Q3 2021 Provention Bio Inc Earnings Call
Good morning, My name is Joe and I'll be your conference operator today.
At this time I would like to welcome everyone to the prevention bio call.
There'll 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 Mr. Robert <unk>, Vice President of Investor Relations for prevention buyout.
Thank you operator, and thank you all for joining us on prevention Bio's third quarter 2021 financial results Conference call joining today's call from the prevention biotech team as Ashleigh Palmer, Chief Executive Officer, and co founder Francisco, Leon Chief Scientific Officer, and co founder, Jason Hoyt, Chief Commercial Officer, and Andrew Drechsler Chief.
Financial Officer before.
Before we begin let me remind you that the various remarks, we will make today constitute forward looking statements. These.
These include statements about our future plans and expectations clinical results regulatory and other developments and timelines related to our product candidates, including fortunate Lizzie man our plans to work with the FDA to address deficiencies identified in the Z R L, including their PK comparability and product quality considerations.
As well as the planned delivery of significant catalysts over the next 24 months.
Pencil safety efficacy and commercial successes fuzzy math and our other product candidates.
Pencil COVID-19 impact on our clinical studies and business plan.
Projections, including our anticipated use of cash in our cash runway and our business plans and prospects, including with respect to any potential BLA resubmission for supposing that projected timing for the same.
Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors.
Including those discussed in the risk factors section of our most recent quarterly report on Form 10-Q, which we filed with the SEC. This morning and in other filings that we may make with the SEC in the future.
Any forward looking statements represent our views as of today only while we may elect to update these forward looking statements at some point in the future. We specifically disclaim any obligation to do so even if our views change except as required by law. Therefore, you should not rely on these forward looking statements as representing our views as of any day.
Subsequent to today.
There is more complete information rework regarding forward looking statements risks and uncertainties in the reports prevention files with the SEC.
These documents are available on prevention web site at Www prevention bio dot com under the investors section. We encourage you to review these documents carefully with that I'll now turn the call over to Ashleigh.
Thank you Bob and good morning to everyone joining us on the call today.
We've made considerable progress across the company over the past few months.
This morning, I will begin by providing an update on the planned regulatory pathway and next steps relating to our efforts to potentially secure approval will tip placement with a delay of type one diabetes in risk individuals.
I'll also provide an update on our project phase three trial of <unk> for newly diagnosed <unk> patient.
Jason will then be sharing with you some of the activities and progress our commercialization team has been making in preparation for the potential approval and launch of <unk>.
Francisco will then discuss the exciting first in human interim data.
We announced last week pertaining to our polyvalent coxsackie by what's being vaccine candidate.
As well as provide status updates on that.
The pipeline candidates targeting serious autoimmune diseases.
Lastly, Rudy will summarize our financial results for the quarter before we open up the call for your questions.
In September we issued a press release updating you on the status of our interactions with the FDA in response to considerations noted in the complete response letter we received this past July.
Specifically, we took pumps in a type a S. P. A meeting in August to discuss those considerations related to product quality and manufacturing.
As noted in the press release, we believe these have either been addressed by amendments filed prior to the issuance of the C O L.
The FDA had not yet reviewed.
Laura items, how team is currently addressing and expects to have completed by the time the BLA is potentially resubmitted.
The C O L. Also noted findings from than recent inspection contract finished facility.
We can confirm this inspection has been closed down by the FDA as expected.
Given this progress we believe the remaining gating factor for our proved the ability of <unk> is our ability to either demonstrate true PK data derived from therapeutically dose patients.
It ought to be commercialized drug product is comparable with material used in prior clinical trials manufactured from drug substance produced by Eli Lilly 11 years ago.
All to provide the FDA with sufficient data to confirm that any difference in PK area under the curve seen in a single fractional low dose PK study in healthy volunteers does not translate into.
Efficacy concerns in patients.
It is our intention to do both of these.
During the first quarter of this year, we initiated a PK PD sub study within the protect trial to collect samples from actual patients receiving cleve, the Eli Lilly source material or the to be commercialized product.
We have since completed the collection of samples from approximately 160 patients.
We currently remain blinded to the PK AUC data.
At the beginning of last month following the Fda's recommendation, we requested a formal type a meeting and submitted briefing documents. So the SBA can formally agree on the population PK models design prior to the UN blinding of data collected from the protests sub study.
The FDA has scheduled this meeting for the second half of this month.
Assuming we receive the Fda's agreement. This type a meeting we will then proceed to populate the PK mogul analyze the results and work with the FDA to determine the regulatory path forward.
In our September press release, we also provided preliminary unblinded pharmacodynamic data collected from the protest sub study.
Our view is that the relevant PD markers, such as lymphocyte counts CD three receptor occupancy and T cell activation indicate both drug products Act on targeted T cells in a consistent and remarkably similar manner.
While we cannot yet claim these markers in isolation are determinative of comparability.
We do believe they are robustly supportive.
Provides strong rationale to present to the F. D. A y P. K AUC comparability differences for this therapeutic antibody may not be clinically relevant.
Switching now to completely novel potential use in newly diagnosed <unk> patients.
We'll for the protect phase III study was to enroll 300 patients within six weeks of their initial diagnosis.
Our guidance for some time now has been the completion of target enrollment would occur in quarter three.
I'm delighted to report that we indeed accomplish this objective at the end of August.
Out of an abundance of caution given the challenges the COVID-19 pandemic has presented the clinical trials across our industry.
We continued enrolling patients to exceed this target.
10% to ensure that we will have sufficient evaluable patients.
I do want to acknowledge and applaud our protect study team.
The collaborators the investigators and clinical trial sites.
And most importantly.
We want to thank the patients in less time for their efforts and participation.
As per prior guidance, we remain on track to deliver topline results from the trial in mid 2023.
Before I turn the call over to Jason to discuss our commercialization preparation is in progress.
Like to remind you that our planning approach to date has been carefully gated and aligned with our regulatory risks and milestone.
As we gain more clarity and confidence in potentially moving forward, we will begin to increase spending on prelaunch activities never.
Nevertheless, despite this prudent gating, Jason and his team have been able to make great progress on a number of proprietary from.
And we would like to update you on this now Jason.
Thank you Ashleigh and good morning, everyone I'm excited to speak with you all today and provide you with an update with respect to the great progress we've been making within the context of the gated spending hiring approach. We've taken is actually mentioned.
Beginning with payer engagement our market access team has been engaging payers to educate on T. One day patient screening and when requested on the deposit map clinical data for over a year now.
As of the end of the third quarter, our team had engaged more than 65 individual payers representing over 200 million lives across the commercial and Medicaid payer segments.
The key areas of interest within this group consists of screening incidence and prevalence of tier one day.
Our planned distribution model sites of care and patient services importantly.
Importantly, these pairs has generally not expressed any concerns related to our C O L or launch timing delay and have expressed interest in further engagement in the event of a BLA resubmission with a new <unk> date. Additionally.
Additionally, our team has developed new resources on auto antibody testing and general tier one D education, including a recently published white paper and a J M C. A payer focus journal.
We continue our pricing research and the feedback with respect to unmet need and to pleasant potential ability to meet that need has been to date incredibly positive. We believe our messages resonate quite well and we anticipate strong coverage across our payer mix.
We're making strong progress with regard to government pricing and contracting policies and we remain on track for those to be in place quickly following an approval.
Our distribution model has been established with key contracts in place and we remain on track to be ready to distribute to pleasant mab as quickly as possible upon approval.
Additionally, our patient services program has been designed with input from key stakeholders, including patients and caregivers as well as health care providers, we've selected and contracted with key partners to deliver our patient services offering designed to meet the needs of families and physicians alike and are on track for launch readiness.
From a marketing perspective, we've conducted extensive market research across multiple stakeholder audiences, including pediatric endocrinologists adult endocrinologist pediatricians N P and P. S. T. A N D patients along with their relatives and caregivers the insights gleaned from this research with more than 1300 participants to date haven't.
Warmed our go to market strategy.
As you May recall, we launched two disease awareness campaigns in late 2020 are type one tested consumer website, which has received national recognition for its content has seen significant traffic and notably the traffic is amplified significantly in the third quarter of this year.
Additionally, our health care provider website connected by T. One D is also exceeding our expectations. Both in terms of traffic along with the amount of time visitors are spending on the site.
Lastly, we've recruited trained and deployed a small sales force pilot team, which has been focused on introducing prevention bio to key customers, providing disease state education and profiling key accounts across the country.
Overall, I'm very happy with the progress our team has made toward launch readiness and I'm pleased to be able to share that with you today I'm now going to pass the call over to Francisco for an update on the P. R V. One O one data as well as further updates on the pipeline.
Cisco.
Thank you Jason.
I am very pleased agenda today to discuss the updates regarding our out immune disease focused pipeline.
Let us first began discussing the exciting top line results from the prevent study.
Our first in human study of <unk>, one O one hour polyvalent inactivated hepatitis b vaccine candidates.
Oh, five key CBD strain associated with <unk>.
CBD is not just the common causes iqs morbidity such a smile because I did I did because I had this many jagged enhance who's my emphasis.
In addition, chronic infection pancreatic intestinal cells.
This is strongly associated with the development of Tijuana and celiac disease many patients.
And is it needs to be a trigger.
The mucus case, leading to the onset of these out of immune diseases.
So that is a placebo controlled double blind randomized first in human study of two dose levels of <unk> P. M E. One O. One in healthy adult volunteers, who will provide the stations and four week intervals.
The interim analysis was conducted all trial participants completed full weeks of follow on after the survey has been has an instant.
An additional six months follow up is being conducted and we expect the final childhood Cogs in the first half of next year.
In the insulin this culture it provided last month.
101 met the primary endpoint demonstrating that it was well tolerated in this study with no treatment emergent serious adverse events.
No adverse events of special interest.
And no adverse events that led to study drug discontinuation or study with bill.
Importantly, <unk> also met the secondary efficacy endpoint.
The new high titers of vital neutralizing antibodies.
Again all of the teams you can see that that's included in the vaccine.
And in a dose dependent fashion.
We spoke to the vaccine was predefined.
Hello Convention for baseline negative subjects or.
Our full time increase in titers.
So baseline positive subjects.
Percentage of subjects, who responded to all five banks.
Well he's a percent in placebo.
7% in the low dose arm.
And hundred percent in the high dose.
<unk> one or.
Overall the results we've seen so far from purely one O one are incredibly exciting.
And a significant step forward for this program.
We believe pizzi, where no one has the potential to be the first vaccine ever could prevent CBD infection.
Many complications and ultimately contribute to decrease the global incidence of both <unk> and celiac disease.
The next steps right now are to complete the follow up from this trial as we engaged in potential partnering discussions to help us advance the program.
Moving now to other key programs in our pipeline.
First let us begin with PSV 015.
Our fully human anti interleukin 15, monoclonal antibody, which is partnered with Amgen and.
And is being developed for the treatment of gluten free diet Nonresponsive celiac disease.
As you know we initiated this trial in August of 2020.
That gives me Christmas of 220 adult celiac patients.
While we managed to push forward despite COVID-19.
<unk> is now have an impact in our time.
In addition to general COVID-19 related disruption, which has led to delays in many trials worldwide. We have also encountered celiac specific factors.
In fact in our study as well Oh celiac trial, according to our competitive intelligence.
Some examples of these factors.
Shutdown of elective endoscopy procedures.
Lack of prioritization of chronic non life threatening diseases.
And reduce exposure to Goodman.
Related to People's reduction in travel and gotten out.
Pandemic.
We are working closely with that way, that's the gaythers on site and implementing several strategic activities.
And we're gonna leave that conditions will also continue to improve as the world began to assume more normal operating conditions.
However at this time, we are adjusting our timeline and guidance for this trial with the expectation that we will complete enrollment and have top line results in 2020.
We believe <unk> has the potential to become the first ever drug approved for the treatment of celiac disease.
Lastly, I would like to take a moment to touch on the presale program developing <unk> $32 79.
Our humanized Bispecific scaffold that.
2015, both CB 32, B and C 17, 90, which is designed to trigger inhibition of B cell function.
Including suppression of auto antibody production without depleting the b cells.
As you know we saw positive results in terms of long lasting b cell inhibition in the phase one B study.
And we are now on track to initiate screening in the phase III trial in.
In systemic lupus erythematosus in the fourth quarter of this year.
The present two study you said 24 week prevention of relapse.
Concept trial.
We look forward to sharing more details on this exciting program once we announced the initiation of the trial.
I will now turn the call back over to Ashleigh.
Thank you, Jason and Francisco <unk>, providing us with those updates.
Before we move into the financial results.
So you will have noted from our separate press release issued this morning.
Our Chief Financial Officer, Andy Drechsler will be retiring at the end of this year.
And his role will be taken forward by T ratio Shay.
Who will be joining us in December and we look forward to introducing you all to to reopen his arrival.
However, today, we recognize Andy.
I can speak unreservedly for the board and my colleagues at prevention in emphasizing what a profound and lasting contribution and he has made to our mission.
And these are discussed in many interactions with you.
Personal impact of Tijuana, the Syriac disease within his own family.
And the associated burdens and challenges.
<unk> face.
We feel fortunate to have had the opportunity to work so closely with Andy and towards benefited so considerably from the crucial role. He has played in bringing prevention bio to this promising stage.
In doing so he has always allowed us to see the world of serious autoimmune diseases through his personal lending.
Andy.
Beyond being a close colleague your close friends and family members to us all.
We wish you every happiness and all the good fortune and good health possible in your retirement. So you can spend more time with your precious family.
Well devote more time and leadership to your advocacy for <unk> patients.
Our families.
Andy.
Thank you Ashleigh.
A special thanks to our board my colleagues on the executive team and the entire team of passionate individuals have prevention.
It has been incredibly rewarding to work in an organization that is so committed to conquering disease that affects so many people, including those in my family.
I am very proud of both the pipeline rebuilt and the team we built.
I am also looking forward to assisting Jerry and his transition as his strategic and commercial finance financial experience. It's a perfect fit for our team and I have no doubt he will be quite successful in helping to guide prevention to the next stage of growth.
I also want to thank all of you in the investment community for the relationships. We've developed over the past 24 years that I have worked in the biotech sector.
Before I begin discussing the financials for the quarter I would encourage you to read our 10-Q that was filed today.
The 10-Q includes our financial statements risk factors as well as management's discussion and analysis of our financial condition.
I would also like to call your attention to the earnings press release, which was issued prior to this call.
Let me start with the P&L.
We generated a net loss for the third quarter 2021.
27 million or <unk> 43 per basic and diluted share.
This compares with a net loss of $31 3 million or <unk> 56 per basic and diluted share in the same period of 2020.
The decrease in net loss is primarily attributable to a decrease in to please the mab manufacturing costs as we incurred significant costs for production of GMP and PQ batches of drug supply and drug product during the third quarter of 2020.
We also saw a decrease in regulatory expenses, which were incurred in the prior year related to the initial <unk> BLA submission.
The decrease in research and development cost was offset by increased clinical development costs for the <unk> phase III protect trial and the <unk> 015, proactive study and celiac disease.
G&A expenses were relatively flat as an increase in corporate infrastructure costs were offset by a $1 $8 million decrease in pre commercial expenses, primarily related to a reduction in our pre commercial activities. Following the <unk> issued by the FDA in July.
Shifting now to cash.
As of September 32021, our cash position was $158 million.
Our net cash based operating expenses, which exclude noncash expense for stock based compensation and depreciation were $24 6 million for the third quarter ended September 32021.
We expect to use between 25 and $29 million of cash for operations in the fourth quarter of 2021.
We expect our current cash cash equivalents in marketable securities will be sufficient to fund projected operating requirements for at least the next 12 months and that will enable us to actively develop all four of our clinical programs.
We plan to provide additional cash guidance on each quarterly call as we continue to progress towards the potential regulatory approval and commercial launch it to put them out.
With that let me turn the call over to Ashley for his closing comments ashleigh.
Thank you Andy.
We open up the call for questions.
Wanted to make a few closing remarks.
We approach the final months of 2021.
I think back to the founding vision from Cisco and I shared about creating a company dedicated to a new paradigm in which the devastating consequences of the advanced stages of serious autoimmune diseases can be intercepted delayed or prevented.
I want to acknowledge and thank our investors for sharing our vision and providing the financial strength to build prevention and acquire and advance our exciting therapeutic pipeline.
We are now working to overcome the remaining hurdles in the way of our potential first drug approval.
I would also like to acknowledge and thank our colleagues at <unk>.
And then one on your Touchtone phone.
If you're using a speakerphone please pick up your handset before pressing the keys.
So withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble IRA auster.
Our first question comes from Alicia Young with Cantor. Please go ahead.
Hey, guys. Thanks for taking my question and congrats on a great career, and then wishing you all the best to two questions. I guess, one you know obviously unpleasant lab can you talk a little bit more about like some of the scenarios that you know kind of scenario and analyzing the FDA conversation that's upcoming just kind of maybe help us.
Understand like how you're thinking about different outcomes in events and and and set that up I know you ultimately wont know until your habit, but you obviously must be planning and thinking about some different scenarios and then on P. R. V. One O. One I know you have the data coming over the next six months for the final analysis.
But can you talk about maybe the next step is potentially for another study for this program. Thank you.
Thanks, very much Alicia for your questions.
So we're taking the S.
SBA interactions one step at a time.
As I mentioned, we have.
The type a meeting in the second half of November.
After that.
That meeting we will immediately populate the mobile analyze the data.
And discuss the appropriate next steps with the FDA.
As I also sent out.
My comments this morning, and the press release previously we think that in parallel with this we have a very.
Very strong robust supportive data for.
For the.
The PD markers and so we believe that we're assembling a very robust.
Proposition.
To address these remaining CRM consideration.
We're planning for success.
As you heard from Jason It's our intent if the data supports.
These arguments to move forward and submit.
The we'll resubmit the BLA at our earliest opportunity and maintained the momentum with respect to an anticipated.
Launch.
That's.
Really all of it at this point, we considering I think to speculate beyond that is is not is.
It's not something that we wanted to do we are.
Very confident.
Later in.
The the arguments.
Support what we've said all along that the comparability.
Comparability.
Is is an important consideration for the FDA, but that ultimately.
It's not clinically relevant.
And then one other one.
Francisco could you explain the next steps in the P. R V 101 program.
Good morning Alexia.
So on the heels of this incredibly exciting data we are going to share the details with the community more broadly.
A couple of short come in scientific conferences.
And then engage.
Potential partners.
That will help us move the program forward.
Our next steps are to come back a.
Pediatric study.
So safety and Immunogenicity is the focus of that study.
In advanced towards proof of concept in children, which is the ultimate target of the vaccine.
Okay that makes sense. Thanks.
Our next question comes from Gregory <unk> with RBC capital markets. Please go ahead.
Okay.
Good morning, Ashleigh and team. Thank you for taking my question and also let me add my congratulations and well.
Well wishes to Andy on on the next leg Postop prevention as a pleasure to work with you Randy.
Just following up on the previous question I'm, just wondering if you could elaborate a bit on prevention disclosure plan. Following the type a meeting and how you were thinking about sharing your views from from that experience as well as the outcomes as as those become clearer to you and then secondly, maybe a question.
For Jason just to build on his commentary.
Just wondering if you could comment a little bit on how you are maintaining that that momentum with respect to the stakeholders post the positive AD com, but as the focus has been on the manufacturing issue and maybe related to that with an eventual re filing how we would think about the inclusion of the three year follow up.
Data that was shared just in flight as Youre preparing for the initial BLA submission. Thank you very much.
Thanks, Greg and good morning.
So we want to leave ourselves room to interact properly with the SBA.
So we anticipate that we will be making a disclosure regarding the outcome of the type a meeting after we receive the minutes.
So we can make sure that.
Our assessment of that meeting is is accurate however, while it's not me.
Indeed be prudent to do so from a disclosure perspective, we'll obviously be.
Working immediately based on the feedback from that Taipei meeting.
Two hopefully.
Underlying the day to run the model and begin the analysis.
Jason do you do.
Do you want to speak to maintaining the momentum.
Yeah, absolutely you know I think we're able to continue the momentum Greg.
Because we did have a little bit of a lead time here right. We've done a lot of work over the course of the past year and a half to lay that foundation.
And we've got our two disease awareness campaign to out in the market, we're continuing to execute on those we've seen a pretty sizable increase in AR.
Traffic and impressions on our sites because of <unk>.
Fine.
<unk> strategy in targeting we've got are very limited pilot team that's out there engaging with health care professionals in the field and I think that's given US a lot of momentum over the last five or six months to be able to have that personal promotion of disease awareness and screening.
And have those direct conversations to supplement the non personal tactics. So I think you know.
The level of education needed around screening and disease awareness I think is really important and the fact that we have both personal and non personal channels that we're executing against has really allowed us to continue that momentum in the field.
Okay.
Yeah.
That's great. Thank you very much and just a just a comment on the three year data and and potential inclusion for a resubmission to the FDA.
I'm, sorry could you repeat the question.
Yes, sure just as far as the tech was enough follow up data at three years that that.
With shared last year, just curious if that's part of that will be part of the package sit to resubmit to the F. D. A.
Francisco do you want to talk about that I'm not quite sure what data.
Greg if you're referring to there.
Greg you referred to our pharmacokinetic data in the.
Okay.
Sorry, if I was just referring to the a D. A a 2020 data that was shared I recall, a flat last year. It was just too close to be part of the submission with the initial BLA filing.
T M 10 study right.
So for instance, yes, no that is that is not will.
Provide an update on safety data.
That was a request of the CRM.
Remember this CRM has no issues with respect to safety or efficacy at all.
So we will.
We will.
Forward the best arguments, we possibly can with the best data through the strongest labeling but our goal is to address this remaining PK comparability considerations and we submit as soon as possible.
Great. Thank you.
Our next question comes from Thomas Smith, with <unk> EZ I think it was go ahead.
Yeah.
Hey, guys. Good morning. Thanks.
Thanks for taking the questions and let me add my congrats and best wishes to Andy on his next chapter.
I guess just to follow up on one of the earlier questions thinking about the timing and cadence for updates.
From the regulatory interactions in the PK data analysis, it sounds like Youre planning to provide an update once you have the FDA meeting minutes, which would presumably be in the second half of December is it reasonable to think that we could see I guess topline data results from the PK PD.
Sub study either.
With that update or perhaps shortly thereafter.
How should we be thinking about the timing too.
Actually seeing results from that the PK sub study.
That's not an unreasonable assumption, but again you know we wanted to make sure that we.
Prevent.
The most accurate and up to date picture based on FDA interactions and so we can't speculate yet what the type a meeting.
Will.
It will result in.
We hope that it will be a.
Straightforward approval of the mobile and be able to initiate the <unk>.
The analysis and.
Then report the topline results as soon as possible from that.
But again, we're going to take it one step at a time, we believe that the mis.
The methodology of the F. D. A here is to make sure that we do everything in a very complete and robust manner. Because this is from from our perspective, when we believe the fda's perspective the remaining.
Iteration that needs to take place.
Be addressed in order to resubmit, the BLA and move forward with a potential approval.
Okay got it got it and then just.
Turning to Europe was wondering if you could just provide an update on how the conversations with the EMA are going and how you're thinking about potential submission in Europe.
And then perhaps a follow up to that you now have your conversations to date include anything related to the PK PD comparability or are they more focused on.
The clinical data and the at risk population.
Yes, so in the 10-Q today, we disclosed that we've had initial discussions.
And are advancing the process with the U K.
I think we've.
<unk> indicated in the past that we.
We are we think the best path forward outside of the United States Post Brexit is to.
To file in the U K first and maintained the momentum from an agency that tends to be more aligned with F. D. A.
If the FDA assessment.
Targeting the filing of the U K.
MAA in the second half of next year and that assumes that we will be able to address the comparability.
Consideration to the Fda's satisfaction.
Because to your point.
Until we can address that.
It is likely to be a consideration for all regulatory authorities.
And then.
We are planning further engagement with the EMA to lap next year, assuming that the PK comparability.
Issue can be properly addressed.
Got it okay that makes sense. Thanks, ashleigh for the color on the updates and again best wishes to Andy on the next chapter.
Our next question comes are ramped up our argument.
Wainwright. Please go.
Go ahead.
Thanks, so much for taking my questions.
Actually just a very quick one with respect to the interactions with the FDA just wanted to clarify whether.
Uh huh.
Coming out of the upcoming FDA meeting.
Anticipate that all other items that were raised in the original <unk> that don't pertain to the comparability data.
Unlikely to either be conclusively addressed or have a definitive.
Pathway to being addressed.
Yes. So thank you for the question Ram we had a type a meeting to address the product quality.
In CMC and manufacturing issues.
Review with the agency the status of those approve ability issues with them and our plans to address any.
Outstanding issues that we had not already.
Addressed by submissions, but they have not reviewed and not Taipei meeting.
Loud us to make.
The statement back in August that we believe to your point they have.
Been addressed Aurora addressable prior to the BLA Resubmission and therefore, they are not on the critical path.
Two to submitting it is the C. R L.
It is the PK comparability considerations.
Is the is really the remaining.
Obstacle to overcome to a BLA resubmission.
CRM also requested a safety data update.
And that's not because there were any concerns over safety.
It's because of the agency obviously prudently.
Wants to make sure that it has all the safety data available to it.
In the period from when we last filed the BLA mm two to this point, there's obviously been studies the protect study and so on where patients have continued to receive the.
The map and they wanted an update on that and we see that as a routine request, which we.
How confident we would be able to comply with.
Okay Perfect and then just following on from what you were discussing earlier regarding the way in which regulators other than the S. P. A R likely to look at the PK comparability data.
Have you actually had substantive discussions with any other regulator beyond the F. D. A regarding the specific topics of concern that the F. D. A originally raised and if so you know what's your read on how similarly, the other regular.
As in other countries are likely to treat this issue relative to the way the FDA has treated.
Yes, thank you for the follow up.
So the comparability consideration is a review issue as a result of submitting.
A.
Hey.
The market application, we have not submitted the market application anywhere else other than in the United States.
And so the substantive conversations that we've had with the U K and with the.
The MAA.
All have been scientific.
Advice conversations.
Looking at the.
Totality of the data the specific clinical trials are the unmet need and receiving advice on how to put forward, a marketing authorization application and and and so therefore, we have not had a.
Substantive discussions with the agencies outside of the United States on the comparability considerations.
Nevertheless.
The likelihood that those age.
Agencies will be satisfied.
If there is no PK.
Consideration from from the Fda's point of view having seen.
The PK in actual patients receiving therapeutic doses.
Over a.
12, or 14 day period I think it is.
Very very likely that they will see the same way.
Okay. Thank you that's helpful.
Just a few financial questions I also wanted to extend my best wishes to Andy on his upcoming retirement.
The questions are as follows firstly.
You know looking at the expenses that you reported today for the third quarter, especially on the G&A line. You know those seem to have declined substantially relative to the amounts that were reported in the first and second quarters and I was just wondering whether the G&A of quarterly amounts quarterly spend.
That was reported in the third quarter is likely to be a more dependable baseline for us to consider for upcoming quarters and then.
The next two questions are accounting related with respect to the revenue reported in the third quarter can you just kind of break down for us precisely what that was and what you expect.
To be reporting on a go forward basis purely driven by type of amortization based considerations and then with respect to the macrogenics milestone that would be due as I understand it the approval left a pleasant labs can you just give us a sense of how you will be treating that from an appeal.
Ontic perspective, and how that's likely to show up on the P&L. Thanks.
Yeah, Andy Brown.
Good morning, I appreciate the questions and the well wishes so Q3 expenses.
What you saw was a reduction in G&A and quite frankly, just a pullback on the pre commercial spend right that we were.
Starting to ramp up in the first half of the year once we receive the CRM, we obviously rein that in but I think it's you know.
It would be reasonable to expect that same rough level in Q4, and that's the only guidance. We've put forward right is that $25 million to $29 million of operating burn in the fourth quarter from a revenue perspective from what you saw in this quarter was the the beginning right of the amortization of those.
Monies that were provided by what all right the upfront money the milestone money, we will recognize that as the activities around that.
Phase III study for lupus.
Or conduct right. So over the next couple of years, we'll end up recognizing that full amount of revenue.
Happy to take offline the conversation on any.
Detailed calculations of that and then finally in Macrogenics.
There is a milestone payment upon approval.
And that would be.
Recognized or haven't paid soon thereafter.
The approval occurs.
Yeah, I think it's paid within about 90 days.
Thank you.
Okay.
Our next question comes from David long with that.
That's M D. C. Please go ahead.
Alright, thanks, so much for taking my questions. So the first one I think is probably one for Jason.
Wondering if you could share a little bit more color are you more granularity on the discussions that you've had with the payers. It sounds like those have been going really well, but I'm just wondering if you know things.
Things like what type of a.
Prior authorization any restrictions how they manage the product if that does come up.
Okay.
Hey, Jason.
Yeah. Thanks, David So I agree with your sentiment I think I'm encouraged by both the.
Feedback the quality of the feedback and the consistency of the feedback that we've been receiving from payers frankly for the past year and a half.
You know I would say that our expectation and our goal strategically is to have a streamline prior authorization to label I think what we've heard from payers is that you know that's how they would anticipate covering this that it would likely be.
Covered as a medical benefit under most plans and that they would anticipate covering to label assuming that they don't see the price as something egregious and we haven't set the price yet so I would anticipate a broad coverage and the anticipated goal that we have is a streamlined PAA to label.
Got it that's really helpful. Thanks for that.
And that just had a couple questions on CRB one to one be.
Vaccine candidate.
So if I'm reading this correctly it sounds like or you know for the next stage that is any kind of phase two efficacy study.
Would be you know you would be wanting to have a partner to really advance. The project forward. So just wanted to make sure. My read is correct. There and then and then similarly, you've also mentioned.
Potential a use case for not only <unk>, but also celiac disease. So I'm wondering if there are any plans at this time to develop it for celiac.
Yeah. Thanks, a lot so yes, I think youre reading it correctly, we think we've.
Created enormous value in this asset by conducting this first in human study in showing the immunogenicity that the polyvalent vaccine is able to generate and this we believe is very good.
Mechanistic proof of concept.
It will allow us to have good partnering discussions because.
We're not a vaccine company and we think that the advanced stages of vaccine development and the ultimate commercialization is best better hand handled by a company that has that expertise and experience.
Okay, great well, thanks for taking my questions and good luck to you Andy in your next chapter.
Thank you.
This concludes our question and answer session I would like to turn the conference back over to Ashleigh Palmer for any closing remarks.
Well. Thank you again for your time and attention this morning.
We look forward to continuing to keep you up to date on our progress going forward and we'd like to wish you and.
All of your families.
Happy and.
Unhealthy.
Holiday season, as we approach that time, thank you very much.
Okay.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.