Q2 2019 Earnings Call
Thank you.
Good morning, and welcome everyone joining us on todays call and thank you for taking the time to join us to discuss our performance over the first half of this year.
We are glad to also had the opportunity to provide updates related to the eliminate three O one and two or four trials.
Before we proceed further Brian when our general Counsel will apprise, you of our potential to make forward looking statements Brian .
Thanks Ben.
During this call we may make forward looking statements within the meaning of the federal Securities laws, which may be identified by words like anticipate expect believe estimate.
Potential plan and other similar words.
Certain statements regarding our expectations for future clinical trials.
The timing and outcome and potential outcomes of clinical studies and interactions with regulatory authorities.
And potential commercial opportunities are examples of such forward looking statements.
As you know forward looking statements are subject to factors that may cause our results and plans to materially differ from those expected factors that may cause. These differences include those described in today's press release.
And the risk factors section.
Of our annual report filed on Form 10-K for the year ended December 31 2018.
These forward looking statements speak only as of today, and we disclaim any intention or obligation to update them.
I'll now turn the call back over to Vince.
Thanks, Brian .
Joining me on the call. This morning are the members of the Idera leadership team, including our newest members Chief Medical Officer lifts, Tarka and Chief Financial Officer, John Kirby.
I believe it will become quite clear during the course of this update that our team has been extremely focused on execution of our Tulsa toll not program during the first half of this year.
I'm very proud of this group for the focus and intensity.
They have demonstrated in advancing health so through our first pivotal registration trial eliminate 301.
And anti PD, one refractory melanoma.
As well as preparing to test it in other tumor types for patients with limited treatment options.
For our call today I'll provide a few opening comments and remarks, and then I'll turn the call over to Liz to walk through an update on itself and told them I program.
John will then provide an overview of our financial results.
And I'll return for some closing comments before we open it up to take your questions.
Amongst the updates lives will provide details related to several informed modifications we've made to eliminate 301.
We believe these modifications to significantly increase the probability of a successful outcome of the trial and the opportunity for Telcel told them on.
To be a viable treatment option for patients who have reached the stage of their disease, where treatment options are extremely limited.
Overall, the progress in the eliminate programs has been strong and execution has exceeded the expectations and timelines that we had set out for you and ourselves.
The thrill one trial has enrolled better than we had anticipated.
We have already accrued 294 patients.
Putting us on track to achieve enrollment four months ahead of schedule for our original target of 308 patients.
This speaks not only to the enthusiasm from investigators and patients and the lack of approved options and the melanoma space.
But also the disappointing results observed with other once promising candidates in this space.
As it relates to eliminate two of four.
Our phase one two trial with an anti PD one refractory melanoma.
We completed enrollment in the first quarter of this year.
As you know we guided to an update on data from this trial in the fourth quarter of this year.
In light of the modifications, we are making in study 301.
We have elected to accelerate our review of the data.
And we'll be providing that update to you today.
This preliminary data update includes overall response rate disease control rate.
And for the first time duration of response and early data on overall survival.
We believe the key take away is that the preliminary data from the ILLUMENATE to vote for trial, our congruency with the feedback we have received from the medical community and our advisors related to their expectations of clinically meaningful benefit to patients in this highly challenging indication with limited to no real treatment option.
Earlier this year, we also completed the ILLUMENATE one no one monotherapy trial and presented data from this trial at a CR.
We are encouraged by the number of stable disease cases observed across a wide variety of difficult to treat tumor types and with patients. So in most cases and progress on all prior lines of therapy.
In fact, even though the trial has concluded we have one patient with uterine flyer miles sarcoma, who continues with durable stable disease.
This patient received their first dose of til so over one year ago.
And is now continuing under a treatment on Monday.
We also recently learned that we have one patient in our melanoma cohort from this trial, who has an unconfirmed resets version 1.1 partial response from till so monotherapy.
The one other one trial has served two objectives.
First confirming till so its mechanism of action through the translational data.
And second provide safety data for Telcel told them out as a monotherapy.
These data also played a key role in strengthening our conviction that this novel approach could be tumor type agnostic and aided in our planning for the multi cohort two of six trial.
We will be initiating eliminate 2.6 this quarter as a triple combination with Eutelsat told them on and Bristol Myers typically don't have been the bowling Matt.
First in microsatellite stable colorectal cancer.
I'll now turn the call over to live to share more of the details of the eliminate programs lists.
Thank you Ben.
Good morning to everyone.
Let me begin by noting how excited I am to be joining idea at this critical time until the tolling lot development and having the opportunity to lead this program and team.
I share the medical community is clear enthusiasm for Tofa told him on as we bear this treatment through the Registrational path and anti PD, one refractory melanoma.
And through various other treatment combinations and tumor type.
I'd also like to recognize Joanna Horobin for all of her efforts with the team in advancing telco to this point and continuing to serve as an advisor to us as we move forward.
Starting with the registration study eliminate three or one we recently implemented a few modifications to the trial has been noted.
These were based on advice from the trial steering committee along with recent discussions conducted with global expertise.
The overarching message was that the clinical outcome assumptions in the original 301 trial design were much higher that experts in the field felts. We're currently necessary to demonstrate significant clinical benefit for patients with metastatic melanoma refractory to a PD one inhibitor.
When the three in one trial was originally designed in 2017.
There were several novel approaches being investigated for patients with melanoma.
Therefore, anticipating significant competition in this indication with real one trial was designed with a high bar for benefit in both survival and response rate.
Since that time many of those approaches have not progressed to approval and the treatment options remain limited.
As a reminder, the eliminate 301 trial is a phase three global multi center clinical trial.
Evaluating the efficacy and safety of intra Tumoral tilted told the hot in combination with the balloon.
Versus ipilimumab alone in patients with anti PD, one refractory melanoma.
This trial is being conducted at approximately 100 sites across the 11 countries.
In the 301 trial overall survival and overall response rate comprise a family a primary endpoint.
Which means that achieving either of these endpoints can lead to a regulatory approval.
Well the overall survival endpoints.
Our original clinical assumptions were intended to demonstrate 18 months median overall survival with Eutelsat plus if the combination.
First with median overall survival of 11.4 months, which is the historical control in subjects receiving it be alone following chemotherapy.
This resulted in a target median overall survival improvement of 6.6 month, which equated to a target effect size of <unk> 0.63.
Instead, our steering committee and external expert suggested that an improvement of 4.6 months would be clinically meaningful which equates to a target effect size <unk> 0.71.
To maintain statistical power that's required an increase in the sample size of the trial from three O eight to approximately 450 patients.
Which is our new enrollment goal.
At this point in time to 194 patients have been randomized into the trial.
Based on our current pace of enrollment we expect to complete randomization in the first half of next year.
As for the overall the endpoint of overall response rate.
The typical of a math alone overall response rate and anti PD, one refractory melanoma has never been definitively studied in randomized clinical trial.
But is generally believed by treating physicians to be approximately 10%.
Our initial clinical assumption what to demonstrate a 20 percentage point difference applying read this version 1.1 criteria to the til. So if the combination versus 50 alone.
However.
Our advisors recommended that an improvement over over it be up 10 percentage points would be a significant clinical benefit in this refractory patient population.
We have solicited feedback from the FDA and they do not subject to these changes.
We also solicited feedback from other global health authorities and anticipate having their inputs shortly.
Moving now to the preliminary results. We provided this morning from the ILLUMENATE two or four trial, our phase one two study of intra tumoral filter told a lot in combination with Ipilimumab.
As of now we have data from 49 efficacy evaluable patients.
I'll be 49 patients 13 achieved a partial response or better representing a 27% overall response rate.
Hi, the Refis version 1.1 criteria.
Of the 13 response.
Our durable.
To find at six month of duration or longer.
Median overall survival has not yet been reached with a range from 1.6 to 35 months.
I'd also like to bring your attention to the disease control rate from this trial.
Overall 36 of the 49 patients for 74% have achieved a best response of stable disease or better.
We believe this rate of disease control in this difficult to treat patient population is encouraging and may correlate with survival benefit.
More often than not in our experience so far patients who have had disease stabilization appear to maintain that status for lengthy duration as well.
We've had patients in this trial with stable disease for periods, such as two years and ongoing.
We also felt it would be informative from an overall survival perspective to review the data from the 26 subjects. We have presented at the 2018 ASCO meeting.
They have been in this study for the longest amount of time.
Among this group of 26 patients 52% of subjects were still and follow up at 12 month, using an overall landmark survival and now.
Our team is planning to submit an abstract of the complete to afford trial data for one of the major oncology conferences next year.
To summarize the melanoma discussion we believe it is quite clear from the medical community and a 4.6 month improvement on overall survival.
And a 10 percentage point improvement in overall response rate would be viewed as a clinically meaningful and exciting option for their patients.
With the expected overall response rate and the early indicators of overall survival presented in the preliminary analysis from 32 or four we believe that till for told them can indeed deliver real benefit to patients.
We are excited and encouraged as we continue to execute that study.
I'm now going to turn the call over to John to provide an overview of our financial results from the second quarter.
Thanks Liz.
Excuse me and I too am excited to be joining me today is idea is new chief financial officer, and providing you with an update of our financial results through the second quarter of 2019.
I will first touch on the financial results for the quarter and then we will provide an update as it relates to our cash position.
Research and development expenses for the three months ended June Thirtyth, 2019 were $10 million compared to $10.9 million for the same period in 2018.
General and administrative expenses totaled $2.9 million compared to $4 million for the same period in 2018.
The difference in general and administrative costs were related to lower employee and facility costs. As a result of cost savings realized in connection with the closing of our Cambridge, Massachusetts facility in July 2018.
In the three months ended June Thirtyth 2018, we also incurred $1.6 million of merger associated costs, which did not exist in the comparative 2019 period.
Net loss applicable to common stockholders for the three months ended June Thirtyth, 2019 was $11.2 million or 39 cents per basic and diluted share.
This compared to net loss applicable to common stockholders of $16 million or 59 cents per basic and diluted share for the same period in 2018.
Revenue for the three month period was $1.4 million compared to $200000 for the same period in 2018.
Moving on to cash as noted in our press release. This morning as of June Thirtyth 2019, our cash cash equivalents and short term investments totaled $52.4 million.
We expect based on our current operating plan, our existing cash cash equivalents and investments will fund our operations into the second quarter of 2020.
We have the financial flexibility to fund our operations through the arrangements with Lincoln Park capital and JMP Securities.
And we'll continue to apply a very disciplined approach to our expenses with that I will turn the call back over to then for closing remarks.
Thank you Liz and John for providing those updates.
I am sure that you would agree we have made a great deal of progress this year until told them on.
As most of you know we are small company with limited resources.
For a team of our size to have progressed, a global multicenter Registrational study as rapidly as we have is a testament to the spirit of our people.
And our focus on delivering for patients who are in desperate need of new solutions.
We are not yet at the finish line, but we are well on our way.
We also feel strongly that we have taken the right steps to enhance the probability of a successful outcome for this first pivotal trial with Telcel total amount.
This is of Paramount importance to the patients suffering from this devastating disease.
Although we've seen tremendous progress in the field, notably with the advancement of checkpoint inhibitors. We truly are just scratching the surface of the potential of immuno oncology.
We believe that total total Oman will be a leader in the next level of innovation of immuno oncology antibody honored and humbled by the awesome task of delivering it to those patients.
This concludes our prepared remarks for our call today, we'll now open up the line to take your questions.
Thank you, Sir ladies and gentlemen at this time, if you would like to ask question over the phone. Please press Star then one on your telephone keypad.
If your questions have been answered or you wish a movie or something like you simply press the pound key.
And our first question will come from a new Pam Rama with JP Morgan. Your line is now open.
Hi, guys. Thanks, so much for taking the question and congrats on all the progress.
A quick one for me on study to a floor I notice in the press release, you highlighted about 40% of patients had E com to performance status, let me talk a little bit about the severity of the patients enrolled in the study relative to say the competitive environment and.
In that context have help us put the overall response rate into context that you are seeing a steady tool for thanks. So much.
Thanks, Tom Great to hear from you.
So let me begin maybe on the second part of your question is the relative comparison, and then maybe Liz can comment on.
The details relative to this the performance data feed cost performance status into a four versus the patient population more along in phase three three or one.
So I'd say, what we what weve.
Observed and analyze touched upon is that.
This is the only study of all the studies that we can compare ourselves to that enrolling the second patient ECOG performance status too.
We took the second for the SEC, which I think is reasonably consistent with what a phase one study would look like and as we noted in our press release, having 43% of the patients that have been enrolled in this study are actually ECOG performance status too.
So we think that's a differentiating factor.
With the data that Weve generated that we have treated the sicker patients in this study.
Now importantly, how does this relate and correlate to what we're doing in phase three and I'll ask Melissa.
Provide that answer.
Hi, Ben.
So the phase three trial does not include patients with metastatic to it.
As you know you talked about two represents a more challenging patient population.
So therefore conceivable that the overall response rate in a phase three trial may be improved over these preliminary results from study two a four.
Since we are not enrolling this more challenging patient population in the 301 study.
Great. Thanks, so much for taking our question.
Thanks.
Thank you and our next question will come from Gena Wang with Barclays. Your line is now open.
Thank you for taking my questions I have a few questions regarding two will fall into three or one.
For the three year, one are you able to see blinded data and how was that trending in line with your adjusted assumption.
Hi, Jane and thanks for your question.
We do not look at the blinded data from an efficacy standpoint, obviously, we have to monitor the safety.
Okay.
Okay. Then another three a one question or two of the three on one question right Joanna Yeah real one.
Right. So no real one were not looking at the data from S&P perspective at all we need to maintain the integrity of the study.
And run it you can comment yet conducted in compliance with GC Chase so.
Oh no no insights from the three I want to study the insights relative to the.
The data were from two of four correlating with the feedback from the steering Committee and our advisors relative to the current view of what's clinically meaningful in this refractory population.
Okay very helpful. And then question for tool for.
13 responses, how many responses was confirmed.
[noise] Shami Lufthansa.
As a shower hemi medical oncology lead for the program Hi, Thank you for your question.
Nine honored the.
13.
Responders were confirmed on for Brian .
Okay and a follow on come from just because it was not enough time or they would not able to be come from.
No many of them were reason.
And we are still waiting for confirmation skin.
Okay. Okay, and then last question is.
But you will for sure.
So the median duration of response is not yet.
And we do analyze that later, we will have this hopefully or.
Nick and I'll spend the next conference.
Okay. So because you give the number right. So the durable response over six months, but out of all the patient to the response what is the median duration of response.
Because of the unconfirmed responses, we did this calculation we intend to issue.
Okay. Okay. That's fair, okay, well thank you.
Thank you Gina.
Thank you and our next question will come from the last while Yom Bakula Ramakanth with HC Wainwright. Your line is now open.
Thank you. This is our came from had C. Wainwright.
Okay.
Hi regarding the data that is expected to be present at ESMO conference could you comment.
On Wall Street could be seen and then.
Based on that get awarded the next steps.
For the four told some monotherapy.
So starting with my questions. So.
You mean at HCR as more asthma.
The ESMO next month.
Okay. So at this point really we are looking at.
You know we have we would like to report more on our patients that had this big pads. The response.
Confirmed Paul who will elaborate more detail on that patient.
I think we will have more detail on our.
Normal for patients.
Which were not included in that.
Previous reports, so I think that Uh huh.
Mobile data will be more interesting insight.
In our K on your second question relative to the plans around monotherapy, we don't kind of additional plans for monotherapy.
That plans to evolve it is focused on two of six and taking the.
The translational data that we've seen in two.
First into the microsatellite stable colorectal cancer, and then into the head and neck cohort.
Okay. Thank you and then in study people one is that an interim look designed into this study at this point.
So the interim look is there is an interim analysis in this study.
The context of that interim analysis RK as around our desire and plan to submit for an accelerated approval around Oh, our our.
And so the the interim analysis the analysis will be to support that Theres no detriment, if you will from a survival standpoint.
Vis-a-vis till so combo versus VIP alone arm.
Mm Hmm.
Okay. Thanks for that and then on the tool for study.
What's the longest follow up yes.
And that's from inpatient.
I think it's the one that probably the first complete responder from May of 2016.
So we're we're out three years.
Okay investing.
Thank you thanks, thank them because.
Thank you RK.
Thank you and our next question will come from Mike you off with Baird. Your line is now open.
Hey, guys. Thanks for taking the question just a quick one for me.
So with respect to the three a one study you know you're sort of upsizing, the patient numbers and you're going to complete enrollment in the first half.
Next year.
Just what's the earliest we might be able to see data should we be thinking you know 2021 potentially thanks.
Thanks, Mike Litch, you want to take that sure. So sometime between nine to 12 months from when the last patient is enrolled in the study we would expect to have the overall response rate and the durability of response.
Great. Thank you.
Thanks, Mike.
Thank you and as a reminder to ask the question over the phone Star and then one.
Our next question will come to the line of Robert Driscoll with Wedbush. Your line is now open.
Hi, guys. Thanks for taking my questions could you talk about any baseline differences are going as expected baseline differences between the patients enrolled and eliminate tool fall versus three a one.
Just in particular with regards to stage of disease, and maybe similar previous treatments and if you saw any striking differences in efficacy it cost across the stage of disease and tool.
So maybe I'll take the last part of that question first Robert we have not.
Analyze the data across the different E com performance status.
Sure I wanted to completely we can say.
That there is there are more responders up to 13 responders that our economy here on one.
We will be scrubbing that data relative to a subsequent disclosure that the specifics we're not ready for today, but maybe shock and give some commentary on the call. It the patient profiles. If you will and you asked in the first part of your question sure you know answering your question about the baseline characteristics.
Really the two study very similar baseline characteristics.
And I think the only important differences our first what we discussed is the E com score that into phase three study, we exclude patients with these cost too.
And the other thing is probably your use of the lease them up as you know a tool for the the.
Ill patients to no Andrew to participate with prior if you are in the phase two study we allow patients that had any color on that and the accident setting so BP.
You see them to static sitting with will be exclusionary.
Got it thanks, and then just with regards to tools Ssix could you elaborate on why MSS colorectal cancer was chosen just given its apparent resistance to at least single agent checkpoint inhibition.
Sure.
Sure. So as we do about the CRC is one of the most challenging tumor types as a cold tumor type and as you know the majority almost over 80% of the patients colorectal cancer emphasis CRC.
So really.
The base to start that study was our big tough from the monotherapy study one on one we saw a patients with stable disease long term stable disease and some of them Interestingly we had actually.
Some reductions in the tumor totaled tumor burden.
Well that's enough of course to reach a response, what we felt that this is a great field Lucy investigate until so and.
And that was really the base. The of course, there are also translational reasons to back this decision.
In terms of resistance to prior.
And other.
Available immunotherapy agents. So I think we have a strong base for the two studies you answer your question.
Yes. Thank you very much right. Thank you Robert.
Thank you and we have follow up questions coming from Gena Wang with Barclays. Your line is now open.
Thank you for taking my follow up.
Just a quick question regarding the interim analysis for potential accelerated approval.
Wouldn't it be feedback on campus and a benefit of an overall response.
The feedback if the FDA did not object to our proposed changes and the amendment.
Okay. So that should be sufficient if you show, 10% who are differences that would lead to the accelerated approval.
Yes.
Interestingly.
That.
In the absence of any other treatments in this in this field, we got the feedback from really experts that no 10%.
A difference will be meaningful.
Of course. This is this is what.
The minimum that the trial can capture so we believe that's you know Phil Sewell will move.
Perform better may perform better and also it's not just the response rate and also the durability of response and that's I think that's an important factor in the agency recently looked into.
Yes, just from the staff standpoint, it's powered to show a difference in overall survival and.
Oh, our arc. So if we achieve our we achieve our objectives in the study we should meet the statistical significance and again on the in the marketplace side of it.
Percentage differences.
Are driven by the views from the actual experts in the field.
Mhm.
Okay. Thank you.
Thank you Gina.
Thank you I'm showing no further questions at this time. So now it is my pleasure hand, the conference back over to Mr., Vin Milano Chief Executive officer for any closing comments or remarks.
Thank you. Thank you again, everyone for joining us here this morning.
Well, we've had a very busy first half of the year I hope that you feel the same way after listening to US here. We wish you a an enjoyable last few weeks of our summer and look forward to giving you an update soon on the progress, we're making with till so and our company wishing you all an outstanding day. Thank you.
Ladies and gentlemen, thank you for your participation on today's conference. This does conclude our program and we may all disconnect everybody have a wonderful day.