Q4 2019 Earnings Call

Thank you. You're welcome to curious his fourth quarter and year-end 2019 earnings call or we begin. I would encourage everyone to go to the investors section of our website at ww.w find our fourth quarter and year-end 2019 earnings rivoli's can related Financial tables.

Unnamed: BF-WATCH TV 2021

Unnamed: Good afternoon, and welcome to the Curis Fourth Quarter and Year-End 2019 Earnings Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on your touch-tone phone. To withdraw 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 Steincross. Please go ahead.

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 about these statements are subject to certain risks and uncertainties an actual results. May differ materially for additional details. Please see our SEC filings.

Joining me on today's call are Jim dancer president and Chief Executive Officer Jim Bob Martel head of R&D. We will also be available for Q&A at the end of the call. I'd now like to turn the call over to cure to CEO condenser Jim. Good afternoon everyone and thank you for joining us today.

Bill Steincross: and welcome to Curis' fourth quarter and year-end 2019 earnings call. Before we begin, I would encourage everyone to go to the investor section of our website at www.curis.com to find our fourth quarter and year-end 2019 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.

2019 was a formative year for Curious. We reported promising clinical data in r c a 49-48 program laying the groundwork for important expansion and first name address in 2020. We retooled our approach to addressing a meaningful oncologic Target Vista with the addition of our CIA 89-93 to our park and we established valuable Partnerships that position curious for sustained momentum. Well into the future.

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

As many of you are acutely aware the evolving covet 1910 demek presents unprecedented challenges to people across the globe. It has also brought to the Forefront off the importance and necessity of medical innovation.

Acuras we are dedicated more than ever to our mission of bringing our targeted cancer therapies to patients. We are closely monitoring developments related to code 19,000. We remain focused on running our business as efficiently and seamlessly as we can.

James E. Dentzer: Thank you, Bill. Good afternoon, everyone, and thank you for joining us today.

James E. Dentzer: 2019 was a formative year for Curis. We reported promising clinical data in our CA4948 program, laying the groundwork for important expansion and further progress in 2020. We retooled our approach to addressing a meaningful oncologic target, VISTA, with the addition of CI 8993 to our portfolio, and we established valuable partnerships that position Curis for sustained momentum well into the future. As many of you are acutely aware, the evolving COVID-19 pandemic presents unprecedented challenges to people across the globe. It has also brought to the forefront the importance and necessity of medical innovation. At Curis, we are dedicated more than ever to our mission of bringing our targeted cancer therapies to patients. We are closely monitoring developments related to COVID-19, and we remain focused on running our business as efficiently and seamlessly as we can.

Now, let's jump into our clinical development programs for next-generation targeted Cancer drugs.

I'd like to start with Iraq for program.

At the conference in December, we reported exciting preliminary data from our ongoing Phase 1 dose-escalation study of CA 49481 Iraq for Thursday for the treatment of patients with relapsed or refractory. Non-Hodgkin's lymphoma including patients with dlbcl waldenstrom's macroglobulinemia, and I'm Mighty 88 mutations.

These data provided the first-ever evidence that targeting Iraq for in this patient population results in anti-cancer activity.

An underscore the potential for C A 49-48 to serve as a novel therapeutic option for these patients.

The study is still ongoing.

But we were pleased to report a dash that the study has advanced into the therapeutic dose range at those levels of two hundred milligrams twice daily and higher 5060 valuable patients experienced a reduction in tumor burden.

James E. Dentzer: Now, let's jump into our clinical development programs for next-generation targeted cancer drugs. I'd like to start with our IRAC-IV program. At the ASH conference in December, we reported exciting preliminary data from our ongoing phase one dose escalation study of CA4948, an IRAC4 kinase inhibitor for the treatment of patients with relapsed or refractory non-Hodgkin's lymphoma, including patients with DLBCL, Waldenstrom's macroglobulinemia, and Oncogenic Mighty88Mutation.

The mean reduction in these patients was 29%

one of these patients

a patient with waldenstrom's provided a really nice single patient example of the strong dose response. We are observing in this study.

This patient enrolled in the study at fifty milligrams twice daily and was escalated to one hundred milligrams twice daily, then escalated again month to two hundred milligrams twice daily with each increase in dose. This patient is seeing further reduction in tumor burden.

James E. Dentzer: These data provide the first ever evidence that targeting IRAC4 in this patient population results in anti-cancer activity and underscore the potential for CA4948 to serve as a novel therapeutic option for these patients. The study is still ongoing. But we were pleased to report at ASH that the study has advanced into the therapeutic dose range, at dose levels of 200 milligrams twice daily and higher. Five of six evaluable patients experienced a reduction in tumor burden. The mean reduction in these patients was 29 percent.

At this patient's individual dose-response is consistent with the overall dose-response seeing with the group as a whole is very exciting.

We are currently evaluating patients at the three hundred milligrams twice daily dose and we will continue to go with escalate until the maximum tolerated dose and or the recommended daily dose is determined. We expect to provide updated safety and efficacy data from this study later this year.

James E. Dentzer: One of these patients, a patient with Waldenstrom's, provided a really nice single patient example of the strong dose response we are observing in this study. This patient enrolled in the study at 50 milligrams twice daily and was dose escalated to 100 milligrams twice daily, then escalated again. 200 milligrams twice daily; with each increase in dose, this patient is seeing further reduction in tumor burden. That this patient's individual dose response is consistent with the overall dose response seen with the group as a whole is very exciting. We are currently evaluating patients at the 300 milligrams twice daily dose.

Also with the ash conference in December data were presented that highlighted CA 84948 as a potential therapy to treat patients with a m l n d s or acute myeloid leukemia or myelodysplastic syndrome who have spliceosome mutations that caused the oncogenic long form of Iraq for a direct Target off of see a 49-48. We plan to initiate this study in the first half of 2020.

In short this year is shaping up to be a busy one for CA 84948 and we are looking forward to updated efficacy data and we are excited to explore the clinical potential of see a 49-48 in patients with a m l m d s and certain spices some mutations.

James E. Dentzer: And we will continue to dose escalate until the maximum tolerated dose and or the recommended phase two dose is determined. We expect to provide updated safety and efficacy data from this study later this year. Also at the ASH conference in December, data were presented that highlighted CA-4948 as a potential therapy to treat patients with AML-MDS, or acute myeloid leukemia or myelodysplastic syndrome who have a spliceosome mutation that causes the oncogenic long form of IRAC4, a direct target of CA-4948. We plan to initiate this study in the first half of 2020. In short, this year is shaping up to be a busy one for CA-4948, and we are looking forward to updated efficacy data, and we are excited to explore the clinical potential of CA-4948 in patients with AML-MDS and certain spliceosome mutations. Moving to our Femipinostat program, we announced earlier today that we are discontinuing our phase one combination study of Femipinostat and Genetic Lab We also did not see an efficacy signal that would warrant advancing this combination to the next stage of development.

Moving to our benefits that program we announced earlier today that we are discontinuing our phase one combination study of feminist and genetic locks.

Although we did not observe any drug drug interactions from the combination. We also did not see an efficacy signal that would warrant advancing this combination to the next stage of development.

given current market conditions as a result of the nineteen pandemic we have decided to focus our resources on see a 49-48 and see I am

I'm going analytical research with Darwin Health to characterize biomarkers and tumor subtype alignments will help guide any future clinical development opportunities within the miles.

Our clinical progress in 2019 has been complemented by recent advancements on the corporate side of our business.

Over the past few months. We have initiated multiple Partnerships and collaborations that we believe position pure as well for the longer-term.

In February of this year. We amended our collaboration agreement with our partner foraging for the development and commercialization of CA 170 an orange available dual inhibitor of this and PDL one.

This amendment enables origin to fund and conduct a large phase to the randomized study of see a 170 in conversation with chemo radiation in patients with non squamous. Non-small cell lung cancer.

James E. Dentzer: Given current market conditions as a result of the COVID-19 pandemic, we have decided to focus our resources on CA-4948 and CI-8993. Ongoing analytical research with Darwin Health, characterized biomarkers, and tumor subtype alignments will help guide any future clinical development opportunities with FIDNAF and Estab. Our clinical progress in 2019 has been complemented by recent advancements on the corporate side of our business; over the past few months, we have initiated multiple partnerships and collaborations that we believe position Curis well for the longer term. In February of this year, we amended our collaboration agreement with our partner, Origin, for the development and commercialization of CA-170, an orally available dual inhibitor of Vista and PD-L1. This amendment enables Origin to fund and conduct a large Phase 2b-3 randomized study of CA-170 in combination with chemoradiation in patients with non-squamous, non-small cell lung cancer.

In return or Jean receives rights to develop and commercialize see a 170 and Asia in addition to its existing rights in India and Russia.

Sure, it's will be entitled to receive royalty payments on future sales of Asia while maintaining full commercial rights to see a 170 in the US with you and the rest of the world outside of Asia.

This update to our collaboration agreement allows us to support the clinical advancement of CA 170 while leveraging Origins expertise and resources for CA 170s late-stage development.

We continue to believe that Vista is a meaningful Target in the cancer setting.

In January of this year, we entered into an option in license agreement within the next for the development and commercialization of anti antibodies.

Including its lead compound ciat 993 a clinical-stage monoclonal antibody designed to antagonize the Vista signaling pathway.

James E. Dentzer: In return, Origin receives rights to develop and commercialize CA-170 in Asia, in addition to its existing rights in India and Russia. Curis will be entitled to receive royalty payments on future sales of CA-170 in Asia, while maintaining full commercial rights to CA-170 in the US, EU, and the rest of the world outside Asia. This update to our collaboration agreement allows us to support the clinical advancement of CA170, while leveraging Origene's expertise and resources for CA 170's late stage development. We continue to believe that VISTA is a meaningful target in the cancer setting. In January of this year, we entered into an option and license agreement with Immunex for the development and commercialization of Antivista Antibodies, including its lead compound, Ci-8993, a clinical stage monoclonal antibody designed to antagonize the VISTA signaling pathway.

We are particularly excited by the prospects of this partnership as it provides us another opportunity to pursue the Vista pathway for the treatment of cancer.

We hope to leverage our experiences from CA 170 to support the development of CIA 89-93 and plan to initiate a phase 1 A-1 be escalation study of CI 89-93 later this year.

Also in January we announced the scientific collaboration with Darwin Health to characterize biomarkers and tumor subtype alignments for chemist at home. We believe this collaboration will deepen our understanding of the Knick mechanism and potentially identify any future development opportunities for for the other stuff.

lastly

I want to touch on the $30 transaction with a Spire Capital that we announced in February.

Bill will walk through the details, but at a high level this deal gives us an efficient and flexible Capital Source from a long-term Health Care focused institution wage to support the clinical development of our candidate.

James E. Dentzer: We are particularly excited by the prospects of this partnership, as it provides us another opportunity to pursue the VISTA pathway for the treatment of cancer. We hope to leverage our experiences from CA-170 to support the development of CI-8993 and plan to initiate a Phase 1a, 1b dose escalation study of CI-8993 later this year. Also in January, we announced a scientific collaboration with Darwin Health to characterize biomarkers and tumor subtype alignments for Pimepenestat.

We're pleased to extend our cash Runway with this transaction as we have an important year ahead of us.

I'll now turn the call over to bill for a summary of our financial results for the year and fourth quarter.

Thank you, Jim. The year ended December Thirty One 2019. We reported a net loss of 32.1 million dollars or $0.97 a month basic and diluted share as compared to a net loss thirty two point six million dollars for ninety-eight cents per basic and diluted share in 2018 in the fourth quarter 2019. We reported a net loss eight point six million dollars or $26.26 per basic and diluted share as compared to a net loss 5.9 million dollars or $0.18 per basic and diluted share the same. 2018 revenues for the year ended off the 31 2019 or ten million dollars as compared to ten point four million dollars for the same period in 2018.

James E. Dentzer: We believe this collaboration will deepen our understanding of the MIC mechanism and potentially identify any future development opportunities for Sumit Pentestat. Lastly, I want to touch on the $30 million transaction with Aspire Capital that we announced in February. Bill will walk through the details, but at a high level, this deal gives us an efficient and flexible capital source from a long-term healthcare-focused institution to support the clinical development of our candidates. We are pleased to extend our cash runway with this transaction, as we have an important year ahead of us. I'll now turn the call over to Bill for a summary of our financial results for the year and fourth quarter. Bill?

Revenues or both. Comprised primarily of royalty revenues recorded on Genentech and roush's net sales of Arabic.

Bill Steincross: Thank you, Jim. When the year ended December 31, 2019, we reported a net loss of $32.1 million, for $0.97 per basic and diluted share, as compared to a net loss of $32.6 million, or $0.98 per basic and diluted share, in 2018. In the fourth quarter of 2019, we reported a net loss of $8.6 million, or 26 cents per basic and diluted share, as compared to a net loss of $5.9 million, for 18 cents per basic and diluted share, for the same period in 2018. Revenues for the year ended December 31, 2019, were $10 million, as compared to $10.4 million for the same period in 2018. Revenues for both periods comprise primarily of royalty revenues recorded on Genentech and Roche's net sales of Aravets.

Revenues for the fourth quarters of 2019 to 2018 with 3.3 million dollars in 2.8 million dollars respectively operating expenses for the year ended December Thirty One 2019 with 34.4 million dollars as compared to thirty nine point eight million dollars for the same. Thursday the 18th operating expenses for the fourth quarter of 2019 were ten point six million dollars as prepared 27.9 million dollars for the same. Wage 2018.

Cost of royalty revenues primarily a month due to third-party University patent license or in connection with Genentech in Roshes service and sales rep zero point five million dollars for the year ended December Thirty One 2019 as compared to zero point six million dollars for the same period of 2018 month cost of royalty revenues work zero point two million dollars for the fourth quarter of 2019 as compared to zero point 1 million dollars for the same period in 2018.

Bill Steincross: Revenues for the fourth quarters of 2019 and 2018 were $3.3 million and $2.8 million, respectively. Operating expenses for the year ended December 31, 2019 were $34.4 million, as compared to $39.8 million for the same period in 2018. Operating expenses for the fourth quarter of 2019 were $10.6 million, as compared to $7.9 million for the same period in 2018. Cost of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche's AeroVision sales.

R&D expenses with 22.3 million dollars for the year ended December Thirty One 2019 as compared to twenty four point four million dollars for the same. In 2018. The decrease was primarily due to lower employee-related expenses resulting from a headcount reduction, which occurred in the fourth quarter of 2018. This decrease was partially offset by increased clinical manufacturing and Consulting costs for our ongoing faith is one clinical trials R&D expenses or seven point five million dollars for the fourth quarter of 2019 as compared to four point seven million dollars for the same. 2018 General and administrative expenses were eleven point six million dollars for the year ended December Thirty One 2019 a Thursday.

Bill Steincross: for the year ended December 31, 2019, as compared to $0.6 million for the same period of 2018. Cost of royalty revenues were $0.2 million for the fourth quarter of 2019, as compared to $0.1 million for the same period of 2018. R&D expenses were $22.3 million for the year ended December 31, 2008, as compared to $24.4 million for the same period in 2018. The decrease was primarily due to lower employee-related expenses resulting from a headcount reduction which occurred in the fourth quarter of 2018. This decrease was partially offset by increased clinical, manufacturing, and consulting costs for our ongoing Phase I clinical trial.

There to 14.8 million dollars the same. In 2018. The decrease was primarily due to lower personnel and stock-based compensation expense combined with the lower legal and Professional Service expenses. G&A expenses are three million dollars for both the fourth quarter of 2019 and 2018, respectively.

Other expense was seven point eight million dollars for the year ended December Thirty One 2019 as compared to three point two million dollars for the same. 2018 Voltz another expense primarily consisted of a 3.5 million dollar loss on extinguishment of debt in conjunction with the March 2019 Thursday of the loan obligation to help care royalty Partners in included interest a four point 1 million dollars resulting from the sale of a portion of Arabic royalties or blinking red or blue capital.

For the fourth quarter of 2019 and 2018 net other expense was one point three million dollars and zero point eight million dollars respectively.

Bill Steincross: R&D expenses were $7.5 million for the fourth quarter of 2019, as compared to $4.7 million for the same period in 2018. General and administrative expenses were $11.6 million for the year ended December 31, 2019, as compared to $14.8 million for the same period in 2018. The decrease was primarily due to lower personnel and stock-based compensation expense, combined with lower legal and professional services.

As of December Thirty One 2019 our cash cash equivalents marketable Securities and Investments totaled twenty point five million dollars off, which we expect to enable us to maintain our planned operations into the second half of twenty twenty-five in order to extend our cash one Runway. We announced in February month that we've entered into a thirty million dollar common stock purchase agreement with a Spire Capital under the terms of the deal expire made an initial investment of $3,000.

Bill Steincross: G&A expenses were $3 million for both the fourth quarter of 2019 and 2018, respectively, net other expenses. $7.8 million for the year ended December 31, 2019, as compared to $3.2 million for the same period in 2018, and that other expense primarily consisted of a $3.5 million loss on extinguishment of debt in conjunction with the March 2019 repayment of the loan obligation to healthcare royalty parties and imputed interest of $4.1 million resulting from the sale of a portion of Arab Edge Royalties to Oberlin Capital. For the fourth quarter of 2019 and 2018, net other expense was $1.3 million and $0.8 million, respectively. As of December 31, 2019, our cash, cash equivalents, marketable securities, and investments totaled $20.5 million, which we expect to enable us to maintain our planned operations into the second half of 2020.

And committed to purchasing up to an additional $27 billion dollars of common shares during a 30-month. Subject to certain limits.

These future purchases will be made from time to time at our request based on the market price at the time of each sale. There are no warrants wage relatives or other share classes associated with the Subaru and we control the timing and amount of the further sale of a common shares to Aspire.

It's facility provides us an accessible source of capital that is based on market prices. We feel it's a great deal for cures and for our shareholders with them. 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 Start than one on your touchtone phone. If you are using a speaker phone, please pick up your handset before pressing the keys to withdraw your question, please press * then two months at this time. We will pause momentarily to assemble our roster.

Our first question comes from cement Roy with Jones trading, please go ahead.

Bill Steincross: In order to extend our cash runway, we announced in February that we had entered into a $30 million Common Stock Purchase Agreement with Aspire Capital. Under the terms of the deal, Spire made an initial investment of $3 million and committed to purchasing up to an additional $27 million of common shares during a 30-month period, subject to certain limits. These future purchases will be made from time to time at our request based on the market price at the time of each sale.

Hello everyone. Thank you for taking the question and hope you guys all think safe quick one on the RX for integer. Is this mutation in dog m d s driver mutation and should we be thinking of you are going to reposition the phone and 4 8 in a MBS setting?

Yeah, thank you, sir. Thanks for calling in. So let me take a first started and then I'll hand over to Bob for a little more detail. So the drugs am bored Hibbett Ur and we initially went at the Non-Hodgkin's lymphoma space and the data that we've gotten so far has been terrific really excited about that. And I think that's the very large commercial space of course because they it looks like it goes everywhere abhi TK goes and the preclinical data suggests. They combine. Well, that's a five billion dollar market today the e l m d s market while smaller is uniquely positioned from a regulatory perspective. It has historically been thought of as a heterogeneous disease.

Bill Steincross: and other shared classes associated with this agreement, and we control the timing and amount of the further sale of common shares to Aspire. This facility provides us with an accessible source of capital that is based on market prices. We feel this is a great deal for Curis and for our shareholders. Operator?

There is very new off the press research that was presented by a physician at Einstein then as identified specific spliceosome mutations that off that need to an overexpression of Iraq for in that disease. This is a place to be TK's can't go in that application. We would we would suggest that his work identifies off the population in ml and DS has having this over expression of the long form of Iraq for short form is is okay the long forms oncogenic and if we can Target them patience, we can take a story to the FDA where we can attribute a very specific population that can be identified by very specific genetic mutations off that are uniquely addressable with our drug. So that that should lead to a very quick regulatory pack. So that's the strategy non non hodgkin's lymphoma really fleshes out that this drug.

Unnamed: We will now begin the question and answer session. To ask a question, you may press star then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the key. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. Our first question comes from Soumit Roy with Jones Trading. Please go ahead.

Soumit Roy: Hello everyone. Thank you for taking the question and I hope you guys are all staying safe.

James E. Dentzer: Just a quick one on the IRAC4 inhibitor. Is this mutation in ML or MDS a driver mutation? And should we be thinking of, you are going to reposition the... 4948 in the AML MDS setting?

works that we can get

The anti-cancer activity in Texas Summers that we saw preclinical e and then of course it can do so in a very large commercial Market ML and DS is taking advantage of hot off the presses researched and identify potentially accelerated path down the down the regulatory path Bob. Would you like to add to that? Yes thanks to see that's a really important question. Uh you slice is so mutations have been known for quite some time in a m l m d s but it's only been recently just as Jim mentioned in the last year has been discovered how they are really regulating the MLM DS and in fact, it turns out that the primary regulator that's geared towards long-term prognosis for these patients is actually this expression of Iraq for long-form and this this form of this protein is constitutive Liang ye

James E. Dentzer: Thank you, Soumit. Thanks for calling in. So, let me take a first start on that, and then I'll hand over to Bob for a little more detail.

James E. Dentzer: The drug's an IRAC-4 inhibitor, and we initially went into the non-Hodgkin's lymphoma space, and the data that we've gotten so far has been terrific. I'm really excited about that, and I think that's a very large commercial space, of course, because it looks like it goes everywhere a BTK goes, and the preclinical data suggests they combine well. That's a $5 billion market today. The AML-MDS market, while smaller, is uniquely positioned from a regulatory perspective.

Yes and drive basically drives prevention of differentiation of the leukemia cells through traffic's and also am really Target nf-kappa be pathway which is essential for the survival of these leukemia cells and we can shut this pathway down dead effectively with CA 49488. So yes, it is a driver mutation. And yes, we will definitely Target that as a registration will pass that we take forward off know I think it'll be close with on the NHL side. We the data we've got so far looks terrific. So at the cutoff point of Ash we were already at therapeutic doses a two hundred milligrams and fire five or six patients are you know, we're shrinking tumors. We're getting a mean reduction of 29% of those patients. Obviously we've accumulated data since then that we're really excited to present later in the year, but dead.

James E. Dentzer: It is a pleasure to be with you.

James E. Dentzer: It has historically been thought of as a heterogeneous disease. There is very new, off-the-press research that was presented by a physician at Einstein at ASH that has identified specific spliceosome mutations that lead to an overexpression of IRAC-4 in that disease. This is a place the BPKs can't go.

James E. Dentzer: In that application, we would suggest that his work identifies half the population in AML and DS as having this overexpression of the long form of IRAC4. The short form is okay; the long form is oncogenic. And if we can target those patients, we can take a story to the FDA where we can identify a very specific population that can be identified by very specific genetic mutations that are uniquely addressable with our drug. So that should lead to a very quick regulatory path. So that's the plan. Non-Hodgkin's lymphoma really fleshes out that this drug works, that we can get the anti-cancer activity and impact on tumors that we saw preclinically, and then, of course, it can do so in a very large commercial market. MLMDS is taking advantage of hot off the presses research and identifies a potentially accelerated path down the regulatory path.

NHL story looks really strong as a commercial opportunity for us on the regulatory side. We expect to take advantage of the hot off the press Lounge element or the Kia commercial even more quickly. Even though it's a smaller Market our drug seems to be uniquely positioned in a way that should excite the FDA. We know it excites the the clinician.

Absolutely. Thank you so much for taking the question and Congress are all the progress.

Thank you. Again. If you have a question, please press * then 1 the next question is from Columbia threadneedle, please go ahead.

Yeah. Hi Jim. Thank you for taking the question two for you one with respect to an ipf couple of years ago passed away was researched by Roche in that space and wondering if you had any discussions with them or if they've been doing anything else with erivedge in the IP space and or related to the coronavirus issue with respect to you know, it's it's infliction on the lungs. That's the first question. The second question is willing to a spire and the pipe financing what other non-dilutive measures are you might you be considering to support the share price and then number two related to that is the Aspire purchases that you mentioned at your discretion or the company's discretion. Is that something that would be made public off?

Robert E. Martell: Bob, would you like to add something to that?

Robert E. Martell: Yes, thanks Soumit, that's a really important question. These spliceosome mutations have been known for quite some time in AML-MDS, but it's only recently, just as Jim mentioned, in the last year, that it's been discovered how they are really regulating AML-MDS. And in fact, it turns out that the primary regulator that's geared towards a long-term poor prognosis for these patients is actually this expression of IRAC4 long form. And this form of this protein is constitutively active and basically drives prevention of differentiation of the leukemia cells through TRAF6 and also really targets the NF-kappa B pathway, which is essential for the survival of these leukemia cells. And we can shut this pathway down fairly effectively with CA4948. So yes, it is a driver mutation, and yes, we will definitely target that as a registrational path that we take forward.

either before or after if you

Sure purchases that Aspire will be conducting in the open market or private Market either way. Thank you. Sure. Thank you. So first name badge and Hedgehog pathway, you know, I think there has there's been a lot of excitement among the scientific community that Hedgehog pathway and where it might go. I know that Roche you had been looking at ipf frankly also Ms. In the past and I believe that they are no longer pursuing that as an opportunity, but I can test in the last quarter. I haven't had that conversation with them. But I know initially that was part of the that the research that of course, they thought that drug might have a place in that setting off on the Aspire transaction. I'm going to limit our comments to of course what can be publicly disclosed I think in hindsight.

Robert E. Martell: On the NHL side, the data we've got so far looks terrific, so at the cutoff point for Ash, we were already at therapeutic doses at 200 milligrams and higher. Five or six patients are, you know, shrinking tumors. We're getting a mean reduction of 29% from those patients.

James E. Dentzer: Obviously, we've accumulated data since then that we're really excited to present later in the year. But the NHL story looks really strong as a commercial... opportunity for us. On the regulatory side, we expect to take advantage of the hot off the presses development, where we think we can get to commercial approval even more quickly, even though it's a smaller market. Our drug seems to be uniquely positioned in a way that should excite the FDA. We know it excites the clinicians.

We did not of course see the coronavirus pandemic coming but an awfully glad we put the facility in place and we did certainly gave the company the financial freedom and flexibility that we need this in this really frankly scary time for for our country and for the world, we certainly plan to make use of that facility took expand upon the trial to do have ongoing. We also have as you know, the the data that we put forth a task was really exciting and and of course we've continued to add patience to me that study. We're not yet prepared to go public with that data but having that data in hand and pursuing the ML and DS as well, we hope to be able to take advantage of the same flexibility afforded by the the Aspire transaction to pursue both of those aggressively and discussed that data as it becomes more mature over the course of this year long.

Soumit Roy: Absolutely. Thank you so much for taking the time to answer the question and congratulations on all the progress.

Unnamed: Thank you.

A. J. Rashid: Again, if you have a question, please press star then 1. The next question is from A. J. Rashid with Columbia Threadneedle. Please go ahead. Hi, Jim. Thank you for taking the questions. I have two for you.

James E. Dentzer: One, with respect to Aeroveg and IPF, a couple years ago, the Hedgehog Pathway was researched by Roche in that space. I'm wondering if you've had any discussions with them or if they've been doing anything else with Aeroveg in the IPF space or related to the coronavirus issue with respect to its infliction on the lungs. That's the first question.

Okay. Thank you. Thank you very much. Thank you. I would like to turn off marks.

James E. Dentzer: The second question is, with respect to Aspire and the pipe financing, what other non-dilutive measures might you be considering to support the share price? And then, number two related to that, are the Aspire purchases that you mentioned at your discretion or the company's discretion. Is that something that would be made public either before or after future purchases that Aspire will be conducting in the open market or private market either way? Thank you.

Thank you Gary in 2019. We positioned Acuras for near-term successes and laid the groundwork for longer-term pipeline growth. We are eager to build on our own successes with CA 84948 and are excited about the opportunities now available to us as a result of several new Partnerships and collaborations.

James E. Dentzer: Sure. Thank you, Adrian.

as we look to 20/20 we are focused on advancing our clinical programs for see a 49-48 and see I 89-93

James E. Dentzer: So, first on AeroVeg and Hedgehog Pathway. You know, I think there has been a lot of excitement among the scientific community about Hedgehog Pathway and where it might go. I know that Roche and Genentech had been looking at IPF, and frankly also MF, in the past, and I believe that they are no longer pursuing that as an opportunity, but I confess, in the last quarter, I haven't had that conversation with But I know initially that was part of the research that, of course, they thought that drug might have a place in that setting, on the Aspire transaction. I'm going to limit our comments to, of course, what can be publicly disclosed. I think in hindsight... We did not, of course, see the coronavirus pandemic coming, but I'm awfully glad we put the facility in place, and we did. It certainly gave the company the financial freedom and flexibility that we need in this really, frankly, scary time for our country and for the world.

before we close. I'd like to thank all of the patients and families who participate in our clinical trials as well as our internal team and curious and our partners at origin and in the next month for their commitment and support.

Thank you for joining our call today, and we look forward to updating you again soon.

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

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James E. Dentzer: We certainly plan to make use of that facility to expand upon the trials that we do have ongoing. We also have, as you know, the data that we put forth at ASH was really exciting, and, of course, we've continued to add patients to that study. We're not yet prepared to go public with that data, but having that data in hand and pursuing the AML and DS as well, we hope to be able to take advantage of the financial flexibility afforded by the ASPIRE transaction to pursue both of those aggressively and discuss that data as it becomes more mature over the course of this year.

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A. J. Rashid: Thank you very much. Thank you very much. Thank you.

Unnamed: 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.

James E. Dentzer: Thank you, Gary. In 2019, we positioned Curis for near-term success and laid the groundwork for longer-term pipeline growth. We are eager to build on our initial successes with CA-4948 and are excited about the opportunities now available to us as a result of several new partnerships and collaborations. As we look to 2020, we are focused on advancing our clinical programs for CA-4948 and CI-8993. Before we close, I'd like to thank all of the patients and families who participate in our clinical trials, as well as our internal team at Curis and our partners at Orogene and Immunex for their commitment and support. Thank you for joining us today, and we look forward to updating you again soon.

Thursday Thursday

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Unnamed: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect. BF-WATCH TV 2021

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