Q1 2021 GlycoMimetics Inc Earnings Call
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Good morning, and thank you for joining the glycol memetics call.
At this time all participants are in listen only mode. Following management's remarks, we will hold a question and answer session and at that time the lines will be opened for you.
Anyone should require operator assistance. Please press Star then zero on your Touchtone telephone.
I'd now like to turn the call over to Sherry <unk> of Investor Relations group at Black on Memetics. Please go ahead.
Good morning today, we work with you our accomplishments and financial results for the period ended March 31st 2021.
I'll also update you on recent achievements.
Yes release, we issued this morning is available on the company's website at www dot like him on that stock com under the investors tab.
This call is being recorded a dial in phone replay will be available for 24 hours. After the close of the call. The webcast replay will also be available on the Investor Relations section of the company's website for 30 days joining.
Joining me on the call today are from glad for Memetics, or Rachel King Chief Executive Officer, and Brian Hamm, Chief Financial Officer, who will start today's call with comments from Rachel Brian will follow Rachel will supervise an overview of the company's financial position and will then open the call for Q&A, our chief scientific.
For certain Doctor, John and Jani, and our Chief Medical Officer, Dr. Eric Feldman will join us in the Q&A.
Questions.
Like to remind you that today's call will include forward looking statements based on current expectations forward looking statements contained on this call include but are not limited to statements about the company's product candidates you per lesser land GMI 13, 59 N G. M. I 16 80 <unk>.
Seven and our other pipeline programs, along with our operations and cash position.
Our statements represent management's judgment and intention as of today and involve assumptions risks and uncertainties like on memetics undertakes no obligation to update or revise any forward looking statement for information concerning the risk factors that could affect the company. Please refer to black them on that.
<unk> filings with the SEC, which are available from the SEC or on look like on my Batiks website, I'll now turn the call over to Rachel.
Thank you Sherry.
This year is an important one for lack of a medics on.
Primary operational focus is on advancing the two you for less land registration programs in AML.
Leading clinicians academic centers collaborative networks on regulatory agencies are working with US here in the U S and abroad as you for less land continues to garner significant attention and interest.
We believe the progress being made in both registration trials stance is testimony to the excitement around this program as do the breakthrough therapy designation granted by both the FDA and the Chinese Health Authority.
Collectively the medics pivotal phase III trial in relapsed refractory AML continue to enroll patients in the U S Australia and in Europe at a steady pace for the first quarter of this year.
Our remaining number of sites continue to be activated in Europe and in the U S. As we make a final push toward reaching our target enrollment numbers. Once again, we're confirming that we anticipate completion of enrollment of all 380 patients by the end of this year.
In parallel the NCI sponsored phase two three registration trial.
[noise] waiting you professionally on in newly diagnosed older and older adults with AML also continues to crew participants at a steady pace.
Based on the information provided by the NCI to date, we continue to anticipate that the trial will complete enrollment of the phase II portion by year end supporting a subsequent interim analysis of event free survival or E. F S and the trials initial 262 patients.
Together to collect telematics and NCI sponsored programs will constitute a large data set of patients treated with you for less land and intensive chemotherapy.
Both are positive we would anticipate filing for approval for treatment of patients in both settings.
Our collaboration with Apolo mix in China underscores the broad global community interest in new cholesterol in and in January of this year you for less land was designated as a breakthrough therapy in China for the.
Treatment of relapsed refractory AML complementing prior designation by the FDA.
In addition at the low mix also announced in March that had dosed the first patient in greater China, and the phase one clinical trial for treatment of adults with relapsed or refractory AML.
As a bridging study that's expected to allow Apple on the expeditiously advance development two phase III trial in greater China.
Beyond working with the NCI and up low mix, we're continuing to receive significant interest from clinicians at key centers of excellence, who would like to pay you for less land with a variety of chemotherapy regiment in other AML therapies.
As the year progresses, we expect to announce initiation of multiple investigator sponsored trials or I S. T.
Signed to extend use of U S land across the AML spectrum and potentially beyond AML as well.
For example, the preclinical research that combined your cholesterol in without a class and the hyperventilating agents are HMA shed light on the novel benefits you for less land could provide in combination with these important therapies.
Similar to the net o'clock, we may have one of the few drugs that in chemotherapy combos actually improve survival outcomes.
Fortunately a uniquely you for Leslie may improve outcomes without incremental toxicity.
As you know uptake on panetta clocks HMA in the frontline unfit AML setting has been strong and more.
60 to 70 per cent of patients achieve a response responses are incomplete and approximately half the patients reducing durability and needing to relapse. Thus.
Thus there remains a significant unmet need.
Just broad clinical program of company sponsored NCI sponsored and investigator sponsored trials supports our single unified vision, namely to establish you pro as a foundational therapy across the entire spectrum of AML.
Whereas most other AML therapies in development are focusing on narrow patient population that's defined by certain genetic markers.
Leslie on targets for bone marrow microenvironment by inhibiting pathways to protect cancer cells from the effects of chemotherapy.
This is a novel approach that we expect could be broadly applicable across the spectrum and range of therapies used for relapsed refractory ordinarily diagnosed patients.
As you know you for less letters E Selectin antagonist science.
The scientific rationale for targeting E. Selectin on the role it plays within the bone marrow microenvironment Scriber for AML resistance is robust.
In addition, our preclinical data supports <unk> protective effects against certain toxicities of chemo such as Mucositis.
You'll recall that in our year end call in March we described the data and research that had been presented at multiple scientific and medical meetings last year. If you haven't already done so I urge you to visit the scientific publications section of our website to review this exciting work.
As we continue to make progress on our pipeline. Our plan is to submit abstracts on key research findings medical meetings in the U S and abroad.
This past month at the meeting of the American Association for cancer Research for a C. R.
We were invited to present a poster on our ongoing phase <unk> study of GMI searching for nine a dual antagonist of E. Selectin Gx here for.
This phase one b clinical trial was designed as a proof of concept study to evaluate pharmacodynamic or PD markers, such as <unk> 30 for mobilization mobilization of circulating tumor cells into the periphery downregulation of soluble E Selectin and other biomarkers for biological activity following both single ascending and law.
All doses within the same patient.
Our goal was to use these PD markers to confirm on on target biologic activity.
We believe we have accomplished this objective is the clinical and preclinical data presented at ACR demonstrates that <unk> 13, 59 is clearly hitting both targets.
This provides us confidence the drug candidate could be broadly active and disrupted the tumor microenvironment with added evidence of immune activation.
On our findings were evaluating indications for moving the program forward in the clinic.
And the sickle cell setting based on inputs on the FCA with respect to Rip a panel as well as feedback from Kols, we're focusing development on GMI 16 87.
We have initiated IND, enabling activities with treatment of acute C O C as a potential lead indication.
We and others believe that GMI 16, 87, maybe ideally suited for this indication as it would enable patients to potentially self administered treatment early in their B O C crisis.
As we've shown clearly from the phase III reset on open label extension clinical analysis early intervention is particularly important to put on to improve clinical outcomes and institute setting.
The intended profile of GMI 16 87.
Fast acting on demand self administered drug candidate also dovetails nicely with the continued shift in patient care for the outpatient setting.
Trend, which has accelerated during the pandemic.
We'll keep you posted as to progress with the 16 87 program as we get closer to first in human dosing, which we anticipate will occur in 2022.
Our research efforts continue to progress, particularly in the collective field.
Also at ACR, Our research team presented new evidence on the effects of one of our collect and three antagonist and a cancer model.
This adds to a robust and broad foundation of preclinical data that demonstrates the high potency and selectivity of our collective three antagonist.
The potency and selectivity of our compounds distinguish us from competitive approaches and we intend to roll out additional data as we move toward our goal of selecting a lead candidate for clinical development.
Also during the first quarter, we promoted Dr. Eric Feldman to senior Vice President and Chief Medical Officer, Eric.
Eric is internationally recognized for his work in the development of new therapies for the treatment of leukemias and related bone marrow disorders.
Our CMO he plays a critical role in overseeing the broad clinical pipeline for Ya Lan as well as for programs that are advancing price.
Importantly, our current cash position provides runway through key milestones and Brian will now comment on our financial results.
Thank you Rachel as of March 31, 2021, glaucoma medics had cash and cash equivalents for a $132 $5 million as compared to $137 million as of December 31 2020.
The company's research and development expenses decreased to $11 $2 million for the quarter ended March 31 2021.
$12 7 million for the same period in 2020 permanently due to lower clinical assay development and manufacturing expenses related to your porcelain.
The company's general and administrative expenses decreased to $4 $2 million for the quarter ended March 31, 2021, as compared to $4 $4 million for the same period in 2020 permanently due to lower stock based compensation expense I'd now like to turn the call back to Rachel.
Thank you Brian.
Before opening the lines to Q&A I'd like to leave you with two takeaways.
First the momentum and excitement around you for Leslie on continues to build as we drive to complete enrollment of two pivotal trials. These are important milestones ahead.
Second in the interim we look forward to sharing both news of newly initiating trials with independent investigators as well as progress on our expanding pipeline underscoring the value of our unique collect on the medics platform.
Operator would you. Please open the lines for the Q&A session.
At this time, if you would like to ask a question. Please press Star then the number one on your telephone keypad once again to ask a question. Please press Star then the number one.
Your first question comes from the line of Stephen Willey with Stifel.
Hey, good morning, Thanks for taking more of a day.
Morning.
Rachel I was just wondering if you can update us I guess on the number of sites that you intend to open across the U S and Europe for the relapse refractory study.
For year end to kind of help you get to that goal and can you just remind us how many sites are activated and open to date.
Yeah. So you. So the sites are generally listed on clinical trials Dot Gov, and I think we have right now around 60 sites open.
Okay and then.
And then just the number that youre, hoping for.
Activate before the end of this year.
So we were near the complete number of sites actually we've got we've got a very robust network currently in place.
We're continuing to activate the small number of sites primarily in Europe for decoupling in the U S. But we're essentially at the full complement of sites today as of today.
Okay.
And just with respect to 13 15 on I know we saw the data.
Our.
And it sounds like Youre evaluating indications.
And which can maybe move is the SaaS on forward.
Maybe just talk a little bit about what those indications may be obviously resolve this in the context of a breast cancer I would imagine there might be on priority, but.
Can you just provide a little bit more color around.
Development options are at this point and if you do move forward in breast cancer is is that also a hormone receptor positive patient population, but you would expect to have.
This against background standard of care.
Any color there would be helpful. Sure sure. So we're not yet in a position to describe the specific next plans, but what will be important though is that whatever we choose is gonna be a targeted and focused indication with Asia again targeted and focused clinical trial. The preclinical data that we've presented has been actually fairly broad in the sense.
Looking at settings, where there is bone involvement in the solid tumor case or in some cases in liquid tumors bone marrow involvement. We also have some very encouraging preclinical data in osteosarcoma. So.
Generally that the scope of indications that we're looking at but again, where we think it's going to be critical both from a strategic and operational standpoint to find the setting where we can move forward in a targeted and focused way and that's going to be of the same as we look through the potential indications that we could that we could take 30 30.
The 59 into.
Okay. Thanks for your questions.
Sure.
Your next question comes from the line of Zach, but Joe <unk> with Roth Capital partners.
Good morning, guys. Congrats on all the progress, particularly on the enrollment for Ya crowd just had a question about that program as well as it relates to ophthalmic Mitch just wondering when you think they might be starting that study after the bridging study.
We expect that to start later this year.
Oh perfect. Okay, and then just again I'm just curious if there's any way for them to leverage some of the phase III data that youre going to be generating as well for approval.
Yes, so I can't speak to their specific path forward for approval in China, I'll leave that to Apolo mix, but we do believe that the programs are complementary and it will be able to there would be able to leverage some of the data on our in our study.
Thanks, Rachel and then again just a follow up I know you mentioned a potential.
Potential investigator sponsored studies for your plan I was just wondering how you plan to leverage those studies for later clinical development and then what indications might you be prioritizing.
Sure. So I wanted to comment on the I S T generally and as we announced them as the year goes forward.
Address each one specifically we've been really gratified in the yoga lesson on program with the.
The support and the interest that we've received from many many kols in the U S and outside of the outside the U S and I think you'd see that of course first in the NCI trial, where where there was a lot of enthusiasm for taking the program forward into the alliance network, but we've continued to see a number of investigators who have come to the <unk>.
With very interesting proposals for <unk>.
Expansion of use of of your per lateral and so were very gratified by that.
And we're working with a small number of investigators to try to go forward in the most well we believe for the most promising areas. So as those as those roll out then, we'll we'll announce them, but I think the general.
Concept is to build on this investigator enthusiasm too.
Broaden the use of the of the.
Drug in these clinical trials, which potentially could give us opportunities as the program advances to continue to to broadened to use ultimately.
In the commercial setting so I would say stay tuned as these trials initiate a one by one we will announce them and then we can speak specifically to each of those approaches as they as they come forward.
Thanks, Nathan on the last one for me just on 17 57, I thought it was exciting but they'll have the different because you guys mentioned.
<unk> solid tumor indications this is a little different from what you're currently doing there just wondering how youre thinking about that opportunity.
Yeah. So the collective represented entirely new opportunity for the company and they they are involved we know from the basic preclinical.
Preclinical science, we know that they're involved in fibrosis as well as in cancer and we think we have a unique approach from a chemistry perspective too.
The creation of a new set of compounds, which as I indicated we believe more potent and more specific than other compounds that have been described by anyone else.
We're continuing right now to explore the potential use of these compounds in a broad range of preclinical studies and and we're also moving towards eventual selection of a clinical asset. So that program is it's early but it's quite exciting in terms of the potential applications and so I think it is too early to describe any specific indication for that but.
But we're very we're very encouraged by the the biological activity by the.
The binding affinities and like I said the specificity that we're seeing in these compounds. We think they are quite unique in the field.
Thank you and actually just one last quick one here. So you do have on solid cash position I think is that as you put it on a 32 million, but I was just curious at multiple programs now in preclinical and clinical development I was just wondering.
What the cash runway might be.
So it's very important looks like go ahead doesn't mean like one comment and then I'll turn it to Brian I think it's really important to recognize that where our operations. Our operational focus remains on your cholesterol and and and that's the that's the that's really where most of the spend is going in with a critical objective of getting the good enrollment completed in these trials, but go ahead Brian.
Certainly.
Let's get on to that.
Cash current cash runway gets us through the end of 'twenty two right now.
Sure.
Thanks, Brian against congrats on all the plan for them.
Thank you thanks Victor.
Your next question comes from the line of Ed White with H C. Wainwright.
Hi, This is Steve Murphy on for Ed wait sorry did you say to the end of 'twenty three for the cash runway.
For the end of 'twenty two right now so we've got about $70 million to $75 million of total expenses in 'twenty, one about $50 million in 'twenty, two so count for getting through the end of that point to for current cash.
Alright, thank you.
Once again to ask a question. Please press Star then the number one on your telephone keypad.
Your next question comes from the line of Kelly <unk> with Jefferies.
Hi, Good morning. This is Jason Bouvier on for Kelly she.
And thanks for taking my questions I just had two questions.
One was from the development of regulatory perspective are there any material differences for a breakthrough therapy designation.
The FDA on the Chinese health agencies on the other question was just.
If you have any specifics on the timing of a data readout for following the interim analysis for the phase two NCI study. Thanks.
Sure as far as the <unk> in China is concerned I can't speak to the specifics of the Chinese designation, but I believe it generally is consistent with what.
But the FDA grants in terms of an opportunity to work more closely with the agency to <unk>.
Tried to expedite development of the of the compound there and as far as data readout at the NCI. This actually is a.
A question that applies both to data readout and a T. I enter data readout for our own trial, which is that too.
Two things have to happen the trials have to complete enrollment and then a certain number of events has to occur to enable to locking the database and.
And so I think as both trials progress more more toward completion of enrollment.
We'll be able to give more specific guidance as to when we might expect the number of events to occur but as of as of today. The NCI has not given specific guidance publicly as to when they expect the number of events to occur, but I think as against a complete enrollment that they may be able to provide some more for more guidance on that.
Alright, great. Thank you.
Sure.
And there are no more questions in the queue I'd like to turn the call back over to Ms. King.
Okay well. Thank you. Thank you very much for your for your questions and for your attention and again I want to.
Emphasized our excitement around the <unk> program.
As well as the.
Asian that we'd be.
Be able to announce ongoing progress just newly initiating trials as the year goes forward as well as.
Some progress with our underlying pipeline. So thanks very much for your support of the company on your interest we appreciate it.
Thank you for your participation. This concludes today's call you may now disconnect.
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On a scale.
On growth.
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This guidance.
Good day.
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On a year.
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