Q3 2025 Inovio Pharmaceuticals Inc Earnings Call

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. This call is being recorded on Monday November 10, 2025, and I would now like to turn the conference over to Danny Wilson. Thank you. Please go ahead.

Jennie Wilson: Good afternoon, and thank you for joining the INOVIO Q3 2025 financial results conference call. Joining me today on today's call are Dr. Jackie Shea, President and Chief Executive Officer, Dr. Mike Sumner, Chief Medical Officer, Peter Kies, Chief Financial Officer, and Steve Egge, Chief Commercial Officer. Today's call will review our corporate and financial information for the quarter ended 30 September 2025, as well as provide a general business update. 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.

Good afternoon, and thank you for joining the <unk> third quarter 2025 financial results Conference call.

Joining me today on today's call are Dr. Jackie Shea, President and Chief Executive Officer, Dr. Mike Sumner, Chief Medical Officer, Peter Keyes, Chief Financial Officer, and Steve <unk>, Chief Commercial Officer, today's call will review, our corporate and financial information for the quarter ended September 30th 2025, as well as provide general.

Jennie Wilson: These events relate to our business plans to develop INOVIO's DNA medicines platform, which include clinical and regulatory developments, timing of clinical data readouts, and planned regulatory submissions of our request for priority review by the FDA of our BLA submission for INO-3107, and our expectation that the FDA will accept the submission by the end of 2025. Along with capital resources, including the sufficiency of our cash resources, our expectations regarding competition, the size and growth of the potential markets for INO-3107, if approved, and our ability to serve those markets, the rate and degree of market acceptance of INO-3107, 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.

A general business update.

Speaker #1: Good afternoon, ladies and gentlemen, and welcome to the INOVIO third-quarter 2025 financial results conference call. At this time, all lines are in listen-only mode.

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 <unk> DNA medicines platform, which include clinical and regulatory developments and timing of clinical data Readouts and planned regulatory submissions of our request for priority review by the FDA.

Speaker #1: Following the presentation, we will conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press *0 for the operator.

Speaker #1: This call is being recorded on Monday, November 10, 2025. I would now like to turn the conference over to Jennie Willson. Thank you.

Speaker #1: Please go ahead.

Of our BLA submission for INR, 30, 107, and our expectation that the FDA will accept the submission by the end of 2025, along with capital resources, including the sufficiency of our cash resources, our expectations regarding competition the size and growth of the potential markets for IL 30, 107, if approved.

Speaker #2: Good afternoon, and thank you for joining the INOVIO third-quarter 2025 financial results conference call. Joining me today on today's call are Dr. Jacqueline Shea, President and Chief Executive Officer; Dr. Mike Sumner, Chief Medical Officer; Peter Kiese, Chief Financial Officer; and Steve Egge, Chief Commercial Officer.

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

And our ability to serve those markets the rate and degree of market acceptance of INR 30, 107 in 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. We refer you to the documents we file from time to time with the SEC, which under the <unk>.

Speaker #2: Today's call will review our corporate and financial information for the quarter ended September 30th, 2025, as well as provide general business updates. Following prepared remarks, we will conduct a question-and-answer session.

Speaker #2: 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 of our request for priority review by the FDA of our BLA submission for INO 3107, and our expectation that the FDA will accept the submission by the end of 2025.

Factors heading identify important factors that could cause actual results results to differ materially from those expressed by the company verbally as well as statements made within this afternoon's press release. This call is being webcast live and a link can be found on our website IR dot <unk> dot com and a replay will be made available shortly after this call's concluded.

Jackie Shea: Good afternoon, and thank you for joining today's call. Today, I'm very pleased to share some important updates on the key progress we've made recently. First and foremost, we have achieved our primary objective for this year, which is completing the rolling submission of our BLA for INO-3107. This represents a milestone in our work to deliver on the promise of DNA medicine for the RRP community and, as our first BLA submission, an important moment for INOVIO as well. We are now focused on the next steps in the process of bringing INO-3107 to patients. First, we expect to receive file acceptance by the FDA by year-end, and we have requested a priority review of the BLA, which, if granted, would provide for a potential PDUFA date around mid-2026. Second, we are continuing to drive commercial efforts forward in preparation for a swift and efficient launch if approved.

I will now turn the call over to <unk>, President and CEO, Dr. Jackie Shay.

Speaker #2: Along with capital resources, including the sufficiency of our class cash resources, our expectations regarding competition, the size and growth of the potential markets for INO 3107, if approved, and our ability to serve those markets.

Good afternoon, and thank you for joining today's call.

Today I am very pleased to share some important updates on the key progress we've made recently.

First and foremost we have achieved our primary objective for this year, which is completing the rolling submission of our BLA for INR 31 seven.

Speaker #2: The rate and degree of market acceptance of INO-3107 and strategic matters. All of these statements are based on the beliefs and expectations of management as of today.

This represents a milestone in all work to deliver on the promise with TMA medicine for the <unk> community.

Speaker #2: Actual events or results could differ materially. We refer you to the documents we file from time to time with the SEC. Which under the risk factors heading identify important results to differ materially from those expressed by the company verbally, as well as statements made within this afternoon's press release.

And as our first BLA submission and important moment for Nokia as well.

We are now focused on the next steps in the process of bringing 31, 7% of patients.

First we expect to receive pile acceptance by the FDA by year end and we have requested a priority review of the BLA, which if granted would provide for a potential <unk> date around mid 2026.

Speaker #2: 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.

Jackie Shea: Although we will be second to market, we continue to believe that INO-3107 has compelling advantages that could make it the preferred treatment by RRP patients and their healthcare providers, based on its clinical results and tolerability to date, and the simplicity of its patient-centric treatment regimen. As we work toward a potential launch date for our first commercial product, we're also advancing our next-generation DNA medicine candidates. I'm pleased to report that landmark proof-of-concept data on our DNA-encoded monoclonal antibody, or DMAP technology, was recently published in Nature Medicine. We are also preparing for an upcoming presentation of promising preclinical data from our DNA-encoded protein, or DPOT, technology at the World Federation of Haemophilia Global Forum. Both of these programs leverage a key strength of our DNA medicines platform: the ability to drive sustained, targeted protein production within the body.

Speaker #2: I will now turn the call over to INOVIO's President and CEO, Dr. Jacqueline Shea.

Second we are continuing strive commercial efforts forward in preparation for Swift and efficient launch if approved.

Speaker #3: Good afternoon, and thank you for joining today's call. I am very pleased to share some important updates on the key progress we've made recently.

Although we will be second to market. We continue to believe this high note 31, and seven has compelling advantages that could make it the preferred treatment by our LP patients and that health care providers.

Speaker #3: First and foremost, we have achieved our primary objective for this year, which is completing the rolling submission of our BLA for INO 3107. This represents a milestone in our work to deliver on the promise of DNA Medicine for the RRP community, and as our first BLA submission, an important moment for INOVIO as well.

Based on its clinical results and Tolerability to date on that.

Simplicity of its patient centric treatment regimen.

As we work towards the potential launch date for our first commercial product. We're also advancing our next generation DNA medicine candidates.

Speaker #3: We are now focused on the next steps in the process of bringing 3107 to patients. First, we expect to receive file acceptance by the FDA by year-end, and we have requested a priority review of the BLA which, if granted, would provide for a potential PDUFA date around mid-2026.

I'm pleased to report that landmark proof of concept data, although <unk> DNA encoded monoclonal antibody or demob technology was recently published in nature Medicine.

We are also preparing for an upcoming presentation of promising preclinical data from our DNA encoded protein or <unk> technology at the World Federation of Hemophilia Global Forum.

Speaker #3: Second, we are continuing to drive commercial efforts forward in preparation for a swift and efficient launch if approved. Although we will be second to market, we continue to believe that INO 3107 has compelling advantages that could make it the preferred treatment by RRP patients and their healthcare providers.

Jackie Shea: We believe our DMAP and DPOT technologies have immense potential to treat multiple diseases, and I look forward to sharing more on our progress in the coming months. Now, I'll turn it over to Mike for some additional details about our regulatory progress and next steps for 3107. Mike.

Both of these programs leverage our key strength, Paul DNA medicines platform.

Ability to drive sustained targeted protein production within the body.

We believe our team up in D technologies have immense potential to treat multiple diseases and I look forward to sharing more on our progress in the coming months.

Mike Sumner: Thanks, Jackie. This is indeed a pivotal moment for our RRP program and for INOVIO. We completed the rolling submission of our BLA on 30 October 2023, submitting a strong application package that we believe clearly articulates the clinical efficacy of 3107 and demonstrates a tolerable safety profile in clinical trials to date. We submitted under the accelerated approval pathway and have requested a priority review, so we anticipate file acceptance by year-end, and if priority review is granted, a PDUFA date potentially mid-next year. In the meantime, we are preparing for our pre-approval inspections for both in-house and external manufacturing sites, and you may remember that the FDA completed our clinical inspection in August this year. We are also working to finalize our confirmatory trial plans.

Speaker #3: Based on its clinical results and tolerability to date, and the simplicity of its patient-centric treatment regimen. As we worked toward a potential launch date for our first commercial product, we're also advancing our next-generation DNA Medicine candidates.

Now I'll turn it over to Mike for some additional details about our regulatory progress and next steps for 31 seven Mike.

Jackie this is indeed, a pivotal moment for our op program and for an overview.

Speaker #3: I'm pleased to report that landmark proof-of-concept data on our DNA-encoded monoclonal antibody (DMAB) technology was recently published in Nature Medicine. We are also preparing for an upcoming presentation of promising preclinical data from our DNA-encoded protein (DPROT) technology at the World Federation of Haemophilia Global Forum.

We completed the rolling submission of our BLA on October 30th submitting a strong application package that we believe clearly articulate the clinical efficacy of $31 seven and demonstrates a tolerable safety profile in clinical trials to date.

We submitted under the accelerated approval pathway and have requested a priority review.

Speaker #3: Both of these programs leverage a key strength of our DNA Medicine platform: the ability to drive sustained, targeted protein production within the body. We believe our DMAB and DPROT technologies have immense potential to treat multiple diseases, and I look forward to sharing more on our progress in the coming months.

So we anticipate solid acceptance by year end and if priority review is granted a <unk> date potentially mid next year.

In the meantime, we are preparing for a preapproval inspections for both in house and external manufacturing sites.

Mike Sumner: We had previously aligned with the FDA on a design for a randomized, placebo-controlled trial, based on guidance indicating that a placebo-controlled arm was required for an indication in patients who had two or more surgeries in the year prior to treatment. We now recognize that the landscape has changed following the recent full approval of PepsiMUS, including how the FDA might view data requirements to support product approvals. The agency has confirmed that we only need to have initiated the confirmatory trial and enrolled a patient prior to approval, which we believe is achievable based upon our progress to date. As you will recall, we are working with more than 20 US academic sites, and have made significant progress with site initiation activities, which should enable us to rapidly initiate our confirmatory trial and deliver results in a timely manner.

Speaker #3: Now, I'll turn it over to Mike for some additional details about our regulatory progress and next steps for 3107. Mike.

And you May remember that the FDA completed a clinical inspection in August this year.

We are also working to finalize a confirmatory trial plans.

Speaker #4: Thanks, Jacqueline. This is indeed a pivotal moment for our RRP program and for INOVIO. We completed the rolling submission of our BLA on October 30th, submitting a strong application package.

We had previously aligned with the FDA on the design for a randomized placebo controlled trial base.

Based on guidance, indicating that a placebo control arm was required for an indication in patients who had two or more surgeries in the year prior to treatment.

Speaker #4: That we believe clearly articulates the clinical efficacy of 3107 and demonstrates our tolerable safety profile, in clinical trials to date. We submitted under the accelerated approval pathway and have requested a priority review, so we anticipate file acceptance by year-end.

We now recognize that the landscape has changed following the recent full approval of Pepsi meals, including how the FDA might view data requirements to support product approvals.

Speaker #4: And if priority review is granted, a PDUFA date is potentially mid-next year. In the meantime, we are preparing for our pre-approval inspections for both in-house and external manufacturing sites. You may remember that the FDA completed our clinical inspection in August this year.

The agency has confirmed that we only need to have initiated the confirmatory trial and enrolled a patient prior to approval.

Which we believe is achievable based upon our progress to date.

Mike Sumner: We nevertheless want the opportunity to further discuss potential options for our confirmatory trial design with the agency and have submitted a request for a Type D meeting. With a potential approval approaching, I'd like to take a moment to highlight the strengths of our RRP program, strengths that have been foundational to our progress so far, and that I believe have the potential to position 3107 as a paradigm-shifting treatment preferred by patients and their healthcare providers. First, we believe that there is a significant unmet need among the adult RRP patient community, even with an approved treatment on the market, and they deserve to have therapeutic options that work for them to reduce the number of surgeries needed to control their debilitating rare disease.

As you will recall, we are working with more than 20 U S academic sites and have made significant progress with site initiation activities.

Speaker #4: We are also working to finalize our confirmatory trial plans. We had previously aligned with the FDA on a design for a randomized, placebo-controlled trial based on guidance indicating that a placebo-controlled arm was required for an indication in patients who had two or more surgeries in the year prior to treatment.

Which should enable us to rapidly initiate a confirmatory trial and deliver results in a timely manner.

We nevertheless want the opportunity to further discuss potential options for our confirmatory trial design with the agency.

And have submitted a request for a type b meeting.

With a potential approval approaching I'd like to take a moment to highlight the strengths of our RFP program.

Speaker #4: We now recognize that the landscape has changed. Following the recent full approval of Pap smears, including how the FDA might view data requirements to support product approvals.

Strengths that have being foundational to our progress so far and that I believe have the potential to position 30, 107, as a paradigm shifting treatment preferred by patients and their health care providers.

Speaker #4: The agency has confirmed that we only need to have initiated the confirmatory trial and enrolled a patient prior to approval. Which we believe is achievable based upon our progress to date.

First we believe that there is a significant unmet need among the adult <unk> patient community.

Mike Sumner: Next, 3107 has a mechanism of action that elicited an antigen-specific T-cell response that corresponded to a reduction in surgery in our phase I-II trial. In fact, the majority of patients experienced fewer surgeries, with most experiencing a 50% to 100% reduction compared to the year before treatment. That clinical benefit continued to improve for most patients in the second 12-month period post-treatment without additional dosing. I also want to highlight that our innovative Selecta administration technology is an integral part of the effectiveness of INO-3107, enabling the targeted, localized delivery of a DNA immunotherapy, and offering a simple, effective, and well-tolerated treatment experience. Building on these foundational strengths, I think what really sets 3107 apart is its potential to address the biggest concern that the RRP community has shared time and again. First and foremost, we know that RRP patients, every single surgery matters.

Speaker #4: As you will recall, we are working with more than 20 U.S. academic sites and have made significant progress with site initiation activities, which should enable us to rapidly initiate our confirmatory trial and deliver results in a timely manner.

Even with them approved treatment on the market.

And they deserve to have therapeutic options the work for them.

To reduce the number of surgeries needed to control their debilitating rare disease.

Next 30, 107 has a mechanism of action that elicited an antigen specific T cell response that corresponded to a reduction in surgery and our phase one two trial.

Speaker #4: We nevertheless want the opportunity to further discuss potential options for our confirmatory trial design with the agency and have submitted a request for a type D meeting.

In fact, the majority of patients experienced fewer surgeries with most experiencing a 50% to 100% reduction.

Speaker #4: With a potential approval approaching, I'd like to take a moment to highlight the strengths of our RRP program. Strengths that have been foundational to our progress so far and that I believe have the potential to position 3107 as a paradigm-shifting treatment preferred by patients and their healthcare providers.

Compared to the year before treatment.

That clinical benefit continued to improve for most patients in the second 12 month period post treatment without additional dosing.

I also want to highlight that our innovative select Trump administration technology is an integral part to the effectiveness of INR 30 107.

Enabling the targeted localized delivery of a DNA immunotherapy and offering a simple effective and well tolerated treatment experience.

Building on these foundational strengths I think what really sets 31 in seven of the pump is its potential to address the biggest concern that RFP community's shared time and again.

Mike Sumner: As we shared at the European Society for Medical Oncology Congress recently, INO-3107 demonstrated continued clinical benefit with a persistent decline in the mean number of surgeries through year two post-therapy. For patients, that means a substantially lower average number of surgeries per year, a 78% drop from baseline to year two, meaning less exposure to the risks and costs of surgery. We also believe one of the key strengths of our DNA medicines platform is the ability to continue treatment beyond the initial treatment regimen, further enhancing the immune response, as we have demonstrated with other HPV-targeted DNA medicines. We believe this provides an opportunity to consider a longer-term treatment strategy to potentially extend or further improve clinical response, which is important for a chronic, often lifelong, virally mediated disease.

First and foremost we know that our RP patients every single surgery matters as we shared at the European Society for Medical Oncology Congress recently, INR 30, 107 demonstrated continued clinical benefit.

With a persistent decline in the mean number of surgeries through year two post therapy.

For patients that means a substantially lower average number of surgeries per year.

78% drop from baseline to year two.

Meaning less exposure to the risks and costs of surgery.

We also believe one of the key strengths of our DNA medicine platform is the ability to continue treatment beyond the initial treatment regimen further enhancing the immune response as we have demonstrated with other HBV targeted DNA medicines.

Mike Sumner: The RRP community has also been very clear in their goal to make surgery a last resort, not a first-line treatment. As I said earlier, that was top of mind when we set out to study 3107, and our treatment regimen stands in stark contrast to Precision's recently approved product. In their clinical trial, prior to the third and fourth doses, patients were scoped to identify any residual papilloma tissue, and if any was found, a surgery was performed to maintain what is referred to as minimal residual disease, or MRD. This process is reflected in the dosage and administration section of the prescribing information. They report these surgeries are performed to mitigate the effect of the immunosuppressive papilloma microenvironment, and maximize the chance of clinical benefit for their product. What does this requirement for maintenance of MRD during the dosing window mean for patients?

We believe this provides an opportunity to consider a longer term treatment strategy to potentially extend or further improve clinical response.

Which is important for a chronic often lifelong virally mediated disease.

The RFP community has also been very clear in their goal to make surgery, a last resort not a first line treatment.

As I said earlier that was top of mind, when we set out to study 31 seven.

And that treatment regimen stands in Stark contrast to precedence recently approved product.

And their clinical trial prior to the third and fourth doses patients with scope to identify any residual papilloma tissue.

And if anyone if any was found a surgery was performed to maintain what is referred to as minimal residual disease or <unk>.

This process is reflected in the dosage and administration section of the prescribing information.

They report these surgeries are performed to mitigate the effect of the immunosuppressive papilloma microenvironment.

Mike Sumner: 83% of patients in their clinical study underwent at least one of these surgeries, with 40% undergoing surgery at both time points. For the patients who later went on to have a complete response, 72% of patients, or 13 out of 18, received surgery in the dosing window. These MRD surgeries during the dosing window were not counted against their efficacy endpoint, as they only started counting surgeries following completion of dosing. In contrast, in our trial for INO-3107, we counted every surgery following the first day of treatment against our endpoint. We believe that every patient deserves a treatment that reduces the number of surgeries they face, and that includes any surgeries that are part of a treatment regimen.

And maximize the chance of clinical benefit for their product.

So what does this requirement for maintenance of MRI <unk> during the dosing window means for patients.

83% of patients in their clinical study underway at least one of these surgeries with 40% undergoing surgery at both time points.

For the patients who later went on to have a complete response.

92% of patients or 13 out of 18 receive surgery and the dosing window.

These MLD surgeries during the dosing window, we're not counted against their efficacy endpoint as they only started counting surgeries following completion of dosing.

In contrast in that trial for 30 107, we counted every surgery following the first day of treatment against our endpoint.

Mike Sumner: That's just one of the core reasons we see so much potential for 3107 and believe it could become the product of choice for RRP patients and providers. With that, I'll turn it over to our Chief Commercial Officer, Steve Egge, to provide an update on the commercial front. Steve?

We believe that every patient deserves a treatment that reduces the number of surgeries. They face and that includes any surgeries that are part of a treatment regimen.

That's just one of the core reasons, we see so much potential for what 30 107 and.

Steve Egge: Thanks, Mike. I'd like to start with why we're confident that 3107 has the potential to become the product of choice in the RRP market. A key advantage for 3107 is a positively differentiated product profile that I believe will appeal to laryngologists and to their RRP patients who are looking for an effective, well-tolerated treatment that minimizes exposure to the risks and costs of surgery, including during the treatment window. This belief is founded on market research. The physicians we've spoken to were most interested in the fact that the vast majority of patients saw a significant benefit of 50% to 100% reduction in surgeries from 3107, and for many of them, that benefit continued to improve over time. Physicians were similarly impressed with the tolerability data, which shows that 3107 was generally well tolerated, limiting the impact on patients' return to daily life.

83% of patients in their clinical study underway at least one of these surgeries with 40% undergoing surgery at both time points.

And believe it could become the productive choice for RP patients and providers.

With that I will turn it over to our Chief commercial officer, Steve <unk> to provide an update on the commercial front Steve.

For the patients who later went on to have a complete response.

32% of patients or 13 out of 18 receive surgery and the dosing window.

Thanks, Mike I'd like to start with why we are confident that 30 107 has the potential to become the product of choice and they are RP market.

These MLD surgeries during the dosing window, we're not counted against their efficacy endpoint as they only started counting surgeries following completion of dosing.

A key advantage for $31 seven as a positively differentiated product profile that I believe will appeal to learn colleges until their RP patients who are looking for an effective well tolerated treatment that minimize exposure to the risks and cost of surgery, including during the treatment window and this belief is founded on market.

In contrast in that trial for 30 107, we counted every surgery following the first day of treatment against our endpoint.

We believe that every patient deserves a treatment that reduces the number of surgeries. They face and that includes any surgeries that are part of a treatment regimen.

Research the physicians we've spoken to were most interested in the fact that the vast majority of patients saw a significant benefit of 50% to 100% reduction in surgeries from 31, 7% and for many of them that benefit continued to improve over time physicians were similarly impressed with the tolerability data, which shows that <unk>.

Steve Egge: This is very important when considering the treatment protocol includes four doses over a relatively short period of time. In terms of the treatment regimen itself, 3107 offers a more patient-centric approach that takes into account real concerns of both physicians and their RRP patients. It can be administered in the physician's office without an ultra-cold chain requirement. The device is simple to use. As Mike noted, very importantly, there's no requirement for minimal residual disease surgeries during the treatment window. We believe, and the market research supports, that there are many laryngologists and RRP patients who, given a choice, don't want to risk additional surgeries as part of the treatment that is intended to provide relief from surgery.

That's just one of the core reasons, we see so much potential for what 30 107 and believe it could become the productive choice for RP patients and providers.

107 was generally well tolerated limiting the impact on patients returned to daily life. This is very important when considering the treatment protocol includes four doses over a relatively short period of time.

With that I'll turn it over to our Chief commercial officer, Steve <unk> to provide an update on the commercial front Steve.

Thanks, Mike.

Like to start with why we're confident that 30 107 has the potential to become the product of choice and they are RP market.

And in terms of the treatment regimen itself 30, 107 offers a more patient centric approach that takes into account real concerns of both physicians and their RP patients. It can be administered in the physician's office without an ultra cold chain requirement. The device is simple to use and as Mike noted very importantly.

A key advantage for $31 seven as a positively differentiated product profile that I believe will appeal to learn golf just until their RP patients who are looking for an effective well tolerated treatment that minimize exposure to the risks and cost of surgery, including during the treatment window and this belief is founded on market <unk>.

There is no requirement for minimum residual disease surgeries during the treatment window, we believe and the market research supports that there are many laryngologist, an RP patients who given a choice don't want to risk additional surgeries as part of the treatment that is intended to provide relief from surgery and <unk>.

Steve Egge: As Mike noted, 3107 has been studied in a broad population of RRP patients, specifically in patients with as few as two surgeries during the year prior to treatment. We believe it's important for patients to start treatment as soon as possible after diagnosis to avoid the risk of irreversible damage from repeated surgery. Of course, in addition to these strengths, we'll learn from the launch of PepsiMUS, and we will plan to be a fast follower in a market that we believe will continue to have significant unmet need when we enter. Moving now to a few updates on launch preparations, we've continued on pace with our regulatory progress. Since our last quarterly report, we've made noted progress on both the market research and operational fronts.

<unk> the physicians we've spoken to were most interested in the fact that the vast majority of patients saw a significant benefit of 50% to 100% reduction in surgeries from 31, 7% and for many of them that benefit continued to improve over time physicians were similarly impressed with the Tolerability data, which shows that third.

Finally, as Mike noted 30 107 has been studied in a broad population of our RP patients specifically in patients with as few as two surgeries during the year prior to treatment. We believe it's important for patients to start treatment as soon as possible after diagnosis to avoid the risk of irreversible damage from repeated surgery.

107 was generally well tolerated limiting the impact on patients returned to daily life.

This is very important when considering the treatment protocol includes four doses over a relatively short period of time.

And in terms of the treatment regimen itself 30, 107 offers a more patient centric approach that takes into account real concerns of both physicians and their RP patients. It can be administered in the physician's office without an ultra cold chain requirement. The device is simple to use and as Mike noted very importantly.

Of course in addition to these strengths will learn from the launch of <unk> and we will plan to be a fast follower in a market that we believe will continue to have significant unmet need when we enter.

Steve Egge: We've continued critical research with payers, developed our initial pricing strategy, commenced price optimization work, and completed targeting, segmentation, and product positioning work, supporting a positively differentiated product profile. We're preparing for commercialization. We're finalizing contracts with our specialty distributor, specialty pharmacy, and patient hub partners, finalizing our go-to-market model, and advancing the build-out of our commercial organization. I look forward to providing more updates on our progress next quarter as we further advance our commercial preparations. We're planning to get out of the gate quickly if approved, and I'm excited about the opportunity to bring this much-needed treatment to the RRP community. With that, I'll turn it over to Peter for a financial update. Peter?

Moving now to a few updates on our launch preparations we've continued on pace with our regulatory progress since our last quarterly report. We have made noted progress on both the market research and operational fronts.

<unk> there is no requirement for minimum residual disease surgeries during the treatment window, we believe and the market research supports that there are many laryngologist in our RP patients, who given a choice don't want to risk additional surgeries as part of the treatment that is intended to provide relief from surgery and <unk>.

We've continued critical research with Payors developed our initial pricing strategy commenced price optimization work and completed targeting segmentation and product positioning work supporting a positively differentiated product profile, we're preparing for commercialization, we're finalizing contracts with our specialty distributor specialty.

Finally, as Mike noted 30 107 has been studied in a broad population of our RP patients specifically in patients with as few as two surgeries during the year prior to treatment. We believe it's important for patients to start treatment as soon as possible after diagnosis to avoid the risk of irreversible damage from repeated surgery.

Pharmacy and patient hub partners finalizing our go to market model and advancing the build out of our commercial organization.

Look forward to providing more updates on our progress next quarter as we further advance our commercial preparations we're planning to get out of the gate quickly if approved and I am excited about the opportunity to bring this much needed treatment to the RP community with that I'll turn it over to Peter for a financial update Peter.

Peter Kies: Thanks, Steve. Today, I'd like to provide an overview of INOVIO's financial results for the third quarter 2025 and provide a snapshot of the year so far. I am pleased to report that we have continued to align our resources to support the development of our lead candidate, INO-3107, and we will be focused on the critical needs ahead as we work towards a potential launch in mid-2026. As you can see here, we've continued to reduce our operating expenses over the past year. Operating expenses dropped from $27.3 million in the third quarter of 2024 to $21.2 million in the third quarter of 2025, a 22% decrease. When you look at the first nine months of 2025, we've reduced operating expenses by 25% compared to the same time period last year.

Of course in addition to these strengths we will learn from the launch of <unk> and we will plan to be a fast follower in a market that we believe will continue to have significant unmet need when we enter.

Moving now to a few updates on our launch preparations we've continued on pace with our regulatory progress since our last quarterly report. We have made noted progress on both the market research and operational fronts.

Thanks, Steve today, I'd like to provide an overview of <unk> financial results for the third quarter 2025, and provide a snapshot of the year so far.

We've continued critical research with payers develop their initial pricing strategy commenced price optimization work and completed targeting segmentation and product positioning work supporting a positively differentiated product profile, we're preparing for commercialization, we're finalizing contracts with our specialty distributor specialty.

I am pleased to report that we have continued to align.

Our resources to support the development of our lead candidate INO 3107, and we will be focused on the critical needs ahead as we work toward a potential launch in mid 2026.

Pharmacy and patient hub partners finalizing our go to market model and advancing the build out of our commercial organization.

As you can see here, we've continued to reduce our operating expenses over the past year operating expenses dropped from $27 3 million in the third quarter of 2000 $24 million to $21.2 million in the third quarter of 2025% to 22% deep.

Look forward to providing more updates on our progress next quarter as we further advance our commercial preparations we're planning to get out of the gate quickly if approved and I'm excited about the opportunity to bring this much needed treatment to the RP community with that I'll turn it over to Peter for a financial update Peter.

Peter Kies: Our net loss for the quarter increased to $45.5 million, or $0.87 per share, basic and dilutive, primarily driven by a $22.5 million non-cash loss on fair value adjustments related to our warrant liabilities. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in significant variability in our reported net loss. However, the net loss from operations prior to other income and expense items for the third quarter of 2025 decreased 22% to $21.2 million from a loss from operations of $27.3 million in the third quarter of 2024. On a per-share basis, both basic and dilutive, the loss from operations for the third quarter of 2025 dropped 58% to $0.41 per share from $0.97 per share for the third quarter of 2024.

Chris when you look at the first nine months of 2025.

We reduced operating expenses by 25% compared to the same time period last year.

Thanks, Steve today, I'd like to provide an overview of <unk> financial results for the third quarter 2025, and provide a snapshot of the year so far.

Our net loss for the quarter increased to $45 5 million or <unk> 87 per share basic and dilutive primarily driven by a $22 5 million noncash loss on fair value adjustments related to our warrant liabilities.

I am pleased to report that we have continued to align our resources to support the development of our lead candidate INO 3107, and we will be focused on the critical needs ahead as we work toward a potential launch in mid 2026.

As the fair value of the warrants fluctuate with our share price and other market inputs. This adjustment can result in significant variability in our reported net loss.

As you can see here, we've continued to reduce our operating expenses over the past year operating expenses dropped from $27 3 million in the third quarter of 2000 $24 million to $21.2 million in the third quarter of 2025% to 22% decrease.

However, the net loss from operations prior to other income and expense items for the third quarter of 2025 decreased 25, 22% to $21 2 million.

Greece when you look at the first nine months of 2025.

From a loss from operations of $27 3 million in the third quarter of 2024.

We reduced operating expenses by 25% compared to the same time period last year.

On a per share basis, both basic and dilutive the loss from operations for the third quarter of 2025 dropped 58% to <unk> 41 per share from 97 per share for the third quarter of 2024.

Peter Kies: You can see similar reductions in our net loss from operations for the first nine months of 2025 versus 2024 as we continue to conserve and direct our resources to support the 3107 program. We finished the quarter of 2025 with $50.8 million in cash, cash equivalents, and short-term investments, compared to $94.1 million as of 31 December 2024. We estimate our cash runway to take us into the second quarter of 2026. This projection includes a net operational cash burn estimate of approximately $22 million for the fourth quarter of 2025. 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 10Q, filed with the SEC today. With that, I'll turn it back over to Jackie.

Our net loss for the quarter increased to $45 5 million or <unk> 87 per share basic and dilutive, primarily driven by a $22 5 million noncash loss.

On fair value adjustments related to our warrant liabilities.

You can see similar reductions in our net loss from operations for the first nine months of 2025 versus 2024, as we continue to serve and direct our report resources to support the 30 107 program.

As the fair value of the warrants fluctuate with our share price and other market inputs. This adjustment can result in significant variability in our reported net loss.

We finished the quarter of 2025.

However, the net loss from operations prior to other income and expense items for the third quarter of 2025 decreased 25, 22% to $21 2 million.

With $50 8 million in cash cash equivalents and short term investments compared to $94 1 million as of December 31, 2024.

From a loss from operations of $27 3 million in the third quarter of 2024.

We estimate our cash runway to take us into the second quarter of 2026. This projection includes a net.

On a per share basis, both basic and dilutive the loss from operations for the third quarter of 2025 dropped 58% to <unk> 41 per share from 97 per share for the third quarter of 2024.

Operational cash burn estimate of approximately $22 million for the fourth quarter of 2025. These cash runway projections do not include any further capital raise activities that we may undertake.

Jackie Shea: Thanks, Peter. While our primary focus continues to be on 3107 and a potential launch mid-next year, we see immense opportunity across the rest of our pipeline as well. We're excited about the potential we see for INO-3112 for head and neck cancer, INO-5401 for glioblastoma, as well as a potential cancer prevention treatment in people with BRCA mutations. While we're currently focusing resources on 3107, we look forward to exploring opportunities to advance those programs. As I mentioned during my opening comments, earlier in the clinical pipeline, proof of concept data on INOVIO's DMAP technology was recently published in Nature Medicine.

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.

You can see similar reductions in our net loss from operations for the first nine months of 2025 versus 2024, as we continue to serve and direct our report resources to support the 30 107 program.

And with that I'll turn it back over to Jacky.

Thanks Peter.

Primary focus continues to be on 30, 187, and a potential launch mid next year, you see immense opportunity across the rest of our pipeline as well.

We finished the quarter of 2025.

With $50 8 million in cash cash equivalents and short term investments compared to $94 1 million as of December 31, 2024, we estimate our cash runway to take us into the second quarter of 2026. This projection includes a net.

Excited about the potential we see for <unk> 31, 12 for head and neck cancer and there are now 50, 401, but glioblastoma as well as the potential cancer prevention treatment and people with BRCA mutations.

And while were currently focusing resources on 31, a seven we look forward to exploring opportunities to advance those programs.

Operational cash burn estimate of approximately $22 million for the fourth quarter of 2025. These cash runway projections do not include any further capital raise activities that we may undertake.

Jackie Shea: This study, led by the Wistar Institute in collaboration with INOVIO, AstraZeneca, and clinical investigators at the Perelman School of Medicine at the University of Pennsylvania, was the first clinical demonstration that monoclonal antibodies, which are complex proteins, can be durably and tolerably produced within the human body without generating antidrug antibodies. Our DPOT technology builds on this research, and our promising preclinical work evaluating the potential to expand into in vivo production of therapeutic proteins will be presented this week at the World Federation of Haemophilia Global Forum, including our first research on Factor VIII production. Our DPOT approach aims to address some of the shortcomings of conventional therapeutic protein replacement treatments, including gene therapy approaches.

And as I mentioned during my opening comments earlier.

Earlier in the clinical pipeline proof of concept data on our <unk> technology with recently published in nature Medicine.

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.

This study led by the Wistar Institute in collaboration with <unk>, Astrazeneca and clinical investigators that the Permian School of medicine at the University of Pennsylvania.

And with that I'll turn it back over to Jacky.

Thanks Peter.

Was the first clinical demonstration the monoclonal antibodies, which are complex proteins can be durably and tolerably produced within the human body without generating antidrug antibodies.

Primary focus continues to be on 30, 187, and a potential launch next year, you see immense opportunity across the rest of our pipeline as well. We're excited about the potential we see for <unk> 31, 12 for head and neck cancer, and <unk> 50, 401, with Glioblastoma as well as the potential.

Our deep technology built from this research on our promising preclinical work evaluating the potential to expand into in vivo production of therapeutic proteins will be presented this week at the World Federation of Hemophilia Global Forum.

<unk> cancer prevention treatment and people with BRCA mutations.

And while we are currently focusing resources on 31 may seven we look forward to exploring opportunities to advance those programs.

Jackie Shea: As we work to bring the first approved DNA medicine to the United States, we are actively looking for future partnerships and development opportunities to advance these and other promising candidates across our pipeline. I'd now like to open up the call to answer any questions you might have. Operator?

Including our first research on tax rate production.

As I mentioned during my comments earlier.

Our deep process approach aims to address some of the shortcomings of conventional therapeutic protein replacement treatments, including gene therapy approaches.

Earlier in the clinical pipeline proof of concept data on the <unk> technology with recently published in nature Medicine.

As we work to bring the first approved DNA medicine to the United States.

This study led by the Wistar Institute in collaboration with <unk>, Astrazeneca and clinical investigators at the Permian School of Medicine at the University of Pennsylvania.

Operator: 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 one on your telephone keypad. You will hear a prompt that your hand has been raised, and should you wish to cancel your request, please press star, followed by the two. I would like to advise everyone to have a limit of one question and one follow-up. If you're using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from the line of Ted Tenthoff from Piper Sandler. Please go ahead.

We are actively looking for future partnerships and development opportunities to advance these and other promising candidates across our pipeline.

It was the first clinical demonstration the monoclonal antibodies, which are complex proteins can be terribly and tolerably produced within the human body without generating antidrug antibodies.

I would now like to open up the call to answer any questions you might have.

Operator.

Thank you ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press star followed like the one on your telephone keypad, you would hear a prompt that Johanna is minimized and should you wish to cancel your request. Please press star followed by the two I would like to advice everyone to have a limit of one question and one follow up.

Deepak technology built from this research on our promising preclinical work evaluating the potential to expand into MPV production of therapeutic proteins will be presented this week at the World Federation of Hemophilia Global Forum.

Ted Tenthoff: Great. Thank you very much, and thanks for all of the update. When it comes to PepsiMUS, have you guys heard if they've officially launched yet? I'm wondering how big of a deal do you think this head start that they have is, especially in a market where it's going to be a lot about education and educating physicians about new therapeutic options. Thank you.

If you're using a speaker phone please lift the handset before pressing any keys one woman piece for your first question.

Including our first research on factory production.

<unk> prostate approach aims to address some of the shortcomings of conventional therapeutic protein replacement treatments, including gene therapy approaches.

And your first question comes from the line of Ted Hoff from Piper Sandler. Please go ahead.

Yeah.

Great. Thank you very much for control of the update.

As we work to bring the first approved DNA medicines, the United States. We are actively looking for future partnerships and development opportunities to advance these and other promising candidates across our pipeline.

When it comes to.

Cut some years.

<unk> heard us deliver officially launched yet.

I'm wondering how big of a deal do you think the hubs.

Jackie Shea: Thanks, Ted. Yep. What we've heard from the public statements is that PepsiMUS became available to order as of 21 October 2023. Steve, do you want to talk about our expectations of being a fast follower and how we see our market entry?

<unk> start for clean harbors.

I'd now like to open up the call to answer any questions you might have.

Firstly in a market, where it's going to be a lot of them.

Operator.

Sure.

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 one on your telephone keypad, you would hear a prompt that Johanna has been raised and should you wish to cancel your request. Please press star followed by the two I would like to advice everyone to have a limit of one question and one follow up.

And educating physicians about new therapeutic options. Thank you.

Thanks, Ted Yes, so what we've heard from their public statements is the seamless became available to order as of October 20 <unk>.

[Company Representative] (Inovio Pharmaceuticals): Sure. We would expect, when we look at rare disease analogies, that in the time period kind of between when they're out and when we would expect to be approved in mid-2026, if the current timeline holds, we would expect single-digit penetration into the prevalent population in that time period. At the time we enter, the majority of the prevalent population will be available. Obviously, the incident annual diagnosed patients will be available, and then over time, we've talked about we would expect continued treatment or redosing also to represent an opportunity. By the time we arrive, the vast majority of the opportunity will remain. Like we've talked about previously, we do expect to have the preferred product profile in this space. Over time, we think there's still a significant opportunity, of course, for 3107.

So Steve do you want to talk about our expectations of being a fast follower and how we see our market entry.

If you're using a speaker phone please lift the handset before pressing any keys one moment. Please for your first question.

Sure.

And your first question comes from the line of Ted <unk> from Piper Sandler. Please go ahead.

So we would expect when we look at rare.

Rare disease analogies that.

Yeah.

When the time period.

Great. Thank you very much for control of the update.

Between when they're out and when we would expect to be approved and in mid 'twenty six if the current timeline holds we would expect single digit.

When it comes to.

Cut some years.

<unk> heard us to officially launched yet.

<unk> into the into the prevalent population in that time period.

I'm wondering how big of a deal would be useful.

So at the time, we enter the majority of the prevalent population will be available obviously the incident annual diagnosed patients will be available and then over time, we've talked about we would expect continued treatment or a re dosing also to represent.

Hum start that hovers.

Firstly in a market, where it's going to be a lot of them.

Hum.

Educating physicians about new therapeutic options. Thank you.

Thanks, Ted Yes, so what we've heard from their public statements.

And opportunity so by the time we.

Ted Tenthoff: Great. Thanks, Steve. Thanks, Jackie.

Arrive the vast majority of the opportunity will remain and like we've talked about previously we do expect to have the preferred product profile in this space. So overtime. We think there is still a significant.

<unk> became available to order as of October 21st.

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

Steve do you want to talk about our expectations of being a fast follower and how we see our market entry.

Jay Olson: Oh, hey. Congrats on the progress, and thanks for taking the questions. Our first question is, do you expect to have a similar label for 3107 versus PepsiMUS? Do you think the requirement for debulking with PepsiMUS is something that could present a key differentiator in the label for 3107? Our second follow-up question is related to, I think you mentioned you're still planning to run a PIVL study for full FDA approval. Is that study also required for ex-US approval? Thank you.

Second opportunity of course for 37.

Great. Thanks, Steve Thanks, Jackie.

Sure.

So we would expect when we look at.

Thank you Scott.

Rare disease analogies that.

And your next question comes from the line of Jay Olson from Oppenheimer. Please go ahead.

And the time period.

Between when they're out and when we would expect to be approved and in mid 'twenty six if the current timeline holds we would expect single digit penetration into the into the prevalent population in that time period.

Oh, Hey, congrats on the progress and thanks for taking the questions.

Our first question is do you expect to have a similar label for $31 seven versus tap Jimmy OS.

So at the time, we enter the majority of the prevalent population will be available obviously the incident annual diagnosed patients will be available and then over time, we've talked about we would expect continued treatment or a re dosing also to represent.

And do you think the requirement for de bulking with patterns Ngos.

Is something that could.

Present, a key differentiator in the label for 30 107.

And opportunity so by the time we.

Jackie Shea: Thanks, Jake. Great question. Mike, maybe I can ask you to take the label question first of all.

And then our second follow up question.

Arrive the vast majority of the opportunity will remain and like we've talked about previously we do expect to have the preferred product profile in this space. So overtime, we think there is still.

Related to I think you mentioned, you're still planning to run.

[Company Representative] (Inovio Pharmaceuticals): Yes, for me. I mean, from a patient population perspective, we studied a broad population. We had two to eight surgeries pre-treatment with INO-3107, and we demonstrated clinical efficacy across the entire range of surgeries. As you're aware, we have a well-tolerated product profile. We do believe our data would justify a broad label similar to what PepsiMUS received.

Pivotal study for full FDA approval is that study also required for ex U S approval. Thank you.

A significant opportunity of course for $30 seven.

Great. Thanks, Steve Thanks Becky.

Thanks, Jamie Great question, So Mike maybe I can ask you to take the Labor question Festival, yes.

Thank you.

Yeah.

And your next question comes from the line of Jay Olson from Oppenheimer. Please go ahead.

So I mean from a patient population perspective, we studied a broad population.

Oh, Hey, congrats on the progress and thanks for taking the questions.

We had $2 eight surgeries.

Our first question is do you expect to have a similar label for 31 seven versus perhaps any OS.

Pre treatment with INR 30, 107, and we demonstrated clinical efficacy across the entire range of surgeries. As you are aware, we have a well tolerated product profile.

Jackie Shea: In terms of the minimal residual disease surgeries that the Precision BioSciences treatment regimen requires, we do think that is going to be a really key differentiator. What we are hearing from our market research is physicians have questions around the logistics of scheduling those surgeries, and so do payers as well. We think in addition to what it means for patients, patients clearly do not want to undergo additional surgeries as part of the treatment regimen. Just from the logistical point of view as well, it also creates some challenges. Steve, Mike, I do not know if you would like to add to that.

And do you think the requirement for de bulking with patterns Ineos is something that could.

So we do believe that data would justify a broad label similar to what pep sending us received.

<unk> a key differentiator in the label for $31 seven.

And then our second follow up question.

So in terms of the minimal residual disease saturates.

As related to I think you mentioned, you're still planning to run.

Precedents treatment regimen requires we do think that that's going to be a really key differentiator.

Pivotal study for full FDA approval is that study also required for ex U S approval. Thank you.

What we're hearing from our market researches.

Physicians have questions around that.

Thanks, Jamie Great question, So Mike maybe I can ask you to take the labor question postal yes.

The logistics of scheduling things Searcher is 17 paths as well. So we think in addition to.

So I mean from a patient population perspective, we studied a broad population.

What it means for patients.

[Company Representative] (Inovio Pharmaceuticals): No, I think you've covered it.

Patients clearly one two months ago additional surgeries as part of the treatment regimen.

Jackie Shea: No, I think it's good. In terms of the confirmatory trial, Mike?

Had two surgeries.

Pretreatment with INR 30, 107, and we demonstrated clinical efficacy across the entire range of surgeries. As you are aware, we have a well tolerated product profile.

But just from the logistical point of view smell. It also creates some challenges.

[Company Representative] (Inovio Pharmaceuticals): Yeah. I mean, obviously, you heard me say today that we have submitted a type D meeting request to the agency to align on what that confirmatory study is going to look like. It's difficult to say exactly the value of that study to a European filing without knowing the exact design. Clearly, any data collected in a rigorous manner is going to help define our efficacy and safety profile. I think any study that we perform will be of value to our European filing.

Mike I don't know if you'd like to Epsilon.

No I think you've covered it.

So we do believe that data would justify a broad label similar to what pep sending us received.

Good.

And then in terms of the confirmatory trial.

So I mean, obviously you heard me say today that we have submitted a type b meeting request to the agency to to align on what that confirmatory study is going to look like.

So in terms of the minimal residual disease surgeries.

Presage any treatment regimen requires we do think that that's going to be a really key differentiator.

What we're hearing from our market researches.

Difficult to say exactly the value of that study to a European filing.

Physicians have questions surround.

The logistics of scheduling things surgeries, so two paths as well. So we think in addition to.

Without knowing the exact design, but and clearly any.

Jay Olson: Great, congrats again on the progress. Thanks for taking the questions.

Data collected under in a rigorous manner is going to help them define.

[Company Representative] (Inovio Pharmaceuticals): Thank you.

Operator: Thank you. Your next question comes from the line of Felix Amrumma from Stephens. Please go ahead.

What it means for patients.

Define our efficacy and safety profile, so I think.

Patients clearly one two months ago additional surgeries as part of the treatment regimen.

Any study that we perform will be of value to our European filing.

Felix Amrumma: Hi. Good afternoon. Congrats on the quarter. This is Felix Amrumma for Sudan. I have one or two questions. Number one, can you please comment on the Salesforce preparedness post 3107 approval? Secondly, if 3107 is approved, given that it's a DNA-based medicine and also PepsiMUS is virus-based, can you comment on switching from PepsiMUS to 3107 if there wouldn't be any cross-reactivity issues there?

But just from the logistical point of view as well it also creates some challenges.

Great. Congrats again on the progress thanks for taking the questions.

Thank you.

Mike I don't know if Mike.

Thank you and your next question comes from the line of Sudan look on Eden from Stephens. Please go ahead.

Mike to Epsilon.

No I think you've covered it.

That's good.

Hi, good afternoon, congrats on the quarter business feel example them up for you Dan.

And then in terms of the confirmatory trial.

So I mean, obviously you heard me say today, though.

One or two questions number one can you. Please comment on the sales force preparedness post 3107 approval and then secondly, if.

<unk> submitted a type b meeting request to the agency to to align on what that confirmatory study is going to look like it's difficult to see.

Exactly.

<unk>.

The value of that study to a European filing.

It is approved.

Jackie Shea: Great questions, Felix. Maybe Steve, you can take the commercial readiness question.

Given that it's a DNA based medicine and also publicly.

Without knowing the exact design, but and clearly any.

<unk> virus based.

[Company Representative] (Inovio Pharmaceuticals): Yeah. As I mentioned in the prepared comments, we're advancing our launch preparations. In terms of what a field force would look like, we are planning to have MSLs, as well as an access team, out ahead of approval to begin to engage in scientific exchange, as well as work with payers on pre-approval information exchange. We haven't guided in terms of the timing on the Salesforce. You've probably heard Precision has shared that they expect a sales team of 18 or 18 territories. I think it's a safe assumption that we would be kind of in that neighborhood, but we haven't provided specific guidance there. We're certainly advancing commercial plans and plan to get out of the gate very, very quickly post-approval.

Data collected under in a rigorous manner is going to help them.

Can you comment on switching from <unk> to 3107.

Define our efficacy and safety profile, so I think.

There wouldn't be any cross reactivity issues there.

Any study that we perform will be of value to our European filing.

Yes.

Great questions failing so maybe Steve can take the commercial readiness question.

Great. Congrats again on the progress thanks for taking the questions.

So we're.

Thank you.

As I mentioned in the prepared comments, we're advancing R. R.

Thank you and your next question comes from the line of Sudan look on Eden from Stephens. Please go ahead.

Our launch preparations in terms of what would a field force would look like we are planning to have <unk>.

Hi, good afternoon, congrats on the quarter business Felix ample amount for Japan.

<unk> as well as an access team out ahead of approval to begin to engage in scientific exchange as well as work with payers I'm Preapproval information exchange and then we haven't guided in terms of the timing on the sales force.

One two questions number one can you. Please comment on the sales force preparedness post 3107 approval and then secondly, Keith.

You've probably heard.

Precedent has shared that they expect a sales team of of 18 or 18.

<unk>.

Is approved.

Given that it's a DNA based medicine and also publicly.

Felix Amrumma: Thank you.

Jackie Shea: Mike, the cross-reactivity?

Territories, and I think it's a safe assumption that we would be kind of in that neighborhood, but we haven't provided.

[Company Representative] (Inovio Pharmaceuticals): Yeah, certainly. There's certainly no reason to suspect there would be any cross-reactivity issues for patients who have previously received PepsiMUS to receive INO-3107. The one thing we would anticipate, though, is it will be important to give the entire treatment regimen, as clearly we present different epitopes to patients. They will need to have all four courses of the treatment.

<unk> virus based.

Can you comment on switching from <unk> to 3107, if there wouldn't be any cross reactivity issues there.

Specific guidance, there, but we're certainly advancing commercial plans and plan to get out of the gate very very quickly post approval.

Yeah.

Great question Felix So maybe Steve you can take the commercial readiness question.

Thank you.

Yes, certainly so that's.

There's certainly no reason to suspect there would be any.

So we're.

As I mentioned in the prepared comments, we're advancing R. R.

Cross reactivity issues.

For patients who have previously received <unk> to receive INR 31 seven.

Our launch preparations in terms of what would a field force would look like.

The one thing we.

We are planning to have <unk>.

Felix Amrumma: Thank you. Congrats again.

Would anticipate though is it will be important to get the entire treatment regimen as clearly we present different epitopes to patients.

<unk> as well as an access team out ahead of approval to begin to engage in scientific exchange as well as work with payers I'm Preapproval information exchange and then we haven't guided in terms of the timing on the sales force.

Jackie Shea: Thank you, Felix.

Operator: Thank you. Your next question comes from the line of Eduardo from H.C. Wainwright, substituting for Fran Salvaragio. Please go ahead.

So they will need to.

Have have all four quarters of the treatment.

Jackie Shea: Hi. This is Eduardo on for Fran. I guess some questions related to the DMAP and the DPOT technologies. I was hoping if you could comment a bit on the levels of expression that you're achieving for the DMAP. I know that there was a SARS-CoV neutralizing antibodies that you guys published in Nature Medicine, as you mentioned. Curious about what kind of titers you guys are achieving and if that compares favorably to kind of existing recombinant kind of titers and doses, and how you're envisioning prioritizing programs within each of these technologies and platforms.

You've probably heard.

Precedent has shared that they expect a sales team of of 18 or 18.

Okay. Thank you.

Congrats again.

Thank you.

Territories, and I think it's a safe assumption that we would be kind of in that neighborhood, but we haven't provided.

Thank you and your next question comes from the line of France.

<unk> from <unk>. Please go ahead.

Specific guidance, there, but were certainly advancing commercial plans and plan to get out of the gate very very quickly post approval.

Yeah.

Hi, This is eduardo on for Rob.

I guess some questions related to the <unk> and the <unk>.

Thank you Mike.

<unk> technologies I was hoping if you could comment a bit on the levels of expression that your team for the demob I know that there was a sharp kohl's neutralizing antibodies that you guys published in nature.

Yes, certainly soon.

Certainly no reason to suspect there would be any cross reactivity issues.

So patients who have previously received perhaps they may ask to receive INR 30 107.

Thank you medicine as you mentioned curious about what kind of partners you guys are achieving and if that compares.

Jackie Shea: Yeah. That's a really great question. We're excited around our DMAP technology. In the Nature Medicine paper, we described production of two different monoclonal antibodies against SARS-CoV-2 within the body. We were able to get sustained expression over 72 weeks. We didn't see any antidrug antibodies being produced. This was a dose escalation and safety study. We were able to see a dose response with an increasing amount of the DNA medicine being administered. We were able to increase the amount of monoclonal antibodies that we were able to detect in the blood by giving a second dose. We were able to demonstrate in this first clinical proof of concept study a concentration in the blood of over 1 microgram per mL.

The one thing we.

Favourably to the kind of existing recombinant.

Would anticipate though is it will be important to give the entire treatment regimen as clearly we present different epitopes to patients.

Yeah.

Kind of tighter than doses and where you can have you how youre envisioning prioritizing programs within each of these technologies and platforms.

So they will need to.

Have have all four quarters of the treatment.

Yeah, that's a really great question. So we're excited around our <unk> technology and the nature Medicine paper, we described.

Okay. Thank you.

Congrats again.

Thank you.

Thank you and your next question comes from the line of from some of that.

Production of two different monoclonal antibodies against South Cavite within the body.

<unk> from each of C. Wainright. Please go ahead.

Yeah.

We were able to get sustained expression over 72 weeks.

Hi, This is eduardo on for Rob.

I guess some questions related to the <unk> and the <unk> part.

Didn't see any antitrust antibodies being produced and this split.

<unk> technologies I was hoping that you could comment a bit on the level of expression that your team for the demob I know that there was a sharp kohl's neutralizing antibodies that you guys published in nature Medicine. As you mentioned I'm curious about what kind of partners you guys are achieving and if that compares.

Dose escalation and safety study and we were able to see a dose response with an increasing amount of.

The DNA medicine being administered and we were able to increase the dose.

By getting sorry increased the amounts of monoclonal antibodies that we were able to detect in the plant.

Favourably to the kind of existing recombinant.

Jackie Shea: That would certainly put us into the right range for a number of different antibody therapies, as well as potentially some protein replacement candidates as well. This was a first proof of concept study. We were able to show that these monoclonal antibodies were functional as well, and as functional as the native monoclonal that we designed this program around. We think this is very promising and has read through to production of other proteins within the body. At the end of the day, monoclonal antibodies are a complex protein to produce, and we think this data bodes extremely well.

Bob.

Kind of titers in doses and where you can have you how youre envisioning prioritizing programs within each of these technologies and platforms.

By giving a second dose.

So we were able to demonstrate in this class clinical proof of concept study.

A concentration in the blood of about although the one microgram per ml.

Yeah, that's a really great question. So we're excited around our <unk> technology and the nature Medicine paper. We described a production of two different monoclonal antibodies against South Cavite within the body.

But certainly put us into the right range for a number of different antibody therapies as well as potentially some protein replacement candidates as well.

But this was the first proof of concept study, we were able to share that these monoclonal antibodies with functional as well and is functional.

We were able to get sustained expression of <unk>.

72 weeks, we didn't see any antitrust antibodies being produced and the splits are.

Native monoclonal.

We designed this program around so.

Dose escalation and safety study and we were able to see a dose response with an increasing amount of.

We think this is very promising and has read through to production of other proteins within the body at the end of the day monoclonal antibodies are complex proteins produce and we think as stated by its extremely well.

Jackie Shea: Great, thanks so much. Any thoughts or comments on what specific programs you're going to potentially prioritize for the development down the line?

The DNA medicine being administered and we were able to increase the dose of by getting Ah sorry increased the amounts of monoclonal antibodies that we were able to detect in the blood by.

Jackie Shea: Yeah. This week, we're going to be presenting our first stage on some of the preclinical work on some undisclosed targets that we've been conducting. This first target that we're presenting on is factor VIII for the treatment of hemophilia A. As we're progressing these programs, clearly, the majority of our resources are going towards 3107 at the moment, supporting the potential launch of 3107. We're going to be looking to advance these programs once we get into the clinic through partnerships or once we have additional financial resources available.

Great. Thanks, so much and any thoughts or comments on what specific programs youre going to.

By giving a second dose.

We were able to demonstrate in this first clinical proof of concept study.

Essentially prioritize and for the development down the line.

A concentration in the blood of about although the one microgram per ml.

Yeah. So we this week, we came to be presenting our first stage from some of the preclinical work on some undisclosed targets that we've been conducted conducting in this first target that we are presenting on is its tax rate for their treatments of hemophilia right.

But certainly put us into the right range for a number of different antibody therapies as well as potentially some protein replacement candidates as well.

But this was our first proof of concept study, we were able to share that these monoclonal antibodies with functional as well and is functional.

As we are as we progressing these programs clearly the majority of our resources are going towards 31, seven at the moment supporting the potential launch of <unk> 31, a seven and said we're going to be looking to advance. These programs once we get into the clinic through partnerships or <unk>.

Native on our panel.

We designed this program around so.

Operator: Thank you. There are no further questions at this time. I want to hand the call back to Jackie Shea for any closing remarks.

We think this is very promising and has read through to production.

The protein within the body at the end of the day monoclonal antibodies are complex proteins produce and we think as stated by its extremely well.

Jackie Shea: Thank you. Before we close, I'd like to reiterate the key catalysts ahead. We're now focused on the next milestones for 3107, which include expected BLA file acceptance by year-end and a potential PDUFA date in mid-2026. We'll also finalize our confirmatory trial design with FDA and have this study underway before approval. We'll continue to advance our commercial preparations so that we'll be ready to launch our first commercial product in the year ahead. In closing, I'd like to take a moment to thank all the patients, advocates, and doctors of the RRP community who have made our progress for 3107 possible. You are at the heart of our efforts to deliver on the promise of DNA medicine and our mission to provide every RRP patient with effective and durable relief from the devastating cycle of surgical interventions.

We have additional financial resources available.

Thank you and there are no further questions at this time I will now hand, the call back to Jackie Shaw for any closing remarks.

Great. Thanks, so much and any thoughts or comments on what specific programs youre going to.

Thank you.

Essentially prioritize and for the development down the line.

Before we close I'd like to reiterate the key catalysts ahead.

Yeah. So we this week, we came to be presenting our first stage from some of the preclinical work on some undisclosed targets that we've been conducted conducting in this first pocket that we are presenting on is its tax rate for their treatments of hemophilia right.

We now focused on the next milestones for 31, seven which include expected BLA file acceptance by yearend and the potential <unk> date in mid 2026.

We will also pilot finalize our confirmatory trial design with FDA and have this study underway before approval.

As we are as we progressing these programs clearly the majority of our resources are going towards 31 seven at the moment is supporting the potential launch of 30, 187, and said we're going to be looking to advance. These programs once we get into the clinic through partnerships or <unk>.

And we will continue to advance our commercial preparations so that will be ready to launch our first commercial product in the year ahead.

In closing I'd like to take a moment to thank all the patients advocates and doctors that the RP community, who have made a progress with 30 197 possible.

We have additional financial resources available.

Jackie Shea: As always, we're moving forward with the patient in mind, knowing that every day and every surgery matters. Thank you for your attention, and good evening, everyone.

You are at the heart of our efforts to tender from the promise of DNA medicine.

Thank you and there are no further questions at this time I will now hand, the call back to Jackie Shaw for any closing remarks.

Our mission to provide every hour up a patient with effective and durable relief from the devastating cycle of surgical interventions.

Thank you.

Operator: This concludes today's call. Thank you for participating. You may all disconnect.

Before we close I'd like to reiterate the key catalysts ahead, we now focused on the next milestones for 31, seven which include expected BLA file acceptance by yearend.

As always we are moving forward with the patient in mind, knowing this every day and to have research really matters.

Thank you for your attention and good evening everyone.

The potential <unk> date in mid 2026.

And this concludes today's call. Thank you for participating you may all disconnect.

We will also pilot finalize our confirmatory trial design with FDA and have this study underway before approval and.

And we will continue to advance our commercial preparations so that will be ready to launch our first commercial product and the arrowhead.

In closing I'd like to take a moment to thank all the patients advocates and doctors that they are a P community, who have made a progress with $31 seven possible.

You are at the heart of our efforts to deliver on the promise of DNA medicine and.

Our mission to provide every are up a patient with effective and durable relief from the devastating cycle of surgical interventions.

As always we are moving forward with the patient in mind.

Knowing this everyday and every search really matters.

Thank you for your attention and good evening everyone.

And this concludes today's call. Thank you for participating you may all disconnect.