Q3 2022 GlycoMimetics Inc Earnings Call

Okay.

Good morning, and thank you for joining the glaucoma medics Q3, 2022 earnings call. At this time, all participants are in listen only mode.

Management's remarks, we will hold a question and answer session to ask a question. During the session you will need to press star one on your telephone you will then hear an automated message advising you your hands raised I would now like to turn the call over to Christian Dinneen Long Company Counsel Act like Goldman Sachs. Please go ahead.

Good morning today, we will review our business updates and financial results for the quarter ended September 32020 to the press release, we issued this morning is available on the company's website at <unk> Dot com under the investors tab. This call is being recorded.

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 <unk> are hurts emerging keeps our chief Executive Officer, Brian Hahn, Chief Financial Officer, Dr. Ed Brock Chief Medical Officer, and Bruce Johnson, Our Chief Commercial Officer, we will start today's call with comments from Peru, who will provide a broad overview of the business and updates on the <unk> development program.

Followed by Ed with additional commentary on you brought muscle and clinical studies, including both company and investigator sponsored trials. Brian will then provide details on the company's financial position before we open the call for Q&A.

I would like to remind you that today's call will include forward looking statements based on current expectations.

Forward looking statements on this call may include but are not limited to statements about the companys product candidates <unk> and our other pipeline programs along with expectations regarding our operations cash position and the conduct of or data from clinical trials as well as planned or potential development regulatory interactions our submissions.

Pre commercialization activities and strategic collaborations.

Such statements represent managements judgment and intention as of today and involve assumptions risks and uncertainties glaucoma that ex undertakes no obligation to update or revise any forward looking statement for.

For information concerning the risk factors that could affect the company. Please refer to our filings with the SEC, which are available from the SEC or on our website I will now turn the call over to Harry.

Thank you Christian and good morning, everyone. This past quarter, we made substantial progress with our pivotal phase III trial of your pro that surround in combination with chemotherapy in patients with relapsed refractory acute myeloid leukemia, and we further strengthened our foundation in line with our goal to become a commercial stage company.

We're particularly excited to share with you today that the U S food and drug administration recently cleared. The addition of an interim utility analysis to argue for less for a phase III study protocol.

Believe this interim futility analysis to be essential given that the blinded pooled patient population in our study is living longer than expected.

As part of our decision we conducted a careful analysis of the follow up data from previous AML trials.

We engaged in multiple discussions with medical experts and we met with the FDA in order to validate our plan.

As a reminder, we completed enrollment of our pivotal trial one year ago. This same week and as we announced in our second quarter earnings call. The phase III population is broadly similar to that of our completed phase one two study with respect to age.

Severity of AML prior stem cell transplantation rates and distribution of relapsed and refractory patients, which taken together gives us confidence that we recruited the appropriate patient population.

The phase III study is slower accumulation of blinded pooled sort of survival events prompts us to extend the overall survival. The event trigger projection for final analysis from midyear 2023 to around year end 2023.

Simultaneously, we see an ethical need for this interim analysis to address the possibility that this slowdown in patient events may relate to benefit from your <unk> study therapy.

As part of the interim analysis. The studies independent data monitoring committee or DMC is expected to meet by the end of Q1 2023.

We will consider whether to continue to the original 100% overall survival events trigger or if the efficacy data for treatment with <unk> in combination with standard chemotherapy is observed to be compelling they'll recommend immediate on blinding and trial analysis completion.

We owe it to AML patients to assess the drivers for slower accumulation of blinded pooled survival events in this disease, which remains one with high unmet need.

And limited treatment options.

Fortunately this interim analysis preserves 95% of the Orajel designs Alpha and enables us to maintain the study blind if the independent DMC recommended continuation to final analysis regardless.

Regardless of whether the Dmc's recommendation enables us to expedite registration filings or we continue the study as originally planned we are excited by your <unk> potential to improve outcomes in the relapsed refractory AML and help patients achieve deeper more durable remissions.

That bridge them to potential curative stem cell transplantation and improve overall survival.

From a commercialization standpoint, we continue to focus on three key areas first to drive awareness and educate medical experts on E. Selectin biology in AML and <unk> unique and differentiated mechanism of action.

Second to drive awareness of <unk> clinical development program and third to expand our partnership with global medical community.

Bruce Johnson, our Chief commercial officer will be available for Q&A to discuss these ongoing efforts, which we expect to position us well as we approach key phase III milestones.

Overall, the third quarter marked a period of significant progress and steady execution for graco metrics. We have the team in place to advance your progress around and delivered the therapy to patients who need it I'm pleased to be joined on this call by Dr. Ed Rock, who we welcomed to glaucoma ethics just yet.

Few short months ago, as our Chief Medical Officer he.

He will provide additional context on our phase III, how it compares with other historical large randomized AML trials and how this comparison reinforces our confidence in <unk> potential to address significant unmet need for more effective AML therapies.

Ed will also share updates on investigator sponsored you perhaps around trials two posters will be presented at the upcoming American Society of Hematology annual meeting that will represent the first clinical data presentations for this therapy outside of company sponsored trials.

These posters provide support for our belief in the potential broad utility of your professor and cross the AML spectrum from treatment naive to notoriously unresponsive treated secondary disease, Ed I'll pass it on to you to share more detail.

Thanks, Robert and thanks to everyone for joining our call today.

Let me begin with how <unk> could fit into the AML treatment landscape.

As a reminder, AML was the second most common type of leukemia, and the highest cause of death, among all patients with leukemia.

About 55000 people in the U S are now living with AML and more than 20000 adults are diagnosed annually.

People with AML suffered dismal outcomes after frontline therapy about 70% of newly diagnosed patients relapse within three years.

Five year survival languishes at 29% despite.

Despite introduction in the last five years of several new therapies high unmet medical need persists, given MLS heterogeneity and drug resistance.

<unk> is our investigational first in class E Selectin antagonist.

E Selectin mediated myeloid cell attachment to blood vessels regulates their survival and thus contributes to chemotherapy resistance you.

You promised land blocks cancer cells from binding to select and on blood vessels, and thus interrupts the pro survival signal conferred by E Selectin binding.

We believe that by targeting this novel carbohydrate recognition mechanism you provide someone will disrupt leukemic cell drug resistance and potentially improve outcomes for patients with this devastating disease.

As <unk> explained in our pivotal phase III study of <unk> in relapsed and refractory AML blinded pooled survival events show that people in this trial are living longer than would be expected based on historical benchmarks.

As such we approached the FDA in late summer about adding an interim analysis to assess whether the slow survival event accumulation relates to <unk> study treatment in <unk> and benefit.

The FDA cleared our plan at a meeting earlier this fall.

Interim analysis will occur once will occur once about 80% of original planned events are observed.

The studies independent data monitoring committee is expected to meet by the end of Q1 2023 to consider whether to continue to the original 100% OS events trigger or alternatively to recommend immediate and complete trial analysis, if efficacy data from study treatment.

With <unk> plus standard chemotherapy is observed to be compelling.

Recent overall survival benchmarks in relapsed and refractory AML are between five and seven months the.

The target survival hazard ratio in our phase III study is 0.68 that represents a 32% reduction in risk of death at any point in time.

Regulators patients and clinicians have agreed that this level of survival prolongation is significant and clinically meaningful.

In contrast to recent trials in relapsed and refractory AML that failed to show improved survival over cytarabine alone too.

Two recent AML trials that did meet their primary survival endpoints had notably higher median follow up duration at the time of analysis.

Telus is phase III Admiral trial showed Gil to written superiority over salvage chemotherapy in <unk> three positive relapsed and refractory AML at 18 months of median follow up and just this phase III study showed <unk> 351 superiority over seven plus three chemotherapy.

In secondary AML at 21 months of median follow up.

Median follow up in our <unk> study was 19 five months as of September 2022.

Based on the time course of events to date. Another 15 months is now projected for accumulation of sufficient survival events to trigger the original protocol specified analysis.

Should the events trigger extend to around year end 2023 that would mean median follow up duration at time of analysis of more than 30 months more than 30 months that number is unprecedented for follow up duration in a trial of novel relapsed and refractory <unk>.

AML therapy.

If interim analysis demonstrates compelling evidence of benefit from addition of <unk> to AML therapy, then we want to recognize that benefit as soon as possible in order to accelerate product availability to all eligible patients with relapsed and refractory AML.

Alternatively, if the DMC recommended we continue the study through the full survival events trigger <unk>.

Specced at around the end of 2023, we remain confident that events are reflected in the original study design may still illustrate substantial patient benefit of <unk> land study therapy.

Interim analysis, we will spend less than 5% of total alpha allocated to the primary endpoint that.

That translates to a final analysis P value of 0.048 instead of the original two sided 0.045.

I also spend within interim analysis is intentionally conservative in order to ensure that any conclusion of benefit would be based on compelling evidence of benefit.

This high stringency threshold for declaring a positive trial is not met at interim analysis than about 95% of Alpha remains for the final survival analysis described in the original protocol roughly the same as the original planned final analysis.

Whether the Dmc's recommendation enables us to expedite registrational filings or we continue the study as planned through the full survival event trigger we remain excited by <unk> potential to improve outcomes in relapsed and refractory AML.

Separately, we are pleased that results from two investigator sponsored trials of <unk> will be presented at the upcoming Ash annual meeting.

These trials are exploring <unk> potential to benefit patients with AML beyond those with relapsed refractory disease alone.

Dr. Brian <unk> of the University of California, Davis will present preliminary results from his phase one study that indicates a tolerable safety profile of <unk> land with Asia Cider, Dean and Venetic lax in people with untreated AML, who are unfit for intensive chemotherapy.

In addition to encouraging safety. This combination also shows encouraging evidence of disease activity, including an overall, 50% rate of <unk> negativity in eight evaluable patients as well as 67% <unk> negativity among these responders with complete responses.

Or cri.

Additionally, Dr. Emmanuel all months of <unk> will present results from preliminary results from the first 10 patients of a phase one b slash II trial, showing that your progress of land with Cladribine plus low dose cytarabine was similarly, well tolerated.

This combination produced an overall response rate of 62% and a very high risk population of treated secondary AML patients, having expected median survival of less than five months.

We're grateful to the clinician scientists running these <unk> for their dedication to exploring potential benefits of <unk> less land in patient populations with high unmet need also we appreciate and thank the patients that have consented to testing investigational you for less land.

These presentations are the first <unk> first clinical you professor Wang data generated outside of company sponsored trial.

Trials in relapsed refractory and frontline fit patients.

Despite limited numbers. These data provide support for our belief in the potential broad utility of <unk> across AML disease indications.

These data demonstrate combinability with other available therapies as well as evidence of a favorable safety profile without dose limiting toxicities.

We look forward to sharing more about these studies at Ash in December .

Beyond the studies described <unk> Atlanta is also being evaluated by the National Cancer Institute or NCI, and an independent randomized open label trial in frontline newly diagnosed AML patients, who are 60 years and older.

This clinical study is evaluating whether addition of <unk> to a standard seven plus three regimen in older adults leads to improved outcomes.

Phase II portion of this phase II slashed III trial completed enrollment of 260 patients in November 2021, one year ago. Further protocol NCI has suspended further enrollment in anticipation of its planned interim analysis of event free survival.

When available we intend to share the outcome of the Ncis phase II interim analysis, and whether the trial will reopen for phase III.

This NCI trial gives us another opportunity to confirm <unk> benefit and potentially to expand our label to include frontline AML.

Importantly, the outcome of Nci's phase two analysis is independent from that of our pivotal phase III study in relapsed refractory AML and thus provides an additional near term opportunity for you for lesser land beyond that in relapsed and refractory AML.

Now I'll hand, it over to Bryan for an overview of financial results. Thank you Ed as of September 32022, glaucoma, <unk> had cash and cash equivalents of $51 $6 million as compared to $90 $2 million as of December 31, 2021 Q.

Q3, cash burn slowed to $8 6 million as compared to $30 $1 million over the first two quarters of 2022.

We expect our current cash resources will fund our operations through the end of 2023 as a result of a decrease in expenses driven by the transition of the phase III relapsed refractory AML clinical trial to follow up.

Completion of key U S land commercial manufacturing activities and realization of savings from the head count reduction in the first quarter of 2020 to.

Allocation of resources will continue to prioritize the advancement of EPS land development program, including key regulatory and pre commercial activities.

The company's research and development expenses decreased to $4 9 million for the third quarter ended September 32022, as compared to $13 $3 million for the same period in 2021 decreased expenses were primarily due to lower global phase III clinical trial and development costs as patients enrollment ended in November 2021.

The company's general administrative expenses decreased to $3 $8 million for the quarter ended September 32022, as compared to $4 $1 million for the third quarter of 2021, primarily due to lower professional fees.

I'd now like to turn the call back to her.

Thank you Brian as today's update demonstrate this is a very exciting time for us at glaucoma metrics.

Given longer blinded pooled survival than expected in our phase III study, we look forward to conducting this analysis this interim analysis.

Regardless of whether the interim analysis demonstrates that the data is compelling enough to expedite registrational filings.

We continue the study as planned through the final overall survival events trigger we're confident and excited about the potential for you for us around to improve outcomes in the relapsed refractory AML and remain committed to bringing this product to market as quickly as possible.

We're proud of our sustained clinical progress not just in this pivotal phase III study of <unk> in the relapsed refractory AML, but also in the Isps that Ed just described.

Though these are preliminary results from a limited number of patients they continue to illuminate for lesser as encouraging potential in additional important AML patients populations.

In parallel with these clinical activities our experienced commercial team led by Bruce continues to prepare our organization to successfully deliver <unk> to patients if approved.

These exciting advances advancements position us well to continue working towards our goal of improving the lives of patients with cancer and inflammatory diseases and we look forward to sharing updates with you on future calls.

Now like to open the lines for questions operator.

Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced please stand by while we compile the Q&A roster.

Sure.

Sure.

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

Good morning, Thanks for taking my questions.

Regarding the potential <unk>.

Meeting and determination in the first quarter of 'twenty three.

Perhaps you can just discuss potential regulatory.

Time and development timelines following that data if it is positive.

Yes, good morning, good to hear your voice.

So yes.

As we said.

We anticipate the independent data monitoring committee to meet by and quarter, one to really discuss one off to.

Possibilities with this utility interim analysis, we either continue the trial as planned at 100% events, which currently we anticipate.

We move that date for a midyear 2023 to <unk>.

<unk> year end 2023, or if there is compelling efficacy.

<unk> seen by the <unk> then they will recommend to the company.

Stopping the trial and the immediate on blinding of the trial to your question at what happens then obviously, we're very committed if whenever that.

For data happens mid at the interim analysis or by the year end.

Remember we have fast track.

Orphan designation and we're already.

Discussing with the FDA as you have seen.

As part of our interim analysis. So we wanted to make sure that we're.

As part of that fast track and of course, the breakthrough designation, we rapidly move forward with our regulatory pathway and our regulatory team is really ready.

And waiting for that moment to happen so stay tuned.

Okay. Thanks, and you did a good job discussing the potential opportunity in the U S. How should we be thinking of potential opportunities outside the U S.

Yes of course, I mean, we're first focusing on the U S and given it's the largest market with the largest opportunity in the first one obviously, but at the same time as a reminder for everyone. Our trial as well balanced and it's enrollment between the U S and ex U S.

So we have a significant presence as well in terms of patient enrollment and medical activities ex U S. As well so the plan would be the moment where.

We're moving forward and then we will focus on on X, yes, but maybe.

Bruce do you want to add a couple of maybe.

Thoughts or color for <unk> of some of the activities ex U S.

Yes. Thank you Ed I mean, we're continuing to engage medical experts around the globe.

We're getting very encouraging feedback on their reception of the data thus far in our current development program.

As <unk> mentioned, we do have ongoing discussions with regulatory authorities in Europe and fully plan to pursue.

Our registration in a variety of major markets around the globe.

I would say also with that we are keeping all options on the table certainly as well as.

Certainly.

Potential partnerships et cetera, but.

We're exploring all options as we look at the opportunity for you for the last one.

Thanks, and perhaps the last question if I may.

Just regarding the.

Isps.

How should we be thinking about the potential there for the company to follow suit and look at these potential indications.

Would you be waiting till after potential approval or is that something that youre looking at now and perhaps we could see something in 2023.

Yes so.

Basically what we are doing guys as a reminder for everyone. We're pursuing we believe that <unk> has a role to play across all.

The populations in AML from the naive treatment naive to the really difficult to treat.

Secondary AML. So the plan is to really make sure that from a regulatory pathway, we pursue our pivotal trial.

In relapsed refractory AML, so that's really our big anchor.

Additional.

Parallel to that is the NCI trial in the frontline setting. These are both registrational great trials that are that are moving and advancing and maturing. The data is maturing as we speak and then you have these additional Isps, that's really supplement the understanding of their all of you for lesser and across different AML.

Subpopulations remember these are populations that are all I would say have a high unmet medical need at different levels.

And there is an opportunity to pursue the addition of your for lesser onto other standard therapies, because we believe with the low toxicity profile of your cholesterol and if it is able to generate additive efficacy then it has the potential to really be adopted across all AML.

Appalachia so.

The whole idea is first we pursue our pivotal trials, obviously, we want to make sure we get to market. But then has as the data is emerging there is a significant opportunity to really advance the clinical development program with <unk> beyond what will possibly the first indication of relapsed refractory.

<unk>.

Yes.

Great. Thank you.

Ed.

It does it does thank you very much.

Thank you.

At this time I would like to remind anyone if you would like to ask a question. Please press star one on your phone.

As there are no more questions I'd like to hand, the call back to Mr. <unk>.

Thank you operator.

And to everyone for joining our call today, we will also be presenting at several upcoming investor conferences, including Stifel and Jefferies in London. This month, we look forward to speaking with many of you then thank you very much back to you operator.

That concludes today's call you may now disconnect. Thank you.

Okay.

Okay.

Okay.

The conference will begin shortly.

As Johan during Q&A, you can dial star one one.

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