Q2 2020 Infinity Pharmaceuticals Inc Earnings Call
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Ladies and gentlemen, today's conference scheduled to begin shortly please continue standby and thank you for your patience.
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Standing by welcome to US and everyone is critical to talk about call. It to discuss the company's operations and financial results for the second quarter 2020.
My name is Shannon and I'll be operator for today's call.
At this time, all participants are in listen only mode.
There will be a question answer session to follow.
If I said this call is seen liquid and citizens for quest.
Now I'd like to introduce your host for today's call Jane Kaufman. Please go ahead.
Thank you Shannon and good afternoon, everyone welcome to today's call to discuss our recent business progress and review our second quarter 2020 financial results on the call with me today are Adelene Perkins, Chief Executive Officer, Larry Block, President and Brian Schwartz consulting cheap position well open up the call for Q1 eight.
Following our remarks.
The press release issued this afternoon details our results and is available on our website at <unk> Dot Com. We've also submitted our 10-Q two the FCC, but the filing is pending resolution due to technical issues that Edgar that are impacting us and other companies.
Please note that during this call we may make forward looking statements about our future expectations and plans, including clinical development objectives, the therapeutic potential of our product candidates, our strategic plans and strategies and financial projections. Our actual results may differ materially from what we project today do.
Well a number of important factors, including the considerations described in the risk factor section of our annual report on form 10-Q for the second quarter of 2020, and another filings we make with the FCC.
These forward looking statements represent our views only as of today and we caution you that we may not update them in the future whether as a result of new information future events or otherwise.
Now I'd like to turn the call over to Adelene.
Thanks, Jane and thanks, everyone for joining us today.
Oh bullet Infinity has been cute on a robust clinical development plan for again, a lift said also known as I cant 5.9.
We are evaluating again.
Yeah.
Having been indication.
Valuate potential to improve outcomes for cancer patients like reprogramming that well pages in the tumor microenvironment croaky excellent anti tumor function.
Last quarter, we provided an update regarding impact Hoguet 19 on our clinical program and stated that we did provide updated guidance I understand.
Oh.
Well, we and our peers are managing the still evolving hoping making situation. We're in a much better position to protect the magnitude of the impact on our trials in Taiwan.
We'll provide more specific updates during halt, but I'll first briefly review updated guidance across our cloud.
I'll start with married to 75, a randomized controlled phase two study in collaboration with being that.
In which we are evaluating ganetespib in combination with opdivo in patients with advanced Urothelial cancer.
As we announced in May we reduced the delta the game lift up from 40 milligrams to 30 milligrams daily and are now evaluating safety and efficacy of the 30 milligram dose for patients enrolled through May.
We're pleased to report that the 30 milligram dose is well tolerated and we will continue to evaluate the patient benefit of this dose combination through the end of year, which will inform next step.
Our next update is one marissa three our phase two study in collaboration with Roche Genentech in which we are evaluating the combination of began to lift up with test centric and abraxane at the frontline treatment in patients with triple negative breast cancer or can be safe.
And in combination with to centric and adapt and as a frontline treatment for patients with renal cell cancer or RCC.
We are on track to present preliminary data from Marriott three at the end of this year.
We also expect complete enrollment of the renal cell cancer cohort by the ended the year and enrollment in the TNBC cohort of the trial by the end of the first quarter of 2021.
From area, one our phase one one be study in collaboration with Bristol Myers Squibb evaluating again, a lift up in combination with opdivo in patients with advanced solid tumors, we intend to present data that name form additional development path by the end of this year.
In addition to these infinity sponsored trials are collaborator ARCUS by Sciences is running another study in patients with TNBC.
This is up a one be study evaluating analysts said in a novel checkpoint inhibitor free regimen that include their dual adenosine receptor inhibitor ABT nights weight and Dr. Paul.
Patients with relapsed refractory TNBC.
Study is proceeding well and we look forward to future updates markets.
Well the situation Cobot 19 continues to evolve we're monitoring it carefully to proactively address any impact on site initiation enrollment patient treatment and protocol compliance with the ultimate goal of ensuring our patients have continued access to treatment with no a minimal disruption.
Before we moved to the more detailed clinical update I'd like to introduce Dr., Brian Schwartz.
Joint Infinity and consulting cheap physician role in April Brian deep experience in oncology drug development has been invaluable in the generation and interpretation of data across our cloud.
We're delighted to have them on team and a fortunate to have in his insight in guy.
Prior to the Infinity.
Hasn't it.
Track record of successful drug development. Most recently, having served as chief Medical officer at our tool up until its acquisitions like Mark in December 2019.
With that I'll now transition that call over the bright bright who will provide a clinical update.
Thank you had it even I'm excited to be collaborating with the team at Infinity.
Starting out with an update on Mario three.
[noise] they'll two cohorts in the ongoing phase two study.
One evaluating began to live in combination with the centric kinda abraxane and the frontline therapy in triple negative breast cancer patients and another evaluating ganetespib in combination with the centric and events than as a frontline therapy to patients with renal cell cancer.
The mario's remotely cohort study.
C or D C patients.
And 60 TNBC patients.
Currently conducted at approximately 25 sites in the U.S.
We have completed.
Safety running portion of both cohorts of the trial and then moved into the expansion phase of this trial in both NBC in RCC.
Now for some exciting news from Mario the three we have made important clinical probably were caught up with a generation of early but highly encouraging signals of clinical activity and the TNBC cohort. We have submitted an abstract to present. These preliminary data at a medical meetings this year and I'll leave.
Providing the first data for my expansion because I live in frontline setting, particularly given the P.M.B.C.
Good day [laughter] of breast cancer with limited treatment options.
Yeah, I would see we are seeing in CNBC from Mario three boots on the T.N.B.C. activity [laughter] aiming the lately I'm sitting in Mario one in combination with Cymbalta map and complements the data we are generating in the second line sitting in collaboration with office with a checkpoint.
EBITDA free Triple combination therapy.
Moving on to the status update for the trial on our last call. We shared that we were experiencing delays in the site initiation enrollment for the trial I can't do they provide an update that the majority of identified five well now up and running and we all disturbing an uptick in studies.
Related activities.
In terms of enrollment despite initial does that delays enrollment at all [laughter] cohort is now progressing well with minimal disruption.
And the TNBC cohort, we all working closely with a critical partners and this euros.
Let me address enrollment delays and encouraged by the progress.
And I didn't mean should we expect to complete enrollment to the RCC coal would this year and then the TNBC cohort, but early 2021.
Moving next to Mario to 75.
Oh controlled randomized phase two study evaluating you get another soap in combination with Opdivo in platinum refractory I own naive patients with advanced Urothelial cancer. This is in collaboration with BMS.
Our last quarter cool, we shared information.
From the food it should yield Mario to 75 independent data monitoring committee well Idmc.
The meeting reviewed safety data from the initial 42 patients treated in the study.
Indeed, 42 patients lumos enzyme elevation of grade three or higher with Siemens seven patients.
Five with great three and two with great pool in these <unk>. While these limitations on innovations were reversible and had resolved without the clearly we implemented a dose reduction from 40 milligrams. Once a day to 30 milligrams QD to address these live elevations.
As a reminder, we're comfortable with the pharmacokinetics and pharmacodynamics the 30 milligram dose because as previously presented this mid competes and sustained inhibition of P.R.K.P. Carey Gamma I'm with you got to listen monotherapy at doses of.
20 milligrams once daily and above.
Our ultimate goal of dose reduction was to reduce these elevations and it appears we have been successful enabling the continued treatment of patients previously enrolled in this study.
We are waiting for this data from these patients to mature and we'll be able to use these data between full next steps for Maria to 75 by they ended the year.
Overall, we are pleased.
Despite the continued challenges associated with cope with 19 patients enrolled in Maria to 75.
Three and Mario one have been able to continue treatment and study visits with limited disruptions.
We will continue to closely monitor the situation and we're close to without crawl thought to ensure that patients maintain access to treatment as well as protocol compliance.
It's important to remember that our patients have have challenging to treat cancer is often with poor prognosis and we're committed to ensuring its safe continued access to treatment.
With highly encouraging early data from Mario three these are exciting times that infinity and we look forward to continue to advance again alyssa as a unique immediacy targeted treatment in the hopes the providing meaningful benefit to patients that expand the reach of immunotherapy.
He across indications and treatment settings.
Before I confusion in the call over to Larry I would like to thank all patients investigators and collaborators at BMS Roche Genentech and all could whose continued dedication as enabled that clinical progress.
With that I'll turn over the coal to Larry.
Thank you Brian.
We're pleased to hear rejoin us infinity really exciting time before to Sheree later this year the early but encouraging illicit clinical data just discussed.
Turning to our second quarter financial results at June 30 years 2020.
Total cash cash equivalents, it'll be able to sell securities Oh $42.7 million compared to 50 point Threemillion March 31st 20 play.
You should develop expense for the second quarter 2020 was 6.1 billion in.
Cool about the same period and 29 cheap.
General and nuisance Commission expense was 2.9 billion the second quarter of 2020 <unk>.
3.8 million the same period in 29 cheap.
The decrease is primarily related to decrease it consulting as well stock compensation.
Net loss the second quarter, 2020 was $9.5 million for basic and diluted loss per common share of 16 cents.
<unk> net loss of 10.5 billion rupees and diluted loss per common share, reaching that's the same period in 2018.
We expect endpoint 20 cash investment balance ranging between 20 and $30 million as they start occurred operating plans, which exclude additional funding Orbitz development activities, you anticipate their existing cash cash equivalents and available for sale securities will be satisfied.
The company's couple of things well into the second half between 21.
But he's potential does not include sensible initial funding corporate development activities.
Its central 5 billion dollar milestone payments from Bcf based upon whole pars ongoing phase three clinical trial I didn't give a topical gel words.
40 milestones from one still the Companys equity interest in coal.
We appreciate your continued support as we move forward Goldman.
At this time.
Call for questions operator.
Ladies and gentlemen to ask questions, we need to press star one or your telephone.
Withdraw your question press the pound key.
Please stand by those compiled acuity roster.
Our first question comes from and upon Mama with JP Morgan Your line is open.
Hey, guys by source for taking my question I'm looking forward to the updates in the second half of the year. So my first question is on Mario three with the update later later this year in the press release, we encourage you talked about this encouraging activity or early activity that you're seeing in TNBC.
Just wondering the size and scope in the data or you think will be getting here and given the competitive landscape. You know how are you guys defining sort of early encouraging activity and that on Mario one just a quick one on the translational data we're expecting later this year.
What what should we be looking for in terms of Biomarkers and things of that nature to kind of underscored the anti tumor activity of IP I like onetime thanks, so much.
So thanks, Anna Palm and I'll turn it over to Brian to elaborate but what I can tell you is on Marriotts screen.
What we've done very deliberately designed the trial.
The same inclusion and exclusion criteria as in past 130, which was the approval trial court roasting and Pat in frontline CNBC with the double combination to tetra kind of wrap thing so while it's not a randomized trial.
By naturally enrollment criteria, we're using that as a benchmark and I can tell you that they are they received accelerated approval in just the patients who had high levels of expression of PD, one and that data was that he our rate less than 10% and a and overall.
Response rate of <unk>, 9%. So that's the benchmark that we need to beat to show that 5.9, it's contributing to.
Adding to that double combination.
We're not yet closed things up.
Dataset that well have that well have because as Brian said in his remarks, well work really hard to get patients enrolled and really clean.
<unk>.
She takes place so I hope, we're working hard to make that.
Well that's to date.
By the end here, but it's too early to comment on that.
And Brian I'd turn it over you.
No I think a editing summarized did really well I think we look at a number of different efficacy parameters and even though the numbers are still relatively small when one looks at a complete response partial response and duration of therapy as well as the safety of the calm, but all the triple combination we very encouraged.
Just with the early data set even though relatively small so we look forward to expanding the data sets and be able to share that by they buy the ended the year.
You know obviously this is a hey uncontrolled trial. So all the nuances go with it but so far I'm the day that has been quite encouraging.
Great. Thanks, so much for taking our questions.
Thank you. Our next question comes from Andrew Dsilva with B. Riley FBR. Your line is open.
Hey, good afternoon fixture pick their <unk> I shouldn't say helpful. But for me if you could just give a little bit of color on me.
And so.
Amendment could be for marketing by.
And then Oh.
Expect to be able to utilize data from existing patients.
That haven't drilled thus far.
This is oh halfway through being yeah.
Yes, so again, Brian can address that.
Just lead in by saying any amendments to the trial will be data driven and so that's why we're watching carefully that we're encouraged by the early safety data.
All the efficacy data and Brian can you elaborate on Wearables always.
Yeah.
So we'll have sort of three additional datasets that will help us.
Define the pull forward, we'll have the you know how the patients are doing who started out at 40 Moneygrams. How the patients are doing who started out at 30 moneygrams to a dose quickly to 30 moneygram in terms of both safety and efficacy we will have long.
Tim date, and looking at the tail of the Cook, which will be very important in urothelial cancer and lost the we'll have the opportunity to define the patient group a little bit more stringently as you know checkpoint inhibitors have now and all being heavily.
Studied in the agile Vince holding the maintenance setting of Urothelial cancer.
So the front the first line setting or patients not receiving prior checkpoints inhibitors isn't changing population. So taking all those things into account once we get that set of data will be able to make a decision in terms of what is the best cost Boyd for the trial.
Okay, Great and then I just have a couple just quick question <unk> guidance and.
The balance sheet as far as guidance goes you know your burn was reduced a little bit could you just give us and sense of where the coming out of I'm, assuming our debt.
Could you.
Please let me now.
Yeah. This is Larry thanks.
It's it's you're absolutely right. It's a it's predominantly coming out of R&D is we're addressing some of the.
Well it challenges from the first half of the or put to the cobot epidemic.
Okay, perfect and then as it relates to the.
Royalty financing and then they asked.
[laughter] place earlier this year.
No [laughter] for her.
Okay.
On the balance sheet, that's essentially non recourse right you.
It's it's on new to be able to make the collection active.
Exactly there it's completely non recourse and.
The repurchase cannot be forced upon.
Okay and for any of that I was just elaborate that's true of both of the royalty Monetizations that we did with both HCR and earlier this year with Bbs that for accounting reasons, there recorded as a liability, but there is no obligation to pay those those are totally.
And completely secured by the royalty stream.
Okay.
Okay. Thank you very much and that's I have a best of luck.
Thank you once again, ladies gentlemen, if you wish that's a question at this time. Please press Star then one are you touched on telephone. Our next question comes from Sumit Roy Jones trading your line is open.
Hello, everyone. Thank you for taking the question congratulations on a pushing forward on every front.
My call dropped off site on the question has been asked already I just had walked with Oh reasoning behind.
The inform all your two seven slight everything behind using the 14, many KMP acuity dose when you could see a target situation that 20 million can book a reason why you didn't want to use coty and moved up to four pm.
Using it to Coty is it probably compromising on some efficacy.
Thanks.
Maybe I had money.
Yeah. So you know as you know in oncology, we tend to push the dose you know a little fall, sometimes and I think in this case, we had data from the Mario one in a bunch of other tumor types with the 40 milligram was sort of on the on the top.
We soon realizing their randomized trial, what the Delta there is between adding the drag versus just single agents, Nevada map. So clearly the 30 Moneygram is a much much safer bet for patients that are going to be on the drug for a long period of time.
But it's just I think it's a function that we often have been in oncology of trying to make sure that we don't under dose anyone.
But clearly they is good holiday inhibition, good Pee Dee I'm reviewing the data at both the 20 and the city Moneygram.
Okay and.
Again at this question has answered already apologies.
Yes.
It would be a powerful could either be seeing into my your 275.
Do you have any further calories that you're seeing you think this is from a synergistic.
Effects from.
For nine for the club deeper or something else. How are you looking through this.
So there is multiple different hypotheses, we know that each driver now on its own a single agent has a degree of impacted toxicity.
And then the combination has some degree of you kinda toxicity, we have a number of hypotheses in that the combination together may elicits a stronger immune response.
And that he is primarily seen in the love thing in terms of a habit a transient top of hepatitis that's controlled reasonably be well what steroids. So it could be that but it could be each drugs contribution.
There are many different factors and it's difficult to tease out that's one of the reasons why are we taking out time with Mario to 75 to make sure. We cover all bases. So for example, if one dry ice stock do you reintroduced the second driving you're able to see does the van Rhee, a cool or not so we'll get a much better idea in terms of.
So what the contribution of each drug is.
Okay. So a year and would we see some of these translational data like.
Enforce PDL ratio even in the 40 minute completions were Super Kokomani completion.
And can be MDC lever that kind of doesn't work.
Correct I mean, we have continued to collect all the biomarkers on all patients and we'll be able to evaluate that.
As soon as it's Randy.
Okay and in addition, shouldn't I'll remind you that.
It is Oh study so.
While we may learn something that as Brian said, well will enable us.
Optimized.
Our net debt.
We may not be able to share that data has we've worked very hard to ensure that we retain a blind.
Perfect.
Thank you so much for taking my question and collectors.
Thanks.
Thank you.
Showing no further questions when I turn the call back over to add <unk> closing remarks.
Thank you Shannon.
As I hope you can tell we're very excited about our continued progress with again, let's step.
All being data and we look forward to price providing you additional update.
The month through the end of the year. So thanks for joining us on todays call and I Hope you how the Nike.
Ladies and gentlemen. This concludes today's conference call. Thank you for participation you may now disconnect.
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[music].
Ladies and gentlemen, thank you for standing by welcome to Us and everyone's critics.
Well I would call to discuss the company's operations and financial results for the second quarter 2020.
My name is Shannon and I'll be operator for today's call.
At this time, all participants are in listen only mode.
There will be a question answer session to follow.
If I said this call if they were acquired any kind of each request.
Now I'll like to introduce your host for today's call Jane Kaufman. Please go ahead.
Thank you Shannon and good afternoon, everyone welcome to today's call to discuss our recent business progress and review our second quarter 2020 financial results on the call with me today are Adelene Perkins, Chief Executive Officer, Larry Block, President and Brian Schwartz consulting cheap physician well open up the call for Q1.
Following our remarks.
The press release issued this afternoon details our results and is available on our website at <unk> Dot com.
We have also submitted our 10-Q two the FCC, but the filing is pending resolution due to technical issues that Edgar that are impacting us another company.
Please note that during this call we may make forward looking statements about our future expectations plans, including clinical development objectives, the therapeutic potential of our product candidates, our strategic plans and strategies and financial projections.
Our actual results may differ materially from what we project today due to a number of important factors, including the considerations described in the risk factor section of our annual report on form 10-Q for the second quarter of 2020, and then other filings we make what the FCC.
These forward looking statements represent our views only as of today and we caution you that we may not update them in the future whether as a result of new information future events or otherwise now I'd like to turn the call over to idling.
Thanks James.
You to everyone for joining us today.
Oh bullet Infinity has been to execute on a robust clinical development plan for Ghana left that also known as I look at 5.9.
We are evaluating again alyssa across different treatment that anything indication to evaluate potential to improve outcomes for cancer patients I read pro rata, well pages and its little Michael environment.
Okay excellent anti tumor function.
Last quarter, we provided an update regarding impacted Hoguet 19 on our clinical program as stated that we would provide updated guidance I understand what the Paul.
Well, we and our peers are managing the still evolving hoping I cant situation. We're in a much better positioning to protect the magnitude of the impact on our trials timeline.
Well provide more specific updates during halt, but I'll first review updated guidance across our trial.
I'll start with Meraki 75, a randomized controlled phase two study in cooperation with the in that.
In which we are evaluating ganetespib in combination with opdivo in patients with advanced Urothelial cancer.
As we announced in May we reduced the delta gamma lift up from 40 milligrams to 30 milligrams daily and are now evaluating the safety and efficacy 30 milligram dose for patients enrolled Tru measure.
We're pleased to report that the 30 milligram dose is well tolerated and we will continue to evaluate the patient benefit of this dose combination through the end of year, which will important step.
Our next update us on Marriott's rate our phase two study in collaboration with Roche Genentech in which we are evaluating the combination of the gas lift up with to Patrick and Abraxane at the frontline treatment in patients with triple negative breast cancer or can be safe.
And in combination with to centric and that's done at the frontline treatment for patients with renal cell cancer or RCC.
We're on track to present preliminary data from Marriott three at the end of this year.
We also expect complete enrollment of the renal cell cancer cohort by the end of the year and enrollment in the TNBC cohort the trial by the end of the first quarter of 2021.
For Merial, one our phase one one be study in collaboration with Bristol Myers Squibb evaluating Ghana lift up in combination with Opdivo in patients with advanced solid tumors, we intend to present data that name form additional development path by the end of this year.
In addition to these infinity sponsored trials are collaborator Argus by appliances is running another study in patients with TNBC.
This is what they want be study evaluating galison in a novel checkpoint inhibitor free regimen that include their dual adenosine receptor inhibitor 89 weight and golf ball.
Patients with relapsed refractory handy state.
Study is proceeding well and we look forward to future updates market.
Well the situation we hope it 19 continues to evolve we're monitoring it carefully to proactively address any impact on site initiation enrollment patient treatment protocols compliant with the Oh no fault of ensuring our patients have continued after treatment with no are minimal disruption.
Before we look to the more detailed clinical update I'd like to introduce Dr., Brian Schwartz.
Joe I do affinity in consulting cheap physician role in April.
<unk> deep experience in oncology drug development has been invaluable in the generation and interpretation of data across our trial.
We're delighted to have them on the team and a fortunate habit in his insight and guide.
Right liquidity right hasn't it.
Track record successful drug development. Most recently, having served as chief Medical officer at our tool up until its acquisitions like Mark in December 2019.
With that I'll now transition all over the brought Brian who will provide our clinical update.
Thank you had any I'm excited that could be collaborating with a team at infinity.
Starting out with an update on Mario three accurate.
They'll cohort in the ongoing phase two study one evaluating you get analysis in combination with the centric kinda abraxane and the frontline therapy in triple negative breast cancer patients.
And another evaluating ganetespib in combination with this entry kinda events than as a frontline therapy.
So that's with renal cell cancer.
The Mario remotely Kona study.
The RCC patients.
And 60 TNBC patients is currently conducted at approximately 25 sites in the U.S. [laughter], we're [laughter] safety running portion or both cohorts of the trial and then moved into the expansion phase of this trial in both NBC in RCC.
Now for some exciting news from Mario the three we have made important clinical progress this quarter with the generation of earlier, but highly encouraging signals of clinical activity in the TNBC cohort. We have submitted an abstract to present. These preliminary data at a medical meetings this year and I'm looking for.
Providing the first data from my expansion altogether.
Frontline setting, particularly given the P.M.B.C.
Good day [laughter] of breast cancer with limited treatment options.
The activity, we are seeing in CNBC from Mario three bolt on the T. NBC activity [laughter] aiming the lifetime thing in Mario one in combination with coupon of map and called the data we are generating in the second line setting in collaboration with all [laughter] with it.
Eric points in EBITDA free Triple combination therapy.
Moving on to the status update for the trial on our last call. We should that we were experiencing delays in the site initiation enrollment for the trial I can today provide an update that the majority of identified five well now up and running and we all disturbing an uptick in studies.
Related activities.
Enrollment the spots initial does that delays enrollments at all [laughter] cohort is now progressing well with minimal disruption.
And the TNBC cohort, we all working closely with our clinical partners and the CRL.
Collectively address enrollments delays and only encouraged by the progress.
As Adelene should we expect to complete enrollment to the Aussie CECO would this year and then the TNBC cohort, but early 2021 now.
Moving next to Mario to 75.
How controlled randomized phase two study evaluating again, let's hope in combination with Optivo.
Refractory Io naive patients with advanced Urothelial cancer. This is in collaboration with BMS.
Our last quarter coal we shared information.
From the shield Mario to 75 independent data monitoring committee well Idmc.
The meeting reviewed safety data from the initial 42 patients treated in the study.
This 42 patients live on Amazon elevation of Great three Ohio was seen in seven patients.
Hi, with great three and two with great. So indeed.
While these liver enzyme innovations were reversible and had results without the clearly we implemented a dose reduction from 40 milligrams. Once a day to 30 milligrams QD to address these live by elevation.
As a reminder, we're comfortable with the pharmacokinetics and pharmacodynamics.
Milligram dose because as previously presented is nearly complete some sustained inhibition of beyond.
Yeah, I'll speak again.
With together this a monotherapy at doses of 20 milligrams once daily and above.
Oh ultimate goal of dose reduction was to reduce these elevations and it appears we have been successful enabling the continued treatment of patients previously enrolled in the study.
We are waiting for this data from these patients to mature.
And we'll be able to use these data between full next steps for Maria to 75 by the ended the year.
Overall, we are pleased.
That despite the continued challenges associated with covert 19.
Patients enrolled in Maria to 75, Mario three and Mario one have been able to continue treatment and study visits with limited disruptions.
We will continue to close we wanted to the situation and we'll close do without crawl side to ensure that patients maintain access to treatment as well as protocol compliance.
It's important to remember that operations have have challenging to treat cancers.
[laughter] poor prognosis, and we're committed to ensuring its safe continued access to treatment.
With highly encouraging early data from Mario three these are exciting times that infinity and we look forward to continue to advance again alyssa as a unique mds the targeted treatment in hopes of providing meaningful benefit to patients that expands our reach of immuno therapy.
Across indications and treatment settings.
Before I conclude the call over to Larry I would like to thank our patients investigators and collaborators at BMS Roche Genentech and all.
This continued dedication has enabled our clinical progress.
With that I'll turn over the call to Larry.
Thank you Brian.
We are pleased that joining us infinity.
Really exciting time.
Sherri later this year the early but encouraging illicit clinical data just discussed.
Turning to our second quarter financial results at June 30 basis points one.
Total cash cash equivalents individual securities.
$2.7 million compared to 50 point Threemillion March 30, Onest 21.
We should develop expense for the second quarter 2000 26.1 billion.
Cool about the same period and 29 chief.
General and administrative.
Interest expense was 2.9 billion the second quarter of 2020.
3.8 billion the same period in 2019.
The decrease is primarily related to decrease in consulting as well stock compensation.
Net loss the second quarter, 2020 was $9.5 million for basic and diluted loss per common share of 16 stores compared net loss of 10.5 billion rupees to and diluted loss per common share, which makes sense for the same period in 2018.
Okay.
We expect endpoint wanting to cash investment balance ranging between.
Okay, and $30 million and based on current operating plans, which exclude additional funding orbitz development activities.
Cash cash equivalents.
So still securities will be allocated to satisfy the company's capital needs well into the second half between 21.
Pretty special does not include potential additional funding corpus development activities.
It's essential 5 million dollar milestone payments from PBF based upon hold farms ongoing phase three clinical trial of kind of give a topical gel.
Well.
40 milestones from solar companies equity interest.
We appreciate your continued support as you move for gold analyst.
At this time.
Call for questions operator.
Ladies and gentlemen, tough question, you need to press star one or your telephone.
Withdraw your question press the pound key please stand by those compiled acuity roster.
Our first question comes from and upon Mama with JP Morgan Your line is okay.
Hi, guys.
Thanks, So much for taking my question I'm looking forward to the updates in the second half of the year. So my first question is on Mario three with the update later later this year in the press release, you incur you talked about the encouraging activity.
Early activity that you're seeing and TNBC, just wondering the size and scope of the data.
You think will be getting here and given the competitive landscape. How how are you guys defining sort of early encouraging activity and that on Mario one just a quick one on the translational data we're expecting later this year.
What what should we be looking for in terms of Biomarkers and things of that nature to kind of underscored the anti tumor activity of ipi.
Thanks, so much.
So thanks, Anna Palm and and I'll turn it over to Brian to elaborate but what I can tell you is on Marriott three.
What we've done very deliberately is design the trial to have the same inclusion and exclusion criteria as an passion 130, which was the approval trial.
Gross to net Pat in frontline CNBC with double combination of centric and Abraxane, so well, it's not a randomized trial.
Bye Bye nachum, new enrollment criteria, we're using that as a benchmark and I can tell you that they.
They received accelerated approval in just the patients who had high levels of expression of PD, one and that data was a CR rate of less than 10% and a and overall response rate of 59%. So that's the benchmark that we need to be tissue.
Well that 5.9, it's contributing to a is adding to that double combination.
We're not yet.
Closing.
The data set that were have that we'll have because as Brian said in his remarks, well work really hard to get patients enrolled we've been really please.
At the site initiation take place so I hope, we're working hard to make that as as robustly dataset profit by the end here, but it's too early to comment on that.
And Brian I'll turn it over you.
No I think it's kind of handling summarized did really well I think we look at a number of different efficacy parameters and even though the numbers are still relatively small when one looks that complete response partial response on duration of therapy as well as the safety of the comp it off the triple combination we very encourage.
Just with the early data set even though relatively small so we look forward to expanding the data sets and be able to share that by they buy the ended the year.
Obviously this is a hey uncontrolled trial, so all the nuances go with it but so far.
The data has been quite encouraging.
Great. Thanks, so much for taking our questions.
Thank you. Our next question comes from Andrew Dsilva with B. Riley FBR. Your line is open.
Hey, good afternoon, thanks for getting traction.
But for me.
If you could just give a little bit of color.
Hey.
Until amendment could be for Mark.
Yes.
Okay.
And then.
I expect to be able to utilize.
Data from existing patients.
That havent adult thus far.
Doses.
Yes, now halfway through that.
Yes, so again, Brian can address that.
Just lead in by thanks.
Any amendments to the trial will be data driven and so that's why we're watching carefully that we're encouraged by the early safety data.
All the efficacy data and Brian.
Elaborate on where we'll go with.
Okay.
So we'll have sort of three additional datasets that will help us.
Define the pull forward we'll have the.
How the patients are doing who started the out at 40 Moneygrams. How the patients are doing has started out at 30 Moneygram. So what does quickie to 30 milligram.
In terms of both safety and efficacy we will have long term date and looking at the tail of the curve, which will be very important in urothelial cancer and lost money will have the opportunity to define the patient group a little bit more stringently as you know.
Checkpoint inhibitors have now and all being heavily studied in the edge ovens within the maintenance setting of Urothelial cancer.
So the from the first line setting all patients not receiving prior checkpoint inhibitors isn't changing population so taking all those things into account.
As we get that set of data will be able to make a decision in terms of what is the best path forward for the trial.
Okay great.
And then I just have a couple just.
Question.
And.
The balance sheet.
As far as guidance.
Your burn was reduced a little bit could you just give us and sense of where coming out of I'm, assuming our debt.
Could you.
Please let me now.
Yes. This is Larry thanks.
This is you're absolutely right.
And coming out of R&D as we're addressing some of the.
Enrollment challenges from the first half of your put to the covenant limit.
Okay, perfect and then as it relates to that.
Royalty financing and then the at.
Seneca place earlier this year.
No.
Sure.
Okay.
On the balance sheet.
That's essentially non recourse right you.
It's it's on you to be able to make the production active.
Is that there is completely non recourse and.
The repurchase cannot be forced upon us.
Okay, and and for any and I was just elaborate that's true up both of the royalty monetization that we did with both HCR and earlier this year with CBS for accounting reasons, there recorded as a liability, but there is no obligation to pay those those are totally and completely.
We secured by the royalty stream.
Okay.
Thank you very much and thats by having a best of luck garbled.
Okay.
Thank you again, ladies gentlemen, if you wish to ask a question at this time. Please press Star then one are you touched on telephone. Our next question comes from Sumit Roy Jones trading your line is open.
Hello, everyone. Thank you for taking the question congratulations on pushing forward on every front.
Mike call dropped off side only question has been asked already.
So instead of what was the.
Reasoning behind.
The format to seven slight everything behind using the 40, many KMP acuity dose. So then you could see Gaga situation at 20 milligrams. Whatever reason why you didn't want to use podium moved up to four PM using it to Coty Toby compromising on some efficacy.
Thanks.
Maybe I am I mean, yes, yes.
As you know in oncology, we tend to push the dose.
You know as it will fall, sometimes and I think in this case.
We had data from the Mario one in a bunch of other tumor types with.
The 40, Moneygram was sort of on the on the Todd.
We soon realizing the randomized trial, what's the Delta there is between adding the drag.
This is just single agents, Nevada map, so clearly the 30 Moneygram is.
A much much safer bet for patients that are going to be on the drag for a long period of time.
But it's just so I think it's a function that we often have been in oncology.
Economy, so that we don't under dose anyone.
But clearly there is good holiday inhibition good PD.
Reviewing the data at both the 20 and 30 Moneygram.
Okay.
And.
Again, a discussion has answered already apologies.
Yes.
The hydro could be that we're seeing in the media to seven five.
Do you have any further color is that you're seeing you think this is from a synergistic.
Effect from my phone line, that's opdivo or something else how are you looking through this.
This multiple different hypotheses, we know that each driver on its own a single agent has a degree of the pack the toxicity.
And then the combination has some degree of the pad toxicity, we have a number of hypotheses in that the combination together may elicits a stronger immune response.
And it is primarily seen.
In the last thing in terms of ahead, a transient top of hepatitis that's controlled reasonably be well with steroids. So it could be that but it could be each drags contribution.
There are many different factors then it's difficult to tease out that's one of the reasons why are we taking out time with Mario to 75 to make sure. We cover all bases. So for example, if one dry ice stock to reintroduce the second drive and you're able to see does the van reoccur or not so we'll get a much better idea in terms of.
So what the contribution of each drug is.
Okay. So a year and would we see some of these translational data like.
Enforce PDL ratio even in the market many completions, we're still talking many completion.
And the Mds 11, let's kind of.
Good work.
Correct I mean, we continue to connect all the biomarker is on all patients and we'll be able to evaluate that.
As soon as it's Randy.
Okay and in addition, I assume that I'll remind you that.
It is up.
Study and so.
While we may learn something that as Brian said, well will enable us.
Optimized.
Our net debt.
We may not be able to share that data has we've worked very hard to ensure that we retain a blind.
Perfect.
Thank you so much for taking my question fan.
Correct, yes.
Thanks.
Thank you.
I'm showing no further questions I'd like turn the call back over to Adelene closing remarks.
Thank you Shannon.
As I hope you can tell we're very excited about our continued progress with again with the original evolving data and we look forward to bright providing you additional updates coming.
Coming month through the end of the year. So thanks for joining us on todays call and I Hope you I'll give an idea.
Ladies and gentlemen. This concludes today's conference call. Thank you for participation you may now disconnect.