Inovio Pharmaceuticals Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 13, 2025

Key Takeaways

  • Inovio remains on track to submit its BLA for INO-3107 in mid-2025 and, with priority review, could see a PDUFA date by mid-2026.
  • The company resolved the manufacturing issue with the single-use array component of its Selectra device and has initiated design verification (DV) testing required for IND updates and the BLA.
  • Phase 1/2 data showed a 72% reduction in surgeries in Year 1 and an 86% reduction in Year 2 for RRP patients treated with INO-3107, with half of the patients requiring no surgeries in the second year.
  • Interim Phase 1 proof-of-concept results for the dMAb platform demonstrated durable in vivo antibody production up to 72 weeks, no anti-drug antibodies, and no serious treatment-related adverse events.
  • In Q1 2025, operating expenses fell 20% year-over-year, but with $68.4 million in cash, Inovio’s runway extends only into Q1 2026, suggesting potential future financing needs.
AI Generated. May Contain Errors.
Earnings Conference Call
Inovio Pharmaceuticals Q1 2025
00:00 / 00:00

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Operator

This call is being recorded today, Tuesday, 05/13/2025. I would now like to turn the conference over to Jenny Wilson, Director of Communications. Jenny, please go ahead.

Jennie Willson
Jennie Willson
Director of Communications at Inovio Pharmaceuticals

Good afternoon, and thank you for joining the Inovio first quarter twenty twenty five financial results conference call. Joining me today on today's call are Doctor. Jackie Shea, President and Chief Executive Officer Doctor. Mike Sumner, Chief Medical Officer Peter Keyes, Chief Financial Officer and Steve Ege, Chief Commercial Officer. Today's call will review our corporate and financial information for the quarter ended 03/31/2025, as well as provide a general business update.

Jennie Willson
Jennie Willson
Director of Communications at Inovio Pharmaceuticals

Following prepared remarks, we will conduct a question and answer session. During the call, we will be making forward looking statements regarding future events and the future performance of the company. These events relate to our business plans to develop Inovio's DNA medicines platform, which include clinical and regulatory developments and timing of clinical data readouts and planned regulatory submissions, along with capital resources and strategic matters. All of these statements are based on the beliefs and expectations of management as of today. Actual events or results could differ materially.

Jennie Willson
Jennie Willson
Director of Communications at Inovio Pharmaceuticals

We refer you to the documents we file from time to time with the SEC, which under the heading Risk Factors identify important factors that could cause actual results to differ materially from those expressed by the company verbally, as well as statements made within this afternoon's press release. This call is being webcast live, a link can be found on our website, ir.inovio.com, and a replay will be made available shortly after this call is concluded. I will now turn the call over to Inovio's President and CEO, Doctor. Jackie Hsieh.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Good afternoon, and thank you to everyone for joining today's call. First of all, I am very pleased to say that we remain on track to submit our BLA for INO-three thousand '1 hundred '7, our lead candidate for treatment of recurrent respiratory papillomatosis or RRP. As previously stated, our goal is to begin rolling submission in mid-twenty twenty five, complete the submission in the second half, and receive file acceptance by the end of this year. This would allow for a PDUFA date in mid-twenty twenty six if we receive priority review. Our primary focus continues to be the submission of our BLA for 03/2007.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

We reported in March that we had resolved the manufacturing issue involving the single use array component of the Selectra device, 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 submissions. We've also been pursuing targeted opportunities to highlight key data from our completed phase onetwo trial. We were delighted to announce the publication of clinical and immunology data from that trial in Nature Communications in February. We also look forward to the publication of the previously announced data on the longer term clinical effect of three thousand one hundred seven, which has been submitted to a peer reviewed journal. In addition, we've been very active at scientific conferences this spring, which has been integral to our strategic outreach to healthcare providers and key opinion leaders.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Mike will provide an update on that shortly. On the commercial readiness front, ongoing market research with physicians, patients and payers continues to support our belief that 3,107 has the potential to be the preferred product for patients and physicians if approved. Steve will provide a brief overview of both market opportunity and insights from our market research with healthcare providers later in the call. And finally, a highlight from our earlier stage pipeline this quarter was the announcement of promising interim results from an ongoing phase one proof of concept trial evaluating DNA encoded monoclonal antibodies or dMAbs. We're excited about the potential of this next generation technology and what it could mean for the future of our DNA medicines pipeline.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

With that, I'll turn it over to Mike for a brief update on our progress with 03/2007 and some highlights from our recent presentations. Mike?

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

Thanks, Jackie. As Jackie noted, we are making steady progress towards our BLA submission goal for INO-three thousand one hundred seven. 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. As a reminder, we have completed drafting all the non device modules, including nonclinical, clinical, and CMC modules, and we'll request to begin the submission of our BLA under the FDA's rolling submission process in mid twenty twenty five. In addition, we remain on track to launch our confirmatory trial targeting more than 20 sites at major US medical centers. While that work is underway, we've leveraged several important opportunities to engage with the RRP community, sharing why we believe thirty one zero seven could be the preferred product for patients and doctors who are eager for an alternative to surgery.

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

Thirty one zero seven 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 regimen. This spring, we have presented key clinical and safety data at multiple scientific conferences, including the inaugural National HPV Conference, the first scientific conference in The US to focus solely on HPV research and related diseases. It was an excellent opportunity to connect with experts from across sectors and to broaden awareness of both RRP and the potential benefit of INO-three thousand one hundred seven. This week, Inovio will also be presenting a year two and three durability data at the combined otolaryngology spring meeting, otherwise known as COSM. This is the largest US national meeting for otolaryngologists, the specialist physicians who treat the majority of RRP patients.

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

At these conferences, we've been able to paint a compelling picture of the potential impact of 03/2007 for the RRP community, for the patients, physicians, and caregivers who know that every single surgery comes with both significant risk and cost. As a reminder, we completed a phase one two open label trial of INO-three thousand one hundred seven called RRP001 in patients who required at least two surgeries in the previous year for the removal of HPV six and HPV eleven related papillomas. Every surgery performed after the initial dose was counted against the efficacy endpoint in our trial, where we followed the patients for twelve months. We also conducted a retrospective trial called RRP-two, where we collected data on 28 of the original 32 patients to assess the longer term treatment effect with a medium follow-up of two point eight years. The key takeaway from these two studies is clear.

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

We saw a statistically significant reduction in surgeries in the first twelve months following treatment. And that clinical benefit continued to improve beyond the initial one year period into the year two and three timeframe. More specifically, in the first year, seventy two percent of patients saw a fifty to one hundred percent reduction in the number of surgeries after starting treatment with three thousand one hundred seven. With no additional dosing, this number increased to eighty six percent in the second year, with half of the patients requiring no surgeries at all. Moving on to next steps, we are focused on completing the DV testing and finalizing the device related aspects of our BLA.

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

As a reminder, this testing is required for both our BLA submission and to update the IND before we can dose patients in our confirmatory trial. Our timeline for the BLA remains the same. We plan to request rolling submission and begin submitting our modules in mid-twenty twenty five and complete the full submission in the second half of the year. Our goal is to have FDA acceptance of our complete BLA filing by year end. And if we receive priority review, that could allow for a PDUFA date in mid twenty twenty six.

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

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. 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 in other HPV related indications. 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. I will now turn it over to our Chief Commercial Officer, Steve Ege, for some insights on the market opportunity for 03/2007. Steve?

Steve Egge
Steve Egge
CCO at Inovio Pharmaceuticals

Thanks, Mike. I'd like to spend a few minutes on the significant market opportunity we see for three thousand one hundred seven and why we believe that three thousand one hundred seven could be the product of choice for patients and providers. I'll start by describing the market opportunity. RRP is a rare HPV related disease that affects around fourteen thousand people in The US. Because HPV vaccination rates are plateauing, and because the majority of the adult population remain unvaccinated, risk of RRP remains.

Steve Egge
Steve Egge
CCO at Inovio Pharmaceuticals

HPV experts believe the HPV vaccine is unlikely to have a significant impact on RRP prevalence in adults in the near term, or for at least a generation. This disease is characterized by persistent wart like growth 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. These surgeries have the potential to cause irreversible harm to the vocal cords and surgery does not address the underlying disease so the papillomas can grow back repeatedly. Patients and doctors have expressed time and again the urgent need for a non surgical treatment option that addresses the underlying cause of the disease.

Steve Egge
Steve Egge
CCO at Inovio Pharmaceuticals

And this is where we see the potential for three thousand one hundred seven. In our trial, three thousand one hundred seven provided significant clinical benefit, was well tolerated, and is delivered via a simple patient centric treatment regimen. After reviewing our data during market research, many laryngologists commented that about eight out of ten patients achieved a fifty percent to one hundred percent reduction in surgeries, meaning the vast majority of patients saw significant benefit from treatment. And this is the data that they found most compelling and that they believe will be most meaningful to patients. Treatment with three thousand one hundred seven was also well tolerated with the most common adverse events being transient injection site pain and fatigue, and there were no discontinuations.

Steve Egge
Steve Egge
CCO at Inovio Pharmaceuticals

The simplicity of our treatment regimen is also key. Most notably, three thousand one hundred seven 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 cost to patients. Three thousand one hundred seven can also be administered in the physician's office and does not require a referral to an infusion center, which leaves the physician in control. 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.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

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. This technology leverages the strengths of our DNA medicine platform to create precisely designed DNA plasmids that encode for specific monoclonal antibodies. These plasmids can then be delivered directly into muscle cells in the arm using our CELLECTRA delivery system. The dMAbs are produced within the muscle cells and then secreted into the blood where they circulate within the body.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

This contrasts with conventional monoclonal antibodies, which are manufactured in in vitro systems and then need to be administered through regular infusions or injections. We're researching the potential of this technology in several disease targets and recently announced interim clinical data from an ongoing Phase one proof of concept trial evaluating dMAbs for COVID-nineteen, led by the Wistar Institute in collaboration with AstraZeneca, the University of Pennsylvania and Inovio and funded by DARPA and JPO, this trial provided the first clinical proof of concept that dMAbs can be durably and simultaneously produced inside the human body. The data showed long lasting in vivo antibody production across seventy two weeks, no anti drug antibodies or immune rejection of the dMAbs, and the treatment was well tolerated with no serious adverse events related to treatment. Of note, we saw that the expressed dMAbs successfully bound the SARS CoV-two spike protein receptor binding domain confirming functional activity. To be clear, this was a proof of concept study of our technology.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Inovio does not have plans to develop these dMAbs for COVID-nineteen going forward. Part of this data will be presented at ASGCT this week by our partners at the Wistar Institute and a manuscript has been submitted to a leading peer reviewed journal and is currently available in preprint on Research Square. We believe this technology has breakthrough potential and could overcome many of the challenges seen with traditional monoclonal antibody production, offering rapid manufacturing, low cost of production, temperature stable storage and distribution, and the ability to redose, dMAb technology could help expand use, reduce cost and enable access in low resource settings. And importantly, our DNA based approach has demonstrated sustained antibody production without generating anti drug antibodies, making it a potentially promising long term solution for conditions requiring continuous therapy. 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.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

For instance, to enable protein replacement therapies and as a potential alternative to gene therapy for some indications. I'll now hand over to our CFO, Peter Keyes, for a brief financial update. Peter?

Peter Kies
Peter Kies
CFO at Inovio Pharmaceuticals

Thanks, Jackie. Today, I'd like to provide an overview of Inovio's financial results for the first quarter twenty twenty five. As Jackie mentioned, we're focusing resources on advancing our lead candidate 03/2007 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 costs. As you can see here, we've been able to significantly reduce our operating expenses over the past year.

Peter Kies
Peter Kies
CFO at Inovio Pharmaceuticals

This quarter's operating expenses dropped from $31,500,000 in the first quarter of twenty twenty four to $25,100,000 in the first quarter of twenty twenty five, a 20% decrease. Inovio's net loss for the first quarter of twenty twenty five was $19,700,000 or $0.51 per share basic and dilutive compared to a net loss of $30,500,000 or $1.31 per share basic and dilutive for the first quarter of twenty twenty four. We finished the first quarter of twenty twenty five with $68,400,000 in cash, cash equivalents and short term investments compared to 94,100,000.0 as of 12/31/2024. We estimate our cash runway to take us into the first quarter of twenty twenty six. This projection includes an operational net cash burn estimate of approximately $22,000,000 for the second quarter of twenty twenty five.

Peter Kies
Peter Kies
CFO at Inovio Pharmaceuticals

These cash runway projections do not include any further capital raise activities that we may undertake. As a reminder, you can find our full financial statements in this afternoon's press release as well as in our quarterly report Form 10 Q filed with the SEC today. And with that, I'll turn it back over to Jackie.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

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

Operator

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the one on your touch tone phone. 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 two. Please go ahead.

Roy Buchanan
Roy Buchanan
Equity Research Analyst at Citizens

Hey, thanks for taking my questions. I guess to start, maybe can you just give any additional detail on the COSM 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?

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Hi, Roy, nice to hear from you. Mike, do you want to give some further background on our COSM presentation?

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

Yeah, absolutely. So we'll obviously be focusing on the surgery counts as obviously every surgery matters to these patients because of the risk and the cost. But we will be able to show a little bit more color around that. Also as part of having an oral presentation at COSM, you also get to submit the data to laryngoscope. So we will hopefully be having that peer reviewed publication available soon also, which will again provide additional color.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Yeah, and I think the real importance of COSM is this is really the primary meeting for otolaryngologists who are the primary treating physicians for RRP. So it really is a good opportunity to get our data in front of the physicians who really matter for RRP patients.

Roy Buchanan
Roy Buchanan
Equity Research Analyst at Citizens

Okay, great. And then a follow on: can you remind me how many MSLs you plan to onboard? And I had a question about epidemiology. I mean, as we know that the 14,000 numbers a bit bit older, you guys and pathogens saying 27,000, although I'm not sure how they're backing that up. Are you coming up with your own number or how do you plan to think about the market and when might we see an updated number if you are? Thanks.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Yeah, both great questions. So maybe we'll take the EP question first of all. So, yep, the fourteen thousand of active cases here in The US is relatively old data. It's the most commonly cited data by most experts in the field. And we have been conducting our own research to try and get a better handle on that number.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Our own research suggests, in common with many rare diseases, that that might be an underestimate. Steve, do you want to add any other comments to that?

Steve Egge
Steve Egge
CCO at Inovio Pharmaceuticals

Yeah, the only other thing I would add is, 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 a count of the 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. But based on what we see, we do think the fourteen thousand 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.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

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. So actually this is, you know, for a rare disease, there is actually a pretty significant pool of patients that need to be addressed. In terms of the MSLs, Mike, do you want

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

I mean, we we haven't specifically guided yet as to the size of the MSL team. But, you know, as as you've heard Steve mention before, I mean, the the actual number of physicians treating RRP is not that large. 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.

Roy Buchanan
Roy Buchanan
Equity Research Analyst at Citizens

Okay. Thank you.

Operator

Thank you. Your next question comes from the line of Jay Olson from Oppenheimer. Please go ahead.

Jay Olson
Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.

Oh, hey. Congrats on the progress, and thanks for taking the questions. Maybe to start with, as you look ahead to potential approval for 03/2007, 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?

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Yeah. That's a great question, Mike.

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

I mean, it's an interesting terminology. I mean, ultimately, I mean, in our discussions with the FDA, I mean, they recognize the clinical benefit is that reduction in surgeries. And so obviously, as you look at our phase onetwo data, we see a statistically significant reduction in those number of surgeries.

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

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 paths lead to a reduction in surgeries.

Jay Olson
Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.

Okay, great. Thank you. And then, since you provided the update on your rolling submission of a BLA, is there any, update on your registrational strategy geographies outside The US?

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Yep, so just as a reminder, our confirmatory trial is going to be in patients who've had two or more surgeries in the prior year. 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. 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. That's our next immediate priority. But certainly we've had some good discussions with European regulators, and and we think we're well aligned with them in terms of the design of of any trials required there.

Jay Olson
Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.

Okay. Great. Thank you.

Jay Olson
Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.

And then, for your dMAb platform, we understand that you used COVID nineteen as a proof of concept. What are you thinking of in terms of your initial indication for the dMAb technology?

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Yep. So outside of those indications that have been disclosed through publications, we haven't disclosed the indications we're currently working on. 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 there.

Jay Olson
Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.

Okay, great. We'll look forward to that. Thanks again for taking the questions.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Thank you.

Operator

Thank you. Your next question comes from Sudan Lokanathan from Stephens. Please go ahead.

Sudan Loganathan
Managing Director at Stephens Inc

Hi, everyone. Appreciate the update today, and congrats on the continued progress toward filing for INO-three thousand one hundred and seven. My question, you know, my first question is regarding the priority review for 03/2007. Could receiving priority review status be in any jeopardy with the potential of another RRP treatment on the market this AugustSeptember potentially with competitors therapeutic? Or is there anything else outstanding that you know, is the final steps to actually making sure that the filing is completed and for prior review status?

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

Thanks Sudan. I mean, when you look at the sort of guidelines around accelerated approval, I mean, talks to obviously both the clinical benefit in most often a rare disease for RRP. But it also talks to the difference of the product we're bringing to market. I think we've always felt that based on some of the Precigen data with potentially their efficacy could be impacted by neutralizing antibodies or by the papilloma microenvironment, neither of which impact INO-three thousand one hundred seven, We've always felt there is a population that can only be uniquely treated with three thousand one hundred seven. So I don't think, you know, if we have to have that discussion with the agency, I think we have a very solid rationale of why three thousand one hundred seven should still be brought to market under the accelerated approval pathway.

Sudan Loganathan
Managing Director at Stephens Inc

Great. Thank you. And my second question really quick is, since your filing is expected to be completed by the year end of twenty twenty five, is there any plans to add any more data 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 it submitted.

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

Yeah. So I mean, obviously, one of the reasons we went ahead and performed RRP-two was to strengthen our overall clinical and safety package. But as I mentioned earlier on the call, that's all now integrated. So from a clinical perspective, it really is pencils down and they're ready to go.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

But it's an important point. We got breakthrough therapy designation and then our initial discussions with the FDA were just on that initial phase one to twelve month data. Since then, we've really strengthened the package with very detailed immunology characterization that was published in February in Nature Communications. And then, you know, what we think is very exciting year two and year three durability data, where we saw that the clinical benefit that we saw in the first twelve month period continued on into the second twelve months and the third twelve month period, and actually improved during the second twelve month period. So I think, you know, we now have a very compelling package to put in front of the FDA.

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

And that's an excellent 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 like for like. 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.

Sudan Loganathan
Managing Director at Stephens Inc

Great. I really appreciate all the added detail and looking forward to the execution in the second half of this year.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Thank you.

Operator

Thank you. Your next question comes from the line of Roger Song from Jefferies. Please go ahead.

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Great. Thanks for taking our question and then for the update. So, two questions from us. One is very interesting for the year two, three durability data from 03/2007. Given your initial approval will be based on the current data, how should we think about the pricing as you continue to accumulate the durability data?

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Second question is related to the confirmatory study and then commercialization. What's the current thinking about the overall cost for the next steps? And then how you will considering partnership or your own to fund this the the next steps. Thank you.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Great, thank you. They're excellent questions. Steve, do you want to comment on our thoughts on pricing for the initial treatment regimen?

Steve Egge
Steve Egge
CCO at Inovio Pharmaceuticals

Yeah, so we've done quite a bit of research with payers. In fact, we've spoken with payers that represent about 70 commercial lives in The US. We've gone through the data with them, talked about kind of price ranges in the rare disease kind of space. Payers felt that that was appropriate, given the product, given the benefits. And the analogy that we've shared, and we've mentioned this before, SpringWorks Therapeutics product, OXIVIO for desmoid tumors, we think is a good analogy.

Steve Egge
Steve Egge
CCO at Inovio Pharmaceuticals

That product is priced at 360,000 per year. And that's kind of the guidance that we've provided around pricing and payers seem very open. They think that's appropriate. We haven't commented or kind of guided on kind of pricing in terms of redosing or continued treatment over time or duration. We haven't kind of guided to that. We've really focused on that initial four doses.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

So, in terms of funding, in The US, we plan to bring 3,107 to market ourselves in The US. We think with the relatively small number of positions that we'll need to reach, we'll be able to do that with a small and efficient field force. Ex US, certainly, we're very open to partnering to to bring 3,107 to market ex US.

Roger Song
Roger Song
Senior Equity Research Analyst at Jefferies

Got it. Thank you.

Operator

Thank you. Your next question comes from the line of Yi Chen from H. C. Wainwright. Please go ahead.

Yi Chen
Managing Director, Equity Research at H.C. Wainwright & Co., LLC

Thank you for taking my question. Does the current tariff policy or the most favored pricing or sales from.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Yep. I mean and clearly, this is a a rapidly evolving situation, and I think we, like like others, are waiting to see how this plays out. 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. So as a first US launch without a product available in another market, that would be something that we wouldn't have to face in those initial launch years.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

But clearly, this is going to be very important for the entire sector, and we'll be paying close attention to this as it evolves.

Yi Chen
Managing Director, Equity Research at H.C. Wainwright & Co., LLC

Got it. Thank you.

Operator

Thank you. Your next question comes from the line of Gregory Renza from RBC Capital. Please go ahead.

Analyst

Hi. This is Mitch on for Greg. Thanks for taking our question. We were wondering if you were planning on disclosing baseline characteristics for the patients in the confirmatory trial, and how might HPV genotype affect these trial results based on the findings you disclosed in your Nature Communications paper? Thanks so much.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Yeah, apologies, we couldn't hear the first part of your question. Could you repeat that?

Analyst

Were wondering if you were planning on disclosing the baseline characteristics for the patients in the confirmatory trial related to HPV genotype.

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

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. There were just over sixty percent were HPV six, thirty percent were HPV eleven, and then there were some patients who were coinfected. So exactly what you'd expect to see in the the normal RRP population. I I think that's in the paper somewhere, but it's been a while since I've I've read it.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

So that was the that was the split in our in our phase one, trial, Mike. You know, in terms of the confirmatory trial, we're we're going to try and recruit a patient population that's very representative of the normal RRP patient population, which is, as Mike said, predominantly HPV six, skews male, and so we'll look to try and recruit the appropriate population, very similar to our phase onetwo, which we do think it was representative.

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

Yeah.

Michael Sumner
Michael Sumner
Chief Medical Officer at Inovio Pharmaceuticals

I mean, hopefully with, you know, the the targeted hundred patients, you know, that that will give us a greater chance to once again replicate what what the actual RRP population is.

Analyst

Thanks very much.

Operator

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.

Jacqueline Shea
Jacqueline Shea
CEO, President & Director at Inovio Pharmaceuticals

Thank you. 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 goal, submitting our BLA for 03/2007 and being prepared for a swift and efficient commercial launch, if approved. I'm really excited about how 03/2007 could change the treatment paradigm for RRP and for the patients who could benefit from it. We're moving forward knowing that each day and each surgery matters to patients and our mission. Thank you for your attention and good evening everyone.

Operator

Thank you. Ladies and gentlemen, this concludes your call for today. We thank you for participating and ask that you please disconnect your lines.

Executives
    • Jennie Willson
      Jennie Willson
      Director of Communications
    • Jacqueline Shea
      Jacqueline Shea
      CEO, President & Director
    • Michael Sumner
      Michael Sumner
      Chief Medical Officer
    • Steve Egge
      Steve Egge
      CCO
    • Peter Kies
      Peter Kies
      CFO
Analysts
    • Roy Buchanan
      Equity Research Analyst at Citizens
    • Jay Olson
      Managing Director & Senior Analyst - Biotechnology at Oppenheimer & Co. Inc.
    • Sudan Loganathan
      Managing Director at Stephens Inc
    • Roger Song
      Senior Equity Research Analyst at Jefferies
    • Yi Chen
      Managing Director, Equity Research at H.C. Wainwright & Co., LLC
    • Analyst
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