Good morning, and welcome to the Intensity Therapeutics Third Quarter 2026 Financial Results Conference Call. Joining the call today is Lewis H. Bender, Intensity's President and CEO, and Joseph Talamo, Intensity's Chief Financial Officer. Shortly before this call, Intensity issued a press release announcing its third quarter 2026 financial results, which is available under the News and Events section of the company website. Shortly after this webcast, a replay of this call will also be posted. Before we begin, the company reminds you that comments made by management during this conference call contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Intensity Therapeutics. These statements include, but are not limited to, statements relating to the company's expected future plans, cash runway, development activities, projected milestones, business activities, or results.
Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Additional information regarding these risks and uncertainties is included in the company's earnings release issued today. For a more complete list and description of risk factors, we encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, its Forms 10-K, 10-Q, and eight-Ks. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 5th, 2026. Except as required by law, the company disclaims any intention or obligation to update or revise any forward-looking statements. I'll now turn the call over to Mr. Bender, Intensity's President and CEO.
Thank you, Wyatt, and thank you, everyone, for joining us this morning. It is my pleasure to provide the latest update of our company's progress in the INVINCIBLE-3 and INVINCIBLE-4 studies, our publications and presentation strategy, our business development activities, and our plans for the rest of 2026 into 2027. First, I will turn the call over to Joe Talamo, our CFO, to discuss our third quarter financial results. Joe?
Thanks, Lou, and good morning. I'm pleased to join you today and to present a summary of our third quarter 2026 financial results. Our research and development expenses were $2.4 million for the third quarter of 2026, compared with $1.6 million for the same prior year period, reflecting an increase of $876,000, or 56%. Clinical trial expenses for our phase III INVINCIBLE-3 study were $1.5 million during the third quarter of 2026, compared with $1 million for the same prior year period. In the current year quarter, we resumed new patient enrollment activities in the INVINCIBLE-3 study in a limited number of U.S. sites after pausing new site activations and patient enrollment in March 2025 due to funding constraints. During this pause, we continued to treat and monitor patients previously enrolled in the study in cooperation with our CROs.
We have prioritized commencing full patient enrollment and site activations once sufficient incremental funding is obtained. Our clinical trial expenses also included $104,000 for our phase II INVINCIBLE-4 study, which also resumed patient enrollment and treatment in the third quarter of 2026. We expect the INVINCIBLE-4 study costs to increase in the coming quarters as we target completing enrollment in this study by the end of 2027. Lou will provide an operational update on both studies shortly. During the third quarter of 2026, we also initiated a new manufacturing batch of INT230-6, incurring $162,000 in higher manufacturing costs. We expect this batch will be completed in the first quarter of 2027 and will likely be sufficient to fully supply both ongoing clinical studies.
Lastly, research and development employee compensation-related expenses were $184,000 higher during the current quarter due to an estimated bonus accrual in the current year period, compared to no bonus accrual in the prior year period. Turning now to G&A. General and administrative expenses were $1.3 million for the third quarter of 2026 and were unchanged compared with the same prior year period. Within G&A, minor increases in employee compensation-related expenses and consulting expenses were offset by minor decreases in insurance costs during the third quarter of 2026 compared to the same prior year period. Overall, net loss was $3.5 million for the third quarter of 2026, compared with a $2.7 million loss for the third quarter of 2025, representing an increase in net loss of $873,000, or 33%.
Our cash burn from operating activities for the nine months ended September 30, 2026, was $6.7 million, reflecting an average monthly operating activities cash burn of $741,000 over the first nine months of 2026. We estimate that our operating cash burn will average approximately $1 million per month in the final quarter of 2026 as we continue to advance our clinical studies and manufacture the new INT230-6 batch. Turning now to our balance sheet. As of September 30, 2026, we had cash and cash equivalents of $8.5 million. During the third quarter of 2026, we raised $1.5 million in net proceeds from the issuance of common stock under our at-the-market facility. For the nine months ended September 30, 2026, we raised $3.2 million in net proceeds under the at-the-market facility.
We expect to continue to use this facility opportunistically to raise capital, and we will continue to explore other sources of dilutive and non-dilutive capital as we seek to scale up our clinical activities moving forward. With that, I will now turn the call back to Lou for a discussion on our clinical programs and business development activities. Lou?
Thank you, Joe. Well, we are pleased to hold today's earnings call following the positive feedback we received from our stockholders and stakeholders after last quarter's call. Today, as I said, I will discuss the continued progress that the company has made this quarter in more detail and provide an update on ongoing activities. As you just heard from Joe, we ended the third quarter with about $8.5 million. In the fourth quarter, we continue to evaluate the opportunities to raise capital via the ATM and other types of offerings or financings as opportunities present themselves to us.
Well, now I'm going to update on the phase III INVINCIBLE trial, which is our open-label, randomized controlled clinical study that is testing our drug INT230-6 as monotherapy, meaning just our drug alone, compared to the best standard of care drugs in second and third line treatment for three types of soft tissue sarcomas. On last quarter's call, we reported that we had initiated new patient enrollment in terms of starting the process for that in the INVINCIBLE-3 study in a limited number of U.S. sites. To make this restart happen, this quarter, we added new CROs to help manage this clinical study, including vendors for statistical analysis and a large organization that specializes in receiving computed tomography, known as CT, images from sites around the world electronically during clinical trials.
The purpose of this change is to establish consistency of the reads by radiologists across all sites, whether a patient's cancer is progressing or not, or regressing, compared to a patient's prior scan. Our key sarcoma thought leaders made a few important observations and recommendations. One was a central read, and the other was a recommendation to use a different set of criteria to determine whether a patient's disease was progressing. In the prior version of the amended protocol, we based disease progression on tumor size, which is standard practice for systemic treatments. However, we have learned for our drug, the tumor becomes larger from the injection, from immune cell infiltration, and from the buildup of fluid as the cancer cells die.
While changes in tumor size using criteria such as RECIST or WHO may be standard practice for determining progression for systemic treatments because it's based on the size of the tumor, we believe those criteria are unsuitable for our unique intratumoral drug. Working with the expert radiology group, we finalized a set of criteria to assess whether a patient's cancer is progressing by measuring the tumor's density compared to its baseline. These criteria are referred to as Choi, and they are often used for certain types of sarcoma. While size goes up, density declines using our drug, and using Choi, we think we will have a better assessment of progressive disease. The endpoint remains overall survival. Sites will send their scans for assessment to the central review group, who will return a report on the Choi scores and provide detailed information on density changes for treated and untreated tumors.
Recruitment began in the U.S. in Q3 enrollment, and several sites are activated and seeking patients. We've also filed the needed documentation to restart the phase III in Europe and Canada in Q3. We expect to have approval to begin under the amended protocol in Europe in Q1. As we've mentioned, as incremental capital is raised, we will assess the timing of when additional sites can be activated in the U.S., the E.U., and Canada. Moving to ESMO now. Last month, Kim Guedes, our Vice President of Clinical Operations, and I traveled to Madrid to attend the Annual European Society for Medical Oncology Conference, known as ESMO. We met with several of the INVINCIBLE-3 investigators who remain excited to resume their participation in the study. The last drug approved for second or third line soft tissue sarcoma of the types in our study was in 2016.
It's been a long, dry desert for these patients. The three-year survival for sarcoma patients at this stage with progression, when we will begin to treat, is low. It's in the single digits. The physician investigators told us that there is an opportunity, given the lack of trial options for these patients, for new therapies. We are motivated to activate sites, enroll, and determine whether INT230-6 can help sarcoma patients live longer with improved safety and better quality of life. Capital is the restriction on speed. Now provide an update on our phase II INVINCIBLE-4 presurgical breast cancer study, which is our randomized, controlled, open-label, multicenter study of INT given before the administration of standard of care neoadjuvant immunochemotherapy regimen in patients with early-stage operable triple-negative breast cancer.
The efficacy endpoint is pathological complete response, referred to as pCR, which is the absence of any live cancer at the time of surgery in the tumor, breast, or lymph nodes. Tumor sizes in our trial are more challenging to treat, as our inclusion criteria uses a larger minimal tumor size than what was used for approval of the current regimen. Larger tumors are more challenging to treat. On October 23rd, we announced new data at ESMO on patients who received our drug, showing an early indication of the potential to improve the percentage of women achieving a pathological complete response, or pCR.
Clinical studies have shown that if triple-negative breast cancer patients have no live cancer at the time of surgery, the pCR, the risk of the disease returning in five years after surgery is significantly reduced, from about 50% without having a pCR to about 16% with a pCR. This difference is clinically meaningful, and many regulatory agencies, including the U.S. FDA and the EMA, accept pCR as an endpoint for certain types of accelerated or conditional approvals. There are two cohorts in the study. The first is one dose of our drug administered prior to the standard of care. This is cohort A. The second cohort B, is the standard of care alone. Patients are randomized one-to-one to each cohort. As reported previously, 71% of patients who received INT230-6 achieved a pCR compared to 42% the standard of care. Very small numbers, it's early data.
But these were patients with a median tumor size of 2.6, which is quite large. We also reported that no invasive cancer cells were detected in the axillary lymph nodes in six of the seven patients in cohort A after INT230-6 treatment, despite five of these seven patients, 71%, being initially biopsy-proven node positive. We don't know the nodes. Results also showed tumor necrosis in all seven cohort A patients. In the pre-surgery MRI, at the completion of neoadjuvant immunochemotherapy, four patients in our group had radiological complete response, and three patients, 43%, had partial response. All seven patients met criteria for breast-conserving surgery. These surgical results are consistent with the results from the study in Ottawa, our completed INVINCIBLE-2 study, that the timing of the surgery is unaffected by the use of our drug, which is a very important factor for patients.
We resumed to dose new patients in the third quarter in INVINCIBLE-4 after the study enrollment was paused late last year to revise the dosing regimen for patients receiving our drug because some patients experienced localized skin issues. Our collaborators in the INVINCIBLE study, the Swiss Cancer Institute, have established an IDMB of qualified experts to review safety data and images from these newly treated patients and assess whether the skin issues have been resolved. The institute team felt, and we agreed, that an independent group of experts reporting that the current dosing regimen had resolved the skin issue would be the best way to assure all the investigators of the safety of this drug with regards to the skin issue.
As a side note, we used a higher dose for tumor size in our completed INVINCIBLE-2 study in Ottawa compared to the revised dosing regimen in the ongoing INVINCIBLE-4 study. In the first study, 60 women received our treatment, and no skin issues were reported when injections were made with ultrasound to guide the needle. The INVINCIBLE-4 study uses higher quality ultrasound than was used in the INVINCIBLE-2. After ESMO, I met and went to Switzerland and met with several of the sites. The meetings included the investigators, the nursing teams, coordinators, pharmacists, and other staff. I presented background data on INT230-6, the data from the Ottawa study, the latest safety and efficacy data from the ongoing phase II INVINCIBLE-4 study, and new results presented at ESMO. I was encouraged by our discussions and the investigators' enthusiasm to enroll their TNBC patients at each site.
At ESMO, we also met with our partners at the group managing the French sites, UNICANCER. Along with a couple of French investigators, we discussed the science and study data. Several sites in France have had their site initiation visit and are activated. We also plan to visit the sites in France, and the remaining sites in Switzerland after the independent safety report is available. We hope to give investigators confidence that a single injection of our drug has the potential to improve efficacy, be safer, and provide patients with the same skin appearance with our drug or without it. These efforts allow us to continue to target completion of enrollment by the end of 2027. It's also important to remember that using today's best immunochemotherapy regimens, only about 50%-63% of TNBC patients achieve a pCR. This depends highly on the size of the tumor.
Half a percent of women die from the current approved regimen. Preliminary findings on safety and efficacy from this randomized control study are encouraging to us and our European investigators. I would now like to discuss our clinical publication efforts. Last quarter, I discussed the 2025 eBioMedicine paper, which focused on translational science of using our drug alone. We continue to pursue additional peer-reviewed manuscript publications from our completed studies to further communicate the important clinical data and results to the oncology community. We have submitted a manuscript to a quality journal from our INVINCIBLE-2 breast cancers trial, and another manuscript from our IT-01 study in metastatic cancer of our drug with immunotherapy to another journal. The journal's editors accepted each manuscript for peer review, and we have received reviewer comments, which we are addressing.
Assuming our responses satisfy the reviewers and editors, we hope to see the papers published next year before Q2. Lastly, we continue to pursue potential partnerships in order to advance our programs more quickly and effectively. While the process is still early, we are pleased with the interest in our science and clinical trials, and discussions continue with several companies. We have also engaged a senior business development consultant to provide supplemental outreach and additional support. To summarize, our cash position is good, we have options to increase capital, our clinical studies are advancing, and we have reinitiated patient enrollment in both late-stage programs. New peer-reviewed clinical publications are in process, and partnering business development discussions continue. This time, I would like to open the call up to questions.
We will now begin the question and answer session. To ask a question, you may press star, then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then two. At this time, we will pause momentarily to assemble our roster. The first question will come from Kumar Raja with Brookline Capital. Please go ahead.
Thanks for taking my questions, and congratulations on all the progress. First, with regard to the INVINCIBLE-4 study, what specific safety endpoints or the metrics will the IDMB looking at in Q1, and what would give confidence that the localized skin irritation has been resolved?
Yeah. Thank you, Kumar, for the question. They are looking at the surface of the skin, whether or not there is any irritation over a period of several months. The patients have been enrolled, we are following them for a number of months. We are going to stop after a certain number of patient months. It is coming up very soon. They are just simply going to look and see if the issues that we saw before, and did not see in INVINCIBLE-2, with this new dosing regimen, exist or not. It is that simple. It is looking at the images of the skin and probably some other metrics that they have, but nothing other than a simple visual, I think, is the key criteria for them.
Okay. You also hinted a little bit about business development. Can you provide any color on the nature of this discussion? Anything you can share with regard to that?
Well, we have been discussing with regional players, we have been discussing with multinational players. We are still in the evaluation part of this. We have a data room, there are CDAs in place, we are in discussion about the programs. What is of interest to these companies is both programs in some cases, one or the other program in other cases. There are multiple discussions, multiple topics. We are really in the get to know each other stage right now, but I can tell you that the interest in a phase III program and phase II program in breast cancer, where it is a single dose and a phase III program in a rare disease like sarcoma, which has literally nothing really for 10 years of any consequence, is of interest to these companies.
Okay, great. Finally, with regard to the INVINCIBLE-3, what are your expectation in terms of getting additional sites activated? Thank you.
Well, as I said, we have opened a number of sites. We are looking for patients. As Joe has said, it will be in a gated way so that we can manage enrollment as we bring in capital. We do not want to get our skis ahead of ourselves and enroll too quickly, which we could possibly do, before we have the adequate cash. Capital will be the gating factor on how quickly we enroll. The enthusiasm is there. We have maintained almost all of the sites over the last, I would say, year and a half since we paused the study. Contracts are in place, budgets are in place. We had almost 32 sites with contracts agreed and another 30 sites with contracts in negotiation when we paused. We could enroll quickly, or quicker than what we are planning, as we get more capital.
It is really going to be definitive on the capital raising that we do.
Okay, great. Thanks so much.
Thanks for the call.
Your next question will come from Charles Wallace with H.C. Wainwright. Please go ahead.
Hi, this is Charles on for RK. Thanks for taking my question. I guess first from me, for the INVINCIBLE-3 study, you mentioned several sites were active and patients identified. I was just curious if any of the patients have been randomized at this point, and how many sites do you expect to have open by year end?
Patients have not yet been randomized. They're going through an evaluation and screening process to make sure they meet all the suitable enrollment criteria that we have. There are a number that have been identified, but that's a process that takes a little bit of time. Ultimately, we will have about 10, we think, initially enrolling, but ultimately, the number of patients we can accept is really going to be dependent on the capital.
Okay. Yeah, that makes sense. I guess another question on INVINCIBLE-3. You mentioned the switch to the density-based CT image. Will that just be for the active arm or also the standard of care comparator? Or will the standard of care still use the size-based image?
So, it's for both arms. Obviously, it has to be for both. In Choi, there is an element of RECIST, right? So, what you have is, if you're measuring the size increase and the density change. If there's no density change and the size increases, then it's a PD, right? So, it's the same for both groups because they have to use one criteria for both groups. Seeing in our drug a Choi score for the tumors that we've selected for the Choi measurements, a density decrease but a size increase, and the density decrease is above 15%, even if the size increase is really high, it's a PR by Choi. Because density is really what we're looking at trying to control, because that means that there's no live cancer.
If there's a lower density, it's become a sack of water, then even if it gets very big, it's a PR by Choi. Now, we don't know that that density change is going to happen in the standard of care, but if it does, and there is an increase, then it's a PR for the standard of care as well. I mean, it's the same criteria, and it is used in sarcoma. Remember, it's only for progressive disease. It is not the endpoint. The endpoint is overall survival, but it is used in both arms.
Great. That's very helpful. I guess final question from me. You mentioned the new CRO initiated in the third, or you paid in the third quarter. Does this cover both of the two studies, and does this kind of affect any timelines? Maybe just a little color on why you switched CROs.
Yeah.
Thank you.
The new CROs are only for the INVINCIBLE-3, because that's the sarcoma study. We decided to fractionate to different groups to help handle different things. So, we have this CRO that's going to be doing the reads rather than the sites. We have the CRO for statistics. We have the CRO for monitoring. We just felt that it would be better to manage it that way than what we were doing before. For the French and Swiss sites, it's the same group. It's Swiss Cancer Institute in Switzerland. It's the same group, UNICANCER in France. So, that study is separate on the CRO side from the sarcoma study.
Great. Then maybe final question from me. So, for the INVINCIBLE-4 study, you mentioned that you expect to complete enrollment by the end of 2027. Does this include any activation of U.S. sites?
It does not. It is solely right now going to be in France and Switzerland. That could change, but right now, that is, we believe, unnecessary.
Great. Thank you so much for taking my questions.
Thanks. Thanks very much, Sean.
Your next question will come from Ilya Zubkov with Freedom Broker. Please go ahead.
Good morning, and thank you for taking my questions. First, on INVINCIBLE-4, as the study is a part of phase II/III program, and assuming the amended regimen pCR holds up, could you elaborate on what would the registrational study look like, and roughly what would it cost?
Yes. What would a registrational study look like? So, obviously, what we're looking at here is an improvement in pCR, but also because of what we're seeing with regard to the safety, certainly with the immune-related adverse events, what we would do is we would take that data back, analyze how much better, if at all, we're seeing in terms of safety, systemic safety, less grade 3 adverse events, less immune-related adverse events. We'd go to FDA with a trial design sized based on this study for a direct comparison of our drug to the standard of care. That study cost, obviously, if we're looking for an accelerated approval endpoint, would be costed based on the size of the pCR data. We'll have to run that through FDA. Now, we will have to do event-free survival, which will be a larger study.
But the question is, will FDA, if we do see the kind of overall safety in terms of reduced grade 3 systemic adverse events and much fewer immune-related adverse events, and our pCR data is, I'm not going to expect it to be 30% better, but it could be a good 10%-15% or 20% better. How is the combination of better safety and a pCR, if it's even smaller than what I just said, suitable to the FDA? I think before we really get into any sizing and cost, we have to have the data from this phase II study, or at least close to the data on this phase II study, and then go back to FDA with a discussion on what the appropriate study would be for approval.
Mm-hmm. Great. Thank you. One more question on the cash spending. I see that cash used in operations was about $2.5 million in Q3, against your $1 million per month second half guidance. What does steady state monthly burn look like for Q4 and 2027 with later sites INVINCIBLE-3 and INVINCIBLE-4, and the new manufacturing batch?
Ilya, so we completed, you're right, about $2.7 million in operating cash burned in the third quarter. We're providing guidance of the same $1 million per month in the fourth quarter, as we exit 2026. The 2027 guidance is going to be largely dependent on bringing in additional capital and how much more we can ramp up enrollment. So, we'll provide what 2027 looks like, but you can get a feel for where we are right now at the current operations, running about $1 million a month. But again, we'll provide better guidance as we head into 2027, once we know what our capital situation looks like.
Great. Thank you very much.
Again, if you have a question, please press star, then one. Your next question will come from James Molloy with Alliance Global Partners. Please go ahead.
Hey, guys. Thank you very much for taking my questions. You guys touched on quite a bit the capital issues, and that has certainly been a capital constraint, as everyone's problem, not just yours, of course. Can you talk a little bit about potential out-licensing or partnership opportunities that could offload some of the cash needs to a larger pharma partner?
Yes. That would be a key objective for us to achieve, that a partner would come in, fund part or all of the programs, and take a license to it. And those are the kinds of objectives and discussions we have. Sometimes partners want to see for themselves how it works in combination with their drug, and may fund some of those kinds of things. So, there's a lot of discussions and a lot of options on the table for the companies with whom we are in discussion. But again, it's still a getting-to-know-you type of stage here, where they like the programs, but also potentially will have complementary products that they would want to partner with us to test our drug with their product. So, there's a lot of diverse ideas being discussed between us and some of the parties that we've been talking to.
Thank you for that. Is there any way to give color for us? I was looking in on sort of the number of companies or the size of the companies, or any potential ties or something that could potentially happen in 2027?
There are several large multinationals and a number of regional players as well, smaller ones. It is very early in terms of the getting to know you, but we are very pleased with the interest that we have gotten so far.
Yeah. Then I think, was it INVINCIBLE-3 where you mentioned you changed from just the sizing to the density to account for false progression? False progression is certainly not unheard of in immune therapies. What sort of drove that change, and how does that make interpreting the results more or less challenging?
Well, what drove the change was the patients were the doctors were seeing on the scans the tumors becoming necrotic and cystic, and then they had to pull them off because the tumor volumes were getting better. So the patients were getting potentially derived benefit, but by protocol, because the size was increasing, they had to pull them off. Then the doctors, they wanted to keep them on, but by protocol, they were obligated to remove the patient. So, that was the primary reason. Then that is when they said, "You got to use this density measurement. We are seeing good results there." Then it was kind of fortunate that we were paused at the time. But ultimately, this switch was recommended by the doctors.
Okay, great. Thank you. Thank you for taking my questions.
Okay. I am going to thank everybody for the call. I just would like to say the following. Look, I believe that to make a real difference in cancer, new and different approaches may be required, even if those approaches go against the current grain of thought. I was recently asked to write a guest column for the October 15th issue of the trade publication, Drug Delivery Leader. In that article, I discussed the long history of attempts to create intratumoral therapies. I also described the common thread for why those prior attempts have really not lived up to expectations. Simply put, the tumor microenvironment is incompatible with water-based drugs. Water-based drugs must be dosed to patients, and we have made a 100% water-based cancer-killing immune-activating product that is highly compatible with a high-fat, high-pressurized tumor microenvironment.
Our phase III INVINCIBLE trial will hopefully show for the first time that a local drug, an intratumoral drug alone, can increase survival in metastatic cancer with fewer side effects. We also hope to achieve improved safety and efficacy for presurgical breast cancer patients with our drug when combined with current treatment. If our trials in sarcoma and triple-negative breast cancer are successful, I believe that this will be a transformational change for cancer patients. I want to thank everybody again for your time today.
Conference is now concluded. Thank you for attending today's presentation. You may now disconnect.