Q4 2021 GlycoMimetics Inc Earnings Call
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Today's conference is scheduled to begin shortly please continue to standby and thank you for your patience.
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Good morning, and thank you for joining the glaucoma and medics call. At this time all participants are in a listen only mode.
Management's remarks, we will hold a question and answer session and at that time. The lines will be opened for you. If anyone should require operator assistance. Please press Star then zero on your Touchtone telephone.
I would now like to turn the call over to Shari.
Since group at Michael Memetics. Please go ahead.
Good morning today, we will review our accomplishments and financial results for both the year and in the quarter ended December 31, 2021. The press release, we issued this morning is available on the company's website at www dot like all the metrics.
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.
Joining me on the call today from Banco Mimetic Safra roots Americana, Chief Executive Officer, Brian Hahn, Chief Financial Officer, and Armand Girard Chief business Officer.
We will start today's call with comments from Peru, Brian will follow and provide an overview of the company's financial position. We'll 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.
Forward looking statements on this call may include but are not limited to statements about the company's product candidates you for lesser land GMI 13, 59, GMI 16, 87, and our other pipeline programs along with statements about expectations regarding our operations.
Cash position and data from preclinical studies clinical trials as well as planned or potential future development regulatory interactions or submissions and potential commercialization activities are strategic collaborations.
Such statements represent management's judgment and intention as of today and involve assumptions risks and uncertainties.
Michael the medics 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 <unk> filings with the SEC, which are available from the SEC around glycol Memetics website I will now turn the call over to Harris.
Thank you Sherry and good morning, everyone two.
2021 was a transformative year for glaucoma metrics.
We advanced from a research based company to a commercially focused organization.
Our number one priority was completing enrollment of our own phase III pivotal trial evaluating <unk> in relapsed refractory AML patients.
Towards the end of the year recruitment for our trial increased significantly reaching full enrollment in November .
Within two weeks of enrollment completion of our trial the phase II portion of the NCI phase two three clinical trial in newly diagnosed AML patients also completed enrollment.
Both trials exceeded their patient recruitment targets with over 650, AML patients enrolled across both studies.
This was a significant achievement, particularly during a global pandemic that had negative impact negatively impacted numerous clinical studies in our industry.
Looking forward our focus is preparing for a potential submission of a new drug application and the commercialization of your per restaurant.
We are diligently collecting and preparing our phase III data for analysis.
Our breakthrough therapy designation provided us an opportunity to interact with the FDA on numerous occasions during 2021 .
Based on these interactions we believe that our non clinical and CMC package will support registration.
You should know that we have also manufactured the registration batches of drug product support the NDA.
To further enhance our NDA readiness, we are taking additional proactive steps that extend beyond clinical operations to bolster our CMC regulatory medical affairs and commercialization teams.
As you know the primary endpoint for our phase III trial of overall survival is event driven.
Based on our current projections, we expect topline results to come in after year end 2022.
As more events occur our goal is to provide more precision on the timing of the topline readout.
With regards to the NCI sponsored trial, we expect to receive the interim analysis of event free survival on the 267 patients enrolled.
We will press release the data when the NCI shares its analysis with us.
The results will determine the next steps for this program. Most importantly, whether the data could support a filing for accelerated regulatory approval.
Whether the phase III portion will move forward or whether the trial will stop.
In the interim analysis, if the interim analysis is compelling the NCI is data in the newly diagnosed setting will be transferred to us for regulatory filing purposes.
Externally you for restaurant is getting featured in clinical journals and expert forums.
In September the phase one two data supporting deep restaurants potential was highlighted in the online edition of blood.
The article reported that 69% of patients achieved minimal residual disease negativity.
Which has been shown to be the strongest predictor for overall survival in AML.
The importance of achieving CR Mardi negativity was highlighted in two recent publications.
One by the group at MD Anderson Cancer Center and another at the University of Wisconsin School of Medicine.
In both these publications.
<unk> conclude that in patients with relapsed refractory AML.
C R with MRV negativity was associated with the best outcomes.
Patients, who achieved CR with MLD negativity had the lowest rates of relapse.
And best two year survival.
Which was driven largely by an increased ability to undergo stem cell transplant.
The blood article also concluded.
First despite over 50% of patients being classified as having high risk leukemia, we observed a 41% CR cri rates with the addition of your progesterone.
Of note, 35% of these responses were full see ours, which highlights the quality and depth of response.
Second 50% of patients achieving a CR cri went onto allogeneic transplant.
And finally all of this culminated in prolonged survival, which is a great outcome for patients.
Just last month. The same article was published in the journals print edition. These data were placed in a blood expert commentary by them and by MD Anderson experts.
The authors confirmed that the results of this phase one two study are encouraging and.
And expressed hope that this approach of targeting the bone marrow niche will improve clinical outcomes in the phase III trial.
We are also pleased to see the role of E. Selectin antagonism being discussed in the clinical education forums.
Last month during the Darva oncology acute leukemia Forum. This novel extrinsic approach to targeting E. Selectin mediated chemo resistance with your progress around was highlighted during several experts presentations.
During the plenary session focused on leukemia microenvironment presentations.
Presentations from three medical experts reviewed data implicating E selectin as a key mediator of leukemic cell drug resistance and the potential role of your progress, Iran and deepening remissions.
Collectively this external recognition gives us great confidence of your pro restaurants potential to positively impact the lives the lives of AML patients.
Dry kinetics is chartering a new approach for treating leukemia.
As Youll recall leukemia lives in the bone marrow.
Their leukemic cells induce the expression of E selectin to promote their pro survival pathways and also to protect themselves from the effects of chemotherapy.
If we expect to have any hope of further improving outcomes in this patient population, we must disrupt these interactions.
You Pressrun represents this new approach of disrupting extrinsic factors of chemo resistance.
We believe <unk> has the potential to be transformative for relapsed refractory AML patients very high unmet medical need still remains.
In addition to these achievements 2021 was also a year of transition for us in terms of leadership.
I joined the company in August when my predecessor retired I saw an organization with a highly novel Microbiology based approach.
A pipeline of first in class drug candidates and the focus on underserved patient populations.
That has significant commercial potential.
After seven months on the job I continue to be enthusiastic about the progress around about the pipeline and definitely about our people.
To complement our strong team we've added three accomplished leaders.
Lisa de Luca joined Us as Vice President regulatory Affairs Dr.
Dr. <unk> is a veteran regulatory expert who has previously led the strategy formation and execution of multiple global NDA submissions and product registrations.
Our focus will be to advance our NDA and continue to engage the FDA and other regulatory authorities.
Bruce Johnson transitioned from our commercial consultant to a senior Vice President and our first Chief commercial Officer Bruce.
Bruce has over 25 years of experience in oncology and his near term focus will be to develop a commercialization strategy for you for us around accelerates competitive readiness deeper medical expert engagement and broaden scientific education.
Finally, Dr. Deepak Tiwari, just joined US as Vice President technical operations.
Deepak brings to our leadership team over 25 years of diverse technical management not only in CMC, but also broad experience contributing to more than 30 regulatory submissions and 15 commercial product launches throughout his career.
As we move our lead product you pull us around forward towards the potential submission of an NDA as well as to develop our pipeline and research product candidates Deepak his breadth of experience and leadership will be valuable for our team.
I would now like to provide insights into five additional operational highlights from 2021.
First our collaboration with <unk> in greater China made significant progress during the year.
In January the team secured breakthrough therapy designation in China for <unk>.
And advanced from a phase one bridging study to a phase III registrational trial in relapsed refractory AML.
Second we announced three investigator sponsored trials collaborating with investigators at MD Anderson.
At UC Davis, and wash U at St. Louis.
All three Isps are currently enrolling patients.
Our hope is that data generated by these prestigious cancer research centers will be submitted for presentation at future scientific conferences and will pave the way for expanding the breadth of clinical use of your thoughts around across AML and other hematologic malignancies.
Third as for all of their efforts in sickle cell disease, we accelerated the development of GMI 16 87 a.
First in class Subcutaneously administered E selectin antagonist for the treatment of acute vessel occlusive crisis.
We know from the post hoc analysis of the phase III reset and open label extension studies with pencil that early intervention is critical to achieving clinical benefit.
Clinicians have told us that an on demand therapy, either self administered at home or given in an outpatient ER clinical setting.
Could be a game changer.
There remains no FDA approved therapy for the treatment of POC and our goal is to submit an IND to the FDA in the first half of this year.
Fourth.
<unk> 13, 59, our dual antagonist of <unk> and E Selectin.
Was showcased in the 2021 ash meeting in December .
Our collaborators at MD Anderson or highlighted the potential for GMI, $13 59, and breaking resistance in AML.
Particularly in patients with <unk> mutations we are exploring strategic options for this program.
And fifth we are advancing our <unk> three program, we have nominated GMI $20 93, as a development lead candidate after observing high affinity specificity and oral bioavailability.
They're all of collecting three in cancer fibrosis, and other inflammatory disease is emerging as a therapeutic target.
And our intent is to advance this program through potential strategic partnerships.
Brian I'll now turn it over to you to provide an overview of our financial results.
Thank you Ruth as of December 31, 2021, Electromedics had cash and cash equivalents of $90 3 million as compared to $137 million as of December 31, 2020.
During the years ended December 31, 2021, and 2020, the company recognized revenue of $1 2 million and $10 $2 million, respectively. All of which was a result of payments received under our license and collaboration agreement with <unk> for the development and commercialization of <unk> and GMI 1087 in greater China.
The company's research and development expenses increased to $12 9 million for the quarter ended December 31, 2021, as compared to 11 $7 million for the fourth quarter of 2020 due to higher development expenses related to the.
Manufacturing cost for <unk> and increased cost for IND, enabling activities of GMI $6 87.
Research and development expenses for the year ended December 31, 2021 increased to $47 5 million as compared to $44 9 million in the prior year increase.
The increase in expense was due to higher clinical development expenses related to our ongoing global phase III clinical trial of <unk> in individuals with relapsed refractory AML increased manufacturing costs and increased IND, enabling activities related to GMI $6 87.
The company's general administrative expenses increased to $4 5 million for the quarter ended December 31, 2021, as compared to $4 million for the fourth quarter of 2020.
General and administrative expenses for the year ended December 31, 2021 increased to $17 1 million as compared to $16 $7 million in the prior year. These increases were due to higher recruiting consulting and legal expenses incurred in 2021 offset by lower personnel related expenses I'd now like to turn the call back to <unk>.
Thank you Brian .
Before I conclude our remarks and begin the Q&A I'd like to leave you with the following thoughts.
The topline data from our <unk> Registrational trial in AML will undoubtedly be transformative for the organization.
As the survival data matures, we are preparing for a successful regulatory submission and commercialization.
Our belief is that drug combinations targeting both tumor intrinsic and microenvironment extrinsic pathways of AML will be essential for the successful clinical translation of new more effective drug combination strategies, we are leading this effort.
Finally, I believe that there are significant significant value, creating opportunities here at <unk> beyond <unk>.
And I look forward to Stewarding your investment in our company to realize this value for the benefit of patients and shareholders, who are counting on us to deliver.
I'd now like to open the lines for Q&A operator.
Thank you.
A reminder to ask a question you will need to press star one on your telephone to withdraw.
Your question. Please press the pound key.
As we compile the Q&A roster.
Yeah.
Our first question comes from Victor Gela of Roth Capital Partners. Your line is open.
Good morning, Thanks for the really helpful update.
Just a few questions I think the first one is just starting up with.
29 <unk>.
Okay.
Can you just kind of curious around the strategy for one thing to perhaps partner it before the program even gets into the clinic.
Just was wondering how you would think about it versus perhaps.
Partnering 16 87 since it seems like your pipeline is more oncology, okay bullshit Lasalle.
Sure. Good morning. Thank you exactly for that question. So I'll say a couple of things and then turn it to al.
Our chief business Officer, Armand Girard towards with US. So obviously as we move <unk> forward, we're very focused on it at the same time, we're getting our additional therapies to key milestones that can open up doors for potential partnerships and the Electra and three program is really on that.
With the 2093, we're very excited about that given.
Beyond oncology, so our mom, maybe some color on how we're thinking about that and 16 87, Yes, Hi Z. Good morning. So the first thing to highlight about 2093 is we wanted to get to I guess three critical success factors for the for the nominating a development. The first is we wanted to have a compound.
<unk>.
That was very potent for the target, but but exquisitely selective and we've achieved that with 2093, but importantly, we also wanted to get to know oral collecting three inhibitor.
If you look at collecting three you'll find that the wealth of data is in the fibrosis setting. If you look at cardiac fibrosis, there's actually an approved diagnostic looking at CRM gluts in three levels and if based on that cardiologists.
So it should intervene aggressively in those patients because they are at high risk of mortality or hospitalization.
But I could create the exact same story in diseases like Nash IPF, where the levels are collecting three are over expressed and so our thinking is that now that we have a development lead identified its the perfect time to get to this compound into partnerships hands, who have a greater experience and depth of understanding of the fibrotic setting and so that's exactly what we're trying.
To do is we've got a great lead we think it's the best in class lead, but fibrosis is not our expertise and so we need to get that in other people's hands and maximize the value of the compound.
<unk> very helpful. Yes. It was 687 Z just to touch on that I mean, I think the we're getting to that point, we want to we want to as you know our focus is on the IND.
Our submission we're going to have a pre IND meeting.
Once we get that guidance from the FDA that is going to be the go from a from a from a potential partnership perspective. So we want to get the Tox package, it's going to be clean, but we want to get all the the <unk>.
<unk> put together and that will be the start of let's say discussions.
Thank you and then can you provide any additional color on how you're thinking about accelerating the development strategy for <unk> 16, 87, or what the study could look like I know, it's still being determined but just any additional color because a lot of folks we have.
The city in the previous sickle cell programs I imagine it looks they rarely curious here as well.
Yes.
We're very excited about that as well.
As you know 60 87.
Benefits from the tremendous data that we have with three of the pencil.
From that trial, we know.
As you know that.
It's critical to do fast intervention. That's why we were very focused on ensuring that <unk> 87 is subcutaneous <unk> by available and there is.
Very strong work, having now on advancing the IND submission.
To your point, how does that trial look like it's a bit too early to tell but maybe a bit more color from our model of how we're thinking.
The beyond.
And this submission yeah, so again Z I think that the.
You need to understand about the sickle cell patients that are having a crisis as they typically see a prodrome where they know the crisis is coming on and then that Vasal occlusive crisis builds and.
Becomes.
Excruciatingly painful over that kind of 18 to 24 hour period.
So the point being is there is plenty of time to intervene in these patients and the key to us is to get to those patients as soon as we can in the development in the initial development.
<unk> hundred 87, so that is going to be the conversation that we're going to be having with the FDA is how do we get moved from let's say a phase one in healthy volunteers to.
Let's say sickle cell patients either in chronic state initially, but we ultimately want to get to patients that are experiencing yossi right off the bat. So that's going to be the dynamic that we're going to be discussing with the agency.
And then thinking about kind of this year is it possible that we might see even initial safety data from patients from $6 87 sometime this year.
Yes, I wouldn't I wouldn't say that maybe a month of July at something else. Yeah. So we don't have any concerns with regards to the safety side of the equation on I'll call. It Selectin inhibition as you know we've had a pan selectin antagonist with river pencils that was most.
<unk>.
We have <unk> language, we're now dosing.
10, 10 to 12 days.
Never seen anything from a maximum tolerated dose toxic dose in animals never had and TD or DLT in humans. So we suspect this is exactly going to be the case with <unk> seven which is an E selectin only antagonist. So.
To us this is all about getting the efficacy and the dosing.
Determined and getting that data.
I want to say, we're cavalier about the safety side of things, but we think from a from a safety perspective This program Steve lift.
Thank you and then the last one here just about the data in the knee.
I know you've been drilling in terms of the timing of the readout, but I was just wondering if.
If we should even think about you know again.
Some data doing 2022.
That study and then any additional details on whether you plan to use that phase two data in the package or after the NCR handled for I D.
And then the phase III portion of the study before.
That plan approval and then lastly, any additional comments on what you plan to discuss with the FDA.
Do your interactions plan for 2020 to be at the CMC plans and things like that anything that you think will be.
Helpful.
Yes regarding regarding the newly diagnosed AML patients.
NCI sponsored trial I mean, we are in a good situation AML, where we have really two shots at goal our own.
Company sponsored trial in the relapsed refractory setting and also the NCI sponsored trial and the and the de Novo setting.
The NCI has not commented about the timing of the event.
As you know it is an event.
But it's not.
Not all S.
Typically <unk> can.
Can be read faster than OS. So to your question is it possible, yes. It is possible for that data to be.
To be maturing phase II aspect of that to be maturing in 2022, and the way. The Registrational version works is that we actually are able to.
If that data is positive it's transferred to us and we have the opportunity to actually use that data in our registrational submissions. So once the time comes and we see the results. It can be either that we continue the phase III or if it's very positive we stopped the try.
And then we will consider that from the Registrational perspective, or if this study is negative then that trial will be stopped so we have the opportunity to actually make that call date or on if it's one file or if it's separate files.
Which is a good position to be in.
And then you had another.
The question the last one if you don't mind repeating.
Just about our plans for your regulatory interactions with the FDA based on your BTT.
Plans to discuss what kind of things do you plan to get cleared ahead of the NDA submission.
Yes.
That's actually a great points regarding having the ability to have multiple interactions with the FDA. We've had multiple interactions with the FDA in 2021, and we're planning more or months you want to comment maybe about that yeah. So I mean.
That's the beauty of DTD. So we've had multiple interactions from the CMC, but also from a non clinical perspective.
<unk> touched on it in the script.
We've had multiple CMC meeting specifically.
We've manufactured the registration batches to support the NDA. These batches are already on ICA stability.
We've also submitted the data from those batches to the FDA under the D. So with those batches complete were now shifting our gears towards the commercialization batches to support the market. So bottom line. We're clearing what we're signaling is we're clearing the deck from the CMC non clinical perspective so.
The only remaining element is the clinical piece and from a CMC perspective.
We think we're ready for the NDA and now planning for commercial launch.
Perfect. Thanks, guys really appreciate it.
Thank you.
Thank you.
Our next question comes from the line of Ed White of H C. Wainwright. Your line is open.
Good morning.
Thanks for taking my question. So I think most of mine were already asked.
So maybe I could just ask.
A question on the timing of the phase three I know you've been saying post 2022.
Does that imply 2023, we could see data or should we be thinking that data won't be seen until out to 2024.
And then do you.
Can you make any commentary on patient deaths perhaps.
Due to Covid in do you anticipate having to break out.
Those patient deaths separately to look at the <unk>.
Patients in different cohorts.
Yes, so good morning, and thanks for your question. So maybe just to tackle the second one first but we have seen a handful of patients.
<unk> died due to Covid, we don't anticipate that that's going to.
Move the needle in our trial.
So that's really kind of where our where we are we stand of course, we continue the course.
Regarding your first question on the timing of the of the 301 topline readout, yes.
Yes, you're right. We've said after year end 2022, and maybe just to give you. Some color why we did that is.
These event driven trials.
Really a bit difficult to kind of anticipate so early on given that it is an overall survival.
Endpoint and there are multiple factors that can attribute and that as you know one of the key things about our trial is that we have not censored transplant patients.
That was a very active choice and conversation with the agency because we do believe that getting more patients to transplant is really the ultimate goal in this patient population obviously the downside of that is from a timing perspective as you know.
Patients, who do make it to transplant generally live longer.
So that means the data maturity takes a bit a bit more so we wanted to make sure that we signal some of that education to the marketplace.
That this is not a 2022 event as many times I've heard and many of US have heard where you say, okay full enrollment end of year you add the average overall survival of these patients are let's say six months seven months. So it should be ready in 2022. So that was really the key driver of why we signaled.
After year end 2022 now to your second part of the question as you know.
Out of 2022, but into 2023 2024, where at this point, what we're saying is that we're going to be very carefully monitoring the full cohort and as we get timing over the next few months, we should be in a better situation to address the timing at least if not in a quarter.
They at least in a half year half year way so.
It will be sometime after 2022 I would say at this point, but stay tuned more work on this.
Okay. Thanks, and perhaps just a last question for Brian just wanted to get your thoughts on cash burn.
Moving to 2022 thanks.
So I guess without ending will begin 'twenty two cash was $90 million of bank, we've been very consistent around $60 million to $65 million spent in the last several years I would anticipate 'twenty to burn to be somewhere around that $60 million range. So that puts us in a good position going into 'twenty three with cash flow in the second quarter of 'twenty three.
Yes.
Okay.
Great. Thanks, Brian .
Thank you Ed.
Thank you.
And again to ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound key.
Our next question comes from the line of Roger song of Jefferies. Your.
Your line is open.
Yes.
Great. Thank you for taking our question.
Yes. So most of the questions has been altered maybe given your phase three.
Neutral AML study already started there for some time could you hurdle, maybe just remind us what is the.
Hollering assumption for those two potential.
Pivotal study.
And also what do you are you a device or devices think is clinically meaningful improvement.
The primary endpoint.
Overall survival in the USA.
Thank you.
Yes, Thank you Roger.
Question so.
Can you just maybe to add some color on the NCI trial as you know the NCI phase two three trial is to evaluate <unk> in newly diagnosed patients 60 years and older with AML just too.
Benefit.
More specifically with a randomized controlled trial design there.
We're looking at to see whether the additional fuel for lesser onto standard.
Seven plus three and older adult patients with previously untreated AML, who.
Who are fit for.
For intensive chemo will improve.
Outcome so.
There are two 268 patients that are now completed and the enrollment of the phase two and that's now triggers a planned interim analysis based on the events free survival. So there are three potential outcomes really from the planned interim analysis of this trial.
The trial could stopped due to efficacy the trial could proceed to phase III to gain more data on overall survival with the combination or the trial could be stopped due to facility.
So specifically if the interim analysis achieves a hazard ratio of <unk> 64, or better the data will be transferred to us.
Roger to support the global regulatory filing in this in this particular population.
Now if the hazard ratio is.
Of the 64 is not reached the NCI will move forward to the phase III portion.
At that time enrolling will resume and.
To reach the full the sample size of 335.
Evaluable patients per arm, so totally it will total patients it will be 617.
<unk> of the of the pace phase II patients obviously.
So basically this is to provide greater than 85% power to detect an improvement in median overall survival from 12 months to 16 months.
So should the DFS analysis not show any benefit.
As defined by the hazard ratio greater than a three then the trial could be stopped by the NCI for futility.
We expect this to be the case.
The trial has already passed the initial futility analysis earlier this year.
So that's kind of where a bit of additional color as to what can potentially happen I mean, the way. We look at it is we're very focused on the relapse refractory population. We think there is a significant unmet medical need in that population and then if both potential expansion into a newly diagnosed population that.
Being added.
Plus for us to think about.
Got it that's very helpful. Thank you.
Alright so.
In terms of the cash burn I think Brian you said.
It's 60 million this year just curious.
Did that include any.
Outside of those two pivotal study.
For your CRO or anything else.
In terms of the Canadian called you out I know youre doing lots of the preclinical stuff.
Any clinical development plan and clear.
Mid influenced this year.
Now Raj and most of that spend is for remaining phase III clinical trial costs for manufacturing costs for the rest of the IND, enabling activities for <unk> hundred 87, and then just the fixed overheads.
Okay got it that's great. Thank you that's all from me.
Thank you Roger.
Thank you.
As there are no more questions in the queue I would like to turn the microphone back to Mr. American.
Okay.
Thank you and I would like to thank you for your time and attention and next several weeks, we will be at two conferences at Cowen virtually dropped in person I look forward to the one on one meetings that will be scheduled and to updating you on our progress and outlook. Thank you very much everyone.
Okay.
This concludes today's conference call. Thank you all for participating you may now disconnect and have a pleasant day.
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