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Provention Bio, Inc (NASDAQ:PRVB)
Q3 2020 Earnings Call
Nov 6, 2020, 8:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good day, ladies and gentlemen, and welcome to your Provention Bio Third Quarter 2020 Earnings Conference Call. [Operator Instructions]

At this time, it is my pleasure to turn the floor over to Mr. Andrew Drechsler, CFO. Sir, the floor is yours.

Andrew Drechsler -- Chief Financial Officer

Thank you, operator, and thank you all for joining us on Provention Bio's third quarter financial results conference call. Joining today's call from the Provention Bio team is Ashleigh Palmer, Chief Executive Officer and Co-Founder.

First, 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, development and regulatory matters and timelines, including for the teplizumab BLA, 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 in the fourth quarter of 2020 and cash runway, and our business plans and prospects, including planned pre-commercial activities across the company in preparation for the 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 the various important factors, including those discussed in the Risk Factors section of our most recently filed quarterly report on Form 10-Q which is on file with the SEC 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.

Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. There is more complete information regarding forward-looking statements, risks and uncertainties in the reports Provention files with the SEC. These documents are available at Provention's website at www.proventionbio.com, under the Investors section. We encourage you to review these documents carefully.

I would also encourage you to read our earnings press release and our 10-Q that was filed today. 10-Q includes our financial statements, risk factors as well as management's discussion and analysis of our financial condition.

With that being said, please allow me to provide our Q3 financials. From a P&L perspective, we generated a net loss for the third quarter of $31.3 million or $0.56 per basic and diluted share. Our cash-based operating expenses for the third quarter were $28.7 million. The increase in net loss over the prior year was attributable to teplizumab related CMC costs, PROTECT study costs, BLA preparation costs, precommercial costs, and medical affairs expenses.

As disclosed in our 10-Q, we spent $8.5 million during Q3 on CMC activities. The significant spend was primarily related to the process performance qualification batches and related analysis. Enrollment and other activities in our PROTECT Phase 3 study resumed from a pause related to COVID, which resulted in increased clinical trial costs during the quarter. Also included in Q3 R&D costs with spend related to the BLA preparation and clinical module submission.

Finally, Q3 expenses also included $6 million of pre-commercial spend and included spend on unbranded marketing and market access preparatory activities as well as personnel costs. Our net loss for the first nine months of 2020 was $66 million or $1.29 per basic and diluted share.

Our cash-based operating expenses for the nine-months ended September 30th, 2020 were $61.8 million. The spend in the first nine months, in particular, the second and third quarters was focused on CMC, pre-commercial, PROTECT study and regulatory activities related to teplizumab and was driven by our potential marketing approval timelines for teplizumab in the US and our positive manufacturing progress to-date.

As of September 30th, 2020, cash, cash equivalents and marketable securities balance was $147.2 million, consistent with our current plans, we expect to use approximately $24 million to $28 million of cash for operating needs in the fourth quarter of 2020, which is slightly less than Q3, as we continue to scale and ready our commercial organization, continue key manufacturing and regulatory activities, conduct the PROTECT Phase 3 study in newly diagnosed T1D patients and the proactive Phase 2b study in non-responsive celiac disease, build out our infrastructure in preparation for the potential launch of teplizumab next year.

We expect that our current cash, cash equivalents and marketable securities will be sufficient to fund our operating requirements to potential FDA approval in the execution of the initial launch of teplizumab assuming a six-month priority review and no significant delays.

With that let me turn the call over to Ashleigh for an update on teplizumab and other developments. Ashleigh?

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Thank you, Andy, and thank you all for joining us today. So far in the second half of 2020 and despite the extraordinary challenges companies are facing in the current COVID environment, we've been able to maintain meaningful and reliable progress across all areas of our business. The most notable recent achievements include the completion of our rolling submission of the Biologics License Application or BLA for teplizumab for the delay or prevention of clinical T1D in at risk individuals and the launch of our Type 1 diabetes early stage disease awareness campaign.

I want to start today by discussing the anticipated regulatory path forward for teplizumab and remind you of the importance of our disease awareness campaigns and update you on the PROTECT study and our other program. The FDA granted teplizumab breakthrough therapy designation in August of 2019 based in part on the landmark TN10 study that was published in the New England Journal of Medicine last year.

Data from this study, which were included in the clinical module of our BLA submission showed that a single course of teplizumab consisting of a daily 30 to 60 minute infusion over two weeks significantly delayed the onset of insulin dependent Type 1 diabetes in pre-symptomatic patients by a median of approximately two years as compared to placebo.

More recently at this year's ADA Scientific Sessions in June, TN10 study follow-on data were presented showing the original 14-day course of teplizumab investigational therapy continued to significantly delay the onset of T1D in study participants by a median of approximately three years compared to placebo adding one more year to the previous two-year median delay.

There were even some patients receiving teplizumab who were still T1D free after 8.5 years. Not only are these results of the TN10 study highly statistically significant with a p-value of 0.006 tied to the original two-year median delay, they are also highly clinically relevant.

As such one of the advantages afforded to us under breakthrough therapy designation was the opportunity to submit our BLA on a rolling date. Earlier this year in April, we announced that we have successfully initiated this process by submitting the BLAs non-clinical module and this was then followed by our submission of the clinical module in September.

Earlier this week, we announced our completion of the rolling submission of the BLA with our on-schedule submission of the remaining chemistry manufacturing and controls or CMC module and the Administrative Information module. The agency will now have 60 days to review our submission to determine if the BLA is complete. And if deemed complete, the application will be considered acceptable for filing and review and the FDA will set a Prescription Drug User Fee Act or PDUFA goal date.

As afforded by the breakthrough therapy designation, Provention has expressly requested a priority review in conjunction with our submission of the Administrative Information module. A priority review designation means FDA's goal is to take action on an application within six months as compared to 10 months understanded review.

I want to commend the extraordinary determination and hard work of our employees and consultants. Under the leadership of our Chief Medical Officer, Dr. Leni Ramos and our Senior Vice President of Regulatory Affairs, Dr. Sharon Rowland who together led our teplizumab rolling BLA submission with selfless dedication.

We have also laid the groundwork to support doctors as well as patients and their families making more informed decisions relating to T1D. As part of this effort, last month we launched two closely aligned Type 1 diabetes early stage disease and screening education campaign connected by T1D and Type 1 tested to help clinicians and patients respectively begin to redefine patient care in T1D by creating awareness of the importance for screening individuals at disproportionate risk due to a family member having clinical stage disease.

When a Type 1 diabetic patient presents with clinical symptoms for the first time, it is because they no longer have sufficient insulin producing beta cells remaining in their pancreas to effectively control their blood sugar levels. For months or possibly years prior to this point, their T1D autoimmunity has been progressing silently. It is possible to confirm this pre-symptomatic process is ongoing by testing for two or more auto antibodies against certain beta cell antigens including insulin itself.

Screening to detect these auto antibodies is currently available through diagnostic companies such as Quest and LabCorp as well as clinical centers of excellence like the Barbara Davis Center for Diabetes in Colorado. When an individual is found to have two or more auto antibodies, it is not a case of if but when they will develop clinical stage T1D. And to those with a family member with Type 1 diabetes, the risk is 15 times greater of developing T1D down for the general population.

In addition to the educational focus on testing individuals with increased familial risk of developing T1D, the connected by T1D campaign targeting clinicians also focuses on educational content regarding the different stages of T1D and the autoimmune destruction of beta cells that occurs long before symptoms present.

Our Type 1 tested campaign emphasizes the potential advantages of getting tested and informs parents and patients how they can arm themselves with additional knowledge. So they can in collaboration with their doctors prepare for clinical T1D and make decisions that may decrease the likelihood of an acute and potentially life-threatening presentation called diabetic ketoacidosis or DKA and other serious risks.

Our call to action is early and routine auto antibody screening to identify patients with pre-symptomatic early stage Type 1 diabetes. Approximately 64,000 new patients present with T1D for the first time each year in the United States. I think about 50% of cases their families first encounter with clinical stage disease is DKA, a metabolic crisis that can be serious enough to require a trip in an ambulance, admission to the emergency room and several days in a pediatric intensive care unit to stabilize the patient, after which they likely referred to an endocrinologist for a lifetime of glucose monitoring and insulin therapy with all its accompanying risks and complication.

We look forward to providing you with updates on our connected by T1D and Type 1 tested campaigns as well as other disease awareness and education initiatives going forward. Looking beyond the potential US approval of teplizumab in the at-risk indication, we are continuing to prepare the submission of our marketing authorization application or MAA to the European Medicines Agency in 2021. In addition, we are also preparing potential post marketing label expansion initiatives to broaden teplizumab's market potential by exploring younger age groups below eight years of age and evaluating the impact of repeat dosing on the delay in progression of T1D.

Following closely behind our efforts to obtain FDA approval of our BLA for teplizumab in at-risk individuals, we are progressing our PROTECT study in newly diagnosed T1D patients. Our goal for PROTECT is the enrollment of 300 newly diagnosed insulin dependent patients aged eight to 17 within six weeks of their initial diagnosis.

Patients will receive two 12-day courses of active or placebo therapy administered six months apart. As you know we temporarily paused randomization in PROTECT in March and for much of quarter two and I'm pleased to confirm that randomization has now resumed at the majority of sites in quarter three. However, we continue to monitor the situation at these institutions closely as recent increases in COVID-19 cases throughout the US and Europe may understandably impact enrollment.

Finally with respect to our longer term plans for teplizumab, we intend to evaluate subcutaneous formulations as well as explore potential combinations of teplizumab with other therapies, including as an adjunct therapy to beta cell transplantation targeting the growing market potential of 1.6 million insulin dependent Type 1 diabetic patients just in the United States alone.

Before we open up the call for questions, let me provide a brief update on PRV-015, an investigational anti-interleukin 15 monoclonal antibody that we are developing in collaboration with Amgen for the treatment of non-responsive celiac disease. Based on prior data, we believe PRV-015 has the potential to intercept damaging effects of gluten in patients and has the potential to be the first ever approved therapeutic for celiac disease.

In the third quarter, we initiated our Phase 2b proactive study of PRV-015, the trial is expected to enroll approximately 220 adults with non-responsive celiac disease across approximately 40 sites in the United States, Canada and Europe. Of note the study does not require a gluten challenge and patients are asked to maintain their usual diets. In addition to the clinical and regulatory milestones achieved this quarter, we were honored to welcome Dr. John Jenkins to our Board of Directors. As the former Director of the office of new drugs at the FDA's Center for Drug Evaluation and Research or CDER, Dr. Jenkins brings tremendous insight as we advance teplizumab through the latter stages of regulatory review and potential approval as well as our label expansion initiatives.

Lastly I would like to call out that November is National Diabetes Awareness month. We want to extend our deepest gratitude to the patients, caregivers and healthcare providers who work tirelessly to improve the lives of people living with T1D and to increase awareness of the series immune-mediated disease.

We continue to be driven by the possibility of bringing the first disease modifying therapy for T1D to market and look forward to continuing to work with the FDA during the regulatory process. Throughout the remainder of 2020, we plan to transition and transform our company into a commercialization ready organization in anticipation of the potential launch of teplizumab next year.

In addition to teplizumab our pipeline is rich with potential opportunities to fundamentally address the unmet needs associated with other serious autoimmune diseases. And we are passionate about advancing our therapeutic candidates to help both patients and their caregivers.

And now we will open the call up to take your questions.

Questions and Answers:

Operator

[Operator Instructions] And our first question comes from Thomas Smith of SVB Leerink. Please state your question.

Thomas Smith -- SVB Leerink -- Analyst

Hey guys, good morning. Thanks for taking the questions and congrats on all the progress in the quarter. A couple of questions on my end. First on the regulatory side for teplizumab, now that you have the BLA submission completed. Can you talk a little bit about the timelines and I guess latest thoughts around expectations for potential advisory committee meeting?

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Good morning, Tom. How are you?

Thomas Smith -- SVB Leerink -- Analyst

Doing well, Ashleigh. Thanks. How are you?

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Good, thank you. So, yes, so we're now in the 60-day acceptance period, which we believe we'll conclude around about the end of this year, beginning of next year. We can then anticipate a 74-day letter that would set out the areas that the agency wants to focus on and the review period will begin in earnest at that point.

We don't have any feedback from the agency at this point with respect to an advisory committee meeting. But as you can imagine for the purposes of prudent and preparation, we're contemplating that there will be one for the purposes of of being ready for it and so we -- as we've shifted now from filing the BLA, we're now shifting toward preparation for the defense of the review and in the context of potential priority review that could lead to a decision in the middle of next year by the agency.

Thomas Smith -- SVB Leerink -- Analyst

Got it. Okay. And then I appreciate the updates on some of the pre-commercial work in the non-branded awareness campaigns. Can you just talk a little bit about your approach to payor engagement over the next eight months as you continue to do some of the pharmacoeconomic work and some of the pricing work around teplizumab, I guess just your latest thoughts around how you're thinking about pricing at this point?

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Thanks, Tom. So if I may introduce my colleagues on the call to answer questions. Today we have Andy obviously, our CFO. We actually have Leni Ramos with us today. She's come up for air having filed the BLA, our Chief Medical Officer and we have Francisco Leon, our Chief Scientific Officer. But we also have with us, Jason Hoitt, our Chief Commercial Officer and that's a question for you, Jason.

Jason Hoitt -- Chief Commercial Officer

Yes, absolutely. Hi, Tom. Thanks for the question. Yes, so as we've mentioned before, payor engagement is of the utmost importance to us this year and it has been all year. What I can say is that over the course of the last quarter, we've continued to engage payers in that one to one setting with our market access team. Year-to-date, we've engaged a number of payors and I would say in aggregate they represent over 100 million covered lives. And what I can say is that the payor feedback has been incredibly positive to-date and it's continued to be positive since the first time we talked about the payor advisory board that we did back in May with medical directors from a number of plans across the commercial and managed medicaid space.

We launched a proprietary payor website to engage them on the burden of illness and burden of disease and we'll continue to do that over the course of this year and as you mentioned, we're wrapping up pharmacoeconomic work right now looking at real world evidence study of the totality of the cost associated with Type 1 diabetes.

Those will feed into the budget impact models and cost effective. This is the cost effectiveness analyzes that will be the foundation of our AMCP dossier and the foundation of the pricing research that you mentioned as well. So we still continue to be on track and intend to engage in pricing research in the early part of next year.

So what I would say is nothing has changed with respect to our thoughts around price and I wouldn't expect them too until we complete that research and I would expect that we'll announce a final price at the time of approval.

Thomas Smith -- SVB Leerink -- Analyst

Okay, great. Thanks, Jason. I appreciate the context, and maybe just one last question on some of the pre-commercial logistics planning, maybe can you talk about some of the work you're doing on the supply chain and distribution side. I guess how do you see teplizumab being distributed when we think about a potential mix between specialty pharmacies, specialty wholesalers?

Jason Hoitt -- Chief Commercial Officer

Yes, absolutely. Great question, Tom.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Another question for you, Jason.

Jason Hoitt -- Chief Commercial Officer

Yes. Thanks, Tom. Sorry for the interruption, Ash. Yes, another great question. So we've now moved into the phase where we've selected our third-party logistics vendor. We're actively engaged in addressing third-party specialty distributors as well as a limited network of specialty pharmacies that have home infusion capabilities across all 50 states.

So while we haven't made final decisions there were in the process of making those selections and would anticipate that we'll be making decisions on that on those providers later -- by the end of this year or early next year at the latest. So that we can get through the contracting process.

I think there will be a mix between specialty pharmacy and buy and bill at the time of approval, but if I had to guess I would think that more of the supply would work through the specialty pharmacy channel versus the specialty distributor channel.

Thomas Smith -- SVB Leerink -- Analyst

Okay, great. Thanks for taking the questions guys and congrats again on a lot of progress.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Thank you, Tom.

Operator

Our next question comes from Alethia Young of Cantor. Please state your question.

Alethia Young -- Cantor -- Analyst

Hey guys, thanks for taking my questions and congrats on the progress as you move toward first fully acceptance and approval. I guess one would be just can you -- as you kind of continue the due diligence the market and perhaps kind of talk about some of the challenges, the biggest challenges you see maybe from a Provention side kind of change in behavior there and like how you plan on thinking about and addressing that. And then on the IL-15 in the non-responsive celiac just -- can you just talk a little bit about that market opportunity and also like what you're looking for in Phase 2 and how hard has it been maybe in light of COVID or to run a study like that? Thanks.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Good morning, Alethia. How are you?

Alethia Young -- Cantor -- Analyst

I'm good. How are you doing?

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Good, thanks. So Jason again perhaps you could provide the answer to the first question and then hand over to Francisco who is really our expert in Celiac.

Jason Hoitt -- Chief Commercial Officer

Yes, absolutely. Thanks for the question, Alethia. So I think to answer your question, the progress and intend to change physician behavior has already begun with the launch of our unbranded disease awareness campaign at the end of last month, right.

So this campaign is geared toward educating endocrinologists and pediatric endocrinologists on why they should be thinking about screening or early in screening often for Type 1 diabetes, the risks of not screening in the family members of those that are already diagnosed who we know are disproportionate at risk of being in the early stages of the disease and trying to change that behavior as early as possible.

And then I think based on the market research that we've done, we've engaged with more than 150 endocrinologists and pediatric endocrinologists over the course of this year. And when we present the profile of teplizumab in a TPP all of them become incredibly excited and talk about the paradigm shifting potential that this drug has.

I would say the one area of concern that they talk about is with respect to a 14 consecutive day infusion. And as we've mentioned in the past, we're anticipating and planning for that by ensuring that we have multiple pathways to product the acquisition.

One, obviously being through the specialty distributor, one being through the specialty pharmacies, providing home infusion capabilities having the flexibility built in, if we can to allow for a physician to start a patient under observation in infusion center and then transition them to home infusion assuming they're comfortable when we get to that weekend infusion time point.

So I think we're working actively to address the most common area of concern and I think when we present to physician, the potential of having home infusion you see there minds start to be set at it with respect to that one area of concern.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Thanks, Jason. Before Francisco takes the call on 015. From my perspective, the single biggest inhibitor to the change in behavior has been the absence of an intervention or therapeutic interception that could make a meaningful difference to the outcome in patients that are identified as having two antibodies in early stage disease. So just the availability and indeed the potential of the availability of the therapeutic interception like teplizumab is a catalyst to change and we are already seeing that catalyst having an impact in terms of the interest level and KOL and patient advocacy groups interest in having the relatives of patients with existing Type 1 diabetes screened. Francisco, 015.

Francisco Leon -- Chief Scientific Officer and Co-Founder

Yes, good morning. So with respect to the commercial opportunity. So, as you know, celiac disease is the last of the large autoimmune indications, which has no therapy on the market. So it's a very substantial total addressable market, it affects 1 million of Americans with non-responsive celiac disease, out of the 3 million total celiac disease population in the US. So 1 million total addressable market.

The trial is a four arm dose ranging Phase 2b trial, which has a primary endpoint symptoms, the registrational endpoints of the celiac disease patient reported outcome. A key secondary endpoint is gut inflammation. And with respect to COVID, we have a number of initiatives to address the pandemic. One is that as part of this endoscopy requirements to assess gut inflammation everybody who undergoes endoscopy has a COVID test. So we can't rule out any potential impact of an infection during the trial.

And in order to enhance enrollment, we are collaborating with the patient support groups, you may have seen recently press releases issued by beyond celiac and the Celiac Disease Foundation, they are excited of working with us because we all recognize this drug has the potential to become the first ever drug approved to Celiac disease. So we see substantial interest in the trial.

Alethia Young -- Cantor -- Analyst

Great, thank you. That's really helpful. Just maybe one follow-up do you think how hard will it be on these in-home infusion to kind of execute and do them. I mean I guess in-home health nursing someone can you just talk a little bit more about those sorts of logistic. I mean I do you think that's like an important swing factor?

Andrew Drechsler -- Chief Financial Officer

Thanks, Alethia. So yes, Jason, you've been taking a close look at that with our market access team. Could you comment?

Jason Hoitt -- Chief Commercial Officer

Yes, absolutely. It's a great question, Alethia. I think there are -- as we're evaluating specialty pharmacy partners out there obviously there are multitude of them, one of the key criteria that we're looking at in selecting that limited group of partners that we'll be working with is that they have those home infusion capabilities across all 50 states, right and ensuring that they have the caliber of nurses that we would want going into a patient's home to be able to conduct these infusions.

And I'm confident that we'll be able to find exactly the right providers for that and I think, out of the gate, I would expect that we'll see probably more patients starting in an infusion center because this is a new molecular entity to a number of endocrinologists and pediatric endocrinologist with the ability to transfer to home infusion when they get comfortable, that mix may evolve over time, I would expect that probably would. But it is a key criteria and a key element of our search for the right partners.

And based on the partners that we've been speaking to thus far. I'm encouraged with our ability to find exactly the right partners to be able to accomplish that home infusion capability.

Alethia Young -- Cantor -- Analyst

Great. Thank you. That's very helpful.

Operator

Any further questions, Ms. Young?

Alethia Young -- Cantor -- Analyst

No, I'm all set. Thank you.

Operator

Thank you. Our next question comes from Justin Kim of Oppenheimer. Please state your question.

Justin Kim -- Oppenheimer -- Analyst

Hi, good morning. Thanks for taking the questions and congrats on the progress especially the recent filing. Just a few from me with the nationwide screening and awareness programs ongoing. Do you expect we might hear any updates from a metric perspective in terms of how many physicians or family patient groups, you might be reaching ahead of a potential launch in 2021?

Andrew Drechsler -- Chief Financial Officer

Good morning, Justin. Thanks very much. Obviously very early days, but Jason do you have any thoughts about when we might have feedback in that regard?

Jason Hoitt -- Chief Commercial Officer

Yes. Hey, Justin. Good morning. Thanks for the question. So obviously we're really excited about these two campaigns right. One geared toward healthcare providers and one geared toward consumers and just the quality of the campaigns that have been put out. I think it's important to note that when you look at those two campaigns, those -- the content of those two campaigns, including the concepts and the messaging and everything that's in there has come from extensive market research with endocrinologist, pediatric endocrinologist, caregivers, patients themselves and so we really feel that captures the voice of the audience, we're really looking to engage here.

That being said our media campaigns are really picking up traction. And so I think it's a little premature to talk about any form of metrics, but we're encouraged with the initial reception and we look forward to providing more details on the campaigns as we continue to gain traction over the course of the coming months and quarters.

Justin Kim -- Oppenheimer -- Analyst

Got it. Many conference. And maybe just for me on the P&L side, maybe for Andy with uptick in R&D, can you just give us any additional color on how you think about the expenses going forward. I know you mentioned sort of the CMC cost, but just wondering would pre-commercial spend sort of make up for that sort of going away and how you plan to maybe build up inventory into 2021?

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Andy?

Andrew Drechsler -- Chief Financial Officer

Yes, thanks for the question. Yes as I discussed on the call, the CMC costs really around these PPQ batches and all the related qualification validation work that has to be done significantly impacted Q3 and Q2 to a certain extent.

We obviously expect those costs to wind down right as we wrap up this year and there was cost related to the BLA filing also included in those R&D costs. So I expect those to come down. I do expect the pre-commercial costs, which we call out separately in the 10-Q to continue to ramp here right as the BLA progresses through the regulatory process there those will ramp.

I think it's important to note, we are projecting Q4 spend in a range of $24 million to $28 million, which is obviously less than it was in Q3. So hopefully that helps gives you a little bit more context.

Justin Kim -- Oppenheimer -- Analyst

Okay, great. Thank you. My final question is just maybe more on the science side. It's really interesting to hear about the potential of teplizumab when jumped to beta cell transplantation. Just wondering if there are any evident from a biomarker perspective that suggest teplizumab would have that type of benefit. I'm just wondering if you could share any details there?

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Thanks very much. So let's hear it from Leni, right, who has been basically hidden away in a cupboard for nine, 12 months now, not having an opportunity to answer questions at calls like this because she has been so focused on filing the BLA.

I know that's frustrated her because she is very much wanted to be part of the executive team and our interactions with our investors and analysts. But Leni is actually a transplant nephrologist and has some insight in this therapy from her clinical background.

Leni, do you -- congratulations to you and your team, incredible effort. I mean it wasn't five-day eight hour weeks, -- eight hour day weeks, it was 18-hour days seven days a week to get to where we've -- where you've gotten us. Maybe you could answer Justin's question about the potential for adjunctive therapy with the transplantation of beta cells and biomarkers.

Eleanor L. Ramos -- Chief Medical Officer

Yes, good morning. Yes, finally Ashleigh gave me the key to get out of the dungeon. Thank you, Ashleigh. But indeed the teplizumab an incredible potential for the area of beta cell transplantation. In fact this molecule has been tested in islet cell transplantation a decade and half ago.

So we do have evidence that it has efficacy in a small number of individuals, but now we have to continue to develop it in the setting of new immune modulators because its slightly is going to need both addressing the alloimmune and the autoimmune response because that's going to be the issue that will have to deal with when we go into beta cell transplantation, traditional beta cell transplantation with teplizumab hitting the autoimmune component and potentially another immunomodulator to address the alloimmune component.

Now with respect to biomarkers, the common thing that you would look at would be how the beta cell is performing. And so what the beta cells do, they release insulin and the way you measure that in people who have probably receiving exogenous insulin, C-peptide.

So C-peptide a very, very common and easy to obtain biomarker clinical biomarker is a way, an easy way to follow the progress of beta cell transplant. I'm sure there will be other more novel biomarkers that we did that you could look at, but that really gives you a sense of the protection of your transplanted beta cells and how they are protected if you would by your immune modulator regimen.

Justin Kim -- Oppenheimer -- Analyst

Okay, great. Thank you very much.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

And I know Justin knows this but for others on the call when insulin is produced endogenously, it's produced by the beta cells as a pro hormone and then it enzymatically cleaved into two units, the active insulin, that has the clinical effect in terms of managing blood glucose as a hormone around the body and then the other part of the chaperone is C-peptide.

So if you measure C-peptide, you get a very good measure of how much insulin is being produced endogenously as opposed to insulin in the blood, which could be a combination of what's been made by the patient as well as what's been injected exogenously as insulin therapy.

Justin Kim -- Oppenheimer -- Analyst

Great. Thanks so much and I'll hop back in the queue.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Thank you very much, Justin.

Operator

Our next question comes from David Hoang of SMBC. Please state your question.

David Hoang -- SMBC -- Analyst

Hey, guys congratulations on the quarter and the BLA filing. So it's just a few questions from me. I guess first in terms of screening the eligible at-risk patient population. Do you think this is something that you see significant traction ahead of the approval with the screening campaign and such or should we expect sort of more of a bolus once the product is approved and on the market.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

So, actually I'm going to ask Francisco to just give you an update on when a screening stands and the snapshot in time, in the throughout the world because screening has been growing and becoming more and more important and maybe Francisco, you can just give us a status as to where things stand in the United States and Europe.

Francisco Leon -- Chief Scientific Officer and Co-Founder

Yeah, absolutely. We should differentiate between screening that takes place in the clinical context when families, parents, bring their kids to test for active antibodies because they already have another kid with T1D in the family and that's something going on for decades now and they are FDA approved tests that are run by the use of big clinical labs like LabCorp and Quest. So that's going on in the background -- identify at-risk patients.

On the other hand, there are consortia, academic groups that run screening studies and initiatives, and that has added probably 1.5 million additional screens in the past 10 years. In the US, we have TrialNet. ASK, TrialNet there are several consortia TEDDY with probably 800,000 patients total screened or subjects. In Europe very large consortia as well, DIP, C-PATH and have -- another probably close to 1 million. So to answer your question while all of this is going on in the background and we expect this to increase as a result of our unbranded campaigns and future campaigns.

There will also be further exponential growth in our estimation once teplizumab is on the market, because even though today screening helps families prepare for T1D and helps avoid diabetic ketoacidosis DKA, there is nothing like having a drug to prevent the disease to become the driver and the motivation for screening. So we do believe and project a potential substantial increase of screening once the drug is in the market.

David Hoang -- SMBC -- Analyst

And Francisco the block if you like to general population screening in a lot of places has been the absence of a therapeutic intervention. We know in countries like Finland general population screening for T1D or to antibodies along with celiac autoantibodies is very well established, but can you just comment on some of the indications you've seen that patient advocacy groups and interested parties are also in parallel to the work we are doing and is ongoing with the consortia like TrialNet and ASK the increased activity with respect to parallel efforts to line up over time the possibility of general population screening.

Francisco Leon -- Chief Scientific Officer and Co-Founder

In these countries that have been promoting preventative medicine for a while like Nordic countries Finland, Germany already have general population screening where all children are screened at intervals in the well child visits. And this is now come into the US. The ASK consortium is already a general population screening, the private consortium in Virginia is a general population screening program. And as Ashleigh mentioned there is a lot of synergy and we can leverage celiac disease to identify more patients with T1D because as you know there are shared genetics, shared triggers like Coxsackie B virus is a shared trigger for both of these autoimmune indications.

So we see that in the future once teplizumab is in the market, there will be very strong rationale for guidelines to be changed in the US for groups like the American Pediatric Association and others. The American Diabetes Association to issue guidelines to recommend general population screening at certain age intervals and potentially one day given into the USPSTF guidelines that's the United States Preventative Services Task Force, which recommends, which screening testing should be done in the entire population at the national level.

David Hoang -- SMBC -- Analyst

Great. That was really extremely helpful. Thanks for all the detail on that. And then I had -- the other point I want to focus on is with the redosing. I know you talked before about looking at markers of T-cell exhaustion and potentially doing that by flow cytometry. So I just kind of want to get a sense how quickly do you think you would take to get that type of assay set up in the commercial setting and is that a big focus to have that ready at launch or is that something you think you can roll out later?

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Thanks, David. So that assay is frequently encountered in the commercial setting already with respect to oncology indications. Francisco, do you want to comment on that and if you consider that to be a barrier at all to us being able to conduct post marketing studies where exhausted T-cells may well be a biomarker for determining when a repeat dose maybe merited?

Francisco Leon -- Chief Scientific Officer and Co-Founder

Yes, thank you. So, David, so flow cytometry is conducted as a routine assay in any tertiary hospital anywhere where there is hematology oncology or infectious diseases services. They have flow cytometry because they need to look at the CD4 CD8 ratio, etc. So it's a matter of adding the exhausted T-cell test, which is looking for a double positive cell KLRG1 positive, CD8 positive digit positive is not very complicated and it can be done in samples with our shift at room temperature. So, blood can be shipped at room temperature, not very expensive to a central lab. So, initially, it will be just a few labs around the country that are already set to these assays and then slowly more and more labs will just validate locally the assay and it can be done in a matter of a few months just for the validation at the local level.

Operator

Our next question comes from Gregory Renza of RBC Capital Markets. Please state your question.

Gregory Renza -- RBC Capital Markets -- Analyst

Hey, good morning, Ashleigh and team. Congratulations on the progress, and thank you for taking my questions. I just wanted to touch on the commercial side, Ashleigh. In light of the certainly unpredictable potential long tail of the pandemic pressures, just curious what strategies are under consideration or would you be employing to prepare for -- the potential for really a virtual or a hybrid launch in 2020, especially in light of the teplizumab profile? And maybe similarly just maybe on the front lines, what observations, if any, on what you have on the screening rates for T1D in this at-risk population, just given the pandemic? Thank you.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Thanks, Greg. Really appreciate the question. And -- first philosophically and culturally, this company is a virtual organization, we're very comfortable with the concept of managing operations on a virtual basis. And so, it's not foreign to us, and I believe that gives us an advantage as we now work with Jason and his leadership team to think through various scenarios depending on the situation, which is obviously outside our control in terms of COVID pandemic and the surgeries and situation that we might see over the winter going into next year, both with respect to preparation, the hiring of individuals on our team and then contemplating how we build relationships with clinical sites and KOLs. And ultimately hopefully if we get approval, launch teplizumab.

So, Jason, do you want to talk about some of that, I know you absolutely are thinking this through very, very carefully and perhaps talk about that with respect to screening as well? Maybe Francisco can help there. There are definitely initiatives that are evolving, that might mean the patient doesn't have to go into a hospital or a phlebotomy lab to get screened and obviously we're dealing with this as well as we think through the ongoing management of our studies, including PROTECT. But Jason, do you want to talk about your commercial plans?

Jason Hoitt -- Chief Commercial Officer

Yeah, absolutely. And thanks for the question, Greg. So, as you can imagine, being less than a year away from a potential approval, we have an internal launch readiness working group from across the company that maps out our launch readiness strategy, our launch readiness interdependencies between the different groups, and one entire work stream of that group is focused on COVID-19 contingency planning. Right? What would it mean, what do we need to do differently to launch in a world where COVID is as it exists today or even in a situation where COVID is kind of back where we were in the spring?

And so, we're thinking through all of that, what additional tactics we need to pull in to be able to launch virtually, even things down to the profile of the sales people that we would want to bring on-board and the importance of the relationships that they may -- that they would already have with the target audience of endocrinologists and pediatric endocrinologists.

And so, there are a multitude of factors that will play into our decision-making as we get into next year and we start recruiting the team and we start preparing the tactics for launch that will almost have a parallel path, right. A pathway where we are in a COVID world and we're launching virtually and a pathway where things improve and we're able to actually get in and speak to physicians face-to-face.

The good news is that we aren't the first company going through this. By the time we get to approval, there will have been numerous other companies that have either been promoting actively in the COVID world and/or having launched in a world where there is a lockdown due to COVID. And I think we have the advantage and ability to leverage best practices from our peers in the industry of what's worked and what hasn't and be able to implement those into our own launch to be set up for the best possible success in that scenario. And those are all things that we're actively doing today.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Thanks, Jason. And Francisco, the screening is evolving as well. There are commercial entities that are developing tests that can alleviate the need to go into a phlebotomy center and have a blood draw for a child to determine if they have autoantibodies.

Francisco Leon -- Chief Scientific Officer and Co-Founder

Exactly, Greg. Just for the sake of time, that is already in place at home testing already pioneered by TrialNet, but now other commercial organizations. And the dysglycemia is something that is now being pushed to -- at home testing, it's not available yet, it's in development, but it will be here soon.

Operator

Our next question comes from Ram Selvaraju of H.C. Wainwright. Please state your question.

Boobalan Pachaiyappan -- H.C. Wainwright -- Analyst

Hi, this is Boobalan dialing in for Ram Selvaraju. Can you hear me OK?

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Yes, thank you. Good morning.

Boobalan Pachaiyappan -- H.C. Wainwright -- Analyst

Good morning. Yeah. I have a few questions and just to start off with the pricing question that was asked previously. So, maybe if you can outline what factors would be taken into consideration when you try to determine the price for teplizumab and what could drive the adoption of the drug during near and long-terms and what elements could impede the drug's penetration and how do you plan to attack on these elements? That's the first question.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Thank you. Jason, pricing, the elements taken into consideration and the factors that could drive or impede adoption?

Jason Hoitt -- Chief Commercial Officer

Yeah. Absolutely. And thanks for the question. So, as I think we've mentioned in the past, we're in the process right now of finalizing a real world evidence study that's looking at both direct and indirect medical costs associated with type 1 diabetes, things like a fact to the effect of a single admission for a patient in diabetic ketoacidosis can cost anywhere from $18,000 to $27,000, right. All of the various medical costs, both direct medical costs, costs of all of the treatments, all of the continuous glucose monitors, pumps, tubing, etc., but also hospital stays, things like that will all be factored into this real world evidence study. Then we'll take that information, input our clinical data and model out cost effectiveness analyses, quality adjusted life years, downstream consequences and all of that will inform our budget impact model, cost effectiveness analyses and lay the foundation for our value proposition.

Now, that value proposition and those data from our real world evidence study in combination with now the three-year data from ADA will be put in front of payers in the early part of next year in a formalized pricing research study to look at the -- what our flexibility may be in terms of pricing. Obviously, our goal is to get to a place where we have coverage of teplizumab with a prior authorization to label as is the case with most specialty products. And so, that's what we'll be working toward, and that's exactly what the research that we'll be doing with payers is geared to do, we'll be doing that in the early part of next year and we'll be able to disclose what the price is at the time of approval.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

And Jason, a lot of your research to-date has been with the two-year median outcome. I think things only get better with the follow-on data that was presented at the ADA in June.

Jason Hoitt -- Chief Commercial Officer

Yeah. That's right, Ashleigh. We did a payer advisory board back in May with a number of medical directors representing more than 70 million covered lives across our anticipated payer mix between commercial, Medicaid, Managed Medicaid and most expressed to us their intent to cover with a prior authorization to label, which I think was incredibly encouraging to hear. The formal pricing research I think will help inform where we can go with the pricing and what that means in terms of getting a prior authorization to label. So, a number of different scenarios will be tested during that research and that will help inform our recently formed pricing committee to make a decision as we get close to the approval date.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

And the -- other than the two autoantibodies and dysglycemia indicating that 75% of patients would convert to clinical stage type 1 diabetes within five years driving adoption, are there any other factors that you would like to highlight in terms of the positive and then what are you -- what have you got your eye on with respect to impeding adoption?

Jason Hoitt -- Chief Commercial Officer

Yeah. No, it's a fair point, Ash, and thanks for the reminder of the second part of the question. I think the -- from the market research that we're doing with healthcare providers, well, when they see the target product profile of teplizumab, most are getting encouraged. I would say, the barrier that is most often raised to potentially impede uptake would be the 14 consecutive day infusion.

And as we talked about during an earlier question, I think Alethia asked the question earlier around how we anticipate getting into home infusion, once we bring up home infusion and the possibility of transitioning to home, whether you want to start at home infusion or start it at an infusion center under observation and then transition to home so that you can do that, those weekend infusions under a certified infusion nurse in the patients' home, does alleviate that concern in the minds of healthcare providers. So, I think that is certainly addressing the most commonly heard barrier that we've seen in market research today.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

But obviously 14 days of 30 to 60 minutes infusions each day versus the potential to have a delay in the progression of clinical stage type 1 diabetes, perhaps with multiple dosing for a considerable period of time, if not in some patients indefinitely is an enormous -- is a fantastic value proposition and our intent as we mentioned in the introductory remarks is to also look at subcutaneous formulations to further improve the situation.

Operator

Ladies and gentlemen, this does conclude our question-and-answer session. Mr. Palmer, I will turn the conference back over to you for closing comments.

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Thank you, Cynthia. So, thank you, everybody, for joining us today. We look forward very much to updating you soon on our continued progress, and we sincerely hope that you and your loved ones stay safe and well. Thank you.

Operator

[Operator Closing Remarks]

Duration: 64 minutes

Call participants:

Andrew Drechsler -- Chief Financial Officer

Ashleigh Palmer -- Chief Executive Officer and Co-Founder

Jason Hoitt -- Chief Commercial Officer

Francisco Leon -- Chief Scientific Officer and Co-Founder

Eleanor L. Ramos -- Chief Medical Officer

Thomas Smith -- SVB Leerink -- Analyst

Alethia Young -- Cantor -- Analyst

Justin Kim -- Oppenheimer -- Analyst

David Hoang -- SMBC -- Analyst

Gregory Renza -- RBC Capital Markets -- Analyst

Boobalan Pachaiyappan -- H.C. Wainwright -- Analyst

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