Q3 2024 Inovio Pharmaceuticals Inc Earnings Call
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Speaker Change: Good afternoon, ladies and gentlemen, and welcome to the Inovio 3rd Quarter 2024 Financial Results Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the operator.
Speaker Change: This call is being recorded on Thursday, November 14, 2024. I would now like to turn the conference over to Thomas Hong, Manager of Investor Relations. Please go ahead.
Speaker Change: Good afternoon, and thank you for joining the Inovio Third Quarter 2024 Financial Results Conference Call.
Thomas Hong: Joining me on today's call are Dr. Jackie Shea, President and Chief Executive Officer. Dr. Mike Sumner, Chief Medical Officer.
Thomas Hong: Peter Kies, Chief Financial Officer, Steve Egge, Chief Commercial Officer, and Dr. Matthew Morrow, VP of Translational Sciences.
Thomas Hong: Today's call will review our corporate and financial information for the quarter ended September 30th, 2024, as well as provide a general business update.
Thomas Hong: Following prepared remarks, we will conduct a question and answer segment.
and many more. Thank you. Thank you.
Thomas Hong: During the call, we will be making forward-looking statements regarding future events and the future performance of the company.
Thomas Hong: 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 and planned regulatory submissions.
along with capital resources and strategic matters.
Thomas Hong: All of these statements are based on the beliefs and expectations of management as of today.
Actual events or results could differ materially.
Thomas Hong: 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.
Thomas Hong: 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.
Speaker Change: I will now turn the call over to Novo U.S. President and CEO Dr. Jackie Shea.
Speaker Change: Good afternoon and thank you to everyone for joining today's call.
Speaker Change: This quarter, we continue to make progress on the key objectives we've been focused on for 2024 to deliver value to stakeholders in the near, mid and longer term and most importantly, deliver on the promise of DNA medicine for patients.
Speaker Change: Those objectives include, firstly, advancing our lead product candidate INO3107 towards commercialization, secondly, advancing our pipeline, and thirdly, continuing to strengthen our business overall.
Speaker Change: Today, I will provide an overview of our progress and then ask my colleagues to provide greater detail.
Speaker Change: To begin with, we've recently announced important additional immunology data supporting the proposed mechanism of action for 3107 and its potential to eliminate or reduce the number of surgeries RRP patients have to face.
Highlighting the ability of 3107 to induce T cell responses.
Speaker Change: that correspond to the clinical benefit observed in our Phase 1-2 trial.
Speaker Change: has been presented at two scientific conferences, including the International Papillomavirus Conference this week.
Speaker Change: We have also presented the full safety and efficacy data, demonstrating that 3107 was shown to be well-tolerated and have clinical benefit in our Phase I-II trial at two recent scientific conferences.
Speaker Change: We believe the powerful combination of this additional data further highlight the potential for 3107 to become the preferred choice for the broadest number of RRP patients should it be approved.
Speaker Change: Mike and Steve will provide further details on this later in today's call.
Speaker Change: Moving on to regulatory matters, in August we held a positive pre-BLA meeting with the FDA.
Speaker Change: Since then, we have continued preparing for submission of our BLA, targeted in mid-2025.
Speaker Change: We expect to have all non-device related modules for the BLA completed by the end of this year.
Speaker Change: You'll recall, during our last quarterly call, we announced we had recently identified a manufacturing issue for the single-use component of our device during the testing required for our BLA submission.
Speaker Change: We believe we have identified the appropriate resolution for this issue and are making good progress in implementation.
Speaker Change: In summary, we remain confident in our ability to deliver 3107 to the market for patients as an important and new therapeutic option to treat this devastating disease.
Speaker Change: As this is our primary focus, we are directing the majority of our resources, both people and financial, towards completion of development, BLA submission, and preparing for our potential commercialization of 3107.
Speaker Change: However, even with 3107 as our primary focus, we are mindful of the significant potential of the rest of our pipeline and have continued to make important progress on several other candidates as well.
but I know 3112.
We've consulted with European regulators.
regarding the design of our proposed Phase III trial.
evaluating 3112 in combination with the PD-1 inhibitor Loctorzi.
Speaker Change: as a potential treatment for locally advanced HPV 16 and 18 positive high-risk oropharyngeal squamous cell carcinoma, also known as throat cancer.
We anticipate conducting this trial in North America and Europe.
Speaker Change: Previous discussions with the FDA have indicated alignment with the proposed trial design.
Speaker Change: Continuing in oncology for INO5401, patients continue to be dosed in the GBM001 trial in newly diagnosed glioblastoma that combines 5401 with Regeneron's PD-1 checkpoint inhibitor, Libteo.
Speaker Change: Regeneron and Inovio have discussed that an appropriate next step for GBM could be a controlled phase 2 trial. A separate trial evaluating 5401 in patients with the BRCA mutation is ongoing at the Bassa Center at the University of Pennsylvania.
Speaker Change: We also have an upcoming meeting scheduled with the FDA later this quarter to discuss the Phase II trial design and development pathway for INO4201 as a heterologous boost to the FDA-licensed Ebola vaccine Avivo.
Speaker Change: From our earliest stage candidates, we expect clinical data from an ongoing phase 1 study with DNA-encoded monoclonal antibodies to be submitted to a peer-reviewed publication by year end.
Speaker Change: We believe this will be the first clinical data for DNA-delivered monoclonal antibodies to be reported and illustrates what we believe to be the transformational potential of our DNA medicines platform.
Speaker Change: Finally, our commitment to financial discipline and strengthening our business is a core component of our strategy for success. While we've made substantial progress on our overall goals, we've done so while continuing to reduce our operating expenses.
Speaker Change: We close the third quarter with $84.4 million in cash, cash equivalents, and short-term investments, and with no debt.
Mike Sumner: Now I'll turn it over to Mike for some additional insights from the new data on 3107. Mike?
Mike Sumner: I think it's important to review why we're working so hard to bring INOD3107 to patients.
Speaker Change: RRP is a rare HIV-related disease characterized by small, wart-like growths called papillomas found in the respiratory tract.
Speaker Change: People with RRP mount an insufficient immune response that's unable to prevent or clear the HP infection from their airways.
So the papillomas can grow unchecked.
Speaker Change: The papillomas often cause difficulty speaking or complete voice loss, difficulty swallowing, shortness of breath, or choking episodes.
Speaker Change: The current standard of care is surgery to clear out the papillomas, but that doesn't address the underlying viral cause of the disease, and the papillomas grow back.
Speaker Change: Setting patients up for an endless cycle of resurgence of symptoms and need for more surgery.
Speaker Change: Every single surgery presents a risk of permanent vocal cord damage, reinforcing what patients have said time and again, that a reduction of even one surgery would be life-changing.
Speaker Change: and many more. Thank you for watching. We hope you enjoyed this video. If you did, please click the Like button and subscribe to our channel. See you in the next video.
Speaker Change: That patient experience has been central to our efforts to develop 3107, which we believe has the potential to change the treatment paradigm for RRP.
Speaker Change: Designed to generate antigen-specific cytotoxic CD8 T-cells targeting both HPV6 and HPV11, 3107 is a potential novel, non-surgical treatment option for RRP patients.
Speaker Change: In our Phase I-II clinical trial, we observed a compelling combination of clinical benefit and tolerability across the disease spectrum of severity and including both HPV6 and 11-driven disease.
Speaker Change: In addition, we saw the generation of a significant and targeted immune response that was associated with a reduction or elimination of surgeries for these patients.
Speaker Change: We believe that the growing body of evidence shows that 3107 could be used to treat the vast majority of RRP patients.
Speaker Change: and supports its potential to be the preferred product of choice by patients, healthcare providers and payers if approved.
Speaker Change: At the International Society of Vaccines Conference and the Fall Voice Conference this past October, Inovio presented its fall safety and efficacy data for the Phase I-II trial, which is summarized here.
Speaker Change: In the trial, the overall clinical response, defined as patients experiencing a decrease in the number of surgical interventions in the year after the initial 3107 administration,
Speaker Change: compared to the prior year with 81% or 26 of the 32 enrolled patients.
Speaker Change: This number includes 28% that required no surgical intervention during or after the dosing window.
These are our complete responders.
Speaker Change: Further, 44% of patients had a partial response defined as a reduction of at least 50% in the number of surgeries when compared to the prior year.
Speaker Change: The overall response rate, calculated by adding our complete responders and partial responders, was 72 percent, or 23 out of 32 patients.
Speaker Change: Importantly, in our trial design, we counted every surgery after day zero, because every surgery matters to patients.
On this slide, you can see our overall safety data.
Speaker Change: 3107 was well tolerated in the study, with the most common treatment-related adverse events being injection site pain reported in less than a third of patients.
Speaker Change: Supporting that our Selectra Electra operation device was well tolerated by patients and was also easy to use by health care providers.
Speaker Change: Fatigue was the next most frequent reported treatment-related AE in just three patients.
Speaker Change: No treatment-related adverse events greater than grade 2 severity were reported.
Speaker Change: One of the core strengths of our DNA medicine platform is the ability to drive a T cell response.
which is particularly important for treating chronic viral disease.
Speaker Change: You can see on this slide the proposed mechanism of action for 3107.
Speaker Change: Inducing HPV antigen-specific T-cell responses in the blood, then having those T-cells travel to and infiltrate the papilloma and airway tissue.
Speaker Change: and ultimately eradicate the HPV-infected cells to reduce or eliminate the need for surgery.
Speaker Change: I'd like to now turn to our new immunology data that we have shared at the recent scientific conferences, including this week at the International Papillomavirus Conference.
Speaker Change: To further characterize immune responses to 3107, we analyzed blood and tissue samples from patients in our Phase I-II trial.
Speaker Change: Our goal was to evaluate the individual steps that combine into the proposed mechanism of action that I just presented.
Speaker Change: We conducted a number of very extensive immunological assessments on blood and tissue samples to, one, confirm the induction, activation, and expansion of cytotoxic T-cells with antigen specificity to HPV6 and 11.
Speaker Change: And two, to assess the level and form of immunological change from baseline, including T-cell infiltration and profiling, and the potential impact of the papilloma microenvironment on clinical effect.
In short, what we discovered was very compelling.
Speaker Change: The data demonstrated the ability of 3107 to do exactly what it was designed to do Induce HPV antigen specific T cell responses in the blood that infiltrate papilloma and airway tissues and that they are the right kind of T cells to eradicate HPV infected cells and ultimately reduce or eliminate the need for surgery
Speaker Change: Overall, the key takeaways from this study include five main points.
Speaker Change: First, INO3107 generates the right kind of immune responses to fight HPV for the vast majority of RRP patients.
Speaker Change: In our research, we see generation of HPV6 and 11 antigen-specific cytotoxic T cells with responses that are durable out to 52 weeks.
Speaker Change: indicating a long-lived memory response which is important for the treatment of a chronic viral disease like RRP.
Speaker Change: Second, the newly generated T cells get to where they need to go. Our data shows that T cells travel from the blood to the papilloma and airway tissue, and the resulting inflammatory and antiviral responses are seen in the tissue.
and many more. Thank you. Thank you.
Speaker Change: Third, the immune response we have observed is targeted and specific to treatment with INO3107.
Speaker Change: We saw expansion of both pre-existing T-cell clones and the emergence of new T-cells in the blood.
These new T-cells could not be detected prior to treatment.
Speaker Change: meaning the majority of T cells seen in airway tissue at the 52 week time point were emergent clones.
Speaker Change: The presence of these new T-cells in the tissue corresponds with the clinical benefit we saw in the trial.
Speaker Change: Fourth, we were also able to show that immune responses in responders are different to those seen in non-responders.
Speaker Change: While all 32 patients in the trial were seen to generate an immune response in the blood, the kinetics and magnitude of that response differed based on the clinical response seen.
Speaker Change: We believe we can build on these initial responses in non-responders through the administration of additional doses.
Speaker Change: And finally, from our evaluations to date, we have looked at elements of the papilloma microenvironment that have been reported in recent scientific literature to impact the potential efficacy of treatment.
Speaker Change: To date, we have not found evidence that these elements appear to restrict the clinical benefit of 3107.
Speaker Change: This immunology data is currently under review at a peer-reviewed journal, and we look forward to providing an update on that publication when available.
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Speaker Change: So in summary, I would like to point out why this new data is so important to the potential of INO3107.
Speaker Change: First and foremost, we believe the immunology data support the biological mechanism of action of 3107.
Speaker Change: This data will be an important component of our upcoming BLA submission and other future regulatory filings.
Speaker Change: The data confirmed that 3107 effectively targets HPV6 and HPV11, the strains that cause the vast majority of RRP disease.
Speaker Change: The data confirmed that 3107 generates new and expands existing populations of T cells and activates them to eliminate the underlying cause of the disease.
Speaker Change: The data also support that 3107 can have clinical benefits across the disease severity spectrum and in both HBV 6 and 11 driven disease.
Speaker Change: Remember that patients tell us that every surgery matters, so our goal is to be able to treat patients with RRP regardless of the severity of disease.
Speaker Change: In short, we believe these data provide compelling evidence that INO3107, if approved, can be a game-changer for RRP patients by reducing their need for repeat surgeries to treat their disease.
Speaker Change: I'd also like to mention that in addition to this important immunology work, we have also recently completed a retrospective study investigating the long-term durability of clinical response seen in patients treated in our Phase I-II study.
We anticipate announcing that data by year-end.
Speaker Change: On that note, I'll now turn it over to our Chief Commercial Officer, Steve Egge, for an update on our commercial efforts. Steve?
Steve Egge: Thanks, Mike. Hello, everyone. At our last quarterly report, I outlined the significant opportunity I see for 3107 based on its compelling product profile.
Steve Egge: Over the last quarter, I've worked closely with our internal team and external consultants to continue to develop and refine our plans for the launch of 3107 if we receive FDA approval.
Steve Egge: We're making important progress and focused on developing a go-to-market strategy that's rooted in ensuring we meet physician, payer, and most importantly, patient needs.
Steve Egge: We've conducted a significant amount of market research to develop key insights with stakeholders to ensure we have a deep understanding of the market and the opportunity for 3107.
Steve Egge: We have repeatedly heard from patients that every single surgery matters and the reduction in even one surgery makes a meaningful difference in the lives of patients.
Steve Egge: Because of the potential of a competitive marketplace, I won't go into significant detail, but at a high level,
Steve Egge: We are making strategic choices in a number of key areas, including pricing and access. From a pricing standpoint, we do expect to price in line with current rare disease pricing, and we've confirmed acceptability of this and feedback from payers that represent the majority of commercial lives in the U.S.
Steve Egge: We're also making strategic choices on distribution, physician and patient targeting and segmentation, as well as product positioning to ensure we're well differentiated.
Steve Egge: We've refined our plan for pathways for product adoption to ensure we provide an optimal customer experience.
Steve Egge: We did hear from the FDA earlier this month that our proposed brand name for 3107 is acceptable at this time. Of course, the decision of the brand name will be confirmed by the FDA during the BLA process.
Steve Egge: We're refining our forecasting and gross-to-net assumptions, and we've also developed strategic imperatives for the business to ensure we're focused on what matters most in a successful product launch, and these include metrics on how we'll measure our progress.
Steve Egge: And finally, we've also planned the build out of the commercial organization, including field teams, in 2025. We're planning for a lean and efficient commercial footprint. And as we've communicated previously, we plan to be launch ready by the end of 2025.
I also want to echo Jackie and Mike.
The new data we've shared today supporting our...
Steve Egge: proposed mechanism of action builds on 3107's compelling product profile and strengthens my belief that 3107 can treat a broad range of RRP patients and that it could be the preferred choice for RRP patients and physicians. I'll now turn it over to our Chief Financial Officer, Peter Kies, for a financial update.
Peter Kies: Thanks Steve. Today I'd like to provide an overview of Inovio's financial results for the third quarter of 2024. As Jackie noted at the start of the call, we are primarily focused on advancing IONO 3107 and our goal to submit a BLA mid 2025.
Peter Kies: To support these efforts, we have continued to control our operating expenses.
Peter Kies: For the third quarter ended September 30, 2024, our total operating expenses
dropped 24 percent.
Peter Kies: from $35.9 million in the third quarter of 2023 to $27.3 million in the third quarter of 2024.
Peter Kies: Annobio's net loss for the third quarter of 2024 was $25.2 million, or $0.89 per share basic and dilutive, compared to a net loss of $33.9 million, or $1.52 per share basic and dilutive, for the third quarter of 2023.
Peter Kies: We finished the third quarter of 2024 with $84.8 million in cash, cash equivalents, and short-term investments, compared to $145.3 million as of December 35, 1, 2023.
Peter Kies: We estimate our cash runway to take us into third quarter 2025. This projection includes an operational net cash
Peter Kies: estimate of approximately $24 million for the fourth quarter of 2024.
Peter Kies: These cash runway projections do not include any further capital raising activities that Inovio may undertake.
Peter Kies: As a reminder, you can find our full financial statements in this afternoon's press release, as well as in our Form 10-Q filed with the SEC.
And with that, I'll turn it back over to Jackie.
and many more. Thank you. Thank you.
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Thank you. Thank you. Thank you.
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Speaker Change: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the number 1 on your touchtone phone. You will hear a prompt that your hand has been raised.
Speaker Change: Should you wish to decline from the polling process, please press star followed by the number 2. If you are using a speakerphone, please lift the handset before pressing any keys.
One moment, please, for your first question.
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Speaker Change: Congrats on all the progress with your 3107 and BLA filing in the U.S. Can you talk about any regulatory updates for 3107 outside the U.S.? It sounds like you're making progress in EU and the UK. What are the timelines for filing in those markets and any update on Japan, China, or other major markets? And then I had a follow-up if I could.
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Speaker Change: Hi Jane, nice to hear from you. Mike, do you want to comment on where we are with our other regulatory filings?
Mike Sumner: Yes, certainly. So, I mean, we have met with the UK.
and they gave very similar advice to their European colleagues.
Mike Sumner: And that was basically that to gain approval in the European Union and the UK, you're going to need placebo-controlled data that needs to be compelling.
and so, you know...
Mike Sumner: but also that that data could be used in those markets.
Mike Sumner: But we are going to have to complete that study prior to submitting in Europe.
Mike Sumner: We have not yet reached out to Japan and China, but clearly they do have RRP. We've spoken to AOLs in some of those regions, and so they are areas of interest for us to progress.
Thank you very much. It's super helpful.
Speaker Change: Congrats also on the new immunology data that you presented at AACR and IPVC. Could you share any physician feedback that you may have received on that data and what what are physicians ultimately looking for?
Mike, do you want to come in here? Yes, certainly.
Mike Sumner: I mean, firstly, look, I think as I talk to it, it really is compelling data. Matthew Morrows, who's also on this call, is our translational sciences person. He's done a great job.
are really characterizing the mechanism of action of 3107.
Mike Sumner: And I think as we've talked to clinicians and scientists about that data.
Mike Sumner: They really can see what 3107 is doing from an immunological basis. And I think that just gives them more confidence in the clinical data that we have presented.
Mike Sumner: So I think it just ties in very nicely and also will tie in very nicely as we submit that BLA to link up the clinical data with what's actually happening from an immunological standpoint.
Mike Sumner: I think we can also say Mike, and you know as evidenced by Professor Steinberg's quotes in our recent press release around the data, you know generally KOLs in the field have been very impressed with the data when we've shared and discussed it with them. I think for them this is part of going after the the holy grail of having the effective therapeutic option to treat RRP.
and many more. Thank you. Thank you.
Speaker Change: Great, that's super helpful. Congrats again on all the progress and thanks for taking our questions.
Rochelle.
Speaker Change: Your next question comes from the line of Roy Buchanan from Citizen JMP. Your line is now open.
Roy Buchanan: Okay, thanks also for taking the questions. Just, I mean, maybe just start on 3107 as well.
Roy Buchanan: Can you just give maybe some additional detail on the steps that you're envisioning to resolve the manufacturing issues?
Speaker Change: Hi, Roy, nice to hear from you. Yep, so as I outlined on the call, we encountered the issue, the manufacturing issue, earlier on this summer, just ahead of our pre-BLA meeting. And we're going through, and this is an issue with a single-use disposable component of our device. We've gone through the steps we need to take to understand the appropriate resolution for that issue. And we're making good progress in implementation. And I think that's all I can really say at the moment.
Speaker Change: Okay, fair enough. And then I think this, correct me if I'm wrong, but the phase 3 start for 3112 was also...
gated by resolving this manufacturing issue.
Speaker Change: Is that correct? And, you know, the device is approved essentially in Europe, right, with the CE mark. Is it possible that you might be able to start first the Phase III in Europe, and when do you think you might be in a position to do that?
and many more. Thank you. Thank you.
Speaker Change: Yeah, that's a great question, Royce. So yes, for 3112, starting that phase 3 trial is dependent on resolving this device issue as well. Mike, do you want to talk about our regulatory interactions in Europe around 3112?
Mike Sumner: Yes, so I mean as we've previously said we've got alignment from the FDA on the design that we propose for that study we're in discussions with the EMA and we're expecting feedback to gain alignment as it
Mike Sumner: HPV is a global disease and in most high-income countries the incidence of throat cancers continues to rise so we would very much like to run this study
Mike Sumner: both regions. So we're anxiously awaiting that feedback, and then we can update you on that at the next call.
Speaker Change: Okay, great. And maybe I'll jump back in queue, but other people asking questions.
Speaker Change: Your next question comes from the line of Sudan Loganathan from Stephens. Your line is now open.
Thank you for taking my question.
Quick question on the competitive landscape. I think presidents
Speaker Change: How do you differ from that product and how do you see the competitive landscape panning out?
Speaker Change: Yeah, that's a great question. So I'll start off by saying first of all we're very confident in the product profile that we see for 3107 and we believe that it has
Speaker Change: The right profile to be the preferred product of choice for patients and physicians.
Speaker Change: and the sort of reasons why we believe in that, as Mike discussed earlier on in the call.
Speaker Change: our ability to drive clinical benefit across the severity of disease across both HPV 6 and 11 and I think this new immunology basis really gives us a very clear idea of exactly how 3107 is doing that.
Speaker Change: So 3107 is the DNA medicine, Prestigen's product is based around the Gorilla Radna virus.
Speaker Change: So, it's using an adenoviral vector to deliver the gene sequences. And it's difficult to compare the clinical data because the two trials were conducted in a very different way.
So for 3107, we believe every surgery matters to patients.
Speaker Change: So we counted every surgery after day zero, and I think in conjunction, Prestigen used a somewhat different trial design that allowed scoping and surgery prior to assessment of the efficacy period. So we really took a very different approach.
Speaker Change: Mike, anything else you want to add to that sort of calls out the differences between those two products?
product candidates. Thank you. Thank you. Thank you.
Speaker Change: I mean, I think fundamentally, they're a very different treatment regimen. You know, while we both have four doses,
Speaker Change: Their treatment regimen at week 6 and week 12 includes proactive scoping and removal of any papilloma that is visualized and so, you know
Speaker Change: They did see a significant number of surgeries at those week 6 and week 12 time point and so we do think that's going to impact sort of how other physicians take up the treatment and also how patients might perceive it.
Thank you. If I can ask another question, the...
Manufacturing plastic molding.
Speaker Change: Would you consider changing the manufacturer? Is that on the table?
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Speaker Change: Yes, so I guess your question relates to the manufacturing issue I mentioned earlier relating to the single-use disposable component of the device.
Speaker Change: And what we're doing here is where we've, as I mentioned, we believe we've identified the issue and come up with a proposed resolution path and we're working very closely with the manufacturer of that injection molded component to implement that resolution.
Speaker Change: So at the moment we're not planning on changing manufacturer, we're working very closely with our existing manufacturer to implement that resolution.
Thank you.
Speaker Change: Your next question comes from the line of Liang Chan from Jefferies. Your line is now open.
Speaker Change: Hey team, thanks for taking our questions. This is Leon Chen for Roger from Jefferies.
Speaker Change: So I guess my first question also about 3107, just wondering, any idea about the confirmatory trial? Are you still thinking about the, you know, the same design or do you envision any implement of recoursing in that study?
Speaker Change: And then also about the 3107, you know, the immunology study. So I just wonder, have you looked at the responders versus non-responders?
and anything you notice there. Thanks.
Speaker Change: Yeah, those are great questions. So we have talked about the design of our confirmatory trial. Mike, do you want to outline that design and why we decided on it?
Mike Sumner: Yeah absolutely, so in discussions with the agency they made it very clear if we wanted to have an indication similar to what we used in our phase 1-2 trial of two surgeries in the preceding year.
then the study had to be a placebo-controlled study.
Mike Sumner: run a randomized study, and we're clearly very confident in the clinical efficacy that we've seen. This isn't gonna be a particularly large study, about 100 patients. We're going to have a two-to-one randomization, and then follow those.
Mike Sumner: patients out. We aren't going to include a redosing element into this study at present and the rationale for that is we have had previous patients
Mike Sumner: treated with an HPV6 only plasmid that have had efficacy out to 500 and over 800 days.
Mike Sumner: So, in discussion with the agency, they were keen for us to have a longer follow-up.
Mike Sumner: than we previously had in our Phase I-II study. And that was also the motivation for us to run the retrospective study that we'll hopefully, well, we will report on.
Mike Sumner: By the end of the year. So we really do think you need a longer period of time to characterize the benefit of 3107.
Mike Sumner: That's why we picked our confirmatory study design and the way we have.
and many more. Thank you. Thank you.
Speaker Change: Thanks Mike and I'll just comment briefly on the immunology data and then I'll ask Matthew to fill in a bit more detail.
Speaker Change: But Matthew, do you want to jump in and add some other comments here?
and many more. Thank you. Thank you.
Speaker Change: Sure, good afternoon. So, yes, in addition to what Jackie has mentioned,
The responses within the tissue of the responders is.
Speaker Change: and just the overall inflammatory response and interferon-alpha and interferon-gamma responses that are being observed. And all of these assessments will be further described in the publication that is forthcoming.
and many more. Thank you. Thank you.
Thank you for watching. See you next time.
Thanks. That's very helpful.
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Speaker Change: I guess also for 3112, just wondering, you know, for the ongoing conversation with these EU regulators, you know, what's needed before you, you know, the crowd initiation? Thanks.
Yeah, Mike, do you want to comment on that?
Yeah, so, I mean...
Speaker Change: Obviously, the purpose of the interaction is to gain alignment with the overall strategic intent of how we've designed 3112.
Speaker Change: And I think, as we've said previously, we actually used global KOLs in this.
and many more. Thank you. Thank you.
Speaker Change: study design and so we have a very good representation from from Europe.
Speaker Change: And so we're optimistic that we can gain that alignment. And then just the practical part is we obviously would have to put a clinical trial application into the EMA before we started recruiting patients.
Got it. Thanks, Mike. That's all for now. Thank you.
Speaker Change: Your next question comes from the line of Yi Shen from HC Wainwright. Your line is now open.
Speaker Change: Hi there, this is Eduardo on CREE. I wanted to thank you for taking the question. I was curious if you could offer a little bit more clarity on the timeline for initiating the confirmatory trial for 3107 and how that fits in with the VLA submission that you already expressed.
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Speaker Change: 2025. We need to start our, FDA have told us that we need to start our confirmatory trial ahead of commencing that BLA submission, and we're expecting to request rolling submission, priority review as part of that BLA submission. So what I can tell you today is mid-2025.
Speaker Change: and many more. Thank you for watching. I hope you enjoyed this video. If you did, please click the Like button and subscribe to my channel. I'll see you in the next video.
Speaker Change: Maybe I'll add a little bit of color around our activities.
Speaker Change: You know, we, the FDA has said we needed to commence that study and, you know, clearly their rationale for that.
Speaker Change: is often sponsors have not been very forthcoming in delivering their confirmatory studies.
Speaker Change: We, however, are at the opposite end of that spectrum. We have almost all our sites identified. We are contracting with sites.
Speaker Change: We have active IRB submissions, so we will be in a very good position to demonstrate our commitment of delivering on that confirmatory study to the agency.
Speaker Change: Yeah, thank you, Mike. That's a great point. I think, you know, we've also really leveraged our experience from our Phase I-II study that we conducted in the U.S.
Speaker Change: where we worked across eight different clinical trial sites really, centers that are at the forefront of treating RRP. So I think that experience of working across different sites as well has been very helpful.
and many more. Thank you. Thank you.
Great, thanks so much for the clarity there.
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Speaker Change: Your next question comes from the line of Gregory Renza from RBC Capital Markets. Your line is now open.
Speaker Change: Hi, team. It's Anishan for Greg. Thanks for taking our questions.
Speaker Change: On 3107 in the selector device, maybe if you could just remind us the duration of the AEs such as injection site pain and fatigue, how rapidly they were resolved, and how this translates to patient and physician expectations when using the selector device. And as you think about the commercial strategy, with Precision also reporting after the close and suggesting a 2025 launch, how are you thinking about your approach and go-to-market strategy, which could support uptake in the market given the prospects of a competitor already being on the market by the time you would launch? Thanks so much.
Speaker Change: Thank you for watching. Please subscribe to our channel. See you in the next video.
Speaker Change: Thanks Nish, great questions. So, in terms of 3107, as Mike
Speaker Change: talked about during the call in terms of our combined safety data. I think, Mike, you can talk about the adverse event profile that we saw and how quickly they resolved.
Mike Sumner: 10 out of the 32 patients reported injection site pain. From a grading perspective, only one of those was grade 2. The rest, in fact, the rest of the entire treatment-related adverse events were grade 1 after that.
And we have.
Daider or from other-
Mike Sumner: electroporation studies that show that the injection site pain associated with the emission administration, you know, really falls off in about a sort of 5-10 minute time frame. And, you know, as part of our
Thank you.
Mike Sumner: The rollout of the device is really going to be around explaining what the patient should expect.
Mike Sumner: how the physician should educate the patient on that. Because clearly, this is a new procedure. So, you know, half of it is around, you know, the unknown. So, as we come to market, we'll very carefully be able to have materials for the patient to know what to expect. And, you know, history says that ...
Mike Sumner: Having that level of expectation in place will, you know, hopefully further diminish any adverse events associated with electroporation and diminish that injections like pain.
The End
and many more. Thank you. Thank you.
Speaker Change: I think it's also very important to note, Mike, is, you know, these adverse events are very transient. They resolve very rapidly, and, you know, certainly we hear from patients that the treatment is very tolerable, and the healthcare providers tell us that the device is very easy to use. So we think, you know, particularly in a disease like RRP, where, you know, it's really having a devastating impact on patients, that the rapid resolution of those AEs is going to be very important.
Speaker Change: So, Anish, does that answer your questions around the 3107 profile? And then we can maybe go on to the 25 launch and go-to-market strategy.
That would be great, thanks.
Speaker Change: Yeah, so as I discussed earlier on in the call, we believe that 3107 has a compelling product profile that will enable it to become the preferred product of choice for the majority of patients and physicians.
Speaker Change: And I'll hand over to Steve to expand on this in a bit more detail. But it's also, you know, we've only seen limited data from Precision to date. We haven't seen the full data package published yet from the second cohort. So I think we'll be very interested to see that data when it's published.
Speaker Change: and you know the difference in the two treatment regimens and approaches I think are going to be very interesting. I think our duration data that we expect to be able to announce later on this year it's also going to be important.
Steve Egge: So Steve, do you want to provide your point of view?
[inaudible]
Steve Egge: Yeah, so, you know, we don't know necessarily that Prestigen will be in the market, you know, before we will, we'll see kind of how things unfold. But regardless, you know, we do plan to have...
Steve Egge: MSLs out of approval, as well as national account managers engaging health plans.
Steve Egge: ahead of approval, which they can do. We think we've got a well-differentiated product based on the data that we've seen so far, so that's certainly what we'll be focused on, but we know there's tremendous unmet need.
Steve Egge: in the market and the burden around surgeries. You know, as we've talked about, every surgery matters. So, you know, as soon as we're able, as soon as we're approved, you know, we will be out there in full force making the case for 3107.
Perfect. Thank you.
Speaker Change: Your next question comes from the line of Roy Buchanan from Citizen JMP.
Roy Buchanan: Thanks for taking the call. It was about the redosing and you actually answered most of it, but I guess just think you're going to run a separate trial to look at redosing.
Speaker Change: 3107, correct. Do you plan to run that in conjunction with the confirmatory trial? Or is it going to be sequenced after the conclusion of that trial? Thanks.
Mike Sumner: Mike, do you want to talk about that redosing approach? Yeah, absolutely. So, you know, we
Mike Sumner: And, you know, we are thinking that, you know, those complete responders, you know, potentially could
The End.
maintain and
Speaker Change: At IPVC this week, there's been a lot of talk around, can you actually eliminate all the HPV-infected cells? And I think that'll be one of the interesting scientific questions that we can look at through continued dosing.
Speaker Change: but that work is going to take a while, and we'll commence that after commercial launch.
Okay, thank you.
[inaudible]
Speaker Change: There are no further questions at this time. I will now turn the call back to Jacqueline Shea for closing remarks. Please go ahead.
Jacqueline Shea: Thank you. The new immunology data that we've discussed today adds to a growing body of evidence that continues to illustrate the potential of 3107 to truly transform the treatment paradigm for patients who've been living with the devastating effects of RRP.
Jacqueline Shea: We are mindful of those patients as we remain focused on moving as quickly as possible to meet the key milestones ahead, including publishing the new immunology data, announcing new durability,
Jacqueline Shea: Submitting our BLA and preparing to be launch ready at the end of 2025, should we receive approval.
Jacqueline Shea: At the same time, we're advancing other key candidates and evaluating ways to strengthen our balance sheet to support our work going forward.
Jacqueline Shea: As we wrap up this year, I'm proud of the important progress we've made in just 12 short months, and we plan to keep that momentum going in the year ahead. Thank you for your attention, and good evening, everyone.
Thank you. Thank you. Thank you.
Speaker Change: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.
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