Q4 2019 Earnings Call

There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to mister Sam Martin from wage. Thank you Andrea, and thank you all for joining us on prevention bios fourth-quarter and full-year 2019 Financial results conference call join us today is call from the prevention by of team are Ashley Palmer chief executive officer and co-founder Andy Drexler Chief Financial Officer Jason hoist Chief commercial officer and dr. Francisco Lyon Chief scientific officer and co-founder on today's call Ashley will provide a corporate update with a focus on p r v. Oh Thirty one or two prism app Jason will then provide a review of the page landscape were to put the mab Francisco will then review the recent positive data for p r v 3279 and discuss next steps with the program.

And he's will then review financials and we will then open up the call for questions.

First let me remind you that the various remarks will make today constitute forward-looking statements for the purposes of the Safe Harbor Provisions under the private Securities litigation Reform Act of 1995. These include statements about our future expectations clinical development and Regulatory matters and timelines the potential success of our product candidates Financial projections and our plans and Prospects actual results, May differ materially from these 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 annual report on form 10-K, 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 teams therefore you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.

There was more complete information regarding forward-looking statements risks and uncertainties in the reports prevention files with the SEC. These documents are available on prevention website at ww.w wage prevention bio.com under the investors section, and we encourage you to review these documents carefully.

I'll now turn the call over to Ashley Palmer chief executive officer and co-founder will provide an update on prevention corporate clinical and Business Development achievements Ashley. Thank you, and thank you all for joining us today to review the remarkable progress. We have made and are compelling plans going forward.

Prevention we are fundamentally Shifting the Paradigm for patients with autoimmune diseases and pioneering a new era in the development and potential commercial organization of the therapeutic options available to them.

By preventing or intersecting autoimmunity prior to irreversible tissue damage and end-stage organ failure or dysfunction. We have the potential to significantly improve the lives of hundreds of thousands of patients around the world who would otherwise endure a lifetime of chronic treatment and organ support or transplantation month.

We are making excellent progress advancing our Diversified portfolio of clinical-stage immunomodulatory Agents targeting a broad spectrum of life-threatening and light bulbs acting immune-mediated diseases including type one diabetes lupus and celiac disease. We are on track to complete the rolling submission off after b l a for a lead program p r v o 31 or Temple is a map in quarter for of this year and diligently laying the groundwork for its potential commercialization in t1d.

This extraordinary flagship.

Ram with its potential to transform the treatment landscape of t1d validate our strategic intent focused on the prevention or intersection of immune diseases today. We also reported exciting data for p r v 3279 are state-of-the-art by specific scam targeting cd32 be and cd79b which Francisco will detail later in our call.

Like this face to any candidate has transformative potential in this case for the treatment of a wide variety of B cell mediated divorce.

Let me Focus my comments today on Temple. Isamar.

There is no better example of an autoimmune disease that is unacceptably diagnosed and treated too late than type one diabetes or t1d.

More than 50% of t1d patients first presented with diabetic ketoacidosis or a life-threatening condition.

In total DEA is responsible for more than 160,000 hospitalizations every year in the United States creating a medical emergency brake placing a significant and unnecessary cost burden on our health care System.

We know very well from the close collaborations and Partnerships. We are forging with patient. Advocacy groups like the JDRF and Beyond type one that once diagnosed with the lives of t1d patients and their families are forever changed.

Despite rigorous glucose monitoring and intensive daily insulin therapy 75% of t1d patients will continue throughout life with life is the quality control leading the serious complications in both the short and long-term.

One of the most sobering statistics is that children diagnosed with t1d under the age of ten will have on average a 16 year reduction in their life expectancy.

2019 was a transformational year for prevention bio and the t1d community.

Data from The Trial Net TM 10 study also known as the risk study in pre-symptomatic patients published in the New England Journal of Medicine and pregnancy that the American Diabetes Association conference in June of last year highlighted the landscape changing potential of capitalism apt to treat t1d autoimmune Home Improvement or delay the onset of clinical States Disease by binding to the CD three co-receptor capitalism has the potential to resent the immune system of pre-symptomatic t1d patients identified by having two or more Auto antibodies.

To be clear these patients have type one diabetes, but have not yet progressed two clinical-stage symptomatic disease.

The blizzard my works by eliminating the pathogenic autoreactive T cells which are responsible for the destruction of precious insulin-producing beta cells, which absolutely leads to clinically relevant organ dysfunction and the diagnosis of insulin-dependent t1d the TN Penn study showed that the single 14-day course of capitalism. A therapy can delay the onset of insulin-dependent type 1 diabetes in autoimmune t1d patients risk of clinical Disease by a median of at least two years.

The results of this study are highly statistically significant and highly clinically relevant.

The Breakthrough therapeutic importance of this data cannot be understated any parent or family who cares for a child or loved one with t1d is well aware of the challenges and the importance of insulin therapy the corresponding fear of hypoglycemic events and diabetic ketoacidosis and the longer-term complications kidney. I heart and nerve damage resulting from chronic for blood glucose control.

Now for the first time we have the potential with the blizzard therapy to intercept or with timely redosing indefinitely delayed will prevent the progression of pre-symptomatic D1 D2 end-stage insulin-dependent disease.

As you would expect the potential for this first-ever modifying therapy is generating tremendous enthusiasm and excitement within the t1d community and we Remain the focus on bringing a blizzard map to Market as rapidly and responsibly as possible.

Regulatory Agencies on both sides of the Atlantic have recognized and validated to place a transformative therapeutic potential the FDA has a breakthrough therapy designation in the United States and the EMA has awarded Temple is the map Prime designation in Europe.

In November of 2019 we began taking full advantage of the enhanced dialogue. We were granted as a breakthrough therapy designee by conducting a type of BFD a meeting to discuss our regulatory power forward for the blizzard man this meeting emphasized the alignment of prevention and the FDA regarding the requirements of a successful rolling b l a submission including confirmation that the pen study data in conjunction with our existing off the set from over 800. Newly diagnosed patients represents a sufficient basis for our clinical module submission.

All proceed with our rolling submission by filing our non-clinical module in quarter two of this year followed by our clinical module in court of three.

As we have stated previously the critical path to completion of our rolling submission will be the filing of our chemistry manufacturing and controls or module.

Previously Eli Lilly partnered with macrogenics had completed manufacturing process development and commercial-scale at commercial scales and we may have successfully transferred that process from Lily's manufacturing site in Ireland to our contract manufacturing partner biologic in Seattle.

The end of 2019 we completed a successful engineering run and this quarter. We will complete our first GMP room with the FDA has asked us to submit an analytical data from both runs to article is amount for the purposes of a comparability assessment against our analytical data from prior Lily Rome, assuming favorable feedback from the FDA. We will then proceed this summer with three commercial-scale process performance qualification or people value. These funds will be used for process validation qualification and stability enabling us to complete our rolling submission by filing rcmc module in quarter of this year.

Following a customer to month acceptance. And assuming we file for priority review under breakthrough therapy designation. We could reasonably expect an easy decision in mid 2021.

In parallel with our regulatory assets. We are engaging with as part of our Prime designation to bring to Blizzard map forward in Europe.

We recently met with the EMA for our Prime kickoff meeting a procedural meeting with the reporter their assessment team and a multidisciplinary group of experts and relevant committee Representatives.

Please kick off meeting will be followed by scientific advice meetings to discuss the potential submission of capitalism a marketing authorization application KO MAA. We currently expect our MAA for the risk indication will follow the submission by approximately 9 to 12 months. So we have targeting the second half of 2021, but that submission.

Halloween closely behind the at-risk indication. We are advancing our protest study in newly diagnosed patients. We remain on track complete enrollment in this study by the end of 2020.

Today, we have not seen any impact from the nineteen pandemic. However, we will continue to monitor monitor the situation closely.

To complement our clinical and Regulatory. We are also preparing our commercial strategies to support a potential launch of duplicity man as the first disease-modifying drugs approved for t1d since life-saving insulin therapy was introduced nearly one hundred years ago.

A recent appointment of Jason Hoyt as Chief commercial officer demonstrates our commitment to building a competent and experienced commercial leaders 15. Jason has had proven success in the planning preparation and execution of specialty specialty biologics launches in mouth disease and nascent Market including previous positions at Dover infomed Sarepta birth ex and Gilead Sciences.

In a relatively short period of time he has already made significant progress advancing our commercial planning and preparation.

We also recently expanded our team with the addition of dr. Jessica lumb see who will lead our Market access and our distribution efforts to critical components of our commercial strategy going forward. Jessica has had nearly twenty years of experience in the biotechnology sector and we are thrilled to have both her and Jason's join our experienced team as we work diligently to bring capitalism out to patients at risk of progressing two clinical-stage insulin-dependent t1dm, and subsequently to patients with newly diagnosed disease.

With this. Let me turn the call over to Jason to discuss the commercial landscape in more detail Jason. Thanks Ashley. Let me Begin by saying how proud I am to be a part of this amazing team at prevention bio since joining in early January. I can say that has been both exciting and Incredibly productive given the critical juncture. We're at as an organization with the blizzard mab prevention has the unique opportunity to bring forward a novel product with transformative potential. We're beginning to execute our commercial strategy and recent publication May reinforce our confidence in our approach last month, the JDRF t1d fund published a white paper that provided Insight on the current t1d landscape and helped lay the groundwork with our commercial discussion.

According to that paper the global cost of t1d.

Reach approximately ninety billion dollars with an estimated Thirty billion dollars in the u.s. Alone their research also reinforced our own estimates on the size of the US market currently 300,000 at-risk patients in the US defined as a symptomatic patients who screen positive for two or more Auto antibodies using a simple inexpensive and commercially available blood test. These patients will ultimately progress to end-stage insulin-dependent t1d without intervention within this group. We believe there are two hundred thousand individuals in the office that have two or more Auto antibodies and test positive for dis glycemia by way of an oral glucose tolerance test.

We also believe based on a paper published by the JDRF endocrine society and American Diabetes Association that without intervention stage two patients have a 7% chance of progressing to stage three insulin-dependent t1d over a five-year period at prevention our initial commercialization effort will focus on a subset of these seem to patients specifically the 15% of at-risk individuals that are direct familial relatives of known type 1 diabetics. This amounts to roughly 30,000 patients who have to Auto antibodies and disclose. I see Mia and up to 45,000 patience with to Auto antibodies alone.

For a company of our size. We believe this represents an ideal initial Focus for our marketing efforts existing screening initiatives are already underway and various countries looking for patients suspected of developing type 1 diabetes as early-stage diagnosis is known to help reduce disease morbidity particularly diabetic ketoacidosis. There are standard TV package blood test already available and over 1.5 million people globally have been screened to date by focusing on the highly motivated family members of t1d patients who are already familiar with the life-changing impact of t1d and targeting the roughly 900 pediatric endocrinologist caring for these patients. We believe we can easily tap into this readily accessible Market immediately upon approval and with a modest commercial infrastructure.

As a reminder, we believe that this initial Market alone could represent a billion dollar opportunity.

In the coming months, we intend to launch an awareness and screening initiative ideally in collaboration with advocacy Partners to encourage those at risk to be screened. We also intend to roll out an hcp awareness and screening campaign intended to encourage them to proactively offer this screening to family members of t1d patients in parallel, but in no way at the expense of effort, we will be working to further expand screening into a broader population of patients. The importance of general population screening is already gaining momentum as is evidenced by a recent study published in the Journal of the American Medical Association highlighting the value of screening for t1d and suggesting that public health screening forty-one D and pre-symptomatic stages May disease burden severity as well as enable disease interception strategies with novel agents such as to

in addition as is the case with many rare disease has the potential availability of a first-ever therapeutic to a

Unmet need is likely to drive expanded surveillance and screening efforts.

We will also continue to work closely with advocacy organizations such as JDRF Beyond type one and the Helmsley Foundation to support more broad-based population screening for children.

Over time we believe this will allow us to identify a greater proportion of those 300,000 stage one and two patients who are not direct familial relatives of known type 1 diabetics off increasing the market size dramatically.

Beyond the at-risk population are ongoing protect trial if successful and resulting in regulatory approval will allow us to expand into the newly diagnosed or stage 3 patient population from The Exchange clinical registry. We know that approximately 64,000 t1d patients are diagnosed each year in the United States because of the severity of the patients conditions and their immediate referral to Pediatric endocrinologist for life-saving insulin therapy. These patients are unfortunately easily found our initial Focus will be on patients ages eight to Seventeen consistent with the profile in the protection longer-term through life cycle management. We will seek to broaden the market potential by exploring repeat dosing off expanding the age groups and eventually looking at subcutaneous formulations and combining to play with other Therapeutics.

We're excited about the many opportunities ahead for for prevention and for the t1d community. I look forward to updating you on our commercial progress planning and insights throughout the remainder of the Year. Let me now turn the call over to Francisco to discuss our recently disclosed and exciting data from our prv 3279 program Francisco.

Thank you. Jason. Do they was reported positive results from the phase 1 B portion of the prevalence study evaluating. 3279 off by specific scaffold targeting both City thirty two B&C 79b and healthy volunteers. We believe that prv 3279 wage potential to intercept Bissell mediated autoimmune diseases such as systemic lupus erythematosus also known as lupus as well as immunogenicity associated with Gene therapies instead of beauty products.

But it's also the study demonstrated that. 3279 was well-tolerated upper multiple administrations and eating heated the function of B cells directly and without depletion these data support our forthcoming Loop of study and our gene therapy efforts.

The face won't be portion of the previous study was double-blind placebo-controlled multiple ascending those study.

Do you have these 3279 was well-tolerated with no serious Adverse Events?

Looking at the parameters. We're generally those proportional and hide receptor-binding resulted in durable pharmacodynamic responses.

That's expected. 3279 did not complete bistros and demonstrated extensive and sustained binding lymphocytes with prolonged thermodynamic life.

This is reflected in the reduction of circulating immunoglobulin M levels while anti-drug antibody production was observed at both those levels tested you managed to do was determined not to affect exposure safety or pharmacodynamic parameters.

These results in conjunction with prior. 3279 clinical data including macrogenics hepatitis A vaccine results an existing evidence of the role of cities to be in Lucas further increased our emphasis for. 3279. We believe these Innovative molecule can rapidly and durably injected activated diesels without depletion.

Every 3279 has a similar effect to that which of our drug the place mapped has on T sets modulation without the place potentially striking a balance between safety and efficacy in lupus and other bezel mediated autoimmune disorders.

do you have your 3279 has the potential to address a wide variety of conditions where B cells play a role from large indications such as rheumatoid arthritis and multiple sclerosis, too often diseases such as idiopathic thrombocytopenic purpura, neuromyelitis, Optica and figures or my life these

we have prioritized Bluetooth as our lease Indian indication, even the unmet need and established proof of mechanism for 30 30 to be agonism in this disease.

Lupus is a chronic autoimmune disorder that can affect nearly every major organ system causing inflammation tissue injury or damage in a patient's organ failure at least one and half million Americans are afflicted with lupus. The pathogenesis of Lupus is characterized by an abnormal overactive of B cells and subsequent pathologic production of autoantibodies.

Mutations in the city to be gene in humans are associated with an increased likelihood of lupus and reduced expression of t72b is apparent in balance from Lupus patients.

The time to commence the face to a portion of the prevalence study and Lupus patients in the first half of 2021.

You know.

Okay. 3279 has the exciting potential to serve as the backbone for the prevention of immunogenicity associated with gene therapy and Thursday. We are currently conducting animal studies in support of this new approach.

Let me know turn the call over to MD for a review of our financials.

Thank you Francisco. Good morning, everyone before I begin. I'd like to encourage you to read our 10-K that was filed today the 10K includes our financial statements risk factor as well as Management's discussion and Analysis of our financial condition. I would also like to call your attention to the earnings press release which was issued prior to this call. Let me start with our current cash position and cash projection as of December 31st, 2019. Our cash balance was 85.4 Million. We expect our current Cash Cash equivalents and marketable securities will be sufficient to fund projected operating requirements for the middle of 2021. We will continue to fund operations for our for active programs and wisdom. AB 679 prv 0 1 5 n p r v 1 0 1 our net cash used in operations for the full year ended December 31st, 2019 down.

41.5 million

We currently expect to use approximately 24 to $29 million operations for the first six months of 2020.

From a p&l perspective. We generated a net loss for the fourth quarter 2019 of 10.5 million or 22 cents per basic and diluted share the increase in that loss compared to Jersey. In 2018 is attributable to increases in research and development expenses of 3.5 million as well as an increase in general and administrative costs of 1.2 million.

Net loss for the full year of 2019 was 43.3 million or $1.06 per basic and diluted share compared to a net loss of 26.5 million or $1.19 per basic and diluted share for the full year of 2018.

The increase in that loss year-over-year is primarily due to an increase in research and development costs of 13.7 million research and development expenses were driven by the project study.

development costs for brv 101 and internal Personnel costs

in addition G&A expenses increased by three point eight million year-over-year.

With that overview. Let me turn the call back over to Ashley.

Thank you, Randy.

As we approach the end of this first quarter 2020 is shaping up to be a very exciting year for prevention. We recognize that we are the edge of a paradigm shift in the development and commercialization of innovative disease-modifying therapies for type 1 diabetes and other life-threatening life impacting autoimmune disease it.

I was completely my program was provided validation for our strategic intent focused on preventing or intercepting immune-mediated disease before it is too long before irreversible tissue damage and end-stage organ failure occurred.

Following closely behind is the map. We are advancing candidate like prv 3279 that further Advance our strategic intent by tugging other Pathways in autoimmunity.

Before we open the call for questions. I would like to thank our investors for their continued support all the investigators and patients participating in our clinical trials my fellow prevention executive and our amazing dedicated expert experienced and expanding team of employees Partners consultant.

Operator not ready to take questions. Thank you.

We will now begin the question-and-answer session to ask a question. You may press * then 1 on your touchtone phone. If you are using a speaker phone, please pick up your handset before pressing the key to withdraw your question, please press * then two at this time. We will pause momentarily to assemble our roster.

And our first question will come from a young of can't or please go ahead. Hey guys. Thanks for taking my questions and congrats on a lot of progress over the past couple of months. So maybe a couple thousand me one. It seems like you kind of got an interesting update from the recently. So I guess I wanted to just talk a little bit more in detail about what the next steps are, you know along with the additional meetings off sounds like it's pretty parallel to the US perhaps but just if you can compare contrast that and then talk a little bit about the manufacturing process that they're looking for their the next question would be on the phone no data, which came out in the healthiest this morning and I just wanted to get your perspective on the fact that there were an anti-drug antibodies but no immune Janessa T. Would you consider kind of pursuing a potentially new toast wage? Then the last part of the question is when you think about starting the first half a 20 21 for the phase to a portion of what other things do you have to do between now and like maybe you know the next day

Eight nine months to get that to a underway. Thanks.

Thank you very much. So we regard the the first kickoff meeting was a procedure.

And we won't get much more additional information until we have those scientific advice meetings, which we haven't yet scheduled so we don't have the the information that you're looking for in that regard. But as we get it throughout the we will definitely be updating. Perhaps I'll turn this now over to fax. So if you could address elitist question regarding antigenicity

Yes, hi Alicia. So as as we mentioned we did see anti-drug antibody production both those levels tested and that was expected to be announced from the prior phase one trial done by macrogenics like with any biotherapeutic but that immunogenicity of the drug wage not affecting exposure that's pharmacokinetics was not affecting safety and was not affecting the ability of the drug to inhibit The Bistro in other words did not affect pharmacodynamic parameters.

and then the final

and with regards to your second question, what comes next is digesting these data discussing with our key opinion leaders and finalizing the the sign of the lupus face to a protocol and then all the standard preparation steps of any child going through regulatory process went out to the site selection gearing towards study start in the first half of next year.

And there's a commercial question. I guess I've seen you make some tires here. Can you talk a little bit about big picture, you know further hires you need to make and kind of the build-out, you know over the next, you know, kind of 2012 to get you out to ready to launch a strong and twenty Twenty-One things.

Thanks very much, Jason. Could you answer that for us, please? Yeah. Sure. Thanks alethea for the question. So right now, you know as you can I think you see what the higher of Jessica blumstein our real focus is on the commercial leadership team, which we would anticipate is, you know, six or seven individuals that are really going to lead the charge over the course of you know, the next the next couple of quarters and then I think any expansion beyond that we're looking at gating factors right like the b l a submission and ultimately the b l a acceptance before we begin more broad-scale Commercial hiring.

awesome, things like guys

Our next question comes from Thomas Smith of s v b lyric, please. Go ahead.

Hey guys, good morning congrats on the progress and the data this morning. I just had a couple of questions around to pelusium have in 3279. I guess first once it's Lizzy mad. Maybe if you could give us just some updated thoughts on how you're thinking about pursuing Europe commercially would be helpful given the recent regulatory interactions.

From so to be absolutely clear. We do not intend to pursue commercialization in Europe directly that is a consideration that we have in the United States in the planning and commercialization work that Jason is doing at the moment with his leadership team is applicable to whether we would go direct or partner in the United States. So that decision hasn't been concluded yet either but the decision has been determined that in Europe. We would we would not attempt to do that and their faith. We are actively seeking a partnership for European commercialization.

Okay, and then on 3279 it sounds like you looked at two levels here. Can you maybe just talk about how you chose the dose levels in the phase? 1B what you're planning for the phase 2A and then can you talk a little bit about the threshold levels of b-cell suppression that you think you're going to need to show uh in order to to translate to clinical benefit and lupus kok. Do you think the doses you've looked at here captured? Um and efficacious therapeutic window or you planning on expanding dose-escalation in the face to a

Thanks, So obviously Francisco is best to answer that the dose levels Francisco and then the threshold.

Yes. Hi Tom. We chose the dosage for the one be based on the escalation work done by macrogenics in the first human study and we have already identified a dose level that is both well tolerated and highly efficacious inhibiting these so funky. So we do not anticipate requiring any additional those finding work in the face to a trial.

Okay. Thanks guys. Appreciate it.

Our next question comes from Rome silver of HC Wainwright, please go ahead.

Hi guys, this is Rob on the call for ROM. I've got a few questions. So I was curious about how you're thinking about potential pricing for temple is Amad in the US and what sort of size is of a sales force. Do you think you would need to support templates and assuming all goes well on the regulatory front then switching over to Europe have you I know that you don't wash commercialize it to yourself in Europe. So have you begun any dialogues with potential distribution or licensing Partners in your particular is Amanda and then I've got a few more but I'll let you answer those two. First name.

I'm sorry to take the last one first. And yes, we are in active discussions with potential partners for European distribution and commercialization Jason. Could you talk to Parts pricing and sales force sizing in the United States? Yeah, sure happy to and and thanks for the question. So, you know as you know, we're we're eighteen months or so away from a potential commercialization. So we're we're we're we're nowhere near finalizing the price but the initial work is now underway around building the health economics story and I think the addition of Jessica blumstein to the team brings a wealth of experience and doing in doing just that so we're building out, you know, the the health economics story and specifically what the total cost to the system is of type one diabetes and and plan to start to engage payers as early as next quarter to start discussing, you know, budget impact models and and cost-effective.

and so, you know the formal pricing research will come later this year and I would you know, I would

Expect us finalizing a price until we get you know much closer to launch. Once we you know, think about sales force sizing again, you know, nothing has been finalized. They're either we woke data to drive us and so, uh, we're actively looking at a claims database analysis, where will come up with a list of targeted positions and you know, their relative desk styling the workload associated with them and ultimately, you know, our our philosophy is that we want to approach this in as lean away as we possibly can to maximize the opportunity and so knowing that there are roughly 900 pediatric endocrinologist out there in the US I would expect a sales force of thirty five to fifty or so. But again, those are Ballpark numbers if we can do it with fewer we certainly will, but we we are you know, our goal being committed to the patients with type one diabetes is to ensure that all patients have an educated physician with knowledge of what to prison math may offer to their page.

And you know, that's that's how we're going to approach the market, but I would expect ballpark to be in the 35 to 50 range.

Okay, sounds good. I've got a few more. So when can we expect to be incredibly expect you to begin? They say testing for p r v 0 1 5 and what sort of design of the Clemson game you think about there and then 4:00. 3 to 7 9 in the phase 2 trial that you expect to initiate in twenty one. When when can we expect top line data from that and any updates on. V 302 this year?

So was the first question about prvo 1-5 the Celiac Antioch 15.

Yeah, okay. Yes. So that is on schedule Francisco. Do you want to say a few words about the AR-15 I used to be study off.

We will command the trial in the second quarter of this year 2020 and it's it's on track. It needs to be trial for 220 patients.

And could you also answer the question regarding 3279?

The 3279 face to a Bluetooth trial will be single dose level as we just mentioned placebo-controlled trial.

It would be at least 12 weeks. But obviously we are now discussing with our opinion leaders the final design, but at least 12 weeks study found it will start in the first half of next year.

Okay. Thank you.

Our next question comes from David Hogue of SMBC, please go ahead.

Hey guys, good morning. Thanks for taking the question and congrats on the 3279 data. I had a couple so maybe just first on Temple eyes and mab if we think about you know, the. We're maybe you're going beyond the 30 K, you know, initial patients or targeting and launch and trying to you know, expand out more broadly. Maybe just walk us through the patient's life. You know, what does it look like in terms of kind of getting the patient into the office and doing you know the screening and and you know, is there anything else payers might kind of look for in life, you know allowing the drug to be prescribed.

Thank you, Dave. You didn't and thank you for initiating coverage on us yesterday Jason. Would you like to wrap a patient Journey? Yeah, so so thanks for the question. So the 30,000 home, uh, initial addressable Market represents those that fall within the enrollment criteria in the T N ten study that was published in the New England Journal. So that would be patience with to Auto antibodies and evidence of dis glycemia. The 45,000 number represents patience with to Auto antibodies. And I think is Ashley mentioned in his opening remarks as as soon as the patient has brought an auto antibodies as far as we're concerned. They have type one diabetes. It's just a matter of when they will progress to that end stage stage 3 insulin-dependent type one diabetes and so off our approach knowing that you've got a highly motivated group of family members of those those known type 1 diabetics who understand the daily struggle.

Of insulin-dependent and monitoring glucose levels screening those relatives is an initial Target through work in partnership with advocacy. Organizations are highly motivated like JDRF and Beyond type one and we think we can we can easily reach that group of patients. I think to go beyond that and and Target the other two hundred thousand to three hundred thousand patients that we know are at risk in the US that happened to not be direct familial relatives of known type 1 diabetics will need to explore things like broad-based population screening. We know right now that there are assays out there through Quest and LabCorp that are are commercially available and reimbursed by payers for familial relatives. So in working in working with advocacy organizations like JDRF Helmsley Beyond type one, we hope to advance more broad-based population screening wage.

You know also including, you know, Physicians societies like the American Diabetes Association and the endocrine Society. I think it'll take more of a coalition to drive that broad-based population screening and potential even the Advent or approval of Tupelo ISM AB so that there's you know, a known known therapeutic. Once they have that diagnosis of the to Auto antibodies to drive that but that longer-term broad-based population screening is happening in parallel and and let me be clear in no way at the expense of a highly concerted effort to identify those 30 to 45 thousand direct familial relatives that we think are are are are addressable at launch through through work with family advocacy and advocacy organizations.

and I think there are ways of

Operating. General population screening with enrichment strategies identifying genetic profiles working with other two immunity, which we know has an increased risk of the type one diabetes. Perhaps even potentially looking at the trigger off type one diabetes, which we believe to be Coxsackievirus. These are all ways that we could identify subgroups of the general population. That would have a higher probability of birth, uh of the risk of type one diabetes got it. Thanks for that. That's that's really helpful, you know, all that additional color and then I just had one other question on Thursday $79, you know as you think about kind of moving forward in lupus, you know, should we think about it as sort of an all Comer lupus population that you really want to go after birth?

You know, is it possible that you know, maybe like some subset maybe lupus nephritis or something like that, you know with also be under consideration.

Thank you. Yeah, so Francisco you want to talk about the second segment in the loop as population or going for the broad?

population

Yes, thanks for the question in principle the mechanism of action of. 3279 addresses that brought lupus population but faith in the face to a clinical trial we will narrow down to one or two subsets as is standard to get a better signal. So what people typically do is to focus on dermatitis and arthritis and lupus manifestations which are very apparent and easy to measure off. So in discussion with our chaos will refine those subsets for our proof-of-concept study.

Okay, great. Thanks a lot.

This concludes our question-and-answer session. I would now like to turn the conference back over to Ashley for any closing remarks.

Thank you everyone for joining us today. We look forward to providing additional updates on the progress of our Temple is a map program and our other pipeline programs throughout 2020. Thank you.

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.