Q4 2023 Agenus Inc Earnings Call and Corporate Update
Participants
Zack Armen; IR; Agenus Inc.
Garo Armen; Chairman & CEO; Agenus Inc.
Steven O'Day; Chief Medical Officer; Agenus Inc.
Christine Klaskin; VP, Finance; Agenus Inc.
Todd Yancey; Senior Strategic Advisor; Agenus Inc.
Emily Bodnar; Analyst; H.C. Wainwright & Co., LLC
Mayank Mamtani; Analyst; B. Riley Securities
Presentation
Operator
Good morning. My name is Audra, and I will be your conference operator today. At this time, I would like to welcome everyone to the Agenus Inc., fourth-quarter and full-year 2023 results conference call. Today's conference is being recorded. (Operator Instructions) At this time I would like to turn the conference over to Zach Armen, Head of Investor Relations. Please go ahead.
Zack Armen
Thank you, Audra, and thank you all for joining us today.
Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory and commercial plans and timelines, as well as time lines for data release and partnership opportunities among other updates. These statements are subject to risks and uncertainties. I refer you to our SEC filings available on our website for more details on these risks.
Joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer, Dr. Steven O'Day, Chief Medical Officer, and Christine class, Ken Vice President of Finance, Dr. Robin Taylor, Chief Commercial Officer, and Dr. Todd Yancey senior strategic adviser will be participating in the Q&A session.
Now I'd like to turn the call over to Carol to highlight our progress in 2023 and to speak To our outlook for 2020 for Ferro.
Garo Armen
Thank you very much. Ladies and gentlemen, today is with great enthusiasm that we gathered to share. The remarkable strides Agennix has made over the past year, our journey has been marked by significant achievements, pivotal milestones and a steadfast commitment to innovation in the field of oncology. In 2023, agenda has three crucial milestones, particularly with our MacMall program and cornerstone of our operational focus.
But valve therapy has undergone rigorous testing in over 900 patients, demonstrating promising activity in cancers that represent significant unmet medical needs, notably colon cancer, where we are poised for potential first approval, impressive response rates, sustained durability and overall clinical efficacy observed across multiple challenging cancer types have garnered attention and excitement from leading experts in the field. It is essential to note that the patients enrolled in our trials have exhausted available standard treatments, making clinical responses achieved all of them are meaningful.
Our achievements in the past year underscore the Indian potential immense potential of potential I-Mab, both as a stand-alone therapy and in combination with balstilimab and all chemotherapy. All of these trials are currently ongoing. The presentation of our data in six prestigious scientific forums and publication in five peer-reviewed journals is a testament to the robustness and significance of our findings Dr. O'Day will delve into the clinical data shortly, providing more detailed insights during this call. The resounding feedback from over 1,000 physicians we engaged with over the past year underscores the transformative impact of our work and the impact it could have on patient care.
Furthermore, the fast-track designation granted by the FDA acknowledges the urgent need for new treatments in our lead indications, which is refractory MSS CRC in London, not liver metastatic disease. As we spend on the threshold of a clinical and a critical phase in our regulatory journey, our focus is squarely on advancing activities for a potential accelerated approval.
And finally, our immediate efforts are directed towards ensuring that our development strategies align seamlessly with the FDA's rigorous standards in 2024. Our primary objective is to pursue a global regulatory strategy to fall back now in our Fast Track indication. Following alignment with the FDA, we intend to initiate the submission of our Biologics License Application, otherwise known as a BLA for potential accelerated approval. Subsequently, pending feedback from scientific and regulatory advice in Europe, we plan to submit to the European Medicines Agency known as the EMA in 2025.
To achieve our regulatory objectives, we are intensifying our efforts to provide regulatory authorities with a comprehensive data package that demonstrates the safety efficacy and clinical pharmacology of backbone in refractory MSS CRC. Our Phase 2 study completed in October 2023, or I should say, completed enrollment in 2023 was meticulously designed to evaluate Maxwell's dosage and the contribution of its components. Additionally, by the end of 2024, we anticipate initiating a Phase 3 study in the patient population of our proposed indication. Our commitment to transparency and stakeholder engagement remains unwavering as we progress towards delivering these potentially life altering treatments to patients.
Looking ahead, our vision to enhance the lives of cancer patients to the power of the immune system remains steadfast. That's been our mission from day one, 10 years ago, of course, today with but by leading the charge in our dynamic portfolio of agents to expedite this transformative journey, we are actively exploring strategic partnerships.
Our ongoing collaborations have already yielded significant returns, exemplified, for example, by the recent $25 million milestone payment from BMS triggered by the commencement of a Phase two study with BMS nine eight six four four two. This is a Cajun bispecific antibody discovered and the early development was done by Agensys and it was licensed to BMS. We have received a total of $250 million from this collaboration thus far. Moreover, we are progressing our efforts to monetize noncore assets and explore royalty financing and project funding opportunities with the potential to generate an additional 200 to $200 million in the relatively near term.
Furthermore, we're engaged in discussions with several prospective pharmaceutical partners exploring avenues for co-marketing and co-development agreements specifically for, but now
Dr. O'day will now provide an overview of our latest clinical findings further eliminating the groundbreaking progress we've made so far. Thank you for your continued support and confidence in agendas. Together, we are pioneering a new era in cancer treatment, one that offers hope and healing to patients worldwide that Jody,
Steven O'Day
Thank you. Go together with our investigators and key opinion leaders, we presented updates from Bob Dowdell development program and Asco GI. Society of Gynecologic Oncology as Moto GIC. toss and at a corporate event hosted during the asthma Congress in October throughout 2023, new clinical data was presented for nearly all of our programs, and I refer you to our press release issued today that provides a comprehensive summary of our 2023 clinical development updates.
Today. I'd like to share a selection of our data updates from the last year, which highlight some of the compelling opportunities we have to transform care for patients starting with safety. We continue to observe a manageable safety profile. As of May 2023, data cut from our solid tumor Phase Ib study with doses of one milligram per kilo or two milligrams per kilo of both silver mAb. In combination with balstilimab, the most common adverse events were immune-related. The most common of these were diarrhea and colitis Grade three or greater treatment-related diarrhea. Colitis occurred in 14% of patients. These findings are consistent with the mechanism of action of Bob Bell as both our immuno oncology agents.
Now turning to our CRC development program for Boston now where we have made significant progress as of our latest update during our corporate event, in October 2023, our Phase Ib expanded cohort of 70 evaluable patients had a median follow-up now of 12.3 months and Rhesus confirmed overall response rate of 24% based on literature review, the response rate in a similar population treated with standard of care therapies ranges from 1% to 6%.
In addition, patients in our trial showed a 12 month overall survival rate of 74%. Median overall survival overall survival has not been reached. We anticipate having top line data from the Phase 2 trial publicly available in the second half of 2024 to align with our planned regulatory time line and allow for sufficient data mismatch duration at Asco GI. in January of this year, data was presented from an investigator-sponsored trial being conducted by Dr. Pasi to Pasi will allow Cornell Medical Center in which 12 patients with colorectal cancer were treated with one dose of BOP at 75 milligrams and two doses about still I-Mab at 240 milligram in a neoadjuvant therapy window of opportunity. Setting surgery was performed on average four weeks after the initiation of immunotherapy.
All three of three MSI-high colorectal patients had complete or near complete pathologic responses and even more importantly, six out of nine patients with MS stable colorectal cancer had pathologic responses of 50% or greater in two, including two complete pathologic responses none of the 12 patients had tumor growth during the treatment interval and no surgeries were delayed during as delayed due to immune-related toxicities.
There were only two instances of Grade three treatment-related adverse events, diarrhea and fatigue, which were reversible. These results represent an important opportunity to move into earlier non-metastatic lines of therapy and potentially change the treatment paradigm, particularly for early stage MS stable colorectal cancer. This IST. is currently adding an additional 24 patients.
The expansion extends dosing of immunotherapy and the timing of surgery from four to six to eight weeks, which is more reflective of traditional neoadjuvant therapy studies. Depending on the data, we plan to prioritize neoadjuvant development and are evaluating study designs for further pivotal studies and lastly, in second-line pancreatic cancer, we reported data on six patients with the combination of both still I-Mab with two chemotherapy agents, gemcitabine and Abraxane as a triplet therapy, all six patients had progressed following the most aggressive first-line metastatic regimen of full view or not chemotherapy and all six had liver metastases. Both the patients achieved marked and sustained tumor marker reductions.
We reported two of the four patients achieving a partial response at 16 weeks with a confirmed target lesion reductions of 47% and 37%, which was pending confirmation at the time the data was reported to other patients showed stable disease at their first eight week scans were tumor reductions of 20% and 13%, respectively. Our randomized Phase two study is currently enrolling, and we anticipate preliminary data being available in the second half of this year.
These results demonstrate clear activity of both cylinders having cold tumors in both the refractory setting and in early disease, combining both the Zone Lab with either but balstilimab or chemotherapy. And this offers hope for patients and families where current standards provide limited benefit. We remain committed to improving patient outcomes and are grateful for the support of our team trial participants and stakeholders.
Now I'll turn the call over to Christine to discuss financials.
Christine Klaskin
Thank you, Stephen. For the year ended December 31st, 2023, we recognized revenue of $156 million and incurred a net loss of $257 million or $0.69 per share. For the fourth quarter ended December 31st, 2023, we recognized revenue of $84 million and incurred a net loss of $49 million or $0.13 per share. Revenue primarily includes revenue under our collaboration agreements, including milestones achieved and revenue related to noncash royalties earned. We ended the year with $76 million in cash, subsequent to which in January 2024, we received the $25 million milestone payment from BMS triggered by the commencement of a Phase two study with BMS nine eight six four four two.
The agenda has discovered a bispecific antibody. Additionally, we've progressed in monetizing nonstrategic assets and future milestones and royalties from ongoing partnerships. These efforts are expected to yield significant cash proceeds by mid 2024. And accordingly, we anticipate being funded through 2024.
In parallel, we're pursuing potential partnership discussions with five biopharmaceutical parties to further expand our cash resources.
I'll now turn the call back to Guara.
Garo Armen
Thank you, Stephen and Christine. As we look ahead, of course, we're excited about the opportunities that will both cancer patients and agendas in 2020 for our steadfast dedication remains centered on providing cancer patients with enhanced treatment options and mission that not only benefits patients, but also enhances shareholder value and secures the long-term prosperity of our company through continued innovation. Innovation has been critical to our existence and our growth, and it will continue to be this year. A paramount objective for us is to present a compelling data package to the FDA seeking their consent to initiate the filing of our biologics license application.
And again, as pioneering advancements in oncology has been more than a mission for us. It's been our enduring commitment for many years. We extend our heartfelt gratitude to our shareholders, partners and the entire Genesis team for their unwavering support. Together, we stand at the threshold of a transformative journey, one poised to make a profound impact on the lives of patients worldwide with the ultimate aim of delivering chemotherapy three treatment options.
Thank you very much for your time and attention. And now we invite any questions that you may have or address peak year at this time.
Question and Answer Session
Operator
(Operator Instructions)
Emily Bodnar at H.C. Wainwright.
Emily Bodnar
Aside from ordinary, we can switch if you have a question further funds on the neoadjuvant therapy study, you mentioned that you're extending the treatment period from four weeks to six to eight weeks. And just curious if you could discuss, Paolo, you think the longer treatment period impact efficacy and if there are any metrics that you think could improve?
Garo Armen
It was a great achievement period and also if you are following patients in that study post surgery to eventually look at their surgical outcomes.
Emily Bodnar
And then second question on MSS CRC. Could you just confirm the timing of the BLA submission. And I believe you were previously saying that 2024, so that stops after that, looking more like second half thinking.
So how do you guys have with the last question on the timing of the BLA submission?
Garo Armen
So as we've guided investors before, the very first step for us is to meet with the FDA, which we're planning on doing midyear and again, giving the specific guidance on our BLA submission. So we do not want to jump the gun ahead of that meeting and provide different guidance than what we will get out of that FDA meeting.
So bear with us, I think we're talking about only a few months from now and that we will be able to give you a much more specific guidance on RPOA. Joe, would you like me to give it out annually in terms of neoadjuvant, the very exciting new adjuvant data very exciting. And in fact, when I was talking to one of our long term advisors yesterday, I the first thing I mentioned in the conversation was how how remarkable this neoadjuvant data is because of all the reasons you cited, Emily and better or they will elucidate further.
Emily Bodnar
Thank you.
Go, Emily?
Christine Klaskin
Yes. I mean, given that MS stable, colorectal cancer immune therapy has not previously been effective on the four week window period was what surgeons were comfortable with allowing, which was essentially no delay in the surgery. And these results are remarkable in terms of the percentage of patients with the tumor regressions in four weeks.
So the extension of the study will allow now a proper six to eight week treatment period. And we do anticipate that over that time, we will see further deepening of responses. So we're looking forward to that. The study is looking at surgical outcomes and obviously post surgery relapses. So this will be a comprehensive neoadjuvant study.
Great.
Thanks, John.
Operator
We'll go next to make Mamtani at B. Riley Securities.
Mayank Mamtani
Good morning. Thanks for taking our questions and appreciate the comprehensive update. So maybe just on the Phase two MSS CRC data, I able to comment on what statistically we should be focused on.
And if the slight push out here is relating to you wanting to have the OS data, mature durability data, which I could see, you know, makes sense if you are thinking about Phase three design and maybe if you could also comment on thinking and timing for launching that Phase three? Should we be aware of any planned regulatory meetings discussions around that? And then I have a couple of follow up.
Garo Armen
Yes. So we have as you know, we have, as we said before, we've completed enrollment in October and typically 80% of the patients respond within six months of the first dose. So when we complete enrollment by the time, the patients get the first dose, you're talking about November. And by the time we get the six month readout for 80% of responses it's sometime around May. Now, needless to say, we have already started cleaning up the data and all of the nitty-gritty process so that we can provide all of them outcomes as soon as possible. So it will be in the next few months.
And our first step is to share this data with the FDA because of timing of the data generation and the meeting will very close. And then after the FDA meeting, we plan on making top-line data public appropriately.
Yes, a Phase three design timing of launch. If you could comment on that split Amatil shares?
Steven, would you like to take that piece?
Steven O'Day
Yes. I mean, our plan for the Phase three trial is in the same line of therapy as the Phase two. And we anticipate getting that trial started by the end of the year. So it can be substantially enrolled at a potential producer date in 2025.
Mayank Mamtani
Got it. And then you've been a bit more precise about your biopharma strategic discussions than you've been before. Gary, could you comment on what areas have more or less alignment that could unlock the CoalCo deal structure that it looks like you're prioritizing. And maybe how much does the new Agilent, the CRC opportunity kind of play a role? Because, you know, it obviously expands the market, but it also comes with a commitment of doing a long-term study there.
Garo Armen
I think as I think it's very important to address your question in a way that doesn't violate any confidentiality. So we have, as you know, talked about partnering but Bell and for the last couple of years now, of course, when we started from our discussions with prospective partners, we had a fraction of the data we have today traction of the data and thanks to our enthusiastic physicians, investigators and of course, of patient inquiries, we have had an explosive gross in our clinical trial enrollment.
I mean, if you look at, for example, our Phase two trial enrollment, we enrolled 230 patients in less than five months, which is a record that has surprised many people now with all of that, you would expect, of course, that there's a fair amount of enthusiasm by prospective pharmaceutical companies amid as we've talked about earlier, all of the fascination with and treatments that will result in weight reduction and radio biopharmaceuticals as well as ADCs.
But when I ask a question to two experts I say, do ADCs and biopharmaceuticals cure cancer. The answer is often not known out. Of course, we don't know if we're curing cancer, we don't know that. And the term curing cancer is a very dicey term because how do you demonstrate how do you clinically demonstrate curing cancer? And the only thing that we know for sure is that there's a product called Yervoy that has cured de facto cured, a slice of melanoma patients, but it's been mostly restricted to melanoma. And the fact that all day was one of the pioneers in clinical development all the award.
Now, of course, one of the attributes you via voice is that it binds to CTLA-4 is very important receptor in the activation of the immune system specifically T cells that we also know that are above and some are map Vice CTLA-4, but it does so many other things. So we are hopeful hopeful that eventually potential I-Mab activity will be broader than what you have or as activity has been in melanoma.
And so with that, of course, we're excited about what we're going to be doing with it and that begs the question of a like minded partners that will put in the resources to develop Matuzumab and balstilimab for the times of cancer patients that deserve it deserve it meaning that our aim is that once we get the regulatory buy-in and we go for our first BLA filing, our aim is an explosive expansion for the development of potential I-Mab explosive expansion because as you know, we've said across nine different indications with varying them denominators of 900 patients in total, we're seeing some remarkable activity.
There is no two ways about it, remarkable activity. And that is, of course, the basis for why the right partner that will be selected hopefully in the next several months would be the partner, not just for us, but for the benefit of the patients to develop this product in the way it deserves to be developed. So again, we have, I think, Christine swift and number of active discussions.
There are a number of active discussions right now that are going on. And unfortunately, on one hand, these discussions take a long time, our longest corporate discussion that has resulted in a significant partnership as taken nearly two years. The shortest route was a year. So I'm not suggesting that ship partnership is going to be a year from now, but I just want to give you guidance that these things take time.
Mayank Mamtani
That's very helpful, Gale. And just maybe lastly, then that market will activity just on the pancreatic and this TKI refractory lung cohort data, what sales level could you talk to what patient numbers you're expecting to have made our second half update for pancreatic and maybe lung condition iron that Thanks. Again for taking the question.
If I may ask either Steven or Todd to address this question and to have more specific clarification for the questions, please feel free two to ask so yes, as mine in terms of tankage, we have a randomized Phase two trial and we expect to treat 60 patients total 30 on each arm.
And that trial is actively accruing for further proof of concept.
Todd Yancey
In terms of the lung data, we have expanded the cohort, as we've said, to approximately 50 patients. This data is maturing. We're showing you the preliminary TKI. data in our press release today, you can see in a very refractory TKI. population of seven patients. We had two patients have responses and both of them were complete as that the overall data continues to mature, and we'll have more data in the second half of the year to report.
Mayank Mamtani
Great. Thanks for taking my questions.
Thank you, Mayank.
Operator
Next we'll go to calling Q-Cells Baird.
Hi, good morning. Thanks for taking our questions. Can you comment what are the outstanding items you think you need FDA feedback prior to the MSR GRC filing, it will be the question. What are the alignments with the FDA that will prompt the potential BLA filing?
Garo Armen
Yes. Okay. So Bob, we will first of all on, we made a strategic decision because we were moving, as I said earlier, we were enrolling our clinical trials rapidly, our for example, Phase two trial and go very rapidly. And it was a very important trial for us to go to the agency with because of the dose selection as well as the contribution of the elements. And of course, we had also a small reference arm. Now, of course, mind you this trial. It's not powered statistically to show any differentiation beyond. However, it is designed to address the Project Optimus questions.
And so the question was for us, if we go to the agency and ask them a question in an abstract form, what is this? What is that the answer is likely to be well when you have the data come back to us presented to us and we'll give you an intelligent answer. And so in order to for us to be able to get to that point, we made a strategic decision calling that we would wait until all the data mature to the point where we had a compelling package to present to the FDA.
So that's the reason why we are waiting until the data matures, which will begin and possibly somewhat before the middle of this year. And as you know, procedurally requesting meetings and a rented meeting sort of a discussion with a comprehensive data package takes a little time. So we are planning on asking for the meeting very soon and planning on having the meeting sometime around midyear plus or minus a month.
Great. Thanks. And then just one follow-up on the pancreatic development program. And we'll have data from the Phase two trial midyear, what would the next steps look like in the development path towards approval there for the pancreatic?
Christine Klaskin
Okay. So just to recap the data package that we will go through the FDA with for the CRC indication is approximately 150 patients in our Phase one trial and 22 patients in non-face-to-face.
Now with pancreatic as the next step for us, and I will ask Dr. Steven O'Day to elucidate more. But the next step for us is to look at the randomized data results from the expansion cohort of the existing trial. As you know, we observed some remarkable activity in second line pancreatic cancer patients that were treated with full theory and then relapse and the standard of care for them is gem Abraxane.
Now the standard of care, unfortunately, is not curative, and these patients relapse within a short period of time. And furthermore, the response rates for these patients according to the experts and published information is in the range of 10% to 15%.
So we're talking about reverse arm being 10% to 15% response rates on being very short in duration. Now, of course, the denominator of the data that we presented is small, but the fact that all patients, I've seen a significant drop in their cancer counts and all patients have seen a shrinkage in tumor. Now mind you, not all of them are classified as responses, but patients have seen a shrinkage in their tumor size has given us a high level of confidence that the trial should be expanded and this is what we're doing. So we have enrolled, I believe, run 30 patients in a randomized trial. Now that data is maturing. And as the data matures and we confirmed the results of the smaller denominator of the initial patients, then I think we will have reason to go to the FDA and ask them for the requirements for a potential accelerated approval for this indication.
We have also, as our colleagues may have said before, other indications that are potentially potentially indications that we will go for approval. One is, again, all of these will be subject to extension of our trials to confirm the initial results of a smaller denominator, but the smaller denominator, our results are so compelling that, for example, in lung cancer in EGFR mutant patients, we will investigate. In fact, there's a subset of a specific EGFR mutation that we will expand that cohort to understand and verify the profound reduction in tumor size that we have seen in our earlier trials. So that will be similar to what J&J did for a larger patient population with their bispecific.
And the last report that I show is for a patient population that is bad, a 10th of the size of what we may be pursuing the estimates for their product is in the billions in sales. So there are opportunities that we will pursue that are driven by small trials, very specific patient populations that will yield very high response rates and typically de facto biomarker driven identification of these patient populations as it applies to lung cancer, certain subsets of lung cancer.
And it applies also in a different format for the new Agilent. And in this particular case, what we have seen in our neoadjuvant trial is a have surgery sparing, which when we talk about surgery sparing, we're talking about surgeries that will be debilitating for the patient removal of the rectum. It's a debilitating outcome, particularly in the younger patient population, particularly I mean, it's debilitating, all patients. But if you're in your 20s and 30s. And you have a lower and our colon lower left colon tumor that is closest to the rectum, and that's going to yield a radical surgery that would be horrible. So if we can prevent that with our new Agilent strategy, we believe that's a tremendous opportunity. So we're looking at all of these options and more for us and stay tuned.
That's very helpful. Thank you. One really quick follow-up, if I can. Just on the neoadjuvant, the next new adjuvant setting study, will that allow for the potential to get surgery altogether? Or will all of those patients proceed to surgery?
Garo Armen
Well, okay. So I'll let Dr. O'Day elaborate.
Steven O'Day
I know at least one patient after a complete response, it refused to answer three. Now, of course, that's a tricky situation because of ethical considerations and which we don't have an approved product in that indication yet. And hence, on that recommendation cannot be made by a physician for ethical reasons right now right now.
But if a patient refuses to answer it is their prerogative. So life. So what you are seeing that kind of a potential development. Of course, I want to stress the fact that everything has to be done properly with appropriate regulatory guidance and everything has to be done in an ethical way so that we don't jeopardize the well-being of patients.
Great. Thank you for taking my questions.
Operator
We'll go next to Matthew at William Blair.
You heard Thanks for taking my questions. So just curious when you say data in the second half from the Phase two colorectal study, do you think you'll have PFS data by that point? Seems like given the poor prognosis patients that could be possible.
Garo Armen
So I will defer to our regulatory experts for PFS in these patients relative to or as a catch a short interval. If instead, I think voice is the gold standard. Pfs is much less STEVEN. Todd, do you have any comments on that?
Yes, you have a of platform model, Todd, go ahead and I'll talk at the South, Matt?
Garo Armen
Yes. I mean, oBviously, we'll have response rate duration of response, PFS and preliminary survival in these patients as they mature over the course of the year from there last have fun when they were accrued. So obviously the composite endpoints. But to Gary's point, clearly, response and duration of response is what drives and prolonged stable disease drive the survival curves. So our primary endpoints are obviously response, duration of response and then ultimately the gold standard survival.
Thanks, Steve. And I guess just curious, Gary, why not disclose at least some indication of the top line results, I guess in May, given the six month follow-up at that point and why wait till after you meet with the FDA to at least I guess, say whether or not or endpoint has been met or something like that?
It's strictly regulatory courtesy. I think it would be not appropriate if we're ready to present this data to the FDA and to make that public right before REST APIs.
Okay.
And I assume then you will make disclosures publicly after receiving the minutes from that FDA meeting. So adding them over time, yes.
Okay.
Thank you.
Operator
Next we'll move to Kelly Shi, please.
Good morning. Thanks for taking my question, Tom. So one quick question, sir.
So for the next update I'm giving you, Steve, I patients carry your voices coming very frank, and there's some crackling in July. And if you can speak closer to the microphone have now.
Yes, better and Okay.
Garo Armen
So just one question on the lung cancer update on giving you've shown 50% and overall response data in naïve patients. Wondering what would be the efficacy you need to see on the next update of that program and into the next stage of development? And if so, what will be the going-forward plan for lung cancer? And also just wondering, you know you remind us what what other data disclosure we should expect in 2020 for our ability PMS partner Tech Data is also at this year, US flow just wanted to confirm? Thank you.
Sure.
So a couple of things here on the lung cancer, as you know, we slowed down overall enrollment in the trial. So what we're doing right now, having dissected the data and looked at subsets of patients that have had significant responses. When I say significant response, I'm talking about complete responses, rapid to complete responses at a low dose level that to us is a significant outcome. So we're in the process of now defining how we would proceed, as I said earlier, with those subsets of biomarker identifiable patients and so that's our next step in lung cancer, but that's going to happen very quickly.
And with regard to data for the balance of this year, we have data coming mature data coming from a larger cohort of pancreatic cancer patients in a randomized trial that would be some time of maybe preliminary data will be by midyear, but more mature data by the year end, we'll have more mature data in melanoma. We will provide the sustainability of responses in sarcoma. And of course, you will see substantially more data in colon cancer shortly after regulatory at meetings.
Thank you, super-helpful.
Operator
And there are no further questions at this time. I would like to turn the conference over to Garo Armen for closing remarks.
Garo Armen
Thank you very much, Andre, and thank you very much for your attentiveness. And so fantastic questions actually. And I think we've covered a great deal here, and I just want to make sure that our stakeholders are ensured of our commitment and to make sure that we stayed for which they focus first of all, because we're in a very unique environment where resources are not as abundant as they were in the past.
And so that maybe that's a good thing because it forces companies not just us, but the industry to do things more rationally. So we intend on delivering outcomes with efficiency. We are poised to be able to potentially launch product, both from a CMC perspective as well as from a commercial perspective, we have a terrific team in each category to do this.
In addition to that, we have assembled a very, very competent medical affairs team so that we can drive our processes through education, education of the system patients, regulators as well as physicians that will eventually prescribe our medicines. So we are tending to all these very important components. We are a small, large company in that sense and an old young company in many ways. But take Thank you very much for your attentiveness and we will communicate with you appropriately at the next time.
And this concludes today's conference call. Thank you for your participation. You may now disconnect, ma'am for your judgment, and we will communicate with you.
