Q1 2025 Agenus Inc Earnings Call
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Speaker Change: Good morning, and welcome to Agenus Inc's first quarter 2025 earnings conference call. Currently all participants are only listening only mode. A question and answer session will follow the formal remarks. As a reminder, this conference is being recorded. I will now hand the call over to Zack Armen, Head of Investor Relations. Please go ahead.
Speaker Change: Before we begin I'd like to remind everyone that today's discussion will include forward looking statements. These statements are subject to risks and uncertainties, which may cause actual results to differ materially from expectations. Please refer to our SEC filings for further detail.
Speaker Change: Joining me today are Garo, Armen, Phd chairman and CEO, Dr. Stephen though de M D Chief Medical Officer, Robin Taylor, Phd Chief Commercial Officer, Richard Goldberg, MD, Chief Development Officer, and Kristine Classic and VP Finance and principal financial and accounting officer.
Speaker Change: Now I will turn the call over to Dr. Garo Armen.
Speaker Change: <unk>.
Speaker Change: Thank you everybody.
Speaker Change: Thank you for joining us today.
Speaker Change: Before we start on today's call I will cover six priorities or I should say, we will collectively cover six priorities.
Speaker Change: Yes.
Speaker Change: We are going to present to you the newest basketball data validating durable responses and historically untreatable cold tumors and I might.
Speaker Change: Stress that we're talking about new data and more mature data.
Speaker Change: We're going to talk about the strategic hire of Dr. Richard Goldberg.
Speaker Change: And his mandate to steer our regulatory path.
Speaker Change: Next we'll talk about operational efficiencies that are on track to cut our operational cash burn to below 50 million annualized in the second half of this year.
Speaker Change: And fourth.
Speaker Change: For formal near term transaction proposals that we have received.
Speaker Change: Including in Emeryville facility sale.
Speaker Change: A significant equity investment at a big premium.
Speaker Change: And to back Val licensing deals.
Speaker Change: Each individually or in combination.
Speaker Change: Designed to materially strengthen our balance sheet.
Speaker Change: And lastly.
Speaker Change: The changes in the new FCA policies that could favor rapid approval of transformative therapies.
Speaker Change: And our recent request for a type.
Speaker Change: The meeting.
Speaker Change: And we will provide you with some details as to the rationale of this.
Speaker Change: So before I get into the business update I'd like to acknowledge a critical and growing public health crisis.
Speaker Change: This underpins everything we do it again.
Speaker Change: Colorectal cancer is under rice.
Speaker Change: Particularly among younger people under the age of 50.
Speaker Change: Colorectal cancer incidences have doubled.
Speaker Change: In the U S adults under 55.
Speaker Change: From $19 95 to 2019 less than 25 years.
Speaker Change: By 2030, colorectal cancer is projected to become the leading cause of cancer related death in men under 50 in the United States.
Speaker Change: These younger patients, especially need treatments other than chemotherapy radiation and life altering surgeries, particularly in the wrong Young this is important for the young and the old but particularly in the young these life altering treatments.
Speaker Change: Can have a lasting devastating effect.
Speaker Change: And hence they deserve an alternative.
Speaker Change: Without life changing side effects.
Speaker Change: And Thats, what we think we offer to patients.
Speaker Change: These younger patients.
Speaker Change: The new leadership.
Speaker Change: It's particularly aware of this.
Speaker Change: The new leadership at HHS and the FDA.
Speaker Change: At ignite this grim reality of today's treatments.
Speaker Change: One of the President's first actions with Senator Kennedy I'm, Sorry Secretary Kennedy.
Speaker Change: So setup the make America healthy again Commission.
Speaker Change: Which is to ensure.
Speaker Change: And issuance Shreveport any day now.
Speaker Change: Secretary Kennedy has pledged to root out conflicts of interest.
Speaker Change: And FDA Commissioner Dr. Marty Macquarrie.
Speaker Change: Repeatedly stressed the need for accelerated approval of meaningful treatments.
Speaker Change: Underlying meaningful treatments.
Speaker Change: This shift in regulatory environment is deeply encouraging to us.
Speaker Change: And for the entire research community, discovering and developing novel and effective therapies.
Speaker Change: So it's an exciting time for us.
Speaker Change: And some of our peers.
Speaker Change: We have new data.
Speaker Change: New leadership.
Speaker Change: New efficiencies and a new environment.
Speaker Change: At the FDA and the government.
Speaker Change: So we will talk about these one by one.
Bob: Bob what kinda fill them up and while still a map, which we called <unk>.
Bob: We are generating consistent and compelling data across different lines of treatment.
Bob: Both in the new adjuvant setting and in later line.
Bob: And across multiple cold tumors that have historically defined.
Bob: Standard immuno oncology therapies.
Bob: These include MSS colorectal cancer.
Bob: Huge.
Bob: <unk>.
Bob: Certain breast cancers.
Bob: Sarcomas.
Bob: Hey, Pat has held <unk> carcinoma.
Bob: And many more.
Bob: At AACE, our 2025 two weeks ago.
Bob: That was a groundbreaking presentation.
Bob: By Dr. Miriam Chalabi of the Netherlands Cancer Institute.
Speaker Change: He presented results from the investigator sponsored study.
Bob: New wafers.
Bob: And cancer study remember this is many different types of cancers.
Bob: In the new adjuvant.
Bob: And if you remember so far prior to this we have generated data in the new adjuvant setting of colon cancer.
Bob: It takes that concept and broadens into many other cancers.
Bob: The study showed pathological complete responses across multiple cancers.
Bob: No dose limiting toxicities.
Bob: And all patients proceeded to surgery.
Bob: On schedule.
Bob: Very important.
Bob: As that Chalabi stated.
Bob: These findings.
Bob: Initiate the importance of this immunotherapy.
Bob: In early treatment settings.
Bob: I would say earlier treatment settings, because these patients are not really early cancer patients theyre stage III.
Bob: And highlight the broad potential utility of this combination.
Bob: What she was speaking of background.
Bob: And liver cancer.
Dr. Anthony: Dr. Anthony <unk> Chief of section of developmental therapeutics at the USC Norris comprehensive cancer Center.
Dr. Anthony: <unk> phase one data in HCC cohort data of bat.
Dr. Anthony: <unk>.
Dr. Anthony: In patients heavily pretreated with available therapies, including PDL, one blockade plus avastin, which are the standard of care in last line.
Dr. Anthony: And still demonstrated.
Dr. Anthony: Deep and durable disease control.
Dr. Anthony: Very important for patients.
Dr. Anthony: Let me talk about <unk>.
Dr. Anthony: Our new leadership.
Dr. Anthony: And of course, we have fantastic leadership, but this is new leadership to be added on.
Dr. Anthony: To support this next phase of development.
Speaker Change: We welcome Dr. Richard Goldberg.
Speaker Change: World right now in Gi oncology expert as our Chief Development Officer.
Speaker Change: His leadership will be pivotal.
Speaker Change: We advance towards regulatory filings in metastatic CRC and other tumor types.
Dr. Goldberg: Dr. Goldberg recently offered a guest editorial okay.
Speaker Change: Cancel the lessor.
Speaker Change: Arguing that Io approvals.
Speaker Change: Should be customized to spare patients.
Unnecessary.
Speaker Change: Life changing toxicities.
Speaker Change: Same theme that we've talked about.
Speaker Change: Rather than speak on his behalf I'd like to invite him to share his perspectives directly with us today Dr. Goldberg.
Dr. Goldberg: Thank you Garo for that kind introduction five years ago, Alright stepped away from formal leadership roles and academic oncology and from active clinical practice that time has allowed me to support companies working on new treatments for Gi cancer and to deepen mining.
Speaker Change: <unk> and patient advocacy.
Speaker Change: But throughout that time I keep hearing the same message from patients from their families and from colleagues, we need better treatments, especially for colorectal cancer.
Speaker Change: People want more time, better time, and ultimately they wont hold for a cure.
Speaker Change: This need is especially acute for patients with MSS colorectal cancer.
Speaker Change: Existing immunotherapies have offered little benefit.
Speaker Change: As an advisor I've had the opportunity to evaluate many programs what stood out about at Janus and what ultimately brought me back into a full time leadership role was a potential for bot and Val.
Speaker Change: This combination represents one of the most promising advances I've seen in my career. It has the potential to shift outcomes not just in colorectal cancer, but across a range of difficult to treat solid tumors, which represent the biggest challenges in achieving cancer cure.
Speaker Change: The opportunity to help move these agents forward to gain FDA approval and make them accessible to oncologists and patients across the world is what compelled me to reenter the field I'm excited to be here and I look forward to working with the exceptional team at Janus to bring forward, new hopes and meaningful treatment.
Speaker Change: For our patients.
Speaker Change: These patients, especially need treatments other than chemotherapy and radiation and life altering surgeries.
Speaker Change: <unk>, an alternative without life changing side effects.
Speaker Change: The new leadership at HHS and FDA recognized this.
Karen: Thank you Karen.
Richard Goldberg: Thank you very much Richard.
Speaker Change: A real privilege to have you onboard given your career and given the fact that you know this disease inside out.
Speaker Change: You had been gracious enough to invest the time to really understand our data inside the app.
Speaker Change: And so with that kind of endorsement, we're very grateful for your leadership and our next chapter.
Speaker Change: As we indicated in our March calls.
We are on track to put our annualized operational cash burn below $15 million in the second half of 2025.
Speaker Change: This is going to see resources.
Speaker Change: But valves and.
Speaker Change: And its full potential not just in colorectal cancer beyond <unk>.
Speaker Change: Because as we mentioned.
Speaker Change: That is a very powerful Io agent that shows activity and this is corroborated by some of the leading experts across different cancers that are familiar with IL.
Christine: So before we move on to the financial review by Christine.
Let me address capital strategy head on.
Christine: Over the past several weeks.
Speaker Change: Genesis received for.
Speaker Change: Although written proposals.
Speaker Change: That would inject.
Speaker Change: Sure.
Speaker Change: The potential to inject.
Speaker Change: Thanks, Phil New capitals.
Speaker Change: Two proposals will allow us to monetize on our state of the art Emeryville Biologics facility.
Speaker Change: Each of these proposals also have the potential to it.
Speaker Change: Expand into broader strategic collaborations.
Speaker Change: The third proposal offers.
Speaker Change: Significant equity investment and a meaningful premium to our.
Current share price.
Speaker Change: And at force.
Speaker Change: Templates.
Speaker Change: Our licensing agreement with upfront cash.
Speaker Change: Myles stones and double digit royalties.
Speaker Change: Our board and our advisors evaluating these proposals.
Speaker Change: With a high sense of urgency I might add.
Speaker Change: And we anticipate announcing at least one of these transactions in the coming days or maybe a few weeks.
Speaker Change: Any of them would materially strengthen our balance sheet, while preserving long term upside for shareholders.
Speaker Change: Most importantly accelerating.
Speaker Change: Accelerating our mission to bring life saving therapies to patients.
Speaker Change: With strong scientific momentum, we remain equally focused on operational discipline.
Speaker Change: With that I will turn it over to Christine to briefly review the financials Christine.
Christine: Thank you Garo.
Christine: We ended the first quarter 2025, with a consolidated cash balance of $18 5 million compared to $40 4 million at year end 2024.
Christine: Cash used in operations for the first quarter ended March 31, 2025, with 25 6 million, which.
Christine: Which is reduced from $38 2 million for the same period in 2024.
Christine: For the first quarter ended March 31, 2025, we recognized revenue of $24 1 million.
Christine: And incurred a net loss of $26 4 million.
Christine: Our $1 <unk> per share for.
Christine: For the first quarter of 'twenty 'twenty, four we recognized revenue of $28 million and incurred a net loss of $63 5 million or $3 <unk> per share.
Christine: Our revenue primarily includes noncash royalty revenue.
Christine: I'll turn the call back now to go to close out the call.
Speaker Change: Thank you very much Christine.
Christine: So in closing.
Christine: For all the reasons we've discussed today.
Christine: Which include new data.
Christine: The leadership.
Christine: Efficiencies.
Christine: And then new regulatory environment in addition to.
Christine: Our anticipated near term corporate transactions.
Christine: We believe agenda.
Christine: Offers a great deal for patients and all stakeholders.
Christine: It is for these reasons that on May five.
Christine: At Janus formally requested a type b meeting with the FDA for <unk>.
Christine: Our dossier built on rigorous data from more than 200 patients.
Christine: And now that is with a two year follow up.
Christine: Showing.
Christine: Deep and durable responses.
Christine: And he is deep and durable responses by the way.
Christine: Full marks.
Speaker Change: Effective Io treatments as our Chief Medical Officer has always set.
And so we believe.
Speaker Change: I don't see them meet every statutory criteria for potential accelerated approval.
Speaker Change: We're hopeful that the agency will engage promptly and judge our submission on its merits.
Speaker Change: Yes.
Speaker Change: Our conviction in bat valves curative potential has never been stronger and our team is absolutely resolved in delivering this breakthrough for patients who have waited.
Speaker Change: <unk> too long.
Speaker Change: Far too long.
Speaker Change: Thank you very much for your continued support and attention.
Speaker Change: And operator, we are ready for questions now.
Speaker Change: Thank you we will now begin the question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad. If you would like to withdraw your question simply press Star one again.
Speaker Change: Your first question comes from the line of Emily Bodnar from H C. Wainwright. Your line is open.
Emily Bodnar: Hi, good morning, Thanks for taking the questions.
Speaker Change: I guess first start with your commentary about regulatory.
Emily Bodnar: <unk>.
Emily Bodnar: How much.
Emily Bodnar: Longer term follow up do you have from the phase two study and have you hit on the overall survival endpoint yet.
Emily Bodnar: And then assuming that you speak to them if they come back and say that you still need the phase III study can you comment on your ability to run a phase III study in place.
Speaker Change: Thank you sure. So I will ask Dr. Stephen though day to comment on the longer term efficacy data and perhaps.
Speaker Change: Can ask back to Bill who has graced us we'd have presence today in addition to her.
Speaker Change: Responsibilities at link.
Speaker Change: As you know she is there.
Speaker Change: Chairman of the executive board over to Janice and overseeing all of our regulatory efforts and the phase two question Phase III question Dr. Jose.
Speaker Change: Thank you Emily so.
Speaker Change: Last year when we.
Speaker Change: <unk> to the FDA, our data set both of our phase one and our phase two.
Speaker Change: Within.
Speaker Change: July based on our March data cuts, we will have approximately one more year of <unk>.
Speaker Change: Data both in our phase one in our phase two the median follow up for the Phase one which now includes 123 patients who is 18 months a substantial increase in duration from last year. The phase II trial has approximately just over 12 months of median follow up also significantly more than it did last.
Speaker Change: Year, so the combination of both of our phase one and phase two data with longer follow up will obviously be.
Speaker Change: A significant factor in the <unk>.
Speaker Change: Next review with the FDA.
Speaker Change: Thank you Steven and also remember what's remarkable about these three seemingly separate studies that is phase one cohort one phase one cohort two and phase two is.
Speaker Change: Is the consistency of data across the board, which obviously makes the results much more.
Speaker Change: Yes.
Speaker Change: Credible.
Speaker Change: And in terms of our next steps as you know.
Speaker Change: No last year, when we had a meeting with the FDA.
Speaker Change: They made in our opinion.
Speaker Change: And everyone use judgment based on a paper that was published which excluded some critical references and some critical data.
Speaker Change: And of course this is not their fault, but because they have a lot on their plate, but this erroneous decision.
Speaker Change: Resulted in them telling us.
Speaker Change: Perhaps this study even with longer term.
Speaker Change: Follow up may not be adequate.
For approvals.
Speaker Change: But.
Speaker Change: What is very clear and staffing really clear to us.
Speaker Change: Is that the longer term follow up.
Speaker Change: Is very indicative of survival benefit.
Speaker Change: These patients you can follow up with two years five years at some point you need to give in and say this is indicative of survival and so this is what we are basically making a point that.
Richard Goldberg: And that's the Goldberg of course looked at all of this data and concurred with this conclusion, that's one of the reasons he's here.
Speaker Change: Otherwise this.
Speaker Change: Very very.
Speaker Change: Accomplish men would have been very difficult to bring in from his stockholder retirement at a young age so I'm going to pass it on to Dr. Bill now to make comments about phase III because of course, we're making plans for phase III, but the question becomes what.
Speaker Change: Indication and what types of phase III trials, we are pursuing that W.
Speaker Change: Thank you thanks, very much Gary I'm, just going to reiterate a couple of points here. Emily you are quite aware of the work that we've done and I think it's an important time, we're grateful for the agency's partnership as we concluded our July meeting last year and now we're as they've requested we're coming back with additional data and Stephen just mentioned we are in.
Speaker Change: More than 40% additional patients more patients on the phase one with very mature follow up and then of course, an additional year of follow up on the randomized phase II, which did include a standard of care arm and we expect to present data on these datasets at a major upcoming conference that will be near term.
Speaker Change: So you'll have a sense of the depth and durability of the responses.
Speaker Change: But as Garo mentioned previously the FDA had mentioned to US again. This was a year ago that the advice submission of the results and this is specifically an outcome of the meeting due to the modest overall response rates and the fact of the ability of the response rates to reasonably predict.
Speaker Change: A meaningful benefit for patients now the reason that this response is really quite surprising to us with it given the clinical outcomes that we submitted at the time, we demonstrated more than fourfold four to five fold improvement in tumor shrinkage of our response rates and a more than doubling.
Speaker Change: Oliver I'll survival, and it's very hard to treat cancer and since then now nearly a year later, our data have further matured reinforcing and extending the clinical impact and which in fact, we've got some patients out beyond four years with no progression.
Speaker Change: So we're really quite excited to bring the data back to the agency and I think with this new.
Speaker Change: Evolving administration, we share the urgency to bring new medicines to patients, particularly in this growing prevalent disease right now.
Speaker Change: Impacting the yen as well as far as next steps. We will also talk with the agency about our randomized design, representing two different approaches to the agency because we have.
Speaker Change: Quite frankly, as Garo mentioned parties, who are really interested in helping us accelerate the development of <unk> for patients with the highest unmet need for which there are currently no available therapies.
Speaker Change: And for patients building on what you observed from the ESCO Gi data.
Speaker Change: And marry them to a lot of these data in patients in the earliest disease Neo adjuvant disease.
Jan: Thank you Jan so as we all know besides the.
Speaker Change: Important MX tricking regulation rules and regulations.
Speaker Change: Drugs have to be demonstrated.
Speaker Change: To be efficacious in other words, they're active.
Speaker Change: In this case.
Speaker Change: Safety is of course relative to the patient population that we're going after.
Speaker Change: And one of the most striking features of what <unk> is.
Speaker Change: Is that in the neo adjuvant setting.
Speaker Change: The efficacy.
Speaker Change: Is black and white.
Speaker Change: Because.
Speaker Change: We're not aware of very many agents out there let alone.
Speaker Change: Since that within a span of four to eight weeks.
Speaker Change: Result in complete resolution of the tumor.
And this is what we have seen visually and in terms of pathologic complete responses.
Speaker Change: In the new adjuvant setting.
Jane: It's too as Jane talked about in the late line setting.
Speaker Change: I think she was being modest by calling the response rate modest of course. She also mentioned that it is <unk>.
Speaker Change: Three four times better than anything out there because as you know in late line setting response rates of approved products out there range from 1% to a maximum of 7%.
Speaker Change: And depending on the patient population, where at least twice that in most cases three times that.
Speaker Change: With a longevity of the durable responses, which should translate to survival benefit.
Speaker Change: So.
Speaker Change: Yes.
Speaker Change: The.
Speaker Change: Specific nuance here. Thank you.
Speaker Change: Thank you.
Your next question comes from the line of Mank Montone from B Riley Securities. Your line is open.
Mank Montone: Yes, good morning team, thanks for taking our questions and please to see Dr. Goldberg joined the team here.
Mank Montone: We can discuss any development plan changes or update in light of the recent ACR update.
Mank Montone: Thinking.
Mank Montone: Places trial did have some non CRC patients like the NBC and also obviously you had the late line FCC cohort update so was this curious how.
Mank Montone: As you go into a diaby meeting some of these non CRC hemodialysis kind of play a role in it.
Mank Montone: Longer term development strategy or are you just very focused on CRC to get.
Mank Montone: This meeting very very focused on CRC, if you could clarify that and then I have a follow up.
Mank Montone: So we believe that the.
Shortest distance between presentation on approval is in the colorectal cancer setting.
Mank Montone: There are two settings, where we believe that this is important.
Mank Montone: One is in refractory disease, either third or fourth line therapy, and one of the interesting observations from the emerging data is.
Mank Montone: The response rate.
Mank Montone: It looks the same and third line and in fourth line.
That I think makes it clear that the mechanism of action of these drugs is diverging from the other drugs that patients have been exposed to.
Mank Montone: Right.
Mank Montone: The other area that we're excited about is in the neo adjuvant setting.
Mank Montone: As you may be aware there was a recent presentation from.
Speaker Change: The team at Memorial Sloan Kettering.
Speaker Change: And Theyre MSI high patients are showing activity in both.
Speaker Change: MSI high colon cancer, and MSI high non colorectal cancers.
Speaker Change: We believe that.
Speaker Change: Our approach is going to expand that indication to the much larger subset of patients who are microsatellite stable who are not MSI high.
Speaker Change: That's the path that they have placed in the MSI high doing business.
Speaker Change: But we hope to follow in the Neo adjuvant setting.
Speaker Change: Both in rectal cancer and potentially in colon cancer.
Speaker Change: Where the potential to avoid.
Speaker Change: All of the <unk>.
Speaker Change: Toxicities on surgery radiation and chemotherapy would be welcomed by patients.
Speaker Change: Does that address your question Matt.
Speaker Change: Yes, I guess the type B meeting focus I heard that it's going to be primarily <unk> focused is that fair and having those two indications late line.
Speaker Change: And the adjuvant, yes, that's clear I guess.
Speaker Change: Are you able to comment on when do you expect the diabetes meeting to occur in.
Speaker Change: The strategic discussions that you alluded to I believe.
Speaker Change: Need to have those minutes.
Speaker Change: Hand, before Youre able to do.
Speaker Change: Ed.
Speaker Change: Move forward in a meaningful way is that fair.
Speaker Change: Yes.
Speaker Change: Okay I'll, let Jan answer this very important question.
We actually have quite a bit of of data and information from the FDA with to satisfy the discussions that you're referring to the strategic discussion. So the path forward from our perspective is really quite clear the opportunity is what we want to speak with the agency, which is the fastest path to get these products available to patients.
Speaker Change: That's independent of the strategic discussions.
Speaker Change: I think.
Speaker Change: Yes.
Speaker Change: And lastly, if you're able to comment on the European counter bypass also.
Speaker Change: That obviously has been a separate engagements so any update there.
Sure.
Speaker Change: We'll tell you what our history has been with Europe, because right after the.
Speaker Change: Unsatisfactory meeting with the FDA last June we engaged with CA <unk> and the European authorities and the outcome of those meetings I'll, let Jim comment.
Speaker Change: Thanks Scott.
Speaker Change: We have not previously disclosed this so this is really the first that we're disclosing.
Speaker Change: The interactions with the agency and the scientific Advisory group last year was incredibly productive the team was very prepared impressively. So.
Speaker Change: They agreed with us on our selected dose Dave agreed that we had achieved contribution of components and they agreed with the two arm randomized trial for.
Speaker Change: For registration now.
Speaker Change: Conditional approval pathway is the possibility for us that we're going to go ahead and pursue we're talking with the U S. FDA and we plan to talk with European DMA and essentially in parallel the initial interactions with the FDA will occur first though.
Speaker Change: Thank you.
Speaker Change: Thank you for taking our questions.
Speaker Change: Your next question comes from the line of Matthew Phipps from William Blair. Your line is open.
Matthew Phipps: Good morning, Thanks for all the detail here on the updates.
Matthew Phipps: I think before you've provided some valuation framework for the <unk> facility and I'm wondering if that value has increased given the focus on kind of onshoring.
Matthew Phipps: Pharmaceutical manufacturing over the past few months.
Speaker Change: I think this is a very very good question and when I say good I'm not dodging the question Matt.
Matthew Phipps: I believe that the totality.
Matthew Phipps: All of the value, we will derive out of the Emeryville facility.
Matthew Phipps: We'll reflect that premium of course.
Matthew Phipps: If we had the luxury to wait another six to 12 months I think that we could get a lot more for it.
Matthew Phipps: Right.
Matthew Phipps: Right now it is a relatively inexpensive access to capital.
Matthew Phipps: Hence we are pursuing that route even though we believe the value will continue to grow.
Matthew Phipps: Yes, that's fair and then I am.
Speaker Change: Sure you can't give us too much more details on some of the agreements beyond what you already gave but the licensing agreement can you just say if that is geographic geography specific or if it is broader worldwide.
Matthew Phipps: The two agreements, which had been submitted to us.
Matthew Phipps: <unk>.
Matthew Phipps: Proposals are.
Matthew Phipps: Our global.
Matthew Phipps: Additional.
Matthew Phipps: Agreements that we are potentially.
Matthew Phipps: Looking at as an important option for us.
Matthew Phipps: Geography specific.
Matthew Phipps: So depending on our cost of capital configurations and immediate needs of course.
Matthew Phipps: Global <unk>.
Matthew Phipps: Licensing agreements with contemplate third pricing underwriting and higher cost of additional trials and registration for back now.
Matthew Phipps: Does that appeal because it will further drive our operating burn rate down.
Matthew Phipps: But let us through these because the sequence with which we consummate some of these agreements.
Matthew Phipps: <unk> brings in class and create value will be critical in determining our next steps.
Matthew Phipps: Okay, great. Thanks, Thanks Carol.
Matthew Phipps: Okay.
Speaker Change: Your next question comes from the line of Choline Cousy from Baird. Your line is open.
Choline Cousy: Great Good morning. Thanks.
Choline Cousy: Thanks for taking our questions.
Speaker Change: Have you had any interactions yet with the new FDA at this point ahead of the <unk> meeting and can you provide a little more color on the publication that you mentioned that led the FDA to its conclusion last summer and why do you think that might be.
Speaker Change: It'd be a different situation in the summer.
Speaker Change: Okay. So I will I will answer the second question first.
Speaker Change: The publication, we are talking about I believe that that will correct me if I'm wrong.
Speaker Change: Was a new England Journal of Medicine article by Dr. Richard <unk> and Julia deeper.
Speaker Change: And this article.
Speaker Change: Made a point.
Speaker Change: That I all in combination with other agents.
Speaker Change: Where the response rates are at a certain threshold do not necessarily result in long term survival. However is it big however.
Speaker Change: One is.
These protocols discussed by and large we are.
Speaker Change: Not.
Speaker Change: Only protocols.
Speaker Change: The Idaho, mainly PD, one plus something else and so that doesn't really reflect the power.
Speaker Change: All the lasting durable responses generated by city law for agents, thanks very much.
Speaker Change: Point very very important point.
Speaker Change: And secondly, this article excluded a number of cases, where we can think about four or five cases.
Speaker Change: Where low response rates and when I say low responses I'm talking about single digits Im talking about 15% to 20% response rate.
Speaker Change: Did indeed translate to longer term survival.
Speaker Change: Somewhat partial and depicting the fact.
Speaker Change: And of course.
That's one issue. The second question that you asked have we engaged with the new FDA.
Speaker Change: The answer is no we have not because of the new FDA is comprised of leadership.
Speaker Change: Dr <unk>.
Marty Macquarrie: Marty Macquarrie.
Marty Macquarrie: And a lot of the senior people at the FDA and I'm not talking about cancer Division and a lot of the senior people.
Marty Macquarrie: And even in the Kansas Division.
Marty Macquarrie: The thing that we're seeing.
Marty Macquarrie: People have left.
And so we're looking at our type B meeting as an opportunity to Reengage. The agency. However, the first step for US is to present the totality of the data.
Marty Macquarrie: When I talk about totality of the data remember Dr Goldberg and I made the point that our sharp shooting.
Marty Macquarrie: Our strategy will be colorectal cancer.
Marty Macquarrie: However, the totality of data.
Marty Macquarrie: Comprising our trials across nine different cancers, and all of those nine different cancers about five of them both in numbers and in terms of durability of responses has matured to a point, where we can proudly demonstrate the consistency of the day.
Marty Macquarrie: From one cancer to another to another to another.
Marty Macquarrie: That's what we will be presenting as well.
Marty Macquarrie: Okay.
Marty Macquarrie: Great. That's helpful. Thank you.
Marty Macquarrie: Dr. Goldberg Congrats on the new role wanted to ask how much of your time do you anticipate being focused on metastatic CRC versus neo adjuvant CRC versus all the other tumor types that barbell shown at Covidien.
Marty Macquarrie: Yes.
Speaker Change: Well, so I think Bob Pal has demonstrated activity really in virtually every setting it's ben.
Speaker Change: Try this.
Speaker Change: The main reason to focus on colorectal cancer is that theres.
Speaker Change: Such a strong need expressed by patients.
Speaker Change: And physicians to have an eye on invention that realize that some of the benefits have been enjoyed by MSI high patients and a much larger subset of colorectal cancer patients that our MSR.
Speaker Change: And the data for activity.
Speaker Change: Alright.
Speaker Change: Approved drugs.
Speaker Change: Late line metastatic colorectal cancer.
Speaker Change: Is quite modest.
Speaker Change: And while very oncology community has embraced those drugs.
Speaker Change: The patient community is disappointed by what they had Brian Alright, and then just looking for something better.
Speaker Change: So we believe that the comparator in the.
Speaker Change: The setting of <unk>.
Speaker Change: <unk> third and fourth line disease.
Speaker Change: Our favorable.
Speaker Change: Comparator arms to the activity going to Jonas was observed.
Speaker Change: Early trials.
Speaker Change: Now from my perspective.
Speaker Change: The most potential is probably on the neo adjuvant setting.
Good.
Speaker Change: The groundbreaking study by Andrea <unk> and her colleagues are Sloan Kettering in MSI high tumors, where patients avoid chemotherapy radiation and surgery.
Alright.
Speaker Change: Really are startling.
Speaker Change: And our.
Speaker Change: Alright benefits patients in ways that we couldnt have imagined.
Speaker Change: Even five years ago.
Speaker Change: We believe that that is translatable to rectal cancer patients with MSS tumors using this intervention.
Speaker Change: And two colon cancer patients tumors above the rectum, alright, where potentially we could come up with a surgery free world for managing stage three colon cancer.
Richard Goldberg: Thank you Richard.
Speaker Change: That's great. Thank you and one last one if I if I may could you talk about your strategy of sharing the phase II data with the street, whether that would be in conjunction with the FDA meeting or or after.
Richard Goldberg: Sure.
Richard Goldberg: Think thats doable and I just wanted to draw your attention to the new adjuvant protocol that was presented at ACR, whereby Miriam Chalabi presented data on.
Richard Goldberg: Patients with a fantastically acceptable safety profile.
Richard Goldberg: There were no real show scarp pricing the safety of the drug.
Richard Goldberg: Of course this is in the earlier disease setting with lower doses.
Richard Goldberg: $25 million 50, but nonetheless, there were no real safety signals of any sort, including colitis too to really worry about.
Richard Goldberg: So we believe that depending on the disease setting as Richard said Neo adjuvant offers the largest potential.
Richard Goldberg: And earlier, the better intervention philosophy of course.
Richard Goldberg: Particularly with immuno therapy.
Richard Goldberg: And in that setting we think we're going to be based on all of the studies that have taken place we're going to be dealing with a safety profile that will be very very acceptable to patients.
Richard Goldberg: Okay.
Speaker Change: Great. Thanks for taking my questions.
Richard Goldberg: Yeah.
Richard Goldberg: And there are no further questions at this time I will now turn the call back over to Garo Armen for closing remarks.
Richard Goldberg: Thank you very much everyone. We are very grateful for your attention and for your persistence with what.
Richard Goldberg: What we're doing for the benefit of patients and stakeholders as I mentioned.
Richard Goldberg: We're also very grateful to our extended team Dr.
Richard Goldberg: Dr. Richard Goldberg adds a deeper level of expertise and a disease that is the focus of our attention right now.
Richard Goldberg: And this particular disease is becoming a major problem in the young.
Richard Goldberg: And the kinds of morbidity.
Richard Goldberg: Generated by existing treatments.
Richard Goldberg: Chemotherapy radiation.
Richard Goldberg: And surgery.
Richard Goldberg: Be eliminated potentially eliminated and this is a very important.
Richard Goldberg: Issue because.
Richard Goldberg: As I said before both with the young and the old of course these are important.
Richard Goldberg: With somebody having to live with these morbidities for the rest of their lives, we're getting patients as young as eight years old with metastatic colon cancer.
Richard Goldberg: Is something remarkable.
Richard Goldberg: And so for young person to live with these difficulties for the rest of their lives because it vigorously.
Richard Goldberg: Very grateful for all of your attention.
Richard Goldberg: And we've been on a path to do what is in the best interest of these patients and as I said with our stakeholders and we very much appreciate your support thank you.
Richard Goldberg: This concludes today's conference call. Thank you for your participation you may now disconnect.
Richard Goldberg: Please wait the conference will begin shortly.
Richard Goldberg: [music].
Richard Goldberg: Okay.
Richard Goldberg: Yes.
Richard Goldberg: [music].
Richard Goldberg: Yes.
Richard Goldberg: Yes.
Richard Goldberg: Yes.
Richard Goldberg: [music].