Q4 2019 Earnings Call
In patients there will be a question and answer session to ask a question. During this session. You want me to press Star one on your telephone if you require any further assistance. Please press star Zero I would now like to hand, the conference over to your speaker today, Patty Eisenhaur cemented vice President of Investor Relations and communications. Thank you. Please go ahead.
Thank you Lisa and good morning, everyone and thank you for joining us today for Mementos conference call to discuss financial results in operational highlights for the fourth quarter and full year of 29 change.
Today's call is being webcast and will be available for replay on the investor section of our website momentum pharma dot com.
Joining me on the call. We're prepared remarks are Craig Wheeler, President and Chief Executive Officer, and young Kwon, our chief financial and business Officer.
Santiago, while our Chief Medical Officer, and Tony Manning, Our Chief Scientific Officer will also be available for the Q and a portion of the call.
During our remarks, we will open the call to questions.
Before we begin I'd like to mention that are called will contain forward looking statements about our financial outlook business plans and objectives, another future events and developments, including statements about the timing of regulatory filings regulatory approvals and launches of our product candidates and products and market potential and reception of our products and product candidates.
Potential competition and revenues for product candidates product development strategies goals and timelines.
It may never product candidates, including design time, even goals of clinical trials and availability timing and announcement of data and result, they use efficacy safety potency tolerability convenience and commercial potential of our product candidates, including their potential is best in class agents.
Hypotheses regarding certain aspects of our product candidates in clinical studies, and non-GAAP operating expense guidance, including our anticipated collaborative revenues and restructuring charges.
These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected each risks and uncertainties, including those described in the slide entitled Cautionary note regarding forward looking statements included in the presentation accompanying this call and under the heading risk factors and her most recent quarterly.
Report on form 10-Q filed with the Securities and Exchange Commission as well as other documents that we may file from time to time with the FTC.
Any forward looking statements speak only as of today's date and we assume no obligation to update any forward looking statements made on today's call.
On the call. We will also discuss fourth quarter 2019, non-GAAP operating expense.
I see the presentation accompanying the for further information and reconciliation of this measure.
With that I will now turn the call over to Craig.
Thank you Kelly and good morning, everyone well those are the who were able to join US at the JP Morgan Conference you got a good you did a fantastic progress our development team made in 2019.
Our pipeline celebrity not biology platform focused on complex immune mediated disorders is really beginning to show its promise.
Excitement is building in the company as we hear several meaningful catalysts coming up this year.
Milestones include proof of concept result from our two lead programs and Mg RTP.
Anticipated all around the here.
Well as expected completed enrollment MH DFM by the end of year.
On today's call I will start with a quick review our strategy then go into more kept on our pipeline programs.
Kuan Archer.
Natural officer will discuss our fourth quarter and you're right 2019 financial results.
In closing for final comments, and we'll open the call to your questions.
Over five years ago, when we formulated our strategy for all your drug discovery Bank.
Two strategic choices.
First what's the focus our initial research on the biology.
I felt there was a broad set of opportunities to be mind.
The second was to combine with biology with a world class cooking design skills already momenta work to optimize molecule class leading potential as we head into the clinic.
These choices turned out to be good ones.
Initial effort, we now have three molecules mcclintock all focused on different aspects of that's the biology.
All the preliminary human or animal data that points to that potentially best in class.
And all that multi disease franchise potential.
In addition.
We have built two new drug discovery efforts based on the protein engineering went into the design of our initial molecule.
Those efforts.
Seem ultimate technology.
Relation technology already opened their first new development program for our portfolio and Kisixty seven RCD 38 body.
As our original strategy began to show its promise we focused forward towards the clinic.
With a clinical strategy that is designed to build a robust dataset, which will optimize the potential of each molecule and enable us to pursue a broad range of indications for each program.
We also make a decision to expand our research efforts to begin a wind assets of immune biology beyond us see.
And already have promising leads that she should yield development candidates in the next two years.
Yeah ever more confident in the portfolio, we have the clinic as well as the potential of our research platforms to feel pipeline growth for years to comp.
2019 was a break out yet from a matter as we made meaningful progress across our development pipeline and 2025.
Further evidence of the value of the strategy for investors.
For today's clinical update we'll focus on them to fight for local talent.
We expect report proof of concept great on both of them this year.
I'll start my program updates with an overview of down to five poor.
These are promising early data ahead of JP Morgan It became clear maybe many investors did not full understanding of the program.
A science behind it and the potential at home.
I guess this isn't surprising as without any hard data available. It has been living in the shadow of nickel tell about our CRM program.
However, it internally we have always believe at this program could create as much more value promomats snorkelling given not falling in the.
That's a large multi indication market and the lack of direct competition.
But I'd like to today is to provide a good overview program.
Summarized that data to date and high potential it might hold to create significant value for patients and all investors.
[noise] M to fight for novel drug because I actually that's a raw material, we enzymatically modified ideology to change the structure of the goal I can on the constriction hygiene.
Hi, extending B.S. feed locking up and terminate them with a high Alec acyclic.
These glide cans or sugars located on anybody I see regions control their buying into receptors.
There's been shown another laboratories in multiple all these models that probably modified tetra silent ideology.
Dramatically enhanced financing planetary activity like GE selling seven to 10 times more potency in the animal models.
With this preclinical data in hand, we feel confident that this agents has the potential to dramatically improve creep into the countless patients currently ideology therapy.
I'd be I keep the very successful drugs selling over $6 billion annually in the auto immune disease space.
It is widely used flatline agent to treat many large immediate autoimmune disease.
Hi, good comps with many shortcomings.
First you'd be affected it must be given high dose confusing often require multiple things minutes using it for patients.
Second because it extremely high volume of protein NPV, many patients experience adverse events, giving the cost of challenging safety profile.
Finally, being a plasma derived product.
Yeah, good availability is limited and it's in chronically short supply.
With us dramatically in her potency and two five poor has the potential to offer strong efficacy at significantly lower doses.
[laughter] potential to reduce dosing in a few in punch for patients and improved tolerability of the tree.
And to five well could also gave lemonade supply constraints of ideology and grow the market as a result.
Our priority when we entered the clinic was to do a quick proof of concept in humans to see if we saw the same efficacy advantage is that we've seen in animal models.
This trial, which we are currently running some multipart phase one two clinical trial idiopathic thrombocytopenic purpura Frac TP.
We have completed part a of the study in healthy volunteers are progressing through part B, which is evaluating them by poor in a single ascending dose cohort about TP patients.
Followed by 1000 milligram per kilogram, how by VIP, which is the standard dose probably be actually and I TP.
We shared data from the healthy volunteer cohort at Ash in December of last year, which show that empty by Fourq is well tolerated.
Importantly, we also disclose some interim data from Nike patients ahead of JP Morgans January.
Okay. There was exciting as it suggests that in humans, we may have even more potency than we saw animal experiments.
Okay, all doses tested so far ranging from 43 milligram per kilogram to 250 milligrams per kilogram patients responded to the drug platelet elevations above the target.
Greater than 50000, microliter at least 20000 increase from baseline.
By obsessed by keeping patients administered empty five core responded.
One non responders, who did not respond to either having to fight for where ideology.
Well that data set a small is promising.
Based on those first patients we have a response rate of over 80% to date.
Potential best in class response rate agents targeting that GP.
We normally would not really interim results at this early stage of the trial, but with the state and it is clear we need to modify our development strategy to explore nowhere doses.
We are now expanding part fees lower dose cohorts to see if we continue to observe consistent signs of efficacy.
As well as tend to determine efficacy levels are maintained at even lower doses.
Yes, our gold had the state enhance the person middle of this year at a major hematology me.
The data holds the game changer for potential of them to fight for.
You're also accelerating our strategy to advance that's program.
First with expanded cohorts in part B of a college ongoing trial.
I expect to be able to streamline the design of this for park trial will be efficacy we have seen continues.
Second we are planning to start phase two trial in chronic and a chronic indications chronic inflammatory keep violating polyneuropathy, where he had to Pete.
In the fourth quarter.
Syndication accounts for 40% of I'd actually sale not I mean just be.
Third given a significantly lower volumes of able bodied early potency data. We are seeing we're beginning to look at a subset of Evercore this product.
Could you had some back administration improvement for many patients on I'd actually today.
Our team has a long experiments with some development and understands that the only a small sample of patients. There is still a lot to learn about this program.
But we're very encouraged by the early data and the promise this program holds.
Well, we look forward to updating you on the results of our expanded lower dose cohorts in Q2 as well as presenting use our plans for CRB Pete on our Q2 earnings call.
I'll now turn to nickel Calmat RF CRH I thought I know, you're all intimately familiar with.
I'd like them to fight for this is a competitive class that is already demonstrated proof of concept.
Our strategy here, so that all the best in class drugs built on the foundation of a molecule that we believe has best in class property.
Our agent isn't like possibly could I just do one antibody.
It was designed to be very potent binder targeting FC binding site on the CRM receptor.
This design has worked very well showing in the clinic that has all of the attributes we hoped would lead to a best in class truck.
Our phase one studies have shown that with a single dose we can achieve maximum nike reduction at around 85%.
As well and our goal of hold receptor occupancy.
For calendar has shown strong predictable dose response good tolerability.
Higher doses able to maintain Nike reduction from baseline for over one month.
Our multi dose phase one data cohorts demonstrated that we can maintain folate receptor occupancy for sustained periods.
And our infusion study is shown to be can safely and tolerably administer our 30 milligrams per kilogram dose to patients and as few as seven of the happening.
Taken together these attributes point.
The potential best in class profile, particularly as compared to the atg four based competitors.
Our strategy principal Calif in the clinic is to build with datasets that allow us to capture the franchise opportunity.
Autoimmune and feed on maternal disorders.
We have three studies running from current two in autoimmune indications my senior rabbits in neurology area.
And warm autoimmune hemolytic anemia, and hematology area.
And one in feed on maternal indication hemolytic disease that the fetus a newborn for H. DFM.
In the future we plan to expand into other auto immune disease areas as well as additional indications in Eagle maternal medicine.
Let me update you on our current trials.
The first of our autoimmune studies to read out we'll be able to facet. He mg phase two clinical study in Mg.
This is a five I'm trial.
Treatment in for Ciena placebo.
The trial is designed to allow us to understand the full dosing model and will provide a large safety database.
Which will hopefully allow us to smaller more focused phase three trial at Mg.
And I'm pleased to announce today that we achieved our target enrollment in this trial and we plan to reserve release topline results in the third quarter.
Unity.
Our global Multicenter phase two study exploring mccallum advocates PFM.
First clinical application of Fcr and inhibition and feed 'em traveled to source.
Our can't be body's ability to maintain full receptor occupancy enables what we believed to be total blockage of pathogenic Hello antibody and auto antibody.
Our passing through the placenta condom mother to the fear.
This study is enrolling well and we expect talk to report topline data from this study 2021.
The third quarter of 2018 relaunch energy, which is our third apoquel in that study and our second autoimmune indications warm auto immune hemolytic anemia.
The study utilizes an adaptive phase to redesign which provides us with the flexibility to incorporate learnings from my proof of concept results in Mg.
We currently have clinical sites active in both the United States in Europe, and will be enrolling patients over the course of the year.
Importantly, momenta elite CRM headers are targeting the syndication and need for calendar has been granted fast track and orphan drug designation by the FDA for warm auto immune hemolytic anemia.
We expect to report topline data from the study Rami and 2021.
These trials.
Cesspool will provide the foundation of freight broad label and best in class profile and we are working to build a winning CRM franchise would have to count on that.
There's enormous commercial opportunity here I look forward to updating your next milestones in this program results for our phase two trial in Mg in Q3.
One final note.
We have disclosed to you on the path, but our manufacturing partner for this product as well she.
We in where she are paying close attention to the corona bias, which require situation in China, but I did want to reassure you that we have at least the six month supply drop on Handfull all of the ongoing trials and she is up and running.
Do not anticipate any significant impact on this program.
I'll now turn to our newest program our development portfolio empty 67.
Hi, CD 38 targeting set body.
In January our executive team or get the preclinical data package on the officially nominated empty 67 has our next development program.
Chambord sign committee has ratified.
[laughter] Perks program from our set body research platform to reach development stage.
As a reminder, our safady platform combines multiple FC from an antibody against known targets.
The goal is to enhance the antibodies effector function to increase cell, killing potency through ADCC.
You can see decrease.
Our initial experiments with the platform have shown that in cellular animal models. This increase in potency significant.
As we demonstrated previously released data on T 38, M.C. Kelly for targeted therapies.
Those early days, an unmet need to parents and TV 38 different diseases, let us to develop this program as our for sale.
As a reminder, cdthirty eight as a target on plasma.
You system self responsible for generating auto antibodies and auto immune disease and proteins and multiple myeloma.
Let me therapies inefficient engagement can limit efficacy and in many patients lead to drug resistant.
Preclinical data suggest this CD 30 to 30, except body maximizes engagement at the FC Gamma receptor and complement Sir.
Has the potential the best in class therapeutic for the management applied the site mediated diseases, such as multiple myeloma al amyloidosis, and other rare auto antibody mediated diseases.
So we believe this program represents another high value opportunity with franchise potential.
Greetings and interesting profitability can both colleges and auto immune disease.
This designation for development programs that we are increasing our investments in the program to refine development ready cell lines.
Since the last preclinical toxicology studies needed to enter the clinic.
You're not will initiate a massage envy, enabling studies for this program and plan to get ready to enter the clinic 2021.
I look forward to update this program as it moves forward.
For completeness, just a few comments and other activities we have underway.
With regard to our empty 30 FC multiple program with CFL CFL is currently running a phase one clinical program to evaluate the safety and Tolerability attempt to fairly healthy volunteers.
CFL, introducing a subcutaneous formulation to the phase one program this year.
Update you on the progress of this program, what we have more information to share.
On the research, but other programs are dancing and we hope to be able to update investors on the depth about research pipeline, possibly later in the year.
With that I'll now turn the call over to young Kwon to review, our fourth quarter and year end 2019 financial result.
I'm reasonably assume the chief financial Officer function. In addition to this role as Chief business Officer.
We've benefited greatly from his leadership and we're thrilled to have some on the key strategic vision guiding us in this capacity.
Yeah.
Thanks, very much Craig and good morning, everyone.
Before diving into our fourth quarter 2019 financials.
I would like to touch briefly on a few financial updates and provide a quick reminder, about how how our product revenue relates to our corporate strategy.
To begin in December together with Sandoz, we entered into a settlement agreement with Nashville General Hospital, resolving all pending litigation relating to Inox apparent sodium injection and ft approved generic version of Lovenox, which we developed together with Sandoz.
As part of disagreements Momenta agreed to pay an aggregate of 35 million to point us.
Also in December we completed a follow on offering of 16.7 million shares of common stock, including the full exercise of the underwriters option to purchase additional shares.
At a public offering price of $15 from 50 cents per share.
Net proceeds from the financing were 244.2 million, which importantly provides capital through our key proof of concept read outs upcoming.
Finally, you'll recall, we formally had and large presence in the complex generics biosimilar space.
From this business, we held onto two legacy programs.
And I'm 710, a biosimilar twilio.
Well it took us revenue stream currently provides non dilutive funding to our portfolio and M. 710 is our sole remaining biosimilar clinical development with Milan.
So even though we are not really in this business anymore. These programs remain important to our strategy and that they do and we'll continue to provide us with capital the funded development and eventually the launches of our novel drug candidates.
Now with regard to the company's financials product revenue for the fourth quarter totaled 7.9 million compared with 10.8 million for the same period in 2018.
The decrease was primarily due to continued competition on cutover.
R&D revenue for the fourth quarter totaled your point Threemillion compared to 32.1 billion for the same period in 2018.
The decrease was primarily due to 28.4 million revenue recognized in the fourth quarter of 2018 related to my lands upfront payments and lower reimbursement revenue.
<unk> expenses in 2019.
Fourth quarter total GAAP operating expenses were 95.5 million compared to 52.5 million for the same period in 2018.
The fourth quarter GAAP operating expenses include the 35 million Nashville, and General Hospital settlements.
Fourth quarter R&D expense increased to 38.3 million compared to 28.7 million in the same period in 2018.
This was primarily due to an increase in manufacturing and clinical trial costs for nipple Kalamazoo and M. Five for.
Offset impart by lower personnel costs following the company's workforce reduction in the fourth quarter of 2018 and a reduction in these costs.
Fourth quarter GNS expense increased to 58.9 million compared to 21.5 million in the same period in 2018.
This was primarily due to the 35 million dollar settlement agreement with National General Hospital related to an auction parents sodium injection.
For the fourth quarter of 2019, our non-GAAP operating expense was 86.9 million.
As a reminder, our non-GAAP operating expense is defined as total operating expenses less stock based compensation less restructuring costs and less collaborative reimbursement revenues.
Finally, we ended the fourth quarter of 2019 with $545.1 million in cash cash equivalents and marketable securities.
Compared to 449.4 million at the start of 2019.
The increase here is reflective of our December 2019, common stock financing offset by our spent.
Turning now to our guidance for 2020.
We are reiterating the guidance we provided in January that we expect full year non-GAAP operating expense in the range of 220 to 240 million.
And with that I'll turn the call back over to Greg for closing remarks.
Thanks, I think we're going to I think we're gonna do.
[music].
Questions about to closing remarks, I'll be lucky cosmetics, and I'm not sure Howard sorry.
[noise] Emery bring you can do your closing remark you ever can vision.
Okay. Thanks.
Hi, Thanks, you invest to recap the very exciting time from all that we are well capitalized to fund our programs to keep proof of concept read out including several key milestones this coming year.
We expect to report updated proof of concept I T. P data from our phase one study at up to about four from the second quarter.
We expect to report topline proof of concept results Nobody Rhapsody MTV, our case, two studies nickel calendar happened Mg and the third quarter.
And we plan to initiate additional phase two study of him to platform CDP fourth quarter and finally, we plan to initiate Amy I'm DNA from study for them to 67.
New security bucket development candidate and we'll continue leveraging our platform technologies like identify additional opportunities abound.
We look forward to keeping up did about all these programs.
Thank you again for joining us I'm not trying to call over to the operator to get Q underway.
Thank you as a reminder, cast a question you want me to press Star one on your telephone to withdraw your question press the pound or hash key please standby will become pilots you in a roster.
Our first question comes from the line I've Robyn Karnauskas from Suntrust Robinson Your line is open.
Hi, guys. Thank for taking my question and congratulations on the progress I guess first buttons on to fight for originally you thought you deals can you give us up hiring or additional analyses preclinically in it.
Maybe a more potent drug I know you're doing down.
Yes, its correctly that even if the logos like the 40 it make protect that you saw equivalent efficacy you I guess I'd across multiple doses. So.
So it didn't look like there was it go through five help me understand like as you goes down like why you think that is the difference you preclinical analysis in the clinic and how long do you think you can go and then the second question I'm not as like how does that translate for the market opportunity the drugs being that it's equivalent and then maybe it's much lower doesn't help me understand what that means.
As far as market uptake. Thank you.
Sure. Thanks, and that's that's a complicated question and I'll try to keep your first brush on asking about turned out back over to Santiago to talk about exactly how we're going after this.
So we saw a efficacy.
Out of six patients so that was patients all doses and we did see one patient who did not have probably termed as a response remember responder here is over 50000 will at least 20000 increase.
Patients.
I didn't respond and I didn't didn't response here.
We do think that at some point, we can look at higher doses to look at improved efficacy whoever and disease like I T. P, where there was such dramatic variability.
He is probably not the place we're really going to be able to do that climbed up a very large number of patients and so that's why we're so thinking about as multi dose and he had he had going forward there.
Tom I think biologically we do understand some aspects of the mechanism here. Some general talk about how we're going after that in the clinic.
But we are encouraged to obviously, many many differences between animals and humans, but we're encouraged so far from what we've seen in humans is that we're continuing to see.
Getting that that efficacy benchmark at the lowest dose and so hopefully, we'll continuously lower which will make it.
Much medical patients globally, Dell Santiago, maybe you can pick up snare talk a little bit about how we're going after this.
Yeah.
Basically below what you were saying we are going to odd says we are already adding some more patients into part b.
We will.
From Boeing decides when we're going to do would pursue im proud to be we would be a scarpino CRT D. P is study with multiple dosing.
At the end of the year.
The data that we've seen no such as.
That is a good groups phones, we very small doses oh power for the whole bird to I'd be a D.
That's actually relates to the preclinical data we sold before.
He centrally bit than in some cases gain as good of we're saying there, but it really deal did that you see significant were really knew that.
And that's why we needed to get a few more preachers prepared to understand. These these meant there to be able to propose a new those or are those for the security be a study.
Great and one more for me so for your sub Q2, 81, you've mentioned that beginning or slide deck, you just give us an update.
First where are you out our development and once you get your deed in third quarter, how quickly could you begin to subcu trial to remain competitive.
For people, who would want to subcu and what's the competitive landscape. Thank you.
Sure.
Up on that so we as we announced earlier, we believe we've already gotten through Cooper constantly now we have a subcu, which is actually performing really well so so far.
Intention is to be able to introduce added the bridging study in parallel with our phase three study so.
Yes, that's on track our we have no no concerns at all terms are going to get there at least to the data at this point. So it's looking quite good at our attempt restaurant apparel bridging study to our MG Thomas we actually I understand dosing.
Great. Thank you.
Sure.
And our next question comes from the line of Eric Joseph from JP Morgan Your line is open.
Good morning, Thanks for taking the questions like a couple of from us.
Both on to fight for can you comment on any immunogenicity findings and because the healthy volunteer or.
He said he portion, but so far.
You should assume that you'd be there just with single doses owning I guess.
And maybe limited in terms of information how are you thinking but the potential for development of neutralizing antibodies to a hyper sialylated ivig overtime.
Sure I'll I'll turn it back to to Tony.
Yes, Thanks, Craig Thanks for the question Eric.
Because into five floors derived from natural.
Polyclonal IBG east from human.
And because they say like I said that we adds to the molecule is naturally occurring.
I wouldn't anticipate that we would have any significant immunogenicity issues and actually it turns out as technically pretty hard also to actually measure that.
Because your administering.
Normal human I'd GE to humans, who have normal human by GE. So so there's a few technical challenges to so however, given that we have not in any about preclinical.
Seen anything suggesting that they would be any immunogenicity issue. So something we're gonna have to keep an eye on as we move forward, but at this stage, we're feeling very very confident.
Got it and maybe just a follow up here on the C or D P opportunity.
It would seem like the indication maybe a little bit more variable in terms of severity and responsiveness to its ideology.
And trying to think about the the read through potential from the initial likely p. data that you're so I can be interesting. So far can talk a little bit about the how tight the relationship between auto antibodies and fee I'd be symptoms and as you look to down dose.
With 254 is there any risk.
Of losing some of the.
Competing activity.
Hi, geez that might be essentially behind I'd be I'd use a mechanism of activity.
Hi, Thanks, I'll stop here, then I'll turn it over the second to talk about our our thinking about CDP.
No. It's an interesting question because there is variability.
Yeah, GE and all of diseases that fits in treating that's actually not uncommon and auto immune diseases.
I would say, it's gonna be hard pressed to have more variability I think people have you actually shows in IP, we showed a slight of JP Morgan.
The measured variability performance of IBG Oliver the map in terms of responses, which is why about it uses.
End of efficacy response.
And see IP with multiple doses, we definitely expect to get more stable leased about connecting inter patient and truncation patient variability.
We think it's actually a quite an interesting that area for us to go and because.
The multiple mechanisms vaccine.
Yeah, and maybe you can talk a little bit about how we're thinking about going until we have we haven't yet disclosed full design of our topic I think center I can give you a good idea of our thinking there.
Yeah, we will go over our design or from finance within makes a quality moving the next winter.
Yeah. He says standard of care for the CDP works will duties a significant amount different superficially maybe are you see I'd be probably goes and the effect size based around between 60 and soon to be present. So he's not NBC is study to do the some so easy.
Usual dependency on probably be are you maybe beaches are depend on the remote. So we're just now working through how to do an efficient likely short, but informative study on c. I'd be knowing and understanding WWDC and does it would be a you know our objective piece.
Two.
Try to reviews as much as folks who would be seen but it really gets entry who basically in groups. The population into a more responder population I think it will give some more clarity or would that be even in a few months.
Great. Thanks for taking the correct.
Thanks.
Well I think after sensors, we are we are doing in.
And this and this study a phase two first just because we'll actually understand the program for the phase three.
Got it understood. Thanks, taking my question.
Okay.
Our next question comes from the line of Carreker Chello from Stifel. Your line is open.
Hi, Bill on for Derek on Congrats on a great 2019, and thanks for taking your questions I'm just a couple on M. Anyone.
Can you briefly talk about sort of the.
The differences in dosing between the indications for him to 81 and sort of you know what mechanistically in those indications drives those differences and dosing and then our second question I think yesterday aleksey on disclose that Theyre, just continuing their anti F. CRN AFA body pro.
Graham.
Assuming they focus on the sent to me in monoclonal antibody.
Can you just sort of talk to the differences and similarities between Mccallum AD and listen to me an asset. Thanks.
Sure I'll take the first one of the differences and dosing and then I'll pass it back to lie.
So your Tony to talk about the differences between our to our antibody design and since area.
It does things fairly straightforward I mean, we're doing dosing rent dose ranging autoimmune disease using our.
No multiple our Mg trial, which we announced we have completed enrollment systematic my comments today.
And we started them adaptive trial design to be able to take advantage of that using those doses Doppler upbeat phase two trial in hemolytic anemia.
I don't think profoundly different in people maternal disorder, and that's because in Peter maternal disorder, What's really really critical is blockage of transport of the IP to east not reduction and.
And antibodies that decided would you reduce moms.
The bodies that are alloy antibodies that could affect the fetus, but the main mechanism is.
Backing the passage of those.
To do that you need to retain pull receptor occupancy so we actually use.
A higher dose every week.
Pete on maternal to make sure that we can keep whole receptor occupancy there and that's the reason for the differences.
So how do you want to talk about the difference between the before us and our and yet you want.
Yeah, Yeah, so just to.
Hi, just any sort of judgment per sale and what we think about other people's molecules. So you know the data would speak for itself.
But I think there we need to recognize that there are some design features that we included in into 81.
That that others didn't is a so we believed it was very important to eliminate all potential for effector function of our antibody. So once we find it feel Iranian to not damage any sharing fair and felt so we use the G. One eight like scaffold, which is devoid of any interim.
Mentioned with the a b C effect or system.
Others, who generated antibodies used another scaffold the agency force scaffold with which has been commonly used in the which has less potential to interact with the factors system.
But it's not devoid of and so.
Let's see on 18, 30 isn't I digi for scaffold.
Antibody and if you just look at they safety data so far.
Which includes headaches.
And which includes only a modest reduction in AG in the 50% to 65% range in a once weekly I'd dosing I think all those things at least have suggested to me that you know the AG for scaffold.
You know may bring with it some characteristics that are going to limit the ability of these antibodies to really fully occupied receptors and fully block or the the mechanism. So I think from our perspective, we're very happy with handle into 81 is performing as performing based on the design.
That we had for the molecule and I think they tolerability profile to date and they shipped our occupancy in the I digi lowering with very very confident will translate into good clinical profile.
Great. Thank you.
Our next question comes from the line at Stacy cue from Cowen Your line is open.
Hi, Thank you for taking my questions and congratulations on the progress.
Yeah.
First given the positive concept actually 20 <unk>.
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I think before so far can you help us understand what you're thinking currently intensive what size scope and type I VIP supplier you might use is commercialized.
And then they have to follow.
Sure. Okay, well, obviously, you know how much FDIC was really depends upon what the minimum doses and so we're paying close attention to that.
Already with what we see no visteon and there we know we got a massive massive supplies in terms of a high percentage of the global supply.
So it means obviously that we could work with one of the major suppliers and that may be very big partnership for us.
Or alternatively, you could work for one of us with one of the smaller suppliers among all the young Kwon comment just briefly because youngest leaving our business in corporate development efforts just to give you a sense of what we've seen so far.
Sure. Thanks, Craig absolutely I mean, as as as Craig said I mean, the lowered the dose that we're able to achieve with two five for NRG PNC NDP.
The better off that we are and we do believe that we won't be able to access supply from.
One of the variety of different I'd be actually players that are out there.
Yes, you can imagine there's been quite a bit of interest based on the initial.
Interim entropy data that we've released [laughter] that's.
Something that we are certainly thinking as it relates to afford our primary goal is to secure are supplied supports the the later clinical studies and commercialization. So were actively thinking about the right kind of business arrangement to obtain that supplies.
That's helpful and so just a few questions.
She said before and.
As we await faulty counts for this Yankee study could you maybe comment on the patient population given kind of misdiagnosis <unk> <unk>.
What measures can be put in place to account for the baseline heavy Canadian CDP patients.
Dan.
[laughter] formulation.
What kind of bridging study if any would be necessary.
[laughter].
They'll buffer to eat at account watch for energy.
Sure. Thanks for that question those are both inside the Atlas wheelhouse, and so I'll turn those right back to him.
Yeah as they see we are you know as I mentioned before we are working on that.
A weakened as saying that type of trying to go with the.
Low number of patients for sure.
Provided you know a real does own it because he improve of course is we are still not there will be able to talk about dug into future ugly risking, though do you feel that.
There are several no issues on how to develop.
The food is study.
We you know many people have done a very long on them baby close. These studies, we have time to do something hopefully a little bit or on the Super Wwes formally for a 21.
Our plan to breach.
Our but I use will you said you'd be moved to study they will do a phase one two people in theory study.
We will discuss we viewed the new mode to do a facing the study to be says okay.
It will depend on the or understanding of the safety of the drug let's say few of the Super New formulation.
Okay. If he can see are north of the understandably note the relationship between AG production and if he can see so if for example, the the reduction if I do you guys are relations who would be a because he understood then it from relation is very well.
So do they did we believe that these for people to make a series b to b.
We've been from relation approved for normally will we saw the neither of them for completion of study.
That's really just to add Santiago at around but the the this study design and the timing we expect to update the CDP strategy, including elements of what the study will look like on our Q2 earnings call.
Thank you.
Thanks.
Our next question comes from the line of Danielle Braille from Piper Sandler Your line is something.
Hi, guys. Good morning, Thanks for the question, Thanks, and congrats on the progress I have a few as well on and to 54, so I understand that you're expanding enrollment to better understand response variability, but can you provide some more color on whats say inconsistent responses looked like did you see variability in like Congress.
On the magnitude.
And our ability or.
Any color would be helpful. And then I have a couple of how a lot.
Sure. Thanks, Yeah, we actually.
Determined that we weren't going to start talking about the individual variability mostly because.
Dataset of saw small we really couldn't interpret it.
So that's one of the reasons that were actually expanding cohorts to make sure we see consistent consistent efficacy as well, it's going to lower doses.
Got it ran when we started digging deeper into if that's why I showed the slide.
JP Morgan.
The variability is so high.
And it's not really studied does is it primarily for patients and enter patients. So so we really before we start that I'm trying to make any had gotten so it doesn't seem to have bigger datasets and that's why we've just talked about basic accuracy.
Looking quite good.
But it's really too premature to start talking about the details in terms of website.
We're seeing him an individual patients.
Got it and Craig how confident are you that regular Ivy I G would be in married at that go through you tested so far and then also just to clarify our you no longer looking at the 500 milligram and 1000 milligram dose cohorts for 255. Thanks.
Sure. So let me let me pass it over to Santiago, because just talk about how we're thinking about the dose cohorts and I think I think you've just got or Tony could all France or what what we do know what has been shown what I'd be actually.
So we can you can just tell you with copper theres not a lot of data, but we can table. We have seen so essentially I watched the person and then Tony Yeah, I wish to how to make a decision about would be if I can do then one sounds more like the one cancer will nor do we like under this is through a possibility.
On the FICO C or lower those will probably be or do you did it leads and there's really very rarely do dug up I mean, we know that he's a at least one of the study that shows that the for intended because much less if he can see that one good I'm from fuel so Doug Doug who looks like these you know you said.
Most reseatings actually for the Q2 minute probably be used between one and two grams and it doesn't agree.
There's really no. Good does the low doses. They believe from physicians as we've discussed is that the doing they don't work, but we don't have any any.
The media TV evidence from the we that he says moved.
We did lose another piece using that in the tell you that shows that the Fig Oh.
You remember progressive doses, increasing doses Oh I via you soon so really modest like you know something were 2.2.
Honestly feel doesn't give you much to find it fig.
But there is nothing materially lower than the consumable into.
I see got it. Thank you. Thanks, so much for the question [noise].
Yes, I guess I'm extend on one aspect to that folks here is that now because we have been getting half that remember, we're setting our product versus a idea here, which stand of care.
And stuff that effect was not much data, but I would imagine with a six 6 billion dollar market and a high high burden.
There were efficacy.
And obviously, we're seeing our doses that the FDIC as part of the figure that out by now but.
There really isn't that much data out there, which would suggest the fact that says that there's not a lot of response is lower doses.
Our next question comes from the line of stuck with no from H.C. right Wainwright. Your line is open.
Hi, good morning, Thanks for taking the questions just.
Maybe starting with Allomap in terms of the sub Q.
In the sort of bridging work that you're gonna be doing it do you think there's a are you going to Lord is your plan to largely replicate dosing regimens that you perform.
The idea formulation.
And do you sort of by avoiding going into human trials sort of miss the opportunity to potentially explore dosing regimens that are opened up by the subcu formulation.
Thanks, I'll take a perfect if that.
There's anymore that my team wants to add on that yeah. We are going to be looking at the sub Q a pretty extensively in our preclinical models as well as an bridging study to understand that.
What are what are our multi dose trial phase two and AMG cost doing that's really helping us understand the behavior of.
The disease at different levels of antibody reductions and how long we can maintain that that reduction so by doing the data between that we'll be able to understand I think pretty well dosing that we're seeing and in subcu.
You may require additional work with by good opportunity student change dosing, but I'll turn it back to you said there has to make any commercial.
Yes, I mean, basically we were doing we do face Fiumicino and obviously study he is tied to the blend of a roadmap of would fees the relationship between AG under the Auxilium also only an improvement of if you can see so once we have Doug you would be very easy to apply those but knowledge to dosing.
Specifically, a patient friendly dosing with supervalu from religion.
You know what would the decades Lucas I think a weakened those with Moody's move a super done is those patients and there are many ways to do that these early stage. We first meet the roadmap, we probably would soon and then from Doug We will decide on what would be debeers those.
Should we kind of those schemes to finish.
Okay, Great and then in terms of the way High study I think you said that it was it an adaptive phase two three.
Design you know what are you looking to learn to apply for the registration component of that study.
Sure.
I will that kind of different gets out there, but it's an adaptive trial design to basically to lucky.
Were blinded to it it's allowed us to look at utility if want to be arm. So both of the arms.
It will happen how close to full enrollment of the trial notwithstanding full enrollment, but it just allows us to construct a patient somewhat arm acquire Michelle and no efficacy.
Because we didnt have a full results of our LNG phase II and so we started with.
Now what we thought was likely to be our dose based on the day, we had it not on a dose was which was higher.
I wanted just talk about the dosing strategy Napa.
Yeah, I mean as you know we have two doses or 30 milligrams per kilo every two weeks on every four week.
The that'd be the Chinese basically is still being one or two and those arms you gave that he's futility.
And ER and we'll be blinded, so we'll be able to announce anything about about duck.
And if you remember from our phase one data what we said.
You know from our phase one data as we think that 30 makes for kids monthly is in has got a decent probability of being our target dose autoimmune disease.
So that's how we get about 30 milligrams every other week just because we didn't have that they didn't happen the phase two yet.
Okay, great we'd be someone who.
You know wait to see the two doses is a good thing to do the answer before gives you a reduction do you even between 50 and 70%.
Something we need antibody two weeks you should assume sooner if I could you be doing 65 for I'm, assuming the freight for sooner so.
This is broadly speaking so we basically are trying to understand two different I'd use the looks from brings is.
Huh.
Again, if he'd like to ask a question that star one on your telephone keypad. Our next question comes from the line I beginning steel from Wells Fargo Securities. Your line is open.
[noise] hi, thanks for taking the questions. So first of all very quick one on M. too high for how many patients worth of data should we expect at the second quarter uptake.
Sure. So now what we're doing this for expanding the cohorts that we've already tied to lower dose cohorts and then going lower.
So the number of patients will depend on the data we see.
You may see you may see double than ever patients, but no. It's not clear yet because we're just still kind of trying to type it with what we see.
With doses, we have to go to where we need to stand.
Yeah, I, just want to add anything to that.
No nothing Vince I mean.
Then decided if we go live that begins to fight and.
We're working through.
Got it and then a question on the nipple kind of map and M. GE study with the enrollment completed I'm wondering how would you be able to talk about the kind of a baseline characteristics and.
The background treatment in terms of whether youre patient population.
Our similar or distances.
Not similar to the trials that competitors have reported.
If that's the right outside of apathy apples to apples.
Yeah, we haven't done but we.
We haven't done doesn't know do seem to North Dakota.
But you do some great beauty I'm, but when we know about inclusion criteria of competitors.
We are pretty much.
Doing the same are going to the same hopefully soon.
Doug older people are going to me then decide to face is that a.
Moderate to severe meet my senior hobbies or they are already treated with really good for because there are always an already moonless represents.
And so it doesn't differentiate the load from other populations or from other companies are looking for.
But they don't have a specific our north American population.
Got it got lastly on the H.D.F. and program I'm just wondering.
So this is that he doesn't have a control arm.
Given it's a high unmet need but do you have natural history data to inform what kind of outcomes can be expected if the patient a if these people aren't worked treated with people kind of map and related to that what is the power of the study was 15 patients.
To detect a meaningful change out of the primary endpoint.
Sure and I'll take that that's a pretty straightforward werent, where in a severe population and so.
We are continuing to gather natural history data. It's important when you do these files and uncontrolled setting, but no. The population that were admitting on average has five future uterine blood transfusions and has.
I'll close to 20% infant mortality rate at high end from morbidity with you personally make here and so.
Endpoint here up pretty profound obviously, if we can have no after either transfusion higher percentage of healthy wiper reduction and reduction in costs. After there's a there's a very powerful a difference.
In the.
In these patients by being able to prevent crashboxx antibodies and so should stop and then bigger signal.
Got it and as a trial is ongoing would you have the ability to communicate data with FDA or do you would you rather wait until all 15 patients data has been collected.
We have the ability to communicate with the FDA cleared out at our.
Our discretion.
Got it thank you very much.
Well just to confirm if you're doing two studies one is the treatment of study.
We just 15 Beijing and we're also doing an observation I'm not sure obesity study, which we are playing through improved 50 basis. Both of them are undergoing them book then I've been brought him. So we'll see how does not through a feasibility study in addition to our reviews.
Data that we have collected.
We have several databases accruals the wording census, and fixing is which provide us a good understanding of what these the metro if you sort of that he sees you done severe patient population.
Got it very helpful. Thank you.
We haven't no further questions in queue I'll turn the call back to the presenters for closing remark.
Okay. Thank you very much operator, and not just like to thank all investors for participating in the call today and we look forward to keeping you updated on but fantastic progress, you're making and we'll talk to you all next quarter. Thanks.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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