Provention Bio, Inc.

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 Prevention Bio call. There will be a question and answer session to follow. Please be advised that this call has been recorded at the company's request. And I would like to send a conference over to Mr. Robert Doody, Vice President of Investor Relations for Prevention Bio.

Thank you, Operator, and thank you all for joining us on Prevention Bio's second quarter 2022 financial results conference call. The agenda for today's call will start off with Thierry Chauchet, our Chief Financial Officer, providing an update on our Q2 financial results, as well as an update on our strategic financing efforts. Ashley 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 Hoyt, our Chief Commercial Officer, who will provide an overview of highlights from our recent Toplizumab 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 timelines 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 prevention files with the SEC. These documents are available on prevention's website at www.preventionbio.com under the Investor section. We encourage you to review these documents carefully. With that, I will now turn the call over to Thierry.

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 conditions. 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 $11.2 million. one million dollars generated through our at the market or ATM program during the second quarter of 2022. We have currently approximately 130 million dollars remaining capacity on our ATM and will 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, all bites 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 30th and will be reflected in the third quarter financial results. Our cash-based operating expenses for the first quarter ended June 30th, 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 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 this financial statement. If the Teplizumab bill is approved, This guidance would be impacted by changes to estimated costs 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 3 trial in newly diagnosed T1D patients, currently expected in the second half of next year. We believe our momentum with a 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 46 cents per basic and diluted shares, compared to a net loss of $29.1 million, or 46 cents 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 Steplisma 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 prevailed 2A trials for odesicumab and PRV3279, 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 activities. During the second quarter, we also recognized $0.7 million of collaboration revenue under our license agreement with Wadong. With that update, I will now turn the call over to Ashley.

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 anti-drug antibody data.

in case it might affect the proposed adjusted dosage regimen.

We promptly updated the model and confirmed that anti-drug 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 three months to November 17th 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 17th 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 except in 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 Prevention 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?

Thank you, Ashley, and good morning, everyone. Again, thank you to all of you who tuned in to the commercial investor event we hosted on May 19th. 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 investor's 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 healthcare provider intent to prescribe, patient likelihood of accepting treatment if prescribed by their physician, as well as a healthcare provider and consumer screening intent if Diplizumab 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 healthcare 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. 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 competitor. In addition to the payer work, all government programs and price reporting policies continue to be on track to support and 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 two 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 eight-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 timeline, 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 Diplizumab as quickly as possible after a potential approval. With that, let me turn the call back over to Ashley. Ash?

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 3 PROTECT trial, PRV3279 for systemic lupus arithmetosis through the ongoing enrollment of our Phase 2A PREVAIL-2 trial, as well as our Amgen-partnered anti-IL-15 monoclonal antibody, audasecumab, being studied for nonresponsive celiac disease in phase 2b proactive trial. We also continued to engage prospective partners with respect to the ongoing development of our PRV101 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 T1B indications. 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 eight years of age, as well as the redosing of patients to potentially extend the three-year median delay in onset of insulin-dependent disease in at-risk T1D individuals. We're 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.

Thank you. At this time, we will begin the question and answer session. To ask a question, you may press star, then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To draw your question, please press star, the two. At this time, we will pause momentarily to assemble the roster. And the first question comes from Justin Kim with Oppenheimer and Company.

Hi, good morning, and thanks for the updates and taking our questions. Just wanted to ask a quick question first on the note about expected FDA requests on proposed labeling and post-marketing requirements. one 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 is sort of the focus catalyst.

Good morning, 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.

Okay. Okay. Got it. And perhaps maybe on a related note with the strength in balance sheet, I know you gave some color in terms of, you know, how TIRI thinks about the spend, but just wondered if there's anything sort of that's now ungated with maybe a healthier balance sheet, you know, any sort of activities that the company is excited to sort of be engaging over the coming quarters.

We remain in a gated manner in, you know, the same way as we did prior to the extension coming up to the approval and the reduction in regulatory risk.

Okay. And maybe just a final question for commercialization. Thanks for the really extensive presentations, Jason, earlier. Just wondered if you know, you could provide some thoughts on how you think about the timing of the hybrid distribution model coming online. You know, just sort of things that we should be thinking about as we think about sort of modeling revenues in terms of things like, you know, getting J codes established, et cetera. Jason?

Yeah, absolutely. Thanks for the question, Justin. So with respect to J codes, as long as we meet our January submission deadline, we'll – 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 one. 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 healthcare providers and patients and caregivers alike. on what the notion of home infusion can mean to them with respect to removing as many barriers as possible with respect to that 14 consecutive day infusion.

Great. Thanks so much, and congrats on the progress.

Thank you, Justin.

Thank you. And the next question comes from Ram Savaraju with HC RainRide.

Thanks very much for taking my questions. 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 hasn't made any difference with regard to establishing the organization and recruiting the people that have on board.

Yeah, thanks for the question, Ron. So from our perspective, we were as close to readiness as we could possibly be when we received word of the three-month delay. So while we've slowed down a few items consistent with the three-month delay that will be reinitiated in due course with respect to the new readiness date around November 17th, we were really well on track toward readiness. So from our perspective, we're using these additional three 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 timelines and making sure that we're using the time effectively to continue to be ready. But I felt really confident going into the August 17th date, and I feel equally as confident going into November 17th with the additional three months.

Thank you. 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 Ashley, on how this is likely to, in the long run, impact the way teplizumab is utilized and deployed within the T1D space? You know, for example, if we consider the work that SEMA has been doing, and Clearly, this may have less relevance for the initial at-risk population, possibly more as the utilization of teplizumab evolves. But just wanted to get your thoughts on that.

Yes, that's 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 eight age group, which was not studied in the TN10 pivotal trial. We obviously want to look at redosing and maybe Francisco, who's 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 one when there's two 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 transplantation therapies would be to administer the transplants with chronic immunosuppression. But trading a lifetime of insulin dependence for a 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 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.

Yes, good morning, Ron. Thanks for the question. So with regards to redosing, we have already 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 the exhausted 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 puberty 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 tissue-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.

Thank you. Thank you, Ram. Thank you.

And the next question comes from with cancer.

Hi, good morning and thanks for taking my questions. So firstly, just to clarify, the anti-drug 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 three 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. Thank you.

Thanks very much. So it was less a case of additional data as additional modeling, taking into account the anti-drug 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?

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 rerun 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 additionally, the data did not affect the outcome of that adjusted dosing regimen. It was the same, and we just resubmitted or we responded to the FDA with the answer to their questions.

Thank you.

Thank you. Thank you. And the next question comes from Thomas Smith with SVP Securities.

Hey, guys. Good morning.

Thanks for taking the questions. Just wanted to follow up there on the last one. And maybe, Ashley, 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 the PK-modeled 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, you guys are on the same page with the PK-modeled proposed dosing.

Yes, thanks very much. I mean, obviously, I'm not in a position to talk about the FDA's VA'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 had already been collected and making sure that that model was replete with consideration of the anti-drug antibody information we had available to us. The agency, you know, has been extremely collaborative and supportive. And, you know, we have a very good, you know, positive, favorable interaction, sponsor-regulator interaction. As far as my experience in the industry is concerned, it's very good.

Okay, yeah, I appreciate that color. And then just, I guess, along those lines, I mean, you do have a 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, you know, 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 designations helping you engage with the agency.

Yes, thank you. I mean, we really don't comment on our regular routine interactions with the agency. We obviously report material 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 three clinical trial when the at-risk data through the NIH trial net study became available. filed for breakthrough therapy designation, received that, and received guidance from the agency as to how to package and analyze this data, which, you know, 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 was 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 TN10 study, which was manufactured 12 years ago now, that 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 that modeling, you know, from the PROTEC 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 two 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.

Got it. Got it. Super helpful.

Thanks, Ashley. Just one last question. Can you just remind us of where you are in terms of manufacturing commercial supply? 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, uh, supply the market.

Yes. Thank you very much. Yes, we are, um, uh, ready to go. Um, in, in terms of, um, material, uh, to, to supply, um, the, the supply chain, Jason, do you want to speak to, um, any details beyond that?

Yeah, I would just say, Tom, we have, we have, um, 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.

Got it. All right. Thanks, guys.

I appreciate you taking the question. Thank you, Tom.

Thank you. And the next question comes from David Wong with SMAC.

Hey, guys. Thanks for taking the questions. So first, I just wanted to ask about, I think, something that, you know, we discussed during the investor day on commercialization. And, you know, in terms of the 14-day infusion regimen, there are, I think, some centers that don't have weekend availability, you know, which would obviously be a hurdle. And so just wondering if, you know, you guys had kind of looked into that anymore or, you know, had approached centers and found that they are amenable to, you know, providing the needed availability and potentially adjusting their hours.

Jason? Yeah, thanks for the question, David. So, you know, what we're hearing, I mean, it's a good point with respect to weekend hours and, you know, 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 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 given an academic center of excellence. But she also noted that at 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, you know, with that being said, we would intend to work our patient services team with healthcare 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 years and just how prospectively they're thinking about staffing those weekend hours. I would say we're hearing more often than not that it's that they're either generating plans or they already have plans in place. But, you know, I can't paint, you know, all infusion centers with the same brush. I would say that from a trend perspective, that's what we're hearing now.

I see. Okay, great. Thank you. That's really helpful. And then I just had one question on, you know, 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?

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 TN10 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 if 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.

Okay, great. Thanks a lot. Thank you, David.

Thank you. And this concludes the question and answer session. I would like to return the call to Ashley Palmer for any closing comments.

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.

Thank you. The conference has now concluded. Thank you for attending today's presentation. May now disconnect your lines.