Inovio Pharmaceuticals Inc. Q1 2023 Earnings Call
Speaker 1: to 2023, as well as provide a development progress update for our DNA medicines platform.
Speaker 1: Following prepared remarks, we will conduct a question and answer segment.
Speaker 1: During the call, we will be making forward-looking statements regarding future events and the future performance of the company.
Speaker 1: These events relate to our business plans to develop Inovio's DNA Medicine 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.
Speaker 1: Actual events or results could differ materially. We refer you to the documents we file from time to time with the SEC, which under their 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 broadcast live.
Speaker 1: And the link can be found on our website, ir.enovio.com, and a replay will be made available shortly after this call is concluded.
Speaker 1: I will now turn the call over to Nobius President and CEO Dr. Jackie Sheh.
Speaker 2: Good afternoon and thank you to everyone for joining today's call.
Speaker 2: In the first quarter of 2023, we made solid progress with several key pipeline candidates. Notably, we made important headway in the development of I-030107, our product candidate for recurrent respiratory papillomatosis or RRP.
Speaker 2: Our Chief Medical Officer, Dr. Mike Sumner, will provide more detail about our overall progress for this product candidate. 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
Speaker 2: for a Phase 3 trial for I-0-3107.
Speaker 2: We also announced that the European Committee for Often Medicinal Products issued a positive opinion on our application for often drug designation for INO-3107, with the European Commission's final decision expected in May.
Speaker 2: These regulatory developments come on the heels of positive data from the second cohort of our Phase 1-2 trial for I-10307 Shared In February and additional combined data on the safety and immunogenicity of I-10307.
Speaker 2: that was presented by Lead Investigator, Dr. Ted Mao at ABIA, a premier E&T meeting in Boston just last week.
Speaker 2: This data shows that INO-3107 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 RLP patients in April .
Speaker 2: In the first quarter, we also announced encouraging data from our Phase 1 trial with I-0-4201 as an Ebola booster for a V-Bow, which not only showed the potential of I-0-4201 as an important tool in extending protection against the Ebola virus.
Speaker 2: but also demonstrated the births utility of our platform and the ability of DNA medicines to relic it potentially protective immune responses across multiple indications.
Speaker 2: Additional safety and immunological data shared last month by Lead Investigator, Dr. Angela Humpner, at the 33rd European Congress of Clinical Microbiology and Infectious Diseases or ECMED, provided more insight.
Speaker 2: on the potential ability of I-04201 to generate robust immune responses and extend protection against Ebola. Michael will also share more details on that data.
Speaker 2: On our last earnings call in March, we announced top-line results for Rabil 2, the second phase 3 trial for VGX3100 as a treatment for cervical high-grade squamous intraepipenial lesions or cervical H-sil. So you families can check on the link below to get you at the link to pick.
Speaker 2: As we shared at that time, the trial results did not meet the primary end points in the biomarker selected population, but did show statistical significance in the all-comers population.
Speaker 2: Since then, we continue to analyse the data to better understand the biomarker population.
Speaker 2: Our goal is to share the results of this analysis with you in the third quarter of 2023.
Speaker 2: We continue to believe that the data from Reveal 2, which showed BGX 3100's ability to promote viral clearance.
Speaker 2: Highlights this drug candidates 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 cell. On INO-5401, our collaboration with Regeneron continues.
Speaker 2: And as we wrap up the phase two study for this product candidate in Bueh Blastoma.
Speaker 2: 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 first quarter of 2025.
Speaker 2: We will continue to ensure our strategic focus and financial discipline as we work to build an important progress to date.
Speaker 2: 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.
Speaker 2: This quarter, we welcome Dr. Cheryl Elder, Senior Vice President of Regulatory Affairs to an overview.
Speaker 2: She joins a seasoned product development team to oversee regulatory strategy and company interaction with global regulatory authorities.
Speaker 2: With over 30 years of experience leading cross-functional teams in drug development in multiple therapeutic areas, Dr. Elder has a successful track record of driving regulatory strategies within both small and multinational biotechnology companies, including Hoffman-LaRosh and most recently University of Chicago through January 4, 2020. Another group of people passing out to record their vehicle must engage in similar lifestyle changes in the past. Another one is successful. The worst aç naprawd? virus.
Speaker 2: I am confident we will benefit from her expertise as we seek to implement efficient regulatory regulatory strategies for key candidates across our pipeline.
Speaker 2: With that, I'd like to turn it over to our Chief Medical Officer, Dr. Mike Sumner, to provide some important thankful highlights. Mike? Thank you very much, Jackie, and greetings everyone.
Speaker 3: totally cool.
Speaker 3: 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.
Speaker 3: One of the challenges of studying the treatment effect of any drug candidate in RLP patients is that the disease can be variable among patients over time. And there are no standardized guidelines for surgical intervention.
Speaker 3: With these parameters in mind, we are preparing to conduct a randomized placebo-controlled Phase III trial. N
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 3107.
Speaker 3: We still have some additional trial details to work out with the agency before we can officially start our Phase 3 trial.
Speaker 3: including questions related to our Selectra 5 PSP delivery device.
Speaker 3: which we are working to address.
Speaker 3: As a reminder, this device was previously successfully used in two phase three trials, reveal one and reveal two.
Speaker 3: 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 innovative pivotal trial. Meanwhile, I'm pleased to report that we've shared the full results from our presentation.
Speaker 3: Dr. Mayer's presentation included more detailed safety, immunological and demographic data, which I would like to share with you today. This slide shows us the glance the impact 31-07 had on the number of surgeries for the patients who were involved in our trial.
Speaker 3: I'm really pleased to summarize that 26 have a 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.
Speaker 3: Patient's experience a median decrease of three surgeries in the year following treatment in comparison to the year prior to baseline.
Speaker 3: As a reminder, any surgery performed following day zero, 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.
Speaker 3: 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.
Speaker 3: The median number of surgeries in the year prior to dosing was 4 with a range of 2 to 8.
Speaker 3: This slide shows 3107's overall safety profile.
Speaker 3: An important hallmark of DNA medicines in general is favorable tolerability and safety. 903107 behaved as expected on that front in our phase 1, 2 trial.
Speaker 3: You can see here the most frequently reported treatment emergent adverse events being related to administration, either injection site pain or procedural pain.
Speaker 3: Treatment emergent AEs observed in the trial, which generally low grade, most of which were grade one. Four of the 32 patients experienced the grade three treatment emergent AEs, but none were deemed related to INO 3107.
Speaker 3: Two serious adverse events were reported during the trial, but again, both were deemed unrelated to 3107. There were no treatment emergent AEs leading to treatment discontinuation, and all subjects who participated in the trial received all four treatments.
Speaker 3: Next, I'd like to highlight data from the staging assessment scores.
Speaker 3: Staging assessment scores include both a subjective functional assessment of clinical parameters.
Speaker 3: as well as an anatomic assessment of disease distribution.
Speaker 3: essentially assessing total disease burden. The combination of the scores, measures, and individuals 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 correlate well with voice related quality of life for the patients.
Speaker 3: which is the most frequently reported symptom in adult patients.
Speaker 3: 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.
Speaker 3: As a reminder of what that actually looks like for a patient, I'd like to share a slide we showed their last quarterly call.
Speaker 3: For me.
Speaker 3: It's a powerful illustration of the clinical benefit of INO-3107 and how it could potentially provide patients suffering from this terrible disease relief.
Speaker 3: 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 HPV6 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.
Speaker 3: week 52, which was 43 weeks after final treatment with INO 3107, indicating a persistent cellular memory response.
Speaker 3: Additional analyses are also ongoing to determine a possible relationship between specific CD4 and CD8 phenotypes and clinical outcomes.
Speaker 3: studying the likely duration of treatment of ink and the requirement for repeat dosing.
Speaker 3: In summary, I'd like to highlight this conclusion, Stock to Mourn May, during his presentation.
Speaker 3: Investigators noted that the data suggests that INO-30107, 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-30107 in...
Speaker 3: view that opinion and make their final decision, which is expected later this month.
Speaker 3: Often designation in the EU would provide an OVO important benefits such as reduce fees for regulatory activities and 10 years of protection from market competition once approved. Furthermore we recognize the considerable burden RRP places on the pediatric population.
Speaker 3: and Belize 31-07 could also provide clinical benefit to these patients. We therefore plan to move forward in both the US and the European Union with a proposal of how to approach pediatric development.
Speaker 3: At the recent International Papilloma Virus Conference in Washington, D.C. that I attended, I was once again reminded of the considerable impact RRP has on patients and their caregivers' lives.
Speaker 3: As an organization, we are keeping that in mind every single day as we work to move I-03107 forward for patients around the world.
Speaker 3: Staying on our HPV franchise, I also wanted to provide some updates on VGX 3100, our product candidate focusing on high grade, squamous, epithelial lesions or H-cell.
Speaker 3: On our last earnings call, we announce results from our Reveal 2 Study.
Speaker 3: 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. However, the study did achieve statistical significance in the all-comers population.
Speaker 3: Looking across the totality of data we've collected for 3100 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.
Speaker 3: Together better handle on the biomarker data. We have been analyzing the results, highlighting two main areas.
Speaker 3: 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.
Speaker 3: infection with other HPV types, clinical site location, age, and smoking status.
Speaker 3: Secondly, we are looking to understand why some patients who exhibited a clinical response were not biomarker-pulsed.
Speaker 3: For this we plan to investigate the micro RNA data set in more detail.
Speaker 3: We expect to be able to provide you further insights into this analysis in the third quarter of 23. This biomark analysis is vital from a competitive standpoint as VGX 3100 must compete with LEAP or the Loop Electro-Searchical Exism Procedure.
Speaker 3: a well-established standard of care in the US for cervical HL.
Speaker 3: Being able to demonstrate a similar risk-benefit profile is going to be important in future regulatory discussions for that indication.
Speaker 3: VTX3100 has however also been studied in other indications including anal H-cell.
Speaker 3: As a reminder, in December 2020, we announced results of our open label single arm Phase 2 trial for ANALH-ZIL, in which we saw that 50% or 11 out of 22 participants.
Speaker 3: had no evidence of HPV 1618 positive H still at week 36. In addition, ANOVA is supporting an ongoing externally sponsored run study by the AIDS Malignancy Consortium, examining the potential of 3,100 in HIV positive individuals with ANOH still.
Speaker 3: ANOH-CIL is mostly caused by HPV 16-18 infections.
Speaker 3: and if left untreated may progress to anal cancer. HPV is detected in over 91% of anal cancers, and HPV 16-18 account for approximately 80% of HPV genotypes detected.
Speaker 3: In the US loan estimates of HPV 1618 related anal H-cell prevalence range from 210,000 to 1.1 million with similar prevalence figures estimated in the European Union.
Speaker 3: While watchful waiting has historically been a common clinical practice for AMLH and still, greater attention is now being paid to proactive treatment options.
Speaker 3: Recent results from the NIH and NCI funded anal cancer, H.C.L. outcomes research, or ANCA study in HIV positive patients showed the treatment of anal H.C.L. is superior in the prevention of progression to cancer.
Speaker 3: At present, treatment of this condition is usually surgical. That includes radio frequency ablation, resections, or laser therapy.
Speaker 3: However, a bleation, which is the most common treatment currently, does not clear the underlying HPV infection and recurrence rates are high up to 49% one year after treatment.
Speaker 3: This leads us to believe analite cell is a disease with significant unmet need that could potentially be met with a therapeutic candidate like VGX 3100.
Speaker 3: The viral clearance data I mentioned earlier from our two phase three cervical H-cell studies, as well as our phase two data, provide additional confidence regarding the potential of 3,100 to treat the underlying cause of the majority of anal H-cell cases.
Speaker 3: Based on post-diffy bank 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. Now I would like to switch gears to IMO 4201, at DNA boost of vaccine targeting Xayya P?ate Bay,??
Speaker 3: As Jackie mentioned recently, Dr. Angela Hutmer, lead investigator of the Phase 1b trial for INO 4201 presented new safety and immunological data at the 33rd European Congress of Clinical Microbiology and Infectious Diseases.
Speaker 3: The trial showed that the single dose of INO-4201, along with intradermal electroperation, was well tolerated and immunogenic compared to placebo in a cohort of healthy volunteers primed with Avibo.
Speaker 3: As you can see on this slide, both binding and neutralizing antibody titers rose significantly after the boost in 100% of subjects.
Speaker 3: with binding antibody titers rising significantly at each time point measured, peaking at week two.
Speaker 3: Likewise, neutralizing antibody titers demonstrated a similar profile.
Speaker 3: On this next slide, you can see a noteworthy engagement of T cells.
Speaker 3: Specifically, we observed an increased production of TH1 cytokines looking at intra-fairmed gamma IL-12, TNF-Alpha from CD4 and CD8 positive T cells following the INO-42-01 boost.
Speaker 3: 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-2, we believe having a strong cellular response profile in addition to the humoral response.
Speaker 3: is a value and a potential booster for Ebola.
Speaker 3: Finally, memory marker phenotyping suggests the cytokine production was generated predominantly from central memory CD4 positive T cells and effector memory CD8 positive T cells, most likely indicative of persistent protection against Ebola. The data presented suggests that a booster dose of IMO-
Speaker 3: African continent consistently since 1976.
Speaker 3: And as the past few years have shown, our globalized world only increases the potential for these outbreaks to jump borders.
Speaker 3: 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 mixed-ups by year-end.
Speaker 3: The latest work with 4201 is an excellent example of the real power of partnerships. Spearheaded by GuardRx, sponsored by Geneva University Hospitals, and funded by the U.S. Defense Advanced Research Projects Agency, or DARPA, this collaboration shows how partnerships can amplify the potential of Inovio's platform.
Speaker 3: 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 two trial for anal HCL and HIV positive.
Speaker 3: sponsored by the AIDS malignancy consortium that I previously mentioned. As well as candidates in two phase one HIV trials sponsored by the National Institute of Allergy and Infectious Diseases. We also have a DARPA fundage collaboration with the Wistar Institute University of Pennsylvania.
Speaker 3: Indiana University, and AstraZeneca to develop anti-SARS-CoV-2 specific DMADs, or DNA-encoded monoclonal antibodies.
Speaker 3: We look forward to sharing updates from our partners as they made available to us and will continue to explore additional partnership opportunities that align with our strategic vision.
Speaker 3: With that, I'll now turn the call over to our CFO Peter Keyes for our first quarter 23 financial summary. Peter? And then we'll go to theI'll be right back to you. Thanks Peter.
Speaker 4: Thank you, Michael. What I'd like to provide today is an overview of Inovio's financial condition for the first quarter of 2023. As Jackie and Mike have discussed with you here today,
Speaker 4: Anobio is focused on advancing the most promising candidates in our pipeline.
Speaker 4: The Nubio is focused on advancing the most promising candidates in our pipeline as quickly as possible.
Speaker 4: Part of this effort has included making sure
Speaker 4: We have enough cash runway to support those research efforts.
Speaker 4: have enough cash runway to support those research efforts. As you can see on this slide,
Speaker 4: I've highlighted how our operating expenses have declined over the last year.
Speaker 4: In the first quarter of 2023, out total operating expenses were 44.1 million, which is down 39% from the first quarter in 2022.
Speaker 4: as well as down 21% from the fourth quarter of 2022.
Speaker 4: $26 million for the same period in 2022.
Speaker 4: A 46% reduction quarter over quarter. The decrease in R&D expenses was primarily the result of lower drug manufacturing.
Speaker 4: clinical trial expenses,
Speaker 4: and outside services related to I&O 4800.
Speaker 4: outside services related to I and O 4800, as well as lower expenses.
Speaker 4: versus 16 million for the same period in 2022.
Speaker 4: which is a 13% drop. The decrease was primarily due to lower non-cash stock-based compensation, insurance, and other outside services offset by higher legal expense.
Speaker 4: Our revenues for the first quarter of 2023 were $115,000.
Speaker 4: which is down from 199,000 in the same period in 2022.
Speaker 4: from $199,000 in the same period in 2022. These factors...
Speaker 4: combined to bring our net loss for the first quarter of 2023 to 40.6 million.
Speaker 4: down 49% from 79.1 million, which was our net loss for the prior year.
Speaker 4: On a per-show basis, both basic and dilutive are net loss for the first quarter of 2023 with 16 cents.
Speaker 4: down from 36 cents for the 2022 period. We finished the first quarter of 2023, was 223.8 million in cash equivalents and short term investments, compared to 253 million as of December 31st, 2022.
Speaker 4: Looking forward, we are maintaining our prior projections of our cash runway taking us into the first quarter of 2025. This includes our cash burn estimate for the second quarter of 2023 of approximately $33 million. These projections do not include any funds.
Speaker 4: that may be raised through our existing ATM at the Market Offering Program or other capital raise activities.
Speaker 4: 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.
Speaker 3: Thank you, Peter. I'd now like to open up the call to answer any questions you might have. Operator? We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad.
Speaker 4: If you're using your speaker phone, please pick up your handset before pressing the keys. And to withdraw a question, please press star then two. 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. Thank you.
Speaker 4: 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 3107 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.
Speaker 2: that you present to regulators on the path ahead. Appreciate your time and thanks again. Yeah, 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.
Speaker 2: You know, we do believe that we have a workable framework going forward for our phase three clinical trial design, and we're very encouraged by the potential I-031-07 has to really be a therapeutic option for patients suffering from our RP. So with that, I'll turn it over to Mike to comment on some of the more specific items you asked about Mike.
Speaker 3: Yeah, thank you. So starting off with the heterogeneity between the two groups, 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 also.
Speaker 3: So we didn't really feel when we put the data set together that we needed to treat cohort one differently from cohort two. And as you saw from a range of surgeries, we saw a range from two to eight. And we saw a...
Speaker 3: same decrease, median decrease in surgery 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.
Speaker 3: 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. And as you can, as I talked to, I mean, the two main elements that we wanted to address that we knew were of concern to the agency.
Speaker 3: discussions with the agency.
Speaker 4: Does that answer your question? Yeah, that was really helpful. Really appreciate the time and congrats on the progress again.
Speaker 4: answer your question? Yeah, that was really helpful. Really appreciate the time and congrats in progress again. Thank you.
Speaker 4: Again, if you have a question, you may press star 1 to join the queue. Our next question will come from Hartaj Singh with Oppenheimer. Please go ahead with your question. Great. Thank you and thanks for the couple of questions. One is just going back to our queue question.
Speaker 3: But thinking about the phase three, when you, about how many patients are you thinking about the trial could be? And, you know, should we just assume that the patients will have at least those two surgical interventions? And just give us a sense of the market, you know, the market, I mean, the total sort of patient sizing for this.
Speaker 3: a bit about the market size so like. Okay so as we have obviously disclosed the final...
Speaker 3: sample size for the Phase III study, but to give you some parameters of sort of how to think about it, you know 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 I II exploratory study. And I think you know the fact that we did see that statistical significance just points to the size of the clinical effect.
Speaker 3: safety database with the agency. 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 three program.
Speaker 2: Thanks, Mike. Great. And, Patos, to talk a bit about the potential market size, in the U.S., I think current epi figures estimate that there may be around 14,000 patients with active RLP, probably a similar number in Europe .
Speaker 2: You know, as you know, HPV unfortunately is everywhere, 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 US.
Speaker 2: 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 our opi 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.
Speaker 2: So we think that there is an appropriate market here.
Speaker 3: Yeah, no, that's great. Thank you for all the color. And then, you know, just send in, you know, like FIL. I know it's been a while since you presented the data. And, you know, how much?
Speaker 3: What 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 a good line of sight into the next step? And what would that be? Would that be a Phase 2, strictly a Phase 2-3? So thanks for the question.
Speaker 2: OK. 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 VGX3100 across multiple studies, multiple indications in terms of its stability.
Speaker 3: 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 anal HCL? Yeah, thank you Jackie. 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...
Speaker 3: treated. We believe we have a good place for VGX3100 in the treatment paradigm of these patients and think that we're confident that we would see a dissimilar effect of 3100 on clearing those HPV infected cells.
Speaker 3: I'm so happy that it is.
Speaker 3: As in all of these things, it is a discussion with the agencies, and we're just in the process of having that. Yeah. Mike, thank you so much. And then, Jackie, just one very quick follow-up. You know, the numbers you cited on RRT, the 72,000 per annum on average, about how long do these patients tolerate these surgeries before sort of...
Speaker 2: children can suffer from...
Speaker 2: and you know, suffer from...
Speaker 2: RRP. You know, as Mike said, you know, the disease course can be variable, but many people have RRP for decades. And, you know, really I think what we're looking for here is a treatment that's going to be appropriate for...
Speaker 2: people who are suffering from a chronic disease. So a treatment that's really going to be suitable across their lifetime. So Mike, do you want to add to that? Yeah, no, I mean, I think from...
Speaker 3: The number of surgeries, I mean, because of the lifelong nature of the condition, I mean, there are several patients out there with, you know, having hundreds of surgeries. I mean, it really is, you know, just drives it home to you the impact RRP has on these patient lives when you start getting out there in the community.
Speaker 3: So, you know, I think we will, you know, 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 4: Great. Thank you. Thank you for all the questions. And our next question will come from Hugh Chenn with HCWaneRite. Please go ahead with your question.
Speaker 5: Thank you for taking my question. Could you give us some additional color on FDA's primary concern regarding the design of the Phase 3 tribe for SOTY 107?
Speaker 3: I 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, we talked about that they concurred with our...
Speaker 3: design of a face research being randomized to see both control trial. We have, because there are no surgical criteria, we're we're partying a way forward in our RP clinical development. So we have some questions around how we can agree what those surgical criteria are. And then the device questions were just
Speaker 3: part of the review of a combination product which occurs when you submit a protocol for phase 3 development. Do you think FDA will require any modification to the injection device? I don't believe, I mean when you look at
Speaker 3: our EP history, and we've administered EP 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: Yeah, and maybe I can just jump in here as well, Mike. We have previously used this device in two 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 5: Once you start the phase three trial, will that increase the quarterly cash flow? 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're still working through everything.
Speaker 6: you want marks
Speaker 2: Thank you for your questions and for joining us today. Anovio has made important headway in the clinical development of our key candidates in the first few months of this year. And we will continue to work hard to build on that progress in the months to come. We plan to present and publish our work at leading medical conferences and journals.
Speaker 2: as well as share additional regulatory and development updates from our key candidates as they become available.
Speaker 2: 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.
Speaker 2: I look forward to sharing updates and our additional progress of our next quarterly report as we drive toward delivering on the promise of DNA medicines for patients globally.
Speaker 2: I look forward to sharing updates on our additional progress of 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.
Speaker 7: Have a great evening, everyone. The conference has now concluded. Thank you very much for attending today's presentation. You may now disconnect your lines.