rajeev <unk> from H C. Wainwright Your question. Please.
Yes. Thank you for taking my questions I was wondering if you could comment on the timeline for completion of the you tracked registry.
And if you could elaborate a little bit on what specific ways in which the registry could be used to inform clinical practice. Thank you.
Hi, Ram class. Thanks for the question I'll turn it over to Jeff to sort of give you a timeline.
On your track, but it will be kind of an ongoing thing because as well as continuously add you know add new accounts, but Jeff do you just want to talk about that is that kind of initial free of accounts that we have signed up.
Sure no it did.
That is correct. It's gonna to continue we're going to continue to add patients and then Ron good question. So once we have.
Enough patients in each of those areas that we talked about.
Whether that's a maintenance whether that's an adjuvant setting you'll you'll start to you'll start to see more data come from that we did look at retrospectively a significant number of patients who are already in the registry more then Olympus and we're looking to obviously get published that data in the future so ever.
Every kind of point, we get patients in once the investigators feel like Theres really enough. There from a data perspective, we will continue to generate data ongoing there's really no set timing, where we're going to stop this we're going to we're going to continue to keep the registry open adding more accounts, adding more patients.
Okay, and then just a couple of other ones firstly on the long term financial guidance I was just wondering if you could confirm you know given the timeline for development of UGI and one O two that the achievement of cash flow breakeven in 2025 could conceivably.
B achieved based on sales of gel might've alone and then if you could give some additional context on the UGI M 301 phase one clinical development program, particularly in the context of how many potential combinatorial therapeutic regimens you expect this study within the context of this.
Graham and if you could offer any specifics regarding what types of chemotherapy or immuno modulating.
Treatments are likely to be utilized in conjunction with you'd be at 301 in the context of the phase one study. Thank you.
Yeah sure but to answer your first question absolutely. We've said this all along that company can be a profitable company supporting the entire pipeline with Justice Yamato revenue. So to your point there is a break even analysis is just based off of jumbo revenue and so with that I'll turn it off.
Mark can give you some more context on phase one and provide some more color around around what we see as potential combinations and those things will just be sort of you know what.
Because as we start to get more data on that end, but mark just wanted to talk about our initial thoughts around that.
Sure. Thanks for the question.
So we have.
As we.
Talked about the initiation of the phase one, which we're involved in right now which will initially study 301 as monotherapy and then.
For the purposes of dose finding.
We're thinking though in terms of combinations, both with immune modulators, which obviously would lead us to examine the combination with 201, our appeal our seven agonist.
As well as other agents.
I think you've heard us talk about this before.
Clearly we have experience with my the mindset there other chemo therapeutics like myeloma.
And there have utility.
And for which there is historic clinical experience in neurology in the treatment of cancer that would be attractive and again in the spirit of what if for example, gemcitabine. So immuno modulators are obviously on our radar like Telos seven agonist.
But also other chemo therapeutics.
That could potentially provide us with an opportunity to perform what is effectively chemo immunotherapy, which is something that's obviously very attractive given its relevance to the metastatic space. So there is a predicate experienced clinically I.
I hope that gives you a sense of where we would be going.
Great. Thank you very much.
Thanks, Sam Thank you.
Our next question comes from the line of Boris Beaker from Cowen Your question. Please.
Great. My first question is on your physician training can you comment what fraction of your target physicians have already been trained for those that haven't been trained what is the timeline do you think to get them through the training program.
Jeff do you want to talk about our position and I'm, assuming you're just talking about for a gym, Idaho installations correct for us.
Yes, correct, yes.
Yeah no so.
I would say I mean definitely thousands have been trained on what Youre seeing now is a combination of.
Both physicians training other positions and then we still have and will continue to grow our group of nurses are nurses do a phenomenal job.
Of training the physician so what youll see in an account lets just say you've got an account that one position used it and theres. Another physician that's identified a patient more times than not the nurse will be training that physician.
But obviously their debt position will talk to the talk to the Doctor that has treated a patient may ask him or her some questions but.
But we're going to continue as we continue to open up accounts.
Our nursing team does a great job.
And making sure folks are adequately trained they are in probably 100% of first installations and then it tapers off after that.
This shouldn't really only needs.
One or two installations to.
Understanding installation and they take it from there but doing it.
Training will continue as we grow accounts.
And it can continue both within the practice as well as utilizing our our nursing team.
Got it and my second question is for your breakeven estimate based on Joe lineup for 2025, I'm curious what is the revenue assumption there.
Yeah, we have not provided revenue assumptions for peak.
For that but suffice it to say when we when we look at our cash burn.
We've given guidance on we don't expect meaningful increases.
Over the next few years right, we have a very efficient model as we've talked about the we expect to keep expenses, where they are in the range of where they are and as we sort of you know.
Bring.
Bring down the clinical studies, we could have some savings there, but as we start new studies and we expect our expenses.
You know any increase of being fairly modest, though I think if you take a look at that you can see where we were expect breakeven to.
Now to be in what we need revenue to beat that without giving specific guidance in there that sort of gives you a range.
Got it and just lastly.
Have you taken any price increases on some idle.
We did Jack do you want to just provide the details on that very very modest and Jeff can explain why there Jeff.
Yes, because this is a buy and bill drug you Ya.
The price increase was one 5% in January and you'll see those smaller more modest increases moving forward just because of the buy and bill nature of the drug.
Got it thank you very much taking my questions.
Thanks, Mark Thanks, Mark.
Thank you. Our next question comes from the line of Chris Howerton from Jefferies. Your question. Please.
Hi, good morning, and congratulations on the progress and thanks for taking the questions.
For me I think one is just perhaps just a clarification for you Jeff on you made a comment that you're seeing more bulk orders of gel meadows I was curious if you could just define that.
What that means and maybe if you could compare that relatively to what your normal orders might look like.
The second question I have is maybe similarly related to the commercial side is.
Obviously, we've seen some labor supply issues on other facets of health care I'm, just curious if that's impacting urology practices and the ability to deploy xiaomi, though.
And then the third question I have I know that we've kind of discussed some of the the combination partners that you've had potentially with 301, but I guess I'll ask a specific question have you considered b C. G in and what might that look like in the combination moving forward. Thank you.
So Jeff why don't you take the first two and Mark.
The third question and thanks, Chris How're you doing.
Yes.
Chris Thanks for the question. So the bulk orders what we see is a lot of these referral centers.
Once they treat a few patients they have a they have a steady number of patients coming in and they don't want it. They just they want to be able to have the convenience of having the product. There. So it tells me that one obviously they are a big referral center for <unk>. They can they can purchase.
Bulk and two.
They have confidence they wouldn't be purchasing Joe murdo. If they didn't think they were going to be using it in the future and so it's slowly growing Chris I got it but it is growing.
Obviously still the majority of accounts.
Prefer or ordering one at a time, but it's something that I didn't really expect this early and it's predominantly as I said in these referral accounts, where they really know theyre going to have that patient flow.
And in the future and I just want to have product they're available to mix.
I apologize your second question.
I it was around kind of labor supply if that's impacting urology practice. It is all or your ability to deploy Jo Malone.
Yeah. That's a great question. So it's getting better we had most of it was more in and around pharmacy pharmacists coming back to work to make sure that we can mix as you know Chris we have a a mixing option if we do run into.
At a hospital pharmacy, we've had to utilize that in a couple of instances, but it is it is improving as is.
Baxter that continues to get better as well so as you see these mandates lifted folks are coming back to work and it really hasn't been.
An issue in getting patients treated it may delay treatment I've talked before about the patient enrollment form typically taking once about once that enrollment forms filled out it takes anywhere between 2% and six weeks to get the patient treated so in instances, where there are labor issues. It may take a little bit longer but.
We're not losing patients because of that.
Mark do you want to take the third one yes.
Chris Thanks.
I think you know, there's relatively new basic science research, suggesting that.
The only for maybe an important local targeted epithelium surfaces, including in the bladder.
So that provides a sort of clear mechanistic.
Now for our interest in locally deploying ADC, killing for in the context of your funeral cancer therapy, and as you point out BCG and immuno modulator for which there is a really important product could experience in urology is and obviously interesting approach to treating this disease and one that neurologists.
<unk> historically.
The combination of <unk>.
301, and BCG is something that we were talking about internally, but it's probably a little bit premature for me to provide further detail about those discussions, but BCG is a very interesting.
Drug in the context of treating non muscle invasive bladder cancer, we are certainly talking about its role and its potential within the context of our immunotherapy program.
I think the only other thing I'll add is mark can you comment on you know the continuing shortage of BCG, but we do think it's an interesting target in a potential combination.
And I also think we're also thinking about the combination of immunotherapy to HLA <unk>, four and PD, one and what would that look like as that sparked and many other tumors, but mark just wanted to comment I think on the BCG shortage I think that's important to continue that you're calling it. Thank.
Thank you yeah. Thank you list. So I think as many of those who are listening understand BCG, which has been a hallmark in sort of a.
E a pivotal agent in the treatment of.
High grade non muscle invasive bladder cancer for many decades is now in very short supply because of production issues.
And.
This is an actual clinical problem in fact, my practice right now is facing acute shortage of this drug which was precipitated.
Problems with delivering patient care. So there is a real opportunity and in fact, the urgent need to come up with alternatives to the use of BCG and we are exploring those as was pointed out in the context.
Thinking of other immuno modulator combinations as well as potentially utilizing <unk> in various forms for there are a variety of forms of BTG available now.
So it's very much of a weight or is something that's important for this particular sub.
A subset of the muscle.
Boston based bladder cancer population. So we are actively thinking about this and working on.
Okay, well, that's very clear and I, maybe if I'll sneak one in winded Merck say that they were going to have that next manufacturing site for D. C. G. Do you guys know that.
Yeah. It was like 10 year it was like many.
Okay got it.
It was several years away. Unfortunately.
Okay, all right well very good well thanks for taking my questions.
Thanks, Chris.
Thank you. Our next question comes from the line of Matt Kaplan from Vandenberg Bellmon. Your question. Please.
Hey, good morning, guys. Thanks for taking my questions.
I guess, just starting off with.
Who shall my though are you see use of the phosphate tube in terms of utilization of that procedure in terms of uptake in the market.
Okay.
Yeah.
Yes, sure. So short answer is yes.
And it continues to go up.
We're going to have additional data.
To go along with what Dr. Marie because it's published with even more patients and so it is increasingly becoming more and more popular to administer gel micro that that route.
Okay great.
And then with respect to an envision trial, how is site initiation ongoing I guess, you're targeting about 90 sites how many how many.
Do you have that so far.
Mark do we even I don't even know the number.
But yeah.
I don't think we've actually talked about the number of sites.
Yeah, Matt as you probably remember one of the one of the really fortuitous things about the envision trial that utilizes sites, we'd already initiated for the Atlas trial. So we have a group of.
More than a small group we have a very large group of educated.
And ready to go investigators.
At these sites.
Who are very familiar both with.
Medication and the.
Concept behind the trial, so although I don't know the exact number we were charging ahead with this trial and fully expect with more with this year.
That makes sense. It seems like that that gives you a bit of a jumpstart.
And then in terms of the Master protocol for the Phase one trials 301 can you talk a little bit about specifically, what's going to work for incorporation of your.
<unk> hundred one.
T L a southern Oregon.
That's correct.
It was going to take them.
Yes, please yes.
So the way this will work is.
We are starting with obviously 301 mono therapy to identify a dose and do some initial safety evaluations.
But because of the way this is set up.
We are able to once the dose is the following in the preliminary safety.
Valuations are done we can actually start combination therapy with 201. So it is staggered but set up in such a way that we don't have to wait till we've completely finished the monotherapy arm of 301 in order to initiate combination combination therapy.
Therapy arm, we expect could take 12 months and again, that's starting this month.
So we would expect that to be completed in the first half of 2023, but we will start to combinations before that and as I've said, our first combination will be was 201.
Okay, great. Thank you and congrats on the progress.
Thanks, Matt.
Thank you. Our next question comes from the line of Lee linked yourself from Oppenheimer. Your question. Please.
Hi, Thanks for taking the questions two questions one for Jeff.
And one for Mark just with reimbursement looking like it's.
You know quite quite broad at this point, you know high 90% with a Medicare or private insurance.
I'm wondering what kind of a key.
Hurdles that the commercial organization is is addressing now with respect to kind of you know meeting the gap.
So continues in its launches it.
No geographic is it community versus more.
Specialized centers.
Is it.
Some some urologists kind of.
They were to change behavior patterns with respect to how they treat.
You Tuc b comment on on that and how you're maybe focusing your efforts on addressing.
Whatever those hurdles may be and then also for Mark.
Wanted to ask with respect to the envision trial that AR is going to produce.
It's going to complete enrollment by the end of the year by your guidance.
To see data.
From that trial by leap.
And next year with the NDA for 'twenty 'twenty four how should we thinking about kind of the first data cut we would see from envision.
As you've risked that final thinking.
Yeah. Thanks, Leland so I'll take the first one yes so.
Yes, we just came out of the national sales meeting with a lot of really great resources.
One of which the EF RM team the field reimbursement team.
Show state by state so when an account has.
A question in and around reimbursement vacancy state by state the number of claims and obviously in all those states. The number of paid claims are going up so that that that is it will always be a focus reimbursement confidence is something that we want to continue to instill that that won't go away, but having said that that's really not the.
The reasons for not using as you alluded to.
What's happening now is we're able to get to more physicians within an account.
When things were locked down or when it was when access was difficult you obviously want to start with one physician in champion, but then you want to grow the number of physicians in that account because every physician as you know were most in the account.
Treating low grade U T C patients and so it's really the focus if I put a number on it you know 70% its probably going deeper in accounts, because we really do and have done a good job of getting a significant number of accounts on board and then we'll always continue to open accounts, we have a big account.
That because of PMT and other issues they've they've just added us to formulary excited there's a big account in the northeast.
And you know that and have actually I just heard today. There are 10 patients in the queue that theyre looking to treat so so the 30% will be opening the new accounts, 70% will be really going deeper.
And then the access helps you always talked about making sure that you have 567 calls on physicians to your point, we youre going to have doctors that are going to prefer a surgical option and the greater number of calls that are representative.
Can make with the resources that they have the better the likelihood of getting that physician to consider gel model for their patients.
Oh yeah.
The second question.
So as you said our plan is to enroll this year. It takes 12 months to get the initial sort of.
A tranche of data that would be sort of fundamentally useful for a submission in submission will take place in 'twenty four with approval expected in 'twenty four as well.
We're also tracking patients who originally enrolled Atlas for the purposes of providing additional <unk>.
Safety data for.
For the submission so we'll have that data set as well, but I think I, probably should defer to lose with regard to the releasing any additional information about the trial during that timeframe.
Yeah, I think it's and you won't see any data from envision in 'twenty three because this is a trial obviously a pivotal study for the FDA has to read that that data has to remain confidential.
Through duration. So you know as we enrolled this year and then you've got to have fabry patients 12 months. So that takes you to the end of 'twenty three that much of a clean the database and stuff you'll start to see the first half of 'twenty for the data, but to Mark's point, we will share in 2023 data on Atlas. So we won't be able to share some of that data.
We are also using that data as part of the submission so its support for the submission.
We'll be in a position to be able to share that data because those patients would have reached that time point. So.
Again, we'll share data with it around.
Around it and then Jim will also actually share data.
This year on our home installation study for one or two for U G. M. By no change. So we want to continue and we also have some patient preference data.
That's coming out that that demonstrates that patients that were in our phase two study.
Accident <unk>.
Almost all of that patient's preferred.
That had had a T <unk> and had.
And one or two preferred can you would you mind sharing all of the patients would actually.
Recommended to other patients. So there is some data that you'll start to see again the end of this year and then data from Atlas in 'twenty three and then the data the first half of 'twenty for us So I hope that's helpful.
Yes. Thank you.
Yeah.
Thank you. Our next question comes on the line never needed this year.
From.
Capital Your question please.
Hi, good morning, Congrats on the progress and thanks for taking my questions.
I would like to have a follow up on the.
Registry that we talked about earlier in the call.
So as you gain these insights are something you track when you say do you plan to sort of incorporate any tweaks that might be.
Relevant.
In the clinical practice and then.
Absolutely ideal time to then you now have this registry or one or two as well.
So yes, we will continue to.
Take the data from the registry.
Take that learnings and well absolutely be publishing those will absolutely be incorporating those.
As appropriate we also hope to use that to inform potential other studies that we may want to do or May we may need to do to to change the label or you know any you know anything around that or if there is data that comes out of that to the registry is being done under.
A very strict protocol and so we hope that potentially out there yeah, we may even be able to talk to the FDA about using it if we need to use that to change anything in the label that we we have a great. You know, we we actually enjoying very nice broad label.
Now, but particularly around safety and <unk>.
Adverse events I think it's really important and Jeff mentioned earlier that we've got over 100 patients in a retrospective study.
We started to set up the registry and that will be published shortly and I think you'll be really pleased to see some of the data coming out of that so we will continue to do that the idea is that we mentioned earlier is to continue to grow the registry. So that more accounts that participate in the registry the better they like to see their own data, so not only but wont be able.
The aggregate data across but we'll actually be able to.
And for them the actual accounts that are participating with their data and their their own data looks like look like and that will be able to continuously you know us.
The data coming out of there for a lot of you know.
A lot of purposes, and then yes, absolutely we would take that and add one acute whenever whenever we launch finance. It. So thanks for the question.
Great that's helpful and then.
Just wanted to know besides the metrics that you mentioned would you be tracking like the different routes of administration.
You know Ah patients.
Using mops and Nephrotomy turbine.
Hum injection every time.
Yeah, Jeff.
Yeah.
Yes, we will be obviously, we know because our nurses are in there either training via a retrograde or nephrostomy tube and that will be.
As mentioned.
More robust data coming out in and around that so it's certainly.
Yes, we know and yes, we'll continue to track and yes, we'll continue to to publish that data and get physicians more and more data. So there.
Comparable if thats the way they would prefer to administer their they have sort of data to support that.
Okay, great. Thank you and then last one about the tier one program.
Is the goal to sort of investigate.
Potential in refractory population with high grade disease as a combination therapy and then maybe.
The other lines of therapy.
Yes, that's correct Yeah, we went to the initial would be post BCG and then we would absolutely depending on the data I want to move it into front line as an alternative to B C. G are in addition to BCG as was mentioned earlier.
Thanks, Jeff.
Thank you.
Thank you. This does conclude the question and answer session of today's program I'd like to hand, the program back to Liz Barrett for any further remarks.
Great. Thanks, operator, and as always we appreciate your support and interest in your agenda. We look forward to continued a pivotal year for us in 2022.
I Hope you guys all have a nice day operator, you may disconnect now. Thank you. Thanks everybody.
Thank you and thank you ladies and gentlemen for your participation in today's conference. This does conclude the program you may now disconnect good day.
Okay.
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