Q1 2023 Agenus Inc Earnings Call
Good day and welcome to the agenda first quarter 2023 financial results conference call.
All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you would like to ask a question. During this time simply press star followed by the number one on your telephone keypad.
Would like to withdraw your question. Please press star one again for operator assistance throughout the call. Please press star Zero and finally, I would like to advise all participants that this call is being recorded I'd now like to welcome Mr. Zack Armen to begin the conference Zac over to you.
Thank you operator, and thank you all for joining US today today's call is being webcast and will be available on our website.
I would 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 timelines for data release and partnership opportunities.
These statements are subject to risks and uncertainties and we refer you to our SEC filings 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 <unk>, Vice President of Finance.
Now I'd like to turn the call over to Garo to highlight our progress and speak to our outlook for the remainder of the year.
Zero.
Good morning, everyone and thank you for joining us for our first quarter 2023 up eight.
They will primarily focus on the significant progress we've made with our groundbreaking.
Right.
And its potential to transform cancer treatments.
Nine different solid tumor types that we've reported so far.
Over the past 10 months.
We presented data at the primary or late breaking session.
Major contracts.
Including <unk>.
Okay.
Absolutely.
S Gilles and C class.
We look forward to sharing further insights.
In conferences. Thank you.
At <unk> in June .
As more Gi in July .
Well so Matt.
Our innovative and multi functional CLA or anybody aimed to revolutionize cancer treatment by extending clinical benefit.
Cold tumors, which.
Historically been unresponsive to the standard of care and other immunotherapy agents, including other <unk> four antibody.
And impressively well filling that has demonstrated clinical responses in both cold and hot tumors.
In a diverse patient population of nearly 400 individuals across nine solid tumor types.
Sure.
And exhausted prior treatment options.
And that has made significant strides in Elisa <unk> responses.
Offering renewed hall for those who have failed all other available treatments.
Let's take a closer look at response rates achieved with both hands.
Of course, all not in solid tumors, we have observed remarkable response rates of up to 50% in highly refractory cancers.
This is truly an impressive accomplishment considering the patient population and Bob.
Many of these responses have proven to be durable responses.
This is a critical factor in evaluating a treatment for essential tremor.
<unk> four <unk>.
Slides in a meaningful way.
Yeah.
But the story doesn't end there.
Preliminary data suggests that potential and that may be exceptionally effective in colorectal cancer patients with tumors that have historically been unresponsive.
Jackie.
Even in hot tumors that have failed standard of care, including immunotherapy scores with or without chemotherapy. We are witnessing unprecedented response.
Similarly, deep responses are being observed in melanoma patients, who failed PD, one therapies as well as in Eagle.
Or is that patients who have exhausted all available therapies.
So and that holds the potential to be a game changer.
Moreover, early clinical data indicates that importantly responses may be achievable.
In the neo adjuvant setting.
Certainly introducing an entirely new treatment approach and enhancing patient outcomes.
The clinical data generated map it is truly inspiring.
And we're thrilled with the progress we've made thus far.
We firmly believe that potential and that has the potential to reshape how we approach treating solid tumors.
And we eagerly look forward to further advance this crucial program.
With our more advanced programs.
As far as on a rate on the regulatory front, we're also making significant strides our phase II activate studies in colorectal melanoma and pancreatic cancers are set to conclude enrollment in 2023.
And we are expediting enrollment April a refractory non small cell lung cancer cohort.
Where we have previously reported 50% response rate in patients who have failed prior PD, one and chemotherapy.
We plan to launch a randomized phase III study if you observed response rates persist in the expanded cohort.
In non small cell lung cancer.
Yes.
We're also proud to announce the fact that but Val combination has generated over has been granted fast track designation by the FDA for treating non MSI high colorectal patients without active liver metastases.
This acknowledgement of our potential to fulfill a significant unmet medical need could accelerate the development and review of our application for approval.
In conclusion.
Our unwavering commitment to advancing our clinical pipeline and delivering innovative treatments for cancer patients remains stronger than ever.
We are enthusiastic about the potential progress in its potential to profoundly impact the lives of patients with solid tumors.
I will now hand, it over to Dr. Steven O'day, who will provide further details on the latest data and then I will be coming back with my concluding remarks after that Steven.
Thank you Garo.
Together with our investigators we presented updates from the bar Bell development.
Program at two major medical meetings last quarter.
Including a late breaking oral session at the American Society of clinical oncology gastrointestinal cancers Symposium in January in San Francisco, and an oral plenary session at the society of Gynecologic oncology annual meeting.
In Tampa in March.
I will now briefly describe these data updates beginning with colorectal cancer.
As Garo said metastatic non MFS high colorectal cancer patients treated with standard of care have a reported 12 month survival rate of only 25%.
And in overall reported response rates to third line treatments up 1% to 2%.
Immunotherapy treatments combinations PD, one and <unk> four.
Similarly reported poor response rates of only one 5% and comparable populations.
Dr. Anthony alcohol hurry associate director for clinical research at the USC Norris comprehensive cancer Center.
And the Keck school of Medicine at USC presented our latest update a boat in silliman programming colorectal cancer at <unk> Gi.
The cohort of 70 Evaluable patients had a median of four prior lines of therapy and a third of the patients had already failed immunotherapy.
Patients who received the combination showed a 12 month overall survival rate of 63% more than twice the reported rate of 25% for standard of care.
In the subgroup without active liver Mets.
<unk> 12 month overall survival was 81%.
This is the targeted population for our phase two study, where we recently received fast track designation from the FDA.
Even in patients with active liver metastasis. The 12 months overall survival was 40%, indicating a survival advantage over standard of care for all patients regardless of the presence of liver metastasis.
The overall response rate for the 70 patients was 23%.
With 69% of the objective responses ongoing at the time of the data cuts.
The disease control rate, which is inclusive of complete responses partial responses and stable disease was 76%.
We will share updated data from this cohort at an oral presentation at ESMO Gi conference.
On June 30.
In Barcelona, Spain.
Next moving on to ovarian cancer. The reported response rates for standard of care in recurrent platinum resistant refractory ovarian cancer with chemotherapy is only approximately 10%.
PD, one and seasonally for combinations have reported response rates of 3% to 10% and comparable patient populations.
Dr Bruno Bob Carney Assistant Professor Harvard Medical School.
<unk> the update of the boat and filling that program in ovarian cancer at <unk> annual meeting in Tampa in March.
24, Evaluable patients were presented who had a median of four prior lines of therapy.
And 21% had already failed immunotherapy.
The majority of patients almost 80% where high grade serous histology, which is the most common and most aggressive form of advanced ovarian cancer.
The overall response rate was 33% in this poor risk group and the disease control rate was 67%.
Responses were durable like colorectal cancer with median duration of response not reached.
This cohort to continues to expand and enroll in our phase <unk> study.
While our primary focus remains advancing the clinical development of Barton bow as we continue to progress. Our focused we also continued to progress our focus number of additional programs in combinations to further expand the therapeutic potential of boat and <unk>.
Unlock the full potential of our portfolio.
Several of these programs have been selected for presentations at the upcoming Astro Conference in June in Chicago.
A gen 2373 is our CD 137 agonist designed to stimulate the activation of both cytotoxic T cells and NK cells, while mitigating the liver toxicities.
Common to the first generation target class complete results from the first in human dose escalation study of AGN. Two three 703 monotherapy in patients with advanced solid tumors will be presented during an ESCO poster discussion session on.
Saturday June 3rd.
We expect to complete enrollment of the phase <unk> study of <unk> to $3 73 in combination with Bolton filling mab in PD, one relapsed refractory melanoma in the first half of 2023.
Dr. <unk> will key director of the sarcoma medical oncology at the University of Colorado School of Medicine, we will deliver an oral presentation.
On a single arm open label Phase two study of <unk>.
Now still a mab with zeller for Allomap, our first generation <unk> four antibody <unk>.
<unk> doxorubicin in patients with advanced Sarcomas at <unk> on Monday June 5th.
Finally insight will be presenting three poster presentations of our clinical partnered programs during the Astro conference.
Now I'll turn the call over to Christine for the financial update.
Thank you David.
We ended our first quarter 2023, with a cash cash equivalents and short term investment balance $189 2 million.
This compares to $193 4 million.
131 2020.
This quarter, and we have great $13 6 million.
Sales under our.
Okay.
Great.
For the first quarter ended March 31, 2020, we recognized revenue of $28 9 million.
And incurred a net loss of $78 9 million, which included noncash expenses of $24.
Got it.
And answer the call.
Thank you, Bob Stephenson and Christine.
In conclusion.
We're very very excited about the progress that we've made in our clinical programs as demonstrated by the age that Stephen and I shared with you earlier.
<unk> combination therapy has shown remarkable potential in improving response rates, which indicate deeper benefits for patients.
At the <unk> GI conference, we reported that this benefit has translated into improved survival in metastatic colorectal patients and.
We are very encourage that.
We will also translate to improved survival in many in all of their cancer.
In fact, we have studied so far.
Our continued innovation and progress highlights our unwavering commitment to advancing cancer care.
As Stephen reported earlier. This progress also includes our ongoing exploration of our diverse portfolio, including a very exciting molecule our anti CD 137 molecule.
<unk> is an agonist antibody.
Iot too on the other hand is valid clinical combinations and of course, the combination of our checkpoint antibodies.
Our Gen 8-K T cell pathways.
In a moment about MC.
<unk> latest update at the ACR conference reported clinical responses in solid tumor cancers with our lead candidate <unk>.
Seven nine set.
And off the shelf and cadence outback.
These data underscore the launch of a clinical trial in metastatic gastric cancer.
Led by Dr. <unk> <unk>.
Who is the chief of GI cancer at Memorial Sloan Kettering.
And this is externally funded by non dilutive grant financing.
Maine will simplify the trial with it in house manufacturing capability, which today can produce 5000 doses per year.
With rapidly expanding capacity.
To enable access to these exciting portfolio with issue that dividend makes shares collateral Janus shareholders in order for them to have the opportunity to participate in the oxy.
Upside of meat directly.
And we recognize our first quarter achievements.
Grateful for the incredible support and momentum, we've built with clinical experts and patients.
Our determination to bringing innovative treatments for cancer patients remains and.
And we eagerly anticipate pushing the boundaries of what's possible in cancer care.
We are actively exploring discussions with potential partners and collaborators to maximize the potential of bookings for the map and the rest of our pipeline.
Our focus is not only on managing these assets prudently and also on building our internal capabilities.
In conclusion as.
Then organization, we're deeply committed to revolutionizing cancer treatment by making access to high quality medicines.
Our very top priority.
We aim to create a simple progressive bottle.
<unk> patients receive the best possible treatments available today.
Drawing inspiration from value based care.
Patient centric care.
Integrated care systems.
We focus on delivering efficient.
Personalized and top notch care for every one who can benefit from it.
Together, we strive to transform the cancer treatment landscape by putting patients first and making state of the art medicines accessible to all.
<unk> EBIT.
You will be hearing more about the strategy and how our initiatives will integrate into these strategies and are coming communications.
With that wed like for now I'll turn the call for any questions. You may have and thank you everybody for joining us today once again.
Anna.
Thank you speakers at this time I would like to remind everyone that in order to ask a question. Please press Star then the number one on your telephone keypad, we'll pause for just a moment to compile the Q&A roster.
Your first question comes from the line of Emily Wagner.
Emily Please go ahead.
Hi, good morning, and thanks for taking the question maybe.
Maybe could you expand a bit more on what we should be expecting you to prevent an ESCO for Gen 373, and how you kind of think about what would be positive data amongst others.
Hello therapy.
And then maybe can you just discuss if there's any.
The other phase two or phase III studies.
You could initiate this year, besides lung and colorectal cancer studies.
So let me make a couple of broad comments, and then I'll turn it over to Steven.
Emily 'twenty.
$23 73 is a very important product very important product makers.
And some very complementary.
Attributes to patient care and patient treatment for example.
And so our map.
We're activating T cells.
Ireland, we're also generating memory and depleting.
Regulatory T cells.
But activating T cells better than the first generation.
<unk>.
What what.
23 73.
Eric.
It's really concentrated on the memory component.
Austin, which becomes critically important.
The ability of immune response and durability of patient benefit.
So.
One bucket and I think that they can expand on it.
Secondly, you asked about other phase II trials that we havent really publicly announced any of our plans with regard to additional phase II trials.
Data from other programs are just as we do very properly until for example, when we get the abstract.
Except at major conferences, we want Coca.
Hey, jeopardizes salaries.
Acceptability of an abstract.
So that's what we do but what's very encouraging to us is that remember as we said during our call today.
Since late June last year.
We have presented data or.
Binary opening sessions.
So many major contracts, which is really unprecedented.
For a single product, okay. So very encouraged but stay tuned for the rest of it Stephen would you like to add any comments about 2373 another plant.
Yes. Thank you for the question.
So our CD 137, we're incredibly excited about and as you said, we will be updating the phase one monotherapy trial at <unk> in a poster discussion session.
In the coming weeks.
The iron World has been focused on inhibitory.
Checkpoints, obviously for good reason for a long time with with <unk> four PD, one and the other the agonists have struggled mightily with toxicity issues, particularly around liver toxicity with first generation and there was great promise that by pushing the accelerator. In addition, the blocking the break of.
The T cell more extraordinary things could happen. So we've designed a nextgen CD 137 that.
Really will hopefully be.
Important combination partner in our Arsenal and obviously for patients. So what we're looking for just from my perspective is obviously, we want to see safety with this new drug design, and obviously single agent activity would be great and.
And it is very important I think in in any Io asset and we will be updating our data in a few weeks so stay tuned.
Great. Thank you very much.
Our next question comes from the line of Mike King.
Jeff Hutton. Please go ahead.
Hi, guys. Good morning, Thanks for taking the question congrats on the progress just real quick two things Garo you had said.
You made a comment about.
Your.
Inclination.
Move forward with a randomized trial in non small cell lung cancer based on the results of the <unk>.
Studying but I didnt catch quite what you had said if you had said some kind of a bar for.
Response rates or some other criteria that would motivate you to move into a randomized trial in non small cell.
Sure.
Good question, Mike. Thank you.
So as you know lung cancer.
Top cancer relatively high cancer.
So while both excellent map has shown profound activity in cold tumors bipolar rates.
Warm tumors.
Also target.
And lastly in lung cancer with.
We've shown that in.
PD one resistant.
As well as PD, one plus chemo unresponsive or resistant tumors.
We're showing with a small denominator admittedly, but we're showing about 50% response rates.
<unk>.
Barry.
Major.
Improvements for the patient.
Now as I said the denominators.
And so what we're doing is really expanding the cohort of lung cancer patients in a relatively short period of time, we can nominate up to 40 50 patients and of course, if we can maintain the kind of response rates you had seen in about 10 basis.
840, <unk> you will see a.
Huge levels.
Game changer interest now.
Now with the early data.
A a few outside groups have shown significant interest and Duane randomized trials.
With potential and that it will be multiple arm trials with standard of care in the earlier stage setting.
So stay tuned we have not yet announced the specific plans, but these plans are well underway for a randomized phase III trial.
Until now.
Plus.
A current standard of care versus.
The.
Versus the other arms that we haven't disclosed yet.
Right.
That trial should be initiated sometime this year.
Sometime this year, Okay Super.
So we have got a ton of questions, but I guess.
On <unk> I am sorry the.
<unk> Gi.
I think the last time you.
So data.
At <unk> Gi.
Colorectal was 70 patients.
And you had the one year response at 63% are we going to get those updated as the end going to change it maybe qualitatively.
Can you tell us what.
The data is going to look like what the complexion will be.
At the ESMO Gi.
I'll turn this to Steven.
Thanks again for the question, yes. So we did report 70 patients at ESMO Gi and obviously that trial was continuing to enroll at the time. It has since completed enrollment as we've launched our phase two.
Pivotal trial.
So you can expect more patients and longer follow up with the next update at ESMO Gi.
Okay great.
Alright, Thanks, I'll jump back in queue.
Our next question comes from the line of my Mom tiny of B Riley. Please go ahead.
Good morning team, thanks for taking our questions and congrats on the progress.
A couple of quick follow ups to questions being asked before and then I have a couple more so it was curious.
That designation.
In line with how the.
CIC data is maturing could you comment.
Specific <unk> that this updated data.
Submitted as part of the question.
Fast track than any.
Any other.
Mechanisms like they compared the other.
Others that are being explored.
You get close to getting randomized control data from the phase II study.
Okay.
I am I am.
<unk> wise not to elaborate.
Question.
Because of the sensitivity.
Many levels.
Suffice it to say that.
We obviously keep gain.
Not just the FDA and other agencies.
Developments.
<unk>.
And several of the other indications as well.
Now one thing that is sure.
To be stretched over and over again.
To be stretched over and over again.
When we treat patients.
Which are metrics metastatic patients for example in CRC.
By ultra either indications.
These patients are typically third fourth fifth line.
Yes.
Treated pretty much everything that's available.
And.
Either haven't responded.
Sure.
After they have responded to these other treatments. So these are pretty sick patients and the kinds of responses that we're seeing which are in the neighborhood of 20% to 50% depending on it.
Vacation.
It is really something very meaningful and of course from a regulatory perspective.
They say well responses not enough, but please explain that to the patient.
Responses are not a good thing so.
We are diligently pursuing of course the next days.
Prices are very important criteria for patient exhausted all options people into the kind of durable responses, we're seeing of the magnitude that I just talked about.
Very meaningful but we're also diligently pursuing that these responses will translate to longer term benefit patients and of course, the data that we showed at ESMO Gi.
With survival curves indicates and of course mind you. This is not a randomized trial.
The differentiation in this patient population in terms of overall survival is such that.
We are confident.
Classes are cooperative translate to longer term benefit including survival.
And I may add that with CLA fours.
Typically.
You do see response rates.
Correlate very well.
The same is that necessarily true.
Other io treatments or other cancer treatments with CLA <unk> targeting agents.
Generally and therefore, they can elaborate on this.
It would be impossible to think about a trial, where response rates will not translate to survival. Stephen would you like to bring in your experience with that.
Sure Joe.
Obviously, yes, I would agree <unk> four as a target because of the durability of responses and the fact that resist one one under estimates clinical benefit because minor responses and stable disease can be.
Significantly durable has correlated well with overall survival I'm, just I would redirect people to the.
Initially it would be <unk> study in melanoma of course, only had a 10% 15% sort of classic resist one one response and yet the survival curves showed a hazard ratio of <unk>, 67%. So about one in three melanoma patients, we're having significant clinical benefit which is double what the response rate was and it mimics.
The plateau of the survival curve at 20% to 25%. So I think in general Cta for base therapies, whether alone or in combination with PD ones have.
Correlated well with with survival.
Based on our duration of response across both <unk> and <unk> are very hopeful it will continue to do that as we look at survival curves in our different solid tumor.
Clinical trials.
They helpful. Thank you.
On the non small cell lung cancer cohort.
The thing to hear your thinking no further randomized phase III.
Can you talk to what Sam boot side, you need to see here.
<unk> confirmed its 50% response rate.
Overtime, and you get a lot of questions about <unk>.
<unk> done.
Responses. So could you just guided glad there was one and then from when you last reported has that been confirmed liberty. Thanks, Ken.
Right. So I'll, just give you a little bit over at hand.
As factual as you know <unk> accelerated the only approved therapy for patients in non small cell lung cancer, who had failed chemo and PD one.
And so this is a low bar with 9% response rate right now so the early indications of responses, we're seeing are far in excess.
On the risk here is a REIT preferentially putting patients that are best prognosis and the answer is category b to that question.
So the 50% response rate.
Continued in a larger denominator will demonstrate a very significant benefit for patients who have.
Failed.
<unk> plus PD, one and who are otherwise go to be treated with paclitaxel, which as I say shows that very low borrowing 9% responses, so far and those not percent responses.
Not.
We show a major benefit for patients.
That's the that's the bottom line.
We haven't released all the details.
No.
We are seeing responses in <unk> patients.
Low T&D.
<unk> low PDL, one expression, which.
Gives you a sense of.
What mechanism Okay excellent map is in terms of.
Lighting up tumors, making treatments higher so if you can take the <unk> patients and treat them with what they saw in that to make them higher which we seem to be doing in our trial and youre dealing with.
Patients that typically don't respond to PD one with.
PD Lone exceptions, those are two very important indicators as to the status of the patients being a.
Very correct poor prognosis patients. So we're very encouraged with this outcome.
And clearly outside groups that we're working with would be at least.
Partially or entirely sponsoring the.
The trial.
Our also.
Thats why we are preceding industry exit.
Did you say, what denominator you might be targeting.
And then just my final.
Sorry go ahead.
We haven't disclosed those numbers yet.
I think we're in the process, so going back and forth and trying to finalize the details.
<unk> sure, it's not going to be a thousand patients.
Thank you and my final question on the.
The <unk> combination study that is approaching enrollment completion in melanoma.
The lender factory.
Could you comment on what appropriate benchmark DARCO date.
This is <unk>.
And.
And what might you be looking to delivered in FY <unk>.
The timeline for that data is.
With input Glenn in 'twenty, three or is it just the enrollment completion you said.
So the accrual to the cohort will we expect to complete in the first half of the year, we won't have data until later in the year at the earliest but in terms of that cohort. Obviously these are very extensively treated melanoma patients that are refractory to Io and BRAF if theyre mute.
So obviously any responses in this group would be up note and we look forward to.
Observing this data as it evolves so heavily pre treated melanoma patients that.
Have had.
The vast majority of had <unk> four and PD, one and BRAF mutant have already exhausted BRAF mutant therapy.
Okay. That's very helpful. Thanks for taking our question.
Okay.
Our next question comes from the line of Matthew Phipps from.
William Blair. Please go ahead.
Thanks for taking my question.
The phase two in CRC has done a good job of.
Certainly contribution to components through different arms.
I'm wondering as you move into more indications such as if you launch the phase III in non small cell lung cancer would you have to show contribution of components in those additional arms with.
Will that monotherapy arm.
So the answer is no we do not have to assure that all over again.
The indication.
Yeah.
Great. Thanks, Gail can you remind us on the timing of any gilead up and decision that completion of this phase one or does it also include the next study in combo with.
Melanoma.
Okay. So I think it's.
Reasons for the couple of things here.
One is.
Our interest.
And gilead interest convert each year and we don't know the answer to that question from their perspective.
Five we retired $23 73.
Okay.
We also believe that.
We need to have freedom to operate with $23 73 for the best interest of jazz portfolio.
It will be a question of negotiation.
Stay tuned.
Towards the end of the year.
The more clarity as to how and if this option will proceed.
Great. Thanks.
Last one I know, we're going to get the volatile.
Sarcoma data at <unk> is there any steps forward for that combination I know the focus is readily switch and switch to fulfill that.
Hi, Matt.
Obviously, our focus is on the next generation seasonally for having said that we think we have.
An excellent first generations utility for that spend in combination.
In cervical and now this will be the first real data in sarcoma. So again.
Yes.
Watch the data as it gets presented and obviously, we will make decisions.
But we certainly won't distract from our primary focus which is boat and sell them up and getting to market.
Yes that makes sense. Thanks Victor.
Okay.
There are no further questions at this time I'll turn the call back over to you.
Mr Garo Armen for closing remarks.
Thank you very much everybody. Thanks again for joining us today.
Clearly there is a lot going on and we are very eager to communicate things to all of our constituencies which include.
Certainly our shareholders, but also very importantly, investigators kols, who are major stakeholders in this because of their interest.
With their patients to either participate in these two.
Trials and or to have these products available to them.
With the allowances that are there prior to approval and certainly post approval as well. So we're very very grateful to all of your support.
The biotech markets have been challenging in the last year or so.
We are proceeding in a way that really supersedes any of these challenges because while we've got a portfolio.
Something very important for the benefit of these patients and certainly patients that have exhausted all options, but even patients.
That are in the earlier stages of disease and can benefit from our compounds in ways that will provide them with enough.
Which is typically not being addressed properly or effectively with current treatments. So thank you again and stay tuned we'll see you at these upcoming conferences as well as in our mix.
Earnings call.
Our conference call. Thank you.
Yes.
This concludes today's conference call you may now disconnect.
Okay.
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