Inovio Pharmaceuticals Q1 2023 Earnings Call Transcript

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Provided by Quartr
May 10, 2023

There are 7 speakers on the call.

Operator

Good day, and welcome to the Inovio First Quarter 2023 Financial Results Conference Call. All participants will be in a listen only mode for the duration of the call. After today's presentation, there will be an opportunity to ask questions. Please also note that this event is being recorded today. I would now like to turn the conference over to Thomas Hong, Manager of Investor Relations.

Operator

Please go ahead.

Speaker 1

Good afternoon, and thank you for joining the Inovio 2023 First Quarter Conference Call. Joining me on today's call are Doctor. Jackie Hsieh, President and CEO Doctor. Michael Sumner, Chief Medical Officer and Mr. Peter Keyes, Chief Financial Officer.

Speaker 1

We also have other members of Inovio's leadership here with us today, who will be part of our Q and A session. Today's call will review our corporate and financial information for the quarter ended March 31, 2023, as well as provide a development progress update for our DNA Medicines platform. 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.

Speaker 1

All of these statements are based on the beliefs and expectations of management as of today. 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.inovio.com, and a replay will be made available shortly after this call is concluded. I will now turn the call over to Innovia's President and CEO, Doctor.

Speaker 1

Jackie Hsieh.

Speaker 2

Good afternoon, and thank you to everyone for joining today's call. In the Q1 of 2023, we made Solid progress with several key pipeline candidates. Notably, we made important headway in the development of INO-three thousand one hundred and seven, our product candidate for recurrent respiratory papillomatosis or RRP. Our Chief Medical Doctor. Mike Sumner will provide more detail about our overall progress for this product candidate.

Speaker 2

But in short, Since our last investor call, we received the initial feedback from the FDA on our proposed Phase 3 plans, leading us to believe we have an achievable framework for a Phase 3 trial for INO-three thousand one hundred and seven. We also announced that the European Committee for Orphan Medicinal Products issued a positive opinion on our application for orphan drug designation for INO-three thousand one hundred and seven with the European Commission's final decision expected in May. These regulatory developments come on the heels of positive data from the 2nd cohort of our Phase onetwo trial for INO-three thousand one hundred and seven shared in February And additional combined data on the safety and immunogenicity of INO-three thousand one hundred and seven that was presented by lead investigator, Doctor. Ted Mao at ABEA, a Premier ENT meeting in Boston just last week. This data shows that INO-three thousand one hundred and seven has the ability to elicit a robust immune response and has the potential to provide clinical benefit to patients who otherwise face a lifetime of disruptive surgeries.

Speaker 2

The data presented was accepted for publication by the laryngoscope, one of the key journals read by physicians who care for RRP patients in April. In the Q1, we also announced encouraging data from our Phase 1 trial with INO-four thousand 2 zero one as an Ebola booster for AVEVO, which not only showed the potential of INO-four thousand two hundred and one as an important tool and extending protection against the Ebola virus, but also demonstrated the versatility of our platform and the ability of DNA medicines Additional safety and immunological data shared last month by lead investigator, Doctor. Angela Huttner at the 33rd European Congress of Clinical Microbiology and Infectious Diseases or ECCMID provided more insight on the potential ability of INO-four thousand two hundred and one to generate robust immune responses and extend protection against Ebola. Mike will also share more details on that data. On our last earnings call in March, we announced top line results for REVEAL 2, the 2nd Phase 3 trial for VGX-three thousand one hundred as a treatment for cervical high grade squamous intraepithelial lesions or cervical H sill.

Speaker 2

As we shared at that time, the trial results did not meet the primary endpoint in the biomarker selected population, but did show statistical significance in the all comers population. Since then, we've continued to analyze the data to better understand the biomarker population. Our goal is to share the results of this analysis with you in the We continue to believe that the data from REVEAL 2, which showed VGX-three thousand one hundred's ability Promote Viral Clearance highlights this drug candidate's potential to address the underlying cause of the disease, the HPV virus, which could make it an effective treatment option for additional indications, particularly anal H sill. On INO-five thousand four hundred and one, our collaboration with Regeneron continues and as we wrap up the Phase 2 study for this product candidate in glioblastoma. We still have patients on study that we are continuing to provide drug for, and we are evaluating next steps for this candidate, which we believe is worthy of further evaluation.

Speaker 2

While we've been making headway on the clinical front, we've also been able to maintain our financial position as we continue to expect our cash runway to take us into the Q1 of 2025. We will continue to ensure our strategic focus and financial discipline as we work to build on our important progress to date. An essential part of our strategy is ensuring that we have the resources and talent in place to advance our product candidates quickly and efficiently. This quarter, we welcome Doctor. Cheryl Elder, Senior Vice President of Regulatory Affairs to Inovio.

Speaker 2

She joins a seasoned product development team to oversee regulatory strategy And company interaction with global regulatory authorities. With over 30 years of experience leading cross functional teams In drug development in multiple therapeutic areas, Doctor. Elder has a successful track record of driving regulatory strategies within both small and multinational biotechnology companies, including Houghton La Roche and most recently Novartis Pharmaceuticals. I am confident we will benefit from her expertise as we seek to implement efficient regulatory strategies for key candidates across our pipeline. With that, I'd like to turn it over to our Chief Medical Officer, Doctor.

Speaker 2

Mike Sumner to provide some important clinical highlights. Mike? Thank you

Speaker 3

very much, Jackie, and greetings, everyone. I'd like to start today with INO-three thousand one hundred and seven, our product candidate for RRP and the development progress we've made since our last quarterly call. As Jackie alluded to, one of the most important developments for this project has been the productive interactions we've had so far with the FDA, which have helped shape the design for our Phase 3 trial. One of the challenges of studying the treatment effect of any drug candidate in RRP patients is that the disease can be variable among patients over time, and there are no standardized guidelines for surgical intervention. With these parameters in mind, we are preparing to conduct a randomized Placebo Controlled Phase 3 trial.

Speaker 3

We believe this trial format reflects the constructive feedback we received from the FDA and provides a clearer path forward to assess both the safety and efficacy of INO-three thousand one hundred and seven. We still have some additional trial details to work out with the agency before we can officially start our Phase III trial, including related to our CELEKRA 5 PSP delivery device, which we are working to address. As a reminder, this device was previously successfully Fully used in 2 Phase 3 trials, REVEAL 1 and REVEAL 2. As we address these details, we have moved forward with engaging a clinical Research organization and are actively identifying global sites as we continue to make the appropriate preparations to conduct this important Meanwhile, I'm pleased to report that we've shared the full results from our Phase onetwo trial at different scientific and medical conferences over the last several weeks, including having our lead investigator, Doctor. Ted Miao present at the ABEA program at COSM in Boston last Friday.

Speaker 3

Doctor. Mao's presentation included more detailed safety, immunological and demographic data, which I would like to share with you today. This slide shows at a glance the impact 3,107 had on the number of surgeries for the patients who were involved in our trial. I'm really pleased to summarize that 26 out of 32 patients or 81% experienced a decrease in surgical interventions in the year after treatment commenced versus the prior year, including 9% or 28% of Patients that required no surgical intervention during that year. Patients experienced a median decrease of 3 surgeries in the year following treatment in comparison to the year prior to baseline.

Speaker 3

As a reminder, any surgery performed following day 0, including during the dosing window was counted against the efficacy endpoint. As a reminder, RRP patients as well as their physicians and advocates have expressed that a reduction in surgeries is the most important outcome to them and that a reduction of even one surgery is a meaningful difference. In terms of demographics of the patients involved in the trial, The median age was 47 years with an age range of 25 to 82. The median number of surgeries and the year prior to dosing was 4 with a range of 2 to 8. This slide shows 3,107's Overall safety profile.

Speaker 3

An important hallmark of DNA medicines in general is favorable tolerability and safety. And IMO-three thousand one hundred and seven behaved as expected on that front in our Phase III trial. You can see here the most frequently reported Treatment emergent adverse events being related to administration either injection site pain or procedural pain. Treatment emergent AEs observed in the trial were generally low grade, most of which were Grade 1. All of the 32 patients experienced a Grade 3 treatment emergent AE, but none were deemed related to INO-three thousand one hundred and seven.

Speaker 3

2 serious adverse events were reported during the trial, but again, both were deemed unrelated to 3,107. There were no treatment emergent AEs leading to treatment discontinuation and all subjects who participated in the trial received all four treatments. Next, I'd like to highlight data from the staging assessment scores. Staging assessment Scores include both a subjective functional assessment of clinical parameters as well as an anatomic assessment of disease distribution, essentially assessing total disease burden. The combination of the scores measures an individual's clinical course and response to the therapy over time.

Speaker 3

There is also data supporting that the anatomic burden of RRP as assessed by the RRP staging system correlates well with voice related quality of life for the patients, which is the most frequently reported symptom in adult patients. As you can see on the slide, there were improvements in the total assessment score based on the combined data for all the patients in the trial. As a reminder of what that actually looks like for a patient, I'd like to share a slide we Clinical benefit of INO-three thousand one hundred and seven and how it could potentially provide patients suffering from this terrible disease relief. Next, I'd like to share some highlights on the cellular and immune response we saw in this trial. Treatment induced cellular responses against Both HPV-six and 11 inducing both activated CD4 and activated lytic CD8 T cells.

Speaker 3

We believe this type of cytotoxic CD8 T cell response may be important in clearing HPV infected cells. T cell responses were also observed at week 52, which was 43 weeks after final treatment with INO-three thousand one hundred and seven, indicating a persistent cellular memory response. Additional analyses are also ongoing to determine a possible relationship between specific CD4 and CD8 phenotypes and clinical outcomes. This will be important as we look at ways to further improve In summary, I'd like to highlight the conclusions Doctor. Mao made during his presentation.

Speaker 3

Investigators noted that the data suggests that INO-three thousand one hundred and seven administered with intramuscular Electroporation was well tolerated with a favorable safety profile. In addition, it also appears to provide clinical benefit to adult patients with RRP and together supports further investigation of INO-three thousand one hundred and seven in a Phase 3 trial. Moving to the next slide, we recently received a positive opinion from the European Committee for Orphan Medicinal Products on our application for orphan drug designation for 3,107. The European Commission will now review that opinion and make their final decision, which is expected later this month. Orphan designation In the EU, we would provide Inovio important benefits such as reduced fees for regulatory activities and 10 years of protection from market competition once approved.

Speaker 3

Furthermore, we recognize The considerable burden RRP places on the pediatric population and believe 3,107 could also provide clinical benefit to these patients. We therefore plan to move forward in both the U. S. And the European Union with a proposal of how to approach pediatric development. At the recent International Papillomavirus Conference in Washington, D.

Speaker 3

C. That I attended, I was once again reminded of the considerable impact RRP has on patients and their caregivers' lives. As an organization, we are keeping that in mind every single day as we work to move INO-three thousand one hundred and to provide some updates on VGX-three thousand one hundred, our product candidate focusing on high grade squamous epithelial lesions or H Cell. On our last earnings call, we announced results from our REVEAL 2 study, which was conducted in patients with cervical H Cell. At that time, we shared that the trial did not achieve statistical significance in the biomarker positive population.

Speaker 3

However, the study did achieve statistical significance in the all comers population. Looking across the totality of data we've collected for 3,100 in HPV related diseases. We remain encouraged by the viral clearance data in various studies, including REVEAL 2 where we saw viral clearance of 37% in the treated group versus 9% in the placebo group. To get a better handle on the biomarker data, we have been analyzing the results, highlighting 2 main areas. Firstly, a determination of why some biomarker positive subjects did not respond to treatment with a focus of looking at clinical Characteristics such as stage of disease, infection with other HPV types, clinical site location, Secondly, we are looking to understand why some patients who exhibited a clinical response We're not biomarker positive.

Speaker 3

For this, we plan to investigate the microRNA dataset in more detail. We expect to be able to provide you further insights into this analysis in the Q3 of 'twenty three. This biomarker analysis is vital from a competitive standpoint as VGX-three thousand one hundred must compete with LEAP or the LOOP electrosurgical excisim procedure, a well established standard of care in the U. S. For cervical HIL.

Speaker 3

Being able to demonstrate a similar risk benefit profile is going to be important in future regulatory discussions for that indication. PTX-three thousand one hundred has however also been studied in other indications, including AMOLH Cell. As a reminder, in December 2020, we announced results of our open label single arm Phase 2 trial for anal HIL In which we saw that 50% or 11 out of 22 participants had no evidence of HPV-sixteen eighteen positive HCL at week 36. In addition, Inovio is supporting an ongoing externally sponsored run study by the AIDS Malignancy Consortium examining the potential of 3,100 in HIV positive individuals with anal H Cell. Anal ageLOC is mostly caused by HPV 1618 infections and if left untreated may progress to anal cancer.

Speaker 3

HPV is detected in over 91% of anal cancers and HPV-sixteen eighteen account for approximately 80% of HPV genotypes detected. In the U. S. Alone, Estimates of HPV-sixteen eighteen related anal HCL prevalence range from 210,000 to 1,100,000 with similar prevalence figures estimated in the European Union. While watchful waiting has historically been a common clinical practice for analatil, greater attention is now being paid to proactive Recent results from the NIH and NCI funded anal cancer HCL Outcomes Research or ANCHOR study in HIV positive patients showed the treatment of anal HIL is superior in the prevention of progression to cancer.

Speaker 3

At present, treatment of this condition is usually surgical. That includes radiofrequency ablation, resections or laser therapy. However, ablation, which is the most common treatment currently, does not clear the underlying HPV infection and recurrence rates are high This leads us to believe anal HIL is a disease with significant unmet need that could potentially be met with a therapeutic candidate like VGX-three thousand one hundred. The viral clearance data I mentioned earlier From our 2 Phase 3 cervical HIL studies as well as our Phase 2 data provide additional confidence regarding the potential of 3,100 to treat the underlying cause of the majority of anal H Cell cases. Based on positive feedback from key opinion leaders, we have started discussions with both the FDA and regulators in the European Union to determine the path forward for this indication.

Speaker 3

Now I would like to switch gears to INO-four thousand two hundred and one, a DNA boost The vaccine targeting Zaire Ebola virus. As Jackie mentioned recently, Doctor. Angela Huttner, lead investigator of the Phase 1b trial for INO-four thousand two hundred and one presented new safety and immunological data at the 33rd European Congress of clinical microbiology and infectious diseases. The trial showed that the single dose of INO-four thousand two hundred and one Along with intradermal electroporation was well tolerated and immunogenic compared to placebo in a cohort of healthy volunteers primed with AVEVA. As you can see on this slide, both binding and neutralizing antibody titers Rose significantly after the boost in 100 percent of subjects with binding antibody titers rising Significantly at each time point measured peaking at week 2.

Speaker 3

Likewise, neutralizing antibody titers demonstrated a similar profile. On this next slide, you can see a noteworthy engagement of T cells. Specifically, we observed an increased production of TH1 cytokines looking at interferon gamma IL-twelve TNF alpha from CD4 and CD8 positive Given the increasing attention on the role that cellular immunity may play in protecting against severe disease and its potential for aiding the durability of protection in infectious diseases such as SARS CoV-two. We believe having a strong cellular response profile in addition to the humoral response is a value in a potential booster for Ebola. Finally, memory marker phenotyping suggests the cytokine production was generated predominantly from central memory CD4 T cells and effector memory CD8 plus T cells, most likely indicative of persistent protection against Ebola.

Speaker 3

The data presented suggests that a booster dose of INO-four thousand two hundred and one has the potential to extend protection against the Zaire Ebola strain and could be an important tool in future Ebola virus disease prevention, a threat that does not seem to be waning. As you can see, outbreaks have continued to pop up across the African continent consistently since 1976. And as the past few years have shown, our globalized world only increases the potential for these outbreaks to jump borders. After consultation with external experts, we believe we are now in a position to share our proposed development pathway with regulatory agencies and have set a goal for alignment on next steps by year end. The latest work with 4,201 is an excellent example of the real power of partnerships, spearheaded by GuardRx, Sponsored by Geneva University Hospitals and funded by the U.

Speaker 3

S. Defense Advanced Research Projects Agency or DARPA. This collaboration shows how partnerships can amplify the potential of Inovio's platform, providing opportunities to innovate, explore indications that could improve human health and ultimately advance our DNA medicines. We have several other externally sponsored programs in the pipeline at various stages of development, including the Phase II trial for anal HIL in HIV HIV positive sponsored by the AIDS Malignancy Consortium that I previously mentioned as well as candidates in 2 Phase 1 HIV trials sponsored by the National Institute of Allergy and Infectious Diseases. We also have a DARPA funded collaboration with the Wistar Institute, University of Pennsylvania, Indiana University and AstraZeneca to develop anti SARS CoV-two specific dMAbs or DNA encoded monoclonal antibodies.

Speaker 3

We look forward to sharing updates from our partners as they're made available to us and we'll continue to explore additional partnership opportunities that align with our strategic vision. With that, I'll now turn the call over to our CFO, Peter Keyes, for our Q1 'twenty three financial summary. Peter?

Speaker 4

Thank you, Michael. What I'd like to provide today is an overview of Inovio's financial condition for the Q1 of 2023. As Jackie and Mike have discussed with you here today, Inovio is focused on advancing the most promising candidates in our pipeline as quickly as possible. Part of this effort has included making sure we have enough cash runway to support those research efforts. As you can see on the slide, I've highlighted how our operating expenses have declined over the last year.

Speaker 4

In the Q1 of 2023, our total operating expenses were $44,100,000 which is down 39% from the Q1 in 2022 as well as down 21% from the Q4 of 2022. Breaking down total operating expenses a bit more, we see that research and development expenses for the Q1 of 2023 were $30,200,000 compared to $56,000,000 for the same period in 2022. A reduction a 46% reduction quarter over quarter. The decrease in R and D expenses was primarily the result of lower drug manufacturing, clinical trial expenses And outside services related to INO-four thousand eight hundred as well as lower expenses, Expensed inventory and outside services related to our Selectra 3P SP device and array automation project among other variances. General and administrative expenses for the Q1 of 2023 were 13,900,000 versus $16,000,000 for the same period in 2022, which is a 13% drop.

Speaker 4

The decrease was primarily due to lower non cash stock based compensation, insurance and other outside services offset by higher legal expense. Our revenues for the Q1 of 2023 We're 115,000, which is down from 199,000 in the same period in 2022. These factors combined to bring our net loss for the Q1 of 2023 to $40,600,000 down 49% from 79,100,000 which was our net loss for the prior period, prior year. On a per share basis, both basic and dilutive, our net loss for the Q1 Of 2023 was $0.16 down from $0.36 for the 2022 period. We finished the Q1 of 2023 with $223,800,000 in cash, Cash equivalents and short term investments compared to $253,000,000 as of December 31, 2022.

Speaker 4

Looking forward, we are maintaining our prior projections of our cash runway taking us into the Q1 of 2025. This includes our cash burn estimate for the Q2 of 2023 of approximately 33,000,000 These projections do not include any funds that may be raised through our existing ATM at the market offering 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 ks filed with the SEC. And with that, I'll turn it back over to Jackie.

Speaker 2

Thank you, Peter. I'd now like to open up the call to answer any questions you might have. Operator?

Operator

At this time, we will take our first question, which will come from Greg Renza with RBC Capital Markets. Please go ahead with your question.

Speaker 5

Hi, guys. It's Anish on for Greg. Great to hear about the continued progress this quarter and thanks for taking my questions. Just on 3,107 and the newly presented combined Cohort 1 and Cohort 2 data, how should we be thinking about the degree of heterogeneity between the cohort in terms of baseline characteristics, Just to get a sense of how well they meld together. And maybe secondly, if you have a sense on the data package and its composition that you present to regulators on the path ahead.

Speaker 5

Appreciate your time and thanks again.

Speaker 2

Yes, thanks. Those are really great questions. And before I ask Mike To respond in more detail, I'd just like to say again how encouraged we are by this combined data set and our interactions with the FDA to date. We do believe that we have a workable framework going forward for our Phase 3 clinical trial design and we're very encouraged By the potential INO-three thousand one hundred and seven has, to really be a therapeutic option for patients suffering from RRP. So with that, I'll turn it over to Mike to comment on some

Speaker 3

of the more specific items you asked about. Mike? Yes. Thank you. So starting off with the heterogeneity between the two groups.

Speaker 3

I mean, overall, we felt that the Two cohorts were very similar in terms of baseline characteristics, as well as clinical response and obviously the safety profile was similar So we didn't really feel when we put the data set together that we needed to treat Cohort 1 differently from Cohort 2. And as you saw from a sort of range of surgeries, we saw a range from 2 to 8. And we saw a same decrease, median decrease in surgeries in both cohorts. So we were actually very pleased from that because it's always nice to get a second set of study results that reinforce the primary results that we've seen. So with respect to the data package, obviously, it consisted of the results that we've Talked about to date as well as the full Phase 3 study outline.

Speaker 3

And as you can as I talk to, I mean, the Two main elements that we wanted to address that we knew were of concern to the agency was The variability in disease among patients over time, and really the only way that you can do that is through a randomized placebo controlled trial. And so that's where we ended up, but it was actually where we expected to end up when we started discussions with the agency. Does that answer your question?

Speaker 5

Yes. That was really helpful. Really appreciate the time and congrats on the progress again.

Speaker 3

Thank you.

Operator

Our next question will come from Hartaj Singh with Oppenheimer. Please go ahead with your question.

Speaker 6

Great. Thank you and thanks for the couple of questions. One is just going back to that RFP question, if that was just us. But thinking about the Phase 3, when you so about how many patients are you thinking about the trial Could be. And should we just assume that the patients will have at least those 2 surgical interventions?

Speaker 6

And just give us a sense of the market, if the market by, I mean, the total sort of patient sizing for this, if it's possible. And then I just had one follow-up question in or HS IL after this. Thank you.

Speaker 2

So thanks very much Hartaj. I think that's a great question. So I'm going to ask Mike to take the Phase And then I'll comment a bit about the market size. So Mike? Okay.

Speaker 3

So as we haven't obviously Close the final sample size for the Phase 3 study, but to give you some parameters of sort of how to think about it. At the end of the day, we saw we were not expecting to see a statistically significant result In either cohort, this was a Phase onetwo exploratory study. And I think the fact that we did see that statistical significance just Points to the size of the clinical effect that we're seeing in both those cohorts. So when we actually looked at the Sample size, we could actually get away with probably a way too small a sample size. And so we also realize that you have to balance that with making sure you have an adequate safety database with the agency.

Speaker 3

So if you run the numbers, don't expect it to be the smallest number that you could get away with. But it is Certainly a very manageable sample size for a Phase 3 program.

Speaker 2

Thanks, Mike. And Bartosz, to talk a bit about the potential market size. In the U. S, I think current efficacy figures estimate There may be around 14,000 patients with active RRP, probably a similar number in Europe. As you know, HPV, unfortunately, is everywhere.

Speaker 2

So there are RRP patients globally. I think an estimate from the RRP Foundation a few years back estimated an average cost of treatment for a patient in the U. S. To be at about $72,000 per annum. So as you can see, just by doing the math, that pretty quickly gets to Some pretty big numbers that are being spent currently on RRP treatment.

Speaker 2

We would expect appropriate Rare disease pricing for this, and we believe that there is a significant High unmet medical need that could be addressed by therapeutic options for RRP and as an alternative to surgery. So we think that there is an appropriate market here.

Speaker 6

Yes. No, that's great. Thank you for all the color. And then just on HSIL, I know it's been a while since you presented the data. And how much sort of insight and confidence have you gotten from REVEAL 1, REVEAL 2 In these forms of cancers and the biomarker data, to kind of give you good line of sight into the next step.

Speaker 6

And what would that be? Would that be a Phase 2, strictly a Phase twothree. And so thanks for the question.

Speaker 2

Okay. So again, before I ask Mike to jump in here, perhaps what I can say is whilst these are separate indications, We have been really encouraged by the data that we've seen now for VGX-three thousand one hundred across multiple studies, multiple indications Viral clearance that we've seen and tissue aggression. So we're really encouraged by the totality of The data as a whole also seen very encouraging safety and tolerability profiles across those studies. So Mike, do you want to expand a bit more on sort of what we're thinking around ANALH

Speaker 3

I mean, obviously, we started at the point that Jackie has just talked to. We're seeing very consistent viral clearance of HPV infected cells. And we actually saw very promising results from the AMOLHC Phase 2 results. So While I can't talk to the specifics of the program we've put in, we do believe now that Anchor has led the way in terms of how ANAL HCL patients should be treated. We believe we have a good Place for VGX-three thousand one hundred in the treatment paradigm of these patients and think that we're confident that We would see a similar effect of 3,100 on clearing those HBV infected cells.

Speaker 3

So, but it is as in all of these things, it is a discussion with the agencies and we're just In the process of having that.

Speaker 6

Yes. Mike, thank you so much. And then Jackie, just one very quick follow-up. The numbers you cited on RRP, the 72,000 per annum on average, about how long do these Patients tolerate these surgeries before sort of, I guess, progressing or dropping off or wherever is the next step after that?

Speaker 2

Yes. Again, a really great question, Hartaj. I mean, unfortunately, RRP can be a lifelong disease. People who have their first occurrence of RRP as children can suffer from Repeated issues throughout their lives. It really is a chronic disease.

Speaker 2

You can also get RRP occurring For the first time in adulthood and even in older adults as well. Once you have RRP, as Mike said, the disease course can be variable, but many People have RRP for decades. And really, I think what we're looking for here is a treatment that's going to be Appropriate for people who are suffering from a chronic disease. So a treatment that's really going suitable across their lifetime. So Mike, do you want to add to that?

Speaker 3

Yes. No, I mean, I think from The number of surgeries, I mean, because of the lifelong nature of the condition, I mean, there are several patients out there with Having hundreds of surgeries, I mean, it really is just drives it home to you The impact RRP has on these patient lives when you start getting out there in the community. So I think we will I think to your previous question, I mean, we didn't see any reason to veer away from Two surgeries in the year, being a reasonable indicator of a need to intervene and hopefully change the course of these patients' disease.

Speaker 6

Great. Thank you. Thank you for all the questions.

Operator

And our next question will come from Yi Chen with H. C. Wainwright, please go ahead with your question.

Speaker 6

Thank you for taking my question. Could you give us Some additional color, FDA's primary concern regarding the design of the Phase 3 trial for 3,107? I

Speaker 3

mean, first of all, I'll say it wasn't a primary concern. These are just routine questions that we have as part of the review. So I mean for we talked about That they concurred with our design of a Phase 3 study being randomized placebo controlled trial. We have because there are no surgical criteria, we're paving a way forward in RRP Clinical development, so we have some questions around, how we can agree what those surgical criteria are. And then the device questions were just part of the review of a combination product, Which occurs when you submit a protocol for Phase 3 development.

Speaker 6

Do you think FDA will require any modification to the injection device?

Speaker 3

I mean, I don't believe, I mean, when you look at our EP history, we've administered to over 18,000 patients, that's obviously intradermal and intramuscular. I think we've established The EP parameters, I don't believe there'll be certainly any changes to the administration profile of electroporation.

Speaker 2

Yes. And maybe I can just jump in here as well, Mike. We have previously used this device in 2 other previous Phase 3 studies both REVEAL 1 and REVEAL 2. And as Mike mentioned, we think these questions are part of the normal review of a proposed Phase 3 study.

Speaker 6

And once you start the Phase 3 trial, will that increase the

Speaker 4

Hi, this is Peter Keyes. That's built in currently right now and we feel like we have Sufficient funds to complete the trial, but we are still working through everything with the feedback from the FDA.

Speaker 6

Okay. Thank you.

Operator

And that concludes our question and answer session. I would like to turn the conference back over to Doctor. Jackie Hsieh for any closing remarks.

Speaker 2

Thank you for your questions and for joining us today. Inovio has made important headway in the clinical development of our key candidates in the 1st few months We will continue to work with our partners and collaborators to advance our pipeline as well as look for new and creative ways to develop our DNA medicines. I look forward to sharing updates on our additional progress at our next quarterly report as we drive toward delivering on the promise of DNA medicines for patients globally. With that, thank you again for your attention. Have a great evening, everyone.

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