Q2 2019 Earnings Call
Good afternoon, ladies and gentlemen, and welcome to the immunotherapy Inc. second quarter 2019 earnings Conference call. At this time all participants are you know these rethink only mode.
He will conduct a question and answer session.
And then instructions will follow at that time, if anyone should require assistance during the conference.
When you factor Star then zero on your attached to one telephone a very minor during this conference is being recorded I would now like turn the conference over to your host Mr., Eric Berg code named Chief Financial Officer.
Thank your main and good afternoon, and thank you for joining us today to discuss Amy in second quarter 2019 financial results and recent operational highlights today's call will be archived and a replay will be available on our corporate website at Aimmune Dot com.
Joining me on the call today are Dr., Jason Dallas, President and Chief Executive Officer, Andrew Oxybate, Chief Commercial Officer, and Dr., Dan Adelman, Chief Medical Officer. After our remarks, we'll open the call for questions.
Before we begin I would like to remind you that during today's call. We will be making forward looking statements. These forward looking statements include Amiens expectations regarding the potential benefits are they all want to one amiens expectations regarding the potential commercial launch of a our one on one including the review period of the B L. A and M.A. for air one on one.
Amen expectations on the announcement of results for its phase two clinical trial for ARQ <unk> two or one.
Amen to expectations regarding the timing and outcome of T.F.D.A.'s APEC meeting.
Our expectations on the planned timing for the announcement of data from its Poseidon trial of air a one on one and Regenerons clinical trial of Arizona, one in combination with Dupilumab Amiens expectations regarding its commercial supply Oh. They are one on one.
The expectations regarding the sufficiency of cash resources and ability to access an additional 130 million from the credit facility and Amy as expectations regarding potential applications of the coach approach to treating life, threatening food allergies, and the adequacy and quality of supply of Airwatch.
Risks and uncertainties that contribute to the uncertain nature of the forward looking statements include the expectation that Amy and we'll need additional funds to finance its operations, Amy wins or any of its collaborative partners the ability to initiate and or complete clinical trials. The unpredictability of the regulatory process. The possibility that Amy is there any of its collaborative partners clinical trials will not be successful Amiens depends on the success or they are one on one the reliance on third parties for the manufacture of our product candidates possible regulatory developments in the United States and foreign countries and Amy its ability to attract and retain senior management personnel. These forward looking statements are based on assumptions and are subject to risks and uncertainties that can cause actual results to differ significantly from those protex. It projected during the call given these risks and uncertainties you should not.
Place undue reliance on these forward looking statements.
Please refer to the company's quarterly report on Form 10-Q .
For the quarter ended June 32019 for some of the important risk factors that could cause actual results to differ materially from the forward looking statements made on this call.
Except as required by law immune disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur. After this call.
Finally, I'd like to point out that Amy as food allergy treatments, our investigational I don't I'm, not if FDA approved and now I'll turn over the call to Jason Dallas.
Thank you Eric Good afternoon, everyone and thank you for joining us this afternoon.
Today, we will provide a recap of our achievements in the second quarter and review our expected milestones for the remainder of the year.
Andrew will give an overview of our ongoing commercial preparations Don will provide a clinical and regulatory update and Eric will then review our financial results for the second quarter and we'll then open up the call for questions.
As we all know food allergy is an extraordinarily large issue worldwide and has been increasing and incidence and prevalence over the last several decades.
In the United States alone 1.6 million children between the ages of four and 17 are affected by peanut allergy and in a recent longitudinal study. It was shown that around a quarter of children's studied were admitted to the emergency room each year due to their food allergies.
These statistics paints an unfortunate picture of how peanut avoidance in the real world is very difficult on for most people an effective way to manage peanut allergy.
Today I'm pleased to find out that were approximately five weeks from unscheduled FDA Advisory Committee meeting as potentially months away from having an FDA approval failed one or one for peanut allergy.
Approval of IL, one the one would mark a significant day for the entire food allergy community as it would be the first ever FDA approved treatment for any kind of food allergy.
In addition to our rigorous preparation for the September Advisory Committee meeting, which we believe will be an excellent forum to discuss and consider our clinical efficacy and safety data. We look forward to underscoring the potential of L. One to one to meaningful meaningfully impact the lives of millions of patients and families living with peanut allergy today.
We also continue to work with the FDA to facilitate the review of our biologics license application or BLE and we're pleased with the agency has completed all clinical site manufacturing inspections that have been scheduled to date.
In the meantime, our organization is focused on ensuring a successful potential launch avail. One no. One we have made great strides in hiring the right people both at our headquarters and in the field to help us deliver on this charge our approach to preparedness includes a thorough and thoughtful understanding of the patient physician and payer communities through our ongoing research as well as developing an optimal mix of tools and resources to assist the broadest appropriate patient population to start and to stay on therapy.
Andrew will provide more color about our commercial preparations in his remarks, but I will say that from my vantage point I am extremely confident in our ability to successfully commercialize a one to one in the United States upon its approval by the FDA.
Turning to other updates from the quarter in June we showed positive results from our phase III Optima trial at the European Academy of allergy and clinical Immunology Congress or Yaqi in an oral presentation.
You'll recall that the trial demonstrated safety and efficacy results that were consistent with those seen in our successful phase III palisade trial.
Instead, the incidentally the lead author of the Austin was presentation Dr. months arrests Fernando's Rebus was named in the ASCII 2019 Award winner for her work on the Optimists trial.
At the AACR meeting, we presented important quality of life data that assessed the psychological burden of living with peanut allergy. We also presented data from an analysis of patients who receive daily treatment will they all want to one during the open label extension of the phase three palisade trial, which showed that these patients experience clinically meaningful improvements in disease specific quality of life as well as continued immunomodulation through daily dosing with our one on one beyond the first year of therapy.
In addition at the May meeting of the International Society for Pharmaco economic outcome research or <unk>, four which is a key payer forum, we presented the quality of life data that demonstrates that the deep psychological and emotional impact the burden of peanut allergy has on teens. This impact is profound I mean, there's simply heartbreaking that foreign 10 teens diagnosed with peanut allergy believed that they have a great all very great chance of certainty of dying from accidental exposure to fight the spot. Despite the fact that 100% of those observed in the report we're actively avoiding peanut products.
The unmet need is great and that is real and it is urgent both in the United States and in Europe were up to 2% of children in many countries are affected by peanut allergy.
To that end, we have submitted a marketing authorization application for our one on one to the European Medicines agency and we did that in June .
The Army has recently validated the filing and has to be done its review.
Based on standards EMEA review timelines, we expect the 12 to 15 months review and potential approval in the EU in the second half of 2020.
Don will give some more insight into the data that I just mentioned when we got to his remarks lastly, we are in a strong financial position with approximately 250 million of cash and investments and potential access to an additional 170 million following approval of am 101 through our credit agreements with KKR. We expect these resources to be sufficient to fund commercialization of a one to one and both the U.S. and Europe and to continue progress on our pipeline programs with that I'll turn it over to Andrew for a commercial update.
Thank you, Jason I'll start by echoing Jasons comments and say how exciting it is to be within months of the first potential regulatory approval of a peanut allergy therapy.
To that end, we've been diligently preparing for the potential commercialization of I don't want to one in the us and we expect to be ready to launch in the fourth quarter of this year.
When we think about commercial readiness, we focused on three critical areas.
First research and insights into the patient physician and payer communities to help us support and communicate effectively with these audiences.
Second the tools and resources necessary to assist patients physicians and our own field force to help support the successful administration available on a wall.
And third having the best people in place to draw on our efforts to successfully introduce and grow the use of they'll want a woman over time.
First let's focus on the patients we've conducted many many hours a fundamental market research to understand how peanut allergy one of the most common food allergies in the United States affects the lives of patients and their caregivers.
Parents speaker the paralyzed the anxiety that results from not knowing when or where the next accidental exposure to peanut will occur.
The greatest fear of these digital parents is something happening when they're not there to protect that child. This fear can result in significant disruption to a family's day to day activities and results in children being excluded from social activities and having to sit at separate lunch tables from their friends at school, just so that I could eat lunch safely without risk.
We recently conducted a quantitative survey amongst hundreds of caregivers a peanut allergy sufferers in the use of those surveyed 75% said that they had a high interest and seeking a treatment that went beyond avoiding peanuts to protect that channel.
And when should the clinical profile of Aon one alone two thirds of the carriage. It was expressed an interest in the product ever approved by the FDA.
For these caregivers avoidance simply doesn't cut it.
We also know that patients with peanut allergy easily identifiable and the estimated 1.6 million peanut allergic patients between the ages of four to 17.
1.25 million are already diagnosed and see a physician an average of five times per year for that peanut allergy and other co morbid conditions.
Turning to the I'll just community, we have amassed a deep knowledge of the approximately 5000 practicing board certified outages in the U.S., which includes a good understanding of the challenges clinics current level of readiness to administer IL one alone.
As well as his or her willingness to prescribe the therapy upon regulatory approval.
For our research, we know that all be I'll, just as I've indicated a willingness to prescribe I'll want to warn when approved approximately 1300 of them or 30% of the total can be characterized as having a clinic sets up that is either ready or is on its way to being ready to safely and effectively administer IL one a one therapy.
Furthermore, analysis of historical patient claims data shows is that approximately 70% of all patients ages four to 17 with a confirmed diagnosis of peanut allergy ACIM by one of the same 1300 allergists.
Therefore, a large percentage of diagnosed patients are seen by a relatively concentrated number of colleges.
Well over time, we will work with the broader population of 5000 allergists across the country. These data allows us to be very focused at launch by targeting the 1300, oncologists, who already see 70% of the diagnose peanut allergic patients.
We also now know at least 1300 colleges close into approximately 800 individual oncology clinics, which allows us to have an even more focused efforts.
With respect to pay as we've had in depth meetings with multiple payers since the beginning of the year, who together couple of 61% of the commercial launch in the US you may recall, we set out to have discussions with payers that come about 80% of commercial launch by launch so we're well on track to meet and even exceed that goal.
We've also conducted additional research with a number of payers of different sizes and configurations everything from small regional managed care plans to launch Pbms.
Collectively the pay is an hour search cover 178 million covered lives.
The key takeaway from both this research as well as from a strategic account director discussions.
Is the pay is immediately recognize the unmet need in the market.
The parents with children with peanut allergy, we actively seek out you don't want to go on therapy.
Beyond the direct benefits to patients and their families. We're also highlighting to pay is the potential reduction of other cost within the healthcare system.
Research shows if you're living with peanut allergy the absence of approved treatment options means that there is a warning for chance. They will end up in the emergency room in any given year.
These evolve as it can be very expensive an approved treatment that reduces the incidence and severity of allergic reactions could help to reduce costs through a reduction of the frequency of beyond visits.
Weve also shared with payers our plans to partner with specialty pharmacies to help manage the l. one on one experience for the patient caregiver ideologist. The feedback that we've received from page has been positive. This approach will allow patients to either pick up the product the outages clinic following their administered dose or two arrangement overnight reliable delivery delivery directly to their homes.
In addition to the patient and physician insights about which I spoke earlier, we plan to provide patients and that can give us a practical and customized solutions to support them, including flexible distribution reimbursement support services and comprehensive patient and caregiver adhere support.
For example, during the dose escalation phase the first dose of these each escalation will be administered in the LNG softness to allow for close supervision after which point the patient will be sent home with the dose for the next day.
The full year of doses for the following two weeks will arrive the next day, the patients' home from one of our specialty pharmacies.
Once the patient reaches the fix therapeutic dose stage, he or she will receive a three month supply of doses from the specialty pharmacy.
Finally to support a successful commercial launch avail 101 in the US we have a regional leadership team in place that is busy interviewing candidates to build our field force of 80 individuals prior to approval.
The interest in joining immune is very strong in fact, we've had over 5000 applications for HCCI account manager roles.
Hello.
Education supports the balance is to ensure that they understand both the clinical profile of the medicine as well as the just logistics that will deliver positive initial experience with they'll want along for both the patient and the physician.
We are confident that the current size of the field force is sufficient for launch and over time as we work through the markets. We will maintain the flexibility to expand the field force as needed.
Finally, let me turn to our commercial progress in Europe , our filing of an M&A with the he may last month was an important step towards our efforts to commercialize a one to one in Europe .
We continue to deepen our knowledge of the individual markets, particularly Germany, France and the UK.
And the staff, our organization with professionals and medical affairs marketing and market access.
For example, we recently hired an experienced general manager and a medical director for the German Austria, and Swiss markets, and we will be opening an office for our German team and the Munich area in the coming weeks.
As we looked at Warner warm potentially becoming the first approved peanut therapy on the markets. We are confident that we can deliver a successful launch based on.
The unprecedented strength of our phase three data.
A strong desire from patients caregivers and physicians for an approved peanut allergy therapy.
The recognition by payers of the value a need of such an important therapy and our investments in the resources needed to help support the adoption of and compliance to Aone hundred one therapy.
With that I will turn the call over to Dom for a clinical and regulatory update.
Thanks, Andrew.
Starting with our potential FDA approval. They are one on one we continue to work closely with the FDA.
We are preparing for the Advisory Committee meeting on September 13, and look forward to the opportunity to discuss the strength of our clinical data in this open forum.
As part of its review the FDA is scheduled and completed six clinical site inspections today and is also completed an inspection correct.
Our contract manufacturing partner.
Following these inspections, we continue to anticipate approval by late January 2020 .
We've continued to expand our medical affairs team with key new hires and medical education and medical information and the Department is now well staffed to help provide information about oral immunotherapy.
Including in medical Science liaison team deployed in the field that it's already interfacing with many allergists across the United States.
Through both on site visits and group meetings.
With respect to Europe is both Jason and Andrew discussed we submitted an M&A for am 101 to the European Medicines Agency in June .
Yes, Hey submission includes extensive data from the only phase three clinical trial program to meet the primary endpoint in children and teens with peanut allergy.
This program included over 1200 patients enrolled into the palisade Ramsey's and artemus trials.
The pivotal European Phase three arguments studies, which represents a key component of the M&A submission reinforce the consistent clinical profile. There were no. One after six months of dose escalation and these recent month therapeutic dosing sets.
The artemus trial enrolled 175, peanut allergic children and adolescents ages four to 17 from 18 sites in France, Germany, Ireland.
Italy, Spain, Sweden, and the United Kingdom.
Assuming a typical you review timeline, we expect a 12 to 15 month review.
As Jason mentioned, we shared results from the positive phase three arm in this trial at the American Congress in an oral abstract.
Presentation back in June .
The results of the trial largely replicated the results observed in the polls that trial and demonstrated that more than half of patients tolerated 1000 milligrams of peanut protein.
After nine months of treatment.
At Yankee, we presented data from an analysis of patients who receive daily treatment with air 101. During the open label extension extension of the Phase III palisade trial.
The data from this trial called Arco for.
Showed that patients experience clinically meaningful improvement in disease specific quality of life as well as continued immunomodulation.
Through daily dosing beyond one year with nearly half tolerating a single dose of 2000 milligrams of peanut protein or or over four grams cumulatively equal to approximately 16 times you observed 125 milligram median dose.
Of accidental exposures as reported in the Marigold stone.
A full two thirds of patients who tolerated less than 1000 milligrams at the end of the policy trial increased the amount of peanut they could tolerate after an additional six months of daily dosing.
In addition, we presented important quality of life data.
And at this for 2019 annual meeting back in May.
At Yankee, we shared results from two studies to assess the psycho social burden of living with peanut allergy.
Results from appeal to.
The first European multi country qualitative evaluation of the impact of living with peanut allergy found that living in fear of a potentially fatal reaction to peanuts has a significant negative impact on the quality of life.
Individuals of peanut allergy as well as their families.
At his sport, we shared results from a study that measured the burden of peanut allergy.
The study of U.S. adolescence, with peanut allergy found that more than half of study participants reported a visit to the emergency room for urgent care and one third required hospitalization.
As a result of peanut exposure in the prior 12 month and this was despite the fact that 100% of those surveyed reported actively avoiding peanut products.
In addition, recruitment for our phase three Preseident trial of Air one no one in the tree for the treatment of peanut allergy in children ages, one to less than four years old is ongoing.
And finally, the phase two trial of they are one on one with adjunctive to pull them out for the treatment of patients with peanut allergy, which is sponsored by Regeneron is also ongoing.
This trial hypothesize that administration of air one on one with two pillar Mab and interleukin 413 antagonists could accelerate the desensitization process and potentially lead to remission.
Of course, we will learn more when the data or read out.
Regarding our rig program, we began screening patients for our phase two clinical trial of hey, or to a one in hens allergy in July .
The phase two trial is a double blind placebo controlled trial in patients ages four to 26.
Diagnosed with an allergy to hens.
The trial is expected to enroll approximately 84 patients at 15 clinical trial sites in the United.
I will now turn it back to Eric for an update on financials.
Thanks, Dan.
We ended the second quarter in a strong financial position with 250 million in cash cash equivalents and investments compared to 296 million on March 31, 2019 in January of this year, we announced that we had entered into a 170 million.
Loan agreement with KKR of which 40 million was funded at closing and the remaining 130 million is available to draw upon satisfaction of certain borrowing conditions, which include the approval of the air when are one BLE.
We expect that this loan agreement plus cash on hand will provide us with sufficient funds to commercialize Arizona, one in both the United States and Europe and progress our coated pipeline.
For the quarter ended June 32019, net loss was $62.9 million compared to net loss of $52.6 million for a comparable period in 2018.
On a per share basis net loss for the quarter ended June 30 was a one dollar one compared to a net loss per share of 91 cents for the comparable period last year.
R&D expenses for the quarter ended June 30, with $32 million compared to 35.3 million for the comparable period in 2018. The decrease was primarily due to lower air one on one clinical trial costs, partially offset by higher regulatory cost related to the Aon one on one via la and M.A. filings and higher manufacturing cost for both at our one on one and air arent to a one.
DNA expenses for the quarter ended June 30 were 31.2 million compared to $18.6 million for the comparable period last year.
The increase was primarily due to additional employee related costs and external professional services as Amy and continued to build its infrastructure to support the potential commercialization of payout one on one.
With that I'll turn the call back to Jason. Thank you, Eric and so to recap we are within months of a potential FDA approval for our one on one for peanut allergy, which would mark the first therapy ever to receive regulatory approval to treat any kind of food allergy, a really exciting achievement for the entire food allergy community.
We are laser focused on ensuring a successful commercial launch of our one on one executing on commercial and medical affairs plans that will enable us to bring our one to one successfully to market shortly following its potential approval.
We expect a standard review for our one on one marketing authorization application in Europe .
Our one on one phase three Poseidon trial, and Regenerons phase two trial of our one on one with attractive depending MABA ongoing and add depth to our pipeline.
They are two a one egg allergy phase two trial has begun and we remain a strong financial position.
We are on the cost of potentially introducing the first ever treatment for full peanut allergy. So patient population that has been desperate for an approved treatment option. They could transform millions of lives we are well prepared and extremely confident in our ability to successfully launch our one on one.
As we conclude I would like to reiterate our gratitude to the many people who have been supportive of us along the way, including our investigators and their staff patients and their families. The food allergy advocacy community, the U.S. and European regulatory agencies, and our dedicated employees have enabled such tangible progress in such a short period of time, we will now open the call to take your questions.
Ladies and gentlemen, if you have a question at this time. Please press. The Star then the number one touchstone telephone. If your question has been answered are you risking move yourself and Vicki Please ask Bob Dickey.
Our first question comes from Charles Duncan of Cantor Fitzgerald. Your line is open.
Hi.
Jason and team thanks for taking my questions and congrats on the progress this year.
And looking forward to some.
Interesting progress in the near term had a quick question regarding the September 13th meeting Im wondering if youve received the briefing book, yet and your respective.
What are you focusing on when you are conducting the moc panels or what do you anticipate will be the focus of the meeting.
So Charles this is Dan.
We have not yet received.
FDA briefing book, we don't expect that for a little while.
The focus of the.
Both our mock panels as well as what we anticipate the focus of the advisory committee will be as evaluation of.
The efficacy and the safety.
Of our one on one and the overall benefit risk profile of the therapy and we are diligently preparing for.
Addressing any and all those questions.
And I think Charles maybe to add one thing is not.
What we expect FDA to be doing and what we have been doing ourselves is to look at the data.
And there's many different ways as we can and cutting it by.
As as many different ways, we can think top so things like age gender baseline peanuts specific high g. skin freight test sites et cetera.
To make certain that every population or sub population in our clinical trials has actually benefited from therapy and what we have found so far is that that is in the truth.
And that's around the encouraging thing for us as we go into the Advisory Committee.
Okay. That's helpful and then.
Possibly even taking a look at the older patients that were in the trials. There is that just completely not in this particular Andy are below.
So as you're alluding the trial.
Was conducted in patients ages four to 55 years old the primary analysis population.
Is four to 17, and we will be presenting data in the adult patients also when we look at.
Overall risk benefit in that population, we also see that it is positive.
It is important to point out though that in that population, we had a hierarchical analysis plan and the adult population was the first piece of that plan, but did not hit statistical significance from an intention to treat efficacy perspective with the P value of 0.07, so thats kind of why we stopped as we went on a hierarchy.
But of course, we will present everything that was in our phase three programs I think that are included in the B law to the Advisory Committee.
Okay. One last question regarding regulatory process.
In terms of the rethink quality of life data as well as continued in men Immunomodulation post a year of continued treatment that Dan alluded to how much do you believe that data will play a role.
In the agency's review.
You know for approval.
Approvability and then and then subsequently for repair.
Pharmacoeconomic column value calculus of how important is that.
So I'll take the first part and I'll hand, the second part over to Andrew.
I think the agency is going to look at the totality of the data that are provided to them, they're going to look at everything that has been submitted an RBL law and they will take all of that including quality of life into consideration.
In their in their ultimate decision.
We're confident that we have.
Good strong data to support.
A positive decision.
Hey, John It's Andrew.
Yes on the payer front, so in conversations with payers they have.
Indicated interest and understanding what that profile looks like of this product beyond year won't as we as we gather more data.
Moving forward and also.
Standing more about the quality of life clearly for the members of different payer plans the quality of life benefit associated with this product is substantial and so.
Further defining and.
Being able to articulate that is something that they've expressed an interest in the standings.
I think one other comment that that is relevant clinically as well as from a payer perspective. Charles is that we continue to be encouraged as we get more and more data and we know this now from the 18 month dataset and we look forward to seeing continue when we looked at the two year data set which is which is coming up relatively soon and that is the fact that both the benefit on the tolerability and safety profile of a 101 improves the longer patients remain on therapy. This is completely expects its what we observed with other.
Immunotherapies Immunomodulators as you get into the Immunomodulation phase of therapy and that is very encouraging for us to see that this remains.
True at 18 months after 18 months of therapy with a one on one.
Excellent. Thanks for the added information look forward to the September year to date.
Your next question comes from Keith.
Of Piper Jaffray. Your line is open.
Hey, guys. Thanks for taking the questions just a couple.
I think I've heard you guys describe now a couple of times this sort of.
80, 20 rule or I guess in this case 70 30 rule in terms of 70% of.
The kids are managed by this 1300 are paying looks like roughly 30% of.
Of the allergy space that you're targeting.
Just kind of curious that thousand Doc population I know you mentioned that the.
You know I think I heard you described them as having.
The.
Wherewith all in the in the desire to use.
Hey, our one on one but is there any can you give any more detail or color as to.
How you measure that specifically I guess the ability to.
You know to have these kids coming in with the kind of frequency, especially in the up dosing phase.
Yeah. Thanks for the question Chris.
First of all from a from a sort of a method methodology standpoint.
We can talk to analysis first of all a lot upscale full set of analysis is a survey of.
Hundreds of Alan just to understand the profile of the practice and at the same time, what the responses were in terms of their eagerness to prescribed a product like this and.
And how the current price assessment compared to that and then we extrapolated that to be able to say well. These are the sort of three or four key variables, which then mapped the level of interest in the level of readiness.
And we're able to then extrapolate to the broader number of practices based on that.
And in terms of what does that practice sets of look like flow to sort of a forex model framework that we're thinking about which is staffing should drilling space and support and so.
From a staffing standpoint, clearly needs to be the appropriate staffing sets up the right mixture of the challenges nurses and office support to be able to.
To administer the drug as the as they currently do with Arrow allergy shots from a share drilling standpoint understanding during the week.
How they would.
Coal for this is that practice, so would it be certain times during the day or would it be for example, we can clinics where they would.
Set themselves up to be able to to put you around this product from a space standpoint do they have.
An area waiting room comment either a common waiting area or specific individual waiting area. They prefer whether child can be there for the the prescribed observation period, and then from a support standpoint, what sort of things that need to be in place to make sure that they're able to health tool to the patients and the caregivers.
So that they understand the need to take the therapy us us prescribed into it to stay on the products will be up dosing phase so that sort of for US model is the framework that we have been thinking through and as we put together some of the solutions that are going to enable Alan just both enough initial 1300 cohort, but also beyond help short and be successful. That's that's the sort of model that we have in mind.
What's also interesting Chris is that these tend to be practices, where they are already doing relatively high throughput subcutaneous immunotherapy for predominantly arrow allergens.
And if you think about that in the initial six month parrot, if you're going for subcutaneous immunotherapy for Aero allergens, you're having a weekly visits for injections, where they are one on one its biweekly and so our up dosing period requires half as many visits in that six month period as a required for compared to subcutaneous immunotherapy.
That's great color. Thank you and I guess, maybe as a follow up so I guess some as I hear you guys described this it seems to me like there is a very receptive market right for a one on one but.
That would if you were not paying attention to what you guys are describing and just reading some of the.
Editorials for example, there was a land set piece recently and even the New England Journal letter to the editor.
You know there's a there's there's there seems to be at least.
Some degree of resistance to all IP and it looks and sounds like air one or one sort of gets lumped into that.
So I guess maybe.
I don't want to put you on the spot, but maybe is this just a loud minority who have seem to get it somehow microphone with respect to this or what's your perspective here as to why these.
We're seeing some of these higher profile yet.
Limited in number.
Negative opinions on the whole concept.
So this is Dan.
I don't know what is the motivating factor I can tell you that some of the things that they are pointing out are not unique at all to oral immunotherapy for these are the types of.
Of allergic reactions that one typically sees with immunotherapy product. Unlike any other drug this is a drug where you're giving people the very thing that they are working.
In order to do sensitize that youre going to put some allergic reaction most allergic reactions tend to happen a predictable times after the dosing they are generally 99% mild or moderate in severity.
And they are readily manageable.
And this is.
In contrast to the.
This is in contrast to.
The unpredictable nature unpredictable severity associated with Occidental exposures.
And so.
I'm.
I don't really know what the motivating factors are but I think that allergan.
Who.
By and large are very comfortable with administrator.
Any type of immunotherapy are going to have.
No problem, managing or one or one desensitization treatments.
Excellent. Thanks, Thank you.
Okay.
The next question comes from Liana Mccracken of Wedbush Securities. Your line is open.
Thank you for taking my question.
Can you.
Tell us different differences between treating patients for egg allergy and peanut we've heard a lot about peanut and AG is new to us.
Can you talk about differences and has regeneron, giving you any idea about data timing for the combination of air winter when you fill in that trial.
So.
As Dan I'll answer the second one first.
Regeneron is pretty.
Tight lipped about giving any type of guidance.
They are enrolling their study.
And when it is it is a.
An 18 month study and it will read out.
Whenever whenever they're down I can't tell you what the data center.
With regard to allergy in contrast to peanut allergy so egg allergy is.
Also in major food allergy certainly here in the United States and in Europe .
It is a.
It is actually the number one food allergy in Asia.
Unlike peanut allergy where.
If you are five or six years old and your peanut allergic you will be peanut allergic for life wears so about 80% of peanut allergic children will habit for life.
In in contrast, with egg allergy, if youre allergic to eggs that.
One or two years old.
By the time, you're 15, 16 17 years old you have about an 80% chance of spontaneously resolving.
There are really two forms of allergy theirs.
Allergy to too.
Okay albumin the law big White.
And there is also allergy too.
Baked products and.
Patients who are both well.
Again, big Big allergic and B the more severe in refractory patients we will be enrolling both groups in our phase two study and we're going to be looking at the ability of air to over one to confirm meaningful desensitization in either population.
And the clinical trial design for our Phase two program is almost identical to the phase two program for our one on one.
The only subtle differences Don alluded to is that there are two different kinds of egg allergy and so we do two different kinds of.
So it's a challenge test at entry and the exit from the study right.
And also the question for Eric could you kind of went out and when you are talking about cash runway and.
How long is your cash less.
Well so what we've said is that between cash on hand and.
Access to the remainder of the KKR trashes.
Assuming were approximately correct with our internal forecast that the commercial launch of Arizona, one in both the U.S. and Europe and the funding of our pipeline as we currently conceive of it should be coverage.
Not like two years.
That slide care fully covered.
Okay. Thank you.
Your next question comes from Zack Wiitala of Roth Capital Partners. Your line is open.
Hi, guys. This is Ed, but just had a couple of questions. Here. So you mentioned that six clinical site inspection had been done in addition, Q and expression of cracks and Joe why don't you know if you anticipate any additional inspection.
Hey, Jason.
It's it's hard to know Sta kind of course do additional infections. If they would like to these are all the inspections that they have thus far informed us about.
And there are no findings in those inspections that we think will impact to either the likelihood of the timing of approval.
Okay, and then just a follow up to that.
In terms of commercial or commercial capabilities. Our production there just kind of lunch now and do you anticipate running into any issues Youre. It you know what what are your production capabilities and how quickly can these products get too.
Patients.
So we are manufacturing our commercial lots as we speak in fact, Weve already started releasing some of the lots and.
We'll have product available if and when we get approved by the FDA.
And as we said, we'll be launch ready in the fourth quarter and that of course includes availability of product.
Okay, maybe give you a bit more specific we think it'll it'll take us two to three weeks to get product.
Two patients once we got approval.
Okay, and then just the last one year.
You had this question with Perry.
Are you running into issues, where they feel from what Mary to what I'm sure. You know published or you think it they're not really referencing that in their conversations.
Well, let me start by saying no, they're really not referencing an oil in conversations and just to add a little bit of perspective to the to the ice to report so.
First of all.
We were deemed cost effective at both 150, k. the quality level and the 100 Cape equality threshold as it is the output of the report.
To sort of put that in some sort of context, we looked at a recent bernstein analysis that said that.
20 out of 76 products that they had looked at across 24 different therapy areas.
Only 20 of those 76 reps redeemed cost effective on Isis, so getting to the point where.
The.
I said considers your drug to be cost effective at those thresholds is very uncommon an unusual thing and so.
To be to be deemed cost effective as an output of the report was encouraging now that said.
On focusing on that in any of our conversations.
As I look at the other aspects of that report what I think was was interesting was that.
Yes, it was talking about the fact that.
Immunotherapy.
Needed some.
To be specific talked about promising were inconclusive.
Evidence ratings and so we said from the very beginning as did most people involved in the food allergy sphere that the.
The report itself was premature and they seem to have sort of reinforce that by some of the conclusions by saying that it was still something whether they need to see some additional evidence and so we also provided I should add some information in confidence that was relating to some of the longer term effects that Jason and Dan alluded to earlier.
Those those were data and information they chose to not include in that model and we're actually excluded and so how they included that then it would have been interesting to see if that storage. Some of those same conclusion. So summary statement is we were pleased that were considered to be cost effective cost effective because of something that rarely happens when.
Products are being evaluated by Lisa.
And at the same time, it's not something that pays have been bringing up in conversations with us.
Thanks for the clarity guys appreciated.
The next question comes from Kennen Mackay of RBC capital markets. Your line is open.
Hi, This is Justin on for Ken. Thanks for taking my question, just sort of as you generate more extended maintenance dosing data out beyond one year I was wondering how much of a focal point you expect that to be at the Advisory Committee meeting in September and Additionally.
How much of those data you've been detailing with payers and what sort of some of the feedback has been there. Thank you.
Sure so.
The the rules of the game with the with the AD Com is that we really can only discuss data that have been presented to us in the BLE.
And so we do have.
Extended safety data that have been submitted to the BLS and we will include those in our conversations with the Advisory Committee.
We were just were just not allowed to.
Present data that hasn't already been reviewed by FDA.
In terms of the conversations with payers as we mentioned earlier the the profile of the product.
Seems too.
Improve over time as the data looks more and more interesting with so to subsequent readout.
The payers are interested in seeing that.
But also because of the fact that they're interested in understanding what our solutions ought to help patients stay on therapy, and so we've been talking with them about what it means to go through the dosing period and also the importance of staying on through the therapeutic dose and beyond so that patients can start to realize the benefits that come from the therapy and staying on longer and longer and so.
It's been encouraging and obviously as the data becomes more available we'll have further conversations about that and the the thing Thats intriguing focus at the moment, both clinically and of course, the payers is given that we've already seen clinical evidence of Immunomodulation that 18 month, most notably in the reduction in the skin test size.
Is that how long do we have to treat these patients before if it happens some of them start going into clinical remission.
And that's something that we'll see as we continue to follow this cohort over time that is of course extraordinarily interesting to to all involved.
Okay.
Yeah.
Our next question comes from Edlain Seeger Man of Credit Suisse. Your line is open.
Hi, guys. This is adrian on for Evan. Thanks for taking my question I was wondering if you could provide any more color on what sort of co factors you've seen in the totality of the EUR one on one data and is the expectation that we should.
Expect a label, which is that either identifies or highlights. These co factors. Thanks.
So the.
I'm, assuming you're referring to the co factors that are associated with some of the systemic allergic reactions. If that's the case you know we we certainly have identified a those in our protocol because they are not unique to oral immunotherapy with a with a a food product but are rather the same co factors that you see for every other form of immunotherapy and.
You know I don't I don't know that we will certainly engage in conversation with the FTC I don't know whether it'll be in the label or if this is just part of the general knowledge and understanding of the allergy community and how do we think about indication something I said earlier is really important and that is that however, we cut the data every population he was treated in our clinical trial program benefits and so.
Our expectation is that they shouldn't be any limitation on the on the indication.
Thanks.
Our next question comes from Paul July of Goldman Sachs. Your line is open.
Hi, This is Ken Jenkins on for Paul Oh, We were just wondering as you approach the commercial launch if you've given any thought a partnerships already sort of other.
Partnering goodbye.
So we've been very clear that our plan is to commercialize our self in the United States I think we've given a little bit more color today to show that we are very ready to do that and continue our buildout.
With regards to other geographies, we are indeed open to partnerships, we have had some external interests.
Over time, I think our our hurdles are quite high because we want to make certain that.
The launch prep in these countries gets the attention it needs and we certainly wouldn't want to do a partnership that puts our one on one into an into an existing field force that hasn't been built specifically to launch into the outages community.
And so what we what we're doing in Europe , specifically at this point is initiating the own our own build out of a commercial organization and if at some point a partnership deal that really doesn't make sense and that addresses our unique needs to be tailor built for allergists than we would be happy to entertain that.
Thanks, and then on the iden drought pediatric trial can you just give us an update on how enrollment is progressing and how we might think about it timing pushing for supplemental filings.
So the study began enrolling patients.
And we continue to open study centers.
Throughout the United States.
And we anticipate that.
The study will be fully enrolled.
Bye.
Probably the middle of next year sometime.
Great. Thank you.
Our next question comes from Derek I care of Stifel. Your line is open.
Hi, sorry about that bill on for Derik.
Can you guys just quickly give us some color on.
What your expectations are for.
Real World adherence once you've launched and then you have any thoughts on how physicians might handle patients who.
Go off therapy, and then decide they want to return therapy will they have to start the upto seeing over again or will they be able to just start back on maintenance things I'll take I'll take the first bit. This is Jason I'll have Dan the second bit so in terms of of real World utilization then and.
Side effects and I think you are getting a little bit about how many patients are going to be successful through the up dosing. We know in clinical trials. It was eight out of 10 about 80% of patients.
It's worth noting that in our clinical trials.
But we also presented data on that we did not allow the concomitant administration of anti histamine noted we allow the concomitant administration of.
PPI or H to block is to reduce gastrointestinal events. Additionally, we had some fairly tight guidance around up dosing.
Trying to keep to about two weeks at each of the up dosing levels and all of those things will make a difference to the up dosing period to the severity an occurrence of JPY.
Side effects and those mild allergic reactions that Dan talked about earlier, so we anticipate that in the real world data should be very similar to the clinical trials or potentially maybe even a little bit better we'll have a better answer for that when we when we actually get the Poseidon data because in the younger children, we are allowing.
The concomitant use of anti histamine.
To just really in a clinical trial setting see the difference with that mix.
And as for the question.
Stopping and restarting.
We had specific guidances were built into our clinical protocols on how to adjust the dose based on how many days of mis dosing one had.
And we have real I mean, we have empiric data.
On the success of that.
We intend to include that in our proposed package insert.
And those obviously will ultimately be the subject of discussions with the FDA as to.
How they show up in the package insert.
Great. Thanks.
Okay.
I am showing no further questions at this time I would now like turn the conference back to Mr., Jason Dallas.
Thank you ma'am and thank you everyone for joining us. This afternoon, we look forward to providing you with further updates on our progress in the future and have a great evening everyone.
Ladies and gentlemen. This concludes today's conference. Thank you for your participation and have a wonderful day you may all disconnect.