Q1 2025 Inovio Pharmaceuticals Inc Earnings Call
Inovio Pharmaceuticals Inc.
Speaker Change: Good afternoon, ladies and gentlemen, and welcome to the Inovio First Quarter 2025 Financial
At this time, all lines are in a listen only mode. [inaudible]
Speaker Change: Following the presentation, we will conduct a question and answer session If at any time during
Speaker Change: This call is being recorded today, Tuesday, May 13, 2025. I would now like to turn the conference over to Jennie Wilson, Director of Communications. Jennie, please go ahead.
Speaker Change: Good afternoon and thank you for joining the Anovio First Quarter 2025 Financial Results conference call.
Speaker Change: Joining me today on today's call are Dr. Jackie Shea, President and Chief Executive Officer.
Speaker Change: Dr. Mike Sumner, Chief Medical Officer, Peter Kies, Chief Financial Officer, and Steve Egge, Chief Commercial Officer.
Speaker Change: Today's call will review our corporate and financial information for the quarter ended March 31st, 2025, as well as provide a general business update. Following prepared remarks, we will conduct a question and answer session.
Speaker Change: 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 Medicine's platform, which include clinical and regulatory developments and timing of clinical data readouts and planned regulatory submissions, along with capital resources and strategic matters.
Speaker Change: All of these statements are based on the beliefs and expectations of management as of today.
Actual events or results could differ materially
Speaker Change: 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.
Speaker Change: Discall is being webcast live, and the 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 Inovio's president and CEO , Dr. Jackie Shea.
Speaker Change: Good afternoon and thank you to everyone for joining today's call.
Speaker Change: First of all, I am very pleased to say that we remain on track to submit our BLA for I-13107, our lead candidate for treatment of recurrent respiratory papillomatosis or RRP.
Speaker Change: As previously stated, our goal is to begin rolling submission in mid 2025, complete the submission in the second half, and receive file acceptance by the end of this year.
Speaker Change: This would allow for a productive date in mid-2026 if we receive prior to your review.
Speaker Change: Our primary focus continues to be the submission of our BLA for 30107.
Speaker Change: We reported in March that we had resolved the manufacturing issue involving the single use array component of the selector device.
Speaker Change: and we have now moved on to the next step, initiating the device design verification testing known as DB testing, required for our IND update and BLA submission.
Speaker Change: We've also been pursuing targeted opportunities to highlight key data from our completed phase
Speaker Change: We were delighted to announce the publication of clinical and immunology data from that trial in nature communications in February .
Speaker Change: We also look forward to the publication of the previous the announced data on the longer-term clinical effect of 3107, which has been submitted to a peer-reviewed journal.
Speaker Change: In addition, we've been very active at scientific conferences this spring, which has been integral to our strategic outreach to healthcare providers and care opinion leaders.
Mike will provide an update on that shortly.
Speaker Change: On the commercial readiness month, on-going market research with physicians, patients and payers, continues to support our beliefs that 31.07 has the potential to be the preferred product for patients and physicians they've approved.
Speaker Change: Steve will provide a brief overview of both market opportunity and insights from our market research with healthcare providers later in the call.
Speaker Change: And finally, our highlight from our earlier stage pipeline is quarter, with the announcement of promising interim results from an ongoing phase one, proof of concept trial, evaluating DNA-encoded monoclonal antibodies or DMAPs.
Speaker Change: We're excited about the potential of this next generation technology and what it means for the future of our DNA Medicine's pipeline.
Speaker Change: With that, I'll turn it over to Mike for a brief update on our progress with 30107 and some highlights from my recent presentations. Mike?
Mike: Thanks, Jackie. As Jackie noted, we are making steady progress towards our BLA Submission
Mike: The manufacturing issue involving the single-use array component of the device has been resolved and we have begun manufacturing the updated commercial grade arrays and initiated DV testing which is a significant component of the device-related BLA modules.
Mike: As a reminder, we have completed drafting all the non-device modules, including non-clinical, clinical and CMC modules.
Mike: and we'll request to begin the submission of our BLA under the FDA's Rolling Submission process in mid-2020-25.
Mike: In addition, we remain on track to launch our confirmatory trial targeting more than 20 sites at major US medical centers.
Mike: While that work is underway, we've leveraged several important opportunities to engage with the RRP community. Sharing why we believe 31.07 could be the preferred product for patients and doctors who are eager for an alternative to surgery.
Mike: 30107 offers the potential for a majority of patients to see significant clinical benefit that improves over time, a favorable safety profile, and a patient-centric treatment
Mike: This spring we have presented key clinical and safety data at multiple scientific conferences.
Mike: including the inaugural National HPV conference, the first scientific conference in the U.S. to focus solely on HPV research and related diseases.
Mike: It was an excellent opportunity to connect with experts from across sectors and to broaden the awareness of both RRP and the potential benefit of INO-3107.
Mike: This week, Anovio will also be presenting a year two and three durability data at the combined Adelaire Ancology Spring Meeting, otherwise known as Colson.
Mike: This is the largest U.S. national meeting for Otto Larrangologists, the specialist physicians who treat the majority of RRP patients.
Mike: At these conferences, we've been able to paint a compelling picture of the potential impact of 3107 for the RRP community, for the patient's physicians and caregivers, who know that every single surgery comes with both significant risk and cost.
Mike: As a reminder, we completed the Phase 1-2 Open Label Trial of IMO-3107, called RRP-001. In patients who required at least two surgeries in the previous year, for the removal of HPV-6
Mike: Every surgery performed after the initial dose was counted against the efficacy endpoint in our trial, where we followed the patients for 12 months.
Mike: We also conducted a retrospective trial called RRP 002 where we collected data on 28 of the original 32 patients to assess the longer-term treatment effect with a medium follow-up of 2.8 years.
The key takeaway from these two studies is clear [inaudible]
Mike: We saw a statistically significant reduction in surgeries in the first 12 months following treatment and that clinical benefit continued to improve beyond the initial one year period into the year two and three timeframe.
Mike: More specifically, in the first year, 72% of patients saw a 50-100% reduction in the number of surgeries after starting treatment with 3107.
Mike: With no additional dosing, this number increased to 86% in the second year, with half of the patients requiring no surgeries at all.
Mike: Moving on to next steps, we are focused on completing the DV testing and finalizing the device-related aspects where BLA.
Mike: As a reminder, this testing is required for both our BLA submission and to update the ID before we can dose patients in our confirmatory trial.
Mike: At Timeline for the BLA remains the same. We plan to request rolling submission and begin submitting our modules in mid 2025 and complete the full submission in the second half of the year.
Mike: A goal is to have FDA acceptance of that complete BLA filing by year end, and if we receive priority review, that could allow for a pedophadate in mid-2026.
Mike: After that, we plan to finalize our longer-term treatment strategy with the goal of maintaining or even improving upon the clinical benefits seen to date and submit a proposed protocol to the FDA to support a supplemental BLA in the future.
Mike: The ability to maintain or increase the immune response over time by continuing treatment is a key feature of our DNA medicines platform and has been demonstrated in our previous work
Mike: And finally, as we noted last quarter, deployment of our medical science liaison team is planned for this quarter, and I look forward to providing an update at our next quarterly report.
Speaker Change: I will now turn it over to our Chief Commercial Officer, Steve Egge, for some insights on the market of Chinti for 31A7. Steve?
Steve Egge: Thanks Mike. I'd like to spend a few minutes on the significant market opportunity we see for 3107 and why we believe that 3107 could be the product of choice for patients and providers.
I'll start by describing the market opportunity.
Steve Egge: RRP is a rare HPV-related disease that affects around 14,000 people in the US because HPV vaccination rates are plateauing and because the majority of the adult population remain unvaccinated risk of RRP remains RRP remains unvaccinated risk of RRP remains unvaccinated risk of RRP
Steve Egge: HPV experts believe the HP vaccine is unlikely to have a significant impact on RRP prevalence in adults in the near term or for at least a generation.
Steve Egge: This disease is characterized by persistent work like growths called papilloma in the respiratory tract. There are currently no regulatory approved therapeutic options available and the current standard of care is surgery, often multiple surgeries a year.
Steve Egge: These surgeries have the potential to cause irreversible harm to the vocal cords and surgery does not address the underlying disease so the papalomas can grow back repeatedly.
Steve Egge: Patients and doctors have expressed time and again the urgent need for a non-surgical treatment of an option that addresses the underlying cause of the disease.
Steve Egge: And this is where we see the potential for 3107. In our trial, 3107 provided significant clinical benefit was well tolerated and is delivered via a simple patient-centric treatment
Steve Egge: After reviewing our data during market research, many learning colleges commented that about 8 out of 10 patients achieved a 50 to 100 percent reduction in surgeries, meaning the vast majority of patients saw a significant benefit from treatment.
Steve Egge: And this is the data that they found most compelling and that they believe will be most meaningful to patients
Steve Egge: Treatment with 3107 was also well tolerated with the most common adverse events being transient
Steve Egge: The simplicity of our treatment regimen is also key. Most notably, 3107 does not require scoping and surgeries during the window as part of the treatment regimen, which is vitally important when every single surgery comes with real risk and costs to patients.
Steve Egge: 30107 can also be administered in the physician's office and does not require a referral to an infusion center which leads the physician in control.
Steve Egge: These and other market insights gathered to date will be critical as we continue to advance our commercial planning. We're currently refining our go-to-market model and planning a further build out of the commercial organization and I look forward to providing more updates on our progress next quarter. With that, I'll turn it back to Jackie.
Jackie Shea: Thanks, Steve. As I mentioned earlier, we're also making important progress with the next generation of DNA medicine, with our DNA-encoded monoclonal antibody or DMAB technology.
Jackie Shea: This technology leverages the strengths of our DNA medicine platform to create precisely designed DNA placements that encode for specific monoclonal antibodies.
Jackie Shea: These cosmetics can then be delivered directly into muscle cells in the arm using our selector delivery system. The demaps are produced within the muscle cells and then secreted into the blood where they circulate within the body.
Jackie Shea: This contrasts with conventional monoclonal antibodies, which are manufactured in in vitro systems, and then need to be administered through regular infusions or injections.
Jackie Shea: We are researching the potential of this technology in several disease targets and recently announced interim clinical data from an ongoing phase 1 proof-of-concept trial evaluating team-ups for COVID-19.
Speaker Change: Led by the Wistorans choosing collaboration with AstraZeneca, the University of Pennsylvania, and Anovio
Jackie Shea: and funded by DARPA and JPO. This trial provided the first clinical proof of concept that the team-ups can be durable and simultaneously produced inside the human body.
Jackie Shea: The data showed long-lasting in vivo antibody production across 72 weeks.
Jackie Shea: No anti-drug antibodies, or immune rejection of the DMAPs, and the treatment was well-tolerated with no serious adverse events related to treatment.
Jackie Shea: Of note, we saw that the Express DMAB successfully bounced the SARS-CoV-2 spike protein receptor for binding domain, confirming functional activity.
Jackie Shea: To be clear, this was a proof of concept study of our technology, Anovio does not have plans to develop these demaps for COVID-19 going forward.
Jackie Shea: Part of this data will be presented at ASGCT this week by our partners at the Wistow Institute, and a manuscript has been submitted to a leading peer review journal and is currently available in pre-print on Research Squats.
Jackie Shea: We believe this technology has breakthrough potential and could overcome many of the challenges seen with traditional monoclonal antibody production.
Jackie Shea: offering rapid manufacturing, low cost of production, temperature stable storage and distribution, and the ability to re-dose. DMAB technology could help expand use, reduce cost, and enable access in low resource settings.
Jackie Shea: And importantly, our DNA-based approach has demonstrated sustained antibody production without generating antitrug antibodies, making it a potentially promising long-term solution for conditions to require and continue historically.
Jackie Shea: We're excited about the potentially broad application we see for this technology, including the potential to leverage the sustained in vivo protein production we have observed, to produce other kinds of proteins beyond monoclonal antibodies.
Jackie Shea: For instance, to enable protein replacement therapies and as a potential alternative to gene therapy for some indications.
Jackie Shea: On now, hand over to our CEO Peter Kies for a brief financial update. Peter?
Peter Kies: Thanks, Jackie. Today, I'd like to provide an overview of Enobio's financial results for the first quarter 2025.
Peter Kies: As Jackie mentioned, we're focusing resources on advancing our lead candidate, 30107.
Peter Kies: and our other strategic priorities. And I'm pleased to report that we've been able to support significant progress towards those goals while continuing to reduce cough.
Peter Kies: to 25.1 million in the first quarter of 2025, a 20% decrease.
Peter Kies: Annovio's net loss for the first quarter of 2025 was 19.7 million or 51 cents per share basic and dilutive compared to a net loss of 30.5 million or a dollar 31 per share basic and dilutive for the first quarter of 2024.
Peter Kies: We finished the first quarter of 2025 with 68.4 million in cash, cash equivalence, and short-term investments.
Compared to 94.1 million [inaudible]
Peter Kies: as of December 31, 2024. We estimate our cash runway to take us into the first quarter of 2026.
Peter Kies: This projection includes an operational net cash burn estimate of approximately 22 million for the second quarter of 2025.
Peter Kies: These cash runway projections do not include any further capital raise activities that we 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 quarterly report, Form 10Q, filed with the FCC today. And with that I'll turn it back over to Jackie.
Jackie Shea: Thanks, Peter. I'd now like to open up the call to answer any questions you might have. Operator?
Speaker Change: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the store, followed by the one on your touch-tone phone.
Speaker Change: You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number 2
Speaker Change: If you are using a speaker phone, please lift the handset before pressing any keys. One moment, please, for your first question.
Speaker Change: Your first question comes from the line of Roy Buchanan from Citizens. Please go ahead.
Speaker Change: And thanks for taking the questions. I guess to start, maybe can you just give any additional detail on that on the cause and presentation coming up in a few days? Are you going to have any data beyond year three and what else are you going to present other than surgery counts?
Speaker Change: Hi, Roy. Nice to hear from you. Mike, do you want to get some further backgrounds on our cousin presentation? Yes, absolutely so. We'll obviously be focusing on the surgery counts as obviously every surgery matters to these patients because of the risk in the cost, but we will be able to show a little bit more color around that.
Speaker Change: Also, as part of having an oral presentation at Cosm, you also get to submit the data to
Speaker Change: So we will hopefully be having that peer-reviewed publication available soon also which will again provide additional color.
Speaker Change: Yeah, and I think the real importance of Colson is this is really the primary meeting for Ovalor and Colleges, who are the primary treating physicians for our RP. So it really is a good opportunity to get our data in front of the physicians who really matter for our RP patient.
Speaker Change: Okay, great. And then a follow-on, can you remind me how many MSLs you planned on board? And I had a question about epidemiology. I mean, as we know that the 14,000 numbers a bit older, you guys and presigents saying 27,000. I'm not sure how they're backing that up.
Speaker Change: Are you coming up with your own number or how do you plan to think about the market and when what might we see an updated number if you are? Thanks.
Speaker Change: Yeah, both great questions. So maybe we'll take the AP questions first of all. The 14,000 is of active cases here in the US. It's relatively old data. It's the most commonly cited data by most experts in the field.
Speaker Change: And we have been conducting our own research to try and get a better handle on that number and our own research suggests in common with many rare diseases that might be an underestimate.
Steve Egge: Steve, do you want to add any other comments to that? Yeah, the only thing I would add is...
Speaker Change: And this is common in rare disease. For RRP, there's no diagnostic code, right? So there's no source to go to get kind of account of of a number of patients. So we have done some research and continue to do research looking at procedure codes that are used to conduct RRP procedures. Even that is not particularly straightforward. Okay, forward.
Speaker Change: But based on what we see, we do think the 14,000 is an underrepresentation, but we're continuing to look at this through research and as we go forward maybe able to share more, but now we prefer to just be conservative and quote the 14,000 but again we do think it's an underrepresentation.
Speaker Change: And then that, of course, is the prevalent pool. And on top of that, there are new cases arising every year. And the figures there are about 1.8 per 100,000 new or instant cases a year.
Speaker Change: So actually this is you know for a rare disease there is actually a pretty significant pool of patients that need to be addressed.
Speaker Change: In terms of the MSL, Mike Chumunter, I mean, we haven't specifically guided yet as to the size of the MSL team, but, you know, as you've heard, Steve.
Mike: mentioned before. I mean, the actual number of physicians treating RRP is not that large.
Mike: And so, you know, as we are considering the number of MSLs, it's really about what we think that sort of key opinion leader base will look like, and also considering just the sort of geography of where we can, where we'll have those interactions and to optimize that.
Okay, thank you.
Speaker Change: Thank you. Your next question comes from the line of Jay Olson from Openheimer. Please go ahead.
Jay Olsen: Well, hey congrats on the progress and thanks for taking the questions.
Speaker Change: Maybe to start with, as you look ahead to a potential approval for 30107
Speaker Change: Do you expect to have a surgery sparing claim in the label and how important is the surgery sparing benefit for differentiation from your competitors?
Yeah, that's a great question, Mike.
Speaker Change: I mean, it's an interesting terminology. I mean, it ultimately, I mean, in that discussions with the FDA, I mean, they recognize the clinical benefit is that reduction in surgeries.
Speaker Change: How the FDA will actually sort of approach that terminology, I think it is too early to predict, but I think it will lead, you know, all positively to a reduction in surgeries.
Speaker Change: Okay, great, thank you. And then, since you provided the update on your rolling submission of a BLA, is there any update on your registration strategy and other geographies outside of the U.S.?
Speaker Change: It's also going to be a placebo controlled trial, two to one randomization, and in discussions with European regulators and with the UK regulators, they've been very clear that they expect to see placebo controlled data for approval.
Speaker Change: So as Mike mentioned earlier on in the call, after we've started our confirmatory trial and after our BLA is in, the next thing we're really going to be focusing on is getting in a protocol for continued treatment.
Speaker Change: That's our next media priority, but certainly we've had some good discussions with Europeans regulators, and we think we're well aligned with them in terms of the design of any trials required there.
Okay, great. Thank you.
Speaker Change: And then for your DMAB platform, we understand that you use COVID-19 as a proof of concept. What are you thinking of in terms of your initial indication for the DMAB technology?
Speaker Change: But as you can imagine, with such a broad and versatile technology, we can apply this to monoclonal antibodies, we can also apply this to proteins that are missing or defective in certain indications, such as enzyme replacement therapies, so we'll be providing more details when we have additional data to share that.
Speaker Change: Okay, great. We'll look forward to that. Thanks again for taking the questions.
Thank you.
Speaker Change: Thank you. Your next question comes from Sudan Loganathan from Stevens. Please go ahead.
Speaker Change: Hi, everyone. I appreciate the update today, and congrats on the continued progress, you know, toward filing for I-307.
My first question is regarding the Priority Review for 3107 The Priority Review for 31077777
Speaker Change: Could receiving priority review status be in any jeopardy with the potential of another RFP treatment on the market this August last September potentially with competitors therapeutic? Or is there anything else outstanding that is the final steps to actually making sure that the filing is completed and for priority review status?
Thanks for that.
Speaker Change: I mean, from when you look at the sort of guidelines around accelerated approval
Speaker Change: I mean, it talks to, obviously, both the clinical benefit in, you know...
Most often, a red disease for RRP.
but it also talks to...
The difference of the product we're bringing to market.
Speaker Change: I think we've always felt that based on some of the presidium data with potentially their efficacy could be impacted by neutralizing antibodies.
Speaker Change: or by the papilloma microenvironment neither of which impact INO-3107. We've always felt there is a population that can only be uniquely treated with 3107.
Speaker Change: So I don't think if we have to have that discussion with the agency, I think we have a very solid rationale of why 3107 should still be brought to market under the accelerated approval pathway.
Speaker Change: Great. Thank you. And my second question really quick is, you know, since your filing is expected to be completed by the year end of 2025, is there any plans to add any more data, you know, to the actual filing or is it already all pencils down when it comes to adding to the data package or the filing package and just now jumping through the hoops of actually getting
Speaker Change: Our overall clinical and safety package. But we, if I mentioned earlier on the call, that's all now integrated. So from a clinical perspective, you know, it really is pencils down and they're ready to go.
Speaker Change: But it's an important point we got right through the therapy designation and then our initial discussions with the FGA were just on that initial phase 12 month date and since then we've really strengthened the package with very detailed immunology characterization that was published in February Nature Communications.
Speaker Change: And then what we think is very exciting year two and year three durability data, where we saw that the clinical benefit that we saw in
Speaker Change: The first 12 month period continued on into the second 12 months and the third 12 month period and actually improved during the second 12 month period.
Speaker Change: So I think, you know, we now have a very compelling package to put in front of the FDA. And at some point, I mean, as we've said on previous calls, we've actually got a three-year history of these patients, so we really can sort of compare light for light.
Speaker Change: and as we talked about on the call, we're seeing a very significant and impressive reduction in surgeries and that only I think becomes more impressive when you look at these patient history. So all of that is now incorporated into our clinical modules.
Speaker Change: Great, I really appreciate all the added detail and looking forward to the execution in the second half of this year.
Thank you.
Speaker Change: Thank you. Your next question comes from the line of Roger Song from Jeffries. Please go ahead.
Great. Thanks for taking on questions.
Speaker Change: and then for the updates. So two questions from us. One is very interesting for the year
France 3107
given your initial approval
Speaker Change: will be based on the current data. How should we think about the pricing as you continue to accumulate the durability data?
Speaker Change: The second question is related to the confirmatory study and then emotionalization. What's the current thinking about overall costs or the next steps?
Speaker Change: and then how you will consider in partnership or your own to fund the next steps. Thank you.
Speaker Change: Great, thank you. That's their excellent question. Steve, do you want to come in some on?
Steve Egge: I thought some pricings for the initial treatment regimen? Yeah, so we've done quite a bit of research with payers. We've effectively spoken with payers that represent about 70% of commercialized in the US.
Speaker Change: We've gone through the data with them, talked about kind of price ranges in the rare disease.
Kind of Space [inaudible]
Speaker Change: You know, payers felt that that was appropriate, given the product, given the benefits.
Speaker Change: and the analogy that we shared, and we've mentioned this before, spring works therapeutic product Axivio for Desmoid tumors, we think is a good analogy that product is priced at 360,000.
for a year, and that's kind of the guidance that we've...
Speaker Change: Provided around pricing and payers seem very open. They think that's appropriate. We haven't commented or guided on pricing in terms of
Speaker Change: Reed dosing, or continued treatment over time, or duration we haven't kind of guided to that, just we've really focused on that initial four doses.
Speaker Change: So, in terms of funding in the US, we plan to bring 31.07 to market ourselves in the US, we think with the relatively
Speaker Change: XUS, certainly we're very open to partnering to bring 3107 to market XUS.
Got it. Thank you.
Speaker Change: Thank you. Your next question comes from the line of Yi Chen from HC Winwright. Please go ahead.
Yi Chen: Thank you for taking my question. Does the Curlin Terrace Policy all of the most favorite
Speaker Change: Yeah, I mean, clearly this is a rapidly evolving situation and I think we like others are waiting to see how this plays out.
Speaker Change: But what I would say at the moment is we're very much focused on our first approval in the US.
That's where our focus is [inaudible]
Speaker Change: So as a first U.S. launch without a product available in another market, that would be something that we wouldn't have to face in those initial launch years. But clearly this is going to be very important for the entire sector and we'll be playing close attention to the sensitive
Got it. Thank you.
Speaker Change: Thank you. Your next question comes from the line of Gregory Renza from RBC Capital. Please go ahead
Speaker Change: Hi, this is me, Chancellor Glad, thanks for taking our question. I wonder if you were planning on disclosing based on characteristics for the patients in the confirmatory trial?
Speaker Change: trial, and how my HPV genotype affects these trial results based on the findings you disclosed in your Nature Communications paper. Thanks so much.
Speaker Change: Yeah, apologies, we couldn't hear the first part of your question, could you repeat that?
Speaker Change: We are wondering if you were planning on disclosing the baseline characteristics.
Speaker Change: For the patients in the confirmatory trial, related to HPV genotype
Speaker Change: I can't remember the details in there, but we've always talked about the HPV serotypes was actually very representative of what the normal RRP population is, so there were just over 60% were HPV 6, 30% were HPV 11, and then there were some patients who were co-infected.
Speaker Change: So, exactly what you'd expect to see in the normal RRP population.
Speaker Change: I think that's in the paper somewhere but it's been a while since I've read it.
Speaker Change: So that was the split in our phase one, two trial mic, you know, in terms of the confirmatory trial, we're going to try and recruit the patient population that's very representative of the normal RRP patient population.
which is, as Mike said, predominant in HPV-6. [inaudible]
Speaker Change: Excuse Mail, and so we'll look to try and recruit the appropriate population. It's very similar to our phase 12, which we do think it was
Replicate what the actual RRP population is.
Subs by www.zeoranger.co.uk
Speaker Change: Thank you. There are no further questions at this time. I'd like to turn the call back to Jackie Shea for final closing comments.
Thank you.
Speaker Change: As I've outlined here today, we're making significant progress and remain focused on the catalysts ahead that will help us achieve our primary goals, submitting our BLA for 30107 and being prepared for swift and efficient commercial launch if approved.
Speaker Change: I'm really excited about how 31.07 could change the treatment paradigm for RRP and for the patients who could benefit from it.
Speaker Change: We're moving forward knowing that each day and each surgery matters to patients and our mission.
Speaker Change: Thank you. Ladies and gentlemen, this concludes your call for today. We thank you for participating and ask that you please disconnect your lines.