Q3 2023 Inovio Pharmaceuticals Inc Earnings Call
As president and CEO, Dr. Jackie Shay.
Good afternoon, and thank you to everyone for joining today's call.
Over the last few months I'm delighted to say that we've made significant progress advancing our lead candidate <unk> 37 for the treatment of recurrent respiratory papillomatosis or RFP.
After two very important regulatory developments, we are closer than ever to delivering on the promise of DNA medicines to patients and bringing the first DNA medicine to markets in the United States.
Specifically in the third quarter of 2023, the FDA granted breakthrough days breakthrough therapy designation to INR $31 seven based on clinical evidence, indicating that it may demonstrate substantial improvement over existing therapies for RFP.
A couple of weeks following that breakthrough therapy designation, we received feedback from the FDA that data from our completed phase one two trial of $31 seven.
Could be used to support submission of a biological license application or BLA for review under the Fda's accelerated approval program.
Our Chief Medical Officer, Mike Sumner will provide more context shortly but this news means that we no longer need to complete our phase III trials for BLA submission.
Will ultimately allow for a potentially much faster development pathway.
We will however be required to initiate a confirmatory trial and satisfy all other FTA filing requirements prior to BLA submission as is usual for the accelerated approval pathway.
To achieve that our team has already submitted a request for an initial comprehensive multi disciplinary breakthrough therapy meeting to the FDA for the fourth quarter.
This meeting will help further align our plans with the FDA and determine the timing for critical deliverables associated with our BLA submission.
As we make progress on this new expedited pathway. We have every intention to utilize the opportunity for increased communication with the FDA and other advantages offered by breakthrough therapy designation.
<unk> is requesting a rolling submission of completed sections of our BLA under priority review of the police submitted BLA.
As a result of this new timeline, we have accelerated our commercialization strategy to be prepared to launch 30 107 should it be approved.
Led by Mark Twyman, our Chief commercial officer him Youll hear from shortly our commercial team has extensive experience, bringing products to market, including innovative new technologies and products in the rare disease space.
Mark will spend a few moments today talking about his team's current efforts to expedite building a number of critical capabilities and establishing pathways for commercial success.
Such as creating the value proposition for 31% and seven putting in place an optimized distribution model.
Eloping path, especially <unk> pharmacy, and pharmacy benefit management strategies to ensure favorable access and preparing to stand up a field organization.
Mark and his commercial leadership team brings decades of combined biopharmaceutical experience from such companies as Sanofi Genzyme, Merck CSL Behring and medimmune.
I've been personally involved in nearly every aspect of successfully commercializing products from sales and marketing to distribution market access and government affairs.
I am really pleased with the progress of this team as they work hand in glove with leaders from across the company to optimize the launch plans for our lead candidate.
In addition to the regulatory achievements and commercial readiness efforts I've described.
Very hard over the past 18 months or so to restructure our corporate organization with the goal of meeting our current focus pipeline needs and reducing spending while at the same time pertaining in building the expertise critical to implement our plans for our late stage pipeline.
After many difficult months and quarters I am pleased to see the collective efforts of our dedicated and experienced cross functional team make a real difference.
With that I'd like to turn it over to our Chief Medical Officer, Dr. Mike <unk> to provide a brief overview of the regulatory and development progress sweep achieved 37.
The next steps in our accelerated development timeline and other key preparations to support a BLA submission and if approved to bring this candidate to market.
Mike.
Very much Jackie and greetings everyone.
As Jackie mentioned, we have made substantial progress with our lead candidate INR, 31% or seven to.
To provide a little perspective on how fast this candidate has been advancing through development. We've created this timeline.
We started a phase one two trial in 2020.
The same year, the FDA granted orphan drug status.
After announcing positive final results from the trial earlier this year.
The European Commission granted orphan drug status in May followed by the Fda's breakthrough therapy designation in September.
Shortly thereafter, we received important feedback that data from our completed phase one two trial could support submission of a BLA for review under the Fda's accelerated approval program.
To take you can deduct from proof of concept to working on our filings.
To filing a BLA in the span of three years is lightning speed and speaks to the hard work and collaboration of the broader and Novo team.
Looking ahead, the opportunity to file a BLA under the accelerated approval program assures that team will need to continue to run fast and hard.
I'd like to speak briefly as to why we have been granted the opportunity to submit a BLA for 31% or seven under the Fda's accelerated approval program.
First keep in mind that the FDA instituted its accelerated approval program to allow for early approval of drugs that treat serious conditions and fill an unmet medical need.
Additionally, they have recently issued a press release identifying their desire to utilize this program to further accelerate the development of rare disease therapies.
In general to qualify a drug candidate must address a serious or life threatening condition with consideration for the severity.
Rarity or prevalence of the condition and available treatment options.
For those who are not familiar with RFP and I must include myself in this category before coming to <unk> last year is a debilitating and rare disease caused primarily by HPV six <unk> HPV 11.
RFP is characterized by the development of small won't like growth or <unk> and.
In the upper respiratory tract.
While these <unk> are generally benign they can cause severe life, threatening airway obstruction and respiratory complications.
The majority of patients with RP need to undergo multiple surgeries year after year to remove the recurring <unk>.
This has a significant impact on quality of life, coupled with the potential for long term impact on vocal cords, which can limit the patient's ability to speak effectively.
We are pleased that the FDA has now recognize the impact this devastating disease has on patients' lives and awareness that in large part is due to the persistent efforts of CRP Foundation.
A patient advocacy organization that has been working tirelessly to raise the need for better and less invasive treatments.
This links with another characteristic required to qualify for the accelerated approval program.
Which is the drug candidates must provide a meaningful advantage over other available therapies.
In this instance, the standard of care for RFP as I mentioned is repeat surgeries to remove the <unk> from the throat and vocal cords.
I am pleased to say that in our completed phase one two study.
81% of patients experienced a reduction in the number of surgeries in the year after treatment versus the year prior to treatment.
This included nine patients representing 28% of patients in the study who did not require any surgeries following treatment initiation.
Further our immunology data provides a potential mechanism of action, which supports the clinical evidence, which I will highlight next.
This slide helps illustrate the scope and impact of the immune response and a natural patients who had undergone six surgeries a year prior to the trial followed by zero surgeries during the trial.
The graph on the left here to pick the CDA T cell response observed in this patients before and after completion of dosing.
As you can see this patient experienced a strong induction of HBV specific CDA T cells that have markers of cellular activation and a positive for Grand science, and perforating, which are known to be key mediators of eliminating virally infected cells by killer T cells.
<unk>.
The data in both graphs indicate that 30 107 expanded these critically important cells in impressive fashion with the most highly active killer T cells, which of those showing expression of all three activation markers.
<unk> close to a 10 fold increase in frequency.
It is these types of cells that we believe are key contributors to reduction in the need for surgery exemplified in photos on the right hand side of the slide.
These are images of the same patients vocal cords before and after treatment with 31% or seven.
Again, this patient went from having six surgeries in the year prior to treatment to zero surgeries in the 12 months following the first dose.
As you can imagine that level of reduction in surgeries has an incredible impact on the patient.
But it is important to highlight that RFP patients and their healthcare providers have indicated time and again that a reduction of even one surgery would provide significant improvement in quality of life.
One important note about that trial design, while AD treatment involved four doses over nine weeks, what we call the treatment window, we counted any surgery conducted after the first dose.
We did not wait until after all four doses word means to start counting surgeries.
Rationale behind this is important as I stated above patients care about every single surgery.
Regardless of when it happens whether it happens during the treatment window on all because each and every surgery impacts that patient's life.
These results add to the growing body of evidence that <unk> DNA medicines candidate, a well tolerated immunogenic and particularly adept at promoting viral clearance and lesion regression in HPV related diseases.
From a regulatory standpoint, we now have several key objectives ahead.
We have submitted a request for an initial comprehensive multi disciplinary breakthrough therapy meeting.
And have asked the FDA for it to take place in the fourth quarter of this year.
At that mode at that meeting, we will discuss key elements of our planned future submission for an accelerated approval review.
Including required immunology data key CMC plans, including process performance qualification or PQ strategy.
Alignment on questions about electric delivery device and other clinical strategy steps.
The outcome of this meeting will be instructive to the timeline of critical deliverables for the BLA submission.
Shortly thereafter, we plan to submit a protocol for a confirmatory trial to the FDA.
Drawing on our previous alignment with the agency on study design.
Under accelerated approval a confirmatory study has always required to verify the anticipated clinical benefit of a candidate and.
And we have been requested to initiate this trial prior to BLA submission.
Throughout the process of submitting a BLA under the accelerated approval program.
We will utilize the benefits of our breakthrough therapy designation status.
Which affords priority access to the Fda's guidance and advice.
To try to quickly resolve any outstanding questions.
We also plan to take advantage of the opportunity to submit under the Fda's Rolling Review program.
And plan to request a priority review once the BLA is fully submitted.
Which has the potential to further accelerate the product development timeline.
Rolling review of allowance for a company to submit completed sections of Obediently for review by the FDA generally over a three month window rather than waiting until every section is completed to submit.
Under priority review the FDA aims to take an action on the application within six months compared to 10 months under standard review.
It's important to recognize that achieving an approval of our BLA requires a team with expertise across an array of functions.
We are fortunate to be working with such an incredible team of experts who bring with them years of prior success in advancing innovative medicines through approval to commercialization.
With the ultimate goal of benefiting patients.
One of the functions I've listed here on slide is critical but just to give you a sense of the work one important area has underway and medical affairs function is focused on developing and implementing plans for scientific engagement medical communications and field operations.
Work done by Medical Affairs is an important juncture between those who work to development <unk> and.
And our partners in commercial who make sure the patients can ultimately receive them.
With that I'll now turn the call over to our Chief commercial officer, Mark Twyman for some important updates on how our commercial team is working to ensure just that mark thanks, Mike.
Before I jump into the specifics of our commercial strategy.
Like to say that it is a pleasure to have the opportunity to speak with you all today and how excited I am about the prospects for IL 30 107.
While this is my first time on our quarterly financial call for <unk> I have been with the company for about six years and as Jackie mentioned earlier I have been involved in the commercialization of biopharmaceutical products for many years for both small and large companies as is my team.
We are extremely excited to begin implementing many of the plans we have been working on to benefit patients who are in desperate need of options to improve their quality of life.
Let's take a few minutes to discuss what we believe our five key areas to achieve success in the launch of an orphan drug.
The first is to create a long term commercial strategy, we're starting early and continuously updating based on end market data it.
It is also important to build up the required resources as early as possible before regulatory approval was granted.
As I mentioned.
<unk> for several years, helping the company prepare to bring DNA medicines to market. We now have the opportunity to leverage existing cross functional capabilities for the development and potential launch of INR 30 107.
The next key element to successful launch of an orphan drug is demonstrating the value of your product to all stakeholders. This value proposition has to be provided in the context of any competition and a much leverage trial data and real world evidence.
Next accompany that successful launches of biopharmaceutical product must ensure that patients have a voice in their care and the options offered this is accomplished by involving patients and patient organizations early in the development process as Mike mentioned, the RFP Foundation is that a wonderful job and advocating for patients.
RFP over the years sharing their experiences with regulators and policymakers alike. We.
We are proud to consult with them on our shared goal to help patients suffering from this debilitating and serious disease.
The fourth key element is to take an active role in disease education with a detailed stakeholder activity plan. This includes selling medical liaisons into the field early and creating innovative sales roles such as patient patient centric field reps and.
And last but probably most importantly is to get the supply chain up to speed as quickly as possible. This includes determining the appropriate distribution strategy model for iron or 31, seven identifying and selecting supply chain partners and really understanding the last mile logistics for the product are complete manufacture to patient solutions.
<unk>.
It's important to note that INR 30, 107 does not require ultra cold or frozen storage or following prior to injection is refrigerator stable at two to eight degrees Celsius, which will be key factors for both distribution and administration.
I am pleased to report that for IL 30, 107, many of the key areas for success I. Just outlined are underway are being addressed for example, we are actively engaging external partners and service providers and have started implementing plans for product distribution and logistics payer engagement and reimbursement.
Specialty pharmacy identification patient and provider awareness and education customer service programs and other sales and marketing activities. It is also worth noting we believe that INR 30, 107 will be considered by payers to be a specialty pharmacy product not a buy and bill product consistent with many other orphan disease treatments.
We are also continuing to deepen our understanding of RFP as the disease the treatment paradigm in the United States and impact of both the disease and the current surgical treatment regiment on patients. We are taking extra care to really understand the needs of patients doctors caretakers and advocates to inform our path forward.
Here's a high level snapshot of what we understand so far.
<unk> is a chronic rare disease caused by HPV, six and HPV 11 occur.
The current standard of care surgery, with many patients facing a lifetime of repeated surgeries as their only option.
The incidence and prevalence of RFP is variable globally and depends on several factors.
Widely cited use epidemiology data estimated that there were 14000 active cases and about one eight per 100000, new cases in adults each year.
A recent publication sites that on average patients with RP undergo about four surgeries per year, these surgeries and surrounding care through tremendous financial burden on patients and the healthcare system.
Based on ongoing market research, we believe that Laryngologist are the primary health care providers treating patients suffering from this contingent conditions that they are comfortable administrative administering drugs and utilizing new tools and devices.
In our discussions with them. They are expressed particular interest in finding a more effective non surgical treatment options for their RP patients.
We estimate that about 300 to 400 laryngologist in the U S conduct the majority of our RFP surgical procedures. We are currently in the process of validating those estimates and geographically mapping their practice locations to support final decisions about the size and alignment of our field based sales team for INR 30 107.
Key opinion leaders estimates that approximately one half of all their oncologist practice and academic institutions and recent discussions with RP patients. We heard that many of them prefer to be treated at these regional academic centers.
As I've outlined today, we are considering every detail that can impact patients healthcare providers and ultimately our commercial strategy as we work to potentially bring a INR 30 107 to market we.
We will continue drawing on the strength of the novo team across functions and working with season partners to meet the demands of this accelerated timeline and deliver on our promise of DNA Medicine, I will now turn the call back to our CEO Jacqui sure for a pipeline update Jackie.
Thank you Mark.
Before I cover some additional updates from our pipeline I'd like to take a moment to reiterate some of the key takeaways from what <unk> heard today from Mike Mark, which highlight why we believe in the commercial potential of <unk> 31 in seven and its ability to potentially transform the treatment paradigm for RFP.
In our completed phase one two trial 31, 7% with April to generate antigen specific T cell responses against both HPV six and 11.
A result that was observed in patients across the spectrum of disease severity.
We also saw a reduction in surgery in HPV, six and 11 positive patients.
And then across the spectrum of disease severity.
31, <unk> seven was well tolerated by participants in the trial, resulting in mostly low grade treatment merchants adverse effects, such as injection site pain and fatigue.
Unlike other T cell generating platform 31, 7% and DNA medicines in General then caused 90, vectra sponsors, which means that $31 seven could potentially be we administer overtime to boost immune response if needed.
Because <unk> is a chronic viral disease that can lead persistently occurring symptom re administration may be an important factor and extending efficacy for a lifetime and we anticipate exploring that opportunity further F 30 <unk> approved.
Thinking further down the line to potential Houston market, it's important to reiterate the point that Mark made earlier 37, it's a refrigerator staple at two to eight degrees Celsius does not require person or ultra cold storage and will be packaged in a single use file all of which will.
Key factors in distribution and administration.
We see iron ore of 31, seven as an exemplar of the larger potential of our DNA medicines platform and we remain dedicated to driving progress across our pipeline.
Locked up potential for patients across the globe.
We believe that this is achievable in a three step process.
As you can see on this slide and the near term and <unk> is focused on optimizing the opportunity for $31 seven as a potential treatment for RP patients.
In the midterm and Nokia is working to advance <unk> clinical stage candidates targeting HPV related diseases cancers and infectious diseases.
But the longer term.
<unk> is developing next generation DNA medicine technology, including DNA encoded monoclonal antibodies or <unk>.
Marketing COVID-19, as well as DNA launch nanoparticles or <unk> targeting <unk> disease targets.
Cancer vaccines that have various disease targets.
This slide provides greater detail on our pipeline. Obviously 37 is closest to market, but we also had several key candidates that we are working to advance.
In particular, we are finalizing the study reports and data analysis on INR 50, 401 for treatment of newly diagnosed glioblastoma.
And continue to support treatment for some patients on the trial.
Currently in discussions about next steps with Kols and our partner Regeneron.
And an excellent example of the versatility of our DNA medicine candidates.
<unk> is also being studied in a phase <unk> investigator sponsored trial by the University of Pennsylvania's fastest center.
Researchers that are evaluating 50 401 in patients with BRCA, one or BRCA two gene mutations.
This vaccine candidate may have the potential to prevent breast cancer for people with those mutations.
The research was recently featured on the today show highlighting the potential of DNA medicine, and the power of partnerships to help accelerate progress for patients.
Aim to continue building strategic partnerships like this one to drive medical progress for patients innovation and ultimately shareholder value.
We also remain encouraged by the final data reported earlier this year from the study of <unk> 31, 12, and head neck cancer in combination with the PD one checkpoint inhibitor.
We are continuing discussions to find a potential PD one checkpoint partner to advance. This promising candidate and believe there is a significant opportunity to be explored for 30 months 12 in combination with a proven PD one checkpoint inhibitor.
On the infectious disease side earlier this year, we announced positive data from our phase one study for <unk> hundred one as a potential Ebola vaccine booster.
We're continuing discussions with our partners for that program to determine next steps and evaluating potential funding opportunities.
We also have some exciting next generation DNA medicines in early clinical development for.
For instance, our team apps and Tnmp's and also candidates in preclinical development.
We believe these next generation candidates built on the strength of our DNA medicines platform with significant potential advantages over other platforms.
I'll now turn the call over to our CFO, Peter Keith from third quarter 2023 financial summary.
Lisa.
Thank you Jackie.
Today I'd like to provide an overview of <unk> operational highlights and financial condition for the third quarter of 2023.
As Jackie noted and as required in today's economic environment.
<unk> is committed to financial discipline as we advance our pipeline.
To achieve our long longer term goals our strategy over the past 18 months has been to re prioritize our pipeline reshape our organization and scale our operational spend.
As you can see from this slide.
We have succeeded in bringing our operational spend down for both the third quarter and the nine month period ended September 32023, compared to the same period.
In 2022.
For the third quarter 2023 operational expenses dropped 20% to $35 9 million from $44 9 million compared to the same period in 2022.
The third quarter included a onetime noncash charge for goodwill impairment that totaled $10 5 million.
Excluding that one time charge our operational expenses.
For the third quarter would have declined 43% from the same period or same quarter in 2022.
For the first nine months of 2023, we cut our operating expenses nearly in half dropping to $117 3 million from 221 8 million in the first nine months of 2022.
Breaking down total operating expenses a bit more for the third quarter. Our R&D expenses totaled $15 5 million in 2023 compared to $33 1 million for the same period in 2022.
The decrease in R&D expenses was primarily the result of lower drug manufacturing.
Clinical trial expenses and outside services related to INR 4800, and other COVID-19 studies.
And lower employee and confidence and consultant compensation, including stock based compensation among other variances.
G&A expenses for the third quarter 2023 were $9 9 million compared to $11 9 million for the same period in 2022.
Revenues for the third quarter of 2023 were 388000 <unk>.
Compared to $9 2 million for the same period in 2022.
The revenue reported for the 2022 third quarter was associated with a procurement contract with the U S Department of defense for <unk> device and accessories to be used for delivery of iron ore 4800.
Which we have since discontinued.
These factors combined.
To bring our net loss for the third quarter of 2023 to $33 9 million or <unk> 13 per share basic and dilutive.
Excluding previously mentioned one time noncash charge for goodwill impairment our loss would have been nine per share basic and dilutive.
For the for the 2022 third quarter, our net loss of $37 8 million or <unk> 15 per share basic and diluted.
We finished the third quarter of 2023 was $167 5 million in cash cash equivalents and short term investments compared to $253 million as of December 31, 2022.
Following feedback from the FDA on the accelerated approval pathway for INR 30 107.
We now estimate that our funds should support operations into second quarter of 2025.
This projection includes a cash burn estimate of approximately $26 million for the fourth quarter of 2023.
These projections do not include any funds that may be raised through our existing at the market program or other capital raise activities.
As a reminder, you can find our full financial statements in this afternoon's press release as well as in our Form 10-Q filed with the SEC.
And with that I'll turn it back over to Jacky.
Thanks Peter.
I'd now like to open up the call to answer any questions you might have.
Operator.
Thank you ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press the star followed by one on your telephone keypad, you will hear an update on plans at Celgene request questions will be taken in the order received should you wish to cancel your request. Please press the star followed with it too.
Using a speaker phone please keep your handset before pressing.
One moment. Please for your first question.
Your first question comes from the line of Roger song from Jefferies. Please go ahead.
Great.
Congrats for that.
Progress and thanks for taking the question.
Maybe just focusing on the RP program.
The first question is related to the BLA filing in the phase III Confirmatory study design.
Just let us know what is the outstanding items for the filing and.
And the confirmatory study design.
And any.
Current guidance around the timing of that.
Finally, and a potential approval. Thank you.
Thanks, Roger it's nice to hear your voice.
So as we mentioned during the call.
The news on accelerated approval pathway is relatively new we just heard in September.
So over the past few weeks, we've really been working to accelerate our timelines.
Together quite a detailed package.
To be considered by the FDA under the upcoming meeting and I'll hand over to Mike to provide a few more details there.
But what we're really hoping to achieve not meeting is to get some alignment with the FDA as to some of the content that needs to go into that submission package.
As well as some further discussion on the design of the confirmatory study.
Mike Thank you Jackie.
I think you hit some of the highlights I mean, obviously since we heard the news in September I think we've made tremendous progress as a team.
We really mapped out every single function on what we need to do to get to a BLA.
In terms of.
The input we need from the FDA I mean, obviously, we have a strategy we need to get the FDA to agree to that strategy, but we're pulling on significant.
The data points that we've had I mean, we've already gone through a <unk> strategy for 3100, we've used <unk>.
Electrode device in a phase III program and we've had we've had several interactions with the agency on what we need to do for the device we know.
Again from a confirmatory studies.
We want to propose and we've had significant input of what we believe is going to be acceptable to the agency and so we need alignment on that protocol as we do need to start that study.
Prior to filing a BLA.
But overall I think.
Based on all the interactions we've had on our platform and specifically around our ERP. We are in a very good place and now it's really just going through through the process of aligning strategy with the agency. So we can move rapidly forward.
Great.
Maybe just a quick question and Ron.
The commercial infrastructure.
With the current grown waiting to second quarter 2025, how should we think about the overall commercialization cost post approval for assuming the approval for the RFP.
Yes, that's a really great question, Roger before I ask mark to jump in there.
Really this this upcoming discussion with the agency will really help us be more definitive on the timelines.
Thank you no more.
Can you talk a bit about this in a bit more detail, but I think one of the encouraging things for us.
It's a relatively small biotech company is that this is a rare disease.
We believe that there are.
A reasonable number of call points for a company of our size to take on we have in house manufacturing fraud device that we think can meet our device manufacturing needs.
We have well established relationships with our drug manufacturing CMO to to manufacture the drug.
But maybe you can talk a bit more about how we're thinking about going to market for 31 87.
Thanks, Jackie great questions I think.
Jackie really hit the nail on the head when she was talking about.
This laryngology space and for RFP and being a perfect fit for <unk>.
<unk>, if we think about the field sales organization.
We're thinking now that rescue Europe's between 300 400, Laryngologist that are performing the majority of the RFP.
In the U S and we really think that a small specialty sales force can can officially address the needs for both patients.
Patients and physicians, but I think the other sort of component and it sort of speaks to the experience that we have in the organization and commercializing products were getting an early start.
It's not just about the sales organization, but it's about everything youre doing behind that from the perspective of your distribution strategy. The early conversations you need to have with with payers and Pbms specialty pharmacy.
So that's all work that's been started.
I think what what is emerging as that we've identified the key.
The key work streams.
We've begun to identify the key partners that we need to have on board and I feel really good about where we are right now.
And being able to leverage this accelerated approval.
Thanks, Mark and Roger to answer your question about costs, we are planning to operate a lean and efficient model. So it makes sense for us to do things in house, we'll do them in house, where it makes sense to leverage other peoples capabilities, such as the contract sales force and potentially deferred expense that we'll be doing.
Matt So I think we'll be able to provide a bit more guidance in terms of fall.
Phasing of our cash runway.
Over 2024 months, we've had that discussion with the with the FDA.
Yes that makes sense. Thanks.
Thanks, a lot for the for the comments.
From.
Thank you once again that is star one to ask the question and your next question comes from the line of <unk> Chen from H C. Wainwright. Please go ahead.
Hi, Thank you for taking my questions.
Could you.
Could you tell us whether any patients in a clinical trial has been re dose.
So everyone knows chairman.
In the real world setting commercially speaking do you think.
Larry geologists that we will have the flexibility of choosing to do how often particular patient should be dosed with certainly what almost you have with all of that could be limited by Payors to let's say just once every year.
So I'll hand over to Mike may be talking about the initial clinical question on the current on the completed phase one two trial and then Mark maybe you and Mike together can address the next question.
So I mean, the starting off obviously one of the real benefits of the DNA medicines platform as there is no anti vector response, and we believe re dosing is capable in fact, we know re dosing escape from many of our oncology programs.
At present.
We have not reduced any of the patients from the phase one two study.
But as we come to think about those patients mainly we obviously saw.
Some patients with complete response, we saw a significant number of patients with <unk>.
Very good partial response with greater than 50% reduction in surgeries and then unfortunately, there were a few patients who.
Such great responsibly for me I keep whole those three buckets.
From a clinical strategy.
But we certainly want to.
In the future sort of examine how we can.
Continue to to build on the excellent clinical efficacy we've seen to date.
Would would say obviously.
Any until that's in our label it would all be off label and.
And so we'll be down to the clinicians to decide.
What they want to do with their patients.
Yes, I think what I would add to that Mike is.
A question where were payers decide.
<unk>.
What I know is that we have a very strong value proposition for IL 30 107.
Can all kind of look at the results to date from a clinical perspective and know that we have a real potential to address this unmet medical need both from a patient perspective.
It's still Unsettles me to know that.
Some of these patients experienced hundreds of surgeries over a lifetime and that comes with significant.
Cost burden.
And how they go about living they're living their daily lives.
But on the other sort of points physicians aren't satisfied I mean, these surgeons are used to sort of treating and resolving an issue that their patient might have and thats just not the case with RP and hence the name recurrent respiratory papillomatosis and I know from having a number of discussions with.
Some of the key Kols and physicians that are doing a large number of surgeries that they are really looking forward to having this option.
And it's really kind of our job. It's the job we've already started to make sure that there is alignment with what the payors, how the payers sort of value INR 30 107.
And the fact that physicians are looking for for a new option for treating RFP. So I'm feeling really good about.
Where we are but.
We'll have to get to the finish line.
We'll re dosing be part of the phase III trial.
We are still.
Still in discussions with the agency.
Adding that and haven't really put the details out there, but it's certainly as I said, it's certainly something that we are thinking about.
Okay. Thank you.
Thank you once again that is star and wanted to ask a question.
There are no further question at this time please continue.
Thank you.
The significant progress we have made in advancing <unk> hundred 30, <unk>. The past few months means that we are moving closer to providing a potentially life changing non surgical treatment option to patients suffering from RFP.
I remain incredibly grateful to the patients patient advocates trial investigators and our dedicated team here at <unk> that has enabled us to achieve this.
I am confident that our experienced team is prepared for the next critical steps to development and potential commercialization Friday of 35 seven and.
And thanks to the corporate strategy, we've been implementing over the past year I'm also confident that <unk> now has the key drivers in place for <unk>.
Our long term success.
We have a diversified pipeline focused on candidates with scientific and clinical promise achievable pathways to market and strong commercial potential.
We have a proprietary DNA medicines platform and technology, along with our history of strong partnerships to accelerate progress in innovation.
And we have the benefits of an incredibly experienced team focused on financial discipline operational excellence and motivated by the patients who could someday benefit from the power of DNA medicine.
There is much left to be done, but I speak for the entire <unk> team when I say that we are energized by what the future could hold for DNA medicine and patients around the world.
With that thank you again pure attention.
Have a great evening everyone.
Thank you, ladies and gentlemen that does conclude our conference for today. Thank you all for participating you may all disconnect.
Okay.