Q2 2021 GlycoMimetics Inc Earnings Call
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And 1 of the 21 will also update you on recent achievements. The press release, we issued this morning is available on the company's website at www dot like on the medics Dot com under the investors tab. This call is being recorded of dial and phone will <unk> will be available for 24 hours after the close.
Of the call. The webcast replay will also be available for 30 days and the Investor Relations section of the company's website.
Joining the on the call today from like him and and extra Rachel King Chief Executive Officer, Doctor, Eric Feldman, Chief Medical Officer, and Bryan on cheap.
Financial Officer, our new C E O. Her roots of marriage and is it also on the call with US. This morning will start today's call with comments from Rachel and Eric Brian will follow Rachel and to provide an overview of the company's financial position and who loot will add some initial comment.
And then open the call to and a I'd.
And 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 company's product candidates you Professor land GMI 13, 59, and GMI 16, 87, and the or other.
Pipeline programs, along with our operations and cash position.
Such statements represent management's judgment and and tension as of today and involve assumptions risks and uncertainties like on the medics undertakes no obligation to update or revise and forward looking statement for information concerning the risk factors that could affect the company. Please refer to click on the medic stylings of.
The S E C, which are available from the S C C or on the clock on the medics website.
And I'll now turn the call over to Rachel.
Thank you Sherri.
And have set and prior calls are primary operational focuses on advancing 3 you per lesson ministration programs and a M L.
Our company sponsored phase 3 trial, and relax and frankly email.
The National Cancer Institute, the trial and newly diagnosed patients and the registration study and try and I'm being conducted by our partner economics.
I'm pleased to report today, the recruitment race and both of our own phase 3 and the National Cancer Institute the faith to portion of its phase 2.3 trial <unk>.
Continue to support and expectation that enrollment will be completed by the end of this year.
During the quarter of interest efforts closed we announced the initiation of 3 new investigator sponsored trials R. I S. T. S that expand the breath of argued the less land clinical research activities, there and now 6 trials of evaluating you per lesson plan, including 3 registration trials and 3 iced teas.
The support of clinicians who are enrolling patients and our global studies and now the new I S T.
Has made it possible to broaden the scope of our you per Leslie and clinical research to address on that needs of patients with hematologic malignancies.
Leaving clinicians academic centers collaborative networks and regulatory agencies are working with US as you Blessed land continues to garner significant attention and interest the breakthrough therapy designation is granted by both the F D. A and the Chinese Health Authority. We believe have added momentum for this program worldwide.
And to reiterate where confirming that we anticipate completion of of enrollment of all 380 patients and our company sponsored registration trial by the end of this year.
As you know the read out of the primary endpoint is the vet driven as we approach completion of enrollment and as we acquire additional data on events to date, we plan to give guidance at the timing of top line data.
And parallel the NCI sponsored phase 2 registration trial the to enrolling you per lesson learned of newly diagnosed older adults with a of milk also continues to accrue participant to the steady pace.
Based on the public information provided by NCI to date, we continued to anticipate the the trial will complete enrollment of the phase 2 portion of by ear and supporting of subsequent inter of analysis of the debt free survival E. F. F F. The trial and the trial the initial 262 patients.
To be clear if the NCI life is it from analysis positive the day, there will be transferred to collect some of that extra support of regulatory filings.
Together, the like of the medics and and see I sponsored programs will constitute the large day to set of over 500 ml patients we would anticipate.
<unk> filing for approval for treatment of patients and both settings should both trials hit their primary and points.
Apolo mix last quarter announced that it had dose of the first patient and greater China and of phase 1 clinical trial for treatment of adults with relapse of refractory a amount the.
The study's of bridging study that's expected to allow apolo mixed expeditiously advanced development to phase III registration trial and greater China.
Beyond working with the NCI and up alone because we've now announced 3 new trucks, and which you per last line is being paired with a variety of chemotherapy regimens and other AML and multiple myeloma therapies. These investigators sponsor trials complement of registration trials and should begin to produce data and 2022, they provide of 3 additional perspectives and could well.
And provide the basis for expanding use of your professional and across the ammo spectrum and potentially beyond day and now as well.
I'd like to add that all 3 of the institution sponsoring these trials have collaborated with us and the past and reflect the <unk> growing enthusiasm for Ya proud that I mentioned before.
And now I'd like to turn to Doctor, Eric Feldman, our Chief Medical officer to describe each of these and a bit more detail Eric.
Thank you Rachel.
I'd like to begin by providing context for the 3 investigators sponsors trials.
We're often asked why I S. PS are important.
The first and foremost these trials provide like on the medics with an opportunity to extend the potential use of your progress on and key areas of abundant need.
Investigators seat and real time, both how newly approved therapeutics are working and how even advances off and leave continued off the opportunities for improving patient outcomes.
Phase 3 and the lots of correct the email and the M. C. I is trial and newly diagnosed a email address those patients.
Undergoing intensive chemotherapy.
As you know with increasing frequency older patients with a M L and those with significant comorbidities or alternatively treated with less and tense of therapeutic regimens such each of the combination of Venetoclax and the Hypomethylating agent.
Despite the progress and with the Venetoclax H and the regimen and the other molecularly target the agents and investigators are the limitations in terms of the depth and durability of responses and.
In particular patients with adverse which features including patients with secondary AML and and those with specific poor risk biological profiles are not achieving high M. R. D negative responses leading to early relapses the.
This is where you per less 1 and they have and important role and is the focus of our 2 ice teas and additional high unmet need frontline and email populations.
The first of all iced tea and a M. L is being conducted at the University of California, Davis and was announced and July.
This trial is especially excited and and that we anticipate that it will shed light on what we believe is an important the opportunity to further improve outcomes by combining our drugs with the Venetoclax H and my regiment.
Although uptake of Venetoclax H M, a and the front line on the fifth and they'll set and has been strong and.
And while of 60 to 70 per cent of patients of Chiba response the.
The responses are incomplete and approximately half the patients as discussed earlier only of minority of patients achieve and M. R D and negative response, reducing durability and leading to relapse a.
A strong scientific rationale for ads and <unk> Pro was demonstrated and preclinical studies done at the M. D. Anderson cancer Center and reported it last year's Ash meeting.
This research shows that the addition of your per less lawn completely restored sensitivity and the xenograft model use and cells from of patient that was resistant of the net Cox and the Hypomethylating agent.
Additional preclinical data has also demonstrated the prior exposure to H amazed increases the expression of the selected log and on the surface of black cells, making the more resistance of chemotherapy and more likely to benefit from treatment with the addition of the people that slot.
Do U C. Davis iced tea will be the first clinical trial to potentially generate human data supporting on preclinical findings importantly, given the safety profile, we have seen so far and our phase 1.2 data we believe that you for less along the way maybe 1 of the few drugs that and the chemo combinations actually improves outcome.
Ms without adding incremental toxicity.
Among the study and points will be the critical evaluation of the improvement and patients achieving a full C R and and M. R. The negative C. R compared the rates reported with as a side of the plus venetoclax alone and the the Ali a registration trial.
And late July we also announced the second the iced tea and a M. L. A phase 1 b 2 study of value I D. You for less on added to Cladribine, plus logos like Terebene and patience with treated secondary a M L. The.
The principal investigator as to Palm Katya and associate professor of leukemia at the University of Texas M D Anderson cancer Center.
Patients with treated the secondary AML many of those who received H amazed as part of treatment for of prior Myelodysplastic syndrome have and extremely poor prognosis with current therapies and.
This is a growing population of patients as the use of H amaze continues to increase and the M. D S and.
As noted previously are preclinical and clinical research supports the potential for patients previously exposed to H amazed to benefit from the addition of eat the less want the current treatment regimens.
If the new study demonstrates the targeting you selected with you put less 1 could help to overcome resistance to other therapies. This would be of significant achievement that underscores the broad potential of our drug candidate.
Specifically the trials designed to demonstrate the safety and Tolerability of the combination therapy as well as to evaluate whether you broke and increase the rate of response and this highly resistant group of patients.
And the last I S. T I will discuss which we announced and April is being conducted at Washington University and St. Louis Dr.
Doctor Keith Stocker, all of Goldstein Professor of Medicine at the last few school of Medicine is the principal investigator.
This is a randomized phase 2 study evaluate of you for the last 1 is a prophylactic agent to reduce G. I toxicities associated with high dose of <unk>, an autologous of Metapolitics stem cell transplantation from multiple myeloma.
G I side effects on the dose lemon and toxicity toxicities of Hydro Smeltz line and auto transplant and all preclinical day to have demonstrated a protective effect of you at the last 1 against kozol damage and edition or phase 2 trial demonstrated the potential of our drug to mitigate severe mucositis and relapse and refresh.
3 a M L patients undergoing tenths of chemotherapy, hence we are optimistic about what we may you learn.
The wash your conditions will be the first to look closely at the potential of you pull of for them to attenuate G I toxicities and multiple myeloma patients undergoing transplants.
If this placebo controlled study demonstrates.
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Operator.
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Terry.
It seems we've lost Doctor Feldman said will pay I'll pick up the call.
As we think about the opportunities before us with our 3 ongoing registration trials and these exciting I S. Ts we believe the enthusiasm of clinicians for your blessing and reflects their shared vision for your price potential is the foundational treatment and email as well as its potential and other hematologic malignancies.
The broad clinical program of company sponsored MTI sponsored now investigators sponsor trial supports our vision, namely to establish your pro is the foundational therapy across the entire spectrum of an L.
Put your per less land targets, the bone marrow micro environment by inhibiting pathways that protect the cancer cells from the effects of chemotherapy.
This is the novel approach that we believe it could be broadly applicable across the spectrum and range of therapies used for relax the factory or newly diagnosed patients before.
Before completing the summary of our clinical work I'd like to remind you that during the second quarter at the meeting of the Americans Association for cancer research or a C. R. We presented the poster on our faith and our ongoing phase 1 of the study of GMI 13, 59 duo antagonist of East selected and CXC are for this.
The study was designed as of proof of concept of study evaluating biomarkers of some organization.
Our Duke University collaborators reported on biological activity as demonstrated by some mobilization redistribution of any and subset profiles and changes and other pharmatech pharmacodynamic markers and and the initial 2 patients created and the ongoing study and patients with advanced breast cancer with bone metastases. The initial clinical data support the Dubai.
Functionality of the compound and the potential of GMI 13, 59 to enhance responses to chemo and to me and therapy.
This provides us with the confidence of TMI $30.59 by potentially disrupting the tumor micro environment could be active across both liquid and solid tumors that trial of continuing to it and all patients and based on findings. So far we were evaluating indication from moving the program forward and the clinic.
And the sickle cell setting based on input from the FDA with respect to rip the panful as well as feedback from K O. L. We've previously reported to you we are focusing on the development of GMI 16.87.
We have initiated and enabling activities with treatment of the cute face of occlusive crisis has the potential lead indication the.
Work continues toward of goal of of initiation of phase 1 and the first half of 2022.
We believe that GMI 16, 87 may be ideally suited for the syndication as it would enable patients the potentially self administer treatment early and their crisis and reverse the underlying inflammatory cascade that's immediate by a selected.
Our earliest state research efforts continue to progress, particularly and the collect and field also and a C. R. A research team presented new evidence on the effects of 1 of our collect and 3 antagonist and of pancreatic cancer model and the <unk>.
Let's see and selectivity of our compounds distinguishes us from competitive approaches and we intend to roll out of additional data as we move toward our goal of selecting elite candidate for clinical development.
Brian without comment on our financial results.
Thank you Rachel as of June 30th 2021, quite chromatics of cash and cash equivalents of $118.9 million as compared to $137 million as of December 31.2020.
Research and development expenses increased the $10.2 million for the quarter and of June 30th 2021, as compared to $9.9 million for the quarter end of June 30th 2020.
This increase was primarily due to an increase in clinical trial costs, and our ongoing and global phase III clinical trial of your professor and and and individuals with relapsed refractory AML.
General and administrative expenses for $4.2 million for the second quarter ended June 30th 2021, and 2020 and now like to turn on the call back to Rachel. Thank you, Brian before I up and the line to Q&A I'd like to leave you with 2 takeaways.
First of we believe we are now left and 6 months from completing enrollment of our pivotal trial, the pupil less land and relapsed refractory AML patients this demand and area with high on that need to improve clinical outcomes.
Second we've delivered on our promise to bring your news of newly initiated trials with independent and investigators. We believe the speaks to the broad enthusiasm around the potential of you per wrestling and it also shows heavier laying a strong foundation for Ya per Leslie and the hematologic Brianna.
All of the speaks to the value of of Ark, Langkow chemistry platform as we look forward to being the petition to share data with you and the future.
And now I'd like to comment on the other announced that we made yesterday that I'll be retiring from my rule. The CEO. It click on the medics and then her roots emerge and will be taking over from me.
Let me begin by sharing some personal reflections.
As many of you know I Cofounded This company together with Germany on Air Chief Scientific Officer 18 years ago.
I feel very proud of what our team Herrick lack of of the medics is accomplished together.
We have progressed the company from its early days as the venture backed the startup 2.
Through its initial public offering and multiple secondary offerings to institute strategic partnerships and the advancement into late stage development of 2 clinical candidates each of which was discovered and our own labs.
Our platform has been very productive and we now have a pipeline of differentiated and exciting drug candidates that I hope and believe will make a difference in the lives of patients.
Loved this job have often reflected to friends and family how grateful I have felt that most of the days and my career I've come to work looking forward to what the day health and at the end of the day of the sometimes tired I have felt gratified by the opportunity to do such deeply meaningful work with colleagues type of like and respect.
So why leave now.
As I'm sure. Many of you will appreciate demands on my personal life as well as my personal of priorities have changed over the years. Our children are grown but I now find myself spending more time addressing the needs of and aging parents, who requires increase and care.
In addition, and my husband and I are new grandparents, and we see increased opportunities for time together with each other as well as with our growing and extended family.
This coincides with the time, it's like of the medics whenever phase III trial of successful the company looks to the potential to commercialize our first drug candidate.
And such a time, it's exciting to bring and a CEO of the caliber of her boots emergent.
<unk> and experienced oncology executive who is ideally positioned to leave the company going forward.
<unk> brings commercialization of expertise of the spot on for what we need at the company and the space. He.
He has overseen several successful hematology oncology product launches, including preparation for the launch of Might've star and and a M L.
During the 16 year tenure at Novartis, the help of strategic and operational hematology oncology.
After that and Ibsen, he served as EVP and Chief commercial officer, where he was accountable for worldwide commercialization and portfolio strategy.
Most recently he served as CEO of immunomedics before of sales to collect particularly at the sciences.
True clearly brings the background and leadership experienced that will no doubt serve as well.
While it's hard for me to leave the job that I've loved I note that the time is right and my personal life to make this change and I'm confident that of root brings just what the company needs route.
We'll be taking the range of CEO tomorrow, so he'll not be taking questions. Today I do know the he looks forward to engaging with you and not only and future earnings call, but also at conferences and and 1 on months.
Today, I would like to officially welcome him and offer him and the chance to share to share some of his thoughts of she comes on board.
Thank you Rachel following and your footsteps and honor and I might add your accomplishments have set of high bar for the professor.
I believe guaco from ethics has exciting opportunities ahead of the across around as of differentiate of the drug candidate already recognized with breakthrough therapy designation from both the F D a and the Chinese regulatory authority.
I am confident based on both preclinical and clinical evidence that this drug candidate has potential for a significant impact across the spectrum of yellow.
And through the asthma of independent investigators as well as the commission's participating and our registration trials provide the foundation for a successful commercialization of clap showed the readout and regulatory interaction of positive.
And while there are just a few of Glasgow biology based on <unk> on the market today, the field of got the biologist rapidly advancing and the rife with opportunity with fire and technical expertise resident and glad from ethics on their lives by confidence and the productivity of the platform.
Most of the pipeline Im seeing novel and potentially game changing therapies.
I look forward to working with the outstanding team Epcot from from ethics, as we strive to make a difference and the lives of patients with cancer and other diseases.
Of course wireless early base to say the please.
Forward to the opportunity to transition this company to a new focus on commercialization of drugs that will change patients lives back to the original.
Thank you for root and I want to extend to you my warmest welcome and know Glycomed ex will be in good hands on to your readers.
Operating if you. Please open the lines for a Q&A session.
Ladies and gentlemen, as a reminder to ask questions you really depressed Taiwan on your telephone again fire..1. So we go on your question <unk> East and Viola compile the killing last day again, so I'd like to ask questions. Please fast Taiwan.
Your first question comes from the line of add like from H C Y right. Your line is open.
Good morning, Thanks for taking my questions.
So maybe start off with the question for Brian.
And.
And as far as SG&A and R&D go they've been pretty steady over the last 2 quarters and I'm just wondering if the change and management will lead to any kind of significant 1 time charges and the third quarter and SG&A and then just and.
Uhm.
Overall thinking about the SG&A and R&D going forward.
How should we be thinking and broke the cash runway.
Thanks, and as far as 1 time impact and Q3, and we will see a slight increase and SG&A of and it'll be of non-cash expense of and.
And that we're still on track with the same forecast with you and and previous quarters. So current cash with current commitments gets us through Q1 of 2023.
Okay, great. Thank you Brian.
And then a couple of questions maybe for Rachel.
I know it's tough to.
Okay.
And.
Sure to look at the timing of data from Isps.
And as the route of your control, but how should we be thinking about how the state is release will be the the state of come at <unk>.
Medical conferences will you be putting amount of and press release or how should we be thinking about it how are we gonna find out about that data.
So of course as investigators sponsor trials, the Gators will be leading the.
The release of the data, but we do and anticipate that that would generally come in the form of of presentations at medical conferences.
And and obviously as as data is from basic medical conferences that would be paired with the press releases from the company. So we would expect us to be coordinated.
Okay. Thank you.
And then 2 other pipelines questions when can we expect to see the next 13.59 data.
And on 16.87, just what are the final hurdles.
For filing the I N D.
Going forward and and how confident of are you in the timing of the filing of the int.
Sure. So in terms of $30.59, I would expect that perhaps at the end of the year, we might see additional patients.
The Duke site is continuing to enroll and as we previously reported that was the trial that's been affected by Covid since the patients are.
Needing to come in for extra.
Extra visits to the hospital and the context of that study, but I would expect that we may have additional data of towards the end of the year as far as 16.87 is concerned.
Well on track with all of the standard things that are normally done for enabling studies, taking nice progress with.
Toxicology manufacturing et cetera, and and we're well on track to initiate enrollment of of Phase 1 study and the first half I would <unk> I would add that and it.
We're particularly excited about that program given how the.
The program is generally we believe derisked by the data from the river the pants on trial with respect to both the day.
<unk> of targeting is selected and pace of occlusive crisis and.
And the value of of getting on board early on which both of which we think 16.87 is well positioned to achieve.
Great, Thanks, Rachel and <unk>.
And it's been a real pleasure working with you over the last few years and and just you know I want to send you all my best for your future.
Thank you. Thanks, a lot of added of pleasure working with you too and as a reminder, I will be staying on the board and really look forward to doing all I can't that continue to help like on the medics and any way that I that I can.
That's great. Thank you and thanks.
Again, the ladies and gentlemen.
And you wanted to ask question please fast Taiwan.
Your next crashes from from the line of like a song from Chafee share. Your line is open.
Great. Thank you for taking the question just a quick 1 also I really needed to those iced tea date of release.
Since you're of course, we know the the registration of study that's the event driven and the potential any of those the iced tea data will be ready and.
Earlier than the pivotal study data just the curious your thoughts maybe of Rachel Eric and you can per license. Besides regarding the receipt from those eyes. She data to your registration of study data.
Uhm share so I'll make a couple of of general comments about those.
The as far as the date of of the 2 AML studies are both open label studies and so that does given the opportunity to the followed them on an ongoing basis until the point where.
It is felt that the the data set is is meaningful enough to be released the third study of the 1 that is being conducted and myeloma patients undergoing transplant that is a randomized controlled trial. So in that case the.
The date of release would wait until the study's fully enrolled and the blind can be can be broken.
As far as read through I think I've I would simply comment that these are opportunities to.
Take different looks at how.
How the drug could work and other populations of AML patients and I think both of the provider both of the Anl iced teas and provide really.
Excellent opportunity to potentially expand the the.
The value of that.
Of that asset.
More broadly than typically the registration trials might allow us to do and.
And both of them follow strongly from the from the excellent scientific rationale of that.
That is has been demonstrated through the preclinical data. So we think that they provide a and important.
Strategic opportunity to to build on that scientific rationale and to to expand the potential use of of your per less line.
Got it thank you.
Or maybe <unk>, yeah, a little quick 1 for the enrollment or the the judicial study so you're you're kind of of maintain the guidance by the end of this year, but we also know the cold the it kind of about the veterans and all of that kind of the different kind of of dynamic. So just curious have you taking care of called the U.
And of a cold the situation also we know of lots of of the M L patient and their and patients Betty.
How did that impact to your kind of the rebalanced to get that at all.
Yeah. So I'm just looking back on the on the pass on that trial, we did have.
A slowdown when Covid first hit last year for about a month or 2 but after that time. The study enrollment rebounded and since then we've had very consistent momentum and of of enrollment.
We're fortunate that we've been and rolling that study and multiple geographies as a reminder, we're treating patients and Australia, and Europe, Anthony and and North America. So we've been able to mitigate some of that risk by by.
By treating patients and different geographies, and we've had very consistent and momentum of enrollment.
And the middle of last year.
So now we're we're close to completion of of enrollment we do.
Expect and certainly and we hope and expect that we'll be able to compete by the end of the year, but we have not seen a drop off and momentum and the past couple of months.
As you point out yourself the patients are in patient. The other thing that's important about the trial that we think has benefited enrollment and and the even and the COVID-19 setting is that because patients have acute leukemia, the treatments can't be delayed.
And the last line is added on top of of the normal standard of care of the patient does not asked to have.
The substantive additional interactions with the health care system through.
True enrollment with this with.
With the study so we think that those factors have have supported the ongoing momentum and and to day, we have not seen a reduction and that momentum as a result of the Delta Marianne.
Got it. Thank you also at my kind of of her [noise].
The the sentiment of retiring and the reality, having and pressure uhm can I share with the what can the thank you. Thank you. Thanks Roger.
And you'll forget question at the sinus very healthy and continue.
Thank you both of to conclude I want to say that I am deeply grateful for my time at the click of the medics and for the opportunity to work with the talented.
And dedicated people here I know that her root and the rest of the team here will continue to make great progress. During this exciting time for lack of the medics very much look forward to supporting him and the company. However, I can as a member of the board as and and as an adviser during the transition and thank you all for joining us today.
Ladies and gentlemen, and thank you bye of participating and today's conference. This concludes the they spoke on and you'll be now disconnect everyone have a great day.
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