Q4 2024 Agenus Inc Earnings Call
We will follow the formal remarks as a reminder, this conference is being recorded I will now turn the call over to you Zach Orman head of Investor Relations.
Thank you Regina.
Speaker Change: Good morning, everyone and welcome to our agenda for this fourth quarter and year end 2024 financial results and corporate update call.
Earlier today, we issued a press release detailing our financial results and key corporate developments.
Speaker Change: A copy of the press release is available on our website at www dot investors to identify our dot com.
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.
Speaker Change: Please refer to our SEC filings for further detail.
Speaker Change: Joining me today are Garo, Armen, chairman and CEO.
Speaker Change: Okay, Chief clinical officer.
Speaker Change: Robin Taylor, Chief Commercial Officer, Christine <unk>, VP finance and principal financial and accounting Officer, now I'll turn the call over to Garo.
Garo: Very good morning, once again and delightful day in Lexington, Massachusetts.
Garo: Thank you very much for joining us.
Garo: First.
Garo: Let me start by saying.
Garo: We are as a company.
Garo: Pleased to report that we deliberately gone our commitment to significantly reduce agenesis operational right.
Garo: By the end of 'twenty 'twenty four.
Garo: We had reduced our annualized burn rates to the level that we had guided everyone and now.
Garo: We are executing on our next page of strategic cost reductions.
Garo: With an annualized burn.
Garo: To approximate 15 million.
Garo: By the middle of this year.
Garo: And we're very much on track.
Garo: For that number.
Garo: Our objective is to direct every available resource towards what truly matters to our stakeholders and patients, particularly.
Garo: To make sure that we are groundbreaking potential.
Garo: While <unk> is realized.
Garo: And patients have access to it.
Garo: As possible.
Garo: <unk> continues to demonstrate.
Garo: Unprecedented clinical activity.
Garo: Recently, we had presented at major oncology forums.
Garo: As a C or immuno oncology.
Garo: What was the first year that ACR organize the immuno oncology division of its annual conference.
Garo: <unk> Gi in January.
Garo: Since <unk>.
Garo: In the fall.
Garo: And small and as more G I.
Garo: And we detailed the most influential.
Garo: Peer reviewed journals.
Garo: Clothing nature medicine.
Garo: Jay Seo Journal clinical oncology and cancer discovery.
Garo: All of these were accomplished in the last 12 months or less.
Garo: We are witnessing transformative clinical outcomes in colorectal cancer and other tumors that.
Garo: That had been historically unresponsive to immunotherapy.
Garo: This is based on the opinion of some of the most prestigious experts in the field.
Garo: In a matter of examples.
Paul: But Paul has demonstrating.
Paul: Durable and I Wanna underlying durable responses.
Paul: And prolonged survival.
Paul: In refractory.
Paul: Microsoft satellite stable colorectal cancer.
Paul: Now this particular cargo colorectal cancer, meaning MSS.
Paul: Is.
Paul: Accounting for these days.
Paul: Over 90% of CRC.
Paul: We're seeing encouraging activity.
Paul: The addition of valves.
Paul: To Fox.
Paul: Which is the standard of care, including bed in.
Paul: In first line MSS CRC.
The early indications of activity.
Paul: But in terms of both efficacy.
Paul: And Tolerability is early signals are very encouraging.
Paul: We have also.
Paul: Either.
Paul: Being complete or near complete pathological responses.
Paul: Very importantly in new adjuvant MSS.
As well as MSI Icrc.
Paul: Even though the trade likes to break these into two categories. We believe based on the results that we have seen.
Paul: Agents.
Paul: Our active in both categories all colorectal cancer.
Paul: This is transformative potential.
To enable.
Paul: Chemo radiation.
Paul: And possibly surgery free options for patients.
Paul: It goes in some cases like rectal cancer.
Paul: Our journey, along with the other standards of care and be debilitating.
Paul: For patients, particularly the fact that Trc and rectal cancer, but not being seen more and more frequently younger patients.
Paul: I'd say these results.
Paul: Based on the opinion of our experts are beyond promising.
Paul: They are potentially revolutionary.
Paul: Also importantly, these outcomes aren't just our internal assessment.
Paul: Leading global oncology centers.
Paul: And experts are independently conducting investigator sponsored trials.
Paul: And in some cases, all we need to do we just.
Paul: Provide products for them and we incur no cost.
Paul: This independent validation by some of the most respected.
Paul: Colleges and oncology centers.
Paul: For our pivotal in securing approval in a breakthrough therapies significantly amplify our confidence in <unk>.
Paul: And its potential for patients.
Paul: Several of these trials.
Paul: Particularly in the Neo adjuvant setting.
Paul: I would expect it to rapidly enroll.
Paul: And potentially organ sparing trials with Blackrock.
Paul: These trials have gotten underway and in fact, we have a new trial.
Paul: <unk> gotten underway this week.
Paul: Inquiries that have come in from patients ahead of the official opening of the trial.
Paul: Additionally.
Paul: We've strategically continuous monitoring and monetizing.
Paul: The potential of our noncore assets.
Paul: Our high value biologics manufacturing facility in Emeryville and Berkeley.
Paul: Our blend in Vaca <unk>.
Paul: To fortify our balance sheet.
Paul: Currently our highest priority projects.
Paul: We're engaged and also late stage partnership discussions the.
Paul: To secure funding for <unk> and my final development and registration.
Paul: With an emphasis on new adjuvant treatment.
Paul: All the early stage.
Paul: Well I shouldn't say early stage intermediate stage colon and rectal cancers.
Paul: Where these are clear opportunities for Blackberry to provide significant benefit to patients.
Paul: With that I'll turn it over to Christine for a quick review of our finances Christine.
Christine: Thank you Garo.
Christine: We ended the year 2024, with a consolidated cash balance of $44 million.
Christine: This compares to a balance of $76 $1 million at December 31, 2023.
Christine: Cash used in operations for the year ended December 31, 2024 with $158 million. This is reduced from $224 million for the prior year.
Christine: For the year ended December 31, 2024, we recognized revenue of $103 $5 million and incurred a net loss of $232 $3 million for $10 59 per share.
Christine: For the fourth quarter ended December 31, 2024, we recognized revenue of $26 $8 million and incurred a net loss of $46 $8 million or $2.04 per share.
Christine: Our revenue primarily consists of the noncash royalty revenue.
Gary: I'll now turn the call back to Gary.
Gary: Thank you Christine.
Gary: In summary.
Gary: While we recognize that our financial position.
Gary: It is not reflective of the high potential on the promise of our product.
Gary: And it's a bit tighter than ideal.
Gary: We are taking decisive actions to continue that and we will continue to take a very decisive actions to bolster our cash position.
Gary: As well as to contain costs.
Gary: Now, we're very heartened by the fact that we've had significant external validation.
Gary: Through numerous selected high quality centers that are doing trials.
Gary: Isps for us.
Gary: And robust clinical activity that we have seen in <unk> <unk>.
Gary: These of course position us to advance our lead programs in 2025 and beyond.
Gary: We remain committed and are strategically aligned to deliver groundbreaking treatments for patients.
Gary: Very important because as each region now.
Gary: Well over a thousand patients.
Gary: Of course.
Gary: Nine different cancers with a heavy concentration of colon cancer.
Gary: And seeing the benefits.
Gary: Sure.
Gary: It's very heartening that we have kept our eye on developing but it is a high priority for us.
Gary: With that I will end my phone and I think we welcome questions that you may have.
Speaker Change: At this time, if you would like to ask a question Press Star then the number one on your telephone keypad, we kindly ask that you. Please limit your questions to one and one follow up our first question will come from the line of Emily Bodnar with H C. Wainwright. Please go ahead.
Emily Bodnar: Hi, Good morning, Thanks for taking my question maybe for the first one if you can kind of help frame the cost reductions for us, particularly where which programs are being impacted the most particularly on the R&D side.
Speaker Change: Especially into mid 2025, I just got it into additional cost cuts.
Speaker Change: Which program looks like the impasse at there and then secondly, if you can kind of walk us through expected catalysts for 2025, and any new updates or regulatory updates that we should be looking out for thank you.
Speaker Change: Okay.
Speaker Change: So the cost reductions really center around head count reductions.
Speaker Change: That are non essential meaning.
Speaker Change: But even our priority being bought.
Speaker Change: Our development and registration.
Speaker Change: We have defined exactly which.
Speaker Change: Experts, we need internally and externally.
Speaker Change: And we have significantly cut.
Speaker Change: Down on the external advisors.
We have limited external advisors, those that will benefit us the most in terms of advancing quite battled a true.
Speaker Change: Oh yeah.
Speaker Change: It's a line of registration.
Speaker Change: And most of the registration work that we're undertaking.
Speaker Change: Flurry because the pool.
Speaker Change: It's already completed.
Speaker Change: Shouldn't there be a window for us and we believe there won't be.
Speaker Change: We will utilize a lot of the work that has been completed.
Speaker Change: To seek potentially registration globally.
Speaker Change: So in terms of our pipeline products, we have not kill them, whereas simply shelved them for the time being and was better than the way that we can reignite them because as you know.
Speaker Change: We got a significant.
Speaker Change: The number of products back from our partners.
Speaker Change: After they have friends in excess of the $800 million collectively.
Speaker Change: Right.
Speaker Change: Not because of any product performance.
Speaker Change: But strictly because of the fact that I O for the time being is that a factor.
Speaker Change: Because we believe our products are implicated in it being a factor in.
Speaker Change: In the pharmaceutical industry things, both hot and cold and right now I O is cold and that doesn't mean that it will remain hold three six months ago.
Speaker Change: So we have put them on hold with any tend to reignite them quickly.
Speaker Change: In terms of a catalyst for 2025 on the regulatory outpace stay tuned.
Speaker Change: Okay.
Speaker Change: Okay, great thinking.
Speaker Change: [laughter].
Speaker Change: Again to ask a question simply press star one on your telephone keypad and our next question comes from the line of my Aikman Tani with B Riley Securities. Please go ahead.
Aikman Tani: Good morning team, thanks for taking our questions and I appreciate the detailed update here maybe.
Aikman Tani: Maybe just a similar question is asked before on the process of monetization of noncore assets.
Aikman Tani: Got it and if you could comment how further along you are and what sort of.
Aikman Tani: Economics, you could derive from that and then I have a follow up.
Aikman Tani: Sure Matt. Thank you for that and if you are if you recall and I'm sure that you report, but in general.
Aikman Tani: The first stage of monetization of our.
Aikman Tani: West Coast assets.
Aikman Tani: <unk> Vacaville.
Aikman Tani: Our Berkeley facility.
Aikman Tani: Came in the form of a mortgage debt.
Aikman Tani: That we obtained back in November.
Aikman Tani: And if you remember.
Aikman Tani: Prior to that.
Aikman Tani: Prior to the elections.
Aikman Tani: Was almost impossible.
Aikman Tani: I stopped paying a mortgage.
Aikman Tani: Impossible.
Aikman Tani: But we got a $20 million mortgage.
Aikman Tani: And a record high of an approximately two weeks.
Aikman Tani: So that was the first stage of monetization.
Aikman Tani: Now in addition to that.
Speaker Change: Those of you who have been to our Emeryville facility.
Speaker Change: No that Emeryville is highly desired state of the art manufacturing facility that is soup to nuts. It starts with cell lines and it finishes with packaging filling finishing in packaging our products now.
Speaker Change: Now given the fact that there has been significant shifts and you.
Speaker Change: U S manufacturing interest.
Speaker Change: We have seen a similar level of interest.
Speaker Change: And we are in discussions.
Speaker Change: <unk> contract discussions with parties.
Speaker Change: Potential consummation of monetization of our west coast manufacturing and real estate asset.
Speaker Change: Okay.
Speaker Change: Thats helpful.
Speaker Change: And then I, usually do share your latest.
Speaker Change: Latest Todd Sun.
Speaker Change: What Registrational program could look like obviously, asking Gi data recently showed.
Speaker Change: A number of different directions, you could go in late line frontline, obviously, new adjuvant.
Speaker Change: Hudson each of those buckets that would.
Speaker Change: It would be helpful for folks to understand.
Speaker Change: The path to market here.
Speaker Change: Yes.
Speaker Change: Sure.
So.
Speaker Change: First off we have a match.
Speaker Change: And enormous amount of data in the late stage setting.
Speaker Change: Theres no ambiguity about our ability to rescue patients.
Speaker Change: Good.
Speaker Change:
Speaker Change: MSS CRC.
Speaker Change: We have exhausted all other options.
Speaker Change: And these patients are now living longer.
Speaker Change: Even though we haven't done a randomized trial in late stage yet.
Speaker Change: There is no ambiguity about the fact that these patients are living much longer.
Speaker Change: Orders of magnitude lower back.
Speaker Change: And patients who have.
Speaker Change: Okay.
Speaker Change: Oh standards of care.
Speaker Change: So we have.
Speaker Change: More than double the response rates in these spaces.
Speaker Change: And we have a.
Speaker Change: And extension.
Speaker Change: Over there.
Speaker Change: A large bank.
Speaker Change: That is based on our current data.
Speaker Change: Essentially doubled.
Speaker Change: What you would see with standards of care and.
Speaker Change: Magnitude of course is of great interest to the experts in this field and pictures in fact, we had patients.
Speaker Change: Our going gum disease screen now pushing.
Speaker Change: Pushing three years, which is almost on pricing.
Speaker Change: Now, that's one area, where with more mature data.
Speaker Change: He will make an effort.
Speaker Change: To get the interest from regulators.
Speaker Change: Around the world.
Speaker Change: Secondly.
Speaker Change: The data from the Neo adjuvant setting.
Speaker Change: He is an unambiguous because when I founded unambiguous.
Speaker Change: It's really black and white.
Speaker Change: These patients are.
Speaker Change: Treated only with my style.
Speaker Change: So no chemo.
Speaker Change: Alrighty Asian.
Speaker Change: And what we're seeing is complete christological responses.
Speaker Change: In more than half.
Speaker Change: Okay.
Speaker Change: And this has been by the way there was some.
Speaker Change: The concern that the data was form a single center.
Speaker Change: Cornell.
Speaker Change: But now the data co.
Speaker Change: Robbery.
Speaker Change: Cornell data.
Speaker Change: Gain 11 centers from Europe.
Speaker Change: And in four times the patients so that's very encouraging.
Speaker Change: Because of the black and white nature of the outcomes in MSS CRC and MSI high.
Speaker Change: We believe that there is a clear path or potential approval.
Speaker Change: Particularly in a setting that will be Oregon Sperry.
Speaker Change: For example, if a patient has MSS rectal cancer.
Speaker Change: There are options are chemo radiation.
And surgery.
Speaker Change: And for these patients rectal surgeries ability.
Speaker Change: And we believe that if we can.
Speaker Change: Sure.
Speaker Change: Products.
Speaker Change: Oregon staring.
Speaker Change: That will be a significant benefit to patients.
Speaker Change: Victor.
Okay.
Speaker Change: Mark. Thank you for the question I would just.
Speaker Change: To elaborate on what Joe said isn't a refractory setting up between our phase one and a phase two trial, we have approximately 350 patients.
Speaker Change: Data is mature and those trials are closed and the data is mature and we look forward to really.
Speaker Change: Watching this durability there were small so treatment free intervals.
Speaker Change: Mature and then obviously interrupt further with regulatory bodies around the state and then I think what <unk> said in the Neo adjuvant setting is really.
Speaker Change: Remarkable in terms of its ability to change paradigms and both BMS stable and obviously the M. S high colorectal setting in rectal cancer.
Speaker Change: Within our sites as a primary first neo adjuvant sort of.
Regulatory approach.
Speaker Change: It's very helpful. Thank you team looking at some of these updates in the coming months.
Speaker Change: And by the way, we have Robert K right here as well who is one of the foremost commercial lending beyond commercial experts in CRC.
Speaker Change: Would you like to add your inputs.
Speaker Change: Yeah.
Speaker Change: Yeah.
Speaker Change: Certainly come to correlate quite happy to buy our goods.
Speaker Change: To hear from you again.
Speaker Change:
Speaker Change: I think the context has been explained certainly in terms of rectal cancer, but I'd also point out that.
Speaker Change: <unk> rectal and colon cancer have a significant opportunity.
Speaker Change: Because we're looking at not only the breakfast cancer potential for chemo sparing sparing radiation.
Speaker Change: And also sparing of <unk> surgery.
Speaker Change: Because if we improve the clinical complete response rate those patients basically will not go into surgery.
Speaker Change: We'll wait and see.
Speaker Change: The evidence that we've seen so far with.
Speaker Change: Early views.
Speaker Change: The therapy typically seasonally for us.
Speaker Change: Sure.
Speaker Change: Translates into a prolonged recurrence free survival.
Speaker Change: And that's a clear benefit.
Speaker Change: So.
Speaker Change: Across all of those matters, we expect we're going to be even brighter.
Speaker Change: Okay.
Speaker Change: Similarly in colon cancer.
Speaker Change: There is that opportunity to be able to improve the.
Speaker Change: First free survival.
Speaker Change: Overall survival in the long run.
Speaker Change: Real question, not being able to reduce the amount of chemotherapy. The patients are receiving particularly on valley plant, which has the potential.
Speaker Change: Permanent.
Speaker Change: Neuropathy in the long run in these patients who have in business.
Speaker Change: <unk> chemotherapy.
Speaker Change: End up with.
Speaker Change: Permanent neuropathy that could be avoided.
Speaker Change: That coupled with the ability to improve on event free survival and overall survival really mix colon cancer, a real significant opportunity as well.
Speaker Change: And finally, just to note that we have.
Speaker Change: Just.
Speaker Change: As Steve has just initiated the memorial Sloan Kettering entering with Andrea surcharge.
Speaker Change: Phase two in rectal cancer.
Speaker Change: They're very excited about efficiency.
Speaker Change: <unk>, which is picking up.
Speaker Change: Very shortly.
Speaker Change: Thank you.
Speaker Change: And that hasn't quite yet.
Speaker Change: And that will conclude our question and answer session I'll hand, the call back over to Garo Armen for any closing remarks.
Speaker Change: Once again, thank you very much for joining us it's always a pleasure to have you and your questions.
Speaker Change: We're very excited about the prospects of our lead programs.
Speaker Change: There is more reason to be excited now with the longevity of data.
Speaker Change: And even six months ago.
Speaker Change: And so we're grateful to our investigators and patients participating in these trials to demonstrate the kind of results that we've come up with so far.
And we look forward to the data are maturing.
Speaker Change: And our trials expanded so thank you very much.
Speaker Change: That will conclude today's conference call. Thank you all for joining you may now disconnect.