Anika Therapeutics Q3 2023 Earnings Call Transcript

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Provided by Quartr
November 9, 2023

There are 8 speakers on the call.

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. This call is being recorded on Thursday, November 9, 2023. And I would now like to turn the conference Over to Mr.

Operator

Thomas Hung. Thank you. Please go ahead.

Speaker 1

Good afternoon, and thank you for joining the Inovio 2023 3rd Quarter Conference Call. Joining me on today's call are Doctor. Jackie Hsieh, President and CEO Doctor. Michael Sumner, Chief Medical Officer Mr. Mark Twyman, Chief Commercial Officer and Mr.

Speaker 1

Peter Keyes, 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.

Speaker 1

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 Innovia's President and CEO, Doctor.

Speaker 1

Jackie Hsieh.

Speaker 2

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-three thousand one hundred and seven for the treatment of recurrent respiratory papillomatosis or RRP. After 2 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 Q3 of 2023, the FDA granted breakthrough therapy designation To INO-three thousand one hundred and seven 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 The data from our completed Phase III trial of 3,107 could be used to support submission of a biological license application or BLA for review on the FDA's accelerated approval program.

Speaker 2

Our Chief Medical Officer, Mike Sumner, will provide more context But this news means that we no longer need to complete a Phase III 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 Q4. 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 Another advantage is offered by Breakthrough Therapy Designation, such as requesting a rolling submission of completed sections for BLA and a priority review of the fully submitted BLA.

Speaker 2

As a result of this new timeline, We have accelerated our commercialization strategy to be prepared to launch 3,107 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 3,107, putting in place an optimized distribution model, developing payer, specialty 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 Behring and MedImmune.

Speaker 2

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 focused 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 With that, I'd like to turn it over to our Chief Medical Officer, Doctor. Mike Sumner, To provide a brief overview of the regulatory and development progress we've achieved for 3,107, the next steps on our accelerated development timeline and other key preparations to support the BLA submission and if approved to bring this candidate to market.

Speaker 2

Mike?

Speaker 3

Thank you very much, Jackie, and greetings, everyone. As Jackie has mentioned, we have made substantial progress with our lead candidate INO-three thousand one hundred and seven. To provide a little perspective on how fast this candidate has been advancing through development, we've created this timeline. We started our Phase onetwo 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.

Speaker 3

Shortly thereafter, we received important feedback The data from our completed Phase III trial could support submission of a BLA for review under the FDA's Accelerated approval program. To take your candidate from proof of concept to working on a filing To filing a BLA in the span of 3 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 Assure us that 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 3,107 under the FDA's accelerated approval program. 1st, 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.

Speaker 3

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 What like growths or papillomas in the upper respiratory tract?

Speaker 3

While these papillomas are generally benign, They can cause severe life threatening airway obstruction and respiratory complications. The majority of patients 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' 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.

Speaker 3

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 onetwo study. 81 percent 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 do 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.

Speaker 3

This slide helps illustrate the Scope and impact of the immune response in an actual patient who had undergone 6 surgeries the year prior to the trial, Followed by 0 surgeries during the trial. The graphs on the left here depict the CD8 T cell response observed in this patient Before and after completion of dosing. As you can see, this patient experienced a strong induction of HBV Pacific CD8 T cells that have markers of cellular activation and a positive for granzymes 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 3,107 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.

Speaker 3

These are images of the same patient's vocal cords before and after treatment with 3,107. Again, This patient went from having 6 surgeries in the year prior to treatment to 0 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's 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.

Speaker 3

While our treatment involve 4 doses over 9 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 are well tolerated, immunogenic I'm particularly adept at promoting viral clearance and lesion regression in HPV related diseases.

Speaker 3

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 Q4 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 Under accelerated approval, a confirmatory study is always required to verify the anticipated clinical benefit of a candidate.

Speaker 3

And we have been requested to initiate this trial prior to BLA submission. Throughout the process 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 3 month window rather than waiting until every section is completed to submit.

Speaker 3

Under priority review, The FDA aims to take an action on the application within 6 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 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.

Speaker 3

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

Speaker 4

Mark? 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 Speak with you all today and how excited I am about the prospects for INO-three thousand one hundred and seven. While this is my first time on a quarterly financial call for Inovio, I have been with the company for about 6 years. And as Jackie 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.

Speaker 4

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 5 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.

Speaker 4

We now have the opportunity to leverage existing cross functional capabilities For the development and potential launch of INO-three thousand one hundred and seven. 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 I 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.

Speaker 4

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 4th key element is to take an active role in disease education The 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.

Speaker 4

This includes determining the appropriate distribution strategy model for INO-three thousand one hundred and seven, identifying and selecting supply chain partners In really understanding the last mile logistics for the product, a complete manufacturer to patient solution. It's important to note that INO-three thousand one hundred and seven does not require ultra cold or frozen storage or thawing prior to injection It 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-three thousand one hundred and seven, 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-three thousand one hundred and seven will be considered by payers to be a specialty pharmacy product, Not a Viandil product, consistent with many other orphan disease treatments.

Speaker 4

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 And 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 surgery With many patients facing a lifetime of repeated surgeries as their only option, incidence and prevalence of RRP is variable globally It depends on several factors.

Speaker 4

The most widely cited U. S. Epidemiology data estimated that there were 14,000 active cases In about 1.8 per 100000 new cases in adults each year, a recent publication sites that on average, Patients with RRP undergo about 4 surgeries per year. These surgeries and surrounding care put tremendous financial burden on patients and the healthcare system. Based on ongoing market research, we believe that laryngologists are the primary healthcare providers treating patients suffering from this condition That they are comfortable administering drugs and utilizing new tools and devices.

Speaker 4

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-three thousand one hundred and seven.

Speaker 4

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 could impact patients, healthcare providers and ultimately our commercial strategy as we work to potentially bring INO-three thousand one hundred and seven 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, Jackie Hsieh for a pipeline update.

Speaker 4

Jackie?

Speaker 2

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 3,107 and its ability to potentially transform the treatment paradigm for RRP. In our completed Phase III trial, 3,107 was able to generate antigen specific T cell responses Against both HPV-six 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. 3,107 was well tolerated by participants in the trial, resulting in mostly low grade treatment emergent adverse effects Such as injection site pain and fatigue.

Speaker 2

Unlike other T cell generating platforms, 3,107 and DNA medicines in general Don't cause an anti vector response, which means that 3,107 could potentially be readministered over time To boost the 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 3,107 is approved. Thinking further down the line to potential use in market, It's important to reiterate the point that Mark made earlier. 3,107 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 We see INO-three thousand one hundred and seven 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 3 step process.

Speaker 2

As you can see on this slide, In the near term, Inovio is focused on optimizing the opportunity for 3,107 as a potential treatment for RRP patients. In the midterm, Inovio is working to advance 8 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-nineteen as well as DNA Launched Nanoparticles or DLMPs targeting infectious disease targets and cancer vaccines that have various disease targets. This slide provides greater detail on our pipeline. Obviously, 3,107 is closest to market, But we also had several key candidates that we're working to advance.

Speaker 2

In particular, we're finalizing the study report and data analysis On INO-five thousand four hundred and one for treatment of newly diagnosed 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-five thousand four hundred and one is also being studied in a Phase 1b investigator sponsored trial by the University of Pennsylvania's BASA Center. Researchers there are evaluating 5,401 In patients with BRCA1 or BRCA2 gene mutations, this vaccine candidate May have the potential to prevent breast cancer for people with those mutations.

Speaker 2

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-three thousand one hundred and twelve in head and neck cancer In combination with the PD L1 checkpoint inhibitor, we are continuing discussions to find a potential PD-one checkpoint partner To advance this promising candidate, I believe there is a significant opportunity to be explored for 3,112 In combination with a proven PD-one checkpoint inhibitor. On the infectious disease side, earlier this year, we announced positive data from 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.

Speaker 2

For instance, our dMAbs and DLMPs 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 Q3 2023 financial summary. Peter?

Speaker 5

Thank you, Jackie. Today, I'd like to provide an overview of Inovio's operational highlights and financial condition for the Q3 of 2023. As Jackie 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 3rd quarter And the 9 month period ended September 30, 2023 compared to the same period in 2022. For the Q3 2023, operational expenses dropped 20% to $35,900,000 From $44,900,000 compared to the same period in 2022.

Speaker 5

The 3rd quarter included a one time non cash charge For goodwill impairment that totaled $10,500,000 Excluding that one time charge, our operational expenses The 3rd quarter would have declined 43% from the same period or same quarter in 2022. For the 1st 9 months of 2023, we cut our operating expenses nearly in half, dropping to 117,300,000 From $221,800,000 in the 1st 9 months of 2022. Breaking down total operating expenses a bit more. For the Q3, our R and D expenses totaled 15,500,000 In 2023 compared to $33,100,000 for the same period in 2022. The decrease in R and D expenses was primarily the result of lower drug manufacturing, clinical trial expenses And outside services related to INO-four thousand eight hundred and other COVID-nineteen studies and lower employee and consultant Including stock based compensation among other variances.

Speaker 5

G and A expenses for the Q3 2023 were $9,900,000 compared to $11,900,000 for the same period in 2022. Revenues for the Q3 of 2023 were $388,000 compared to $9,200,000 for the same period in 20 22. The revenue reported for the 2022 Q3 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-four thousand eight hundred, Which we have since discontinued.

Speaker 5

These factors combine to bring our net loss for the Q3 of 2023 To $33,900,000 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 Q3, Our net loss of $37,800,000 or $0.15 per share basic and diluted. We finished the Q3 of 2023 with $167,500,000 in cash, cash equivalents and short term investments Compared to $253,000,000 as of December 31, 2022. Following feedback From the FDA on the accelerated approval pathway for INO-three thousand one hundred and seven, we now estimate that our funds Should support operations into Q2 of 2025.

Speaker 5

This projection includes a cash burn estimate of approximately 26,000,000 for the Q4 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 Jackie.

Speaker 2

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

Operator

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Questions will be taken in the order received. Your first question comes from the line of Roger Song from Jefferies. Please go ahead.

Speaker 6

Great. Congrats for the progress and thanks for taking the question. Maybe just focusing on the 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 In the confirmatory study design, and any current guidance around the timing of the BLA filing and the

Speaker 2

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.

Speaker 2

We 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.

Speaker 3

Mike? Yes. Thank you, Jackie. 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.

Speaker 3

We've really mapped 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 I mean, we've already gone through our PPQ strategy for 3,100. We've used our Selectra device in our Phase 3 program. We've had several interactions with the agency on what we need to do for the device.

Speaker 3

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 at BLA. But overall, I think we're 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.

Speaker 6

Great. Thanks. Maybe just a quick question around The commercial infrastructure, with the current runway into Q2 2025, how should we think about The overall commercialization cost post approval for assuming the approval for the RRP?

Speaker 2

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 time lines, 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 core 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.

Speaker 2

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 3,107.

Speaker 4

Thanks, Jackie. Great questions. I think that Jackie 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, I mean, if we think about the field sales organization, we're thinking now that there are roughly between 304 100 laryngologists that are Forming the majority of the RRP, surgeries in the U. S. And we really think that a small specialty sales force can officially address the needs for both Patients and physicians.

Speaker 4

But I think the other sort of component and it sort of speaks to the experience that we 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 Behind that from the perspective of your distribution strategy, the early conversations you need to have with payers and PBM Specialty Soda 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.

Speaker 4

And I feel really good about where we are right now, and being able to leverage this accelerated approval.

Speaker 2

Thanks, Mark. And Roger, to answer your question about costs, I mean, 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 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.

Speaker 6

Yes, that makes sense. Thanks a lot for the comments. That's it from us.

Operator

Thank you. And your next question comes from the line of Yi Chen Farooch, C. Wainwright. Please go ahead.

Speaker 7

Hi. Thank you for taking my questions. Could you tell us whether any patients In the clinical trial has been redosed with INO-three thousand one hundred and seven. And in the real world setting, commercially speaking, do you think Laryngologist will have the flexibility of those choosing to dose how often a particular patient should be dosed with S-three thousand one hundred and seven or that

Speaker 2

So I'll hand over to Mike maybe for talking about the initial clinical question on the current on the completed Phase To trial and then Mark, maybe you and Mike together can address the next question.

Speaker 3

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 of many of our oncology programs. At present, we have not redosed any of the patients from the Phase III study. But as we come to think about those patients, I mean, we obviously saw some patients with complete response. We saw a significant number of patients with a very good partial response with 8.50 percent reduction in their surgeries.

Speaker 3

And then unfortunately, there were a few patients who did show such great response. I mean for me, I keep all those 3 buckets From a clinical strategy, but we certainly want to in the future sort of examine Now how we can continue to build on the excellent clinical efficacy we've seen to date. But I Would say obviously, any 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?

Speaker 4

Yes. I think what I would add to that, Mike, is the question where payers decide. I think that what I know is that we have a very strong value proposition for INO-three thousand one hundred and seven. 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 on but the other sort of point is that physicians aren't satisfied.

Speaker 4

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 IMO 3,107 and the fact that physicians are looking for a new option for treating RFP. So I'm feeling really good about where we are, but we'll have to get to the finish line.

Speaker 7

Will re dosing be Part of the Phase 3 trial.

Speaker 3

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.

Speaker 7

Okay. Thank you.

Operator

Thank you. There are no further questions at this time. Please continue.

Speaker 2

Thank you. The significant progress we have made in advancing INO-three thousand one hundred and seven 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-three thousand one hundred and seven. 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.

Speaker 2

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 are 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.

Speaker 2

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.

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Earnings Conference Call
Anika Therapeutics Q3 2023
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