Q2 2021 ChemoCentryx Inc Earnings Call
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Good afternoon day it seems your operator you conference.
To begin please continue to standby.
Once again and this is you're out there and your conference is about to begin please continue to standby.
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Yeah.
Okay.
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Yeah.
Good afternoon, and welcome to the chemo centric second quarter 2021 financial results conference call.
At this time, all participants are in and listen only mode. Later, we will conduct a question and answer session. As a reminder, this conference call will be recorded.
I would now like to turn the call over to Lee Roth of Burns Mcclellan Mr. Roth. Please go ahead.
Thank you Paul Good afternoon, and welcome to the Chemo centric second quarter of 2021 and financial results Conference call.
Earlier today, the company issued a press release, providing an overview of its financial results for the quarter ended June 30th 2021.
And a copy of this release along with a few slides that you may find helpful. While you listen to the call are available on the Investor Relations section of our website at Www Dot chemo centric dot com.
Joining us on the call today and as Dr. Thomas Schall, President and Chief Executive Officer for Chemo Centrex, who will review the company's recent business and clinical progress. Following his comments, Susan <unk> Executive Vice President and Chief financial and administrative officer will provide an overview for the company's financial highlights for the quarter before turning the call back over to Tom for closing remark.
Next to Heath, Tosspot Executive Vice President and Chief operating Officer, and John Thomas and Susan for Q&A session.
During today's call will be making certain forward looking statements as explained on slide 2 of the presentation. These forward looking statements are based on current information assumptions and expectations that are subject to change and Boston number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements. These risks.
And are described in the company's filings made with the Securities and Exchange Commission, including our annual report on form 10-K filed on March <unk> 2021.
You are cautioned not to place undue reliance on these forward looking statements and chemo centrex disclaims any obligation to update such statements.
In addition, this call contains time sensitive information and accurate only as of the data and for live broadcast August 9th 2021, Chemo centric undertakes no obligation to revise or otherwise update any forward looking statements to reflect events or circumstances. After the date of this live conference call with that it's now my pleasure to turn positive.
Sure Tom.
Thank you Lee and good afternoon, everyone listening. Thank you for joining us on our second quarter 2021 conference call. Please move to slide 3 and our presentation.
Many years ago, and keep a centrist embark on a voyage of discovery and development with our lead candidate of Aqua and the treatment of income associated vasculitis in order to see if we might improve the lives of patients with that rare, but often oregon, threatening or even life threatening disease.
Our science, which was and is unlike that and any other sponsored showed that the C..5 day receptor inhibition might constitute an entirely new mode of therapeutic action in the treatment of debt disease.
This motive action was a specific way.
Arresting complements driven inflammatory cells that are at the very core of tissue and Oregon destruction.
The vasculitis.
This mode of action is a highly targeted approach, which was and is attempted for the first time and this disease and quite unlike the broadly immunosuppressive regimens that have been used for nearly 50 years and are still in use today.
Urged on by anchor experts and importantly to anchor patients, we applied ourselves to try to bring something new and useful to the treatment paradigm and a disease.
As most of you know we progressed ivanka pan through 2 phase II trials, and then a pivotal phase III trial.
<unk> phase III trial advocate represents the largest and longest randomized clinical trial ever conducted for a new molecular entity and this relatively rare, but often deadly disease.
The results ever and the trial, we believe were positive across many therapeutic metrics and those results. After careful review by peers and data analysts were published and the New England Journal of Medicine.
1 week after I reported to you on our first quarter results and FDA Arthritis Advisory Committee unmatched chips withheld and was essentially deadlocked on the key questions posed by the FDA on our backlog and for use in income.
Eric.
While disappointed by that discussion we took to heart. The stated idea that we had not yet clearly enough explaining the findings and their significance to the agency and to the community at large.
We wished to make clear that of aqua and could potentially be and additional therapeutic tool to place in the hands of patients and their physicians, whose current treatment armamentarium is quite limited and the.
Fight against income vasculitis.
Discussion and the Advisory Committee meeting also illustrated certain dynamics facing all of US when medical innovation may offer new hope and and orphan disease.
How do you test and new drugs and how do you assess results and an area of major unmet need and when the scarcity of patients limits. The realistic size of the trial and B how to conduct such a trial given that pragmatically. It also needs to reflect the practice of real World Medicine, if any.
1 is to enroll and then.
We as sponsors and innovators and the orphan disease space struggled with these questions all the time as to our colleagues and regulatory agencies because to be clear and a clinical trial and an orphan disease available patients are not only rare by definition, but they realistically and ethically expect.
And must have access to currently available standard care practices.
Still the trial must rigorously test the key variables of what the new drug can achieve.
Such conundrum it must be solved if we are to offer these patients new benefits of additional efficacy better safety or a combination of both.
Every patient able to enroll and an orphan disease trial becomes fundamentally.
And since enrolled patients are limited the number all of the data 1 can glean from each and every 1 of those patients must be carefully harvested and considered.
This can sometimes make for complicated trials.
But the luxuries of non orphan disease trials for example, the feasibility of doing larger studies and additional trials are typically simply not available and rare disease.
Such where the dilemmas and such was the nature of the discussion underlying the advocate trial.
Discussions that we had with experts.
With regulators and with patients before we launched the trial.
These discussions were productive and to US represented a victory of collaborative thoughts.
After the May Advisory Committee meeting, we engage the dialogue with the FDA to learn what additional information from the advocate trial would be useful to them and reaching their decision and to share relevant apocope and data from other disease areas.
Agency was helpful and clear and their information requests and we endeavor to provide additional necessary data and analyses in order to attempt to chart, a clearer understanding and Pat.
On July 6 we announced that the additional information that we provided to the agency was deemed by the FDA to be a major amendment to the NDA for <unk> and anchor vasculitis.
We commend the agency for that judgement and fully support the extension of the due for target date to October 7.
There is much important information to be digested.
And all parties wish to reach correct conclusions.
We stand ready to work productively with the agency during this review time and beyond.
Looking beyond that time should a license to be granted and I'll cover 7 we will be ready for a potential U S. U S lunch.
We have established network of specialty pharmacies and distributors.
We have been training, our product representative professionals and determining location and characteristics characteristics of the highest need demographics.
We've been talking with patient organizations and conducting disease education programs.
And we have engaged with payers and allowable interactions of information exchange with the goal of building a strong patient access program to support patients and clinicians and the early months before formulary decisions are made.
So again should the FDA decide positively on the value of abacus and in this disease area, we will be ready as we have made considerable investments and being prepared to bring the drug to patients.
These investments represent not only that considerable type of time people and money over the last couple of years.
But and investment and fundamental innovation, which goes back nearly 20 years.
All of this has been done and the firm belief.
And we might improve lives and even save lives.
We stand by that conviction.
Outside of the U S. We expect regulatory decisions and our barkla Pan and anchor Vasculitis later this year from the Europeans European Medicines agency as well as Japan's pharmaceuticals, and medical devices agency.
Our partner B for pharma is making similar preparation for commercial launches in Europe and Japan.
Should have a co pay and be approved and the territories licensed for commercial distribution day by for it and its sub licenses.
<unk> will revert to us royalties teens to mid 20%.
Potential net sales of 1 aggregate net sales line.
Turning to slide 4 we are well underway and our strategic aim to makeup aqua pan pipeline and a drug.
With phase II data supporting its potential and <unk> and and the debilitating and disfiguring skin disease, hidradenitis suppurativa or Hs.
For for US the conviction that a backup and can help patients who have major unmet need stems from our understanding of the detailed advocate data and the fact that such day to see and interconnected with observations and other diseases.
Increasingly we find evidence for pathology driving role of the <unk> receptor and other debilitating disorders. These are disorders, where we believe that a backup and novel precise targeted mechanism of action could add to the current care and providing additional <unk>.
Options for physicians and patients.
For example, and Hs Hidradenitis Suppurativa, we previously reported top line results from our phase II Aurora trial.
With a subgroup analysis, showing that and the most severe form of Hs the pre specified Hurley stage III patients for whom almost no effective therapy suggest Apocalypse had demonstrated a statistically higher response and placebo after 12 weeks of therapy.
Which is guiding our further clinical development.
Increasingly our work with <unk> provides a strong mechanistic rationale for the therapeutic effect of a backlit pan and early stage III and thus the underpinning of our phase III trial approach.
While it is well known that extensive sub dermal tunnels are a signature feature of Hurley II versus the more moderate early 2 stage disease work here at <unk>, having now examined many hs patient biopsy sections suggests that even where tunnels exist and the less severe for.
And my early stage to disease, the very architecture and.
And the immune activation status of these structures is different.
We see 5 a and C..5 day receptor seeming to play and a larger role and the early 3 disease.
We hope to present, our continued work on the C..5 day <unk> receptor expression and early stage 3 patients at the upcoming American Association of Dermatology meeting and other dermatological symposia this year.
As referred to and slide 5 the Aurora Phase III trial identified a and effective dose b. The patient population that we should target and a phase III trial and see that we can do so with good safety and based on the evidence to date.
We aim to discuss with the FDA our plans for a pivotal phase III trial of <unk> and patients with severe Hs.
Our current thinking is that this will involve approximately 3 to 400 patients across 2 arms using the hidradenitis Suppurativa clinical response score I score as the primary endpoint at 12 weeks with an open label follow up period.
Yeah.
With an estimated 30 to 50000 patients and the United States with early stage III disease. This represents another highly significant indication for a backup plan and we continue to pursue orphan drug designation for her at least stage III Hs patients.
We noted also a connection between kidney benefits seen in the advocate trial, the Banca vasculitis with the accolade clinical trial of abacus and for the treatment of <unk> allowed for Pete where C III cheap.
Both trials showed improvement and kidney function as measured by estimated glomerular filtration rate for Egfr.
Slide 6 reviews, the results dramatically showing how our backlog and treatment and <unk> led to an improvement and the estimated glomerular filtration rate as opposed to deterioration and patients and the control arm.
Egfr is what most nephrologist, what's considered to be the gold standard for measuring kidney function.
And we find it encouraging that of Aqua Pantryman produced these results in 2 different renal diseases.
Another interesting findings from the accolade trial is the change in kidney fibrosis progression seen in patients and the placebo arm after they crossed over to the tobacco and therapy.
The C..3 key Histologic index, Denise Chronicity score went up during the first 26 weeks for patients on placebo.
Evidence of the progression of kidney fibrosis, and then came down and when those patients were switched to <unk> and the second 26 weeks as shown on slide 7.
We are planning to meet with the FDA later this year to discuss evidence of clinical benefit from <unk>.
The kidney improvement effects seen in both anchor vasculitis and C. III G may bode well for our future plans for debacle Tan and lupus nephritis for L and.
Uncontrolled complement activation has been implicated and kidney destruction and Elliot.
And the disease and supporting controlled with broad immuno suppression.
So here again, the precisely targeted novel Potently anti inflammatory mechanism of action of about per pad may prove to be an important differentiator and therapy for Ellen.
Our timing for launch and clinical development is now the first half of next year 2022 and.
And we plan to develop and a 2 step process first to demonstrate the early effects of a backup plan and are focused patient groups and then expanding to a population of the scope size and length to provide a definitive findings regarding <unk> potential and this underserved indications.
With an estimated prevalence of 65 to 100000 patients from the U S. Lupus nephritis is yet another orphan disease targets for a barcode scanner.
So our ambitious plans comprising the pipeline and a drug strategy for Apocalypse and remain entirely undiminished and.
And it's fair to say also that because of our focus on the anchor vasculitis NDA. However.
Execution overall and the other non Inc. Abacus and indications is taking a little longer than we had originally planned as we await further clarity on October 7.
As important as Ivanka Pan is to our efforts to improve patients' lives with orphan and rare disease.
There are also other novel therapies, and the <unk> pipeline of which we are justified viably proud of it.
Please see slide 8 as we touch briefly on our novel orally administered small molecule checkpoint inhibitor for the treatment of cancer.
<unk> 505, 9 is a novel orally administered and PD, 1 PD lone interaction inhibitor.
And as referred to on Slide 9 we launched our phase 1 clinical trial of <unk> with site Activations. Shortly before the end of Q2. We are now pleased to report that we have dosed a cancer patient in this trial and we are already accumulating early data on such things as the pharmacokinetics.
Yes.
We remind you of the promising preclinical data and including in vivo tumor data reported at the American Association for cancer Research earlier, this year, where tumor shrinking and tumor remission with <unk> $505.9 was clearly evident and our model systems.
<unk> 9 we believe based on our in house work is differentiated from the very few other small molecule PD, 1 PD lone inhibitor programs by having better drug like properties direct comparisons suggest <unk> $5.9 is more potent and.
Has significantly better in vivo coverage.
Potentially leading to cumulative advantages, which may be up and order of magnitude better or more and.
And then other candidates.
We look forward to the results from this study and we will keep the community posted as to our progress.
I will now turn the call over to Susan to outline our financial position.
Thank you Tom our second quarter 2021 financial results for included in our press release today and are summarized on slide 11.
Revenue was $1.8 million for the second quarter of 2021 compared to $49.4 million and the same period in 2020.
The decrease in revenue from 2020% and 2021 was principally attributable to the acceleration of revenue recognition in 2020.
Associated with the decision to discontinue development, and TCE insulin and Florida zero and focal segmental glomerular sclerosis or SGS.
Research and development and expenses were $20.9 million for the second quarter of 2021 compared to $18.8 million and.
For the same period in 2020.
This increase was largely into the manufacturing and commercial supply and anticipation of the launch of a marker pens and the treatment and maintenance and you see and escalators and higher research and discovery and <unk>.
Please note associated with the development and <unk>.
And I find it.
<unk> 9 <unk>.
We administered small molecule checkpoint inhibitor.
These increases were partially offset by lower fees to release and extended is the completion and muscle pain and grow and phase II clinical trial in patients with <unk> and <unk>.
Continuation of further clinical development, and H and SSG and in 2020.
General and administrative expenses were $19.7 million for the second quarter of 2021 compared to $10.3 million and the same period and 2020.
This increase was primarily due to higher employment related expenses, including those associated with our launch readiness efforts and higher professional fees.
Lastly, we closed June 32021, with $410.6 million and cash.
And in net.
Tom.
Thank you Susan.
To summarize our next steps with about and as you can see from slide 11.
We have filed with the FDA is considered a major amendment to our new drug application or NDA and the new targets to do for the date goal date is October 7.
Should the FDA granted <unk> license for Barco Pan and therapy <unk> associated vasculitis.
We believe we are thoroughly prepared for potential commercial launch soon after this date.
We aim to meet with the FDA later this year on other abacus and related matters, including a discussion of results of the clinical trial of <unk> and the treatment of <unk>.
Also our intention to launch a phase III trial of abacus and and early stage III hidradenitis suppurativa patients as well as our intended study of a vehicle and in lupus nephritis.
Importantly, apart from the <unk> program and our pipeline continues to develop.
We are now and the clinic per plan with our novel and we believe best in class orally administered small molecule checkpoint inhibitor.
Our aspiration is to make <unk> by $5.9 a part of the next wave of innovation and cancer care.
As Susan has just indicated we are and a strong position financially to reach key regulatory and clinical milestones.
Strength of conviction matters.
We believe conviction based on evidence is true science.
We strive to be ever more clear unrelatedly evidence showing the potential of <unk> to help people with rare but devastating diseases.
We realize that the science and medicine around such diseases as frequently but necessarily complicated.
We appreciate those that have taken the extra time to understand what we believe can be a valuable new tool to add to.
And to the all too few options that patients with such diseases as anchor assisted <unk> associated vasculitis have so far.
Every patient accounts every decision we make matters in terms of their well being and their lives.
Just like you and me, but suffering from rare diseases are counting on us. It is why we continue to act upon our firm belief and and.
And intervening and the complement pathway and its remarkable potential to help patients with rare devastating diseases.
Resolve and resilience lay up the core of human centric.
Our mission is to help people.
We won't stop until we're done.
Yeah.
I will now turn the call over to the operator for your questions operator.
Thank you Sir.
We will now begin the question and answer session. If you would like to ask a question. Please do so by pressing star 1 on your phone once again, that's a star 1 on your phone to ask a question and then.
Please limit yourself to a question and a follow up.
Please standby, while we compile the Q&A roster.
Yes.
Your first question is from Steve <unk> with Raymond James.
Hi, This is Ryan Deschner on for Steve <unk>.
Wanted to ask will you or have you submitted additional data after the data package that was set in July and are you.
You are currently engaged and labeling discussion.
And so thank you for the question of the package, we sent and July was very comprehensive indeed, I won't comment beyond what.
Information exchange might've occurred beyond that.
Since our conversations with the FDA are obviously very important.
And to escalate will.
Discussions again.
Need to very much respect the fda's need to very thoroughly and confidentially engaged and all manner of disc.
Discussions and meeting around the label, so I'm going to respectfully us put aside any questions on label discussions and label negotiations at this time.
Okay.
Appreciate that and I can understand that and then.
And then real quick.
Can you shed some light on which key secondary efficacy endpoints will be focusing on and the phase 1 and subsequent studies for CTX and $5.59 and is this an adaptive trial progression.
It is well it's a it's a bayesian.
Trial design and so we certainly are going to be looking primarily at safety pharmacokinetics and pharmacodynamics.
But all of the folks and the trial has some form of cancer and so we will be secondarily looking on <unk>.
King at tumor progression as well and we'll have more to say about the details of that trial as soon as we get through this very first step.
And can talk a little bit more about.
Coverage and pharmacokinetics.
Excellent. Thank you Thomas.
Thank you.
Okay.
Your next question is from Michelle Gilson with Canaccord.
And is open.
Hi, Thank you guys for taking my question.
I was hoping for a box and in a day you could help us understand a bit more the additional data that you submitted you mentioned the safety data from Hs and <unk> trials and.
And my understanding your comment earlier correctly that the FDA specifically requested these data from you.
Or was this I guess interaction more a response on your part to the issues that the FDA identified or for express.
Thank you Michelle So we had a lot of active dialogue and engagement with the agency. Following the Advisory Committee meeting I think we developed a much better understanding of all of their issues and concerns.
So our amendment was prepared with those kind of learnings and mind. So for example, yes, we thought it would be very useful.
To help you.
And I understand there was additional safety data from <unk> in the Aurora Hidradenitis, Suppurativa trial, as well as and the epilogue accolades and <unk> trial. So we supplied debt.
Couple of other issues that came out at the AD com, which we very much wish to clarify help understand the use and analysis of non study supplied glucocorticoids I E. Those those other outside the standard steroid taper that we supply and the kit.
And the relevant and Sun glucocorticoid toxicities of those.
Credit quite so overall and proactively addressing some other concerns and sort.
The proposed label indications and such like.
So to the extent and who asked what and who proactively gave us it's kind of obscured and just the richness and extensive nature of those discussions and back and forth, but suffice it to say I believe that.
All of the items that we added including the safety data will help the agency have a clearer picture of the properties of the drug and help them make their decision based on the fullness of the day.
And if I can.
And just 1 more.
Thank you Mei.
A few years ago, you actually submitted PMA and had that exact day and went through.
For.
For the PMA process.
And did that I guess.
And the process give you a better line of sight.
And through that.
And to see jumpy.
You know in terms of what matters to the EMEA around these boxes and submission and AZ do feel pretty confident that you understand the emails I guess use the data and.
And of the program as a whole.
From I guess your process a few years ago.
Yeah, you are quite right Michelle a few years ago based on the 12 week phase II data from the clear trial, where there was very good evidence debt.
We could with a backup and eliminate.
The daily oral prednisone taper at least through the 12 weeks that we were using.
The drug and the trial, we put in.
Conditional marketing authorization approval application that was evaluated extensively by the EMA.
So we got a lot of excellent experience from that I do think it's been helpful and B and may a or the full marketing authorization approval process, but to be clear at the time, we were controlling the CMA as as <unk> centric subsequently now when we license.
For commercial rights to be for pharma and their collaboration with Fresenius through before international or people from.
Before for <unk> medical care renal pharma.
They're technically responsible for that filing and so you would have to ask them about details about whether they found our previous experience and the data and knowledge that we were able to and parts of them to be useful, but certainly I think we had some major excellent learnings from that and.
And with very <unk>.
Technical areas and CMC and so forth I thought it was invaluable experience for the program.
Okay and for security you know what.
What is the gating factor for a.
A question and FDA meeting are you waiting for data to accrue or something else before you do meet with the FDA.
Yes with absolute.
Candor about this and I alluded to it and my remarks, we just would like to have more clarity on on what's going on with anchor vasculitis, we don't want although <unk> and with a different division per se.
Would prefer the agencies through all divisions to not get distracted with any other applications or intense discussion right. Now so clarity on October 7 is I think what we're looking for and once we have that clarity.
We'll then decide exactly how to engage but we'll be very.
We're ready to do a number of things as quickly as possible.
Okay well. Thank you so much for taking my question and good.
Good luck from Keybanc.
Thank you for over 7 obviously our cornerstone.
Yeah. So.
[laughter] area.
And maybe it needs a day.
<unk> always pleasure talking with Michelle.
Your next question is from Joseph Schwartz with SBB Leerink. Your line is open.
Hi, everyone. Thanks for the update and for taking my question.
I was.
Just hoping to ask when you say that you'll be prepared to launch of our coupon if it.
We're too.
<unk> licensure.
And since it's been a little while and obviously a lot of happened.
Between the company and the FDA I was wondering if there's been any change too.
And the positioning of the bank upon and AAV.
Are you for your prepared for more scenarios now.
And is there any change to the range of a value and pricing that you think that drug might have and the.
Quote unquote real world if it is able to day.
And the approved.
Very good questions, Joe I'll answer some of them.
Alright, generally, but I think hopefully and formidably listen there is still and immense need for this kind of therapy and the anchor associated vasculitis community.
A delay of 3 months I don't think changes fundamentally that demands.
And all will depend of course on what the FDA decides if they decided to give us the license and that is of course their decision.
And then of course the details of.
And how the what the label looks like but having said all of that.
I don't see big changes and how we position the drug at all physician input continues to be very strong, but they would love to see this drug approved so that they have an additional tool to use the patient input continues to be very very strong they would very much like.
To see this drug approved they feel they have very limited options and they do I mean, theres only been 1 drug really approved for this indication and the us and Thats Writeups and Mab, which is always use in combination with as you know various doses of glucocorticoid typically quite high doses over time.
Look and said that was over a decade ago, where that approvals for staff and so I think people feel it's high time to think about additional drugs that could be used for good purpose and this indication, particularly 1 is highly differentiated and just debacle.
And remember.
Everything we do and debacle Pan is really quite different and what's done with glucose.
Glucocorticoid effects for cyclophosphamide effects for premise I'm, sorry, or a rituxan map. This is something new and could be again, a very powerful added tools and the arsenal. So I don't think we are really modifying our position very much at all.
Thank you for all the context and good luck guys.
Thank you.
Your next question is from Donald Hall with Stifel. Your line is open.
Hey, good afternoon, and Tom and Susan just to tag on from Stifel. I guess, just going back to the Avago Pan story on anchor.
I don't know if you cannot actually answer this question, but I'm just not very familiar with the process. So with the could do for extension can.
Can you speak to the frequency of dialogue that can still happen between you and the FDA and whether or not and those discussions is it purely and limited to you and the FDA or can you actually get some K well participation.
To your point to try and provide a little bit more context around the clinical need and the merits of the drug and then a follow up is.
Going back to the safety data that I'm, assuming has been submitted as part of your supplement.
The data cutoff has been 28 weeks and 12 weeks for ore and accolades.
What was the most recent data cutoff with a safety database that your supplements for the agency.
Guess tag on thank you, we were able to prioritize the.
Full trial periods through the active dosing for Aurora analyze that data and be able to take that those stages. The agencies for those go out to 36 weeks. So that's been very helpful.
And those data.
Principally reflect what I reported already a topline at 12 weeks very very few kind of Smes and that trial.
We believe reflecting the fact that the drug and they should be fairly safe with very few off target effects.
But also the Hs trial population is quite a bit younger and they have far fewer concomitant medications and they are generally speaking other than this terrible skin element, which is not to be diminished in any way, but generally speaking they are somewhat healthier so again.
The anchor patient population very complicated as many concomitant medications and generally have many more comorbidities and co mortality steel and so yes, we were able to give longer safety data from Aurora, we prioritize debt analysis and brought that forward to the agency.
We I believe we were limited to what we had before and <unk> to the 26 week data blinded data analysis that we had at the time, but again those look very favorable.
Somewhat smaller trial and of course, but Aurora as many subjects and it.
So with respect to the how the conversations progressed and the nature of those.
And in a nutshell, obviously, the FDA has from the driver's seat they tell us what they want to know when they want to know and we respond as best we can the FDA I'm sure and I won't speak for them, but they can avail themselves of any number of experts to the extent that we bring other voices to the table again theirs.
Somewhat.
And that's both somewhat more constrained, but not impossible and and.
I won't say anything beyond that and we've availed ourselves I hope and I believe of every appropriate opportunity to bring additional out analysis and expertise to be to the discussion.
Great. Thanks for the clarity and best of luck from me as well.
Thank you.
Yeah.
Your next question is from non path with Piper Sandler Your line is open.
Great. Thank you very much and.
And I keep going over the course of new Herb deferral and correct yes.
And so quickly.
Alright.
And that's the.
For the kitchen cabinet.
Got it.
Sure.
And we'll have to require etc.
Thank you very much.
Thank you Ted again, I'll, just generally say the agency asked for additional information through their process right up to the day of the Dupont.
So without going into any more detail I would I would merely say debt even beyond our amendment there has been information.
And exchange through through channels that are I think are important for the process, but again I want to respect the fda's process here. So I won't say much more I won't say anymore than that about the details.
Understood.
What is clear and I appreciate that and.
Wishing you the best of luck on that and then with respect to Lucas what other sort of the gating.
Gating factors too.
And this table that study so has there been any kind of learning and so as a result of either incremental data or the intellectual with the FDA about how to design.
Thanks, so much.
Right. Thank you Ted.
So lupus nephritis as I understand it will like will go into the same division of zinc associated vasculitis being categorized among other things as a rheumatologist will disorder. So we wanted to respect the division's process with escalators and.
Not at this point create any additional distraction.
And with the lupus nephritis and Thats why we are holding back and that's really the principal gating.
Makes a lot of sense. Thanks, so much guys and listen to all of that.
Thank you Sir.
Your next question is from and why.
H C. Wainwright your line is open.
Good evening and.
Hi, Tom Hi, Susan Thanks for taking my questions.
Our debt.
Hi.
For the first question is on Hs is this similar to <unk> that you haven't requested the FDA meeting yet.
Or had you already requested it.
And I won't be moving forward until after the <unk> date.
Yes.
Yeah.
I would again I want to not go into too many details about regulatory interactions and with respect.
I would say again we.
And we'll hope to be able to move very rapidly. Once we have clarity on October 7 and that's not to say that there are no interactions with various parts of the FTA on hydro Super Tivo, because we think it's a super important area and there is a number of things that we would like to achieve and Claire.
<unk> with the agency, but.
And I think the past there is fairly straightforward because b.
The ability to be.
Very much different than what's gone before and the limited regulatory precedence that the agency has to our mind.
There's not a ton of degrees of reasonable.
Variation other theme so.
There is although theres been learnings since the pioneer trials, which are the sole trials that led to the approval of the 1 drug humira for hidradenitis Suppurativa.
The big parameters around endpoints and so on don't seem to have changed for a much. So we are proceeding I think and a very straightforward and thorough fashion.
But again, we will wait for clarity around anchor vasculitis and debacle and.
Per.
Prior to putting any new initiatives in place, but I will certainly be happy to give you a lot more details after October 7.
Yeah.
Okay.
Operator.
Yeah. Thank you for life.
Welcome to our last question is from Jan and Xu with Wells Fargo Securities. Your line is open.
Yeah.
Operator, we're not picking up the audio.
MS. Xu your line is open.
Oh, sorry about that sorry about that.
Hi, Tom Hi, Susan.
Have you had.
Have you had any additional data submission since the major amendment.
So that's the first question and also could you review.
The possible outcomes at the Purdue for date.
Would there be a possibility for an approval and a subset of patients for example.
Thanks.
So yeah, the asbestos about additional data I will stress that the non of information we put in that was judged by the FDA to be a major amendment was considerable.
We tried to be very comprehensive and address the agency's concerns that arose.
<unk> apparent to us and the AD com, we added additional data and tables figures listings.
I would say that we did a very comprehensive job on.
And what was again announced as a major amendment.
The agency's discretion on July 6 so.
Suffice it to say I believe there is sufficient and materials.
And the of the agency.
And so.
You know I don't I'm, not I don't think I'll comment too much at all and there's always a possibility that agency could.
Decides and their own.
Based on their own evaluation, how they want to label the drugs. So again, we'll just leave that to there.
And our judgment.
And further discussions potentially but.
I don't you know we did a study with a <unk>.
Predetermined primary endpoint.
We delivered the data on net and point, we believe the endpoint was successfully achieved.
So.
I think that a label that generally reflects what we trialed and advocate.
It would be a reasonable thing.
So, let's again defer any discussion around the details of that generally on.
On October 7.
The outcomes will either be.
As you mentioned, we'll get a label of some definition or we will assemble.
I believe where we're certainly planning we've always been planning because we think the strength of the evidence is in favor of the data and patient needs. So that's what we're planning for.
And we'll go we'll go from that point onward.
Got it from that that's very helpful. A quick follow up with regard to our sales force.
Could you.
Sure.
What percentage.
And to what extent you built filled out your sales force prior to the AD Comm meeting and has there been any reduction.
Sales force.
To date.
Very good questions, we made considerable investment prior to the <unk>.
Headcount and meeting and building out our sales force.
Fully intending to be ready to launch the drug.
On the original Paducah target date of July 7th and shortly thereafter launching the drug.
So we did 8 and I think and excellent job and amassing not just sales representatives, but also medical science liaisons and the appropriate <unk> ratio to be ready to launch the drug.
We've suffered very little attrition to that force since debt, we're using the extra time.
To do additional disease education and.
And among other important things to ensure and even better launch given the extra time, so we haven't and excellent.
Commercial force and excellent commercial organization and I am very pleased to say that they are.
Getting more ready by the day.
And we believe fundamentally that that was a good investment to make prior to may 6 prior to July 7 and a good investment to keep making through October 7.
So we'll be ready and we'll be very very ready.
Got it thanks for the current and best of luck.
Thank you very much.
We have a follow up question from Ed White.
And with H C. Wainwright your line is open.
Hi, It seems like I got cut off there prior to my second unintentionally.
And I'm sure it was it Tom.
So so just a question on Ccs 559.
I know it's early in.
And the initiation of the study.
I'm just wondering if you have any thoughts on when we can see data there or any update on the number of patients enrolled and.
And you know it's.
Has there been any impact or do you expect any impact on the study due to the Delta variant and I know you worked very diligently through the first 18 months of the pandemic to enroll patients and your various studies and I'm just wondering if there's any if you're seeing anything from the delta variant and what learnings from the last.
18 months, you can put forward to perhaps alleviate any concerns over the delta variant. Thanks, Yeah.
And I could I have so many thoughts and it's a pick.
But I'll try to constrain myself and it'd be very.
Synced here, So you live and <unk> 9 program in fact, our first sites.
We worked very hard to get them up and in Australia for variety of pragmatic.
And other reasons and Australia has got a great reputation for doing wonderful work and early oncology studies and later oncology studies as well. So we got those sites are up and running and and we were right on plan.
And then Australia went into lockdown because of the very thing Youre discussing so we were ready to dose essentially when they went into a month long locked down and new South Wales.
While we got through that and eventually got another we started first in human dosing and another state in Australia and that wasn't locked down and it has had already and effect now we hope we can limit that effect and of course with these cancer patients feature folks was fairly advanced cancer.
Yeah, and they don't really have a choice they need to be in the clinic, 1 way or the other they are happy to engage and a trial.
Especially a trial with this kind of rationale so I'm, hoping it won't slow us down 2 months 2 months, rather, but I'm going to defer when we're going to start talking about data and.
Well I have a little bit better handle on debt myself, but I would I'm very keen to get through at least this first step and report to the community. What we know even at an early stage because I think we have an excellent compound.
Beautiful pharmacokinetics and animal models, and I think early data again without going into details.
Is supportive of that this is really going to be a good looking program in my opinion, we will just have to see how it how it continues to progress, but my commitment to you as soon as we have meaningful data, we're going to start talking about it to this community.
Overall delta is going to be a problem.
Early for clinical trials I think Thats, just fact, there's hesitancy of sites to even engage and discussion about the initiation of new trials.
And although last year, we and others and the whole industry, we're very happy about how we seem to be managing through the initial.
Covid crisis.
You know quite frankly longer term studies and endpoints and follow on visits and all that stuff. It really is going to affect and the long term. How these studies are going to pan out. So I think we've got a challenge <unk> had in our industry and we're certainly thinking about it very seriously here at human centric, but it's going to.
It's going to have an effect there's no question about that.
Yeah.
Okay Tom.
Thanks for your insight and and thanks for taking my follow up question.
Thank you Sir.
Okay.
Yeah.
That concludes our question and answer for today I will now turn the conference back to Dr. Thomas Schall for closing remarks.
Thank you very much I appreciate the time and everyone has spent with US this afternoon.
And all the insightful questions and I very much look forward to updating you.
And the not too distant future. So thanks very much have a great afternoon, and a great evening you may now disconnect now bye bye.
Ladies and gentlemen.
Ladies and gentlemen. This concludes today's conference call. Thank you for joining you may now disconnect stay safe and well.
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