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spk03: Good morning and welcome to the Novant, Inc. quarterly update conference call and webcast. As a brief reminder, all participants are currently in the listen-only mode. If anyone requires operator assistance during the event, please press star zero on your telephone keypads. Following the presentation, there will be a question and answer session. Note that this webcast is being recorded at the company's request and a replay will be made available on the company's website following the end of the event. At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations, or future projections. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the federal securities laws and are based on NoVAN's current expectations and actual results could differ materially. As a result, you should not place under reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from this contemplated by such forward-looking statements are discussed in the periodic reports NoVAN files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Joining us on today's call from the Novant leadership team are Paula Brown Stafford, Chairman, President, and Chief Executive Officer, and John M. Gay, Chief Financial Officer. I would now like to turn a call over to Paula Brown Stafford, Chairman, President, and Chief Executive Officer. Ma'am, please proceed.
spk07: Thank you, Jesse. Good morning and welcome all to NOVAN's quarterly update. To start and reiterate, NOVAN is a world leader in nitric oxide-based science. And we're bringing a technology platform to the clinic to support delivering safe and efficacious therapies, looking to be the world leader. The company has really never been in a stronger position. It's been a transformational year for us, and it's a testament to our team and to our commitment. We have made significant progress across our three lead programs. In June, for SB206, our lead product candidate, we reported positive efficacy data for our pivotal phase three study. And in September, we reported our final favorable safety data as expected. Now we're advancing towards an NDA submission, and we're targeting quarter three of 2022, less than a year away, and we are planning for success. With SB204 for acne vulgaris, the most common form of acne, we are advancing towards a pivotal phase three study in 2023. And with SB019 for SARS-CoV-2, we announced yesterday additional positive preclinical data and our intent to advance towards an IND in the second quarter of 2022, and the initiation of a phase one trial in humans. In short, we are targeting three NDA submissions over the next three years. Each represents a significant market opportunity in the U.S. and beyond. Since June, we've had the chance to report out and recap our positive top-line results from the Phase 3 study. So while some of you are aware of the robust nature of our data and study results, we think it's important to now touch on it again as we believe it's indicative of the potential of our entire platform and other pipeline assets. And I'll share some updates regarding our pre-commercial activities that are now underway. As I mentioned, in June, we reported top-line efficacy and safety results at Week 12 for our pivotal Phase III study with SB206. The primary efficacy endpoint was complete clearance at Week 12 of all treatable lesions and that means lesions that were reported at baseline and any that erupted during the trial. You can see here that we saw a 12.7 percentage point difference at week 12, and even a 3.6 percentage point difference as early as the week 4 visit. With statistical significance at weeks 4, 8, and 12, And we believe this is also a clinically meaningful treatment difference at week 12 and perhaps before. We also achieved statistical significance for all four of our secondary endpoints when comparing our SB206 gel to vehicle, the placebo. Based on previous guidance from the FDA, we believe that we have met all criteria necessary to use B-simple-4 as our pivotal phase three study in our new drug application planned for 2022. Based on the strength of these results, we're focusing most, really nearly all, of NOVAN's resources on the NDA submission and all that supports a submission for NOVAN. Last quarter, we finalized the B-4 Safety Readout. Results were consistent with earlier studies and demonstrated a favorable safety profile. We also initiated pre-commercial activities. We're now focused over the next three quarters on our manufacturing PAI readiness, NDA enabling stability testing, and pre-NDA meeting preparation and conduct, all before submitting our NDA in the third quarter of next year as we're targeting. With that said, NOVAN is planning for success, which includes planning for commercialization of SB206, And last week, we announced our conditionally accepted brand name for SB206. Part of that planning includes reviewing the market potential and planning accordingly. There remains a need for an at-home solution for molluscum, a highly contagious skin infection mostly in children. The addressable market in the U.S. alone is approximately 6 million cases. Today, molluscum is either not treated or it's treated with an in-office procedure. There is currently no therapeutic alternative to Novan's SB206 product candidate for in-home use. So therefore, we expect there will be good reimbursement due to the lack of competitors and favorable efficacy and our favorable and efficacy and safety profile. In September, we initiated our commercial planning activities. This started with the selection of Cineos Health as our end-to-end commercial solution provider. And last week, we rehired Brian Johnson as our chief commercial officer. Brian brings tremendous commercial experience from a number of companies, including UCB and Galderma. In fact, while he was at Galderma, he served the role of chief digital officer, which I think is very important in today's world especially, and he helped launch seven dermatological products. Also last week, we announced that the FDA provided a response, as I mentioned, and conditionally accepted Consolis as the brand name for SB206. As is customary, we will request final acceptance of the brand name upon submission of the NDA. We're excited with the potential for Consolis, I really like this name, as we believe our product can be a kind solution for patients suffering from molluscum. Finally, work is underway with Cineos Health and our internal team of experts, Brian and others, to strategically position SB206 in the market ahead of a potential launch. I'd now like to spend a couple of minutes on an area of high interest. With additional and encouraging preclinical results that we shared publicly yesterday, we are advancing towards submission of an IND or SB019 for the treatment of SARS-CoV-2. Over the past 18 months, we've all been impacted by COVID-19. And during this time at Novan, we continued to expand the utility of our Nitrosil platform. We took the opportunity to evaluate the potential of our technology as an intranasal treatment option for COVID-19. After positive preclinical efficacy results observed in deterring transmission of the disease in vivo, we evaluated also in vivo the safety and toxicity of bradasmer sodium when intranasally administered via the SB019 formulation. We demonstrated in this 14-day repeat dosing GLP study that SB019 was well-tolerated at the highest dose tested, which was 14 milligrams per day. The intranasal administration of bradasm or sodium marks a notable extension to our previously assessed routes of administration. To date, all clinical administration has been via gel or cream with our Berdasmir sodium API. We've now unlocked, unlocked, just to say it again, unlocked real opportunity with a new possible route of administration for Berdasmir sodium. What Novan wants to focus on is an intranasal formulation that works against respiratory infectious diseases. So as Novan continues to progress this product, we strive to be prepared for COVID-19 or possibly other infectious diseases. Thus far, we continue to provide encouraging and positive preclinical data and continue to advance forward with a program with real differentiation and real opportunity. This is obviously a broader indication than our two lead assets, which are both dermatological products, suggesting, though, that our platform and API can apply in more ways than dermatological needs only. So enough of that. Let's transition to a discussion on our financial position at the end of the third quarter. John, will you cover our finances and broader opportunities for potential value creation?
spk05: Certainly. Thank you, Paula. Good morning, and thank you all for joining our update call today. This morning, we followed our 10Q for September, in addition to our corporate update press release. I'll point you to those reports for additional detail. However, I'll touch briefly on a few key points regarding our current positioning. As of the end of the quarter, we ended with $60 million in cash and cash equivalents. We expect that this balance, plus expected contractual payments to be received, provide us with the subvention capital to get us past our targeted Q3 2022 NDA submission for SB206. Our current expected runway gets assumed to Q4 2022, with our capital being focused on the continued progression of our platform, as Paula noted, primarily on the regulatory and supporting efforts to submit an NDA for SB206 and initial efforts to support commercialization for that asset. We believe getting a product candidate submitted to the FDA to be a transformative event for the company This is indeed an exciting time. In addition to the molluscum, acne, and COVID programs Paula discussed, we also have other opportunities with additional product candidates currently in our pipeline that represent potential value in the future, both in the U.S. and potentially in ex-U.S. geographies. This includes our SB4 and 4 candidate for atopic dermatitis, SB207 for genital warts, and NVN 4100 for companion animal health. While these assets are currently planned for progression internally, we do continue to look for potential avenues to move these assets forward, including with potential partners or other strategic arrangements. With that, I'll turn it back to Paula.
spk07: Thanks, John. Some frequently asked why Novan and why now? Well, 2021 was truly transformational for Novan. We're a different company today than we were just a year ago. We've proven our platform technology across three programs. We're planning to submit three NDAs in three years. We have robust Phase III clinical data for Sb206, confidence to advance Sb204 in acne, and important preclinical data related to Sb019, all give us and me tremendous confidence to proceed as we've shared today. Novant has ambitious goals, yet reasonable goals. There's significant opportunity with our three lead programs alone, and John shared our expansion opportunity that exists with the additional pipeline indications, and we believe there's significant potential upside across the entire platform. I'm proud of our team and their tremendous achievements in 2021 and their commitment to meeting our goals in 2022. As I conclude our prepared comments today, I'll end where I started. Fundamentally, the company has never been stronger. We've got a lot left to do for the remainder of 2021, and we're excited for all ahead of us in 2022. We appreciate your support and interest in NoVAN. And I'll now ask our operator, Jesse, to facilitate questions.
spk03: Participants, we will now begin the question and answer session. To ask a question over the phone, you may press the star key followed by the number one. To withdraw your request, you may press the pound key. Again, that's star one to ask a question or the pound key to withdraw your request. Thank you.
spk06: Good morning and congrats on the progress, guys. I was wondering, I had a first question for John. With your guidance that 60 mil lasts through 2022 or almost through that, could you please tell us roughly how much of that flows through the income statement for modeling purposes and, therefore, how much is CapEx?
spk05: Certainly, Jonathan. Good morning, and thanks for your question. So, you know, if you look at our most recent results, you know, in our 10Q that we filed this morning, you know, with the continued build-out of our headquarter facility and small-scale manufacturing capabilities, you're correct. We do have some significant capex. You'll notice in our disclosures we have roughly $4 million accrued for at the end of the quarter. However, you know, as we continue to move forward, we will have additional costs. I think that the majority has already been either capitalized or is on the balance sheet. So I would expect maybe a few, you know, no more than a couple of more million to come through. But, you know, that is part of that expected cash runway getting this through the end of the quarter or end of Q4 of 2022.
spk06: Okay. Thank you. Paula, you know, despite the 019 progress, Do the Merck and Pfizer COVID pills, you know, those positive results incline you to rethink at all how you'll prioritize that program?
spk07: Yeah, that's a good question. Thanks, Jonathan. And really, we, you know, obviously we're not going to be the first treatment to the market, but as we've seen with other, you know, products elsewhere, that it's often good to be the second, third, or fourth treatment option. And we're going to take it one step at a time. But right now, because we believe, as I mentioned, our advancing this product forward, maybe it's not COVID-19 even in the end, but it's another infectious respiratory disease. So we will continue to advance it one step at a time. you know, at a time. But we're very confident in the data that we're seeing that we should do that.
spk06: Okay, thank you. That's an interesting strategy. That makes sense. How long are you actually doing the consola stability testing for? And is it all real time or is any of it like heat accelerated?
spk07: Well, it's both. There's accelerated and then there's the real time and there's the drug substance that we have and the drug product. And both have to be on stability for a certain number of months. And all that is, you know, a discussion with the agency. And so that's, you know, in terms of our tech transfer and manufacturing and getting that on stability. And it's that testing that will happen in the first half of next year.
spk06: Thank you guys.
spk07: All right. Thank you, Jonathan.
spk03: Next question is from Jennifer Kim of Cantor Fitzgerald. Your line is now open.
spk01: Hey, thanks for taking my questions and congrats on the quarter. I have a few questions here. Maybe to start off with the Moleskine landscape and this might be for the whole team as well as Brian. How do you think about the CRL received by your competitor in Moleskine and does that change the way you think about the market you could be entering upon approval?
spk07: Right now, it doesn't change anything for us. I really can't comment on anything with our competitor. I don't know where that stands. We wish them success. And as we've said before, whether they're in the market or not, we have a place in the market because we have an at-home solution. And they would bring more awareness to Moleskine if they go ahead of us. And you know, we, you know, wish them well in that. But we think that there, as we've always said, there's room for both in the market because theirs is administered in office over several visits typically, and our product is at home used by the patient or administered by the caregiver. Thanks, Jennifer.
spk01: Oh, no, and for OpEx, I'm just wondering, do you have any color on how we should think about those costs going forward? I know I saw R&D went down partially from lower personnel costs and reduced costs related to the 4014 program. So I was just wondering how to think about that as well with the pivotal 204 trial planned after 2022. Thanks.
spk05: Certainly. So from an OpEx perspective, you know, the 23, that would be the expected timing of the incurrence of the cost for the trial. You know, I would say anywhere, you know, roughly 20 to 30 million for the clinical work. With regards to our OpEx, we will continue at a pace that's pretty consistent with where we're at at present, including as we continue to ramp up our costs associated with our sinews work and commercialization work. So, yes, R&D will tick down with regard to our clinical work on SB204, but SG&A will tick up a bit as we look forward to doing additional work with sinews.
spk01: Okay. And my last question is more generally, the opportunity for SB201, given, you know, the known phase three data, could you maybe, you know, lay out the topical RX market and how you think about the positioning of that product in the market?
spk07: Are you talking about 204? You said 201. I just want to make sure, Jennifer.
spk01: 204 for acne. Yeah.
spk07: Okay. Yeah, I was getting confused in terms of those. And so I think in terms of that, do you want to speak to that? I've got Brian Johnson actually here with me in terms of acne in the market.
spk00: Sure. Yeah, happy to. And good morning, everybody. So, you know, the great thing about the acne market on the professional side is that it's a huge market. There's a tremendous number of patients that are being seen in the medical profession, and there's a lot of prescriptions that are being written for the condition. What we typically see is that physicians will choose more than one modality. So they will put together a regimen. And in market research, the joke is, you know, if you've talked to one dermatologist, you've talked to one dermatologist, and they have a regimen that they believe in. But they kind of come back to the different activities that the different drugs have. So you have a group of retinoids, you have a group of antibiotics, antimicrobials, and then you'll have systemic antibiotics. And then most recently, you have a product like WinLevy, which is a different mode of action that is going to contribute to some different activities for the acne patients. We believe that SB204, based on our understanding of how it works in acne and the impact that nitric oxide can have on the acne pathogenesis, that we will have a different mode of action than any of the other products that are out will be antimicrobial, will also be anti-inflammatory. That lends the opportunity to be used very early in the treatment regimen when combined with the safety profile that we saw in the previous 204 trials and then across all of our clinical programs thus far. So I would expect that there will be some patients that get it by itself, But I think the majority of patients, like other products in the market, would be receiving SB204 along with another or potentially other multiple products as well.
spk07: Thanks, Brian.
spk01: Thank you, Jennifer. Thanks, and congrats, Brian.
spk03: Thank you. Next question is from John Vandermosten of Zacks. Your line is now open.
spk02: Hey, good morning, Paula, John, and welcome aboard, Brian. Can we get an update on the new manufacturing facility bill and how it's coming along?
spk07: Sure. We're looking at each other. So, yeah, it is progressing as planned. It is here in our Durham headquarter facility, and we are progressing and currently on track. You know, not to say that the supply chain issues aren't always a challenge for us here, as they are for each of you individually. So, we're managing through those. And right now, there's nothing taking us off track. But, you know, we'll have that up and running in the early part of next year.
spk02: Okay. And I wasn't sure, what will the CapEx be in 2022, just approximately? I know you said there's going to be more in the fourth quarter. And I assume it'll be – all the CapEx will be complete in 2022. Is that right? How much will that be?
spk05: It will be complete in 2022. I mean, there'll be some cash outlays, obviously, through 21. Good morning, John, by the way. There'll be some CapEx throughout the year and then into the first part of the next year, even after we finish the build-out. If we look at the total magnitude, we can expect probably – and it's dependent, right? With our lease agreement, we do have a TI – allowance that helps offset or defray the costs that we're incurring for the CapEx. But, you know, from a cash outlay perspective, from basically here through the completion, call it, of the cash flow in Q1, roughly another $5 million or so.
spk02: Okay, great. And then will it be completed on a modular basis? I mean, I guess you're probably less than six months away from getting it done, but will it be modularly completed or will it be just all done at once?
spk05: No, so, John, we actually took, you know, so it's modular. We've been in the building, the front half of the building, as we describe it, since May of this year. As we continue the back half of the building, which is the manufacturing suite, we expect that to be done by the end of the year.
spk02: Okay, so two different parts of it. Okay, great. Can you just remind us of the capabilities of the facility?
spk05: Certainly. So it has a small-scale capability for API manufacturing and limited drug product manufacturing that's really thought about for future use for potential CTM for continued development. So really the purpose of the plant here is to continue our development from an R&D perspective, but also to support our supply chain with our CMO counterparties that we're utilizing. Now, the facility here will be used initially to support the API manufacturer for registration campaigns for SB206, and it will be part of the greater supply chain for our potential commercial quantities.
spk02: Okay. Great, great. Last question is just on SB204 to follow on what some of the other analysts had asked. I think it's still expected to be a 1,000-patient trial. What is your estimated cost on a per-patient basis for that, and should we just assume it's going to be similar to B-simple-4?
spk07: The design is obviously different, yet we are taking our learnings from 206. The design is obviously different because it's acne, but the execution would be very similar, again, from what we've learned from our successful 206. In terms of cost, we haven't given a per-patient cost, but you can do the math. We've said that the trial is probably between $15 million and $20 million to run that trial.
spk02: Okay, great. Thank you, Paula.
spk07: Yeah. Thank you, John.
spk03: Operator, any other questions? This question is from Kent Dolliver of Brookline Capital. Your line is now open.
spk04: Great. Thank you, and good morning. and not to split hairs given the prior discussion, but with regard to SB204 and SB019, how far do you assume you will advance each given your current guidance?
spk05: Certainly, Morning Camp. So our current guidance and runway, if you will, encapsulates not only the regulatory piece for 206, But as it relates to SBL-109, that's to get it through a Phase I trial in the first half of next year so that Phase I work is included in that forecast. With regards to SB-204 for acne, that does not include the anticipated Phase III trial in 2023, but it does include activities related to preparing for that trial.
spk04: Okay.
spk07: Thanks, Kemp. Any other questions? Thank you. All right. Operator, any other?
spk03: No further questions, ma'am. I'll now turn the call back over to Paula Brown-Stafford for closing remarks.
spk07: All right. Thank you, Jesse. Well, thank you all. We are excited for what's ahead. So we're looking forward to 2022, and we thank you for joining us today. Thank you.
spk03: This concludes today's conference call. Thank you all for joining. You may now disconnect.
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