Inovio Pharmaceuticals, Inc. (NASDAQ:INO) Q3 2023 Earnings Call Transcript

Inovio Pharmaceuticals, Inc. (NASDAQ:INO) Q3 2023 Earnings Call Transcript November 9, 2023

Inovio Pharmaceuticals, Inc. reports earnings inline with expectations. Reported EPS is $-0.13 EPS, expectations were $-0.13.

Operator: Good afternoon, ladies and gentlemen and welcome to the Inovio Third Quarter 2023 Financial Results Conference Call. At this time all lines are in a listen-only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] This call is being recorded on Thursday November 09, 2023. And I would now like to turn the conference over to Mr. Thomas Hong. Thank you. Please go ahead.

Thomas Hong: Good afternoon, and thank you for joining the Inovio 2023 third quarter conference call. Joining me on today’s call are Dr. Jacque Shea, President and CEO; Dr. Michael Sumner, Chief Medical Officer; Mr. Mark Twyman, Chief Commercial Officer and Mr. Peter Kies, Chief Financial Officer. Today’s call will review our corporate and financial information for the quarter ended September 30, 2023, as well as provide a development progress update for our DNA medicines platform. Following prepared remarks, we will conduct a question-and-answer segment. 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, 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. 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, 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. Jacque Shea.

Jacque Shea: Good afternoon, and thank you to everyone for joining today’s call. Over the last few months, I’m delighted to say that we’ve made significant progress advancing our lead candidate, INO-3107 for the treatment of recurrent respiratory papillomatosis, or RRP. After two very important regulatory developments, we are closer than ever to delivering on the promise of DNA medicines to patients, and bringing the first DNA medicine to market in the United States. Specifically, in the third quarter of 2023, the FDA granted breakthrough therapy designation to INO-3107, based on clinical evidence indicating that it may demonstrate substantial improvement over existing therapies for RRP. A couple of weeks following that breakthrough therapy designation, we received feedback from the FDA that data from our completed Phase 1 and 2 trial of 3107 could be used to support submission of a biological license application, or BLA, for review under the FDA’s accelerated approval program.

Our Chief Medical Officer, Mike Sumner, will provide more context shortly, but this news means that we no longer need to complete a Phase 3 trial before BLA submission, and will ultimately allow for a potentially much faster development pathway. We will, however, be required to initiate a confirmatory trial and satisfy all other FDA filing requirements prior to BLA submission, as is usual for the accelerated approval pathway. To achieve that, our team has already submitted a request for an initial comprehensive multidisciplinary breakthrough therapy meeting to the FDA for the fourth quarter. This meeting will help further align our plans with the FDA and determine the timing for critical deliverables associated with our BLA submission. As we make progress on this new expedited pathway, we have every intention to utilize the opportunity for increased communication with the FDA and other advantages offered by a breakthrough therapy designation, such as requesting a rolling submission of completed sections of our BLA and a priority review of the fully submitted BLA.

As a result of this new timeline, we have accelerated our commercialization strategy to be prepared to launch 3107, should it be approved. Led by Mark Twyman, our Chief Commercial Officer, whom you’ll hear from shortly, our commercial team has extensive experience bringing products to market, including innovative new technologies and products in the rare disease space. Mark will spend a few moments today talking about his team’s current efforts to expedite building a number of critical capabilities and establishing pathways for commercial success, such as creating the value proposition for 3107, putting in place an optimized distribution model, developing payer speciality pharmacy and pharmacy benefit management strategies to ensure favorable access, and preparing to stand up a field organization.

Mark and his commercial leadership team bring decades of combined biopharmaceutical experience from such companies as Sanofi Genzyme, Merck, CSL Bearing, and MedImmune. They’ve been personally involved in nearly every aspect of successfully commercializing products, from sales and marketing to distribution, market access, and government affairs. I am really pleased with the progress of this team as they work hand in glove with leaders from across the company to optimize the launch plans for our lead candidate. In addition to the regulatory achievements and commercial readiness efforts I’ve described, we’ve worked very hard over the past 18 months or so to restructure our corporate organization with the goal of meeting our current focus pipeline needs and reducing spending, while at the same time retaining and building the expertise critical to implement our plans for our late stage pipeline.

After many difficult months and quarters, I’m pleased to see the collective efforts of our dedicated and experienced cross-functional team make a real difference. With that, I’d like to turn it over to our Chief Medical Officer, Dr. Mike Sumner, to provide a brief overview of the regulatory and development progress we’ve achieved for 3107, the next steps in our accelerated development timeline, and other key preparations to support a BLA submission, and if approved, to bring this candidate to market. Mike?

Michael Sumner: Thank you very much, Jacque, and greetings everyone. As Jacque has mentioned, we have made substantial progress with our lead candidate, INO-3107. To provide a little perspective on how fast this candidate has been advancing through development, we’ve created this timeline. We started our Phase 1/2 trial in 2020, the same year the FDA granted orphan drug status. After announcing positive final results from the trial earlier this year, the European Commission granted orphan drug status in May, followed by the FDA’s breakthrough therapy designation in September. Shortly thereafter, we received important feedback that data from our completed Phase 1/2 trial could support submission of a BLA for review under the FDA’s accelerated approval program.

To take a candidate from proof-of-concept to filing a BLA in the span of three years is lightning speed and speaks to the hard work and collaboration of the broader Inovio team. Looking ahead, the opportunity to file our BLA under the accelerated approval program assures that our team will need to continue to run fast and hard. I’d like to speak briefly as to why we have been granted the opportunity to submit a BLA for 3107 under the FDA’s accelerated approval program. First, keep in mind that the FDA instituted its accelerated approval program to allow for early approval of drugs that treat serious conditions and fill an unmet medical need. Additionally, they have recently issued a press release identifying their desire to utilize this program to further accelerate the development of rare disease therapies.

In general, to qualify, a drug candidate must address a serious or life-threatening condition with consideration for the severity, rarity or prevalence of the condition, and available treatment options. For those who are not familiar with RRP, and I must include myself in this category before coming to Inovio last year, it’s a debilitating and rare disease caused primarily by HPV-6 and/or HPV-11. RRP is characterized by the development of small, wart-like growths or papillomas in the upper respiratory tract. While these papillomas are generally benign, they can cause severe, life-threatening airway obstruction and respiratory complications. The majority of patients with RRP need to undergo multiple surgeries year after year to remove the recurring papillomas.

This has a significant impact on quality of life, coupled with the potential for long-term impact on vocal cords, which can limit the patient’s ability to speak effectively. We are pleased that the FDA has now recognized the impact this devastating disease has on patients’ lives, an awareness that in large part is due to the persistent efforts of the RRP Foundation, a patient advocacy organization that has been working tirelessly to raise the need for better and less invasive treatments. This links with another characteristic required to qualify for the accelerated approval program, which is that a drug candidate must provide a meaningful advantage over other available therapies. In this instance, the standard of care for RRP, as I mentioned, is repeat surgeries to remove the papillomas from the throat and vocal cords.

I’m pleased to say that in our completed Phase 1/2 study, 81% of patients experienced a reduction in the number of surgeries in the year after treatment versus the year prior to treatment. This included 9 patients, representing 28% of patients in the study, who did not require any surgeries following treatment initiation. Further, our immunology data provides a potential mechanism of action, which supports the clinical evidence, which I will highlight next. This slide helps illustrate the scope and impact of the immune response in an actual patient, who had undergone six surgeries the year prior to the trial, followed by zero surgeries during the trial. The graphs on the left here depict the CD8 T cell response observed in the patient, before and after completion of dosing.

As you can see, this patient experienced a strong induction of HPV-specific CD8 T cells that have markers of cellular activation and are positive for granzyme and perforin, which are known to be key mediators of eliminating virally infected cells by killer T cells. The data in both graphs indicate that 3107 expanded these critically important cells in impressive fashion, with the most highly active killer T cells, which are those showing expression of all three activation markers, exhibiting close to a tenfold increase in frequency. It is these types of cells that we believe are key contributors to reduction in the need for surgery, exemplified in photos on the right-hand side of the slide. These are images of the same patient’s vocal cords, before and after treatment with 3107.

Again, this patient went from having six surgeries in the year prior to treatment to zero surgeries in the 12 months following the first dose. As you can imagine, that level of reduction in surgeries has an incredible impact on a patient, but it is important to highlight that RRP patients and their healthcare providers have indicated time and again that a reduction of even one surgery would provide significant improvement in quality of life. One important note about our trial design. While our treatment involved four doses over nine weeks, what we call the treatment window, we counted any surgery conducted after the first dose. We did not wait until after all four doses were administered to start counting surgeries. The rationale behind this is important.

As I stated above, patients care about every single surgery, regardless of when it happens, whether it happens during the treatment window or not, because each and every surgery impacts that patient’s life. These results add to the growing body of evidence that our DNA medicines candidate, a well-tolerated, immunogenic, and particularly adept at promoting viral clearance and lesion regression in HPV-related diseases. From a regulatory standpoint, we now have several key objectives ahead. We have submitted our request for an initial comprehensive multidisciplinary breakthrough therapy meeting and have asked the FDA for it to take place in the fourth quarter of this year. At that meeting, we will discuss key elements of our planned future submission for an accelerated approval review, including required immunology data, key CMC plans, including process performance qualification or PPQ strategy, alignment on questions about our CELLECTRA delivery device, and other clinical strategy steps.

The outcome of this meeting will be instructed to the timeline of critical deliverables for the BLA submission. Shortly thereafter, we plan to submit a protocol for our confirmatory trial to the FDA, drawing on our previous alignment with the Agency on study design. Under accelerated approval, a confirmatory study is always required to verify the anticipated clinical benefit of a candidate, and we have been requested to initiate this trial prior to BLA submission. Throughout the process of submitting our BLA under the accelerated approval program, we will utilize the benefits of our breakthrough therapy designation status, which affords priority access to the FDA’s guidance and advice to try to quickly resolve any outstanding questions. We also plan to take advantage of the opportunity to submit under the FDA’s rolling review program and plan to request a priority review once the BLA is fully submitted, which has the potential to further accelerate the product development timeline.

Rolling review allows for a company to submit completed sections of a BLA for review by the FDA, generally over a three-month window, rather than waiting until every section is completed to submit. Under priority review, the FDA aims to take an action on the application within six months compared to 10 months under standard review. It’s important to recognize that achieving an approval of our BLA requires a team with expertise across an array of functions. We are fortunate to be working with such an incredible team of experts who bring with them years of prior success in advancing innovative medicines through approval to commercialization, with the ultimate goal of benefiting patients. Every one of the functions I’ve listed here on the slide is critical, but just to give you a sense of the work one important area has underway, our medical affairs function is focused on developing and implementing plans for scientific engagement, medical communications, and field operations.

The work done by medical affairs is an important juncture between those who work to develop medicines and our partners in commercial who make sure the patients can ultimately receive them. With that, I’ll now turn the call over to our Chief Commercial Officer, Mark Twyman, for some important updates on how our commercial team is working to ensure just that. Mark?

Mark Twyman: Thanks, Mike. Before I jump into the specifics of our commercial strategy, I’d just like to say that it’s a pleasure to have the opportunity to speak with you all today and how excited I am about the prospects for INO-3107. While this is my first time on a quarterly financial call for Inovio, I have been with the company for about six years, and as Jacque mentioned earlier, I’ve been involved in the commercialization of biopharmaceutical products for many years for both small and large companies, as has my team. We are extremely excited to begin implementing many of the plans we have been working on to benefit patients who are in desperate need of options to improve their quality of life. Let’s take a few minutes to discuss what we believe are five key areas to achieve success in the launch of an orphan drug.

The first is to create a long-term commercial strategy by starting early and continuously updating based on in-market data. It is also important to build up the required resources as early as possible before regulatory approval is granted. As I mentioned, I’ve been at Inovio for several years, helping the company prepare to bring DNA medicines to market. We now have the opportunity to leverage existing cross-functional capabilities for the development and potential launch of INO-3107. The next key element to a successful launch of an orphan drug is demonstrating the value of your product to all stakeholders. This value proposition has to be provided in the context of any competition, and it must leverage trial data and real-world evidence. Next, a company that successfully launches a biopharmaceutical product must ensure that patients have a voice in their care and the options offered.

This is accomplished by involving patients and patient organizations early in the development process. As Mike mentioned, the RRP Foundation has done a wonderful job in advocating for patients with RRP over the years, sharing their experiences with regulators and policymakers alike. We are proud to consult with them on our shared goal to help patients suffering from this debilitating and serious disease. The fourth key element is to take an active role in disease education with a detailed stakeholder activity plan. This includes sending medical liaisons into the field early and creating innovative sales roles such as patient-centric field reps. And last, but probably most importantly, is to get the supply chain up to speed as quickly as possible.

This includes determining the appropriate distribution strategy model for INO-3107, identifying and selecting supply chain partners, and really understanding the last mile logistics for the product, a complete manufacturer-to-patient solution. It’s important to note that INO-3107 does not require ultra-cold or frozen storage or thawing prior to injection and is refrigerator stable at 2 to 8 degrees Celsius, which will be key factors for both distribution and administration. I’m pleased to report that for INO-3107, many of the key areas for success I just outlined are underway or being addressed. For example, we are actively engaging external partners and service providers and have started implementing plans for product distribution and logistics, payer engagement and reimbursement, specialty pharmacy identification, patient and provider awareness and education, customer service programs, and other sales and marketing activities.

It is also worth noting we believe that INO-3107 will be considered by payers to be a specialty pharmacy product, not a buy-and-build product, consistent with many other orphan disease treatments. We are also continuing to deepen our understanding of RRP as a disease, the treatment paradigm in the United States, and the impact of both the disease and the current surgical treatment regimen on patients. We have taken extra care to really understand the needs of patients, doctors, caretakers, and advocates to inform our path forward. Here is a high-level snapshot of what we understand so far. RRP is a chronic, rare disease caused by HPV-6 and HPV-11. The current standard-of-care is surgery, with many patients facing a lifetime of repeated surgeries as their only option.

Incidence and prevalence of RRP is variable globally and depends on several factors. The most widely cited U.S. epidemiology data estimated that there were 14,000 active cases and about 1.8 per 100,000 new cases in adults each year. A recent publication cites that on average, patients with RRP undergo about four surgeries per year. These surgeries and surrounding care put a tremendous financial burden on patients and the health care system. Based on ongoing market research, we believe that laryngologists are the primary health care providers treating patients suffering from this condition, that they are comfortable administering drugs and utilizing new tools and devices. In our discussions with them, they have expressed particular interest in finding a more effective, non-surgical treatment option for their RRP patients.

We estimate that about 300 to 400 laryngologists in the U.S. conduct the majority of RRP surgical procedures. We are currently in the process of validating those estimates and geographically mapping their practice locations to support final decisions about the size and alignment of our field-based sales team for INO-3107. Key opinion leaders estimate that approximately one-half of all laryngologists practice in academic institutions. In recent discussions with RRP patients, we heard that many of them prefer to be treated at these regional academic centers. As I’ve outlined today, we’re considering every detail that can impact patients, health care providers, and ultimately our commercial strategy as we work to potentially bring INO-3107 to market.

We will continue drawing on the strength of the Inovio team across functions and working with seasoned partners to meet the demands of this accelerated timeline and deliver on the promise of DNA medicine. I’ll now turn the call back to our CEO, Jacque Shea, for a pipeline update. Jackie?

Jacque Shea: Thank you, Mark. Before I cover some additional updates from our pipeline, I’d like to take a moment to reiterate some of the key takeaways from what you’ve heard today from Mike and Mark, which highlight why we believe in the commercial potential of 3107 and its ability to potentially transform the treatment paradigm for RRP. In our completed Phase 1/2 trial, 3107 was able to generate antigen-specific T-cell responses against both HPV-6 and 11, a result that was observed in patients across the spectrum of disease severity. We also saw reduction in surgery in HPV-6 and 11 positive patients, again across the spectrum of disease severity. 3107 was well-tolerated by participants in the trial, resulting in mostly low-grade treatment emergent adverse effects, such as injection site pain and fatigue.

Unlike other T-cell generating platforms, 3107 and DNA medicines in general don’t cause an antibacterial response, which means that 3107 could potentially be readministered over time to boost immune response if needed. Because RRP is a chronic viral disease that can lead to persistent reoccurring symptoms, readministration may be an important factor in extending efficacy over a lifetime, and we anticipate exploring that opportunity further if 3107 is approved. Thinking further down the line to potential use in market, it’s important to reiterate the point that Mark made earlier. 3107 is refrigerator-stable at 2 to 8 degrees Celsius, does not require frozen or ultra-cold storage, and will be packaged in a single-use file, all of which will be key factors in distribution and administration.

We see INO-3107 as an exemplar of the larger potential of our DNA medicines platform, and we remain dedicated to driving progress across our pipeline to unlock that potential for patients across the globe. We believe that this is achievable in a three-step process. As you can see on this slide, in the near term, Inovio is focused on optimizing the opportunity for 3107 as a potential treatment for RRP patients. In the midterm, Inovio is working to advance eight other clinical stage candidates targeting HPV-related diseases, cancers, and infectious diseases. For the longer term, Inovio is developing next-generation DNA medicine technology, including DNA-encoded monoclonal antibodies, or DMABS, targeting COVID-19, as well as DNA-launched nanoparticles, or DLNPs, targeting infectious disease targets, and cancer vaccines that have various disease targets.

This slide provides greater detail on our pipeline. Obviously, 3107 is closest to market, but we also have several key candidates that we’re working to advance. In particular, we’re finalizing the study report and data analysis on INO-5401 for treatment of newly diagnosed with glioblastoma and continue to support treatment for some patients on the trial. We’re currently in discussions about next steps with KOLs and our partner Regeneron. In an excellent example of the versatility of our DNA medicine candidates, INO-5401 is also being studied in a Phase 1b investigator-sponsored trial by the University of Pennsylvania’s Wistar Center. Researchers there are evaluating 5401 in patients with BRCA1 or BRCA2 gene mutations. This vaccine candidate may have the potential to prevent breast cancer for people with those mutations.

The research was recently featured on the Today Show, highlighting both the potential of DNA medicine and the power of partnerships to help accelerate progress for patients. We aim to continue building strategic partnerships like this one to drive medical progress for patients, innovation, and ultimately shareholder value. We also remain encouraged by the final data reported earlier this year from the study of INO-3112 in head and neck cancer in combination with a PD-L1 checkpoint inhibitor. We are continuing discussions to find a potential PD-1 checkpoint partner to advance this promising candidate and believe there is a significant opportunity to be explored for 3112 in combination with a proven PD-1 checkpoint inhibitor. On the infectious disease side, earlier this year we announced positive data from a Phase 1 study for INO-4201 as a potential Ebola vaccine booster.

We are continuing discussions with our partners for that program to determine next steps and evaluating potential funding opportunities. We also have some exciting next-generation DNA medicines in early clinical development, for instance our dMAbs and dLMPs [Ph] and also candidates in preclinical development. We believe these next-generation candidates build on the strengths of our DNA medicines platform with significant potential advantages over other platforms. I’ll now turn the call over to our CFO, Peter Keyes, for our third quarter 2023 financial summary. Peter?

Peter Kies: Thank you, Jacque. Today I’d like to provide an overview of Inovio’s operational highlights and financial condition for the third quarter of 2023. As Jacque noted, and as required in today’s economic environment, Inovio is committed to financial discipline as we advance our pipeline. To achieve our longer-term goals, our strategy over the past 18 months has been to reprioritize our pipeline, reshape our organization, and scale our operational spend. As you can see from this slide, we have succeeded in bringing our operational spend down for both the third quarter and the nine-month period ended September 30, 2023, compared to the same period in 2022. For the third quarter 2023, operational expenses dropped 20% to $35.9 million from $44.9 million compared to the same period in 2022.

The third quarter included a one-time non-cash charge for goodwill impairment that totaled $10.5 million. Excluding that one-time charge, our operational expenses for the third quarter would have declined 43% from the same period or same quarter in 2022. For the first nine months of 2023, we cut our operating expenses nearly in half, dropping to $117.3 million from $221.8 million in the first nine months of 2022. Breaking down total operating expenses a bit more, for the third quarter, our R&D expenses totaled $15.5 million in 2023 compared to $33.1 million for the same period in 2022. The decrease in R&D expenses was primarily the result of lower drug manufacturing, clinical trial expenses, and outside services related to INO-4800 and other COVID-19 studies, and lower employee and consultant compensation, including stock-based compensation, among other variances.

G&A expenses for the third quarter of 2023 were $9.9 million compared to $11.9 million for the same period in 2022. Revenues for the third quarter of 2023 were $388,000 compared to $9.2 million for the same period in 2022. The revenue reported for the 2022 third quarter was associated with a procurement contract with the U.S. Department of Defense for Inovio’s device and accessories to be used for delivery of INO-4800, which we have since discontinued. These factors combine to bring our net loss for the third quarter of 2023 to $33.9 million, or $0.13 per share, basic and dilutive. Excluding previously mentioned one-time non-cash charge for goodwill impairment, our loss would have been $0.09 per share, basic and dilutive. For the 2022 third quarter, our net loss of $37.8 million, or $0.15 per share, basic and dilutive.

We finished the third quarter of 2023 with $167.5 million in cash, cash equivalents, and short-term investments, compared to $253 million as of December 31, 2022. Following feedback from the FDA on the accelerated approval pathway for INO-3107, we now estimate that our funds should support operations into second quarter of 2025. This projection includes a cash burn estimate of approximately $26 million for the fourth quarter of 2023. These projections do not include any funds that may be raised through our existing at-the-market program or other capital raise activities. As a reminder, you can find our full financial statements in this afternoon’s press release, as well as in our Form 10-Q filed with the SEC. And with that, I’ll turn it back over to Jacque.

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

Operator: Thank you. [Operator Instructions] Your first question comes from the line of Roger Song from Jefferies. Please go ahead.

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Q&A Session

Roger Song: Great. Congrats for all the progress and thanks for taking the question. Maybe just focusing on the RRP program, the first question is related to the BLA filing and the Phase 3 confirmatory study design. Can you just let us know what is the outstanding items for the filing and the confirmatory study design? And any current guidance around the timing of the BLA filing and the potential approval? Thank you.

Jacque Shea: Thanks, Roger. It’s nice to hear your voice. So as we mentioned during the call, the news on accelerated approval pathway is relatively new. We just heard in September. So over the past few weeks, we’ve really been working to accelerate our timelines. We’ve put together quite a detailed package to be considered by the FDA under the upcoming meeting. And I’ll hand over to Mike to provide a few more details there. But what we’re really hoping to achieve in that meeting is to get some alignment with the FDA as to some of the content that needs to go into that submission package, as well as some further discussion on the design of the confirmatory study. Mike?

Michael Sumner: Thank you, Jacque. I think you hit some of the highlights. I mean, obviously, since we heard the news in September, I think we’ve made tremendous progress as a team. We’ve really mapped out every single function and what we need to do to get to our BLA. In terms of the input we need from the FDA, I mean, obviously, we have a strategy. We need to get the FDA to agree to that strategy. But we’re pulling on significant data points that we’ve had. I mean, we’ve already gone through our PPQ strategy for 3100. We’ve used our selector device in our Phase 3 program. We’ve had several interactions with the agency on what we need to do for the device. We know, again, from a confirmatory study, what we want to propose, and we’ve had significant input of what we believe is going to be acceptable to the agency.

And so we need alignment on that protocol as we do need to start that study prior to filing our BLA. But overall, I think based on all the interactions we’ve had on our platform and specifically around RRP, we’re in a very good place. And now it’s really just going through the process of aligning strategy with the agency so we can move rapidly forward.

Roger Song: Great. Thanks. Maybe just a quick question around the commercial infrastructure. With the current runway into second quarter 2025, how should we think about the overall commercialization cost post-approval for assuming the approval for the RRP?

Jacque Shea: Yes, that’s a really great question, Roger. Before I ask Mark to jump in there, I think really this upcoming discussion with the agency will really help us be more definitive on the timelines. I think Mark can talk a bit about this in a bit more detail, but I think one of the encouraging things for us as a relatively small biotech company is that this is a rare disease. We believe that there are a reasonable number of call points for a company of our size to take on. We have in-house manufacturing for our device that we think can meet our device manufacturing needs. And we have well-established relationships with our drug manufacturing CMO to manufacture the drug. So, Mark, maybe you can talk a bit more about how we’re thinking about going to market for 3107.

Mark Twyman: Thanks, Jacque. Great questions. I think that Jacque really hit the nail on the head when she was talking about this laryngology space and for RRP and being a perfect fit for Inovio. If we think about the PhilTels [Ph] organization, we’re thinking now that there are roughly between 300 and 400 laryngologists that are performing the majority of the RRP surgeries in the U.S. And we really think that a small specialty sales force can kind of fiercely address the needs for both patients and physicians. But I think the other sort of component, and it sort of speaks to the experience that we have in the organization in commercializing products, we’re getting an early start. It’s not just about the sales organization, but it’s about everything you’re doing behind that, from the perspective of your distribution strategy, the early conversations you need to have with payers and PBM, specialty sort of pharmacy.

So that’s all work that’s been started. And I think what is emerging is that we’ve identified the key work streams. We’ve begun to identify the key partners that we need to have on board. And I feel really good about where we are right now and being able to leverage this accelerated approval.

Jacque Shea: Thanks, Mark. And Roger, to answer your question about cost, we’re planning to operate a lean and efficient model. So where it makes sense for us to do things in-house, we’ll do them in-house. Where it makes sense to leverage other people’s capabilities, such as a contract sales force and potentially defer expense there, we’ll be doing that. So I think we’ll be able to provide a bit more guidance in terms of our phasing of our cash runway over 2024, once we’ve had that discussion with the FDA.

Roger Song: Yes, that makes sense. Thanks a lot for the comments.

Operator: Thank you. [Operator Instructions] And your next question comes from the line of Yi Chen from H.C. Wainwright. Please go ahead.

Yi Chen: Hi. Thank you for taking my questions. Could you tell us whether any patients in a clinical trial has been redosed with INL-3107? And in the real-world setting, commercially speaking, do you think laryngologists will have the flexibility of those choosing to dose, how often a particular patient should be dosed with 3107? Or that could be limited by payers to, let’s say, just once every year?

Jacque Shea: I’ll hand over to Mike, maybe, for talking about the initial clinical question on the completed phase 1/2 trial. And then, Mark, maybe you and Mike together can address the next question.

Michael Sumner: So, I mean, starting off, obviously, one of the real benefits of the DNA medicines platform is there’s no anti-vector response. And we believe redosing is capable. In fact, we know redosing is capable from many of our oncology programs. At present, we have not redosed any of the patients from the phase 1/2 study. But as we come to think about those patients, we obviously saw some patients with complete response. We saw a significant number of patients with a very good partial response with greater than 50% reduction in their surgeries. And then, unfortunately, there were a few patients who did show such great response. For me, I keep all those three buckets separate from my clinical strategy. But we certainly want to, in the future, sort of examine how we can continue to build on the excellent clinical efficacy we’ve seen to date.

But I would say, obviously, until that’s in our label, it would all be off-label. And so it would be down to the clinicians to decide what they want to do with their patients.

Mark Twyman: I think what I would add to that, Mike, is the question, will payers decide? I think that what I know is that we have a very strong value proposition for INO-3107. I think we can all kind of look at the results to date from a clinical perspective and know that we have a real potential to address this unmet medical need, both from a patient perspective. It still unsettles me to know that some of these patients experience hundreds of surgeries over a lifetime. And that comes with significant cost burden and just how they go about living their daily lives. But the other sort of point is that physicians aren’t satisfied. I mean, these surgeons are used to sort of treating and resolving an issue that their patient might have.

And that’s just not the case with RRP, and hence the name recurrent respiratory papillomatosis. And I know from having a number of discussions with some of the key KOLs and physicians that are doing a large number of surgeries that they are really looking forward to having this option. And it’s really kind of our job, and it’s the job we’ve already started, to make sure that there’s alignment with what the payers, how the payers sort of value INO-3107, and the fact that physicians are looking for a new option for treating RRP. So I’m feeling really good about where we are, but we’ll have to get to the finish line.

Yi Chen: Will re-dosing be part of the Phase 3 trial?

Jacque Shea: We’re still in discussions with the agency regarding that and haven’t really put the details out there. But it’s certainly, as I said, it’s certainly something that we are thinking about.

Yi Chen: Okay. Thank you.

Operator: Thank you. [Operator Instructions] There are no further questions at this time. Please continue.

Jacque Shea: Thank you. The significant progress we have made in advancing INO-3107 over the past few months means that we are moving closer to providing a potentially life-changing non-surgical treatment option to patients suffering from RRP. I remain incredibly grateful to the patients, patient advocates, trial investigators, and our dedicated team here at Inovio that has enabled us to achieve this. I’m confident that our experienced team is prepared for the next critical steps of development and potential commercialization for INO-3107. And thanks to the corporate strategy we’ve been implementing over the past year, I’m also confident that Inovio now has the key drivers in place for broader long-term success. We have a diversified pipeline focused on candidates with scientific and clinical promise, achievable pathways to market, and strong commercial potential.

We have our proprietary DNA medicines platform and technology, along with a history of strong partnerships to accelerate progress and innovation. And we have the benefit of an incredibly experienced team focused on financial discipline, operational excellence, and motivated by the patients who could someday benefit from the power of DNA medicine. There is much work to be done, but I speak for the entire Inovio team when I say that we are energized by what the future could hold for DNA medicine and patients around the world. With that, thank you again for your attention. Have a great evening, everyone.

Operator: Thank you. Ladies and gentlemen, that does conclude our conference for today. Thank you all for participating. You may all disconnect.