Q2 2020 Curis Inc Earnings Call

All participants will be in listen only mode.

Operator: All participants will be in listen-only mode. Please signal a conference specialist by pressing the star key, followed by zero. After the company's prepared remarks, call participants will have an opportunity to ask questions. To ask a question, you may press the star key, then 1 on your touchtone phone.

Should you need assistance. Please signal a conference specialist pressing the star key followed by zero.

After the company's prepared remarks call participants will have an opportunity to ask questions.

To ask a question you May Press Star then one on your Touchtone phone.

To withdraw your question. Please press Star then too.

Operator: To ask your question, please press star, then 2. Please note, this event is being recorded. I would now like to turn the conference over to the company's Chief Financial Officer, Bill Steinkraus. Please go ahead.

Please note this event is being recorded.

I would now let's turn the conference over to the company's Chief Financial Officer Bill Steinkrauss. Please go ahead.

Thank you.

Bill Steinkraus: Thank you, and welcome to Curis' second quarter 2020 earnings call. I would encourage everyone to go to the Investor section of our website at www.investor.com. [inaudible] find our second quarter 2020 earnings release and related financial tables. I would also like to remind everyone that during the call, management will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially.

Welcome to procure since second quarter 2020 earnings call.

Before we begin I would encourage everyone to go to the Investor section of our website at Www <unk>.

[music].

And our second quarter 2020 earnings release and related financial tables.

I would also like to remind everyone that during the call management, we make forward looking statements.

And our current expectations.

These statements are subject to certain risks and uncertainties and actual results may differ materially.

Additional details please see our SEC filings.

Bill Steinkraus: For additional details, please see our SEC file on, Joining me on today's call are Jim Dentzer, President and Chief Executive Officer, and Bob Martell, our Head of R&D. We will also be available for a question and answer period at the end of the call. I'd now like to turn the call over to Curis' CEO, Jim Dentzer.

Joining me on todays call, our Jim Dentzer, President and Chief Executive Officer.

Marcelo.

Barbie.

We will also be available for questions to answer period at the end of the call.

Now I'd like to turn the call older procure CEO, Jim Dentzer Jim.

Thank you Bill.

James E. Dentzer: Thank you, Bill. Good afternoon, everyone, and thank you for joining us today. As many of you know, our mission at Curis is to develop the next generation of targeted cancer therapy to meaningfully improve and extend patients' lives. Our novel pipeline is driven by our team's expertise and ability to identify untapped targets in oncology that we believe have significant potential to address unmet patient needs. In the second quarter, we executed against both clinical and financial goals, making significant progress toward our key targets for the year.

Good afternoon, everyone and thank you for joining us today.

As many of you know our mission at Cumulus is to develop the next generation targeted cancer therapies.

Easily improve and extend patients lives.

Oh, no pipeline is driven by our teams expertise and ability to identify untapped targets in oncology that we believe has significant potential to address unmet patient need.

In the second quarter, we executed against both clinical and financial goals, making significant progress toward key targets for the year.

We adapt dose escalation in our ongoing study CH 49, 48, or IRAK four program in patients with relapsed or refractory non hodgkin's lymphoma or NHL.

James E. Dentzer: We advanced dose escalation in our ongoing study of CA4948, our IRAC4 program, in patients with relapsed or refractory non-Hodgkin's lymphoma, or NHL. We initiated a second IRAC4 study in patients with relapsed or refractory acute myeloid leukemia, or AML, and high-risk myelodysplastic syndromes, or MDS. Also in the second quarter, we received FDA clearance to proceed with our investigational new drug application, or CI 8993, our monoclonal anti-vista antibody. Lastly, we also completed a significant financing transaction with several fundamental health care investors. It was a very eventful quarter for Curis and, in aggregate,

We initiated a second IRAK four study in patients with relapsed or refractory acute myeloid leukemia, or AML anhydrous myelodysplastic syndromes or Mds.

Also in the second quarter, we received FDA clearance to proceed on our investigational new drug application.

<unk> 80, 993 hour monoclonal anti this antibody.

Lastly, we also completed significant financing transaction with several fundamental healthcare investors.

It was a very event.

Quarter for carrots and in aggregate.

These accomplishments set us up for exciting data catalyst later this year and continued momentum as we look to 2021.

James E. Dentzer: These accomplishments set us up for exciting data catalysts later this year and continued momentum as we look to 2021. We're moving full steam ahead at Curis, and I look forward to building on this progress in the third quarter. With that, let's jump into our clinical development programs, starting with our small molecule IRAK4 kinase inhibitor, CA4948. As a reminder, we are currently evaluating CA4948 in an ongoing Phase I dose escalation study for the treatment of patients with relapsed or refractory non-Hodgkin's lymphoma, or NHL, including patients with diffuse large B-cell lymphom In this Phase I study, we are currently evaluating patients being treated with 300 mg twice daily of CA-4948 after observing clear dose response and tumor reductions at previous dose levels. The pace of enrollment slowed in the second quarter as many clinical sites temporarily halted enrollment due to the COVID-19 pandemic.

We're moving full steam ahead to curate and I look forward to building on this progress in the third quarter.

With that let's jump into our clinical development programs, starting with our small molecule IRAK four kinase inhibitor see a 49 48.

As a reminder.

We're currently evaluating see a 49 48 in an ongoing phase one dose escalation study for the treatment to patients with relapsed or refractory non hodgkin's lymphoma, or any child, including patients with diffuse large b cell lymphoma, Waldenstrms Macroglobulinemia and oncogenic Mydeighty eight.

You take actions.

In this phase one study we are currently evaluating patients being treated with 300 milligrams twice daily.

See a 49 48.

After observing clear dose response and tumor reduction at previous dose levels.

The pace of enrollment slowed in the second quarter as many clinical sites temporarily halted enrollment due to the covert 19 pandemic.

Fortunately following new guidance in protocols.

James E. Dentzer: Fortunately, following new guidance and protocols, several of our Phase I study sites have reopened and are actively enrolling new patients. So while the data are not yet mature enough for us to declare a recommended Phase 2 dose today, we are confident we will be in a position to provide updated safety and efficacy data as well as finalize the recommended phase 2 dose by the end of this year. That said...

Several of our phase one study sites have reopened and are actively enrolling new patients.

So while the data are not yet mature enough for us to declare a recommended phase two dose today.

We are confident we will be in a position to provide updated safety and efficacy data as well as finalize the recommended phase two dose by the end of this year.

That said.

The tumor reduction data, we have seen so far are very encouraging.

James E. Dentzer: The tumor reduction data we have seen so far are very encouraging. It is with these data in hand that we are excited to announce today our plan to initiate the combination study of CA4948 with ibrutinib, the market-leading BTK inhibitor, in preclinical models. Both IRAC4 and BTK inhibition have been shown to provide significant anti-cancer benefits.

It is with these data in hand.

We are excited to announce today our plan to initiate the combination study I see a 49 48 with ibrutinib the market leading BTK inhibitor.

He preclinical models.

IRAK four and BTK inhibition have been shown to provide significant anti cancer benefit.

As one might expect given their different mechanisms of action.

James E. Dentzer: As one might expect, given their different mechanisms of action, they also appear to be highly synergistic. We and our clinical investigators are eager to see if this preclinical efficacy in combination therapy translates to the clinic, as well as the single-agent efficacy data have with today's announcement. We are initiating work with our clinical sites and the FDA and expect to begin enrollment in a Phase I study of CA4948 in combination with ibrutinib before year end. Now, let's move to leukemia. Our study in CA-4948 in patients with relapsed or refractory AML and high-risk MDS, including those with spliceosome mutations, driving expression of the oncogenic long isoform of IRAC4.

They also appear to be highly synergistic.

We and our clinical investigators are eager to see if this preclinical efficacy in combination therapy.

Translates to the clinic as well as the single agent efficacy data half.

With today's announcement, we are initiating work with our clinical sites and the FDA and expect to begin enrollment in a phase one study of CA 4948 in combination with Ibrutinib before yearend.

Now, let's move to leukemia.

Our study in CA 4948 in patients with relapsed or refractory AML in high risk Mds, including those with slice. It so mutations driving an expression of the oncogenic long isoform of Iraq for.

Last month, we announced the dosing of the first patient you know open label Phase one dose escalation study a C. Four nine freight monotherapy in these patient populations.

James E. Dentzer: Last month, we announced the dosing of the first patient in our open-label phase one dose escalation study of CA4948 monotherapy in these patient populations. We have been eager to start this study ever since the seminal presentation by Drs. Amit Verma and Daniel Starzanowski at the ASH Conference last year, in which they identified specific spliceosome mutations as drivers of disease by causing the expression of the long While the short isofoam of IRAC4 is normal, they demonstrated that the long isofoam is oncogenic.

We've been eager to start this study ever since the seminal presentation of Dr. on in pharma and Dr. Daniel stars in ASCII at the Ash conference last year in which the identified specific slices so mutation.

As drivers of disease like halting the expression of the long isoform of Iraq for.

Well the short isoforms of Iraq for his normal they demonstrated that the long isoform, it's opera Jack.

Further demonstrated that blocking IRAK four with a treatment a four name for eight dramatically reduce the formation of leukemic blast.

James E. Dentzer: Further, they demonstrated that blocking IRAC4 with a treatment of 4R948 dramatically reduced the formation of leukemic blasts. Their work changed the landscape of AML and MDS by identifying IRAC4L as the first and only known driver of disease that affects over half the population of patients with AML and MDS. With the findings of Dr. Verma and Dr. Starzanowski in hand, as well as the preliminary data from our NHL We worked quickly with our clinical investigators and the FDA to design a study of CA-4948 in the AML and MDS population, and we are pleased to have dosed our first patient just six months later. This phase 1 dose escalation study is enrolling a minimum of 3 patients at each dose level, starting with 200 mg twice daily.

There were changes the landscape of AML and Mds by identifying IRAK four L. As the first and only known driver of disease that affects over half the population of patients with AML and Mds.

With the findings of Dr. pharma and Dr. starts and asking in hand.

As well as the preliminary data from our NHL study.

We've worked quickly with our clinical investigators and the FDA to design a study I see a 49 48 in the AML and Mds population and we are pleased to have dose our first patient just six months later.

This phase one dose escalation study is enrolling a minimum of three patients at each dose level, starting with 200 milligrams twice daily.

As I mentioned earlier, we're excited to be starting this study at a potentially therapeutic dose level.

James E. Dentzer: As I mentioned earlier, we're excited to be starting this study at a potentially therapeutic dose level, following FDA sign-off, as 200 mg twice daily was determined to be both safe and capable of achieving encouraging biological activity and clinical efficacy in our Phase I NHL study. The primary objective of this study is to determine the maximum tolerated dose and recommended phase 2 dose of CA4948 based on safety and tolerability, dose-limiting toxicities, and pharmacokinetic and pharmacodynamic findings.

Following the FDA sign off as 200 milligrams twice daily was determined to be both safe.

And capable of achieving encouraging biologic activity and clinical efficacy in our phase one NHL study.

The primary objective of this study is to determine the maximum tolerated dose and recommended phase two dose I see a 49 48 based on safety and Tolerability dose limiting toxicities and pharmacokinetic and Pharmacodynamic fundings.

We could not be more excited to have this study underway and we look forward to reporting initial data by the end of this year.

James E. Dentzer: We could not be more excited to have this study underway, and we look forward to reporting initial data by the end of this year. Now I'd like to turn to our VISTA program and our first-in-class monoclonal anti-VISTA antibody, CI-8993. Vista is a target we're really excited about. When activated, it plays a critical role in suppressing T-cell activity.

Now I'd like to turn toward Vista program.

And our first in class monoclonal anti this the antibody Cie 80 993.

This is a target we're really excited about.

When activated Vista plays a critical role in suppressing T cell activity.

Conversely, walking that stuff has been shown in preclinical studies to prevent T cell suppression.

James E. Dentzer: Conversely, blocking VISTA has been shown in preclinical studies to prevent T-cell suppression and thereby reactivate anti-tumor immune function. We also see potential in targeting VISTA in combination with a PD-1, PD-L1, or even a CTLA-4 inhibitor, as preclinical studies suggest that blocking VISTA significantly improves the efficacy of those checkpoint regulators. As many of you remember, we previously developed a small molecule that targeted PD-L1 and VISTA. While that small molecule was active, it did not produce efficacy competitive with the monoclonal antibodies in development at that time in our target population. We believe this was probably for two reasons. First, as a large molecule, a monoclonal antibody provides complete coverage of a receptor across multiple binding regions. By comparison, a small molecule interrupts only one or two contact points on a target receptor. Second, monoclonal antibodies tend to firmly wrap around a receptor, almost like Velcro, as opposed to a small molecule which continually bounces on and off its target.

And thereby reactivate anti tumor immune function.

We also see potential in targeting Vista in combination with a PD, one PD L. One or even a CTL a four inhibitor as preclinical studies suggest that blocking vista significantly improves the efficacy of those checkpoint regulators.

As many if you remember we previously developed small molecule that targeted PDL one investor.

Wow, that's small molecule was active you did not produce efficacy competitive with the monoclonal antibodies in developing at that time in our target population.

We believe this was probably for two reasons.

First as a large molecule.

Monoclonal antibody provides complete coverage ever receptor across multiple binding regions.

By comparison, a small molecule interruption, only one or two contact points on a target receptor.

Second monoclonal antibodies tend to firmly wrap around a receptor almost like velcro.

As opposed to a small molecule, which continually bounces on and off its target.

For these reasons.

James E. Dentzer: For these reasons... We began a search last year for the best IP, the best library of drug candidates, and the deepest understanding of VISTA biology. In Immunext, we found a partner with all three. And in January of this year, we entered into an option and license agreement with them for the development and commercialization of CI 8993 and went immediately to work on developing it in June, just five months later.

We began a search last year for the best IP.

The best Library of drug candidates and the deepest understanding of Vista biology.

And then you next we found a partner with all three.

And in January of this year, we entered into an option in license agreement with them for the development and commercialization of C. <unk> 80, 993 and went to immediately to work on developing it.

In June just five months later.

The FDA cleared or I N D application for C. <unk> 80 993.

James E. Dentzer: The FDA cleared our IND application for CI 8993, making it the only anti-VISTA antibody currently in development to enter testing in humans. We're pleased with the interest and excitement we've received from the clinical community on this program, and we believe CI 8993 has the potential to be a game-changing cancer therapy.

Making it the only assay this to antibody currently in development to enter testing in humans.

We're pleased with the interest and excitement we've received from the clinical community on this program.

And we believe see I 80, 993 has the potential to be a game changing cancer therapy.

We look forward to initiating a phase one study a C. <unk> 80 993 in patients with solid tumors later this year.

James E. Dentzer: We look forward to initiating a Phase I study of CI8993 in patients with solid tumors later this year. To wrap up... We're very excited about our clinical progress so far this year. We hope the next few months will bring us even closer to developing meaningful therapies for patients fighting cancer. With that, I'll turn the call back over to Bill to review our financial results for the quarter. Bill?

To wrap up.

We're very excited about our clinical progress so far this year.

We hope the next few months will bring us even closer to developing meaningful therapies.

To patients battling cancer.

With that I'll turn the call back over to Bill to review our financial results for the quarter.

No.

Thank you Jim.

Bill Steinkraus: Thank you, Jim. In the second quarter of 2020, Curis reported a net loss of $6.7 million, or $0.17 per share on both a basic and diluted basis, as compared to a net loss of $7.2 million, or $0.22 per share on a specific and diluted basis for the same period in 2019. Revenues for the second quarter of 2020 were $2.4 million as compared to $2.1 million for the same period in 2019. Revenues for both periods comprise primarily of royalty revenues recorded on Genentech and Roche's net sales of Araved. Operating expenses for the second quarter of 2020 were $7.8 million, as compared to $8.2 million for the same period of 2019. Cost of royalty revenues was $0.1 million for both the second quarter of 2020 and 2019.

Second quarter of 2020, Curis reported a net loss $6.7 million or 17 cents per share on both basic and diluted basis as compared to a net loss of $7.2 million were 22 cents per share.

And I alluded basis for the same period in 2019.

Revenues for the second quarter 2020 were $2.4 million, that's compared to $2.1 million for the same period 2019.

Revenues for both periods comprised primarily of royalty revenues recorded Anja men Tech and roche's net sales or a badge.

Operating expenses, the second quarter, 2020, or $7.8 billion as compared to $8.2 million same period 2019.

Cost of royalty revenues are zero point $1 million.

Both the second quarter 2020 and 2019.

Research and development expenses were $5.3 million second quarter, 2020, as compared to $5.6 million for the same period 2019.

Bill Steinkraus: Research and development expenses were $5.3 million for the second quarter of 2020 as compared to $5.6 million for the same period in 2019. The decrease was primarily attributable to reduced clinical trial costs related to CA-170 and therapenistat. General and administrative expenses were $2.4 million in the second quarter of 2020, as compared to $2.5 million in the same period of 2019. The decrease was driven primarily by lower stock-based compensation, legal, and professional services fees, partially offset by higher occupancy costs.

The decrease was primarily attributable to reduced clinical trial costs related to see a oneseventy there what kind of step.

General and administrative expenses were $2.4 million second quarter 2020.

As compared to $2.5 million the same period 2019.

The decrease was driven primarily by lower stock based compensation.

Legal and professional services fees.

Partially offset by higher occupancy cost.

Other expense net was $1.3 million the second quarter 2020.

Bill Steinkraus: Other expense net was $1.3 million for the second quarter of 2020, as compared to $1.1 million for the same period in 2019. Other expense net primarily consisted of imputed interest expense related to future royalties. As of June 30, 2020, our cash, cash equivalents, and investments totaled $23.6 million, which included net proceeds from our $17.5 million registered direct offering that closed in June. Additionally, as of June 30, 2020, there were approximately 50.6 million shares of Common Stock outstanding.

As compared to $1.1 million for the same period 2019.

Other expense, Matt primarily consisted of imputed interest expense related to future royalty payments.

As of June 32020, our cash cash equivalents and investments totaled $23.6 million.

Which includes net proceeds from our 17.5 million dollar registered direct offering that closed in June.

As of June 32020, there were approximately 50.6 million shares of common stock outstanding.

We expect at our existing cash cash equivalents and investments should enable us to maintain our planned operations beyond our end of the year data catalyst and into the first half 2021.

Bill Steinkraus: We expect that our existing cash, cash equivalents, and investments should enable us to maintain our planned operations beyond our end-of-the-year data catalyst and into the first half of 2021. Note that our forecast does not include any potential proceeds from our stock purchase agreement of up to $30 million with Aspire Capital. With that, I'd like to open the call for questions. Operator. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchstone phone. If you are using a speakerphone, please pick up your handset before pressing the key.

Note that our forecast does not include any potential proceeds from our stock purchase agreement of up to $30 million worth aspire capital.

With that I'd like to open the call for questions operator.

We will now begin the question answer session.

To ask a question you May Press Star then one on your Touchtone phone.

If you were using a speakerphone please pick up your handset before pressing the keys to withdraw your question. Please press Star then to.

Operator: To draw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. The first question comes from Alethea Young with Cantor.

At this time, we will pause momentarily to assemble our roster.

The first question comes from Alithia Young with Cantor. Please go ahead.

Alethea Young: Please go ahead. Hey guys, thanks for taking my question and a couple of questions I have here. One, just on 4948, and at the end, you know, you have data coming now at the end of the year. I guess maybe you can help us think about maybe how many people that might be, and was it kind of the impact of COVID, or is it just that you kind of need more data to kind of appreciate what the dose is? And then my second question is just around the combination with Brutinib and how you're thinking about And then my third question is, what are the rate-limiting steps related to, like, starting the anti-VISTA program in the second half of the year? Are there any, or do you kind of expect that you're in the final stretch of doing that thing? Sure. Hi Alethea.

Hey, guys. Thanks for taking my question a couple of questions I have here one I just don't 49, 48 and that the and you have datacom and now it ended the year I guess, maybe you can help us like think about maybe how many people that might be and was it kinda impact of covered or the just the I need more data to kinda appreciate what to do.

And then my second question just around.

Combination with Britain had been how how you're thinking about what will be the right. That's level to use there and then my third question that Ah where the rate limiting that was related to like starting out at that that's the program and the second half of the are there any or or do you kind of ex that you're in the bio strata doing that thanks.

Oh sure highly Theo thanks for calling in [laughter]. So.

James E. Dentzer: Thanks for calling in. So, three questions. Your update that we said was getting delayed by COVID, the combo, and then, of course, the anti-VISTA rate limiting factors. So...

Three questions meet your update a that that we said that that's getting delayed by co bid a the combo and then of course, the anti Vista rate limiting factors. So.

The enrollment in the lymphoma study you're exactly right. We did have an impact a uncovered 19 some of the shakes did shutdown a entirely the good news is they have come back up and started to enroll again. So while we're we're only looking for a handful of extra patients. We have got some new patients on entry.

James E. Dentzer: You're exactly right. We did have an impact on COVID-19 enrollment. Some of the sites did shut down entirely. The good news is that they have come back up and started to enroll again. So while we're only looking for a handful of extra patients, we have got some new patients on, and frankly, we just need to have those patients be on the drug long enough to read out the data. So just to let the data mature. We do have confidence, based on the patients that we haven't been able to enroll since they've reopened, that we will be in a position to finalize that phase two dose by the time we get to year end. But unfortunately, yeah, the...

Finally, we just need to have those patients be on drug long enough to read out the data. So just to let the data mature we do have confidence based on the patients that we haven't been able to roll enroll since they've reopened that we will be in a position to to finalize that phase two dose by the time, we get to yearend.

But unfortunately, yeah that that.

The break with cobot impacted us just like it impacted a lot of folks in the industry.

James E. Dentzer: The break with COVID impacted us just like it impacted a lot of folks in the NBD. On the combo study, could you remind me your second question again? Oh, you know, you said, I just wanted to know how you thought about finding the right dose there. Oh, yeah.

On the combo study could you remind me your second question again.

Oh, a you know you said I just wanted to how you thought about finding the right does there oh, yeah for that I know I thought you were kind of some of the 40 I 48 work yeah. If they want your best so would've been a a no brainer. If we had the phase two dose identifying the pharma. We just start there I think the issue with the with the combo study was.

James E. Dentzer: Before that, I know, I thought you were using kind of some of the 48-I-48 work in earlier studies that formed your data. So, it would have been a no-brainer if we had the Phase II dose identified in the forma; we would just start there. I think the issue with the combo study was that we now know enough for sure that we're going into Phase II. We know enough about that data that the data looks good. The question was really, well, what dose is the right dose? And we had two choices.

We now know enough for sure that we're going into phase two we know enough about that data that the data looks good.

The question it was really well what dose is the right dose and we had two choices one was delayed until we finalize the phase two dose and let all the data mature or since we know we're ready to go and we know 200 works, let's just get this this study up and running I'm guessing.

James E. Dentzer: One was to delay until we finalized the phase two dose and let all the data mature. Or, since we know we're ready to go, and we know 200 works, let's just get this study up and running. Get them on the dose that's therapeutic, which is 200. And if they clear that dose, we'll just dose escalate, just as we have been doing on the monotherapy side. So. Sorry, really, that's just the answer on the combo side. On Vista, there really is no rate limiting factor.

Them on the dose that therapeutic which is 200 and if they clear that those will just dose escalate just as we we have been doing on that monotherapy side.

So.

So really that's just the answer on the combo side or on Vista.

There really is no rate limiting factor I would say that the discussions with the FDA, where frankly, I'm more productive and more effective and <unk> and faster than we anticipated. So we are moving at breakneck pace to get our sites open as fast as possible. So it's really now just blocking and tackling of working with the sites now that there.

James E. Dentzer: I would say the discussions with the FDA were, frankly, more productive, more effective, and faster than we anticipated. So we are moving at a breakneck pace to get our sites open as fast as possible. So it's really now just the blocking and tackling of working with the sites now that they're also up post-COVID to get them through all of their processes and start enrolling patients in that study. Okay, great. Thank you.

Also up postcode that.

To get them to through all of their process season started enrolling patients in that study.

Okay, great. Thank you sure.

The next question is from sound that ROI with Jones trading. Please go ahead.

Soumit Roy: The next question is from Soumit Roy with Jones Trading; please go ahead. Hello everyone, thank you for taking the question and congrats on pushing through the Ibrutinib combo in NIH, really powering the asset. Wanted to get your sense on following this monotherapy trial with 4948. Are you seeing or are the physicians enrolling more non-GCB patient types, or is that a focus you would focus on more in the abrutinib combo trial? and if you can give us some color of what line patients you are seeing, what percent are transplant relapsed or naive, some kind of color on the patients in NHL. Sure, thank you Soumit, first and foremost.

Hello, everyone. Thanks for taking the question I know congrats on pushing through the <unk> combo in NHL.

Really powering the asset.

Wanted to get your sense on a falling as monotherapy trial gets a 4948.

Are you are you seeing or are are the physician enrolling more non GCB patient type or is that a focus you would focus on more in the Ibrutinib Campbell no trial.

And if you can give us some color of what your line patients you are seeing or they are what percent are transplant relapse or.

Naive or some kind of coming on the patients in NHL.

Sure I'm thinking from at first and foremost thanks for calling and we appreciate your interest so in terms of a patient being enrolled a I would say, there's there's certainly a white mix of indications.

James E. Dentzer: Thanks for calling in; we appreciate your interest. So in terms of the patients being enrolled, I would say there's certainly a wide mix of indications. We don't yet have the data back. But we will have the data back eventually, certainly by the time we report on MITEI-88 mutations.

And we don't yet have the data back we will have the data back eventually is certainly by the time, we report out of Mydeighty eight mutation, we're very interested in knowing that as well, but we've been pleased that there's been a broad swath abroad sampling of patients across multiple indications to put into the study and they are relapse.

James E. Dentzer: We're very interested in knowing that as well. But we've been pleased that there's been a broad swath, a broad sampling of patients across multiple indications to put into this study. They are relapsed refractory patients. We're finding that they have on average about three and a half lines of prior therapy before they come in, so they are pretty sick.

Factory patients were finding that they're they're on average about three and a half lines of prior therapy before they come in so they are pretty sick, but of course, we're encouraged that interest level and getting them. It is high dose response has been so clear and we're very interested in knowing as we get the final data back on might.

James E. Dentzer: But of course, we're encouraged that the interest level in getting them in is high, that the dose response has been so clear, and we're very interested in knowing as we get the final data back on MITEI-88 alterations where the data tend to correlate, even though it's a small number of patients. I think every little bit of information is going to be very helpful for us as we go forward. Wait a minute... Go ahead, go ahead.

88 alterations, where the data tend to correlate even though it's small number of patients I think every little bit of information is going to be very helpful. For us as we go forward.

Right I mean.

Got it right.

The non G D. Ibrutinib combo trial would you focus on non GCB type or would you leave it wide open to the physicians is crucial.

James E. Dentzer: The Ibrutinib combo trial, would you focus on the non-GCB type, or would you leave it wide open to the physician's discretion? Yeah, I think so. There are two thoughts.

Yeah, I think so there's two thoughts.

First I think the intensive. This study is is really building on the preclinical data that we have so that you may remember that the preclinical data that we have a slide in our corporate presentation shows that have a single agent.

James E. Dentzer: First, I think the intent of the study is really building on the preclinical data that we have. So that you may remember that the preclinical data that we have on a slide in our corporate presentation shows that as a single agent, IRAC4 and BTK inhibition are both really powerful. It's in combination that they appear to be very synergistic and, of course, more powerful than either on its own. So with that thought in mind, we're really looking to target patients who would otherwise be on ibrutinib. So any indication where ibrutinib is used, full out, we would expect to see synergy. Now, that said, while it's broadly open to those populations, anybody whose tumor type is at least partially driven by the toll-like receptor pathway should have an increased sensitivity to therapy and should respond even better. But we would expect, based on our preclinical data, that wherever we can find patients that are responding to BTK therapy, adding 4948 to it should make it a more effective therapy. And that's really the population we're after.

IRAK four and BTK inhibition are both really powerful it's in combination that they appear to be very synergistic and of course more powerful than either on its own so with that thought in mind, we're really looking to to target patients.

Who would otherwise be on I've written up so any indication where I've written it gets used full out.

We would expect to see synergy now that said, while it's broadly opened to those populations.

The body, whose tumor type is at least partially driven by the toll like receptor pathway should have increased sensitivity therapy in should respond even better but we would expect based on our preclinical data that wherever we can find patients that are responding to BTK therapy that add.

Adding four nine for a two it should make it a more effective therapy and that's really the the population where after.

Thank you and.

James E. Dentzer: Thank you. Thank you. One question on the AML front, with Takeda's... In the high-risk MDS population table, let's have a slide showing a fairly good response rate, CR rate of 52%. Do you see the competitive landscape changing? And do you see...

One question on the on the Amazon front.

We took he does.

Oh, hi into Heidi same gets publishing Abel, let's as if I didn't shrinks fairly good response rate tough CR rate of 52% do you see the competitive landscape changing and do you see.

James E. Dentzer: The path to registration is not going to be as simple as X-letter approval but rather a full Phase III controlled arm trial. Do you see any change in strategy? Actually, Bob, it might be a good idea for you to chime in on this one.

<unk> costs to the station is not going to be as simple as an excellent approval, but rather be a full phase three.

Controlled on trial do you see any change in strategy.

Yeah, I actually Bob it might be a good idea for you to chime in on this huh.

Robert E. Martell: Yeah, so that's a great question. You know, we're launching a study that's in both AML and myelodysplastic syndrome. And each of these indications, including both high-risk and lower-risk MDS and AML, do have different treatment algorithms, and we do anticipate that that's going to evolve over time. But, as Jim mentioned, one of the unique aspects about IRAC4 is that it is a key driver of the disease that was initially determined to be so.

Yeah, no that's great.

We're a lots in that study that then both ammo and Oh My God, It's flat <unk> syndrome, and each of these indicates and creating both I regret and lower risk Mds and though they do have different treatment algorithm and we do you anticipate that that's going to evolve over time.

But as Jim mentioned, one of the unique affects about Iraq or is that it is a key driver of the disease that would.

It's going to be so oh God directly target that so we think that that's going to be a key component of treating M.L. and yet.

James E. Dentzer: The drug directly targets that, so we think that this is going to be a key component in treating AML and MDS. We do know, in terms of combining this drug with other drugs that are used, and MDS, that there are potential synergies, and so that would also factor into that, but Yeah, so we do field trials, but right now, there are a number of registrational pathways that we think are very viable. So first, I know our phones seem to be cutting out. We did not plan our earnings call date for the date the hurricane would hit the Northeast.

You know.

In terms of combining this drug with other drugs that are.

No. It's not that there are potential synergies into that but also factor into that but.

Yeah. So we we just feel solving but right now.

There are a number of a registrational path that we think are very viable.

Yeah, Let me I'd, let me add two things to that Schmidt So first.

No our phone seem to be cutting out we did not plan our earnings call date for the date the hurricane would hit the northeast [laughter] I appreciate your patience and trying to catch every other word as our individual phones do cut.

James E. Dentzer: I appreciate your patience and trying to catch every other word as our individual phones cut off. But second, just building on what Bob said, I do think the landscape in oncology in general, and certainly where we're headed, is always changing as new therapies come to light. One of the advantages of the small molecule 4948 is that it does combine well with multiple things. And the other thing is, as Bob mentioned, and just to hammer home, in AML and MDS in particular, while there are therapies that will prove effective in this space, there is only one driver of disease that impacts half the population, full stop. And we have the only drug in oncology currently in the clinic that directly targets that bad actor, that driver of And that, of course, is IRAC4L and 4948 targeting IRAC4L.

That second Yeah, just building on what Bob said I do think the and the landscape in oncology in general and certainly where we're headed.

He is always changing whereas new therapies come to light.

One of the advantages of the small molecule for nine freight is that it does combine well with multiple things and the other thing is as Bob mentioned, then just to hammer home in AML and Mds in particular, well there are therapies that will that will prove effective in this space. There is only one driver of disease that imply.

Next half the population.

Stop.

And we have the only drug in oncology currently in the clinic that directly targets that bad actor that that driver of disease and that of course is IRAK four L and front end freight targeting IRAK four hour. So while I do expect that there are other things that may work in this population and I certainly hope that.

James E. Dentzer: So while I do expect that there are other things that may work in this population, and I certainly hope that as an industry we can generate lots of things that will help this population, uh... I think the key drug that most of the investigators are looking to is the one that really targets the driver. Thank you so much and congratulations again on pushing forward on every front. Again, if you have a question, please press star, then 1.

Story, we can generate lots of things that will help this population.

I think the key drug that most of the investigators are looking to is the one that really targets. The the driver of disease, which is our reader.

Hi, Thanks, so much and congratulations again on pushing forward on every front. Thank you.

Again, if you have a question. Please press Star then one.

The next question comes from Yale Jen with Laidlaw <unk> Company. Please go ahead.

Operator: The next question comes from Yale Gen with Laidlaw Company, please go ahead. Hi, good morning, good afternoon, and thanks for taking the question and congrats on the speedy sort of progression, which has exceeded our expectations. So a couple of quick questions here. The first one is, given the data, the time you want to release the data, 9-48, would ASH be the venue to contemplate? Yeah, so that's a great

Yeah.

Hi, Good morning, Good afternoon Bank.

Congrats.

The progression or low they keep our expectation. So a couple of quick question here. The first one is giving the data at the time you underneath the date up 49 48, what actually the band you to contemplate.

Yeah. So that's a great question I think in general.

Yale Gen: I think, in general, our approach to releasing data is that we would ideally like to release data at a medical conference. So, whenever the data mature to a sufficient level that it merits being released, we would, of course, look to the next appropriate medical conference where that can happen. If those dates coincide, terrific.

Our approach to releasing data is that we would ideally like to release data at a at a medical conference.

So whenever the data mature to a sufficient level that it merits being released you know we would of course look to the next appropriate medical conference where that can happen. If those dates coincide terrific if not what we have done in the past and we may well doing the future is if data mature and there isn't an imminent medical.

James E. Dentzer: If not, what we have done in the past, and we may well do in the future, is if data mature and there isn't an imminent medical conference, we may just release top-line information and then follow that up with a more detailed presentation at a medical conference. But I like the idea of having our investigators, frankly, get on the stage and describe the data that they've been working with in front of their peers, and it provides the opportunity for a more objective view, which I think is always helpful. And frankly, given that all three of the data sets that we are looking at in the next five months are all cutting-edge, these are all really novel targets, these will be very exciting data sets.

The conference we need just released topline information and then follow that up with a more detailed presentation at a medical conference, but I like the idea of having our investigators frankly get on the stage and describe the data that they've been working with in front of their peers and it provides the opportunity of a more.

Objective view, which I think it's always helpful and frankly, given that all three of the datasets that we're looking at in the next five months are all cutting edge. These are all really novel targets. These will be very exciting datasets, it's gonna be very important to have our investigators speak to that had a very detailed level.

James E. Dentzer: It's going to be very important for our investigators to speak to that at a very detailed level. So, my hope is that as these data mature, a conference will be nearby, but if not, look for a short top-line press release from us followed by that more detailed presentation. Okay, great. That's helpful. And for the two, first of all, for NHL at this point. Is the LPCL more likely to potentially be the leading indication you may explore going forward, for instance, in the combo study, or do you still want to do a sort of broad catch-all? type of study to cast the largest net. Great question!

So my hope is that as these data mature conference will be nearby but if not look to a look to a short topline press release from US followed by that more detailed presentation.

Okay, Great that's helpful.

And for that you personal coding that show.

Oh boy.

It's the LPC ill more likely to potentially beat a leading up so indication you may explore gold or well instance, NB combo study or you still want to do a sort of broad catching all.

Hi, all studied to cast the largest the net.

A big question, so I'll answer that really in two ways.

James E. Dentzer: So I'll answer that really in two ways. First, I think the preclinical data that we have, both BTK inhibitors and our IRAK4 inhibitor are really looking to target NF-kappa-B indirectly. So in all of the indications, whether it's DLBCL, whether it's MZL, MCL, CLL, whatever ibrutinib gets used today, it's really targeting indirectly NF-kappa-B. That's what our drug is looking to do as well. So those very same indications as monotherapies would be the ones that we would pursue. It's the same indications that you'd see in a BTK therapy. But because it's a new mechanism of action, we did expect to see in the preclinical work, and we were very pleased to see it bore out that way. The synergy is really there.

First I think that the preclinical data that we have.

Suggests that.

In both BTK and <unk> inhibitors, and IRAK four in or IRAK. Four inhibitors are really looking to target Nf Kappa B indirectly.

So I mean in all of the indications whether its de LBC, all whether its NCL and see how CLL were ever I Bruton. It gets used today, it's really targeting indirectly Nf Kappa B, that's what our drug is looking to do as well. So those very same indications as a monotherapy.

Would be the ones that we would pursue it's the same indications that you'd see a BTK, but because it's a new mechanism of action. We did expect to see in the preclinical work and we were very pleased to see it bore out that way.

The synergy is really there. These are two different mechanisms of action to separate ways to get at Nf Kappa B, So with that thought in mind, our first goal was.

James E. Dentzer: These are two different mechanisms of action, two separate ways to get at NF-kappa B. So, with that thought in mind, our first goal was... We have already established the scientific theory for why this new mechanism of action makes sense. We then developed the preclinical data set to support that this new mechanism of action would work. We have now shown an initial data set last December, and we're gonna update that data set in the next five months with clinical data that shows the preclinical data holds up, that as a single agent, this drug shrinks tumors. The next logical step is, again, building on our preclinical data, and it says the combination is even better. So our view would be we want to pursue both as monotherapies and as a combo therapy. Any indication where ibrutinib is approved? As a monotherapy, it would provide an alternative. If, for whatever reason, someone wants to use an iRec4 as opposed to a BTK, that option is there.

We have already established the scientific theory for why this new mechanism of action makes sense. We then develops the preclinical dataset to support that this new mechanism of action would work. We have now shown an initial data set last December and we're going to update that dataset in the next five.

Months with clinical data that shows the preclinical data hold up.

That as a single agent this drug shrinks tumors.

The next logical step is again building on our preclinical data and it says the combination is even better so our view would be we want to pursue both as a monotherapy and as a combo therapy.

Any indication where I bruton it is approved.

As a monotherapy it would provide an alternative if for whatever reason someone wants to use and direct for as opposed to be teekay that option is there.

We would see the preclinical data as very compelling.

James E. Dentzer: We would see the preclinical data as very compelling about the combo therapy, so we're going to pursue as quickly and aggressively as we can the prosecution of that clinical study to see if that preclinical data is as predictive as all the other data have proven. A really long answer to your question.

About the combo therapy, so we're going to pursue as quickly and aggressively as we can prosecution of that clinical study to see if that preclinical data. It's predictive as all the other data have proven to be.

Okay, I really don't bother to question I hope that was helpful.

Very helpful. I, maybe I'll, not only got which is that.

James E. Dentzer: I hope that was helpful. It's very helpful, and maybe just a little follow-up on that, which is that... If we look at the LBCL sort of landscape at the moment, that's a little bit cloudy there, would that be some other sort of indication if the clinical data bet out to be the, let's say, primary target for future development, would that be a sort of easier path going forward? for bearing fruit.

We look at the RBC out so the landscape at that moment that Olympic I'll do that or would that be other right. So the indication if the current good data back out to beat up let's say the primary target for the future development would that be so easier craft goes forward.

Well, well well bearing fruits Oh, yeah, I think it's a little preliminary to say that just yet it's exactly the right question, which is of all these different indications that we could pursue as either a monotherapy or a combination therapy in the lymphoma space, which one is going to gain priority.

James E. Dentzer: Yeah, I think it's a little premature to say that just yet. But it's exactly the right question, which is, of all these different indications that we could pursue as either a monotherapy or a combination therapy in the lymphoma space, which one is going to gain priority in terms of a regulatory strategy of trying to get to approval as fast as possible? And our view is we're on the brink of finishing up that phase one dose escalation study. And with that data in hand, and having done the analysis of all of the additional biomarker data that we're collecting, including the MITEI-88 data, we're going to want to try and identify which indications. It clearly seems to benefit patients to have this drug available, and we're going to want to pursue all of those.

And you know in terms of a a regulatory strategy of trying to get to approval as fast as possible and our view is where we're on the brink of finishing up that phase one dose escalation study and with that data in hand, and having done the analysis of all of the additional a biomarker data that we're collecting including the Mighty 88 data we're gonna.

I want to try and identify which indications it clearly seems to benefit patients to have this drug available and we're going to want to pursue all of those but we're certainly going to want to prioritize those indications where everything we have the best and fastest shot at regulatory approval and.

James E. Dentzer: But we're certainly going to want to prioritize those indications where we think we have the best and fastest shot at regulatory approval, and whether that is DLBCL or one of the other indications where you frequently find ibrutinib used remains to be seen just yet, but that's exactly the right question, and we will be looking to answer that question and address it publicly when this data is mature over the next few years. Okay, great. That's very helpful. Maybe two more quick questions.

Whether that is Dl bcl or one of the other indications where you frequently find I bring abuse remains to be seen just yet, but but that's exactly the right question and we will be looking to answer that question and address it publicly when this data is mature over the next few months.

Okay, Great. That's very helpful. Maybe two more quick question number one is that Andy Yeah, AML and Mds.

James E. Dentzer: Number one is that in AML and MDS, would that be more for AML, or do you treat both indications equally at this point in terms of patient recruitment and try to see what will be the outcome from those escalating data at this point? Sure. I'm going to answer this one briefly, and then I'm going to ask Bob to jump in.

The yet or what not be more.

Yeah, now or you see vote indication so the equally and at this point in terms of patient recruitment and tried to see what sort of there wont be dotcom underground, but so does that grading data at this point sure. So I think we would we would treat I'm going to answer this one roughly in that I'm going ask Bob to to jump in so.

We're looking at both AML patients and high risk Mds patients of course with AML patients were looking to address the disease outright and with the high risk Mds, we want to make sure that these patients don't have disease that transforms to and Tamil right. We're looking to address both patient populations and our study is open to enroll in both.

James E. Dentzer: We're looking at both AML patients and high-risk MDS patients. Of course, with AML patients, we're looking to address the disease outright, and with high-risk MDS, we want to make sure that these patients don't have a disease that transforms into AML. We're looking to address both patient populations, and our study is open to enrolling both. Bob, would you like to jump in?

Bob would you like to jump huh.

Yeah, so both as we talked about earlier or a different treatment algorithms as well.

Robert E. Martell: Yeah, so both, as we talked about earlier, have different treatment algorithms as well. You know, for example, that, you know, 4948 can reduce engraftment in AML leukemic mice. So that was published by Amit Verma recently, and so we anticipate the direct impact on the AML population. Additionally, with regard to MDS, and especially high-risk MDS, you've got some different endpoints there. One would be transitioning to frank leukemia and likewise, reducing supportive care needs such as transfusions. So we look at these as two different paths.

[laughter] you know we do know for example that are important for a can can reduce <unk>.

Engraftment and ml leukemia glass, so that was published by I'm at Verma recently, and so we anticipate the.

Direct impact impact <unk> ml population. Additionally, with regards to MDF in high, especially high risk Mds you got to different endpoints. There one would be transition to a think leukemia.

And likewise reduction in support of care needs such as confusion. So we look at even two different path.

You wait to see hopefully well monotherapy there a that may be sufficient, but we'll also look towards combinations with.

Robert E. Martell: Hopefully, we'll have a model therapy there that may be sufficient, but we'll also look toward combinations with agents that are used in each of those situations. Okay, great. And maybe switch gears a little bit to CI 8993. And you guys anticipated some data coming out late this year, probably in the dose escalating power. So the key..., highlight we should pay attention to is safety. In other words, if there are cytochrome release syndromes and if that can be managed, then that will be a big win for Starway. That's exactly right.

With the agents that are used in each of those situations.

Okay, Great and then maybe it switchgear little bit to see I 80, 80, 993, and that you guys. They anticipate some data come out late this year, probably in the dose escalating powered that so is the key.

Hi, like would you pay attention to is the safety in other words, if there's a that'll crumb really syndromes and if that can be managed and Dow will be when to starwood.

That's exactly right.

So this calendar year. The emphasis is gonna be safety next calendar year would be efficacy and just as a reminder, this lead molecule is one that has already been in the clinic.

James E. Dentzer: So this calendar year, the emphasis is going to be safety. Next calendar year, it will be efficacy. And just as a reminder, this lead molecule is one that has already been in the clinic. J&J or Janssen, their subsidiary, originally licensed the IP from Immunex back in 2012; they then developed this antibody.

This what.

JNJ or or Johansson their subsidiary.

Regionally license the IP for me Immunex back in 2012.

They then developed this antibody it wasn't developed by Curis or by any next it was developed by Jane Jay.

James E. Dentzer: It wasn't developed by Curis or by Immunex; it was developed by J&J. And then they put it into the clinic, and at very early sub-therapeutic doses, they ran into CRS. They expected at the time, as we do, that you needed to get to somewhere around 0.5 to 2.0 mgs per kg in exposure to get to efficacy levels. That was the therapeutic window. They never got to that window because both at 0.15 and at 0.3, they only had one patient at 0.3, they ran into cytokine release syndrome, and to be fair to them back then, this was in the early days of CAR-T, CRS was kind of scary. There were no guidelines for how to manage it.

And then they put it into the clinic and in very early sub therapeutic doses. They ran into Crs. They expected at the time as we do that you needed to get to somewhere around 0.5 to 2.0, a mix for keurig in in exposure to get to efficacy levels that was the therapeutic window they never got.

To that window, because both it's 0.15 and it was <unk> 0.3, the only one patient at 0.3, they ran into cytokine release syndrome.

And I think they were to be fair to then back then this is in the early days of party Crs. It was kind of scary and there were no guideline for how to manage it those guidelines from the NCCN weren't even issued till 2018.

James E. Dentzer: Those guidelines from the NCCN weren't even issued until 2018. So I would say the oncology community as a whole has learned a lot about how to manage CRS, and we feel very comfortable with the co-administrative therapies, steroids, tocilizumab, and, in fact, some of the additional work that's been done at Dartmouth over the last five years since they got the rights back, about how to modify the regimen of this particular monoclonal antibody to help desensitize patients. All of that information, I think, gives us a lot of confidence that we'll get to the therapeutic window, but we still need to prove it. So I think this first step is that we put together what I think is a very solid plan for how to manage CRS. We've taken advantage of the guidelines that have been issued since Janssen abandoned the program. We've taken advantage of the knowledge developed at Dartmouth and, frankly, the experience of the oncology community more broadly. We've run that by the FDA.

So I would say the oncology community as a whole has learned a lot about how to manage Crs and we feel very comfortable that with the told administrative therapies steroids it towards listen had and in fact some of the additional work that's been done at Dartmouth over the last five years since.

They've got the rights back about how to modify the regimen of this particular monoclonal antibody to help desensitized patients all of that information I think gives us a lot of components that will get to the therapeutic window, but we still need to prove it.

So I think this first step is we put together what I think is a very solid plan for how to manage Crs. We've taken advantage of the guidelines that had been issued since since the onset abandoned the program. We've taken advantage of the knowledge developed at Dartmouth and frankly, the experience of the until.

Energy community more broadly.

We've run that by the FDA DFT is now comfortable as we are they're optimistic that we're going to be able to manage crs effectively and get to that therapeutic window, but this calendar year. It is really that's the objective.

James E. Dentzer: The FDA is now comfortable, as we are. They're optimistic that we're going to be able to manage CRS effectively and get to that therapeutic window. But this calendar is really, that's the objective. Let's get a couple patients on drugs. We know that CRS should show up in the first few hours after treatment. We need to be able to say at year end that we've had multiple patients on the drug, that our plan for managing CRS seems to be effective, and that we have a greater confidence level that we will be successful in escalating into the therapeutic window. And if we can do that, I think we're gonna be in a very exciting place. Thank you for joining us. We will now end your event. Okay, great.

Let's get a couple of patients on drug.

We know that Crs should show up in the first few hours after treatment.

We need to be able to say at year end that we've had multiple patients on drug that our plan for managing Crs seems to be effective and that we have a greater confidence level that we will be successful in escalating into the therapeutic window and if we can do that I think we're going to be in a very exciting place.

Between now and year end.

Okay, Great and then maybe.

Ladies and one more quick one well below that I look at the second quarter operating expenses.

Yale Gen: One more quick one for Bill, the look at the second quarter operating expenses is a step lower than the first quarter, and given the guidance, should we anticipate operating expenses for the second half of this year will sort of be boosted a little bit more? Yeah, thanks, Neil. I appreciate the question.

At lower than the first quarter and given the guidance. So when I say, hey to operating expenses for the second half of this year will be sort of boost up a little bit more.

Yeah. Thanks I appreciate the question Yeah. So I think from a trend wondering I remember that we did have some costs related to the option on license agreement in Q1 that didn't recur here in Q2, and we're also starting to see a little bit the cost savings as we start to wind down some previous trials.

Bill Steinkraus: Yeah, so from a trend point of view, one thing to remember is that we did have some costs related to the option and license agreement in Q1 that didn't recur here in Q2. And we're also starting to see a little bit of the cost savings as we start to wind down some previous trials related to CA-170 and to philhepinestat. But I think, you know, from a guidance perspective, I still think that we will kind of remain consistent in the back half of the year while we do add these programs. We're building off our existing infrastructure. So from a cash burn perspective, I still think, you know, $7, 8 million a quarter is the appropriate average. And obviously, some quarters will be a little bit less, and some quarters may be a little bit higher. But I still think that it's the appropriate range for the rest of the year.

Related CA, one seven day and become dependence that well I think you know from a guidance I still think that we will kind of remain consistent in the in the back half the year why would you add these programs we're building up our existing infrastructure. So from a cash burn perspective, I still think seven 8 million a quarter that range.

Is the appropriate average and obviously some quarters will be a little bit less in some quarters, maybe a little higher but I certainly not the appropriate range for the rest of year.

Okay, great. Thanks again.

Yale Gen: Okay, great. Thanks a lot again and congrats on the speedy progression. Thank you. This concludes our question and answer session. I would like to turn the conference back over to the company's President and Chief Executive Officer, James Dentzer, for any closing remarks. Thank you, Operator, and thank you all for participating in today's call. I also want to thank the patients and families who continue to participate in our clinical trials, our team at Curis for their hard work and commitment, and our partners at Orogene and Immunext for their support. We look forward to updating you again soon. Operator? The conference is now concluded. Thank you for attending today's presentation. You may now disconnect. BF-WATCH TV 2021, The Ultimate Parody Site! BF-WATCH TV 2021

Congrats on the BT progression.

Thank you. Thank you very much.

This concludes our question and answer session I would like to turn the conference back over to the company's President and Chief Executive Officer, James Dentzer for any closing remarks.

Thank you operator, and thank you all for participating in today's call.

I also want to thank the patients and families who continue to participate in our clinical trials our team at Curis for their hard work in commitment and our partners at Aurigene and Immunex for their support we look forward to updating you again soon.

Operator.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

[noise].