Impel Pharmaceuticals Inc.

Ladies and gentlemen, welcome to the InPol NeoPharma second quarter 2021 earnings and corporate update conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press the star line on your telephone. Please be advised that today's conference is being recorded, and if you require any further assistance, please press the star zero. Thank you. I would now like to hand the conference over to your speaker today, Impulse Chief Financial Officer, Mr. John Lehman. Thank you, sir. Please go ahead.

Thank you, Operator, and good morning, everyone. We are delighted that you could join us today for Impel Neurofarmers' first quarterly earnings conference call, during which we will review our second quarter 2021 financial results, as well as provide a general corporate update. Joining me from MPEL this morning is Adrian Adams, MPEL's Chairman of the Board and Chief Executive Officer. Before we begin, I would like to remind everyone that we have a slide presentation to accompany our conference call this morning, which can be viewed at our website at www.mpelnp.com. If you're listening to this call on your telephone, you may access a synchronized slide deck on our website by choosing the link on our webcast page that says, click here to listen. If we could advance to slide two, I'd ask everyone to review the forward-looking statements. And I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. With that, I will turn it over to Adrian.

Thank you, John. And good morning, everyone. We certainly appreciate the time you are giving us this morning. On this next slide, slide number three, you will find the agenda for this morning's call. I will begin with a brief overview of our business and the potential value-generating opportunities that lie ahead. Then we'll review in a little more detail the commercial opportunity and potential for Tradesa in the rapidly growing and dynamic acute treatment of migraine market, including an overview of our core prelaunch and launch activities and plans. Following that, I will provide a summary of the market opportunity and outline plans for another of our development assets, INP 105, before turning the call back over to John to review our second quarter financial results in more detail. I will then conclude with a summary of recent and upcoming milestones before opening the call up for your valued questions. Turning now to slide number four. On this slide, I would like to highlight several points which we believe illustrate an attractive investment opportunity within Pell NeuroPharma. Earlier this year, the FDA accepted for review our new drug application for IMP104, the acute treatment of migraine headaches with or without aura in adults, a large and growing market opportunity. IMP104 is dihydroargotamine mesylate, or DHE. delivered directly into the vascular-rich upper nasal space using Impel's unique and proprietary POD technology. If approved, IMP104 will be marketed under the trade name Trudessa in the United States. The FDA has set a PDUFA target date of September the 6th of 2021, which reflects a standard 10-month review timeframe and is just three weeks away. We are planning to launch Trudessa early in October with a highly targeted go-to-market strategy, which will fully leverage existing knowledge, experience, and indeed support in use with DHE among neurologists and headache specialists. I will review this in a little more detail shortly. In parallel, we're also advancing our second lead asset, IMP105, which is being targeted for the acute treatments of agitation and aggression in autism. another disease area with significant unmet need. IMP105 also utilizes the unique Impel pod technology targeting the upper nasal space. To further illustrate our focus pipeline progress, you will see on our next slide, slide number five, the clinical candidates that we are currently evaluating. We believe that the Impel pod technology has the potential to unlock the therapeutic viability of a previously untapped treatment pathway, the vascular-rich upper nasal space, for a variety of serious medical conditions. Although we are initially focused on CNS disease, our strategic intent is to evaluate its broad utility potential in other therapeutic areas, either through internal organic development or through value-added corporate development and licensing activities. Please note to refer to our next slide, slide number six. Over the past year, we have carried out a tremendous amount of both qualitative and quantitative market research, including in-depth discussions with key opinion leaders, broader healthcare providers, and the patient community, all with the aim of better understanding what physicians and patients are looking for in terms of an ideal acute migraine treatment. Patient-reported outcomes were a critical part of our pivotal STOP301 Phase 3 study design, and this study produced excellent results. We are pleased that these study results were just published in the August 7th edition of Headache, the official journal of the American Headache Society. This is perfect timing, given our planned October launch timeframe. We believe that these data reinforce the potential for Dredessa to be a differentiated, well-tolerated treatment that, subject to approval by the FDA, has the potential to deliver rapid and reliable symptom relief for patients with acute migraine. In fact, the exploratory data show improved and sustained patient-reported pain freedom and pain relief rates compared to existing standard of care. Turning now to slide number seven. I would like to illustrate the strong growth that is being seen in the acute migraine market. At the end of 2020, there were 27 million prescriptions written in this market, an impressive growth of 15% year over year. This robust growth has continued into 2021, and it's important to note that much of this growth is being driven by non-tryptan therapies, and in large part, by the neurologist and headache specialist communities. It is also worth noting that despite this strong growth and the shift away from triptans, there is still a lot of turnover in therapies as patients and physicians continue to search for more effective and better tolerated therapy. This is the opportunity for Tredesa. I'd now like to summarize our planned go-to-launch market strategy as shown on our next slide, slide number eight. We will adopt a disciplined commercialization approach, and with an initial sales force size of 60 experienced sales professionals, we will pursue a highly concentrated prescriber base of around 8,000 physicians that are responsible for approximately 35% of market prescriptions. These 8,000 physicians will comprise of 4,000 neurologists, and 4,000 high prescribing primary care physicians. Importantly, our target neurologists account for nearly 90 to 95% of all prescriptions that are written for acute migraine amongst the neurologist community. These target neurologists are important, not just because of their strong influence on growth, but also because of their historical and current experience and support of DAT, a product that is recognized as being the gold standard efficacy product for acute migraine treatment. As we make progress during our initial launch phase, we do plan to further invest into this opportunity by doubling the size of our sales force and increasing our reach to nearly 45% of the marketplace. You will see on our next slide, slide number nine, that our commercial strategy also includes promoting swift and accelerated pair adoption to early introduction of Impel and Trudessa to the top five payer organizations. This work has been ongoing as part of our pre-launch efforts and utilizes our experienced medical affairs and market access professionals. We recognize the importance of developing strong market access in the post-trips and failure space, and we've set a goal of approximately 70% of commercial lives covered by the middle of 2022. In summary, we are progressing well with our pre-launch efforts and are confident in our disciplined and targeted approach to building share in this large and rapidly growing market. As we move to our next slide, slide number 10, I would like to underscore the broad clinical possibilities that we see with our pod technology platform. On the cusp of the imminent FDA decision with Tradesa, We believe that the POD technology has the potential to deliver numerous additional therapeutics, of which the next in line is IMP-105. IMP-105 is comprised of a powder formulation of olanzapine, which is the most commonly used treatment for acute agitation and aggression. But its use is currently limited to intramuscular injections. We believe that IMP 105 has the potential to significantly reduce emergency room visits for patients with autism spectrum disorder. We've uncovered this as being a major unpept need as there are at least 220,000 emergency room visits a year, a large majority of which relate to patients that cannot be controlled in the home setting. Therefore, there is a significant market opportunity to bring a more humane approach to deescalating agitation and aggression episodes in the autism patient population. As we illustrate on our next slide, slide number 11, by targeting the upper nasal space in the studies we've conducted, IMP 105 achieved rapid IV-like absorption, which may provide an effective, convenient, and noninvasive future alternative for treating acute agitation and aggression in the home, community, or hospital setting. These phase 1 study results of IMP105 in healthy adults were published in the Journal of Clinical Psychiatry last year. The findings demonstrated that IMP105 reached peak plasma levels approximately twice as fast as intramuscular olanzapine, currently marketed as Zyprexa, and 10 times faster than orally disintegrating tablets. An ideal desired medication for acute agitation and aggression in autism, according to a 2005 expert consensus, is easy to administer, non-traumatically administered, provides rapid tranquilization without excessive sedation, has a swift onset of action with sufficient duration to prevent untimely recurrence, and has low risk for adverse events and drug interactions. This is the goal with IMP 105, and we are planning to initiate a phase two proof of concept study in the fourth quarter of this year. With that, I'll now turn the call over to John to review our financial results for the quarter. John?