Garo Armen; Chairman of the Board, Chief Executive Officer, Co-Founder; Agenus Inc
Emily Bodnar; Analysts; H.C. Wainwright & Co., LLC
Good morning and welcome to Agenus’ third quarter, 2024 conference call and webcast. All participants will be in a listen-only mode until the question-and-answer session. Please note this event is being recorded. If anyone has any objections, you may disconnect at this time. I would now like to turn the conference over to Alexa buffet from corporate communications. Alexa. Please go ahead.
Thank you, operator, 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 timelines for data release and partnership opportunities among other updates. These statements are subject to risks and uncertainties, and we refer you to our FEC filings available on our website for more details on these risks.
Joining me today are Dr Garo Armen, Chairman and Chief Executive Officer; Dr Robin Taylor, Chief Commercial Officer; and Christine Klaskin, Vice President of Finance; Dr Stephen O’Day, Chief Medical Officer will be participating in the question-and-answer session. Now, I’d like to turn the call over to Garry to highlight our progress in the third quarter.
Thank you, Alexa and good morning, everyone and thank you all for joining us today as Agenus, we are driven by the belief that we can redefine what is possible in cancer treatment.
This belief is embodied in the progress we’ve made with.
But Mao is showing unprecedented results in cancers that have resisted all previous therapies as well as in patients with earlier stages of disease, who face morbidities associated with conventional treatment options such as chemotherapy radiation and radical and sometimes debilitating or even mutilating surgeries.
But will represent a paradigm shift in how we approach cancer treatment in the neoadjuvant setting. For example, BWE has demonstrated the potential to address diseases such as MSs colorectal cancer, which do not typically respond to immunotherapy and which account for more than 85% of all colorectal cancers.
The initial data we presented at ESMO GI in 2024 just a few months ago from the Cornell study highlights this potential.
These results in a tumor type, historically resistant to immunotherapy are absolutely groundbreaking ongoing trials in Italy and the Netherlands will further expand on these results and provide insights with data anticipated early next year.
We believe these studies will reinforce the strength and breath of Belt, not just in colorectal cancer but across multiple cancers which generally respond poorly to other treatments.
While the science is advancing the financial challenges we face are significant.
Developing therapies with this level of promise requires significant resources and we’re operating under financial constraints. For example, we ended the quarter with just $44.8 million in cash and subsequently raised another $7 million in change.
These figures underscore the need for decisive action.
Let me give you a glimpse of what we’re doing.
First, we’ve implemented measures that have significantly reduced cash output, ensuring we remain focused on our highest priorities and internalizing as many extensive functions as possible, such as CRO and CD mo services for which we have spent a significant amount of money in the first nine months of this year.
Second, by the way, these were necessary expenditures.
So, but now we are internalizing this as we wind down some of these activities as trials are maturing.
Secondly, for the first time in almost a year, the window is opening up for us to monetize on our positivo estate assets.
Remarkably, this effort has gained momentum with the improved financial environment following the US elections just a week ago.
And the assets that we’re talking about are valued or they are appraised at our backable property at over $45 million. That’s an appraisal about a year ago and our Berkeley facility, which was our first manufacturing facility, which is a phrase that $25 million.
And thirdly and most importantly, we are in advanced discussions on several strategic transactions designed to deliver substantial value and resource.
We see one or more or a combination of these transactions as key to our long-term growth, enabling us to sustain and accelerate our progress. With Black.
These steps reflect our commitment to building a strong foundation for Jets.
One that allows us to deliver on the extraordinary promise of while meeting the needs of our patients.
The progress we’ve made thus far is a testament to the strength of our science and the dedication of our team with that. I’ll now turn it over to Dr Robin Taylor, our Chief Commercial Officer to provide further insights into our business strategy and patient access initiatives. Robin.
Robin Taylor
Thank you, Garo and good morning everyone.
Building on Garo’s remarks, I’d like to provide more detail on the strategic initiatives that are driving our progress.
First, let’s start with the clinical data.
BOT/BAL results are reshaping expectations for immunotherapy, especially in microsatellite, stable colorectal cancer. A setting that has been resistant to treatment with prior immunotherapy approaches.
These unprecedented outcomes combined with data across multiple tumor types are driving significant interest in BOT/BAL from key stakeholders including the medical community, patient advocates and potential collaborators.
From a business development perspective. We are actively engaged in discussions with pharmaceutical partners, regional collaborators and other stakeholders to ensure bot valve reaches its full potential. These discussions are focused on optimizing value creation for both patients and shareholders.
We are also advancing our compassionate use and named patient programs globally. Ensuring that patients with limited options will have broader access to bodal outside of clinical trials.
These initiatives are critical for addressing the urgent needs of patients around the world.
On the financial front, our strategy is built on a combination of operational discipline, asset monetization and strategic transactions. The recent uptick in market conditions particularly following the US elections has bolstered the value of our positivo estate and operational assets.
We expect to close on these monetization opportunities soon which will provide a bridge to a transformative transaction. Currently under active discussion, this transaction which we anticipate finalizing in the near term is expected to bring in significant resources to support our mission while optimizing long term value for our shareholders.
In summary, we are making significant strides in advancing BOT/BAL and positioning Agenus for long term success.
I’ll now hand it over to Christine to discuss the financials.
Christine Klaskin
Thank you, Robin Agenus ended the third quarter, 2024 with a consolidated cash arqueo of $44.8 million compared to $76.1 million on December 31, 2023.
As Garrow mentioned, we have raised $7.1 million through sales of common stock under our market issuance sales agreement since the end of the third quarter, cash used in operations for the nine months ended September 2024 was $129.7 million.
This is a reduction from spend of $183.8 million for the same period in 2023 for the three and nine months ended September 30, 2024 we recognized revenue which includes non-cash revenue of $25 million, $77 million dollars respectively.
This compares to $24 million and $7 million dollars for the same period in 2023 net loss for the three and nine months ended September 30, 2024 is $67 million and $186 million respectively.
This net loss includes noncash operating expenses of $41 million for the third quarter and $112 million for the nine months ended September.
This compares to a net loss for the three and nine months ended September 30, 2023 of $65 million and $20 million dollars respectively. Oh, sorry, $205 million respectively.
I’ll now turn the call back to Garo.
Garo Armen
Thank you, Robin and Christine.
As we close, I want to leave you with a sense of what we are striving for Agenus.
But while it is not just a new therapy, it is an opportunity to redefine the future of cancer treatment.
And these are the sentiments of not just Agenus team members but the sentiments of schools of clinicians around the world BV is an opportunity to redefine cancer treatment in ways that we think will benefit patients in an unprecedented manner in colorectal cancer and other hard to treat cancers but is showing that it’s possible to intervene earlier more effectively and with outcomes that could preserve not just the survival but the quality of life that patients deserve. You will see significant evidence of that at conference presentations very early next year, two separate presentations representing two separate trials in the neoadjuvant setting. One in colorectal cancer, one in cancers that are across the board.
This is why we are so committed to advancing this therapy.
We know the financial challenges we face and we are addressing them with deliberate and focused action by reducing costs, monetizing assets and advancing discussions on strategic transactions. We are laying the foundation for sustained progress.
This is a critical moment for our company and for me.
The science is strong, the clinical momentum is positivo and the opportunities ahead of us are extraordinary.
But above all, this is about the patience those who are counting on us to deliver a hope and a path forward.
I want to thank you for your continued support and belief in our visit.
We remain committed to realizing the full potential of BOT/BAL for the benefit of patients, shareholders and the broader medical community.
With that, we’ll now open the call for questions operator.
Operator
(Operator Instructions)
Your first question comes from the line of Emily Bodner with HC Wainwright.
Hold on a moment please, please go ahead.
Emily Bodnar
Oh, Hi, Good morning. Thanks for taking the questions. I guess first one for me now that you have guidance from the FDA and the E MA around the phase three design, Can you maybe just summarize how you’re thinking about the phase three design and and next steps and timelines for getting that study initiated. And then on the three investigator trials that you mentioned in the new adjuvant setting, maybe just go through each of those and kind of how the designs for those studies differ and maybe set some expectations what we can see in the early 2025 data readout. Thank you.
Garo Armen
Okay. So, the first question I will ask Robin Taylor to answer because he has been in deep discussions with potential collaborators and investors in the company on this very issue. And the second question I have to ask our Chief Medical Officer Dr Steven O’Day to address.
Robin Taylor
Hi Emily. To address your question around the phase three design and timing, you know, we now have, as you, as you’ve noted, we have feedback, both E MA and FDA that really allows us to proceed. Of course, we will do that when we have a strategic partnership that allows us to be able to finance the study and that can come in either through our efforts on the financing side or through a potential collaboration with a farmer partner, both of which we are in active discussions at the moment. And so, you know, that is really the level of detail that we can provide at the moment. But we definitely are excited by the fact that you know, the door is now open for us to be able to proceed with that study.
Garo Armen
And our two neoadjuvant studies beyond Cornell, there has been some concern, Steven that because of some personnel changes at Cornell, our neoadjuvant efforts had come to a halt. But in reality, it’s just the opposite. In fact, they have expended if you can accumulate without disclosing too much data so that we don’t jeopardize ours.
Steven Oday
So thank you Emily for the question. As you know, we presented our nest data, which is the Cornell data at several conferences most recently at ESMO G, updating that data which continues to really be remarkable in the signal that it’s giving in both MS stable and MS high colon cancer. There are two as Aniquilamiento referred to. There are two other data sets that are emerging, which we will be presented in early 2025 both from Europe. One of them is a similar scenario to the Cornell in the sense that it’s looking at colorectal cancer in the DIA setting with BOT/BAL and we look forward to sharing that independent second data set in the setting of the of what Cornell showed. And then the other data set that’s emerging here is from the Netherlands and this will be a broader patient population that includes colorectal patients, but also includes other solid tumors that historically have had major challenges or had in inability to respond to immunotherapy. So those are the two other data sets that will be emerging in the in the first part of next year?
Emily Bodnar
Got it. Okay. Makes sense. And then maybe just lastly on the phase two, relapse your factory setting in CRC. I believe previously, you were saying you would have additional data, I believe in the first half of 2025. Is, is that still on track.
Steven Oday
Emily? Thank you, Steve O’Day again. Yes, that, that data has continued to mature. The last patient with a role in the phase two colorectal or factory study in November a year ago. And we look forward to continuing to allow that data to mature and present it at a conference in early 2025.
Emily Bodnar
Okay, great. Thank you so much.
Operator
Your next question comes from the line of Max Phipps with William Blair.
Matt Phipps
Great. Hi, this is Madeline on from that. Thanks for taking my questions. First, should we expect any data from some of the cohorts and other tumor types like melanoma and pancreatic cancer in the near term? Or could you provide any updated timing for those cohorts.
Garo Armen
I mean, Stephen O’Day will address that. But as you know, we have generated data across approximately 10 instruments.
And most recently at ESMO, we presented data on Sarcoma, the data as it matures is getting more and more compelling. And our investigators at places like ESMO that convene and discuss the prospects for treating their patients in the future are very excited about the need to make available for their patients at a wider scale. But Dr O’Day is the gatekeeper of all of these ethics and, and he’ll give you more color.
Steven Oday
Thank you for the question. In addition to our phase two colorectal data, two other phase two trials, as you mentioned, one in pancreas in a refractory setting and one in Melanoma in a very refractory setting, have completed a cool and are maturing and we expect to have randomized data in those settings in the first half of the next year.
Matt Phipps
Great. Thank you.
Operator
Ladies and gentlemen, that concludes today’s call. Thank you all for joining you. May now disconnect.
