Q3 2021 GlycoMimetics Inc Earnings Call
Ladies and gentlemen, this is the operator today's conference is scheduled to begin momentarily.
Until that time your lines will again be placed on hold thank you for your patience.
Again today's conference is scheduled to begin momentarily.
Until that time your lines will again be placed on hold.
Thank you for your patience.
[music].
Okay.
Good morning, and thank you all for joining the glycol kinetics call.
At this time all participants are in a listen only mode.
Following management's remarks.
We'll hold a question and answer session.
And at that time, the lines will be open for you.
Anyone should require operator assistance. Please press star zero on your Touchtone telephone.
I would now like to turn the call over to MS. Sherry any.
Of the Investor Relations group.
Black kinetics. Please go ahead.
Good morning.
We will review our accomplishments and financial results for the period ended September 32021.
We will also update you on recent achievements. The press release, we issued this morning is available on the Companys website at Www Dot Geico Memetics Dot com under the investors tab. This call is being recorded a dial in phone replay will be available for 24 hours after the call.
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 Psychomimetic several risks Merton Chief Executive Officer, Dr. Eric Feldman, Chief Medical Officer, and Brian Hahn, Chief Financial Officer will start today's call with comments from our route and then Brian will then follow to provide an overview of the company's financial position.
And then we will open the call to Q&A.
I'd 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 companys product candidates <unk> GMI $13 59, and GMI $60 87.
And our other pipeline programs, along with statements about expectations regarding our operations plans for future development and potential commercialization and cash position.
Such statements represent management's judgment and intention as of today and involve assumptions risks and uncertainties Psychomimetic undertakes no obligation to update or revise any forward looking statements for information concerning the risk factors that could affect the company. Please refer to glaucoma.
<unk> filings with the SEC, which are available from the SEC around the glaucoma medics website I will now turn the call over to Rick.
Thank you Sherry and good morning, everyone. This.
This is my first earnings call as glaucoma, <unk>, Chief Executive Officer, and I am grateful for the dedication and perseverance of our employees and the support of our board of directors special the during my CEO transition period.
Im excited about the strong momentum and the opportunities we have in front of us.
Prior calls we've shared that our operational focus is advancing your for us around to commercialization and positioning it as a new foundational treatment in AML.
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.
As a potential first in class therapeutic that selectively disrupt extrinsic pathways of chemo resistance, we believe <unk> can be transformative for AML patients.
My goal is to transform glaucoma metrics from our research and clinical development organization to a commercialization powerhouse leveraging the advancements of your progress around these.
These types of transitions have been a particular area for focus for me and the oncology hematology space for the past two decades.
With too advanced for us around registration programs in AML, we have much to plan for from a path to commercialization perspective.
These programs include first our company sponsored phase III trial in relapsed refractory AML and second the National Cancer Institute trial in older newly diagnosed patients fit for chemotherapy.
We have seen robust enrollment during the past quarter in our phase III trial.
I am pleased to share that completing enrollment of 300 patients 280 patients in our company sponsored phase III trial is now imminent.
Our plan is to announce this important milestone in a separate press release once it concludes shortly.
As you are aware the primary endpoint of overall survival is event driven.
Based on our current projections, we expect topline results to come in after the year end 2022.
As more events occur our goal is to provide more precision on the timing of the topline readout.
In parallel we can also report significant CMC and the regulatory achievements, we have had interactions with the FDA under breakthrough under breakthrough therapy designation to align on key elements of our CMC program.
Consistent with that guidance, we have completed the drug product registration batches are required to support our NDA submission for <unk>.
I'd like to thank our internal team and our CMC partners for getting us to this stage of NDA readiness.
Now shift our CMC focus to making the commercial batches to support a potential global product launch.
Additionally, we have also reached alignment with the ft on the clinical pharmacology and non clinical elements of our NDA.
Our goal has been to work closely with the agency on as many aspects of the program as possible prior to the top line Readouts from our pivotal program.
I'm also pleased to report today that the National Cancer Institute Phase II portion of its phase two three trial is also very close to completing enrollment of the required 262 participants for the phase II analysis of event free survival.
The anticipated eminent achievement of this milestone reflects the enthusiasm of our investigators that participated in this trial for this novel combination involving your cholesterol.
Like our all phase III trial once we learn that enrollment is completed we will issue a press release.
Thereafter.
Interim event free survival analysis is positive the data will be transferred to us to support glaucoma metrics regulatory filings.
Eric will provide you with more detail in his remarks.
Completion of enrollment in each of these pivotal trials will be a major accomplishment, especially in light of the logistical challenges over the last year and to have associated with COVID-19.
Additionally, as you may have hurt our partner Apolo mix.
<unk> shortly to initiate their own phase III trial in China, evaluating <unk> plus salvage chemotherapy in the relapsed refractory AML.
The progress the <unk> team has made integrating the program.
<unk> phase one PK bridging study getting breakthrough therapy designation and now being on the cusp of initiating the phase III Registrational study has been remarkable we couldnt have a stronger partner for you for us around in greater China.
The groundwork we are laying out in 2021, and 2022 should enable us to file for an approval for treatment of patients in both the relapsed refractory and newly diagnosed settings should both our trial and the NCI trial hit their primary endpoints.
Be clear if either one is positive we intend to pursue regulatory approval in that particular setting.
I'll now turn the call to Eric to elaborate on our clinical program and to highlight the findings of our phase one two study recently published in blood Eric.
Thank you Farooq.
Just to underscore what <unk> said.
Believe we will complete enrollment of our own registration trial in relapsed refractory AML in the days to come.
As we approach completion of enrollment.
Have been coordinating with our investigators across 70 sites in nine countries to ensure a seamless closure of patient enrollment.
Additionally, we have shifted our focus from enrollment to data collection and data cleaning. So that we can plan to have the entire database ready for launch.
In advance of the event final event trigger we.
We are making excellent progress on this front.
I would like to take this opportunity to thank all of our clinicians our research nurses trial coordinators, and our glaucoma medics clinical operations team for enabling a timely enrollment, particularly in a challenging COVID-19 environment.
Additionally, I'd like to provide detail on what it means for the NCI to be nearing completion of the enrollment of the phase III portion of study.
As you know the Nci's phase III trial is evaluating <unk> in newly diagnosed patients 60 years or older with AML.
More specifically with a randomized controlled trial design.
We're looking to see whether the addition of <unk> to a standard cytarabine Doner <unk> seven plus three regimen in older adults with previously untreated AML fit for chemotherapy will improve patient outcomes.
Completion of enrollment of 262 patients will trigger a planned interim analysis based on event free survival.
There are three potential outcomes from the planned interim analysis.
The trial stopped due to efficacy with a hazard ratio of <unk> 64 or better.
The trial could proceed to phase III to gain more data on overall survival with the combination or the trial would not proceed to phase III due to a lack of benefit.
Additional details on the Nci's protocol for data analysis.
Please refer to the poster presented by the alliance in 2019 at Ash, which is published on <unk> web site under publications.
Since this is an independent study the progress of which has communicated to us by the NCI on a very high level.
Unable to give you a sense of timing on readout of PFS or topline results at this time.
We do expect enrollment to complete imminently.
We'll have to wait until the NCI shares the results of its internal projections.
Before I hand, it back to her route I'd like to provide my own perspective on the recently released blood publication of our phase one two trial in AML.
First while there have been a number of approvals in AML over the past couple of years single agent targeted therapies based on AML genetics have not resulted in deep and durable responses in the majority of patients.
What has become clear is that drug combinations are needed and must target both intrinsic mutational factors as well as extrinsic micro environmental factors.
<unk> refers to the molecular changes that are inherent to the tumor cells that drive chemo resistance, such as Bcl two overexpression P 53 mutations et cetera.
Extrinsic resistance is president regardless of molecular subtype and is mediated by interaction between the leukemic cells in the bone marrow microenvironment, such as E. Selectin simply put leukemia lives in the bone marrow and we must disrupt tumor stromal interactions in addition to chemotherapy.
<unk> targeted agents, if we expect to have any hope of further improving outcomes in this patient population.
By targeting the E Selectin E selectin ligand axis in the bone marrow that drives leukemic niche hijack <unk> represents a new approach for disrupting and extrinsic factor of chemo resistance.
This novel Extrinsic approach with you for less loan was shown in our phase one two trial to result in the following four main findings.
First a high remission rate was seen compared to experiences with salvage chemotherapy alone.
In the population enrolled in the phase one two trial, 41% achieved a CR or Cri with the addition of you for less line compared to a 20 or 25% expected response with chemo alone.
Of note, 35% of patients achieved a full CR, which highlights the quality and depth of the response.
A majority of the Evaluable patients, who achieved CR achieved <unk> negativity.
I'd like to underscore the high rate of NRG negative full Crs, which has been strong shown to be the strongest predictor for overall survival in AML.
Third a high percentage of responding patients underwent a subsequent to transplant of.
Of the 22 patients achieving a CR or cri half went onto a potentially curative allogeneic transplant.
This suggests that the activity and importantly, the safety of the addition of <unk> as induction therapy, allowing patients to get to transplant and a deep response and with a preserved performance status. Both critical factors for success of transplantation.
Finally, all of this accumulated in a prolong survival, which is a great outcome.
I urge you to read the blood article as it provides the basis as to why we are confident in the results and the ongoing phase III programs.
I'll now turn things back to her route.
Thank you, Eric and the Glycobiarsol space, we have indeed established a leadership position and lay the foundation for future success. This field has been recognized as an untapped source of novel Therapeutics.
For that reason focused as we are on our registration trials. We are further enhancing the value of our platform by advancing the development of GMI $13 59, GMI 16, 87, and with our <unk> three inhibitor.
With regards to GMI 13, 59, we have agreed with the investigators at Duke University School of Medicine to close the current phase one study at the end of this year.
As you know the primary objective of this trial was to gain additional data on the pharmacodynamic effects of GMI $13 59 and to establish a biologically active dose for subsequent phase II trials with this drug candidate.
With clear evidence of dual antagonism now observed.
Both E Selectin and <unk>. It is time to shift our focus to the next clinical trial, we are defining those clinical options as we speak.
The IMD, enabling program for GMI 16, 87 is progressing as planned.
With filing of <unk> for acute <unk> occlusive crisis in sickle cell disease and first in human dosing is expected in the first half of 2022.
For our direct and three program, we have demonstrated robust activity across numerous animal models and clear evidence of PK bioavailability and anti fibrotic activity following oral dosing.
This potentially enables us to treat chronic indications with pills, rather than needles, which is a major breakthrough for our chemistry team.
Interest in GMI, $30, 59, GMI $16 87, and our <unk> three program is high and we continue to explore all avenues to maximize the value of these assets and accelerate their development, including potential third party collaborations.
Brian I'll now turn it over to you to provide an overview of our financial results.
As of September 32021, Electromedics had cash and cash equivalents of $101 $9 million as compared to $137 million as of December 31, 2020.
Research and development expenses increased to $13 3 million for the quarter ended September 32021, as compared to $10 $7 million for the quarter ended September 32020, the increase was due to higher clinical trial costs for ongoing global phase III clinical trial of <unk> in individuals with relapsed refractory AML in.
Kris manufacturing cost with U S land validation batches and expenses related to IND, enabling studies for our GMI 60, 87 drug candidate.
General and administrative expenses were $4 1 million for the third quarters ended June 32021 and 2020.
I'd now like to turn the call back to Murray.
Thank you, Brian before I conclude our remarks and begin the Q&A I'd like to make everyone aware of some personnel changes that are occurring at the cosmetics.
Eric Feldman, our Chief Medical Officer has decided to leave platform ethics to explore other opportunities. We have initiated a search to find a replacement and hope to have a new CMO in place in the coming months.
I'd like to thank Eric for his contributions to glaucoma metrics and wish him the best in his future endeavors.
We continue to attract top talent at Geico metrics and I am pleased to say that we have higher than new VP of regulatory affairs, we will make an announcement when she starts her first day of employment later this month, but I wanted to let you know that she has expense extensive experience.
And the hematologic malignancies that served as the regulatory ahead.
Humerous approved therapies and the C suite leader.
Per.
Direct experience, leading NDA submissions in biotech companies will prove invaluable to us as we begin to prepare the regulatory dossier for you for us around.
Additionally, we brought in a commercialization leader Bruce Johnson, Bruce brings a tremendous wealth of this.
This wealth of oncology hematology experience from his 25 year career across commercial and development at Novartis oncology.
<unk> VP and global franchise had malignant hematology, VP and global disease leader leukemia franchise, including Might've store in an AML and.
<unk> oncology brand leader.
Ruth has also was also VP global commercial development.
Abbvie in oncology and worked on the need to flex.
His focus will be to help prepare us with your thoughts around commercialization strategy for lesser and commercialization strategy competitive readiness and medical education efforts. So the market understands our science and embraces us as we are.
Our 301 data mature.
I am now going to turn it back over to the operator for Q&A.
Sure.
At this time, if you would like to ask a question. Please press star one thing or the telephone keypad again that expire one on your telephone keypad.
Your first question comes from the line of Ed White.
Your line is open you may ask your question.
Yes.
Good morning, Thanks for taking my question.
The first question I have is just on.
13 59.
Wasn't mentioned in the press release, So you did discuss it on the call.
Just curious if theres any change in the prioritization of this program and also.
You said that the you will finish.
Enrollment of the trial at the end of this year.
Are we going to see data at the end of this year and how should we be thinking about the next step is that something you will discuss it in.
In 2022.
Yes. Thank you Ed for that so I'll answer the first part inventory and turn it over to Eric for further details, but there isn't any change in our direction with 13 59 one.
One that we had set up the study we wanted to understand further about its activity and we have that data.
So from that perspective, we're making sure we're making progress on it and within 2022 will further communicate when the when the appropriate what can be the future direction of potential indications, we will look at but maybe Eric you want to add something yes, we do.
Good.
A small trial at Duke and breast cancer, primarily to demonstrate proof of mechanism of action. The words. This is a dual inhibitor of <unk> and E selectin.
And with a small number of patients we were able to show that at a tolerable dose at $13 59, we achieved targeting on both CXC are foreign E Selectin and.
So.
We have achieved what we needed to see in that trial and we're now discussing what will be the next steps.
Great. Thank you and a question maybe for Brian.
R&D was up 30% sequentially.
You had mentioned about the CMC and manufacturing.
I'm just curious is it.
What we saw in this quarter could be considered a baseline going forward as you're starting to manufacturer.
Product for commercialization or is this more of a one time.
Tick and expenses should continue back at the rates we've seen in the past few quarters and then any.
Guidance on cash runway.
Thanks, Ed So, yes, I would say it is more of a more of a one off for this year from the validation batches from CMC and then a little bit of increase off of the clinical trial as we complete enrollment.
Shortly here Youll see some of the clinical trial costs start to come down a little bit as well as the manufacturing batches current cash on hand gets us into the first half of 2023.
Just to remind you we had a little bit more aggressive in the budget with a little bit higher head count, but we're currently it's about 50 employees of fixed burn is still about two to $2 5 million a month.
We've been burning about $15 million of cash.
See that going consistently out may be dropping a little bit in 2022.
Okay great.
Last question you have.
Several.
Isps with you pro.
Those that.
<unk> and UC Davis, and MD Anderson I am just wondering if we should expect any updates.
At ash or.
Perhaps any comments you can make on data expected in 2022.
Thank you.
No we won't we won't have anything at ash.
<unk> <unk> and have started they are enrolling obviously these are being run by the individual investigators at their sites. So we don't we don't control that but we do expect that as the data comes in and how it looks that there would be.
Potential to in.
In 2022 to share some of that data publicly.
Okay. Thank you for taking my questions.
Thank you.
Your next question comes from the line of Zigbee Liana. Your line is open you may ask your question.
Good morning, Thank you for taking my questions and thanks for the update.
Just wanted to ask a couple of quick questions.
Good question.
I think for me.
No clarity.
Some of the CMC issues, just trying to think about.
Anything that could influence the timeline of the NDA.
Thank you Graham.
Yes.
Yes. Thank you for that question and our whole idea is to really as part of our.
Breakthrough designation to close close to collaborate with the agency at this point there are no issues.
Regarding CMC, we're just advancing get based on the guidance that we get from the agency as part of our ongoing dialogue and of course our next.
<unk> thinking about is how do we make sure that we have our commercial batches.
In track for a potential commercialization.
Thanks, and then in terms of.
The timing Mike link between when the data reads out and the NDA filing any comment on what that could look like I guess I'm just trying to estimate when the add Andy could potentially be found.
Yes, no I appreciate that.
So as you know regarding the topline readout, that's really is event driven.
We wanted to make sure in this forum.
We gave guidance on whatever we know which is at this point.
It will be after a year end 2022.
That will involve afterwards is really making sure that we are preparing for the NDA.
Some of those steps actually we're taking it from now making sure that we have a VP of regulatory in place somebody who has had that experience having the external partnership.
And collaborations in place.
Advancing on some of these things in parallel.
So thats when the time comes we're able to turn that into an NDA submission as as fast as possible.
Given.
Guidance from what other companies do so we plan to really move into that direction.
As fast as possible after the topline readout.
Thank you and then another follow up there.
On the commercial aspect just kind of thinking their background is there anything unique that you might be doing from a commercial perspective, you also mentioned.
And on Wednesday.
Wondering what you thought that the stock is under pressure.
Why do you think that might be there.
Dan.
Obviously that would be a part of part of where we are.
Until now we've been very focused on getting trial enrollment.
And our phase III I mean remember this is our first phase III that we run it where's the sponsors. So we're very excited about where we have achieved.
This.
Almost full enrollment milestone and now is the time to pivot to really thinking about commercialization and commercialization thinking is really about positioning how do we ensure we get our rightful position in the marketplace. How do we ensure that we have the right education.
Efforts going on.
How do we ensure that we're really pricing it appropriately when the time comes.
So really maximizing the opportunity depend.
Depending on where the data readout comes positive.
In the relapsed refractory ore in the de novo or potentially both.
So these are discussions that we believe we need to have from now and that's why we brought in Bruce.
Work with us to really think about some of these these areas as we speak as you can appreciate these are not conversations we can have last minute. We can adjusted after the topline readout, what we got to anticipate some of these scenarios and Thats, what we plan to do within 2022.
Thanks, and then the last one for me just about $13 59. Thank you might still be trying to figure out what indications to kind of proceeding with the study that youll be ready, but if you can comment on that that would be great and then lastly lengthy investigation.
<unk> sponsored studies.
And then the assumption that some thank you similar to 13 59 will be done meaning quickly trying to figure out the <unk> and.
An efficacy signal and then transition that into study be in line with Nymex.
Yes regarding 13 59, I mean in general what we're doing as well as doing two things one is really advancing gift for lesser on making sure that we don't Miss a beat and moving it forward to a potential commercialization route at the same time, expanding our our rich platform to ensure that we have certain <unk>.
Millstones that we're hitting across $13 59 across 16, 87 and across <unk> three particularly for $13 59, we have what we needed from the study that was initiated at Duke. So now it's really time to say, okay, where do we take it from an indication perspective so.
That's something I want to make sure that we're thoughtful about it.
And we're thinking about what where the maximum potential opportunities and do we do with ourselves do we partner all of these are things which are on the table at this point. So we don't want to take off anything off the table. So.
So thats regarding $30 59 regarding.
Your second part of the question on the Isps and potentially turning them into.
And Jacob <unk> sponsored trials I think it's just too early to tell at this point.
What we really appreciate over the last few months is in the face.
Pace in the space of AML not only do we have two registration grade trial is going on but there are three and actually for ISP is looking at Europe lesser on across different parameters within AML or time to transplant.
So we're very excited about those let's see what the data says and then we will we will get back to the community as to what potential next steps would be so we're looking forward as well to seeing some of that data in 2022.
Thank you for taking my questions.
Thank you David.
Again, if you would like to ask a question. Please press star one on your telephone keypad again that is star one on your telephone keypad.
Your next question comes from the line of Roger Song Your line is open.
Great. Thank you for taking the question.
Yes Lovely question had been asked maybe just two quick ones from me. So the first one is related to the <unk> study understanding you potentially will have data in 2022 before.
The phase two and the phase III pivotal study.
Yes.
By year end the NCI, just curious how should investors view those ice data if it's available before those pivotal data any read through you would like to see from those two data to your pivotal data.
Yes, we'll have Eric maybe give a bit more color Roger.
Roger Yeah, Hi, Roger I mean, those Isps that really enable us to expand.
The indications for you for less than one in a sense that we are targeting different subpopulations of AML. So for example, the one that we add <unk> to the backbone of the Hypo <unk> agent plus venetic lax.
That one is really <unk>.
Exciting because we can see that we will be able to deepen the responses.
Two treatment in that population.
<unk> is very active but you don't get a lot of <unk> negative responses and therefore, the durability is is not so great and what we saw in our phase one two in the in the relapsed study was that we do get these deep responses. When you add you for less one and so if we see that.
We're deepening the responses in that HMA venetic lax unfit population that would be additional evidence that you have for less law as it as targeting extrinsic resistance is a clear important path to have to target and the other one is the MD Anderson <unk>, where we're adding it to it.
Backbone chemotherapy in patients with this treated secondary AML, which is an emerging.
A larger group of patients at more patients with Mds get a society Dean.
Their MBS and then evolved to AML Thats, a particularly bad group of patients and so if we see higher response rates and what would be expected that again would be further evidence that <unk> is adding benefit.
Those are those are our important Isps and we'll see.
As the data emerges when we will be able to share it.
Yes, Hey, Roger I mean to think about all of these Isps will give us further information on what we said in the beginning that we believe that drug combinations targeting both the tumor intrinsic and microenvironment extrinsic pathways in AML will be essential for their success and.
This area. So those are all different shots at goal that will inform us with further further insights.
Got it that's very helpful. Maybe just one last one from me is understanding I think Brian you said the cash run way into first half of 2023.
Your pivotal study data coming after 2022 year end.
Just curious how flexible is the cashier and where would you like to kind of accommodate.
The pivotal and Mali Readouts.
Hey, Roger as we stated earlier Theres a lot of levers within the budget. We're still only 50 employees of fixed expense is still.
Relatively low so.
$102 million, we have on hand right now.
Run rate will drop a little bit. So there is some movement. Some levers we can pull within that budget to help extend that cash runway.
Got it thank you that's it.
I appreciate it.
Thank you Roger of course.
That's one thing I appreciate about glaucoma ethics, when I joined us that nimbleness of the operations.
As I also mentioned potential partnerships. These are areas. We are discussing since all three of the assets. In addition to the Beast.
Besides rhopressa on are all things that are generating interest so we'll see.
With time, but between the nimbleness in terms of the and the external interest.
Our positive leave.
Flavors for our cash runway.
Excuse me presenters there are no more phone questions.
Back to you.
Thank you so to conclude there is significant momentum behind you for lesser on from a clinical CMC regulatory and now commercialization perspective.
Which gets us exciting about the full potential of your per restaurant in helping AML patients.
Our platform continues to be productive productive engine with good advancements on our three additional assets GMI 16, 87, <unk> <unk> 59, and our Gallatin III program.
In the next several weeks, we will be at two conferences, both virtually and in person I look forward to the one on one meetings that will be scheduled to introduce myself and of course to further discuss our progress and outlook. Thank you very much everyone for joining us today.
Ladies and gentlemen, thank you for participating in today's conference.
This concludes today's program you may all disconnect everyone have a great day.
[music].
Okay.
[music].
Yes.
Yes.
Okay.
Yes.
[music].
[music].
[music].