Q2 2020 GlycoMimetics Inc Earnings Call
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Good morning, and thank you all for joining Glycomimetics corporate update conference call. At this time, all participants are not listen only mode.
Following management's remarks, we will hold a brief question answer session and at that time in the lines will be opened for you.
If anyone should require operator assistance. Please press Star then zero and your touched on telephone.
I would now like to turn the conference over to you Miss Sherri Ana.
<unk> Investor Relations group at Glycomimetics. Please go ahead.
Thank you. Good morning today, we will review our accomplishments and financial results for the second quarter of Twentytwenty. The press release, we issued this morning is available on the company's website at Www Dot Glycomimetics dotcom under the investors tab.
This call is being recorded a dial in phone replay will be available for 24 hours. After the close the call <unk>. The webcast replay will also be available in the Investor Relations section of the company's website for 30 days.
Joining me on the call today from Glycomimetics or Rachel King Chief Executive Officer, Brian Han Senior VP and Chief Financial Officer.
And Dr. Helen background, our senior VP of clinical development and Chief Medical Officer.
We will start today's call with comments from Rachel and after that Brian will provide an overview of the Companys financial position. We'll then open the call for Q1 day, when Dr. factory will be available to respond to your questions.
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 for less Alam G.M.I. 13, 59, GM I 16, 87 and river Pan.
So as well as there are other pipeline programs and the potential impact of the ongoing global coated 19 pandemic on the company's clinical programs operations and cash burn.
Such statements represent management's judgment and intention as of today and involve assumptions risks and uncertainties Glycomimetics undertakes no obligation to update.
Or revise any forward looking statement for information concerning the risk risk factors that could affect the company. Please refer to glycomimetics filings with the FCC, which are available from the FCC around the Glycomimetics website I'd now like to turn the call over to Rachel.
Thank you Sherry and thanks, all for joining our call. This morning.
Yes in fact began or last call I'd like to say that the entire team hopes that you and your family's remain healthy and the faces a myriad of challenges presented by the Coca 19 pandemic.
Here at Glycomimetics, we've continued our work largely from our homes with minimal disruption to our operations. Although we're happy to report that our scientists have been able to return to our labs and a staggered basis.
And compliance with CDC in Maryland State guidelines.
We're diligently coordinating our activities to maintain ongoing business operations.
We begin by saying the second quarter was a busy and productive one for us.
Enrollment continues in our pivotal phase three registration trial evaluating you for less land and relapse refractory or you know.
The enrollment rate for the quarter was such that we're maintaining our prior guidance, we expect completion of enrollment in the second half 2021.
We also saw steady progress in our collaborative multi centered registration trial with the National Cancer Institute and see I, where you put less lenders being studied in newly diagnosed elderly AML patients who are fit for intensive chemotherapy.
With respect to reverse handful, we believe our additional analyses efficacy data represent an opportunity to reassess the potential viability of this drug.
We now plan to explore with the FDA, whether there's a path forward for this drug candidates for treatment of phase of Occlusive crisis or do you see in sickle cell disease.
I'll now comment on each of these achievements and cover several other highlights as well.
First update on you professional and we did see an initial slowing in enrollment in our company sponsored and I'll trial during early days to covert pandemic.
However, enrollment rates recovered well and accordingly, we are affirming our prior guidance, namely that we expect to complete enrollment in the second half 2021.
We will continue to actively monitor the ongoing impact of the pandemic on patient enrollment and study progress.
Clearly enthusiasm for our trials one clinicians continues to be high again, underscoring you cholesterol and potential to provide benefit across a host of clinical endpoints.
These include improving chemotherapy outcomes and ameliorating some of the serious adverse events of intensive cytotoxic chemotherapy.
Remember that Theres, a second registration trial now underway as you professionalism.
Being conducted by the National Cancer Institute, and just treating patients with newly diagnosed and now.
For this trial as well I can report that accrual slowed during the early days of the Koby pandemic insights are now actively enrolling again.
As soon as the anti publicly shares an update on that trial enrollment will provide that information to you.
Well work in the clinic, both in our own relapse refractory CLL trial and in our collaborative in CCI trial continues to progress.
I also like to call attention to the preclinical data we presented at this years first virtual annual meeting the American Association of cancer research or a CR.
At that meeting we presented animal data that further supports the potential of our compounds in the treatment of AML.
Typically co targeting and in addition of E. Selecting gx here for and Flint three with GM 13, 59 in combination surrounding that was shown to protect normal Connecticut leases at his blood cell formation and more efficiently produce.
Leukemia burden compared to surrounding that alone.
This resulted in extended survival into patient derived the three mutated and they'll model.
Preclinical data also addressed opportunities and setting of stem cell transplant patients.
Additionally, new information was presented on the potential of transcriptome profiling to identify those tumor types and patients most likely to benefit from targeted east like that inhibition.
He mechanism of you professionalism and supportive of a biomarker driven approach to treating patients with pay I know.
Was there analysis for the second like anti constellation Jeans supports our belief in the prognostic importance of this gene expression signature in a ml highlighting the potentially use have you professional in AML and other hematologic malignancies.
Let's now turn to Britain Panful.
We shared with you and our yearend call Pfizers decision to return to collect kinetics its rights to Griffith handle our investigational drug pervasive occlusive crisis or vo see in sickle cell disease.
The transfer back to Glycomimetics these rights and licenses.
Hi, Andy for the clinical development program and the entire dataset for the phase three recent price is now complete.
Over the past few months, we've been actively analyzing the phase three data.
Term and if there's a potential path forward for this asset in sickle cell disease.
We're committed not only to sharing the details of these analyses with the scientific community, but also to defining varies potential options, if any that could be available to come to us to carriers a path forward.
Of particular note in June we were able to share the first data gleaned from Indepth analysis of the reset study, including new data evaluating the primary efficacy endpoint.
Specifically patients treated with your depends on within approximately 26 hours along on the basement occlusive crisis experienced statistically significant improvements in time to readiness for discharge compared to placebo.
To remind you the phase three recent trial evaluating 345 patients who were experiencing acute BMC and required hospitalization for treatment.
The patients ranged in age and six years two adults with immediate mean age of 22 years.
I will say showed that patients treated with recent pampa early in their acute painful episode experienced a statistically significant improvement on the primary efficacy endpoint. The P value 0.03 hazard ratio 0.58 immediate improvement compared to placebo 56.3 hours in other words, if treatment with your who council was an issue.
Hi, good early patients receiving was a pounds were ready for discharge over two days earlier those patients randomized to placebo.
We're often asked let me explain that the time to readiness for discharge endpoints with the endpoints specifically agreed to with the U.S. FDI.
It reflects achievement of multiple clinical criteria, assessing healthcare utilization and to patient medical improvement prior to leading hospital, including no longer meeting IP opioids, I'd be hydration or other people needed treatment.
Equally important we observed in patients treated with through Pampel showed a deep rapid sustained and statistically significant reduction in soluble E selecting an inflammatory biomarkers of acute seat.
We believe this shows that over the past, we'll have to intended on target biological effect.
The effective observed on cyber East luck admits in this trial provides valuable insight into the mechanism for the improvement in the clinical criteria for discharge from the hospital observed in those patients treated early in their acute PMC.
They just from the reset trial, Additionally, demonstrate and favorable safety profile for risk tangible safety profiles of the panel observed in this trial is evaluated in the population pediatric adolescent and adult patients.
Okay, Thats, the case for potential risk benefit value proposition escaping the tangible.
We are exploring various options for the depends in this acute treatment setting for which there are no proof drugs into our knowledge no drugs currently in late stage development.
As part of that process, we intend to discuss these data with the FDA to determine what if any next steps could be taken to carrying this program forward in acute PSC.
In the interim the support of efficacy analysis, and then do biomarker data will be presented at the September meeting of the foundation for sickle cell disease research or FSC VR.
At the CDR posted the abstracts on its website efforts CPR dot or in mid June and they're available for your review.
We've also completed additional analyses on the phase three reset trial, we further support the potential benefit written council may provide an acute c., we hope to publish and are present these new findings at upcoming medical meeting.
In addition to the over the past the poster and abstract containing data on quicker than that it's more selective and highly potent east selected antagonists GMR 60, maybe seven has been accepted for an oral presentation by FX CDR for their September meeting.
The G.M.I. 16, 87 abstract includes data from a preclinical model showing that drug candidates potential as a subcutaneously administered treatment for vmc.
Through the council now back in our own hands GMV 67 provides an opportunity for potential follow on product with subcutaneous administration.
Prior to Pfizer's returned the company Panther right. We were prohibited for pursuing this molecule sickle cell disease by India, enabling activities are now underway. That's our belief that Gms 16, 87 could provide an opportunity for patients to be treated at home as soon as the acute pain. If you see begins.
Opportunity to do so could potentially aboard give them for vascular coagulation and potential organ damage occur.
Sure. We now know that early targeted destock in intervention can have an impact an acute PMC. This asset is uniquely suited to address that meet.
Needless to say, it's an exciting time that glycomimetics.
We have two pivotal programs progressing well in a in house.
Uhhuh Council rights to return and additional analyses completed and plan to engage in discussions with FDA and with the tangible and our portfolio of novel molecular medic drugs includes multiple candidates that are truly differentiated.
Now I'd like to turn to Brian to review, both the quarter's financial results to provide perspective on our financial situation Brian.
Thank you Rachel as of June Thirtyth 2020, liking, what it took cash cash equivalents of $149.8 million as compared to $158.2 million as of December 30, Onest 2019.
The company's research and development expenses decreased to $9.9 million for the quarter ended June Thirtyth 2000 twice as compared to $13.1 million the second quarter 2019.
The company's research and development expenses decreased to $22.5 million for the six months ended June Thirtyth 2020.
As compared to $24.8 million same period in 2090.
[noise] decreases were primarily due to a decrease in manufacturing reformulations expenses, resulting from lower raw material costs as a validation manufacturing batches will purchase the prior year.
The decreases were offset in part by higher clinical expenses as result of increasing on the ongoing global phase three clinical trial of your personal and individuals or relapsed refractory AML.
On a phase two three clinical trial being conducted by the National Cancer Institute.
Contract research services consulting and other costs were lower in 2020 as research activities were affected it outside universities and travel by research and development personnel was largely eliminated the cobot 19 pandemic.
Now turning to generate census.
General administrative expenses increased to $4.2 million for the second quarter ended June Thirtyth 2020.
So to $3.8 million for the second quarter 2019.
General and administrative expenses for the six months ended June 32020 increased 8.7, $9 as compared to $7.1 million in the same period in 2019.
Personnel related expenses increased due to additional general and administrative headcount.
Annual salary adjustments or work in the first quarter of 2020 and retention bonuses.
Legal fees consulting and other professional expenses into the brick and officers insurance premiums increased as compared to 2019.
Other general administrative expenses speakers for both the three and six months' time to do for 2020 as compared to the same period 19, lower travel expenses as a result of the cobot 19 pandemic.
Now I'll turn the call back over to Rachel.
Thank you Brian.
For opening up the call to your questions I'd like to reiterate our confidence in the clinical pipeline at of course in our specialized glycan emetic chemistry platform, our chemistry insights to fueled several innovations that we believe have the potential to improve the standard of care and and now it may do the same in sickle cell disease and other diseases as well.
Now operator, please open the call for questions.
Ladies and gentlemen, if you have a question at the time, Please press star and the number one and you touched on telephone. If your question has been answered all your question Little yourself from the Q. Please press the pound key.
Our first question comes from the line of the bed Gela with Roth Capital Partners. Your line is open.
Good morning, I think for the very detail uptake. It had a quick snacks right about the preclinical athlete ships why don't you get a sensitive.
How you're prioritizing that lets say, let's call that I was particularly since you mentioned now you are staggering employees into the lab. So how you prioritize their pocket our efforts so but the key focus there.
Sure Hi, Steve Good morning, Thanks for your question I'm. So.
Are there going to answer that in two ways. We have as you know the preclinical assets that we've mentioned in the earnings call today and previously its Pacific with 16 87.
13, 59, and both of those actually upside for Tuesday nights courses in the clinic, but 16 87 as the preclinical assets is currently an idea enabling studies what we're doing in the labs is actually work, even even earlier to that were where we're focusing on some of the more basic chemistry opportunity.
We have to potentially develop even additional.
Molecules, where we're focusing on the collections and we have compounds that target galectin three as well as compounds that target those collected three and you select them. We've got some very exciting a novel compounds that that we still haven't.
Yep.
Brought forward into advanced preclinical testing. So we're doing a lot of chemistry work and we're continuing to do evaluations in our in our asset group for activity of these and other molecule. So it's that type of activity that we're doing in the labs.
Thank you and then just a quick follow up under the pants or just kind of wanted to know hi, playing to discriminate. It's in the additional post hoc analysis that you plan to contribute to Dan.
So in the normal course of our work we typically present. This data we submit the stated an abstract to scientific meetings and so I will continue to do that as we have the opportunity as the meetings come up enough. The abstracts are are ready to be submitted.
So I can take a look in fact here about next that's on Pampa sure sure. Thanks. So just it just to clarify I can't speak to specific meetings until obviously until abstracts are accepted but in the normal course of things. We would we would prepares us abstracts and submit them as the meetings as it makes come up.
Okay perfect. Thank you.
Next week.
Your next question is from at White with H.C. range right. Your line is open.
Hi, good morning, everyone.
Right.
So maybe Rachel just I don't know if I missed it but last quarter you had mentioned that Gms 13 59.
Phase one study was halted.
Can you give us an update.
On that.
So that study currently enrolling patients.
And then also.
Just for.
And a timeline update on both 16 87.
And river pencil.
Can you give us any thoughts on 16 87, the timing of and I MD filing and then for revoked hands. So I.
Any thoughts on when you are going to meet with the FDA them. Once you meet with the FDA.
FDA are scheduled meeting with the FDA would you be.
Alerting investors to that is that right now.
Sure. So with respect to 13 Fiftynine, yes that trial was put on hold in the early days of the pandemic and we do expect that we'll be able to start enrolling patients again soon very soon and that in that study.
Unlike our email trial.
Page that study is not specifically treating it's not it's not.
Fit quite on top of the standard of care the way the email trial is and so we so we don't see the acute need to treat those patients away milk patients are currently need to be enrolled and treated and treated acutely.
In terms of 16 87 timeline.
As we were describing under the agreement that we had with Pfizer, we actually were not able to develop any other of our of our compounds for sickle cell disease, including 16 et cetera, now that the rights are back we are initiating the idea enabling.
Studies for 16, 87, and as we have a timeline. So that we will make we will make that no, but we have not specifically announced yet when we'll be starting or what would be anticipating filing your R&D for that but we will let you know when they have more tangible plan for that.
And as far as your Panful grows we do intend to meet with the FDA. We've not we would not expect to initiate this or just to announce the specific date of an FDA meeting.
But we would give any guidance that we can once we have information from the FDA as you'd expect those conversations are interactive they take place overtime.
So we don't expect that there's going to be a.
Specific moment, where we're able to say.
Now the we have the meeting you have a particular specific.
Sort of guidance, but rather that over time, we would expect that we'd be able to have ongoing conversations with the agency that that would clarify their guidance I'm, telling would you like to anything to that.
Okay.
I think thank you Rachel I think since in terms of the FDA guidance for the tantalum I fully agree it had nothing further to add.
I would.
Also just note for the 30 to 59 trial in 30 59. This this as Rachel said this is a trial that is in outpatient setting it's not in the acute treatment setting but assessing for.
Alright, pharmacokinetics pharmacokinetics pharmacodynamics, we're looking for dosing information to inform a readiness for phase two and that is an elective.
Treatment setting for patients and sell it at the point that patients are being excepted back into the clinic. We would expect at that study would be enrolling we are expecting that its retrofits researcher experienced here.
Great. Thank you.
And maybe just a question for Brian Brian can you give us any thoughts on cash runway and then also how much.
Do you have left in the ATM facility.
Thank you.
So current cash runway now gets us about mid second middle of the second half of 22.
Hmm is about 60 million left on that.
On the program.
Great. Thank you.
Thanks Seth.
Thank you know next question is from Brian and then with Jefferies. Your line is open.
Hi, guys. Thanks for taking my questions, maybe I'll just focus on rubber capsule.
Comes from my culinary I guess in terms of this analysis. In addition to all the time to administration of or pass will from from the onset of Livio C.
Did you look at any other subgroup variables to see if there were any differences or not.
Across the primary and secondary endpoints.
Hi, beer and thanks for your question, Yes, we have but we just not disclosed anything beyond what's in the abstract at worst.
That was made public interior until we may have further comments about that going forward, but to date as it was disclosed to the answer to the extent of the data disclosure at this point.
Got it and then I guess racial.
How is the 26.4 hour cut off established <unk> was that I guess a pre specified.
All the time point, but you looked at or or what.
That doesn't post hoc.
Let me, let me add to for that to Helen.
Thank you Rachel.
And can morning. This 'cause it 26.4 hours was not pre specified it was it will be determined in further additional analyses. After the initial reported top line data on it was however, the first quarter tile of the duration of time seen across the range of patients for.
Onset of pain to initiation of study drug so it is a Chris.
Interval to report first quartile, it's not an arbitrary interval and I would think that's that's an important point.
And as it relates to this cohort.
As you also.
You know see any benefits on the secondary outcomes like times discharge for example, or.
Ivy opioid consumption.
Well again that was not disclosed in the abstract that's been made public so far.
Okay, great well, thanks for taking my question.
Sure.
Thank you and our next question comes from the line of seasoned Wiley with Stifel. Your line is open.
Hi, good morning, Thanks for taking the questions.
Maybe just to piggyback little bit of both Berens last question.
Have you guys looked at all at the at the prior stage two study.
To see just whether or not patients.
Receiving treatment was in short order of experiences you see showed similar type of benefit as was described.
In the retrospective analysis.
So Steve that's a great question and I think that that's the kind of analysis that the companies in the processes are performing.
But we have not disclose anything further than what was in that abstract.
Okay.
And then just given that youre going to.
We're given that you're potentially narrowing.
The.
The window of treatment opportunity here.
Do you think that you could maximize the commercial opportunity with a drug like where the tangible requiring acute care administration or.
Do you think that this opportunity than kind of really best positions. It's also something would.
60 meters.
Well I think the opportunity and we're depends what could be substantial because remember that.
The current guidance, it's given to sickle cell patients is that they stay home.
And delay seeking care in the hospital treating themselves with.
Oral pain relief as long as they possibly can so.
It could represent a change in the treatment paradigm of trained a change in the in the way people think about.
Giving guidance to sickle cell patients if if they were to be encouraged to seek treatment more quickly and in that context, and I think could potentially have a drug like where the panel delivered in the outpatient setting earlier in crisis. So it's not that says that the.
Drug would be limited to let's say a quarter patient Roger one was encouraged.
Any patients suffering from DRC to go in to seek treatment earlier, so I do think there's an opportunity.
Potentially if this were too.
To.
Go through the various stages of evaluation that we described the potential for the past two to it in fact address some important needed an acute setting and held and maybe you could comment more on them.
[noise], Yes, I think one thing that is interesting is the install first core tile reported a 26.4 hours is impact a day after onset of pain.
We would expect that in the real world setting patients would be coming in at point that they need to have their pain treated we would expect also perhaps in the clinical trials setting that.
It might take a little bit longer to initiate treatment after presentation to the hospital because at the processes that need to be.
Administered for participation in the clinical trial, so in the real world setting I think there is a very real potential for treatment for patients to be treated relatively early and that get provides an opportunity for treatment and that are what the agent so whether its I'd with the pen for weather detainees.
60, 87, I think there the opportunity to give patients.
And effective as an effective agent early in the first of the there is this is there and it is similar potential regardless of the agent or opportunity. We heard the pencil is to assess whether there is a potential whether to pencil to be used in this way and that's a discussions.
Refer back to the discussion that we.
Tend to have it sta.
Great. Thanks, a lot for taking my questions.
Sure. Thank you Steve.
But as a reminder, ladies and gentlemen, if you'd like that's a question at this time, Please press star and the number one.
Our next question comes in alignment for Speaker with Cowen Your line open.
Great. Thank Soc in mind. This isnt there on for Boris I'm, just curious regarding enrollment for filling in for less flat.
Can you provide a little bit contracts level, and then Alex between Q1 long cave and do you see increasing enrollment or just to return to baseline on 5% no. One really knows but are you anticipating asps were down in the fall.
Oh, I'm, sorry, I Didnt understand your question, where you think comparing Q1 to Q2.
Correct.
I'll, let dynamics correct.
Yeah.
Now lets could you speak to that.
Yes.
Sure so.
We have seen very high interest for rolling on this trial with investigators in the sites.
Involved in the trial, we have seen that they have identified you cholesterol in end of phase three trial or something they want offer to their patients and theres been a brisk uptake.
In terms of a slight starting on the trial and then enrolling patients. Once they are active on the trial that has not changed over the course, ESCO pandemic and that differences between Q1 in Q2. So the interest is there that.
Deliberate offering trial to patients.
When they centuries open to running clinical trial and the only thing that has changed really of the and number of hospitals that have limited their clinical trial participation at the point of the highest.
And pace as patients coming in and their own hospital at Wisconsin pandemic I would reiterate that we have a global clinical trial with with the gorilla in phase three on and that gives us the opportunity to have centers open an actively enrolling across the world that means that.
Any impact of.
Pandemic on an individual hospitals ability to continue regular clinical trial activities is limited to that hospital and when there's a region that were affected there the regions that have been best affected and that has allowed us to maintain a fairly continue mr. ongoing enrollment across the globe.
Individual hospitals responding to the pandemic locally as they need to so I think what we're seeing and reporting to you now is that they enrollment has.
Continued there's been some some briskness today valeant, it's allowed us to keep our guidance for.
Closure, if the trial to be the team.
Alright, great. Thank you for taking your question.
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Thank you don't I'm not showing any further questions. So now I'll turn the call back over to Rachel King for closing remarks.
Great. Thanks, very much. Thank you operator, and thank everyone for your questions and for taking the time to listen to our call.
Ladies and gentlemen, thank you grew to spitting today's conference. This concludes the program you may now disconnect everyone have a great day.
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