INTS Q3 2026 earnings call transcript, November 5, 2026

Of $876,000, or 56%. Clinical trial expenses for a Phase III Invincible III study for $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 III study in a limited number of U.S. sites after pausing new site activation. and patient enrollment in March 2025 due to funding constraints. During this pause, we continue 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 IV study, which also resumed patient enrollment and treatment in the third quarter of 2026. Respect the Invincible IV study. Invincible IV study costs to increase in the coming quarters as we target completing enrollment in this study by the end of 2027. Blue will provide an operational update on both studies shortly. During the third quarter of 2026, we also initiated a new manufacturing batch. of INT 230-6, 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 period, same prior year period. Overall, net loss was $3.5 million for the third quarter of 2026 compared with a 2.5 million. $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 2020. As we continue to advance our clinical studies and manufacture the new INT 230-6 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. In September 30, 2026, we raised $1.5 million in net proceeds from the issuance of common stock under our at-the-market facility. And 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'll 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'll 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. As you just heard from Joe, we ended the third quarter with about $8.5 million. In the fourth quarter, we continued 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 Invisible 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 III 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 computer 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 read.

by radiologists across all sites whether a patient's cancer is progressing or not or regressing compared to 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 RESIST 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 progression. The end point 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 US in Q3 enrollment and several sites are activated and seeking patients. We've also filed the needed documentation to restart the Phase 3 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 EU, and Canada. Moving to ESMO now. Last month, Tim Getz, our Vice President, of Clinical Operations, and I traveled to Madrid to attend the annual European Society of Medical Oncology Conference, known as ESMO. We met with several of the invincible three investigators who remain excited to resume their participation in the study. The last drug of 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. And 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 INT 230-6... ...can help sarcoma patients live longer with improved safety and better quality of life. Capital is the restriction on speed. Now I'll provide an update on our Phase 2 Invincible 4 Pre-Surgical Breast Cancer Study, which is our randomized, controlled, open-label, multi-centered...

study of INT given before the administration of standard of care immunohemotherapy 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, 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 INT-230-6 achieved the PAP-CR.

compared to 42% of the standard of care. It's 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 auxiliary lymph nodes in six- of the standard of care. Of the seven patients in cohort A after INT 230-6 treatment, despite five of these seven patients, 71%, being initially biopsy-proven node positive, we don't notice the nodes. Results also showed tumor necrosis. In all seven cohort A patients. In the pre-surgery MRI, at the completion of neoadjuvant amino chemotherapy, 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 II 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 and dosed new patients in the third quarter in Invincible IV 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 independent data monitoring board 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 report. 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 INT 230-6, the data from the Ottawa study, the latest safety and efficacy data from the ongoing Phase II, Invincible IV 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 amino chemotherapy regimens, only about 50 to 60 percent, 63 percent of TMBC patients achieve a pathological complete response. This depends highly on the size of the tumor. Half a percent of women die from the current approved regimen. Deliberate findings on safety and efficacy from this randomized controlled study are encouraging to us. and our european investigators. Now I'd like to discuss our clinical publication efforts. Last quarter I discussed the 2025e biomedicine 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 ITO1 study in metastasis. 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 discuss continue with several companies. We've 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.

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