Q1 2023 GlycoMimetics Inc. Earnings Call
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Okay.
Yeah.
Good morning, and thank you for joining a guy called me Medics Q1 2023 earnings call.
At this time, all participants are in listen only mode.
Following management's remarks, we will hold a question and answer session.
At that time lines will be open for you.
If anyone should require operator assistance. Please press Star then zero on your Touchtone phone.
I would now like to hand, it turn the call over to Christian Dinneen Long company Counsel and glaucoma medics. Please go ahead.
Good morning today, we will review our business updates and financial results for the quarter ended March 31, 2023 press release, we issued this morning is available on the company's website at <unk> Dot Com. This call is being recorded and a dial in phone replay will be available for 24 hours after the close of the call the.
The webcast replay will also be available for 30 days in the investors section of our website.
Joining me on the call today from <unk> are hurts emerging Chief Executive Officer, Brian Hahn, Chief Financial Officer, and Dr. Edwin Rock Chief Medical Officer.
Today's call will include forward looking statements based on our current expectations.
Forward looking statements may include but are not limited to statements about the company's product candidate <unk> or our other pipeline programs along with statements of our expectations regarding operations. The conduct of our data from clinical trials planned or potential development activities regulatory interactions our submissions pre commercialization activities and our cash.
Position.
Such statements represent management's judgment and intention as of today and involve assumptions risks and uncertainties glaucoma Med X 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 Glycomed mathematics filings with the SEC, which are available from the SEC or through our website.
I'll now turn the call over to Eric.
Thank you Christian and good morning, everyone. We have continued to make excellent progress advancing <unk> clinical development and setting the stage for our transition to a commercial stage company.
At the heart of this progress is our ongoing pivotal phase III trial of <unk>.
That's run in patients with relapsed and refractory AML, which continues to be projected to reach its final survival events trigger within the first half of 2024.
Patients in this study continue to live longer than expected leading to a median follow up prior to primary analysis that is currently greater than 27 months.
The slower than expected accumulation of survival events presents an ongoing ethical obligation.
Valuation potential benefit from your cholesterol in India observed results.
Accordingly in February 2023, we carried out an interim futility analysis based on 80% of plan survival events that incorporated a highly conservative analysis threshold. This conservative threshold preserved statistical power of the Orajel analysis plan.
An independent data monitoring committee conducted an interim analysis of the unblinded data and recommended we continue to the originally planned final analysis importantly, the DMC noted no safety concerns.
Thanks to our team's excellent performance in preparing the clinical trial database and enabling the interim in that utility analysis, we're well positioned to complete trial analysis rapidly. After the final survival events trigger projected to occur within the first half of 2024.
We're optimistic and excited about <unk> potential to improve overall survival in relapsed refractory AML and are fully focused on delivering the potential of this important first in class therapy for patients in need of new more effective treatment options.
We remain keenly aware of our ongoing ethical obligation to patients to evaluate the potential benefit of <unk> as soon as possible.
We will continue to monitor our primary event accumulation closely to ensure that this potentially important adoption reaches patients who need it.
As part of our strategy to explore potential rhopressa and benefit and patients across the AML spectrum. We're proud to work alongside the National Cancer Institute and the alliance for clinical trials in oncology.
The alliance will conduct a pre planned interim analysis of event free survival and its ongoing phase two three clinical trial evaluating <unk> in newly diagnosed older adults with AML, who are fit for chemotherapy.
We expect to provide updates on the on the outcome of interim analysis when available.
With our experienced team and cash runway to fund operations late into fourth quarter of 2024, we are well positioned to execute on our strategy and continue advancing area plus around development program, including our pivotal phase III trial in relapsed refractory AML and.
On today's call I'm happy to be joined by our CFO , Brian Hahn and CMO, Dr. Ed Rock at I'll pass it over to you to give more details on our ongoing trials.
Thanks, a route and thanks to all of you on the line for joining our call today.
Route mentioned median follow up for our phase III trial of <unk> in relapsed and refractory AML is now at 27 months.
That means this study will potentially have the longest median follow up duration of any trial in relapsed and refractory AML at time of primary analysis with median follow up of more than three years.
Our trials population continues to live longer than expected based on historical benchmarks seen in other AML studies.
Importantly, the independent data monitoring committee's recent interim utility analysis showed no safety concerns and preserved statistical power to support final analysis of the primary survival endpoint.
We continue to monitor primary event accumulation closely to ensure that this potentially important treatment option reaches patients who need it as soon as possible.
We remain encouraged by <unk>, notably one remarkable safety profile and are optimistic about its potential to change the treatment paradigm for patients suffering from relapsed and refractory AML.
In addition to our phase III trial. There is a second randomized trial of <unk> that also has a pending readout, which may have been affected by slower than expected primary event accumulation. This latter trial in the large AML the large frontline AML setting.
The NCI Alliance phase two three trial, a 041 701 randomized 267 fit patients aged 60 years and older with newly diagnosed AML to seven plus three chemotherapy, either with or without <unk> less land.
This study enrolled from the first quarter of 2019 through December 2021, we are now at 16 months after enrollment completion.
For reference the expected <unk> medians for this trial for seven months for the control group and 11 months for the <unk> group.
Yes.
AML incidence increases with age and at time of diagnosis over half of AML patients are older than 60.
Yet prognosis remains poor for these patients as they are more likely to experience treatment related toxicities and early mortality.
New novel therapies remain needed to address the significant unmet need in this patient group.
And the NCI Alliance trial and improvement in median PFS from seven to 11 months would generate an <unk> hazard ratio of 0.64.
If the phase II portion of this trial reads out with a hazard ratio of 0.64 or better. These data will be transferred to <unk> for regulatory purposes.
Conversely, if the phase two hazard ratio was between 0.64 and 0.831.
The trial will proceed to phase III enrollment of 670 total patients.
Hazard ratio above 0.831, the trial would stop for futility.
NCI Alliance trial as <unk> 701 is being run under a confidential data safety monitoring board.
When the pre specified events trigger for phase two is reached.
Ryan Statisticians will perform <unk> analysis, and inform NCI, then glycomed memetics on next steps for the trial.
This trial sponsor the NCI division of cancer treatment and diagnosis confirmed last week that it has not yet been informed by the alliance that the RFS trigger has been reached.
We remain excited about the NCI Alliance trial and as it appears that the apparent long duration of follow up.
<unk> similarly to our own ongoing phase III study.
If successful this trial has potential to position <unk> as a foundational adjunct to both intensive and reduced intensity chemotherapy regiments.
Our biologic hypothesis is that <unk> will generate deeper more durable disease response responses.
That deliver more people to and through potentially curative stem cell transplantation.
Now I'll turn it over to Brian for a review of financial results.
As of March 31, 2023, cyclone <unk> had cash and cash equivalents of $65 million as compared to $47 9 million as of December 31 2022.
During the first quarter the company raised $28 $7 million from sales of shares of common stock under its existing ATM facility.
These additional proceeds are expected to extend our cash runway late into the fourth quarter of 2024.
We intend to use our capital resources to advance the clinical development and prepare regulatory filings for marketing approval of <unk> and.
And the plan to equal our plans potential commercialization to continue the evolution of psychomimetic into a commercial stage company.
The company's research and development expenses were $5 $4 million.
For the quarter ended March 31, 2023, as compared to $9 6 million for the same period in 2022.
Final redoubt projected within the first half of 2024.
Also we're excited about our partnership with the NCI in the alliance and their face to three trial of your professor an elderly patients with frontline AML as we work to understand the drugs unique potential to improve lives of AML patients.
We are grateful to the investigators in patients who make these large randomized trials possible.
We are well funded to complete these trials and continue our transformation to a commercial stage company capable of delivering impactful medicines to patients in need.
I look forward to sharing updates with you in the future calls.
I would now like to open the lines for Candy operator.
Thank you.
We will conduct Q&A session as a reminder.
Kinder to ask a question do you need to press Star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one one again please.
Please stand by while the compiled the Q&A roster.
The first question comes from Rajasthan of Jefferies, You're lying is now open.
Great. Thanks for the update and taking a little question. So first one.
Maybe since you are confirming the.
Projections for them.
<unk> for the Iron I ml phase III data is first half 2024, just curious have you take a new look of them.
Data since the interim analysis in February .
And that will give you the confidence.
Take if you took a look at the they in turn will give you confidence. This well you happen in first half and then maybe more broadly what will have been the.
The key drivers to have you make the protection. Thank.
Thank you.
Yeah. Thank you Roger are part of the question answer with here. So yeah, I mean, yeah as we have communicated multiple times before the way we've been handling these projections I mean overall survival is our primary endpoint, we continue to build a very robust.
Analytical model that continues to project.
Sure events trigger one dollar final events trigger and we've been communicating that sense.
November 2021, when we finalized our enrollment and we continue to do that Roger So we haven't really disclosed like every time, we do another projection, but that's ongoing basis.
And as as it stands now as we look at that projections.
We believe that H. One 2024 is the appropriate timeline, where we think that projections will will land obviously it all depends on as we go forward as months passed as well a number of events that happen and what subgroups of patients will happen. All these would dictate.
Future projections, and we'll keep you updated but as of now H. One 2000 2004 is where we are.
Great. Okay, maybe another question ASD.
The the current Kashering way funds through the end of 2024, just curious how much the pipeline development is making a cache your own way and if.
If anything update on your pipeline outside of the <unk>.
Yeah, maybe I'll I'll take the first part and then Brian can give you a bit more color about hour, how we have extended the cash or on the way in addition to the to.
The fuel up that we've done.
Earlier this year.
It's really important to kind of look at it and say, okay. We have a platform where a platform company Geico biology, we really believe is now at the cusp of starting to have medicines based on this platform and your cholesterol is really our most advanced.
Asset that we have as you know 60 87 as an asset that we have ready for clinic that has.
That has cleared INV. We have 13 59 that has been already in clinic and we've done a phase one.
But to be honest, we really have been putting all our efforts on your progress around we are at that 11th hour. We really wanted to make sure that we have pulled you press run through and then use some of the cash or on the way into funding our other therapy. So at this point, we don't have anything new if we're starting any new clinical <unk>.
Grams with 60 87.
As an example, but.
Always stay in tune to that Roger that's always on the back of our mind that though the faster we can do we get there the better it is but at this time, it's really fun.
Maybe Brian on the side of giving.
Giving some color on our cash runway extension rod.
As we had disclosed.
Disclosed previously we were running about $15 million, a quarter and earn that sort of reduced down to about 10 million a quarter, it's mostly from the reduced costs from the clinical trial expenses and one of the manufacturing expenses. So his room was saying a lot of the focus now is around you bless land with some small amounts to two other research areas.
Excellent. Thank you that's if on us.
Thank you one moment.
For our next question.
And our next question comes from Forest Peaker of television talent.
Line is open.
Great. Thanks for taking my question. This is Nick on for Boris just two quick ones for me first you mentioned that you will complete the final analysis pretty rapidly. After the hours spent trigger. So I was wondering if we should expect data in the first half of 2024 as well or if it will take a little bit longer to like consolidated.
Through everything.
And then the second question that I have is are there any additional isd Charles running testing you grow I noticed there were two that had some positive data. It actually was early so I was wondering if you have any idea on potential new data for these icy trials or anything else in that matter. Thank you.
Sure. Thanks, Nick maybe I'll I'll tackled the first question.
You can give an update on Isps.
So.
From our part.
Sorry, Nick can you just repeat your first question I would just Wanna make sure I understood correctly.
Yeah definitely yeah. So for the event the final OLS event triggers expected and when I was trying to 24 hours you guys have mentioned so I was wondering if we should expect data then two or if it will take a little bit longer to parse through the data and everything and then that will push the date of release back a little bit.
Got it okay. So maybe I'll give it a couple of things the way we are thinking about it so as we went into the interim analysis snake.
We had to get ready in Turkey in case, we passed that interim analysis and that's high threshold. We wanted to make sure that we are ready to really expedite in data due to data base lock and move into final analysis very very quickly.
So that step has already been done thanks to the efforts of the team over the even though over the holiday break as well December January to really get us ready. So we don't really have to do that again that really shortens the time from the time when.
The DMT will take a look at it until we we have the full analysis now it all depends on when within H, one we will have that.
Analysis neck, so if we're having it some time in the middle of the <unk>.
<unk>, So, let's say end of Q1, I'm not saying, that's what's going to happen. It just as an example, then within within weeks after we can get that data.
If it's going to happen later in Q2, then there might be a spillover outside of H. One. So just some goal posts for you to think about is the good news is we have really accelerated the data cleanup and.
And as you know a lot of the patients are now on long term follow up.
So that will make the job of our clinical teams to go back and get some of the queries and the data hopefully much faster now that we have the good good base. So that's kind of how you would want to think about it from a data disclosure perspective, and maybe on the Isps adds any updates that we have Nick.
Thank you for asking as you know we reported assure the investigators reported ash on two ice teas.
One in treatment of frontline AML unfit for intensive chemotherapy at the University of California, Davis by Brian Jonas There were eight evaluable patients of whom six had complete responses and four of those six head <unk> negative responses, we thought that was encouraging data.
That trial continues to enroll we're not disclosing numbers at this time and like you were keenly interested in progress of the trial as it moves forward. The other trial was at MD Anderson led by Dr. Katie are there and that's in patients with treatment.
Treated secondary AML, they are receiving <unk> win in combination with low dose cytarabine and cladribine.
Similar numbers similar responses and similar M O D negative responses as the Jonas trial. Similarly, we understand enrollment continues and we are not disclosing those numbers at this time.
Great. Thank you very much that's really helpful.
Excellent.
Thank you one moment for our next question.
And our next question comes from at Y a H C. Wainwright Your line is open.
Hi, This is Steve <unk> and thanks for taking our questions.
So for a G. M. I 687 are you getting any partnering interests and do you think you could find a partner.
For the program this year.
Yeah. Thanks, Steve 16, 87 remains a very solid second program for us. After your <unk> as you know this is a market sickle cell market and potentially other indications.
Given its unique mechanism of action as well so at this point, we're not disclosing any specific partnership that discussion. Steve is continues to be ongoing for us what's important as well as not only partners who bring.
Funding to the table, but also capabilities and competencies.
And the fact that we have been successful and refueling.
As well as from a cash for all the way perspective really gets us focus on your Pulitzer on so stay tuned to that by this point, we're not disclosing any specific partnership discussions.
Okay, great. Thanks, and one more if I may.
So how should we think about SG&A and R&D expenses going forward as you prepare for the upper less on lunch.
Sure may be Brian .
<unk>.
For the guidance this year and into two.
24, I would still anticipate about 10 million burn per quarter.
And then after we get the trial results will be given guidance on what we think the expenses will be for a launch.
Okay. Thank you very much.
Thanks, Steve.
Thank you is there are no more questions and he would like to turn the microphone back to Mister <unk>.
Thank you operate there and thank you for everyone for joining our call today, we look forward to keeping you updated on Glycomed aches and seeing some of you at the Jeffries Health conference at <unk> and DHA, it's going to be very busy and good time. Thank you so much.
Thank you. This concludes today's conference call. Thank you for participating and you may now disconnect.
Okay.
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