Good morning. My name is Rocco, and I will be your conference operator today. At this time, I would like to welcome everyone to the Provention Bio conference 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. Now I would like to turn the conference over to Heidy King-Jones, Chief Legal Officer of Provention Bio. Please go ahead. Thank you, operator, and thank you all for joining us. Ashleigh Palmer, Chief Executive Officer and Co-Founder of Provention Bio, will be providing an update regarding our announcement this morning and share some insights about why we're so excited about our partnership with Sanofi through a co-promotion agreement and equity purchase agreement. He will then turn the call over to Jason Hoitt, our Chief Commercial Officer, who will provide an overview of how this announcement complements our existing teplizumab commercial launch plan. Lastly, Thierry Chauche, our Chief Financial Officer, will discuss the terms of the agreement and our cash position. 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 in connection with the agreements we entered into with Sanofi and the potential commercialization of teplizumab, 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, the potential safety, efficacy, and commercial success of teplizumab and our other product candidates, 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 forward-looking statements as a result of various important factors, including those discussed in the Risk Factor section of our most recent quarterly report on Form 10-Q 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 Provention reports we file 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 Ashleigh. Thank you, Heidy, and good morning to everyone joining the call today. We are excited to announce that we are joining forces with Sanofi, a leading global biopharma company with an established endocrinology commercial in-market infrastructure. As many of you know, teplizumab is currently under BLA review by the U.S. Food and Drug Administration for the delay of clinical type one diabetes in at-risk individuals with a user fee goal date of November 17th, 2022. If approved, teplizumab has the potential to become the first-ever type one diabetes, or T1D, disease-modifying agent, bringing a potential breakthrough designated therapeutic option to a population we believe has been significantly under-recognized, underappreciated, and underserved. We are thrilled to be working alongside Sanofi, leveraging the outstanding reach and relationships of its customer-facing field teams as we prepare for potential launch of teplizumab in the United States. This co-promotion arrangement, which comes after many months of due diligence conducted by Sanofi, reinforces Provention's planned teplizumab commercialization with increased and complementary resources focused on extending, expanding, and enhancing our penetration into the nascent at-risk T1D market. By entering into this agreement, we are honoring our corporate commitment to the T1D community and our mission to bring this innovative and disruptive potential therapy to the patients and at-risk individuals we serve. Not only does this co-promotion agreement with Sanofi significantly enhance our ability to bring teplizumab, if approved, to a greater number of T1D at-risk individuals, it also allows Sanofi time to negotiate for global commercialization and other rights in T1D. Specifically, we have given Sanofi a right of first negotiation to research, develop, manufacture, and commercialize teplizumab globally in T1D in exchange for a non-refundable $20 million payment. We are very excited about Sanofi's high level of interest in building a global teplizumab T1D franchise and look forward to our ongoing dialogue with them. As further evidence of this high level of interest, at Provention's discretion within 90 days of anticipated approval, Sanofi will make a $35 million investment in Provention at a 40% premium. We are thrilled that Sanofi shares our vision for the disruptive potential of our groundbreaking lead therapeutic candidate, and we are looking forward to working closely with them in the coming weeks and months. With that, let me hand over to Jason to discuss the co-promotion agreement with Sanofi in greater detail. Jason? Thanks, Ashleigh. Teplizumab has the potential to become the first ever immunomodulatory agent to intercept the underlying pathophysiology of type one diabetes. More than a century after the introduction of insulin to treat T1D, through our market research to date, we believe that patients and their families are eager for additional treatment options, particularly for stage two disease. We're excited about the opportunity to potentially bring this new therapy to patients and their families, alongside our new colleagues at Sanofi. As we approach the November 17th FDA action date, we've been ramping up our commercial preparation efforts, and our co-promotion with Sanofi both complements and expands these efforts. As a part of the agreement, Sanofi will commit commercial resources in the United States, including diabetes field specialists, dedicated account directors within the sales organization, field-based reimbursement, and medical science liaisons. Together with our team of 60 therapeutic specialists and 13 field medical scientists, the agreement more than doubles our field presence and significantly expands the number of key healthcare professionals we can reach during the initial launch. Importantly, from an economic perspective, for the majority of the FTEs covered, we'll only be paying for a part of their time, but will benefit from the relationships that every member of the Sanofi team has developed over many years with endocrinologists and the broader diabetes community in the United States. Let me touch on some of the advantages we believe flow from our co-promotion agreement with Sanofi. First, in terms of reach, we believe, alongside our dedicated field teams, the additional FTE resources from Sanofi will be able to drive greater awareness of teplizumab and the benefits of screening for at-risk individuals as we launch into this nascent market. We gain access to their diabetes field force with their long-standing relationships, infrastructure, and knowledge resulting from Sanofi's more than two-decade investment in this space. As I've mentioned previously, our go-to-market strategy has always first focused on the pediatric endocrinologist alongside high decile adult endos and other specialties with a vested interest in T1D care. This agreement allows us to immediately leverage Sanofi's long-standing relationships with over 40,000 healthcare providers, including adult endocrinologists and primary care physicians, significantly expanding our reach during the launch. We've built a fantastic team here at Provention that's eager to get out into the market to promote teplizumab, pending approval. The resources from Sanofi, we believe, will only accelerate our momentum. Second, we believe this co-promote enhances our own efforts focused on minimizing barriers to reimbursement and treatment. Under the agreement, we gain dedicated account directors to supplement our team's work in key accounts. The Sanofi team can be deployed disproportionately against high-value adult endocrinology accounts, difficult to activate accounts, and accounts with significant opportunities to optimize logistics through their extensive care networks. Additionally, we gain involvement from Sanofi's field-based reimbursement managers, who will supplement our own COMPASS navigators or case managers, giving them the opportunity to focus their time where it matters most, engaging with patients and families as they navigate the reimbursement and treatment process. Finally, the additional Sanofi resources will allow us to amplify the reach of our disease education and screening efforts. Through this arrangement, we gain both breadth and depth, leveraging the Sanofi presence in adult endo and primary care offices alongside our work, which is skewed toward the pediatric side of the treatment paradigm. It augments our own medical and KOL contacts by adding medical affairs personnel and thought leader liaisons focused on diabetes. We also believe we will see a stronger presence and influence at nationally recognized diabetes centers and industry conferences. Provention will continue with our plans to work with other key stakeholder audiences such as public policymakers, physician societies, KOLs, advocacy groups, and others with a vested interest in T1D to make population-based screening a reality in the United States. Quite simply, through the complementary nature of this partnership and anticipated deployment model, we believe we will be able to expand our reach faster, deeper, and more efficiently than Provention could do on our own. We anticipate being able to identify more patients through enhanced screening and, with the additional cross-functional resources, help to compliantly deliver a more robust and streamlined patient experience. In terms of the structure of the agreement, we continue to maintain control over the commercial strategy for teplizumab launch, including pricing. Sanofi and Provention Bio will work together via a joint steering committee, which will focus exclusively on key operational and tactical elements and decisions, including marketing materials development and review, as well as account planning and execution. Provention will retain sole responsibility for teplizumab's ongoing research, clinical development, manufacturing, and regulatory affairs, and our many potential label expansion and lifecycle management opportunities. Now I'd like to turn the call over to Thierry to discuss the financial elements of the announcement today. Thierry? Thank you, Jason. Let's now review some of the financial aspects of the co-promotion and equity agreement. Provention will record 100% of teplizumab revenue and will reimburse sales force-related expenses for more than 100 FTEs and certain allowable expenses that Sanofi will incur in connection with its commercial activities under the co-promotion agreement. These expenses will be capped at $33 million. This transaction with Sanofi will help bolster our cash position. If teplizumab is approved, Sanofi will purchase $35 million of Provention common stock at a 40% premium to the five-day volume weighted average price prior to the closing date, with this closing date being at our discretion, but no later than February 16th, 2023. As Ashleigh has mentioned, we have given Sanofi a right of first negotiation through June 2023 to research, develop, manufacture, and commercialize teplizumab globally in T1D in exchange for a non-refundable $20 million payment. This right of first negotiation does not extend to teplizumab rights in any indication outside of T1D, allowing us flexibility and optionality in how we leverage this asset. In terms of cash, as a reminder, at the end of the second quarter, we reported a cash position of $96 million. In July, we completed a $60 million private placement with two existing shareholders, and in August, we secured a term loan facility of up to $125 million, of which $25 million was drawn upon closing, and an additional $40 million tranche is available upon approval of teplizumab. Additionally, as you know, we have an ATM that we draw down on opportunistically. We continue to be prudent and gated in our spending as we work towards the potential approval of teplizumab. We believe that our current cash position enables us to support a successful commercial launch of teplizumab if approved, and in the event of an expected further delay in the approval to continue operations through 2023, beyond the top line results of our PROTECT trial expected in the second half of next year. We will provide you with an update and more information on our cash runway when we release our Q3 earnings. Please let me now turn the call back to Ashleigh for closing comments. Thank you, Thierry. We look forward to working with Sanofi to realize the potential of teplizumab, which in closing, I want to remind you, is Provention's lead therapeutic candidate in our pipeline of clinical stage assets focused on intercepting or preventing debilitating and life-threatening autoimmune diseases. I especially want to thank the Provention Bio team for all their efforts as we advance our mission and work to bring teplizumab and the rest of our development pipeline to the precious patients and families we serve. With that, let's open up the call for questions. Thank you. We will now begin the question and answer session. To ask a question, you may press star one. If you're using a speakerphone, we ask that you please pick up your handset before pressing the keys. To withdraw your question, please press star then two. Today's first question comes from Thomas Smith at SVB Securities. Please go ahead. Hey, guys. Good morning. Thanks for taking the questions, and congrats on the deals here with Sanofi. Maybe just to start, just on the commercial strategy, can you provide a little bit more color on some of the specific aspects of the co-promote agreement? Specifically, I guess, was there a specific detailing position that was negotiated for teplizumab versus the other Sanofi endocrine products? And is there any minimum level of detailing that Sanofi needs to commit to and deliver on as part of the agreement? Good morning, Tom. Thanks for the question. We're going to save some of those details for a later update. I think the key this morning is focusing on the fact that Sanofi brings 40,000 you know, call lists skewed towards adult endos and primary care practitioners with a special interest in diabetes versus our 8,000 predominantly pediatric endocrinology call list that we were you know, focusing on at launch. Jason, I don't know to what extent you would like to address some of the other details, but that's essentially where we're at today. Yeah, absolutely. Thanks for the question, Tom. I think, you know, it really varies by the field team that we're engaging with on the Sanofi side. We're gonna have various teams at our disposal on the field side. We will have a dedicated team of account directors that are focused exclusively on teplizumab. In addition to that, we will have a percentage of time from other field-based organizations within Sanofi that obviously more than doubles the presence that we would have had if we had gone alone. We will be monitoring through a joint steering committee the activity and execution across all of the various field teams within Sanofi. To answer your question, some folks will have this as a P one, and others will have this as a potentially P two or P three, based on the amount of time that's being dedicated by the various field-based groups. Hope that gives you a little more clarity. Okay. Got it. Yeah, that's helpful. It's not that we haven't covered these details, but obviously we need to be respectful of Sanofi's position that a lot of these details are competitively sensitive information. Right. Understood. Yeah. Thanks, Ashleigh and Jason. Then I guess just with respect to your own sales force build out and commercial infrastructure plans, it doesn't sound like there's really any change in the way you guys are approaching this. Can you just kind of confirm that? Then I guess talk a little bit about, you know, it sounds like you're gonna leverage the Sanofi sales force here to really expand the reach and the overall awareness of teplizumab, kind of beyond your initial target endo population. Can you just talk about and maybe quantify how you think about the expanded reach? Yeah. Obviously, I'll hand that over to Jason as well. The way I think about this is if teplizumab gets approved, it means more functional beta cells in the world, better screening, better, awareness, disease education, better penetration into a nascent market, and that's a really good thing. Jason? Yeah. I think, you know, to answer the first question, Tom, this does not in any way change our hiring plans. We are still moving forward with our 60 therapeutic specialists that will, you know, directly operate in the field with their Sanofi counterparts. You know, we're still planning on contingent offers that would go effective as of November 18th, with a deployment date for the full co-promotion in the first week of January. You know, we're still moving forward. I think the beauty of this deal from my perspective is that, you know, the additive and complementary nature of the Sanofi field force with our field force, right? They're disproportionately focused on the adult endocrinology and primary care segments of the market. We've historically always been focused on the pediatric side, primarily. This allows us to definitively go out and expand our reach at the time of launch into those segments that, frankly, we would have only been able to cover a small subsection of with our 60-person therapeutic specialist team. Now, with that being said, their team and our team will go through training together later this year so that they can deploy in that first week of January, as I mentioned. We've also said historically, our team has intended to call on just under 8,000 healthcare providers. Sanofi. The teams that we're joining forces with at Sanofi have a call list of 40,000 healthcare providers. That in and of itself dramatically expands the reach at the time of launch. Hope that helps, Tom. Thank you. Our next question today comes from Justin Kim at Oppenheimer & Company. Please go ahead. Hi. Good morning, and congrats on the deal. You know, just with respect to the agreement, just wondering if the team is able to discuss, you know, what insight Sanofi has regarding the ongoing review of the BLA. Just kind of, you know, to what extent they may have any additional information than the market today. They've obviously done extensive due diligence, which includes confidential due diligence of our regulatory interactions. If there was any substantial material information with respect to the regulatory review, we would announce that to the public market. Thank you. Our next question today comes from Chris Howerton at Jefferies. Please go ahead. Great. Well, congratulations. Really appreciate you taking the questions. I guess the observation that I would make is that it seems like the deal is skewed for some sort of potential licensing or transaction after approval, given, you know, the time component of the right of first refusal. I guess, could you give us some information into what might be helpful, from a label perspective that you think would be attractive to Sanofi to actually license the product? Or is there some performance metric that they might be looking for at the beginning stages of the launch? It would just be helpful to know what might be attractive to your new partner. Yes. Thank you very much. There really isn't a connection in terms of how the co-promotion has been structured with regards to the right of first negotiation. The right of first negotiation is there because it takes time for ongoing due diligence, especially outside of the United States and international markets and with respect to other functionality. We simply haven't the time to complete those discussions or negotiations. That's the purpose of the right of first negotiation. However, Sanofi is really excited about the prospect of supporting Provention with regards to the potential launch of the first disease-modifying therapy in T1D. They want to be part of that disruption. They're excited, they're passionate. I have enormous respect for their leadership and their vision. The co-promotion agreement has been put in place to enable us or to enable them to do that, for us to be able to combine our forces. Thank you. Our next question today comes from Prakhar Agrawal with Cantor. Please go ahead. Hi, good morning, and thanks for taking my questions, and congratulations on the agreement. My first question is: The term of the co-promotion expires end of 2023, so why such a short agreement compared to other co-promotion agreements, and what could be the plans post the expiration? Does Sanofi have any intention to extend it? I'm asking because Sanofi has publicly said that they are looking to de-emphasize diabetes, at least on the research side, but it seems that they are still looking to be a part of commercialization. Yes, thank you for the question. Obviously, I can't speak to Sanofi's strategy and priorities with respect to R&D. I know that Sanofi has a leading diabetes customer-facing presence and capability on a global basis. They certainly want to put that to the best use possible with respect to the benefit of patients. Sanofi is really patient-centric and really wants to make a difference and use its in-market infrastructure and expertise and experience to do so. We're very privileged and honored to have them as a co-promotion partner. I think that the right of first negotiation time period simply sets out a reasonable period of time for the two parties to be able to do a full evaluation and determine if we want to negotiate together the global rights to teplizumab in T1D beyond this co-promotion. It is just that, a right of first negotiation. Those negotiations, you know, have I guess begun in the context of the co-promotion and the U.S. participation, but the rest is still to come. Thank you. Our next question today comes from Gregory Renza at RBC Capital Markets. Please go ahead. Congratulations on the announcement today, and thanks for taking my question. Ashleigh, just maybe on the timing of the collaboration. I'm just curious, certainly with respect to some of the timeline extension it enabled you and the team to take advantage of that time ahead of commercial preparation. I'm just curious, why now? What has changed or evolved since the other opportunities ahead of a decision date that could have enabled a co-promoted opportunity. Thank you. The announcement now is a reflection that we have several weeks now to plan and prepare for launch together. Obviously the risk would go down if we waited until after the PDUFA date. If we did that, we wouldn't have the benefit of joining forces and collaborating together to be ready to maximize that opportunity. If we're able to get that approval to be able to go out there and begin properly commercializing the therapy. I think that's really the timing. You know, based on the information that we know and you know, you know, we're very hopeful that the approval will be forthcoming. As we've said in the past, a major amendment that results in a 90-day delay in the review or extra time for the review is usually done because the agency needs more time to review to get to yes. It's not usual for the agency to seek more time in order to be able to say no. I think that, you know, both teams will go forward now and plan in earnest on the assumption that an approval will be forthcoming. Thank you. Ladies and gentlemen, this concludes our question and answer session. I'd like to turn the conference back over to Ashleigh Palmer for closing remarks. Well, thank you very, very much indeed for participating in the call today. A special thanks to all our analysts and a special thanks to our shareholders and other stakeholders listening in. Without you, none of this would be possible. As I stated at the beginning of the call, by partnering with Sanofi, we are honoring our corporate commitment to the T1D community and our mission to bring innovative and disruptive potential therapies to patients and individuals at risk of life-threatening and debilitating autoimmune disease. We look forward to keeping you updated on our progress throughout the remainder of the year. Thank you. Thank you. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.