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spk05: Greetings, and welcome to the Beyond Air third quarter 2022 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this conference is being recorded. I'll now turn the conference over to your host, Maria Yonkowski, head of investor relations. You may begin.
spk00: Thank you, Operator. Good afternoon, everyone, and thank you for joining us. Today, after market close, we issued a press release announcing the third fiscal quarter of 2022 operational highlights and financial results. A copy of this press release can be found on the Investor Relations page of our website. Before we begin, I would like to remind everyone that we will be making comments and various remarks about future expectations, plans, and prospects which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Beyond Air cautions that these forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated. We encourage everyone to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's Form 10-K, which identifies specific factors that may cause actual results or events to differ materially from those described in the forward-looking statement. Additionally, this conference call is being recorded and will be available for audio rebroadcast on our website, www.beyonddare.net. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast. February 10th, 2022. Beyond DARE undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. Joining me on today's call are Steve Lisi, our chairman and chief executive officer, Duncan Fatkin, our chief commercial officer, and Douglas Larson, our chief financial officer. With that, I will turn the call over to Steve Lisi, our CEO. Steve?
spk04: Thanks, Maria. And good afternoon to everyone joining us on today's call. As always, I would like to start by thanking the Beyond Air team as they continue to embody the mission of our organization and move us forward towards regulatory approvals and R&D pipeline progression and expansion. We continue to believe in the potential of LungFit PH to revolutionize the treatment of persistent pulmonary hypertension of the newborn, or PPHN, in the United States and cardiac surgeries around the world. Today, our commercial team continues to prepare for a U.S. commercial launch of LungFit PH in anticipation of a regulatory decision in the first half of this calendar year. I will have our Chief Commercial Officer, Duncan Fatkin, discuss this preparation in much greater detail shortly. BeyondAir continues to work collaboratively with the FDA to bring our device to the market as quickly as possible. I won't be able to comment further on our ongoing interactions with the FDA, except to assure everyone that the dialogue is productive and we have provided the agency with all information and support we believe they need to grant approval for LungFit PH. Additionally, we remain on track to receive CE Mark in Europe in the first half of this calendar year. We expect to secure an international commercial partnership for LungFit PH for ex-U.S. markets following CE Mark and will provide more information on our global strategy at a later time. Turning now to recent operational highlights. In December of last year, we expanded our leadership team and welcomed Dr. Andrew Colon as our new Chief Medical Officer. Dr. Colon has been a valuable contributor to our Scientific Advisory Board since 2013, and his advice has been instrumental to the progress of our ongoing clinical programs to date. He has been tasked with leading our late-stage development efforts of both LungFit Pro and LungFit Go systems, given his medical background as a board-certified pediatric pulmonologist with more than four decades of clinical experience in respiratory physiology, cystic fibrosis, and lung infections. With regards to scientific updates and our presence at upcoming medical conferences, I am happy to report that we have been accepted to present new data from our pipeline programs at three leading scientific conferences all within the next four months. I will start off our pipeline commentary with our LungFitGo NTM lung infection pilot study. As you may recall, in December 2020, we began screening for refractory NTM patients for this pilot trial in Australia. In October, we released interim data where a total of eight refractory NTM patients had been titrated up to the maximum dose of 250 parts per million nitric oxide in the hospital over several days and then sent home to self-administer therapy. There were no dose reductions, no study discontinuations, and no treatment-related serious adverse events reported. Our team was very encouraged by this initial safety profile. We have now been accepted to present additional results from this pilot study at the American Thoracic Society International Conference being held from May 13th to May 18th in San Francisco. Beyond the safety profile, this study aims to evaluate efficacy parameters such as quality of life, physical function, and bacterial load, among other metrics. Remember, this is a pilot study designed as a single-arm, 12-week at-home trial aiming to enroll up to 20 cystic fibrosis or non-CF bronchiectasis patients with a refractory NTM lung infection, either mycobacterium avium complex or mycobacterium abscessus. It is important to note that NTM is a disease area of focus for FDA. In fact, 50% of patients will die in less than five years from from the initial diagnosis of mycobacterium abscessus lung infection. As such, the success of this trial could signal that LungFit Go has the potential to be a game changer for this patient population and start to open up the enormous potential of the home market for our system. We have always had an interest in investing in other indications with our LungFit Go system and have announced our intention of beginning a pilot study to treat severe COPD exacerbations due to lung infections over the next 12 to 24 months. Moving on to our viral lung infection program, which uses the LungFit Pro system at 150 parts per million nitric oxide to treat community-acquired viral pneumonia in adults and bronchiolitis in children under two years of age. As many of you may recall, we presented interim data from our adult cohort of hospitalized pneumonia patients last May at the American Thoracic Society International Conference. At the time of the cutoff period for these data, we analyzed a total of 19 patients on an intent-to-treat basis, 9 of the patients in the NO treatment arm and 10 in the control arm, all of which were COVID-19 patients. These data show that 150 parts from laying NO administered by a LungFit Pro was deemed to be safe and well-tolerated, with no treatment-related or possibly related adverse events or serious adverse events. Additionally, 22% of subjects in the NO treated group required oxygen support beyond their hospital stay, compared to 40% of control subjects. With respect to duration of oxygen support, NO treated patients averaged two days less than control. A 26-hour reduction in mean duration of hospital stay between the NO treatment group and control was observed when adjusting for extreme outliers. Since presenting these data, we have kept the study active with trial sites open for enrollment. I am happy to report that we have been accepted to present new data at the 32nd European Congress of Clinical Microbiology and Infectious Disease being held April 23rd through 26th in Lisbon. Our team is excited to have the opportunity to share these additional data with the scientific and medical communities. Finally, I would like to provide updates on our private affiliate, Beyond Cancer. Late last year, we successfully raised $30 million in a private placement of common shares to spin out our oncology program developing ultra-high concentration nitric oxide, or UNO therapy, for the treatment of solid tumors. We believe UNO therapy may not only partially ablate or shrink the primary tumor, but also can arm the immune system to recognize and attack same tumor cells if they metastasize to other regions in the body. Our preclinical data show that treating a tumor with UNO therapy will cause local cell death, exposing the immune system to tumor antigens, thereby creating a memory immune response. For patients, this could mean preventing recurrence or metastases. Under the leadership of CEO, Dr. Selina Chasson, Beyond Cancer has established its six-member board with the recruitments of Mr. David Dvorak, previously the CEO of Zimmer Biomed, and Dr. Gregory Burke, a clinically trained physician who is currently serving as a chief medical officer and interim CEO of GT Biopharma, a clinical stage immuno-oncology company. Additionally, Beyond Cancer will present two data sets at the American Association for Cancer Research annual meeting, which is being held from April 8th through 13th in New Orleans. Recall, we previously presented in vitro and in vivo preclinical data for ultra-high concentration gaseous nitric oxide at several conferences in 2020, which suggested that direct administration of UNO therapy to solid tumors triggers a systemic anti-tumor immune response, which could serve as the basis for an effective immunotherapy. These new preclinical data being presented in April will continue to build upon this growing body of evidence, and we are excited to support the progress as a partner of Beyond Cancer. I will now turn the call over to Duncan Fatkin, the Chief Commercial Officer of Beyond Air, to provide additional details on the U.S. commercial launch for LungFit PH.
spk01: Thanks, Steve, and good afternoon to our investors. As I highlighted last year, the commercial organization is ready to launch LungFit PH domestically as soon as we receive FDA approval. Our strategy has not changed, as we aim to focus on a limited release for the first six to nine months post-launch and target a select number of hospitals that have level three or level four NICUs and staff experienced with inhaled nitric oxide. We continuously refine our marketing plan and work to optimize our customer service model as we draw closer to a decision date from the FDA. Our launch team is securely in place and consists of highly experienced individuals with decades of nitric oxide experience who will work closely with our target hospitals to ensure that we provide the best possible logistics support, customer service, and product performance. As I have said before, since many of our target hospitals are currently in multi-year contracts with cylinder-based nitric oxide suppliers, we'll be targeting hospitals with fewer than 12 months left on their existing contracts, and we anticipate it taking approximately four years to have an opportunity to convert every hospital that uses nitric oxide in the United States. As a reminder, here are the main areas of immediate focus for the commercial team. First, building and developing the team. Our pre-approval launch team is ready to be deployed immediately following approval. We continue to build on the nitric oxide experience that our team has brought to Beyond Air through our intensive internal training program. As I previously mentioned, we have numerous respiratory therapists on staff and experienced leaders to run our sales and marketing efforts. Our launch team is also preparing for the execution of our ex-US partnership plans following CE mark, anticipated in the first half of 2022. Second, we are refining our logistics plan to ensure that the first phase of Beyond Air customers have an optimized customer experience. We're especially excited to launch our customer service and support program upon approval with a focus on flexibility and transparency with all of our customer stakeholders. Last, we are confident that customers will see significant value compared to cylinder-based systems as LungFit PH would be the first and only FDA-approved system that generates nitric oxide from room air. We look forward to sharing the logistical patient workflow and healthcare economic benefits with you in more detail upon approval. These messages will also be highlighted on the LungFit PH website, lungfitph.com, which will be made publicly available on day one of our launch. We are planning to attend all the major neonatal and respiratory conferences throughout 2022 and look forward to engaging with potential customers when appropriate. We will continue to maintain a highly visible presence at these conferences to showcase LungFit PH and the benefits of our innovative system. Our vision is to harness the power of nitric oxide to unlock access, empower healthcare providers, and transform more lives in more ways. LungFit PH is a groundbreaking all-in-one nitric oxide generator, monitoring, and delivery system, and we are extremely excited to share our story with potential customers in the U.S. and beyond. Thank you, and I will now turn the call over to Doug for the full financial review. Doug.
spk03: Thanks, Duncan, and good afternoon to our investors. Before I jump into the financials for the past quarter, I'd like to address a couple of housekeeping items. First of all, it's important to note that our balance sheet, P&L, and cash flows now include Beyond Cancer, our private oncology affiliate. Due to our majority ownership position, their financial statements are fully consolidated with those of Beyond Air. The P&L and equity sections in our 10-Q break out the amounts attributable to the non-controlling interests that own 20% of the common stock in Beyond Cancer. Second, we had a large number of warrants exercised for common stock in fiscal Q3, especially our warrants issued in January of 2017, which expired in January of 2022. We issued just over 748,000 shares of common stock upon exercise of warrants in Q3 and brought in almost $1.4 million from those transactions. Balance of the warrants from January of 2017 were exercised in January of 2022, bringing in almost $4.6 million of additional cash, which we call out in our note on subsequent events in our 10-Q. With that, I will now turn to the brief review of our financial results for our third fiscal quarter of 2022, which ended on December 31st, 2021. Revenue for the fiscal quarter ended December 31st, 2021 was zero as compared to 0.1 million for the fiscal quarter ended December 31st, 2020, all of which was licensing revenue. Research and development expenses for the fiscal quarter ended December 31st, 2021 were $2.5 million compared to $3.4 million for the fiscal quarter ended December 31st, 2020. General and administrative expenses for the fiscal quarter ended December 31st, 2021 were $4.9 million compared to $2.5 million for the fiscal quarter ended December 31st, 2020. Other income and expense for the fiscal quarter ended December 31, 2021, was a loss of $0.5 million. For the fiscal quarter ended December 31, 2021, the company had a net loss of $8 million, of which $7.7 million, or 29 cents per share, was attributable to the shareholders of Beyond Air Inc., compared to a net loss of $5.8 million, or 33 cents per share, for the fiscal quarter ended December 31, 2020. For the fiscal quarter ended December 31st, 2021, the company used $6.3 million of cash for operating activities. As of December 31st, 2021, the company had cash and cash equivalents of $83.5 million, of which $54.5 million is in Beyond Air and $29 million is in Beyond Cancer. And keep in mind, this does not include the additional $4.6 million we brought in in January that I mentioned earlier. We believe that our cash on hand is sufficient to fund operations well beyond the next 12 months, including through the commercial launch phase of LungFit PH in the U.S. And with that, I'll hand the call back to Steve. Thanks, Doug.
spk04: Operator, we're ready for Q&A now.
spk05: Thank you. And at this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
spk06: One moment, please, while we poll for questions. And our first question comes from the line of Greg Fraser with Truist.
spk05: Please proceed with your question.
spk09: Thanks. Good afternoon, folks. Amongst the PAs, I appreciate the color on your interactions with the agency. It sounds like there's nothing outstanding from your end. Is there anything specific that you're aware of that's gaining approval at this point, or you just have to wait to see what the agency comes back with next?
spk04: Yeah, Greg, I wish I could give you something more specific, but we're just kind of waiting to see what they come back with at this point.
spk09: Got it. Okay. How important will the transport system be to the broader launch strategy when you expand to more hospitals, and can you speak to the timing of approval for a transport system?
spk04: I'll speak to the timing, and I'll let Duncan tell you how important it is. You know, the timing will be, you know, I would say within the first two years after we launch the product, so maybe sometime in the 15 to 18 month time period or so to speak after we get the approval is probably when you'll see the transport unit.
spk01: Yeah, Greg, thanks for the question. So the transport system, it's important that there is a transport system that the hospital has access to. The good news for us is that we have made the decision to have a controlled phased launch. And in that first period where in the first six to nine months we go to the 10 to 12 hospitals we've previously talked about, we don't anticipate there to be any resistance to there not being a transport system available. And, in fact, based on the feedback we've had from many of the customers that have approached us, they can definitely use our system without a transport system being available for a significant period of time, by which time we will have a transport solution, and we believe it will have some significant differentiation that will be welcomed by our customers.
spk09: Got it. Thanks. That's very helpful. And then on LungFit Pro, will the additional data from the study that you'll be presenting be for the same group of patients, or will you have data for additional patients, including non-COVID folks?
spk06: Yeah, there'll be more patients for sure. Got it. Thank you. Thanks for taking the questions. Thanks, Greg.
spk05: And our next question comes from the line of Suraj Kali with Oppenheimer & Company. Please proceed with your question.
spk07: Good afternoon, everyone. Steve, a couple of questions for you and one for Duncan. Specifically, Steve, and I appreciate your commentary about not giving specifics on the FDA process for PPHN. I was wondering at least if you all could give us a flavor. Was there any new data provided since the last conference call? And also, Steve, the subpart for you is any color you can provide with the ongoing bankruptcy of Malincrot, and are you seeing any structural changes in the marketplace as you prepare for commercial launch? I'll throw in the question for Duncan also. Duncan, for Beyond Cancer, and I'm drawing a blank here in terms of your previous commentary, maybe you could just kind of highlight for us how – From a modeling perspective, we should think about OPEX or Beyond Cancer flowing through Beyond Air. Gentlemen, thank you for taking my questions.
spk04: All right. Siraj, I'm going to give that last one to Doug on the Beyond Cancer side. That's a finance question there. So let's take them kind of in order. So why don't you just do me a favor, because we were a little bit shocked. You had said question for Duncan, and it came out as a cancer question. So just kind of recap your question so we can take them in order, please. I apologize.
spk06: Real quickly, don't say the whole question again. Siraj? Hi, Siraj, is your phone on mute?
spk07: Steve, can you hear me now? Sorry.
spk04: Now I can, yeah.
spk07: Okay, apologies. So very briefly, any new info provided on PPHN? Okay.
spk04: Yeah, the answer to that is no new information has been provided.
spk07: Okay. Any structural changes in the marketplace with the ongoing Malincroft bankruptcy as your commercial launch?
spk04: Yeah, I mean, I don't want, you know, whatever is in the public domain about their bankruptcy is in the public domain. But with respect to the market, I don't think we've seen much change over the past, you know, two years. you know, from just prior to their bankruptcy and up until now. It's been, you know, the competition from Praxair and Vero has been there. And I don't think the bankruptcy has really impacted much. And now that they're coming out, we don't really see much difference, honestly. Duncan, if you have anything else to add.
spk01: No, I think Steve's captured it. It's certainly nothing that changes our strategy.
spk06: Okay. Just...
spk07: And Steve, maybe for Duncan or for Amir, just the Beyond Cancer OPEX flow, how should we think about it from a housekeeping perspective? Gentlemen, thank you.
spk04: So the expenses for Beyond Cancer, they'll be consolidated to Beyond Air. We own 80%, so we'll consolidate all those expenses, and you'll be able to see that broken out as 20%. that's not owned by Beyond Air will have to be broken out in our financials. And I think, Doug, you may want to just comment on how it's shown in the 10Q.
spk03: Sure. So right now we're consolidating 100% of Beyond Cancer into Beyond Air. So when we had the $30 million investment, the 20% or $6 million flows into non-controlling interest. And then as we generate, in this case, losses through the quarter, 20% of the losses also flow into non-controlling interest. And in future Qs and Ks, we're going to be breaking that out so that you can see the equity bridge from the $6 million in non-controlling interest to the ending position for the quarter. Thank you.
spk05: And our next question comes from the line of Matt Kaplan with Lattenberg-Dalman. Please proceed with your question.
spk02: Hey, thanks for taking the question, and congrats on the progress. Just wanted to focus a little bit more on the PMA process ongoing. Can you give us any sense? It seems like you're basically ready to launch any day now. Can you give us a sense in terms of – what the next steps are with FDA? Is it just waiting for approval? You're expecting another turn and more questions from them.
spk04: So Matt, it's an ongoing process. So we continue to work with FDA to get to this end game of approval. So, I mean, I'm not going to say much more than that or no more than that, let's say. And, you know, as for the commercial team, they're ready to go. I mean, if FDA were were to give us a call tonight and say, you know, you're approved on Monday, Duncan's team will be ready to launch it on Tuesday. No problem. That's not going to happen. I'm just giving you an example. Okay.
spk02: Fair enough. Fair enough. And maybe just switching to some of your programs that you have in pilot stage of development. Long take, can you give us a sense in terms of the ongoing pilot study at home in the at home setting? When do you think that study could complete and then what the next steps are for developing in NTM and kind of map that out for us a little bit? I guess you did announce you plan to launch additional work in COPD in the next 12 to 24 months, but focusing on NTM, what are the next steps there?
spk04: So, you know, we're going to have some data at ATS. And the study, you know, since it is a 12-week follow-up, that'll complete over the summer, the last patient followed up. And then it'll be a several-month process to take all the data and put it into a pre-submission to give to FDA. We also have some work being done in the lab. So once we get the final sputum samples from the last patients, we'll be sending it out to a lab for further analysis, which I think is important. for everyone to understand, you know, and we want to present that to FDA. So we're going to wait for all that data to come in, go to them and run through the process and see how that'll work out. And I think sometime, you know, probably in the middle of 23 or back half of 23, we'll embark upon starting a study. And what I mean by that is, you know, we'll embark upon, you know, identifying sites and speaking with them and trying to get them up and running with all the process that takes. And as you know, this process can take, you know, six to nine months to get sites up and running. So, you know, I would look at that kind of a timeline. Could it be faster? Sure. But I really want to be cautious on this because, you know, these things do take time. And, you know, it's a new ground for everyone, for FDA, for the physicians, for the patients of what we're doing here. And hopefully the data will work out to be very strong and you know, people will catch on quickly. But until that happens, I'm going to keep that kind of a rough timeline. And, you know, LungFit Go, as you mentioned, COPD, yeah, I mean, we want to do COPD as well because this is also targeting mostly for patients at home. And obviously we feel confident that our LungFit Pro system, which was used in this pilot study, will become our LungFit Go system is ready for prime time in the home market or we wouldn't be embarking into COPD. So we're very excited about how the system performed, how it held up, how simple it was to use, and the feedback we got from the participants, not just the patients, but also the engineers and physicians and medical staff, you know, halfway around the world from us, and we were obviously managing this remotely, this study. So the feedback was fantastic. And this is why we're now trying to push for COPD. And if we can get something started up this year, fantastic. We'll do everything we can, but it may be in 23. Again, sometimes it's tough to push things really fast when it's so new for the people that you're talking to. Right, right. Okay, fair enough.
spk02: And just to be clear, so final data from the pilot study late this year and then embark on potentially a pivotal study starting mid to second half of next year. Does that make sense?
spk04: I think that, yeah, I don't think there'll be any patients enrolled in 23, Matt. I think that that would probably be later on because, again, it does take time to get sites moving, getting them set up, getting through IRB process and so forth. So I would look more uh, towards maybe, you know, best case end of 23, more likely a first half of 24 type of, you know, getting paid in to a study. I think, uh, I, and again, I hope it's faster than that, but I just, you know, these things, you know, they, they take time where we've surprised a few people with what we've tried to do. And, uh, you know, we realize not everybody is, is up to speed on what nitric oxide is and does, but, uh, I think people will get catching on based on the progress we've made over the past few years. Okay, good.
spk02: And then just similarly for LungFix Pro, the pilot study that you have going there, help us understand kind of the next steps there in terms of, I guess you can have some additional data in April, but in terms of wrapping up that study and moving to the next phase of development.
spk04: Yeah, that study is wrapping up now. I mean, as the winter is You know, we're in the back half of the winter now. So we're wrapping this study up. And, you know, we're moving as fast as we can here. And the key for this is it's seasonal. We need to do a study that all the patients we're targeting are enrolled within the same winter season. So we're fighting against the clock here to try to get things done and work with FDA to get this study off the ground so we can get going coming up this November. So we're working on that. Stay tuned. If we can get everything done in time, we'll be doing a study this coming winter.
spk06: Okay, great. All right. Thanks for taking questions, Steve. Thanks, Matt.
spk05: Our next question comes from the line of Yale Ken with Ley Law & Company. Please proceed with your question.
spk08: Good afternoon, and thanks for taking the questions. I just want to follow up what Matt had asked, maybe the last one, which is for the long-fit probe, the study you were talking about, would that be for pediatric or for adult or you have not decided? It would be for adult. Okay. And two quick questions here. First one is, it's a little bit more fun, which is that the Have you guys given a formal name for the oncology treatment at this point?
spk04: So we're using UNO therapy right now for ultra-high nitric oxide. So, you know, we'll see how that goes, but we're calling it UNO therapy at the moment. Okay. So not like the card game, but, you know, we'll see what we can do with it. But that's the name now. And we'll see how that progresses as we go forward.
spk08: And last question here is just actually for Duncan. I'm just curious in terms of for the long-term PH, as you promote that, do you potentially will go through some of the group purchasing organization or that's purely not relevant and just go to each hospital specifically?
spk01: Yeah, thanks for the question, Yale. Just a reminder, we're definitely not promoting the product right now, obviously.
spk08: I understand. After you launch, though.
spk01: For the record. But certainly going forward, of course, we will engage with buying groups as appropriate. Because we have a phase launch, the initial phase, that group of hospitals I mentioned, there's certainly not going to be any of those kind of arrangements in place. But there definitely have been contacts from various groups and a lot of the key hospitals that you would know around the country. There's a lot of interest in our technology. And we will negotiate and discuss that with them accordingly. But reinforcement that we don't expect to be competing on price. We're focused very much on the benefits that we provide both potentially clinically, logistically, and in terms of patient workflow. That's a long yes, but not now.
spk08: Understood. And maybe just squeezing one more. In terms of long-fit goal, in terms of the level of nitroxide based on PPM, is that the same for the NTM versus the COPD, or they could be different? And thanks.
spk04: Thanks, Yale. So for NTM, we titrate up to 250 parts per million. For patients with underlying COPD who have lung infections that cause severe exacerbations, again, we'd be treating the exacerbation, not the underlying disease of COPD. We haven't decided on where that ultimate high end of the range will be for treatment, but obviously, it'll be at least 150 parts per million minimum. So it could be 200 or 250. We're just not sure yet, but I don't think we can go above 250 parts per million just yet. So that'll probably be the highest we possibly would go at this moment in time. It's not machine related. It's not a device related. It's more of a, you know, what we've learned so far that we're able to do with staying within safety parameters. Okay, great.
spk08: That's very helpful. Again, congrats on the progress and look forward to launch.
spk06: Thank you.
spk05: Again, as a quick reminder, if you have any questions, you may press star 1 on your telephone keypad. The next question comes from the line of Scott Henry with Roth Capital. Please proceed with your question.
spk10: Thank you. Good afternoon. Just a couple questions. Most of mine have been answered already. I guess for Doug, a couple modeling questions. First, G&A was certainly above trend in third quarter. Is there some one-time events in there from the Beyond Cancer transaction, or perhaps maybe it should take a step up as you have that entity as well, just trying to get a sense of how to think of G&A going forward?
spk03: Sure. Yeah, no problem. Thanks for the question. So, there were a couple things that happened in there. Certainly, the setup of the cancer business did generate some legal fees, especially, you know, some one-time costs around that creation. You may have noticed we didn't use a bank, but that didn't keep the legal fees down. So, we did have those. We also had a restricted share grant in the quarter. And the way we account for that, so this is a non-cash item, obviously, but the way we account for that is we take each tranche and spread it over the life of the tranche. And so whenever we have a grant, we have a pickup through the P&L. That's fairly significant. So between those two items, that explains the biggest chunk of the increase.
spk10: Okay, great. You did mention the warrant transactions, particularly in January. I haven't seen the queue yet, but could you give us a sense of where the real-time shares are today?
spk04: You mean how many shares are out?
spk10: Shares outstanding in real time.
spk04: Yeah, so we just put up the shelf registration. So the share count is in there, I believe.
spk03: It's actually first page of the queue as well. It's 29, 28 million.
spk04: Yeah, there you go. Yeah, I think it's almost the same as what we had in the shelf.
spk10: Yeah. Okay. Perfect. Thank you. Final question. I think you've talked about this in the past, Steve, but as we get closer to potential launch, how would you kind of categorize the manufacturing capacity, any supply issues, or do you feel pretty good about that for the considerable future?
spk04: So I think for the first six to nine months of our focused launch, we're all set. I think There's nothing really that concerns us with respect to supply or manufacturing capacity for that timeframe. But as we go beyond that, we have to manage the supply chain. I don't think our capacity, our actual manufacturing capacity is fine. It's really supply chain. I mean, there are still things that are difficult to source out there. I'm sure we're not the only company to say that, nor is our industry the only one to have the problem. I think things are getting a little bit better. And you know, I hate to say it, but I mean, I wish we had approval already, but you know, this little bit of a push out has helped us to be able to source some of these things so that we do feel more comfortable going beyond that first six to nine months. So we do feel a little bit better about that, but I don't want to say it's, it's something that isn't a concern. It has to be a concern given the environment, you know, in the world right now. So, but we're, we're, we're certainly comfortable to get through the first phase and enter the second phase of our launch and But I don't want to be too bold and say it's not an issue. But I'm very comfortable with the team and the things that they put in place to make sure that we're going to do okay in the next, you know, two to three years with supply chain. I'm actually quite impressed with the team. Glad I have them because they know more than me. So it's a good thing.
spk10: Okay, great. Thank you for the color and thank you for taking the questions.
spk04: Thanks, Scott.
spk05: And we have reached the end of the question and answer session. I'll now turn the call over to Steve Leacy for closed remarks.
spk04: Thanks, everyone, for joining today. Much appreciated, and we look forward to the next time we speak.
spk05: And this concludes today's conference, and you may disconnect your lines at this time.
spk04: Thank you for your participation.
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