Provention Bio, Inc. (PRVB) on Q2 2022 Results - Earnings Call Transcript
Operator: Good morning. My name is Keith, and I will be your conference operator today. At this time, I would like to welcome everyone to the Provention Bio Call. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the company's request. And now I would like to turn the conference over to Mr. Robert Doody, Vice President of Investor Relations for Provention Bio.
Robert Doody: Thank you, operator, and thank you all for joining us on Provention Bio's second quarter 2022 financial results conference call. The agenda for today's call will start off with Thierry Chauche, our Chief Financial Officer, providing an update on our Q2 financial results, as well as an update on our strategic financing efforts. Ashleigh will then join the call to review our 2022 progress to date and share some insights into what to expect going forward. Before turning the call over to Jason Hoitt, our Chief Commercial Officer, who will provide an overview of highlights from our recent teplizumab commercial launch planning investor event, as well as relevant updates. Before we begin, let me remind you that the various remarks we will make today constitute forward-looking statements. These include statements about our future plans and expectations, clinical results, regulatory and other developments and time lines related to our product candidates, including our plans to continue working with the FDA as they review our BLA resubmission and continuing our efforts towards securing a potential FDA approval for and commercialization of teplizumab for an at-risk indication, as well as the planned delivery of significant catalysts over the next 24 months, the potential safety, efficacy and commercial success of teplizumab and our other product candidates, the potential COVID-19 impact on our clinical studies and business plans, financial projections, including our anticipated use of cash and our cash runway, and our business plans and prospects and projected timing for the same. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent quarterly report on Form 10-Q, which we filed with the SEC this morning and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change, except as required by law. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. There is more complete information regarding forward-looking statements, risks and uncertainties in the reports Provention filed with the SEC. These documents are available on Provention's website at www.proventionbio.com under the Investors section. We encourage you to review these documents carefully. With that, I will now turn the call over to Thierry.
Thierry Chauche : Thank you, Bob. Before I begin discussing the financials for the second quarter, I would encourage you to read our 10-Q that was filed today. The 10-Q includes our financial statements, risk factors, as well as management's discussion and analysis of our financial condition. I would also like to call your attention to the earnings press release, which was issued prior to this call. Let me start with our current cash position and cash projection. As of June 30, 2022, our cash, cash equivalents and marketable securities position was $96.1 million. This includes net proceeds of $11.1 million generated through our at-the-market or ATM program during the second quarter of 2022. We have currently approximately $130 million remaining capacity on our ATM and we'll continue to be opportunistic on the use of this program. Also, following the regulatory update we provided early July, we completed a private placement with two of our shareholders. The transaction brought in net proceeds of approximately $57.2 million, which will support our preparation towards the potential launch of teplizumab, albeit in the same prudent manner in which we have been operating. This additional cash generated from the private placement is not included into the cash figure I cited for June 30 and will be reflected in the third quarter financial results. Our cash-based operating expenses for the second quarter ended June 30, 2022, were $27.2 million, which excludes non-cash stock-based compensation of $3.2 million and depreciation expense of $0.2 million. This number came below the lower end of our guidance, driven by our prudent approach to expenses and cash management. We expect our cash-based operating expenses to be between $27 million and $31 million in the third quarter of 2022, reflecting a slight increase in program spend and launch-readiness activities as we prepare for the potential FDA approval of teplizumab in Q4 2022. Based on our current business plans, we believe that our cash, cash equivalents and marketable securities on hand, inclusive of the proceeds from the private placement will be sufficient to fund the company's operating requirements for at least the next 12 months from the issuance of these financial statements. If the teplizumab BLA is approved, this guidance would be impacted by changes to estimated cost of commercialization and potential milestone payments. In a scenario where the approval for teplizumab is not obtained from the FDA in November, we estimate that our cash runway would extend through 2023, which is beyond the top line data readout from the PROTECT Phase III trial in newly diagnosed T1D patients currently expected in the second half of next year. We believe our momentum with the potential approval of teplizumab later this year provides us with optionality to raise capital, and we will continue to be both strategic and opportunistic when evaluating potential financing alternatives as evidenced by the most recent private placement. We will provide updates on our estimated cash-based expenses and cash runway as we progress towards the potential regulatory approval and commercial launch of teplizumab and continue to position ourselves for long-term success. Moving to the P&L. We generated a net loss for the second quarter of 2022 of $29.7 million or $0.46 per basic and diluted share compared to a net loss of $29.1 million or $0.46 per basic and diluted share for the second quarter of 2021. R&D expenses were $16.6 million for the second quarter of 2022 compared to $17 million during the same period in 2021. The decrease year-over-year was driven by lower costs for the company's teplizumab program, including the PROTECT study as target enrollment was reached in August of 2021 and lower regulatory costs compared to the prior year. R&D cost decreases were partially offset by increased costs associated with the enrollment of the PROACTIVE and PREVAIL 2a trial for ordesekimab and PRV-3279, respectively, as well as increased manufacturing costs for commercial batches of teplizumab. G&A expenses were $14 million for the second quarter of 2022 compared to $13.2 million in Q2 2021, driven by an increase in our pre-commercial activity. During the second quarter, we also recognized $0.7 million of collaboration revenue under our license agreement with Huadong. With that update, I will now turn the call over to Ashleigh.
Ashleigh Palmer : Thank you, Thierry, and good morning, everyone. Throughout the second quarter, our team has continued to collaborate with the FDA in support of our resubmitted teplizumab BLA for the delay of clinical type 1 diabetes in at-risk individuals. In mid-June, we received an information request from the agency asking for our jointly developed population PK model to be revised to include the most up-to-date antidrug antibody data in case it might affect the proposed adjusted dosage regimen. We promptly updated the model and confirmed that antidrug antibodies do not significantly impact either the output of the model or any corresponding adjustment to dosing regimen for exposure matching purposes. By the end of June, we received notification that the agency would be treating the update as a major amendment, extending the action date for its ongoing review by 3 months to November 17 of this year. While this is extremely frustrating for our company and its stakeholders, especially the T1D patients and families we serve who have waited so very long for a disease-modifying therapeutic option, we believe the extension does bring with it good reason to be optimistic about the prospect of ultimate approval. While a scenario in which the FDA does not approve our BLA, but instead issues a second CRL remains possible. It is our understanding that it would be unusual for the agency at a point this close to the original August 17 action date to request more time just to say no. We believe that it is more likely that the agency is seeking additional review time to be able to say yes. Indeed, the FDA's guidance stipulates that accepting rare circumstances, a decision to extend the review clock should be limited to those occasions when additional review time could lead to approval within the current review cycle. We are committed to collaborating with the agency to support its ongoing review and remain hopeful and optimistic that this coming November we'll see Provention Bio well positioned to potentially bring the first-ever disease-modifying therapy to individuals in the United States who are at risk of developing clinical stage type 1 diabetes, and who, up to this point, have had no option available to them other than a lifetime of insulin therapy with all of its inherent challenges, concerns and complications. I will now hand over the call to Jason to summarize our launch preparations, which he and his leadership team presented during an investor event focused on commercialization that we hosted last quarter. Jason?
Jason Hoitt : Thank you, Ashleigh, and good morning, everyone. Again, thank you to all of you who tuned into the commercial investor event we hosted on May 19. At the event, we spent 90 minutes highlighting our preparations for the potential launch of teplizumab for patients at risk of developing clinical stage T1D. For those of you who have not yet had the opportunity, I strongly encourage you to listen to the replay, which remains available on the Investors page of our corporate website. In addition to presentations made by our commercial leadership team, we were honored to be joined by key opinion leader, Kimber Simmons from the Barbara Davis Diabetes Center at the University of Colorado. In addition to providing her insights on both the current patient screening approach, along with her thoughts on how this may evolve in the future, particularly if a treatment for early-stage T1D is available. In addition, she highlighted the preparations that are being made in Colorado for a potential approval of teplizumab. During the event, we provided overviews of our progress toward launch-readiness, focusing on key functional areas, including medical affairs, marketing, sales, including our go-to-market strategy and deployment model, and finally, market access comprised of payer strategy and efforts to secure access. We also discussed some key insights gleaned, primarily those derived from quantitative market research, including health care provider intent to prescribe, patient likelihood of accepting treatment if prescribed by their physician, as well as a health care provider and consumer screening intent if teplizumab is approved for Stage 2 T1D. On the market access and distribution side of things, we continue to make good headway and progress toward launch-readiness. As reviewed during Investor Day, payer feedback through individual meetings, focus groups and market research has been quite positive regarding the response to teplizumab and the potential benefit it could bring to this area of significant unmet medical need. Similarly, in pricing research, where typically payers who are blinded to us and anonymous are the most critical and negative, we received incredibly positive feedback. Payers, key opinion leaders and health care providers all perceive a high unmet need in type 1 diabetes, especially for Stage 2 patients based on this research. When the target product profile for teplizumab was introduced and the participants were asked to rank teplizumab's perceived clinical benefit of meeting that unmet need on a scale of 1 to 5 with 1 being no benefit and 5 being major benefit. KOLs gave teplizumab a 4.5, which is impressive on its own. Payers even more astoundingly in my opinion gave teplizumab a 4.2. But for payers to rank a product above 4 is rarely seen in blinded market research and reinforces just how important treatment with teplizumab will be perceived. While we're not a gene therapy or a cure for established end-stage T1D, ratings this strong are usually reserved for those such products in the opinion of our market research provider. When asked for pricing benchmarks, those a payer would on their own think of when they think of a price point comparator for teplizumab, they really couldn't come up with any. The good news was insulin was not in their minds as a comparator. In addition to the payer work, all government programs and price reporting policies continue to be on track to support an approval. We shared the core elements of the limited distribution model we've designed, a key goal of which being to provide options with respect to site of care, including our 2 network specialty pharmacies that have home infusion capabilities in all 50 states and reduce as many barriers as possible that come with a 14 consecutive day infusion. In addition, we shared the development of our patient services program, branded as COMPASS, also designed to compliantly reduce barriers to physician and patient access through elements like benefits investigation, co-pay support for eligible patients and infusion training. Lastly, during the presentation, we introduced our plans for building a field force to support the launch of teplizumab, which began with our 8-person pilot team, alongside our sales leadership team. This team will scale up to 60 sales reps following a potential approval. As we noted during the presentation, our intention initially was to begin providing conditional offers to potential candidates around now. However, in light of the delayed review time line, we will continue the recruitment process and shift the conditional offer timing closer to the new action date with the goal of bringing the entire team on by the end of the year. Our team continues to utilize this time to have focused conversations around disease awareness and screening for early-stage T1D while simultaneously dotting all the i's and crossing all the t's with respect to launch-readiness and plan to launch teplizumab as quickly as possible after a potential approval. With that, let me turn the call back over to Ashleigh. Ash?
Ashleigh Palmer : Thank you, Jason. Throughout the last quarter, our team continued to make progress across all of our priority autoimmune disease focused clinical development programs, including teplizumab for newly diagnosed T1D patients in our Phase III PROTECT trial. PRV-3279 for Systemic Lupus Erythematosus through the ongoing enrollment of our Phase IIa PREVAIL-2 trial, as well as our Amgen-partnered anti-IL-15 monoclonal antibody, ordesekimab, being studied for non-responsive celiac disease in Phase IIb PROACTIVE trial. We also continued to engage prospective partners with respect to the ongoing development of our PRV-101 polyvalent coxsackievirus B vaccine candidate, which demonstrated tolerability and proof of mechanism by way of Phase I data reported earlier this year. We believe we are well on our way to catalyzing a fundamental paradigm shift in the approach to managing serious life-threatening and debilitating autoimmunity. This will become a reality with the potential approval of teplizumab for the at-risk T1D indication. And thereafter, we look forward to pursuing teplizumab's full potential by way of label expansion, including our plans to study its use in patients under 8 years of age, as well as the redosing of patients to potentially extend the 3-year median delay in onset of insulin-dependent disease in at-risk T1D individuals. We are also excited about the prospect of using teplizumab as an adjunct to beta or stem cell transplantation. Beta cell transplantation targeting a prevalence of 1.8 million patients with established end-stage disease in the United States alone remains challenged by having to depend upon chronic immunosuppression to protect transplanted cells from the autoreactive T cell attack that destroyed a patient's original pancreatic beta cells. With that, operator, we would like to open up the call for any questions.
Operator: And the first question comes from Justin Kim with Oppenheimer & Company.
Justin Kim : Thanks for the updates and taking our question. Just want to ask a quick question first on the note about expected FDA request on proposed labeling and post-marketing requirements 1 month prior to the extended PDUFA date. Just wondering if this is something that we can expect an update by that point or whether it's really the PDUFA that, that is sort of the focused catalyst?
Ashleigh Palmer : Justin, thank you for the question. So we would expect to provide an update on our regulatory status at the time of the Q3 results.
Justin Kim : Okay. Okay. Got it. And perhaps maybe on a related note with the strength in balance sheet, I know you gave some color on in terms of how Thierry fixed about the spend. But just wondered if there's anything sort of that's now ungated with maybe a healthier balance sheet, any sort of activities that the company is excited to sort of be engaging over the coming quarters?
Ashleigh Palmer : We remain in a gated manner in the same way as we did prior to the expansion coming up to the approval and the reduction in regulatory risk.
Justin Kim : Okay. And maybe just a final question on for commercialization. Thanks for the really extensive presentations, Jason earlier. Just wondered if you could provide some thoughts on how you think about the timing of the hybrid distribution model coming online? Just sort of things that we should be thinking about as we think about sort of modeling revenues and in terms of things like getting J-codes established, et cetera?
Ashleigh Palmer : Jason?
Jason Hoitt : Yes, absolutely. Thanks for the question, Justin. So with respect to J-codes, as long as we meet our January submission deadline, we'll have a permanent J-code effective as of the beginning of July. So as long as we hit that January deadline for the submission of the application for the permanent code, we'll be notified of the permanent code at the beginning of the second quarter and that code will go live at the beginning of the third quarter. So we'll be working essentially with a miscellaneous J-code from the time of approval until essentially the beginning of July of 2023. With respect to the hybrid model of distribution, that model will be ready to go essentially day 1. But with that being said, I would anticipate that we'll see, especially in the early days, more of the infusions than not happening under observation in an infusion center. And then as people get familiarity using teplizumab, as they develop comfort, we would envision that they would potentially start transitioning patients to home infusion, just given the reaction that we heard in qualitative market research with health care providers and patients and caregivers alike on what the notion of home infusion can mean to them with respect to -- or removing as many barriers as possible with respect to that 14 consecutive day infusion.
Operator: And the next question comes from Ram Selvaraju with H.C. Wainwright.
Raghuram Selvaraju : Firstly, I was wondering if, Jason, you could maybe comment on if there have been any challenges to commercial readiness associated with the extension of the PDUFA date? Or if from your perspective, effectively, it has any difference with regard to establishing the organization and recruiting the people that we have on board?
Jason Hoitt : Yes. Thanks for the question, Ram. So from our perspective, we were as close to readiness as we could possibly be when we received word of the 3-month delay. So while we've slowed down a few items consistent with the 3-month delay that will be reinitiated in due course with respect to the new readiness data around November 17, we were really well on track toward readiness. So from our perspective, we're using these additional 3 months to continue to drive disease awareness messaging, to drive screening messaging, to engage with key opinion leaders and key stakeholder groups like advocacy organizations. And just cross the i's and dot the t's, like I mentioned during the prepared remarks with respect to readiness and the new time lines and making sure that we're using the time effectively to continue to be ready. But I felt really confident going into the August 17 date, and I feel equally as confident going into November 17 with the additional 3 months.
Raghuram Selvaraju : That's very helpful. And then just a quick follow-on. With respect to some of the development work that is being done in the type 1 diabetes space, can you comment on -- and maybe this is a question mostly for Ashleigh on how this is likely to in the long run impacts the way teplizumab is utilized and deployed within the T1D space? For example, if we consider the work that Semma has been . And clearly, this may have less relevance for the initial at-risk population and possibly more as the utilization of teplizumab evolves. But just wanted to get your thoughts on that?
Ashleigh Palmer : Yes. Thanks very much, Ram. No, we're very excited about the prospect initially post approval for label expansion as a monotherapy to make sure that we optimize the potential. We certainly want to examine the under age group, which was not studied in the TN-10 pivotal trial. We obviously want to look at redosing and maybe, Francisco, who is on the line can speak about the redosing opportunity. But then to your point, we want to look outside of at-risk. We've got newly diagnosed with the PROTECT study, which is now fully enrolled, and we're expecting top line results in the second half of next year. And then to examine in both directions going earlier, looking at whether we can intercept this disease in Stage 1 when there's 2 autoantibodies and no dysglycemia yet, but then to your point, established end-stage disease in patients who would otherwise have a lifetime of insulin dependence, can we support the 1.8 million patients in the United States that have the prospect of transplantation therapies, where we would be used in combination. At the moment, the near-term vision for those transplant patient therapies would be to administer the transplants with chronic immunosuppression. But trading a lifetime of insulin dependence for lifetime of chronic immunosuppression, especially in young children and adults, where there's a lot of type 1 diabetes. Then that's not necessarily a clear win for the transplantation therapy. But if we could reset or reboot the immune system with teplizumab as those -- as those beta cells are transplanted and now allow them to take and be maintained and preserved, that's a different outlook. Obviously, I realize some of the transplantation therapies are looking at gene editing and other more advanced technologies to avoid immunogenicity and allow the transplants to be independent themselves, but I think that's some way off. Francisco, do you want to talk about redosing and maybe also our vision for how teplizumab could be used outside of type 1 diabetes and also in combination with tolerogenic technologies and other combinations?
Francisco Leon : Yes. Ram, thanks for the question. So with regards to redosing, we have overly -- redosed over 400 newly diagnosed patients successfully. So we know it can be done safely. We know it enhances the efficacy. So the next step is to do a clinical study post approval in at-risk patients, and we believe we can use some of the biomarkers we have, such as exhaustive T cell levels, to help guide the optimal timing for redosing. We will test that hypothesis experimentally. Potentially, by redosing two, three, four times over childhood, you could prevent clinical T1D indefinitely and get people through when the risk becomes much lower in adult age. With regards to non-type 1 diabetes indications, we have a lot of scientific knowledge that supports the use of teplizumab in driven diseases, for example, celiac disease, but also rheumatoid arthritis, multiple sclerosis, Crohn's disease, et cetera. And we intend to study some of these indications post approval as well. We already have proof of concept in psoriatic arthritis in addition to transplantation as we mentioned earlier.
Operator: And the next question comes from Prakhar Agrawal with Cantor.
Prakhar Agrawal : So firstly, just to clarify, the antidrug antibody was already part of the original PK model and the FDA asked for some update. So first question, what exactly is this updated data? Is it from the ongoing Phase III product trial? And secondly, I think I heard this, but given its importance if you can confirm again on whether after the inclusion of the updated ADA data in the PK model, the PK parameters were still about 80% for the lower limit of 90% confidence interval?
Ashleigh Palmer : Thanks very much. So it was less a case of additional data as additional modeling, taking into account the antidrug antibody data that we had, making sure that it was all included in the model and updating that model to include that data. Francisco, would you like to add some more color to that?
Francisco Leon : Yes. So as you know, the PROTECT clinical trial is ongoing, and we have generated some additional ADA data real-time in PROTECT. So the FDA just asked us to include these additional data in the model where we already have ADA data and then revamp the model for the adjusted dosing regimen that we are proposing in the resubmitted BLA. So we did exactly what they asked us to do. And the additional ADA data did not affect the outcome of that adjusted dosing regimen, it's just the same. And we just resubmitted or we responded to the FDA with the answer to their question.
Operator: And the next question comes from Thomas Smith with SVB Securities.
Thomas Smith : Just wanted to follow up there on the last one. And maybe, Ashleigh, if you could just talk a little bit about the FDA's overall level of comfort and I guess your overall level of alignment in terms of the PK model proposed dosing? I know you guys developed the model consistently together, but it sounds like you're incorporating some new data from the PROTECT study. So I guess just if you could speak a little bit in terms of your overall level of confidence that you guys are on the same stage with the PK model proposed dosing?
Ashleigh Palmer : Yes, Tom, thanks very much. I mean, obviously, I'm not in a position to talk about the FDA's comfort, but we certainly responded to all of their routine information requests in a timely manner. And as I mentioned, the information request in mid-June is really updating a model with additional data that was -- had already been collected and making sure that, that model was replete with consideration of the antidrug antibody information we had available to us. The agency has been extremely collaborative and supportive. And we have a very good positive favorable interaction sponsor, regulator interaction as far as my experience in the industry is concerned, it's very good.
Thomas Smith : Okay. Yes. I appreciate that color. And then just I guess along those lines, I mean you do have breakthrough therapy designation. Can you just talk a little bit about how frequently you're in contact with the agency at this point during the review, how dynamic is the dialogue? And similarly, it sounds like the FDA is really working with you to -- as you put it to try to get the application over the finish line here. But maybe if you could just provide some color in terms of how breakthrough therapy designation is helping you engage with the agency?
Ashleigh Palmer : Yes. Thank you. I mean we really don't comment on our regular routine interactions with the agency. We obviously report material non-public information when it becomes available. But the whole breakthrough therapy designation has had a very significant impact on the development of teplizumab for the at-risk indication. As many of you will recall, we acquired teplizumab from MacroGenics with the initial intent to do the newly diagnosed indication, and repeat a Phase III clinical trial when the at-risk data through the NIH TrialNet study became available, we filed for breakthrough therapy designation, received that and received guidance from the agency as to how to package and analyze this data, which met breakthrough therapy designation requirements, potentially compelling efficacy data against a disease with significant unmet need. That led to a rolling BLA submission during the original BLA submission, which was extremely useful and helpful culminating in the last module, which is the CMC module being filed in November of last year. It led to a six-month review. Once accepted by the agency in January of last year, it led to an advisory committee and a subsequent CRL, which clearly showed that the safety, efficacy or risk benefit equation had been met, because the CRL really didn't raise any deficiencies with regards to safety or efficacy. From a clinical assessment point of view, we were left with this challenge of the agency wanting to be reassured that the material that had been historically used in the TN-10 study, which was manufactured 12 years ago now, but that material would be comparable with the material we intended to launch with. And so that's what we have been working with the agency to address that need throughout the last 12 months. And they've been very supportive with regards to guidance on how to build a population PK model in order for us to unblind data that was collected from actual patients on therapeutic dosing using the two materials in our PROTECT study, having a model that there could be a very significant difference in PK from the fractional low-dose study that was done before the advisory committee meetings were held last year in healthy patients. And, of course, you know the recent history that data from or that modeling from the PROTECT study at therapeutic dosing brought the point estimates well within the PK comparability range, but the lower confidence interval for key PK parameters fell just below that. The PD biomarkers indicating the impact of the 2 materials was essentially indistinguishable. But the agency advised us to make a proposal regarding a dosing adjustment to ensure that the PK exposure was matched, and that would then bring the lower confidence interval within the range, and that's what we've done.
Thomas Smith : Got it. Got it. Super helpful. Just one last question. Just can you just remind us of where you are in terms of manufacturing and commercial supply as supposing that it sounds like you're going to be pretty much ready to go pending approval in November. But just remind us how much commercial inventory you're building up at this point to supply the market?
Ashleigh Palmer : Yes. Thank you very much. Yes, we are ready to go in terms of material to supply the supply chain. Jason, do you want to speak to any details beyond that?
Jason Hoitt : Yes. I would just say, Tom, we have adequate supply to launch, that's essentially ready to go that as soon as we get a final blessing on packaging, we can start to package the product. So I feel confident that we have adequate supply going into a launch later this year.
Operator: And the next question comes from David Hoang with SMBC.
David Hoang : So first, I just wanted to ask about, I think something that we were discussed during the Investor Day on commercialization. And in terms of the 14-day infusion regimen, there are, I think some centers that don't have weekend availability, which would obviously be a hurdle. And so just wondering if you guys had kind of looked into that anymore or had approached centers and found that they are amenable to providing the needed availability and potentially adjusting their hours?
Ashleigh Palmer : Jason?
Jason Hoitt : Yes. Thanks for the question, David. So what we're hearing -- I mean, it's a good point with respect to weekend hours. And we've seen, I would say an evolution with respect to the feedback we're hearing about this over the course of the last couple of years. What I would say is that Dr. Kimber Simmons, who is the KOL who participated in our commercial investor event, as you know, discussed the preparations that she and other centers in Colorado are taking. Specifically, she mentioned how Barbara Davis is preparing for a potential launch and that they already have weekend hours at their center, which isn't necessarily surprising giving an -- given an academic center of excellence. But she also noted that a Colorado Children's Hospital, where they've been in conversations and just speaking with them about their potential setup that they hadn't had weekend hours, but that they're actively planning for ways that they can staff the infusion center over those weekend days. So I think what we're seeing is an evolution toward more and more centers and more and more infusion centers, thinking about ways that they will intend to staff, many of whom have already put in place ways that they'll have weekend hours. Obviously, we can't say universally that that's the case. But it's specifically for that reason, David, that we designed the distribution model the way that we did, so that we would have the potential should a clinician and/or a patient or their caregiver want to transition to home infusion for that first weekend of care, that option is available to them. But with that being said, we would intend to work our patient services team with health care providers and infusion centers in their local area as best they can on a case-by-case basis based on where patients live. But it's nice to see and refreshing to see the way that they've evolved over the last couple of years and just how prospectively they're thinking about staffing those weekend hours. I would say we're hearing more often than not that they have -- they're either generating plans or they already have plans in place, but I can't paint all infusion centers with the same brush. I would say that from a trend perspective, that's what we're hearing them.
David Hoang : I see. Okay. Great. That's really helpful. And then I just had one question on going back to redosing. I understand that once we hopefully get an approval, there's some work to be done there in fleshing out the redosing strategy perhaps more formally. But do you expect that there will be any type of language in the drug label itself for the initial approval that refers to redosing or has this come up with the FDA where they want to say anything necessarily about redosing upon approval?
Ashleigh Palmer : We've not had conversations with the agency to this point on redosing. It's not something that we have discussed regarding labeling. But I would suspect that the labeling will indicate the experience that was had with the TN-10 study, which was a single dose. And it will be up to the company to then provide data for the agency to add to the label in regards to whether redosing makes sense, and then so how to assess when to do it. And then certainly to provide that data if the label is expanded to payers, who will clearly want to understand that a second dose of teplizumab leads to a better outcome.
Operator: Thank you. And this concludes the question-and-answer session. I would like to return the call to Ashleigh Palmer for any closing comments.
Ashleigh Palmer : Well, thank you, Keith, and thank you all again for your time and attention this morning. We very much look forward to keeping you updated on our progress throughout the remainder of this year. And we sincerely hope that you enjoy the rest of your summer with your families. Thank you.
Operator: Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.
