Q1 2022 GlycoMimetics Inc Earnings Call

Good morning, and thank you for training the glycol memetics call at this time, all participants I think listen only mode. Following management's remarks, we will hold a question and answer session at that time the lines will be open for you if anyone should require operator assistance. Please press Star then zero on your Touchtone.

The phone I'd now like to turn the call over to Cheyenne is of Investor Relations Group. That's glad go Memetics. Please go ahead.

Good morning today, we will review our accomplishments and financial results for the quarter ended March 31st 2020 to the press release, we issued this morning is available on the company's website at www dot like on the medics Dot 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 for 30 days in the Investor Relations section of the company's website.

Joining me on the call today from Black on Memetics or her roots American Chief Executive Officer, Brian Hahn, Chief Financial Officer, and Armand Girard Chief Business Officer will start today's call with comments from her real Brian will fall follow to provide an overview of the company's financial position.

Well then open the call for Q&A I'd like to remind you that today's call will include forward looking statements based on current expectations.

We're looking statements on this call may include but are not limited to statements about the company's product candidates you put less of land GMI 16, 87, and other pipeline programs along with statements about expectations regarding our operations cash position and data from preclinical.

Clinical studies or clinical trials as well as planned or potential feature development regulatory interactions and submissions and potential commercialization activities or strategic collaborations such statements represent management's judgment and intention as of today and <unk>.

Thousands assumptions risks and uncertainties glaucoma medics 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 glaucoma medics filings with the SEC, which are available from the S. E T.

Around the glaucoma medics website I'll now turn the call over to her route.

Thank you Sherry and good morning, everyone.

In our year end call eight weeks ago, we shared our outlook and strategy for the year ahead.

We provided updates on both our regulatory and commercial readiness activities all designed to advanced glaucoma ethics, and our lead program for you for us around where their focus towards commercialization.

Our highest priority today is collecting and confirming the data from the 70 sites in the U S Europe , Canada, and Australia that enrolled a total of 388 patients in our phase III Registrational trial in relapsed refractory AML.

This is an ongoing effort that will position us to move quickly to data analysis topline readout and subsequent regulatory submissions once the overall survival events trigger is achieved.

Today, we are updating the projected timing of the event trigger for our topline data readout.

As our phase III data matures, we continue to track events in real time based on current projections, we now anticipate reaching our overall survival events trigger in mid 2023 with top line data disclosure shortly thereafter.

Our plan is to provide updates with even more precision on the timing of this milestone.

We're confident that your plus Ron will prove to be an ideal combination with standard chemotherapy.

It is highly differentiated and hasnt mechanism of action that is complementary to the salvage therapies used today.

Importantly by targeting extrinsic factors of drug resistance in the bone marrow microenvironment, <unk>, Molecularly cytogenetics, Lee and treatment regimen agnostic.

The clinical and research communities are taking note.

Several of the key opinion leaders shared perspectives on your cholesterol and its potential role in treating AML patients and recent medical education programs.

In parallel we have launched a comprehensive effort to prepare for you for restaurants anticipated market entry.

This effort is currently focused on scientific communications.

It will be central to educating the AML community on the role of targeting extrinsic factors of chemo resistance. Some of these materials can be now viewed on our website.

As you know your cholesterol and is also being evaluated in the frontline AML setting by the National Cancer Institute Youll recall that the phase two portion.

This phase two three trial enrolled its last patient last November as well.

As per our protocol the NCI has suspended enrollment in anticipation of its planned interim analysis.

The outcome of the Ncis event free survival analysis of the phase II data is communicated to US we will issue a press release.

Under the terms of our partnership with the NCI, we will be able to access the nci's data in the newly diagnosed setting for regulatory purposes.

In addition to advancing two registrational stage programs, we have several investigator sponsored trials currently evaluating your pillar surrounds potential in additional indications we continue to collaborate with the principles with the principal investigators of these trials we share.

<unk> goal of publishing their findings at major medical meetings as the data matures.

I would now like to comment on the progress we have made with GMI $16 87 in sickle cell disease.

I am pleased to report that the IMD, enabling program for GMI 16, 87 has been completed.

GMI 60, 87 demonstrated no safety concerns from G. L. P 28 day toxicity studies in two different species.

The standard battery of IND, enabling studies of GMI 16, 87 also showed no safety concerns.

We have received pre IMD guidance from the FDA that will be incorporated into our submission.

And we have manufactured GMP drug product that is now on stability to support its use in first in human clinical study.

We remain on track to file the IND in the first half of this year to evaluate the compound in sickle cell disease patients with acute V. Oc has the lead indication.

Filing the R&D represents an important milestone for positioning GMI 16, 87 four partnerships.

I remind everyone that there remains no FDA approved therapy for the treatment of acute <unk> occlusive crisis in sickle cell patients as of today.

With <unk> now in late stage development.

Our third asset <unk> 16, 87 about to enter the clinic.

And the declared orally bio available lead candidates in the collecting three program. We have created a pipeline of assets to accelerate our transformation to a commercially focused organization.

Consistent with this journey last week, we reduced our headcount by approximately 20%.

The reductions were largely in the early stage research and chemistry departments, while we maintained our key expertise and institutional knowledge to support our development efforts.

We greatly appreciate the efforts of our colleagues who helped produce a rich pipeline of future opportunities.

By streamlining basic research, we now have greater flexibility to invest in activities that will advance <unk> commercialization efforts.

Brian I'll now turn it over to you to provide an overview on our financial results. Thank you route as of March 31, 2022, Glycomed X had cash and cash equivalents of $76 $5 million as compared to $93 million as of December 31, 2021.

The company's research and development expenses decreased to $9 6 million for the quarter ended March 31, 2022, as compared to $11 1 million for the same period in 2021.

Decreased expenses were primarily due to lower clinical trial and development costs related to our ongoing global phase III clinical trial of <unk> land and individuals over the last refractory AML as patient enrollment ended in November 2021. The decrease was partially offset by higher manufacturing expenses for <unk> for less land validation batches.

The company's general administrative expenses increased to $5 1 million for the quarter ended March 31, 2022, as compared to $4 2 million for the first quarter of 2021, primarily due to commercialization startup expenses for U S land and higher patent fees.

I would now like to turn the call back to her route.

Thank you Brian .

So to conclude.

We believe <unk> has the potential to transform outcomes in AML patients by achieving deeper more durable remissions higher rates of <unk> negativity and by bridging more patients to a successful stem cell transplant.

This is a novel approach to AML chemo resistance not addressed by existing therapies.

However.

I'd like to stress that the opportunity here at <unk> extends well beyond AML.

The E Selectin ligand and other glass cans are now known to play important roles in cancer inflammatory disease and fibrosis over the years, we have generated a pipeline of active drugs positioned to serve as the foundation of future therapeutic breakthroughs the timing.

Now to demonstrate its full clinical potential.

I would now like to open the line for Q&A operator.

Ladies and gentlemen, if you have a question at this time. Please press the star and the number one key on your Touchtone telephone. If a question has been answered or you wish to remove yourself from the queue. Please press the pound key.

Ladies and gentlemen, if you have question at this time. Please press star and then the number one on your Touchtone telephone.

Your first question comes from the line of Ed White with H C. Wainwright. Your line is open.

Good morning, Thanks for taking my questions.

So just a couple of questions on your pro to start.

Could you give us an update perhaps on your thoughts on the timing to submission.

Following the topline data.

Such as what CMC work, you're doing right now et cetera.

And also.

With the hiring of a chief commercial officer I, just wanted to get your thoughts on the market and maybe you can give us some idea of your.

Initial sales strategy.

Yeah. Thanks, Thanks, Ed for your questions.

So.

Yes, the way the way, where we're thinking of this add is.

We have a great opportunity now to prepare ourselves as data matures. So thats one that event trigger happens within a few weeks, we're able to communicate the topline data and as part of our breakthrough therapy designation.

We have ongoing.

Discussions with the agency anyway, so that we wanted to make sure that we bring that forward fast if just to remind everyone.

Once data matures and that is positive that means for a segment of patients that have not had any true innovation for more than 30 years and that segment is the relapse refractory patient populations fit for chemotherapy that I'm sure everybody will be very motivated for us to move forward.

So that we're planning from now by using our time proactively to make sure where we're cutting time on the backend.

Now the second part of your question regarding.

From a commercialization strategy.

It's too early to kind of talk about the overall.

Strategy from a commercialization perspective, but think of this.

There are 20000 patients in the U S who are diagnosed with AML every year and 12000 of them die every year.

And in the 60% of the patient population that is deemed fit for chemotherapy.

There really hasnt been much advances in the relapse refractory population, which is about 8000 patients of that so you know.

From that perspective, you can imagine there is going to be a lot of ramp the pent up demand given that it's not a competitive market a lot of people have tried to bring in therapies in this area and unfortunately for patients that has not really been working out the last of them was to Rafael.

Pharma asset. So we're very excited to have a shot of bringing in a new therapy for these patients. It's 8000 to start with in the relapse refractory.

More if you take the frontline as well so we're making sure that people are educated.

From now on the mechanism of action because the mechanism of action is quite novel. This extrinsic chemo resistance is quite novel and complementary. So we'll use that time from that perspective. So its first education, and then really ramp up to really focus on that high unmet medical need I hope I answered your question.

Yes, thanks to route and maybe.

<unk> for Brian .

You had mentioned the reduced head count of 20%.

Last week.

How should we be thinking about operating expenses going forward.

For 2022.

As the impact mostly in R&D.

And also if you can give us your thoughts on your cash runway.

<unk>.

Thanks, Ed.

I think previously we had guided to about a $60 million spend for 2022. The reduction is several million dollars from the head count reduction, but will continue to be laser focused on where we spend our resources. So I would say that 2022, and maybe a slight reduction in some of the spend and constantly reviewing to make sure where we actually are spending on.

Money.

With that current cash on hand gets us into the third quarter of 2023.

Yeah.

Yeah.

Great. Thanks, Brian .

Your next question comes from the line of Boris Becker with Cowen Your line is open.

My first question is on the NCI study could you comment on the timeline. When you think we'll get the data from the phase II part of the study and the second component of it do you know what's required kind of what the threshold is in order to commence the phase III part.

Sure Boris good to hear from you maybe maybe I'll.

Before I pass it to Armando.

We're very excited about that partnership we've been having ongoing dialogue with the NCI and <unk>.

<unk> is leading that effort. So do you want to comment on this Omar Yeah, Hey, Boris So the phase II component is event based its event free survival.

We don't get details with regards to the you know the specifics of when that analysis because it would be conducted so the way the trial runs as they've completed enrollment.

In November of last year.

Enrollment is suspended for the time period at which they are waiting for the data to mature and when they conduct the actual analysis.

When the analysis is done they will.

Communicate the outcome to US and then we also have they will also transfer the data to us confidentially to support our regulatory.

Submissions.

With regards to.

The decision points.

Basically two of them.

They are trying to show is that it.

The combination arm of <unk>, plus seven and three achieves a hazard ratio of better than 831.

Then the study will proceed as promising into phase III and.

And if the hazard ratio is better than six four.

That's what they would classify as overwhelming efficacy.

Then then that would be a signal that.

That we would act on.

Sure.

But it sounds like you don't have an estimate of timing of when we should see that data at this point.

Yeah, Dan has not communicated that Boris.

Different versions, but it would be.

More rumors in anything else.

As our mindset once they are ready they will communicate to us.

It would be typical to think that in <unk>.

Primary endpoint trial should theoretically faster Nols.

But again that would be more ask estimating rather than having a official communications from them.

Got it great. Thanks, very much for taking my question.

Yes.

Your next question comes from the line of Roger song from Jefferies. Your line is open.

Great. Thank you for taking our questions. So first one also about the <unk> phase III. So can you just comment on what drive this mid year projection for the event triggering leica enrolment or the events. So far also can you comment on the current job portray our event rates.

Did that kind of in line with your previous expect expectation.

Yeah. Thanks, Roger so.

This does that.

Things that we have disclosed I mean as you know the start the trials started in November .

18 and ended in November 21, so over a three year period, we have.

Enrolled 388 patients.

And the study is in overall survival.

And driven so what drives it is events.

The more the more we have events towards the pre specified number the faster the data.

Event trigger what's happened.

The way the way I think about it is once we are saying midyear 2023.

You look at.

<unk> patient enrolled is November 2021.

And <unk>.

Event trigger is estimated at the middle of 2023 that cycle, It's 18 months 19 months.

Period.

What drives it is events.

But if we have faster events, we have a faster trigger if we have slower events.

We have a slower triggered a timeline.

<unk>.

As I've mentioned, a couple of times before.

I would rather be in a situation where there is slower events, obviously puts more pressure on getting data out there, but that means that patients are living longer now obviously with the right caveats of we don't know which arm there on when you don't have access to anything other than the pool data.

But that's kind of what's driving it is when you have those events you put them into the statistical model and we've run this several times now.

It's indicating at this point towards a mid year 2023.

Got it that's helpful. Okay. So.

Regarding the early pipeline so with the recent kind of.

The reduction what would be the development plan for the other a couple early stage pipeline like the <unk> 59 and <unk>.

Collect tends to <unk> inhibitors.

Yeah. So just to reiterate what we've said the reduction in head count has been predominantly in the early research discovery.

Part of the organization and in fact, we're looking at the later stage or the development part.

Medical affairs part to be to be enhanced over time.

It doesn't have any impact on those Roger because.

A lot of the biotechs will have one lead asset and that said we have one of these assets. We have 13 59 that wasn't clinic now 16 87, we're filing an IND. So that can be ready for clinic and then we have <unk> and three where we declared eight weeks ago, the orally bio available.

Our lead asset of 2093, so we already have four assets to to really advance and the whole point, what we wanted to do is to really keep the institutional knowledge of Glycobiarsol. Because we believe that is really the differentiating factor for us versus other players out there.

We've honed this over last 18 years, but to do additional work in chemistry and early development at this point, that's kind of what we've paused and we're really pivoting towards a commercialization focus meaning more development Medical affairs education activities and we can always.

Go back and ramp up that department as we advanced <unk> because of the fact that we're keeping that institutional knowledge in house Roger So.

We've been very deliberate about how we go about doing it.

As you know biotechs have to make choices, especially these days, but we're in a position where we already have four assets, where we are.

We're looking at and we believe we have the team that can advance them over the next 12 to 18 months until data maturity with your crossroads.

Got it yes, that's helpful.

Glad to see you still keep the bulk of the pipeline. Okay. So maybe just a last quick one in terms of the <unk>.

And the cash runway guidance I remember last time, you say that cover the <unk> pivotal studies CMC and.

R&D, enabling studies for 16 87, just wanted to confirm for the 60 87 face one that's mostly just the weighting seeking for partnership not kind of included in your current cash runway guidance right.

Correct, yes, so what we're doing with 16 87, Roger is really advancing the IMD, we believe that filing an IND and getting.

Notice for.

Safe to proceed in humans is going to be a very important milestone.

That can you know then we will be more open to partnership discussions and of course, when we are talking partnerships not just not about the funding of the of the clinical trial, but also like minded people, who can bring in expertise and who will believe like us that the vascular occlusive crisis of sickle cell patients.

Ah remains a very high unmet medical need that we want to tackle.

So yes that is not in the cash runway at this point beyond the IND filing for $16 seven.

Got it. Thank you that's it for.

Thank you.

Yes.

Yes.

Yes.

Your next question.

Comes from the line of <unk> <unk> with Roth Capital Partners. Your line is open.

Yes.

The first one I think it's probably just a follow up to that.

Last one.

Todd.

As <unk> 87, which just.

I was just kind of curious there about.

How are you thinking about the partnership.

No you just had a reduction in your ear tube and I was wondering do you anticipate looking for something with that.

Yes.

Or more on the backend and what's coming up on when you would think that you could use that.

It works.

Perhaps mckinney air team or additional capital towards accelerating.

I shall plans for your plan.

Yeah, Thanks, Doug rather than a nice to catch up again so.

I mean in partnerships and we're flexible from a partnership perspective.

Open to different ideas as long as we're we're not flexible is the thinking that we want to really address the vaginal occlusive crisis.

Sickle cell patients. So that's kind of where we appeal passionately about it and we wanted to have a like minded partner, who can advance obviously funding will be important.

But also this direction is also as important as.

As the caching upfront is it afterwards, we're open to it obviously the more cash it would be upfront and we're going to have to give.

Value on the backend and so on so forth. So we will evaluate these carefully as they as they mature.

Idea is that it.

We believe it has to be a credible partner in terms of vision as it first starting point and Armand do you want to comment.

Hey, Z I would I would I would say right off the bat the stage of the asset matters. If it was a preclinical asset.

Typically those deals are more back ended but.

And I N D is a significant derisking and also a value creating event for glaucoma medics and.

This compound is a thousand fold more potent than new per less land and while we always expected a clean tox profiles showing at demonstrating it.

As an important fact, along with the making of the drug product and have it on stability and ready to go in the clinic. So we think we're in a very strong position. There has always been interested in this program, but having the IMD and thats safe to proceed.

Go from the FDA is going to be valuable to us, but also very valuable to.

Prospective partner and we think that should translate into deal terms.

Thank you and I think the data even for Liza canceled and those are just some further mine. Thank you provide.

Efficient proof of concept and now you're just using that discipline.

February net debt, but that's that's really interesting and I think another question that I wanted to ask just about you proudly China estimate when we could see the data at that maybe it'll be helpful for you to remind folks on.

What are you seeing the standard of care agents should provide intends that yes, that's in the newly diagnosed setting or in terms of OS.

The relapsed refractory setting.

Okay.

Yes.

In the newly diagnosed setting.

Yes.

<unk> Z was just what is the expectation with regards to.

What we're trying to beat is that what you're trying to get at.

Yeah. So what is the standard of care agents actually got a got you and then I guess, we'll be looking for anything beyond that yes.

Yes, so with regards to the frontline setting on the <unk> you would expect something around seven months best case.

And so what we're trying to show is something in excess of 11 plus.

Okay.

And then on the relapsed refractory is yeah. As you know it says that's has been quite stable for many many years around that six months overall survival.

Point.

With with transplant rates hovering around 15%, 20%.

Lately with some advances in transplantation techniques that has inched a bit higher to more like 25% ish. So that's kind of an area of focus for us is.

Getting patients to a deeper remission with <unk> negativity as the indicator.

We've seen a 69% in our phase two data and as we know them already negativity recently, there's been several publications that say that's the best indicator for how patients will do post transplantation. So we're trying to beat.

You see that six months overall survival, but really how by by getting deeper remissions by MRV negativity by bridging more patients to transplantation. That's why our phase III has not been censored for transplant and we're pleased with those directions and all of that hopefully will translate into a <unk>.

Longer overall survival.

So we're eagerly waiting for that data too.

Two comments, so that we can see what's what's happening, but that's the plan that's what we're trying to beat.

And I would add and see that the NCI trial is not censored for transplant, either so transplant, that's a good outcome for us so.

With ESI, that's either failure to get a response relapse or death, but.

If they get transplanted, which we hope they do that's not going to be censored at the time that that occurs that's a good outcome.

Thank you Ellie help win that additional color.

Nonsense or English.

As people try to try to estimate what we could actually see the data and then the last one he is just a combo question I think the first part.

The lead program I know you've mentioned plans to kind of partner that I was just wondering where you are with that effort again I think folks would just be interested in kind of understanding potential play additional cash coming in from any of these partnerships and then the last one is just on GMI 13 59.

Again, what are the plans there are you planning to move. This forward are you going to put any additional capital into this program.

Also may be considering partner he had as well.

So let me address your last question first and then I'll ask our Monterey on your first question. So on the 13 59 Z I mean, obviously, we have <unk>.

Eight weeks ago, when we announced that we have closed the Duke trial.

Phase one given that we have seen activity.

On both the <unk> and E. Selectin components. So we were pleased with that Thats why we close that trial.

And then we're now we're more into strategic options for 13 59 to be honest, because where we are is we got to make some some choices.

That we have gotten it to a point where it's.

It is ready for our next phase, but we got to kind of think.

I think of our cash runway and we're really doubling down on your cholesterol and 687 accelerating it towards a.

Indeed.

And of course on the Galaxy <unk>, three as well before I hand, it to our <unk> for comments, we've also eight weeks ago.

Now the.

Now we declared a orally bio available dose so maybe or Mark can you give us some color if any over there yeah, no listen I think that.

While we were what we wanted to get to was having an oral compound neglected three plays a significant role in diseases like Nash.

Cardiac fibrosis.

Video Pathic pulmonary fibrosis as well as some cancer settings in the data.

Is very strong in those arenas, but having an oral compound was was a significant breakthrough for us.

We are in full partnering discussion mode on GMI 2093, and the goal is to get to a point of having a research collaboration and option agreement with <unk>.

With a partner and those activities are ongoing as we speak.

Thank you William pass at the Frac guys Congrats.

Thanks, again, ladies and gentlemen, if you have a question at this time. Please press Star then the number one on your Touchtone telephone.

As there are no more questions in the queue I would like to turn the microphone back to Mr. Sam Hi, Shang.

Thank you and I would like to thank all of you for your time and attention and May and June were planning to be in two different investment conferences in person.

At HC Wainwright Global investment conference in Miami at the Jefferies Healthcare Conference in New York City. So we look forward to our one on ones that can be scheduled and to updating you on our progress and outlook. Once again. Thank you so much for joining our call and have a great day.

Ladies and gentlemen. This concludes today's conference call. Thank you for your participation and have a wonderful day you may all disconnect.

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