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Provention Bio, inc (PRVB) Q2 2021 Earnings Call Transcript

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PRVB earnings call for the period ending June 30, 2021.

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Provention Bio, inc (PRVB 1.18%)
Q2 2021 Earnings Call
Aug 6, 2021, 10:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, everyone. My name is Jamie, and I will be your conference operator today. At this time, I would like to welcome everyone to the Provention Bio call. [Operator Instructions] Please be advised that this call is being recorded at the company's request.

At this time, I'd like to turn the conference call over to Mr. Robert Doody, Vice President of Investor Relations for Provention Bio. Sir, you may begin.

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Robert Doody -- Vice President of Investor Relations

Thank you, operator, and thank you all for joining us on Provention Bio's Second Quarter 2021 Financial Results Conference Call. Joining today's call from the Provention Bio team is Ashleigh Palmer, Chief Executive Officer and Co-Founder; and Andrew Drechsler, Chief Financial Officer; and the other members of the Provention Bio leadership team.

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 expectations, clinical results, regulatory and other developments and timelines related to our product candidates, including our plans to work with the FDA to address CRL deficiencies, including their PK comparability and product quality consideration and the 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, including with respect to any potential approval of teplizumab 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 report Provention filed with the SEC. These documents are available on Provention's website at www.proventionbio.com, under the investor section. We encourage you to review these documents carefully.

With that, I will now turn the call over to Ashleigh.

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

Thank you, Bob, and good morning to everyone joining us on the call today. It is now being just over three years since Provention Bio's initial public offering, and it is worth taking a moment to reflect on our remarkable accomplishments and the evolution of our disruptive and paradigm shifting company in that relatively short period of time.

When we acquired the rights to teplizumab from MacroGenics in May of 2018, our plan was to develop this novel immunomodulatory agent for the treatment of new onset clinical stage type 1 diabetes. The intent was based on our understanding from prior trials that protecting a newly diagnosed T1D patients precious remaining beta cells from ongoing autoimmune destruction can potentially lead to better clinical outcomes. Today, we find ourselves rapidly approaching the completion of target enrollment for our Phase 3 newly diagnosed PROTECT trial, and we are on the verge of evaluating data from a PK/PD sub study to potentially address the FDA's remaining consideration for what we hope will become teplizumab's first approved indication to delay the onset of clinical stage type 1 diabetes in at-risk individuals. This breakthrough therapy indication was not even under consideration when we first acquired teplizumab in 2018, let alone contemplated to become the basis for potentially commercializing the first ever disease modifying therapy for T1D well in advance of receiving topline results from our PROTECT trial.

Also let's not forget that the successful progression of teplizumab, our lead therapeutic candidate, targeting the intersection of T cell mediated disease validate this company's foundational strategic intent and distinctive core competence. Throughout these three years, we've been a public company. We have expanded and progressed our pipeline of conceptually related therapeutic candidates targeting a diversified portfolio of serious autoimmune diseases, including PRV-3279 for lupus and other B cell mediated diseases, PRV-015 targeting the innate autoimmunity driving diseases such as celiac disease and PRV-101 to prevent what we believe to be a viable trigger of both T1D and celiac autoimmunity. This progress sets the stage for a series of significant catalysts over the next 24 months. These catalysts are in addition to the ongoing progress of teplizumab, not only with respect to the potential approval of a 14-day course of therapy to delay the onset of T1D in at-risk individuals, and the topline results of the PROTECT study in new onset T1D patients, but also the potential for label expansion, repeat dosing and combination therapy, including in conjunction with beta cell transplantation therapies in established type 1 diabetics, as well as the prospect of a subcutaneous formulation and the fertile portfolio of potential lifecycle opportunities including targeting other T cell-mediated diseases such as Crohn's, celiac and rheumatoid arthritis.

Throughout 2020 despite the unprecedented challenges of a global COVID pandemic, our team worked diligently to prepare package and present data from the trial of 76 at-risk T1D subjects conducted over more than seven years by an NIH sponsored academic consortium using teplizumab drug substance made by Eli Lilly more than 11 years ago. Every piece of data had to be reformatted, compiled a meticulously analyzed to present the TN 10 study as a pivotal trial in a breakthrough therapy designated BLA submission. We further supported this BLA with the submission of confirmatory evidence in the form of a meta [Phonetic] analysis of C-peptide decline across other studies previously conducted in new onset T1D patients. These studies were also integrated into a database for the purposes of safety analysis.

Meanwhile, we accelerated a manufacturing technology transfer process originally scheduled to take place over three years, starting up commercial scale GMP production in less than half that time and successfully completing thee PPQ validation runs over the summer of last year. As a result, we completed our rolling BLA submission last November to meet an ambitious and highly challenging self imposed time line. As a result, the FDA accepted and filed our BLA at the outset of this year, setting July 2nd PDUFA date and scheduling a May 27th advisory committee meeting.

As many of you witnessed, the endocrinology divisions advisory committee seemed unfamiliar with immunomodulatory agents and more used to reviewing Phase 3 trials approaching a thousand patients or more in diseases such as type 2 diabetes and osteoporosis. Nevertheless, with the help of supportive briefing documents from the FDA and an incredible outpouring of support from T1D patients families, commissions, advocacy organizations in the broader community, we ultimately received a vote in favor of approval, and thereafter a Complete Response Letter issued on July the 2nd without any deficiencies related to the efficacy and safety data packages we submitted to our BLA. This progress toward potentially bringing the first ever disease-modifying therapy to type 1 diabetics in the centennial year of insulins lifesaving discovery is truly pioneering and nothing short of amazing for a company barely four years old.

The July 2nd CRL also clearly set out what we believe to be the remaining substantive hurdle to obtaining approval for the commercialization of teplizumab for at-risk T1D patients. While they were no physico-chemical comparability issues throughout the manufacture of our 2b commercialized product batches. As we reported back in April, the FDA considers a single low dose PK/PD bridging study conducted in healthy volunteers to have failed to show adequate PK comparability relative to product originating from drug substance manufactured by Eli Lilly for prior clinical trials. Specifically, in it's advisory committee briefing document, the FDA reported its extrapolation of the main zero to infinity area under the curve or AUC, for our 2b commercialized product to be approaching half that of the Lilly source material and attributed this difference to faster clearance. However, from our perspective, pre-specified rule determined that the zero to infinity AUC could not be reliably estimated from the single low dose administered in the bridging study because teplizumab blood levels were too low for both products beyond 48 hours. While blood levels of the 2b commercialized product did fall slightly below the target AUC range within the first 48 hours, we do not consider these differences to be clinically relevant.

We also believe that the AUC zero to infinity difference extrapolated by the FDA is likely to be much smaller when modeled using actual blood levels sampled from patients receiving teplizumab's therapeutic dosing regimen rather than the single fractional low dose used in the PK/PD study. It's important to note that teplizumab is a fast-acting monoclonal antibody with a relatively short half life of four days as compared to other monoclonal antibodies that typically have a half-life in the order of weeks. Teplizumab targets the CD3 cell surface receptor, converting auto reactive T cells into exhausted T cells to improve immune regulation. The main mechanism of clearance of teplizumab from the circulation is via internalization of the teplizumab and CD3 receptor into the T cells themselves. This is phenomenon is called target mediated drug disposition and is well understood and characterized. In fact, this teplizumab clearance mechanism has been previously invoked in connection with the Protege Phase 3 study in newly diagnosed T1D patients. Previously published results reported that a lower dose and a shorter course, both demonstrated greater clearance than the standard 14-day therapeutic dosing regimen. Therefore, we believe that when the teplizumab therapeutic dosing regimen is followed, the exposure achieved by the 2b commercialized profit will be above the threshold associated with T1D efficacy and the protection of beta cell function as measured by C-peptide.

Indeed. pharmacodynamic markers in the single low dose PK/PD bridging study in healthy volunteers, including lymphocyte drop which is closely associated with clinical response, all demonstrated comparability as did the safety and immunogenicity profiles, as well as Cmax, which reflects the strength of the product. in the CRL, the FDA expressed, and I quote, the need to establish PK comparability appropriately between the intended commercial product and the clinical trial product or provide other data that adequately justify why PK comparability is not necessary. Earlier this year, we took the precautionary initiative to commence the PK/PD sub-study within the ongoing PROTECT trial to enable us to collect blood samples from patients being treated with a 12-day therapeutic dosing regimen of either the Eli Lilly sourced clinical material or our 2b commercialized product. We expect relevant samples from this sub-study to be processed by this -- by the end of this quarter and the data generated to be analyzed by independent unblinded third parties to maintain the integrity of the Phase 3 PROTECT placebo-controlled trial.

Upon review of these results, the company will be determine whether to submit our data to the FDA for review along with any other relevant data and analyses to support PK comparability or otherwise justify why PK comparability is not necessary. We believe these data and and these arguments have the potential to address FDA's comparability concerns and we look forward to sharing more information with you once we have had the chance to conduct our analysis and discuss our results with the FDA.

Before I turn the call over to Andy to provide an update on our financial progress, I'd like to provide some additional updates from across our company during this period. We recently announced that teplizumab has been awarded the Innovation Passport designation in the United Kingdom for the delay of onset of clinical type 1 diabetes in at-risk individuals. We are honored to have been only the fourth drug sponsor to receive such a priority designation since this program's inception earlier this year. This designation is part of a new U.K. Medicines and Healthcare products Regulatory Agency initiative to accelerate development of innovative medicines following Brexit. The U.K. has one of the highest prevalence of type 1 diabetes globally with approximately 400,000 patients, including roughly 39,000 children 19 years or younger. New diagnoses in the U.K. are increasing by about 4% every ear and similar to the United States, T1D is managed through insulin therapy and glucose monitoring and there is no approved disease-modifying treatment targeting the underlying cause of T1D. We look forward to continuing our engagement with the U.K. regulatory bodies and participating in the review and approval process for this priority market. We will provide a better sense of timing for this process and opportunity during future updates.

Also later this year, we expect to initiate the Phase 2a prevail study with PRV-3279 in lupus patients. And in the fourth quarter, we are excited to be having our first look at data from the Phase 1 study of PRV-101. Our vaccine candidate against coxsackievirus B, which we believe to be a key trigger in the onset of autoimmunity in type 1 diabetes and celiac disease.

With that, I'm now going to turn this call over to Andy to provide you with an update on our financial progress and then return for some closing remarks. Andy?

Andrew T. Drechsler -- Chief Financial Officer

Thanks, Ashleigh, and good morning, everyone. Before I begin, 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 the P&L. We generated a net loss for the second quarter 2021 of $29.1 million or $0.46 per basic and diluted share. The increase in net loss compared to the second quarter of 2020 is the result of an overall increase in research and development expenses of $2 million, driven primarily by cost for our teplizumab program, including the PROTECT Phase 3 trial regulatory activities and the build out of our medical affairs infrastructure to support teplizumab, which includes type 1 diabetes disease state awareness and screening education programs. The increase in research and development costs was offset by lower teplizumab manufacturing costs compared to the prior year period as the company incurred significant costs for production of GMP and PPQ batches of drug supply and drug product during the second quarter of 2020. The increase in net loss also resulted from an increase in general and administrative costs of $5.4 million, which was comprised of an increase of $2.1 million in pre-commercial expenses and an increase of $3.3 million in other general and administrative expenses resulting from the build out of our infrastructure.

Shifting now to cash. As of June 30th, 2021, our cash position was $176.4 million. This cash balance reflects the receipt of $1 million from the sale of our 2019 New Jersey net operating losses in April. Our net cash-based operating expenses were $26.8 million for the second quarter ended June 30, 2021. We expect to use between $31 million and $36 million of cash for operations in the third quarter of 2021. We expect our current cash, cash equivalents and marketable securities will be sufficient to fund projected operating requirements for at least the next 12 months and that will enable us to actively develop all four of our programs, teplizumab for type 1 diabetes; PRV-3279 for lupus; PRV-015 for celiac disease; and PRV-101, a coxsackievirus B vaccine. We plan to provide additional cash guidance on each quarterly call as we continue to progress toward the potential regulatory approval and commercial launch in teplizumab.

With that, let me turn the call over to Ashleigh for closing comments. Ashleigh?

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

Thank you, Andy. Before we open up the call to address any questions, I certainly hope we've made it clear today that we have a tremendous sense of gratitude for all of the hard work, dedication and collaboration from everyone who has played a role over the last three to four years in helping to grow Provention from just a conceptual idea to now being at the forefront in the development of autoimmune disease modifying immunomodulatory therapy.

We are acutely aware of all the hard work and challenges that lie ahead of us, and our team is dug in and doing everything reasonably possible to succeed in our mission for patients, their families and clinicians, and the entire T1D community, as well as our investors who have stood by us and supported us from the very beginning. Thank you. We appreciate your support and encouragement and it continues to keep us motivated and focused on our mission and the responsibilities and expectations we carry on our shoulders every day.

With that, operator, we'd like to take any questions.

Questions and Answers:

Operator

[Operator Instructions] And our first question today comes from Alethia Young from Cantor Fitzgerald. Please go ahead with your question.

Emily Bodnar -- Cantor Fitzgerald -- Analyst

Hi, this is Emily on for Alethia. Thanks for taking our questions. I'm curious what are your expectations for the PK/PD comparability data from the PROTECT study and is there anything different about the process from the original study? And also, maybe you could provide an update on your regulatory submissions as for Europe, and if there have been any developments there in light of the FDA concerns? Thank you.

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

Thank you for the questions, Emily. So taking the last question first. We will provide an update on the European and U.K. regulatory process after we've completed the analysis of our PK/PD sub-study later this quarter along with the discussions that we're having with the FDA. But I'm going to hand the first two questions over to Francisco to respond. Francisco?

Francisco Leon -- Chief Scientific Officer and Co-Founder

Good morning, Emily. The process for the PK/PD sub-study is to add a few time points for PK samples and to add a few pharmacodynamic PV biomarkers in a subset of patients. This will provide us with robust data that we believe will be able to address the FDA's concerns.

Operator

And our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead with your question.

Gregory Renza -- RBC Capital Markets -- Analyst

Hey, good morning, Ashleigh and team. Thank you for all the color today and also thank you for taking our questions. Just with respect to FDA alignment, I'm just curious, Ashleigh. At this point, do you have agreement that the sub-study from PROTECT will be sufficient? Or is it that you're -- just your belief that it's sufficient at this point? I'm wondering if you do have agreement perhaps, whether in writing on this design of the comparability study that you're doing, especially with historical FDA preference of the single dose bioequivalence and comparability being the way to go just given the increased precision? Thank you very much.

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

Thanks, Greg, very much for the question. So I think we've quoted one of the paragraphs from the Complete Response Letter, which really puts the FDA's perspective in writing as you mentioned. So the first thing that the agency would be looking for is data to support PK comparability and we believe we set out in the opening remarks this morning that that PK comparability can be accomplished by looking at patients that get therapeutic dosing over the therapeutic regimen of 12 days or 14 days. What we believe occurred in the single fractional low dose PK/PD study in healthy volunteers is that the PK/PD or PK AUC was at a sub receptor saturation threshold and so that exaggerated any difference, and that difference will close and comparability will fall within an acceptable range as the higher doses administered over several days.

The agency extrapolated out to infinity, AUC zero to infinity for a monoclonal antibody that is rapid-acting, has a relatively short half life and we believe that it's really the first 24 hours to 48 hours that make a difference. And for example, Cmax maybe more clinically relevant than PK AUC, AUC to infinity. And so, that is exactly what this sub-study will accomplish. It will collect data to hopefully demonstrate that.

Now the other thing that was in writing in the Complete Response Letter, which we felt showed the agency's open mind, if PK comparability is not relevant at Zero to Infinity, provide them with data to show that PK comparability is not necessary. And there, the PD biomarkers demonstrating clinical relevance and being the efficacy signal and showing that those are comparable in therapeutic dosing between the two products, is an option to demonstrating PK comparability.

Now, we don't think that's an either/or situation and intend to do both. We intend to provide the data that the agency is looking for, and to prove our hypothesis, regarding target mediated drug disposition being the basis for clearing clearance, and as well as provide strong arguments and supportive data. But whatever difference or if there is a difference, that that is in PK comparability, that that is not clinically relevant.

Gregory Renza -- RBC Capital Markets -- Analyst

Thanks. Actually, that's very helpful.

Operator

Our next question comes from Justin Kim from Oppenheimer and Company. Please go ahead with your question.

Justin Kim -- Oppenheimer and Company -- Analyst

Hi, good morning. Thank you for taking our questions and the update, maybe just to dive. And to that point around why PK comparability may not be as relevant, what pieces of evidence does the team think might demonstrate? And I'm just wondering, as you think about these two concurrent paths, are there sort of specific data that are already available, to suggest that -- how do you make that case around Cmax being more clinically relevant than PK you see, and sort of the full PROTECT study be the next piece of evidence, that actually demonstrate that?

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

Thanks Justin. Yeah. I mean the PK AUC at zero to Infinity is really what we struggled to believe is clinically relevant, say relative to PK AUC, zero to 24 and Cmax and there is published evidence, that we believe supports the mechanism of clearance which is this target mediated drug disposition. And I'm going to ask Francisco to explain that, because it is an important nuance with teplizumab. It's fundamentally linked to its mechanism of action and IV administration and the regimens that have been developed by experts over the years to arrive at the therapeutic dosage regimen. Francisco?

Francisco Leon -- Chief Scientific Officer and Co-Founder

Good morning Justin. So just to clarify, it's not that we say compatibility, it's not relevant. What we say is that, comparability has to be assessed in its totality, the totality of the data. So first, we have shown that the products are comparable in vitro, all the panel of assays for release of the product, shows comparable potency and comparable physical chemical properties. Second, in-vivo in humans, we have a single low dose study, and that's where we believe we cannot solely rely on a single, low dose for assessment, because for a drug that has target mediated disposition, this particular experiment is not representative of the clinical situation. In the clinics, we dosed multiple times higher doses. We have evidence and it is published that, increased doses partially saturate the clearance by target mediated disposition, by binding The CD-3, and that has been published in the Protege Phase III trial, where the full dose regimen had less clearance than the low dose or the partial dose regimens.

And finally, we have the pharmacodynamic data, that shows that the product proposed for commercialization has comparable impact on immune cells -- on the immune system than the Lilly product used in TMK. So when you look at the totality of the data, we firmly believe the products are comparable. We don't have any difference in safety, immunogenicity, so when you put this in the context of the unmet need, that's where we make the case to the FDA, and we believe that products comparable and that teplizumab should be approved.

Justin Kim -- Oppenheimer and Company -- Analyst

Understood. Thank you so much. If I can just inset maybe one more question, just with 3279, can you talk a little bit about what markers, might be accessible in this healthy volunteer population, and what gives you potentially confidence to move into the affected lupus population?

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

Francisco?

Francisco Leon -- Chief Scientific Officer and Co-Founder

So with regards to -- first to lupus. We have three pieces of evidence, that our drug could work in lupus. First, B cells are validated targets in lupus. Benlysta was the first drug approved in just few years -- a few years back. So this is validated. Second patients with lupus have polymorphisms in CD32B, that lead to underfunctioning CD32B, which is a natural down regulator of B cells. And we have evidence that when you incubate, these are strong lupus patients, in vitro, with our drug, we can reduce the activation of lupus B cells, and it is their production of ancillaries. So there is strong evidence of a role for CD32B in lupus.

With regards to the healthy volunteer data, we have demonstrated that our drug is able to reduce the activation and the production of antibodies by B cells for about one month after a single dose and six months after three doses of drug in healthy volunteers, and specifically reduced the antibody production to new antigens being presented to those subjects in a hepatitis sub-study that we conducted in Phase I.

Justin Kim -- Oppenheimer and Company -- Analyst

Okay, great. Thank you so much.

Operator

Our next question comes from Thomas Smith from SVB Leerink. Please go ahead with your question.

Thomas Smith -- SVB Leerink -- Analyst

Hi guys, good morning. Thanks for the updates and for taking the questions. I guess just to follow-up on some of the earlier questions; can you provide any additional details on the PK sub-study within PROTECT, specifically looking for numbers of patients that are going to be included in this sub-study? I guess some of the timepoints for data collection, how long you're following these patients? And then any other -- Francisco I think mentioned some additional data that could potentially be collected here, I guess any additional data beyond the PK-PD biomarkers that we're going to look to evaluate here?

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

Good morning, Tom. Thanks very much. We have not disclosed the target numbers. We can state categorically, that we believe the numbers that we are collecting will be sufficient for an adequate PK-PD analysis. We are on schedule to have completed the analysis by the end of this quarter. Very pleased with the progress in collecting these more frequent samples from patients that are being or have been enrolled in the in the PROTECT study. Francisco, do you want to make any comments regarding particular biomarkers or sample parameters that are being selected?

Francisco Leon -- Chief Scientific Officer and Co-Founder

Good morning Tom. So in the subsidiary, in addition to the lymphocyte counts which is the clinically relevant PV market we have traditionally collected in this program, because there is a transient drop in lymphocytes for the first five days, after multiple dosing, then it recovers quickly. That drug correlates with efficacy in past studies, based on C peptide. So in addition to the lymphocyte drop, we just have a panel of immune activation parameters that we measure on the cells of the patients, to characterize the impact of teplizumab on T-cells and other cell subsets.

Thomas Smith -- SVB Leerink -- Analyst

Okay, great. And just to follow-up on, I guess, the completion of the analysis by the end of this quarter. How do you guys intend to communicate the results from that analysis? Should we expect a press release with some top line data, or maybe you can just walk through how you're intending to communicate?

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

We've not determined that yet. We prefer to complete the analysis and our discussions with the FDA, and then make a decision regarding the publication of that.

Thomas Smith -- SVB Leerink -- Analyst

Okay. And then just one other follow-up in terms of your level of alignment with the FDA, on the sub-study design. Maybe if you could clarify, have you participated in a Type A meeting after the CRL? And I guess specifically, maybe following up on Greg's question, has any of the feedback been memorialized in writing or is this parsing the TVs from the FDA via the CRL language?

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

We don't comment on our interactions with the agency. All I can tell you, is that the agency remains very engaged and we have the option for informal meetings and formal meeting requests as and when we need them.

Thomas Smith -- SVB Leerink -- Analyst

Okay. Thanks for taking the questions guys. Appreciate it.

Operator

And our next question comes from Ram Selvaraju from HC Wainwright. Please go ahead with your question.

Raghuram Selvaraju -- HC Wainwright -- Analyst

Hi, thanks very much for taking my question. Just very simply, I need to fully understand a little bit more about the process of how you are going to furnish the comparability data to the FDA, and what criteria the FDA is likely to need to utilize, in order to determine whether comparability has been satisfied, or you've demonstrated that comparability doesn't need to be demonstrated? And just to be specific, if we look in particular at the PROTECT study, do we currently have a clear understanding or do you currently have a clear understanding of specifically what the threshold of data is likely to be from that study that would be likely to satisfy the FDA, or that would satisfy the FDA? And can you give us a sense of, specifically the timing with which such data would be furnishable? Thank you.

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

Thanks very much for the question Ram. So as we stated, we believe we have sufficient data and we are on schedule to be able to analyze that and discuss that with the agency by the end of this quarter. The mechanism then by which that data would be formally furnished to the FDA, would be by a BLA resubmission, and that BLA resubmission would then be responded to by the agency, with respect to a determination of the class of resubmission. We anticipate that the nature of that resubmission would be a Class II submission, which is a 180-day review. But I would like to think that under the circumstances, since we believe from the Complete Response Letter, that the comparability considerations by the agency is the primary concern, that the agency, in light of the unmet need and the open public hearing call for therapy like this to be made available to patients at risk, that the agency would do its best to beat that 180 day time requirement. But we obviously can't guarantee that.

Operator

And our next question comes from David Hoang from SMBC. Please go ahead with your question.

David Hoang -- SMBC -- Analyst

Hey, good morning. Thanks for taking the questions. So I did want to dig a little bit deeper into some of the comments you made about the lower-than-therapeutic dose regimens that were explored in the PROTECT study. Can you talk a little bit about maybe -- even just qualitatively, the six day regimen in the 14 day low dose, it's not a fully therapeutic dose regimen. How much does the clearance differ from the full dose? And is that -- over what time period is that -- that you see you expect doses to convert? Is that a couple of days or do you really need to get close to 14 days to see the full effect?

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

Thanks for the question. So I'll ask Francisco to respond to that in detail. But I mean overall, we believe that that published evidence is very strong support for our belief that the mechanism of clearance for teplizumab is target mediated drug disposition, and that if you evaluate in different studies or different batches, if you evaluate teplizumab comparability at too low a threshold in dose, or in accumulation of dosed, the venue will exaggerate differences that will not necessarily disappear, but substantially close, as you saturate those receptors and reach a plateau above the target receptor saturation pressure. So that's the general concept, but Francisco can you recall some of the details from the actual Protege publications regarding the six-day dose, versus the 14-day dose, as well as the lower dose arm versus the full dose?

Francisco Leon -- Chief Scientific Officer and Co-Founder

Good morning, David. The publication listed the three arms, 6 days of full course versus 14 days, which is the full therapeutic dosing. And then the third arm is the 14 days at one-third of the dose. Basically they were comparing full strength for the totality of the 14 days versus all 14 days, but just one set of a dose, or the full daily dose, but only for six days. And both the abbreviated course and the one-third of the dose course has very substantial increased clearance, with respect to the full therapeutic course. The exact percentage of clearance or the exact number has not been published yet, and we haven't disclosed, but it is very substantial and it fully supports our hypotheses, that the reason we saw less or a substantial difference in that clearance in the single, low dose study, is that target mediated disposition is not saturated upon single, low-dose, and will be partially saturated in our PK-PD sub-study. That's our expectation.

David Hoang -- SMBC -- Analyst

I see, OK. That's really helpful. Thanks for walking me through that. And just maybe one follow up. It seems like you've really zeroed in on this TMVB as the really -- the driver of the PK differences you're seeing here. But I mean, have you considered any other possibilities and I know it's hard to hypothesize, but for example, could there be anything with FcRn or any other mechanisms that you may have thought about, that could be contributing to the difference -- clearance differences aside from TMVB?

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

So we've obviously put a lot of thought into this. The issue is that, we can't detect comparability differences outside of this low dose -- single low dose PK-PD study that was done as a bridging study for the PROTECT trial. The manufactured product is comparable, you know it falls within all of the physical, chemical comparability ranges that were agreed in advance of moving forward with our GMP production, our PPQ batches validation and so on. You have parameters within the PK-PD study that was conducted, including Cmax and the lymphocyte drop that show comparability. What we really have been evaluating with that laser focus is why is there this single PK AUC anomalous outlier? And we're very pleased, to be quite honest that we feel we have a legitimate, well thought through and evidentially supported hypothesis, that is this target mediated drug disposition. It makes sense and it explains the observations that we've seen and it also means that the sub-study we're doing in PROTECT, has a very good possibility of meeting the requirements, of supporting our arguments and providing data to the agency, that at therapeutic dosing, there is sufficient comparability there, and any differences is not clinically relevant, as shown by the PD biomarkers.

But Francisco, do you want to add anything else to the specific question?

Francisco Leon -- Chief Scientific Officer and Co-Founder

I would just that, in the case of this year, and which obviously was an initial hypothesis, potential explanation, it is a laser mechanism of prevention of clearance by recycling the antibody. It's not as rapid as the difference that we saw in that single low dose study. So the timing really suggests that, the difference between the two antibodies, which we believe is very small and still will be within reasonable margins, is something that happens rapidly, and it is well known that the main mechanism of clearance is binding to CDC, the target mediated drug disposition. So when you put those two factors together, it really bonds toward target mediated disposition. And the second comment is that FcRn binding its partners, the standard package of release for any therapeutic monoclonal antibodies. So while we have not disclosed any specific information, you can imagine that, that has been done.

David Hoang -- SMBC -- Analyst

Got it. Thanks so much for providing the context to both of you. Thank you.

Operator

And ladies and gentlemen. With that, we'll conclude today's question and answer session. I'd like to turn the floor back over to Ashleigh Palmer for any closing remarks.

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

Thank you again for your time and attention this morning. We hope you all have a great day and we look forward to speaking with you again soon.

Operator

[Operator Closing Remarks].

Duration: 54 minutes

Call participants:

Robert Doody -- Vice President of Investor Relations

Ashleigh W. Palmer -- Chief Executive Officer and Co-Founder

Andrew T. Drechsler -- Chief Financial Officer

Francisco Leon -- Chief Scientific Officer and Co-Founder

Emily Bodnar -- Cantor Fitzgerald -- Analyst

Gregory Renza -- RBC Capital Markets -- Analyst

Justin Kim -- Oppenheimer and Company -- Analyst

Thomas Smith -- SVB Leerink -- Analyst

Raghuram Selvaraju -- HC Wainwright -- Analyst

David Hoang -- SMBC -- Analyst

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