Q4 2023 Inovio Pharmaceuticals Inc Earnings Call
Participants
Thomas Hong; IR; INOVIO Pharmaceuticals, Inc.
Jacqueline Shea; President & CEO; INOVIO Pharmaceuticals, Inc.
Michael Sumner; Chief Medical Officer; INOVIO Pharmaceuticals, Inc.
Mark Twyman; Chief Commercial Officer; INOVIO Pharmaceuticals, Inc.
Peter Kies; CFO; INOVIO Pharmaceuticals, Inc.
Hartaj Singh; Analyst; Oppenheimer & Co. Inc.
Roy Buchanan; Analyst; JMP Securities LLC
Roger Song; Analyst; Jefferies LLC
Yi Chen; Analyst; H.C. Wainwright & Co., LLC
Presentation
Operator
Good afternoon, ladies and gentlemen, and welcome to the Inovio Fourth Quarter and Year End 2023 financial results conference call. At this time, all lines are in listen-only mode. And following the presentation, we will conduct a question and answer session. If that if at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Wednesday, March sixth, 2024. I would now like to turn the conference over to Thomas Hong, Manager of Investor Relations. Please go ahead.
Thomas Hong
Good afternoon, and thank you for joining the Inovio 2023 Fourth Quarter and Full Year Financial Results Conference Call. Joining me on today's call are Dr. Jacqueline Shea, President and Chief Executive Officer; Dr. Michael Sumner,, Chief Medical Officer; Mark Twyman, Chief Commercial Officer; and Peter Kies, Chief Financial Officer of today's call will review our corporate and financial information for the quarter and full year ended December 31st, 2023, as well as provide a general business update. Following prepared remarks, we will conduct a question and answer segment.
During the call, we will be making forward-looking statements regarding future events and the future performance of the Company. These events relate to our business plans to develop Inovio's DNA medicines platform, which include clinical and regulatory developments and timing of clinical data readouts, along with capital resources and strategic matters.
All of these statements are based on the beliefs and expectations of management as of today, and actual events or results could differ materially. We refer you to the documents we file from time to time with the SEC, which under the heading Risk Factors identify important factors that could cause actual results to differ materially from those expressed by the company verbally as well as statements made within this afternoon's press release. This call is being webcast live and a link can be found on our website, ir dot inovio.com and a replay will be made available shortly after this call is concluded.
I will now turn the call over to INOVIO President and CEO, Dr. Jacqueline Shea.
Jacqueline Shea
Good afternoon, and thank you to everyone for joining today's call. The past 12 months have been transformational for Inovio. Today. We are a company planning to submit our first BLA in the second half of this year and preparing for the potential commercial launch of our first products in 2025. If approved, I know 3107 could also become the first nonsurgical therapeutic option for patients with our RP and be the first DNA medicine available in the United States.
To achieve this transformation, we have prioritized our product pipeline to focus on 3107 and other promising late-stage assets, all with high unmet medical need and strong commercial potential. We remain committed to financial discipline, cutting our operating expenses nearly in half compared with 2022 and focused on leveraging the advantages of our platform to deliver on the promise of DNA medicine.
In addition to the significant progress made with 3107, our strategic refocus help drive progress across the pipeline, including a new clinical collaboration and supply agreement with Coherus Biosciences to develop minus 3112 in combination with bulk towards East for thyroid cancer we also shared encouraging results, primary 42 or one as Maple a booster vaccine, continue to advance other clinical-stage candidates and made progress with promising preclinical research opportunities for next-generation candidates adding to the positive momentum.
Looking ahead, several key catalysts will help continue that momentum across our pipeline in addition to submitting our BLA for 3107 on the FDA's Accelerated Approval Program. We plan to initiate a confirmatory trial in the second half of 2024 and will continue preparations for a potential 2025 launch for our immuno-oncology candidates. We plan to finalize the trial design for evaluation of 3112 in combination with Block 2C in patients with three set as well as determine next steps for 54A1 in glioblastoma, a deadly form of brain cancer.
We also expect some key milestones for our infectious disease candidates, including discussions with collaborators and potential partners around development plans Brian, a 4201 as an absolute booster vaccine in the first half of 2024 and the readout of the first clinical data from the Phase one trial evaluating the N T cells could be two d-mab candidates in the second half of 2024.
I'd now like to pass the call over to our CFO, Mike Sumner, who will provide some additional details on our clinical progress over the past year and our goals for the year ahead.
Michael Sumner
Thank you very much, Jackie and greetings, everyone. As Jackie outlined, we have made significant progress across our pipeline over the past year. Thanks to a strong strategic vision that prioritizes promising candidates with strong commercial potential. One of the highlights has been the significant progress of INO 3,001.7 for the treatment of recurrent respiratory papilloma ptosis or RRP. For those who are not familiar with our IP, it is a devastating rare disease of the respiratory tract caused by HPV six and 11. It is characterized by what light growth called papilloma virus that can develop through out the respiratory tract, primarily affect the larynx and vocal codes.
RRP most commonly causes difficulty speaking or complete voice, less difficulty swallowing shortness of breath and choking episodes. In rare cases, papilloma can spread to the lungs or become malignant. Incidence and prevalence of RRP is variable globally and depends on several factors. The most widely cited U.S. epidemiology data published in 1995, estimated that there were 14,000 active cases for both adults and juveniles and about 1.8 new cases per 100,000 adults per year.
The only way to remove the papilloma surgery, but surgery doesn't address the underlying HPV infection. So the papilloma is grow back often forcing patients to have multiple surgeries a year in the worst cases that could be hundreds of surgeries over a lifetime. This puts some extreme physical and emotional burden on patients, including the threat of permanent vocal cord damage, impacting the patient's ability to speak.
Normally ever. Again, a recent study found that even patients who had had less than five surgery, faced a 50% chance of permanent vocal cord damage in patients who have had 10 or more surgeries that increases to a 98% chance from our conversations with patients and health care providers. Our RRP patients are desperate for a nonsurgical treatment option as Kim MacLellan, President of the RRP Foundation reiterated last week at the White House forum on rare diseases, even one less surgery here would be life-changing for patients.
This slide shows the very real impact of INO-3107 has had in reducing surgeries for ROP patients in our Phase one two trial. As you can see here, the majority of patients, 81% ,saw a reduction in surgery after treatment with 28%, meaning no surgeries at all during the year after treatment. As a reminder, we counted all surgeries, including any surgeries performed during the dosing window.
We believe 3107 has the potential to completely change the treatment paradigm for patients as a therapeutic adjunct to surgery. As you can see on this updated time line. We have achieved some major development and regulatory milestones in just over a year. In the first quarter of 2023, we shared positive results from our Phase 1 two trial, which were later published in a leading peer-reviewed journal read by our future physician customer base.
In the second quarter, we received orphan drug designation in the European Union followed by breakthrough therapy designation from the FDA in the fourth quarter. We now have an established path to BLA submission under the FDA's accelerated approval program and announced plans earlier this year to submit a BLA in the second half of 2024.
Looking forward, some of the key catalysts on the horizon for INO-3107 include completing submission of our BLA under the accelerated approval program in the second half of '24, initiating a confirmatory trial prior to that submission requesting rolling submission and priority review, which would lead to possible action on our BLA application within six months compared to the usual 10-month review, we will also target publication of our immunological data supporting the mechanism of action of 3107 in the second half of the year. And finally, commercial launch in 2025.
If we receive FDA approval, our Chief Commercial Officer, Mark Twyman, will provide an update on our commercial preparations, and we look forward to accelerating the development of this promising product candidate over the next year and ultimately delivering on the promise of our DNA medicine for our RP patients across the United States.
Shifting gears now to another late-stage DNA medicine. I'd like to spend some time talking about I know 3112 at our exciting new clinical collaboration and supply agreement with Coherus bioscience sciences that we announced earlier this year. This partnership will allow us to evaluate 3112 in combination with Block 2C, a PD-1 inhibitor that recently received FDA approval for treatment of nasal fairing GEO carcinoma.
We will be studying this combination therapy as a potential treatment for patients with local regionally advanced high-risk HPV 16 and 18 POSITIVE oropharyngeal squamous cell carcinoma in combination. This therapeutic approach is designed to leverage the antigen-specific T cells elicited by 3112 and the antitumor immunity generated by Block 2C to potentially provide improved patient outcomes. Under the terms of the agreement, Coherus will provide look towards use in the planned Phase three clinical trial and provide support for regulatory interactions with this collaboration in place, we have submitted our clinical development plans to the FDA and expect to receive feedback in the second quarter.
So what is oropharyngeal squamous cell carcinoma, a type of head and neck cancer that occurs in the base of the tongue tonsils and or soft palate and is most commonly referred to as throat cancer for cancer is typically causally related to high-risk subtypes of HCV, which are responsible for 70% to 80% of all oropharyngeal cancers diagnosed in the United States. They are also associated with tobacco and alcohol use.
HPV positive for cancer is rapidly increasing in incidence among patients in high income countries and has surpassed cervical cancer as the most common HPV-related cancer diagnosed in the U.S. with nearly 20,000 new cases each year. Most are cancer patients are diagnosed with local regionally advanced disease, and the current treatment practice is focused on curative options through the use of multi therapeutic approaches, including surgery and chemo radiotherapy.
With this treatment protocol, about 75% of patients do very well as measured by a three year progression free survival However, those 25% of patients who have their cancer progress faced very poor clinical outcomes. Our proposed trial of INO-3112 in combination with look towards he will be in patients who are HPV, 16 or 18 posted an exhibit a high-risk of recurrent disease with the goal of preventing disease progression. There are an estimated 3,000 to 4,000 new patients in the U.S. every year who are deemed to meet these criteria.
Based on previous trial data and the growing body of research indicating that DNA medicines are adept at combating HPV related diseases. There is a strong rationale in combining 3112 with a proven PD-1 inhibitor. Results from a Phase 1 two trial of 3112 as a single agent treatment in 22, HPV-positive head and neck squamous cell carcinoma patients demonstrated T cell responses and infiltration of CD8 positive T cells into the tumors.
In early '23 updated results were also published from a different phase one two trial of 3112 in combination with AstraZeneca's PD-L1 checkpoint inhibitor development showing an overall response rate of 28%, which was comprised of four complete responses and four partial responses in 29 evaluable patients. This was accompanied once again by increased peripheral HPV specific T cells and tumor of CD8-positive T cells.
The efficacy of this combination of 3112 with development resulted in a median overall survival of more than 29 months. This compares favorably to immune checkpoint blockade therapy alone, which reports median overall survival of approximately 12 months. This combined data set provides compelling evidence to support our belief in the potential of INO 31, 12 unlock 2C.
I will now turn the call over to Mark to provide an update on our commercialization efforts for I&S 31st, oh seven. Mark?
Mark Twyman
Thanks, Mike. Hello, everyone. I'm pleased to share that our commercial efforts for INO. 3107 are well underway as we continue to prepare for potential 2025 launch. While there's still much work to be done. I'm confident in our commercial launch strategy for several important reasons. First, we have made understanding patients and their experience is a top priority in every step of the way to continue building on our understanding of the market.
We held an advisory board pay October of last year with adult patients suffering from ROP, and they shared their journeys from diagnosis to treatment and provided invaluable insights into the unmet needs of the RP patient community. At large, we have also conducted other advisory boards with health care provider specializing in the treatment of RRP and with caregivers of juvenile patients.
Next, we understand that mapping the physician landscape will be critical to our commercial success. To this end, we have initiated a very comprehensive market analysis of physicians that treat RP that will allow us to focus field and to allow us to focus field deployment and make smart investment decisions. We also have an experienced commercial team that is well-versed in every aspect of the commercialization process for innovative products, particularly for rare diseases.
Our collective expertise in putting the plans in essential systems in place for a successful launch has been essential to our progress thus far and will help ensure that we stay on track moving forward. And perhaps most importantly, we believe that INO-3107 offers potential compelling clinical and commercial advantages that will serve as an important foundation through our commercial efforts.
As you can see here, the FDA has advised that we can use the data from our completed Phase one two trial submitted BLA under the accelerated approval program in the trial. I know 3107 was immunogenic and generally well-tolerated in over 80% of patients across the disease. Severity continuum had a reduction in the number of surgeries compared to the previous year. This data was key in supporting our application for subsequent receipt of breakthrough therapy designation from the FDA.
From a commercial standpoint, I know 3107 offers several key differentiators. It targets and has shown similar efficacy across both HPV six and HPV 11, which cause RP patients in our trial had a range of two to eight surgeries in the prior year, with efficacy demonstrated across the range of disease severity. I know 3107 also offers important attributes typical of our DNA medicines platform, including the potential for redosing and stability for up to three years at refrigerator temperatures administration with Selectra, our proprietary electroporation device was well tolerated by patients was easy to use for health care providers in the Phase 1 two trial, consistent with issues in other trials.
Also important for the commercialization of IN. 3107 was our well-defined commercial scale manufacturing process as well as orphan drug orphan drug designations in both the US and EU, which offer the potential commercial incentives and regulatory mechanisms in those markets. I'll now turn the call back to our CEO, Jacqui Shea, some additional pipeline update. Jackie?
Jacqueline Shea
Thank you, Mark. Michael highlighted the important progress we've made with baseline of 3107 and I know at 3112 and we are focusing the majority of our internal resources on advancing those candidates. However, we have several other late-stage clinical-stage assets and next-generation candidates that we plan to advance through partnerships and collaborations across industry, academia and governmental agencies.
I'd like to provide a brief update on each of them earlier, I mentioned the encouraging results we announced in early 2023 from our Phase Ib clinical trial of 4201 as a parallel vaccine booster candidate. More recently, we received feedback from the FDA and identified a potential development pathway and are now in discussions with collaborators and potential partners to define mix that I don't know, 5401 has two common disease targets for glioblastoma.
We're in discussions with our partner, Regeneron and investigators about next steps and our goal is to have a finalized plan in the first half of 2024. Second target is to prevent cancer or reoccurrence of cancer and other cancer or non-cancer patients with Bracco one or two mutations. A Phase 1b study is being conducted by the University of Pennsylvania, and we look forward to updates as they become available.
Our partner Apollo buyer is also conducting a Phase three trial of VGX-3100 as a therapeutic treatment in cervical, each cell caused by HPB. 16 and 18, a Phase two trial sponsored by the AIDS Malignancy Consortium is also underway, evaluating VGX-3100 and HIV positive participants with NOH still caused by HPV 16 and 18. And there was also exciting work advancing next-generation DNA medicine technology, including a trial with our collaborators at the Woodstock Institute, evaluating DNA launch nanoparticles or TLMP.s. Lnps are designed to provide high maintain levels of antibody responses, including neutralizing antibodies while continuing to generate T cell responses.
First D. and MP. to enter clinical trials. I know 61 72 is a preventative HIV vaccine candidate in a Phase one trial sponsored and funded by NIH, and finally, Western partners from AstraZeneca, the University of Pennsylvania and Indiana University, and leading a Phase one trial using our DNA encoded monoclonal antibody or Dmab technology to develop T-MAP space, therapeutic and preventative treatments for COVID-19. We're excited about what the future holds for these innovative technologies and look forward to sharing more in the year ahead.
I'll now turn the call over to our CFO, Peter keys for our fourth quarter and full year 2023 financial summary data.
Peter Kies
Thank you, Jackie. Today, I'd like to provide an overview of Inovio's operational highlights and financial condition for the fourth quarter and full year of 2023. As Jackie, Mike, and Mark have noted, we have made significant progress across our pipeline over the past year, advancing key candidates while working successfully to reduce our operational spend after our pipeline reprioritization.
As you can see from this slide, we have again reduced our total operating spend, dropping from $56.1 million in the fourth quarter of 2022 to $27.5 million in the fourth quarter of 2023, a 51% decrease. Our full year operating expenses were also nearly cut in half from $277.8 million for 2022 to $144.8 million for 2023.
Breaking down operating expenses a bit more. Our R&D expenses in the fourth quarter of 2023 totaled $17.3 million compared to $42.1 million for the same period in 2022. Our full year R&D expenses for 2023 were $86.7 million compared to $187.7 million for the same period in 2022. The year-over-year decrease in R&D expenses was primarily the result of lower drug manufacturing, clinical trial expenses, outside services, and expensed inventory related to INO. 48 hundred and other COVID-19 studies and lower employee and consulting compensation, including stock-based compensation among other variances.
G&A expenses for the fourth quarter 2023 were $10.2 million compared to $14 million for the same period in 2022. G&A expenses for the full year of 2023 were $47.6 million compared to $90.2 million for the same period in 2022. Revenues for the fourth quarter of 2023 were $103,000 compared to $125,000 for the same period in 2022.
Revenues for the full year of 2023 were $832,000 compared to $10.3 million for the same period in 2022. Note that revenues reported for 2022 was associated with a procurement contract with the US Department of Defense for Inovio's devices and accessories to be used for the delivery of INO-4800 our COVID vaccine candidate, which we have since discontinued. These factors combined to bring our net loss for the fourth quarter of 2023 to $25 million or $1.10 per share basic and dilutive. And our net loss for the full year 2023 to $135.1 million or $6.9 per share, basic and diluted.
We finished the fourth quarter of 2023 with $145.3 million in cash, cash equivalents, and short-term investments compared to $253 million as of December 31, 2022. INOVIO estimates as cash runway to extend into the second quarter of 2025. This projection includes an operational net cash burn estimate of approximately $26 million for the first quarter of 2024. This amount excludes repayment of $17 million in remaining principal and accrued interest on coupon convertible senior notes that matured on March 1, 2024.
Including the repayment, the total net cash burn for the first quarter of 2024 is expected to be approximately $43 million. These cash runway projections do not include any funds that may be raised through an at-the-market 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-K filed with the SEC. And with that, I'll turn it back over to Jackie.
Jacqueline Shea
Thanks, Peter. I'd now like to open up the call to answer any questions you might have. Operator?
Question and Answer Session
Operator
(Operator Instructions) Hartaj Singh with Oppenheimer.
Hartaj Singh
Great. Thank you and thanks for the questions. I guess I have a couple actually, if you don't mind on. One is I know the confirmatory trial has been in discussion with the FDA for a little bit. In fact, I believe you're going to start that sometime last year, early this year. And then the FDA kind of guarantee that accelerated approval process. Can you maybe just give us some color on what that looks like and especially how long would it take to recruit on the valuation period?
And lastly, when I could read out and again, we're not looking for any guidance up. And then secondly, you know, Tom, we've talked a lot of KOLs about this therapy therapy. They think it should broadly apply to a lot of patients. And there's academics literature that suggests that some cost of surgery $70,000 to $100,000 per patient per year, but it adds up over time, just how you're thinking of pricing comps. So just any color there or any thoughts that get back to the question.
Jacqueline Shea
Good afternoon. To those. Those those are great questions. So I think we covered in the call in a BTD. multidisciplinary meeting that we held with the FDA just before Christmas. We got guidance on a number of different elements that needed to go into our BLA submission. And then and part of that was getting some further guidance on the design of that confirmatory trial. So I'm going to hand over to Mike to provide a bit more detail there. And then perhaps, Mark, you can talk about some of the comparators and thoughts on placing the mix.
Michael Sumner
Yes, thanks, Jackie, and hi, Hartaj with respect to the confirmatory trial. I think we're in the final stages with discussing the details with the agency. So I'm hoping we will soon be in a position to reveal the sort of details around our design and future strategy. And you also asked about sort of recruitment and readouts. And until we get the final on the sample size, it's difficult to totally predict how long it's going to take. But what I what I can say is we included eight clinical trial sites in our original Phase 1/2 study, and we're certainly going to go broader than that for a confirmatory study.
And I think we've talked consistently about the patient need and and their openness to receive treatment for a nonsurgical option. So I'm really hoping that we'll be able to recruit the subjects pretty quickly. And again, with respect to readout, that's really going to depend on what the final final design and settle on length of observation that we're going to need to include. But hopefully next quarterly call, I'll be up to provide some more color around that Thanks, Mike.
Jacqueline Shea
Thanks Mike, and Mark on the price.
Mark Twyman
Hey, Hartaj, good to talk to you. So I'm I think what we've said previously is that RRP is a rare disease and we would anticipate being a rare disease pricing for this asset. I think with that said, though, there are a number of rare disease analogs, some of which also are positioned as alternatives to surgery. But we're assessing as a part of the pricing work that we're doing. And I would say that as we get closer to launch, we'll be in a better position to say more about that.
Hartaj Singh
I'm not sure if I go if I can. I have a quick follow-up on just that. I mean, will you be publishing pharmaco-economic data also as you get closer to launching or maybe after that on one 3107. And thanks for the question.
Mark Twyman
I think I'm Hartaj. I'm going to direct that question to Mike. Mike, would you like to respond to that?
Michael Sumner
Is that may I mean, we we obviously didn't include too many quality of life for our impact on the patients in our Phase one two study. I mean, we will we are certainly in the process of assessing how we can document the impact to net of RP. on patients. And we will most likely include more measures Pro prospectively in our confirmatory study. So again, we will have I mean, obviously, we will aim to and we have supporting evidence for the price that we eventually set.
Hartaj Singh
Thank you, all.
Operator
Roy Buchanan with Citizens.
Roy Buchanan
Hey, great. I guess maybe just sticking 3107 for a second. Then I have a few others, but I'll just when you say commercial scale manufacturing, how many patients do you think you can address in 2025? If you can address the entire population or just what are you thinking for initial penetration?
Jacqueline Shea
So Mark, do you want to take them?
Mark Twyman
I'm sure I'll take a whack at that. And if there's some additional comments, feel free to add.
I guess the way I'd respond to that question is we've, as you would expect, we've done sort of a lot of modeling and we've been working closely with our with our manufacturing team. And so we're confident that sort of based on our market projections and our estimates around the adoption, et cetera, et cetera, that we'll be able to sort of fully meet the demand for for 3107?
Jacqueline Shea
Yes. I mean, if I can just add on the manufacturing side, you know, we had already got to commercial scale up some other product candidates. And you know, this is a rare disease in terms of dose requirements. The actual numbers of dose requirements is very manageable for us from a manufacturing standpoint. So I think we're pretty well positioned from a manufacturing standpoint to be able to build up the launch inventory and be able to support the market need as the first couple of years pretty easily.
Michael Sumner
Sorry, perfect. Switching to the pipeline deeper pipeline and then I guess for 3112 on 18, you could tell us about the design that you submitted for that Phase 3, do you expect that it can be registrational by itself?
And then the last slide deck, you had eight additional clinical stage candidates. Can you just help us understand a bit what I guess, level of development you can do for those candidates given the runway into into 2Q 25?
I guess what does that runway assume in terms of what you can develop out of that pipeline beyond 3107 makes us great fits.
Jacqueline Shea
And Mike, why don't you take the 31, 12 Phase three design and what we're thinking down now than I can talk about the rest of the pipeline candidates.
Michael Sumner
Yes. Thank you. And so we as you heard in the call today, we clearly sort of articulated the patient population that we're going after high-risk patients with local regionally advanced disease and high risk really comes down to based on tumor size, local infiltration, local node involvement and also smoking history. And so I think we did a lot of work with KOLs on a global basis to define that population I mean, as we think of developing this candidate, I mean, based on the well-known safety profile of PD-1 inhibitors and also the well documented safety profile of our DNA medicines, we certainly feel we can do a registration study.
Obviously, that will ultimately be decided by the agency. And as we as we look to that design, we followed sort of very traditional ways. I mean, obviously, the agency is going to want to understand contribution of components. So that is clearly an element of the design we submitted to the agency. And so we're really waiting to have that discussion with them in quarter two to determine what our actual pathway, what really looks like.
Jacqueline Shea
Thanks, Mike. And just to talk about the rest of the pipeline. As I mentioned on the call, clearly, we're focusing the majority of our internal resources on advancing 3107 before its license here and then the launch hopefully next year and then moving 30 month, 12 forward. And we do have a number of partnerships in place, the other assets in our pipeline, and we're going to be leveraging those partnerships nondilutive funding mechanisms, grants, et cetera, to be able to help move those candidates forward. And some of the earlier stage work, particularly the preclinical work, we can also move forward ourselves so we think we have ways leveraging those partnerships, nondilutive funding mechanisms of moving those candidates forward to to generate some meaningful progress slow.
Roy Buchanan
Yes. Thanks for taking the questions.
Operator
Gregory Renza, RBC Capital Markets.
Hi, guys. It's Nishant on for Greg. Thanks for taking my questions. Just a couple from me firstly on 31, oh seven and RP., just on thinking about thinking ahead to market shaping, what sort of the pushback you've gotten to date when engaging KOLs on getting patients onto therapy like 3107 versus standard of care surgery? And how is that feedback been built into your awareness and education directives?
And secondly, a question on 3112. If you could just walk us through how the collaboration with Coherus came to be the selection of luck towards the as a combination candidate among other potential potential candidates and how you can best leverage the partnership going forward. Thanks again.
Jacqueline Shea
Thanks, finish. The really great candidates and to ask Mark to comment on how we're thinking about 3107.And Mike, maybe you'd like to comment on some of the clinical aspects, the efficiency argument and
Mark Twyman
yes, that's the first thing I would say from a commercial perspective, I've never been more excited about launching new products. And I think it speaks to specific that I'm going to address your question. And we've conducted multiple advisory boards with both HCPs that are treating RP. as well as sort of patients. We've been closely aligned with listening to what the RP. Foundation suggests is important for probably the last three or four years.
And one of the things that we've heard is that physicians don't like doing the surgery, right? They're looking for an alternative to surgery, as Mike has alluded to, I mean, surgery doesn't address the underlying infection, but is in this cycle of surgical procedure after surgical procedure. And it's actually the surgery that's driving that morbidity. So they're looking for an option right.
And this is sort of unlike other launches where you're replacing a surgical alternative in that physicians are welcoming it, but there's no disincentive for them to use a service. I know 3107 because the current standard of care is wholly inadequate. And similarly from a from a patient perspective, and as Mike mentioned, it's a devastating disease and even with the reduction of sort of one surgery a year can be life-changing for them. So I'm really, really confident that everything that we've learned about this marketplace, pretends that on we're going to have a really successful launch with 3107.
Jacqueline Shea
Thanks, Mark. And Mike, do you want to talk about some of those clinical aspects and the need that the patients and the physicians are highlighting.
Michael Sumner
Yes, absolutely. So I mean, as you heard me talk about today, I mean, the latest data that was published by a sudden best from John Hopkins around the ability to cause permanent vocal cord damaging is really in the mind of all the sort of RRP surgeons we've spoken to. They recognize that while surgery is hugely beneficial for the patients. They they understand that sooner or later they there is going to be damage caused. And so from a surgical perspective, as Mark said, they really would they just as excited as the patients, I think for looking for a nonsurgical treatment for these patients.
And I keep going back to sort of having discussions with Kim MacLellan, it really is there every surgery just impacts a patient's life. And so you saw on the graph I showed earlier, the tremendous impact we've had on reducing surgical burden in the RRP. population. And so I once again, I really feel you you you see that clinical efficacy and you associate it with that safety data we have accomplished or accumulated on 3107 to date, there really isn't any reason that we've heard from the patients of why they they wouldn't want a nonsurgical option. So we're very excited to move this program forward.
Mark Twyman
I can add one other point real quick. What other sort of really important dimension of the patient component of this market is that unlike in other rare diseases. And when I was at Genzyme, this was the case here. We spend a lot of effort identifying patients, right and getting them to originate for therapy means that won't be the case with RPM. And these are patient two who originate for treatment. And the primary primary reason is because the the impact on voice quality, right? So again, the combination of patients who originate for treatment for RRP, the fact that surgery is inadequate and burden and causes a lot of morbidity and that physicians are looking for alternatives. It really puts us in a good position with 3107,
Jacqueline Shea
And I think those are excellent points, Mark. So moving on to 3112. So I think maybe if we just take a step back here for 3112. We saw really encouraging data both as a monotherapy and in combination with durvalumab and and you know, Bob, we were disappointed that AstraZeneca decided not to move and the map forward in the head and neck space. We were very excited by what we saw in that study, and it really goes back to one of the strengths of the platform, our ability to generate these antigen specific cytotoxic CD8 T cells that we know we're capable of getting to the tumor. And we know we announced some of our other HPV. displays.
Your programs are capable of clearing HPV. precancerous lesions and leading to viral clearance. And so when we we wanted to move 31, 12 forward. We saw a lot of promise for 3112 and we really conducted quite extensive analysis looking for the right and PD-1 to using combination and might maybe now the point where you might want to jump in and talk about some of the reasons why we're so excited about look towards it.
Michael Sumner
No, absolutely. I mean, conducting any clinical partnership. I mean, the first of all is finding a partner that's just too excited about the program as you are and the fact that look towards the new works with a lot of the same KOLs that will hopefully eventually prescribed 3112.
Yes, it gives them a unique insight into seeing the value of what we see with 3112 and look towards the home and so in as a partner there, they are great to work with. They share the enthusiasm for the program, having a very recent approval for with Mazor fairing GEO carcinoma, I think is they want to also see the use of lactose expand. And so so far, everything every interaction we've had with Coherus has been very positive. They bring knowledge of the head and neck space to the table as well. And so we're just really very encouraged to continue with that partnership and perform the clinical trial.
Thanks.
Operator
Roger Song, Jefferies.
Roger Song
Please go ahead and good afternoon. Basically on channel for Roger and thank you for taking our questions. So I guess from us, we arm. So regarding to the confirmatory study of 3107, could you comment on how you're thinking about kind of a care package them on the different sites, how do you see that impacting study results? And how at this point, what sort of what's the powering assumptions that you are thinking about for the confirmatory study? Thank you.
Jacqueline Shea
Yes, but Mike, can you take that one?
Michael Sumner
Absolutely. And thanks, Roger. So we can't yet obviously talk about the sample size element. So I can certainly address the clinical trial site elements. When we in our Phase one two study, we actually had eight recruiting sites and the results. And Phil, while we only had 32 subjects in the Phase one two study. We didn't we didn't analysis.
There was certainly no site-to-site variation. So we believe the results will be very consistent. And as we look to utilize more sites in our confirmatory study so that that is certainly not a concern for us. And obviously, as we look to on sites using the five PSP. device, we have a lot of experience from a previous Phase three program with 3,100. So again, that isn't of any concern to us.
Jacqueline Shea
And Mike, maybe I can add in here, you know, in addition to working with eight sites, we also enrolled patients across the disease spectrum, and we also know patients with both HPV. six and HPP. 11 so I think you know, in our Phase one two study, we built up a good understanding of that variability within that patient population.
Michael Sumner
Yes, absolutely.
Roger Song
Thank you. Maybe another question if I may still regarding the 30 well, seven Phase one two data, I know one key difference from the previous studies that you included the 30th right after, including through the treatment window. So and maybe could you remind us what do you see if you do not only include surgeries after that after the treatment window?
Jacqueline Shea
Yes, that's a great question. I mean, we designed this trial because every surgery matters to the patients in that spot. We've heard time after time from the patients every surgery matters. Mike, do you want to talk about the data because I'm not sure if we've disclosed that yet, if it's published.
Michael Sumner
No, we haven't provided any details of that. And I think also if we were going to do a like-to-like comparison. We don't obviously want to include a full 52 weeks after excluding any surgeries from the surgical window. So I mean, do we will be looking at collecting that data. So but that's not going to be available in the short term.
Roger Song
Got it. Thank you. That's it from us.
Operator
(Operator Instructions) Yi Chen, H.C. Wainwright.
Yi Chen
Thank you for taking my questions. Could you comment on the typical age range of the RP patients or what percentage of patient population actually are on Medicare and how much time do you think it would take to secure Medicare reimbursement following potential FDA approval in 2025?
Jacqueline Shea
Great question that Mike, do you want to talk about the age range. And then Mark, I think we'll take the Medicare question.
Michael Sumner
It absolutely. So RRP in bowls, all age age groups, and there's actually sort of three peaks to the instant. So the first one is the pediatric peak, which usually is around the sort of 5 to 7 year old mark. Then there is a earlier adult on peak, which obviously follows sexual activity onset, and that's usually around the age of 35. And now what is also developed is a later onset peak, which is usually around the age of 65. So it really encompasses all age groups, but the vast majority is still actually not the vast majority. The majority is still around the 35 age group with the elderly population growing rapidly It's Mark and Mark, thanks for the thanks for the question is really the question from.
Mark Twyman
I think what I've said earlier in my comments is that sort of focus and precision is going to be key for our success in consistent with that, particularly as it pertains to kind of what the best mix is for these patients private versus versus Medicare Medicaid we're going to get a lot of additional information there. And from this work that I mentioned earlier, not only are we going to be assessing sort of the physician landscape, but the analysis all starts from the patient level, and we'll be able to sort of identify and where claims are being adjudicated, whether it's been adjudicated in the private sector or in the in Medicare or Medicaid.
And that are really kind of help us focus our efforts on both the commercial payers that are important, but also to help us understand what our approach needs to be from the perspective of Medicare and Medicaid. There are really kind of three pillars that we're super focusing on for for commercial launch on distribution and then the market access piece as well as field deployment. So we're moving as fast as we can. I can't give you a specific time line for when only to say that we started early with the objective of making sure that patients both private and in Medicare Medicaid have access to either 31 to seven as quickly as possible.
Yi Chen
Thank you. Could you comment on the regulatory pathway going forward in the European Union?
Michael Sumner
I think so we have obviously engaged with the European Union. Some we have not yet disclosed what their strategy is going to be with with Europe. I certainly believe there's a pathway forward based on the information we have received, and I think we'll be able to give more details in upcoming calls.
Yi Chen
Okay. Thank you.
Jacqueline Shea
Yes, if I can just add to Mike's comments about universal ROP. Unfortunately, if I take the PPS, it's everywhere, there is a strong, an unmet medical need as well in Europe, that is the standard of care may differ slightly from the U.S. So that's also an important consideration to take into account, but we'll certainly be trying to provide some more details on that as our discussions with the European regulators progress.
Yi Chen
Okay. Thank you.
Operator
Ladies and gentlemen, there are no further questions at this time. I'll now turn the call back over to Jackie Shea, President and CEO for closing remarks.
Jacqueline Shea
Please go ahead and here by open this call by highlighting the transformation Inovio has undergone over the last year, a transformation made possible by our renewed strength, take focus on the strengths of our DNA medicines platform and our aim to become a commercial stage company. We've made more than just progress we have built a foundation for long-term success that we will continue to build on. And we have advance DNA medicines to patients around the world that could potentially benefit from its promise. I look forward to sharing more updates on progress with you in the year ahead.
With that, thank you again for your attention and have a great evening, everyone.
Operator
Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.
