INTS

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management successfully raised over $23 million since Q2 2025, enabling the resumption of clinical programs that were previously paused due to funding constraints. The Phase III INVINCIBLE-3 study was optimized during the pause by incorporating feedback from sarcoma thought leaders, leading to refined inclusion criteria and a shift to centralized scan reading. Performance in the Phase II INVINCIBLE-4 study for triple-negative breast cancer (TNBC) showed a preliminary 71% pCR rate, which management attributes to the drug's immune-activating mechanism when used prior to standard care. Strategic positioning is bolstered by peer-reviewed publication in eBioMedicine, which management believes validates the drug's ability to induce an abscopal effect and extend survival in refractory patients. Operational flexibility has been maintained through tight fiscal management and the opportunistic use of a $60 million ATM facility to scale clinical activities. Management highlighted that the high unmet medical need in metastatic sarcoma, where 3-year survival is less than 10%, continues to drive strong investigator interest in their Phase III trial. Management expects new patient enrollment for the INVINCIBLE-3 study to begin in the U.S. within the next couple of months, followed by a phased restart in five European countries. The company estimates a total incremental capital requirement of approximately $30 million to complete the INVINCIBLE-3 Phase III study over the next several years. Enrollment for the Phase II INVINCIBLE-4 study is targeted for completion by the end of 2027, contingent upon the successful activation of planned sites in Switzerland and France. Operating cash burn is projected to average approximately $1 million per month for the second half of 2026 as clinical activities scale up. Future site activations in the U.S. and Europe for the Phase III trial will be sequenced based on the timing and volume of incremental capital raised. The INVINCIBLE-4 protocol was amended to a single-injection regimen with reduced drug volume to address localized skin irritation issues observed in earlier patients. Management implemented a new exclusion criterion for INVINCIBLE-3, barring patients with tumors exceeding 15 centimeters to ensure the study population can realistically benefit from treatment. Regulatory complexity in the EU, requiring documentation translation and multi-country coordination, is cited as a primary factor for the slower restart of European sites compared to the U.S. The company is replacing seven patients in the INVINCIBLE-4 Cohort A to account for the transition from the original dosing regimen to the new single-injection protocol. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that while the current $10 million cash balance supports a limited U.S. restart, a 'bolus' of approximately $30 million is needed to fully turbocharge the global study. The company will continue to use the ATM facility as the 'cheapest cost of capital' to incrementally open sites if a single large funding event does not occur. Management is consulting with statisticians to determine if the 21 patients enrolled prior to the pause will remain in the primary intent-to-treat analysis due to protocol changes. The company maintained database integrity and pharmacovigilance during the pause to minimize long-term disruption to the study's survival tracking. Management reported over 20 meetings with potential partners, ranging from regional players to multinationals seeking global rights. Interest is being driven by recent clinical publications, though management emphasized that discussions are in the 'very early' stages with no definitive timelines for a deal. Early data suggests a trend toward a meaningful reduction in Grade 3 immune-related adverse events when INT230-6 is added to standard immunochemotherapy. Management believes the 71% pCR rate is particularly significant because the study enrolled patients with larger, harder-to-treat tumors compared to landmark trials like KEYNOTE-522.

Image source: The Motley Fool. Tuesday, Aug. 11, 2026 at 8:00 a.m. ET President and Chief Executive Officer - Lewis H. Bender Chief Financial Officer - Joseph Talamo Operator: Good morning and welcome to the Intensity Therapeutics Second 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 second quarter 2026 financial results, which is available under the News & Events section of the company's 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 8-Ks. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Tuesday, August 11, 2026. Except as required by law, the company disclaims any intention or obligation to update or revise any forward-looking statements. I will now turn the call over to Mr. Bender, Intensity's President and CEO. Lewis Bender: Thank you, Betsy, and thank you to 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 business development activities, and our plans for the second half of 2026. But first, I will turn the call over to Joe Talamo to discuss our second quarter of 2026 financial results. Joe? Joseph Talamo: Thanks, Lou, and good morning. I am pleased to join you today to present a summary of our second quarter 2026 financial results. Our research and development expenses were $1.8 million for the second quarter of 2026, compared with $1.5 million for the same prior-year period, reflecting an increase of $292,000, or 19%. Clinical trial expenses, which primarily consist of our Phase III INVINCIBLE-3 study costs, were $1.2 million during the second quarter of 2026, compared with $936,000 in the same prior-year period. As previously reported, we initiated plans in April 2026 to resume enrollment 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 or monitor patients 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. Clinical trial expenses also included, to a lesser extent, costs related to our Phase II INVINCIBLE-4 study, which resumed patient treatment in July 2026. Lou will provide an operational update on both studies shortly. In addition, research and development employee compensation-related costs were $106,000 higher during the second quarter of 2026, which were offset by $113,000 of lower stock-based compensation expense during the current quarter. Turning to general and administrative expenses, our G&A expenses were $1.3 million for the second quarter of 2026, compared with $1.2 million for the same prior-year period, reflecting a marginal increase of $87,000, or 7%. This marginal increase was primarily due to $76,000 in higher employee compensation-related costs and $155,000 in higher other G&A expenses, including Delaware franchise costs. These increases were partially offset by $144,000 of lower stock-based compensation expense during the current quarter. Overall, net losses were $3 million for the second quarter of 2026, compared with $2.5 million for the second quarter of 2025, representing an increase in net loss of $470,000, or 19%. Turning now to our balance sheet and cash flow, as of June 30, 2026, we had cash and cash equivalents of $9.5 million. During the second quarter of 2026, we raised $1.6 million in net proceeds from the issuance of common stock under our $60 million at-the-market facility, which was established in March 2026. Since June 30, 2026, we have also raised an additional $1.3 million in net proceeds under the ATM facility. And we expect to continue to use this facility opportunistically to raise capital as we seek to scale up our clinical activities moving forward. Lastly, our cash burn from operating activities for the first half of 2026 was $4.2 million, and we estimate that our operating cash burn will average approximately $1 million per month in the second half of 2026. With that, I will now turn the call back to Lou for a discussion on our clinical programs and business development activities. Lou? Lewis Bender: Thank you, Joe. We're having this call because it's a different way to communicate to stakeholders the information being distributed via our 8-Ks and 10-Qs. And today we're going to discuss the significant progress that the company has made over the past 15 months and to provide an update on ongoing activities. As you just heard from Joe, our cash position is just under $10 million as of June 30th. We've continued to raise capital into the third quarter this year. Overall, since the beginning of Q2 2025 and after the company paused our randomized controlled Phase III INVINCIBLE-3 study due to funding reasons, Intensity has raised over $23 million to date. With this influx of capital over the last 15 months, coupled with our tight fiscal management, we have significantly improved our balance sheet and operating flexibility. I'll now provide an update on the Phase III INVINCIBLE-3 clinical trial, which is an open-label, randomized, controlled study testing our drug INT230-6 as monotherapy compared to the best standard-of-care drugs in second- and third-line treatment for three types of soft tissue sarcomas. As just discussed, we initiated these plans in April this year to resume the new patient enrollment in the INVINCIBLE-3 study in a limited number of U.S. sites after the pause and the site initiations in March of 2025. This trial enrolled 21 patients who continue to be treated during the pause or followed for survival. We maintained the database, we conducted pharmacovigilance, safety, and other study-related activities in cooperation with our CROs at a significantly reduced cost. We also took the time last year and this year during the pause to speak with our key investigators and sarcoma thought leaders. We obtained important feedback and recommendations about the trial, and based on those discussions, we made modifications to the protocol. The FDA reviewed the amended protocol, and we're now expecting newer patient enrollment to begin in the next couple of months. At the same time, we're preparing the needed documentation to restart the Phase III in the five targeted countries: France, Germany, Italy, Poland, and Spain. As incremental capital is raised, we will assess the timing of when these additional sites can be activated in the U.S. and Europe. It's also important to know that prior to the pause, site engagement for this study was quite advanced. NDAs were executed, feasibility analyses on whether sites had the resources to conduct the trial were made, and sites were inspected. Over 60 qualified sites in 8 countries were either contracted or in contract negotiations at the time of the pause. Activation of sites was well advanced. We believe that many sites remain highly interested in participating in the INVINCIBLE-3 study, given the outreach we have received from investigators inquiring about the timing of the restart and the lack of approved new products for second-line treatment in the sarcoma types being included in our trial. The restart of enrollment gives us reason to be excited for patients, their caregivers, our investigators, our study nurses, our site coordinators. Because metastatic sarcoma remains a deadly cancer, with 3-year survival in the second- and third-line treatment setting of less than 10%. The unmet medical need remains high. I'll now provide an update on our Phase II INVINCIBLE-4 study, a randomized, controlled, open-label, multi-centered study to analyze the clinical activity, safety, and tolerability of INT230-6 given before the administration of the standard-of-care immunochemotherapy regimen in patients with early-stage operable triple-negative breast cancer, a most aggressive form of the disease. The efficacy endpoint is a pathologic complete response, referred to as pCR, which is the absence of any cancer at the time of surgery in the tumor, breast, or lymph nodes. There are two cohorts. The first is our drug dosed prior to the standard of care. This is Cohort A. The second cohort, Cohort B, is the standard of care alone. Patients are randomized 1-to-1 in each cohort. Enrollment has been paused to review the dosing regimen in patients in Cohort A due to some patients experiencing localized skin issues. However, last month, our investigators in Switzerland resumed treating new patients in the INVINCIBLE-4 study following authorization by the Swissmedic, the Swiss regulatory authority, and the Swiss Ethics Committee of the amended protocol. For which now Cohort A uses a single injection with some reduction in drug volume relative to the size of the targeted tumor. Also, I'm excited to report that the same protocol was authorized by the European Medicines Agency, and we opened a site in France for accrual. We're currently targeting to complete enrollment by the end of '27, which is about 45 more patients needed, and this timeframe is subject obviously to the readiness and the opening of the planned number of sites. Earlier this year, we reported preliminary data from 14 patients previously enrolled in the INVINCIBLE-4 trial, showing the potential for improvement in the percentage of women having a pathologic complete response. Now, based on two large studies, one published by Cortazar and the other by Sikov, if triple-negative breast cancer patients have no live cancer at the time of the surgery in the tumor, breast, or lymph nodes, that pCR reduces the risk of the disease recurring in 5 years after surgery from somewhere around 50% of risk without having a pCR to about 16% with a pCR. It's a big difference. The difference is clinically meaningful. And regulatory agencies, including the U.S. FDA and EMA, accept pCR as an endpoint for certain types of accelerated or conditional approval. Unfortunately, using today's best immunochemotherapy regimen for women with TNBC, only about 50% to 65% of patients achieve a pathologic complete response, depending on the size of the tumor and whether the nodes are positive at the time of diagnosis. Patients having larger tumors have a lower chance of achieving a pCR. The early data from our 14 patients, where 7 were treated in each cohort, showed that 71% of Cohort A patients, those who received INT230-6 prior to the standard of care, achieved pCR, compared to 42% of standard of care. These were patients with a median tumor size that was quite large, almost over 2.4 centimeters. However, it is important to also know that there was a trend in Cohort A to a meaningful reduction in the total number of Grade 3 adverse events, including immune-related adverse events, compared to Cohort B. These results are important because 0.5% of women will die from the current standard-of-care regimen, and 50% of deaths are attributed to the immunotherapy. So why does adding our drug prior to the standard of care potentially reduce adverse events, especially for those that are immune-related? Well, if you recall, the journal OncoImmunology published a paper in 2019 about the immune-activating mechanism of INT230-6. The lead author and the senior author were from the National Cancer Institute. And all work was conducted at the NCI by their scientists using our drug. We were co-authors on the paper, which reported preclinical in vivo data indicating that INT230-6 induced tumor-specific immunity and was synergistic with checkpoint inhibitors. So in addition to pathologic complete response, we will continue to follow the potential for our drug resulting in fewer Grade 3 or higher adverse events, especially a reduction in immune-related adverse events in this study when combined with this harsh immunochemotherapy regimen. The preliminary findings on safety and efficacy from this randomized controlled study are encouraging, and we are very excited about the study's resumption in Switzerland and the accrual beginning in France. We plan to attend the upcoming annual European Society for Medical Oncology, ESMO Conference in October, which is a leading global cancer meeting, and we expect to meet with some of our European investigators to discuss our two trials while we are in Europe. We'll now discuss our clinical publications efforts, including a major achievement made last year. In November, the Lancet group's journal, eBioMedicine, focused on translational science, published a paper reporting the safety and efficacy data from our Phase I/II IT-01 study on the use of INT230-6 alone for the treatment of metastatic or refractory cancers. This paper was co-authored by us and many of the leading clinical researchers at top academic hospitals in North America, including Columbia Presbyterian in New York, Johns Hopkins in Baltimore, the University of Southern California's Keck School of Medicine in L.A., and Princess Margaret Hospital in Toronto. eBioMedicine is a strong Quartile 1 ranking translational science and oncology journal with an impact factor of 11 that focuses heavily on biomedical research bridging preclinical science and early human clinical trials. The journal eBioMedicine ranks 19th out of 191 journals in the research and experimental medicine category. The impact factor of 11 indicates its average article is cited roughly 11 times over a 2-year window, representing a strong scientific influence. Journals of this quality have rigorous peer review, low acceptance rates, and present pioneering research. We are thrilled to have had our clinical data published in such a high-quality journal. The paper reported on the safety and potential for meaningful efficacy of our drug administered alone to refractory patients having over 20 types of metastatic cancers such as colon, pancreatic, triple-negative breast, and sarcoma. These are patients who had progressed following a median of three prior therapies. They were sick. And a local therapy administered showing a disease control rate for metastatic patients, which was 75%, a median overall survival rate of OS, which for 64 patients was nearly 12 months, well above the 4 to 7 months that many systemic therapies typically report when treating these types of patients, which we believe, a first of its kind for a local therapy. Further, those patients who received a dose of more than 40% of their visible tumor burden had a median overall survival of 18.7 months, and nearly 20% of those patients had uninjected tumors shrinking, known as an abscopal effect, at a rate much higher than has been reported for another local treatment, radiation, which is usually less than 1%. We continue to pursue additional peer-reviewed manuscript publications for our completed studies to further communicate the important clinical data and results that we generate to the oncology community. Lastly, we continue to pursue potential partnerships to advance our programs more effectively. At the BIO International Convention in San Diego in late June, we had over 20 meetings with potential strategic partners. While early, and I want to emphasize early, we're pleased with the interest expressed by many of the companies in our science and our clinical trials. Many meetings were requested by the companies. The meetings, I believe, and the interest was driven by our publications, especially our clinical publications, and we expect to continue the discussions with these companies in the second half of 2026. To summarize, our cash position is much improved. Our programs are advancing. New patients are being enrolled. Our clinical data has been published in a top journal, with additional publications now proceeding through the review process. We are in a good place. And at this time, I'd like to open the call up to questions. Operator: [Operator Instructions] The first question today comes from Swayampakula Ramakanth from H.C. Wainwright. Swayampakula Ramakanth: I have about two or three questions. I apologize. To start off on the INVINCIBLE-3 study, could you elaborate on what sort of capital requirement do you have to get the enrollment going from the limited site restart, which you're planning for third quarter '26? And which specific operational milestone can this balance get to, you know, without assuming additional ATM and gross savings? Lewis Bender: Good morning, R.K. I'm going to let Joe answer the financial issues and the milestones. Joseph Talamo: Good morning, R.K. So you can see with today's guidance we're estimating a monthly cash burn of $1 million per month for the balance of 2026. That, given where we are today, what we need, the INVINCIBLE-3 study, it's about an incremental $30 million to complete that study. So clearly we don't have the capital today to open all sites and all the regions for enrollment. So it's $30 million to get us over the next several years. So, we'll continue to utilize and tap into the ATM. As we can accelerate funding, not only through the ATM, but if we have opportunities to raise capital through other measures or business development activities, partnerships as Lou referenced, we'll be able to accelerate these timelines. But at this point, maintaining the open enrollment in the limited U.S. sites is what we need to do so as we don't outrun our cash balances. So we'll continue to operate on that premise. Swayampakula Ramakanth: And then a little bit, will all the 21 patients that had been enrolled before the pause remain in the primary intent-to-treat analysis? And, did the interruption affect anything, especially the anticipated timing or number of overall survival events that need to happen? Lewis Bender: Yes, it's a good question on the 21. We've changed a little bit of the inclusion criteria and the criteria for which a patient is considered to have progressed. So we're talking to our statisticians about whether those changes would affect the intent-to-treat population for all or some of those patients. I don't have the answer yet. We have to take a look at it. We haven't really looked at those patients in any detail for obvious reasons, but we will make a decision on whether to include them at the appropriate time. Swayampakula Ramakanth: And then on INVINCIBLE-4, how many patients have now been randomized and treated, including the first set of patients under the amended regimen? Lewis Bender: Yes, so we've treated a couple under the new protocol and 14 under the prior. We need about 45 more patients or thereabouts. Swayampakula Ramakanth: Okay, and then a couple more questions. One is on the TNBC study. How should we think about what you've seen so far, the 71% pCR versus the 42% comparison, and that's from different cohort sizes, right? And in terms of tumor stage, status, and other prognostic factors, were they all balanced? And also, what does this tell you? Lewis Bender: Yes, so they're randomized, they're balanced. They're all triple-negative patients. The tumors ranged in size quite broadly as you saw, the mean was 3.1, I think the median was 2.4, something like that. So they're larger tumors, in KEYNOTE-522, half the patients' tumors were under, I think, 2 centimeters. So we're treating the harder-to-treat population, which is why the standard of care was not as good because they're lymph node-positive and a lot of other bad things like with big tumors. So we're happy with the, I mean, 31% decrease is huge. Merck had a 7% improvement in path CR when they added their drug to the prior standard-of-care chemotherapy regimen. But I'm excited about the fact that we are seeing a good trend to a meaningful reduction in Grade 3 adverse events. So once we have this data from these patients and the study is completed, we'll obviously look at the safety and efficacy and decide how we're going to proceed and probably have a discussion with the FDA. Swayampakula Ramakanth: The last question is, you certainly seem to be excited coming out of the BIO meetings. I know they are early stage, but in general, what sort of partnership format are you thinking of when you want to go ahead and continue these discussions? What is it that you're looking for with these potential suitors? Lewis Bender: Yes, so there are multinational companies that will probably want global rights that we're talking to. There are regional players that want anything from 1 country to several countries in their region. All of which can help us in many ways. So look, we believe that the best thing for patients is to move this drug around the world as fast as we can, to treat as many patients as we can, and to get that to patients as quickly as possible. So we are evaluating all the options. Again, it's very early interest. We haven't even heard from all of the companies yet. Some have signed CDAs, some are in the data room, some are still getting back to us based on the fact that this conference is speed dating squared, because you're just so well organized at BIO and you meet so many players, and the companies themselves are overwhelmed with a lot of requests. We're very fortunate that many companies requested to meet with us. We had great meetings. We're open to a lot of ideas. There's a lot of possibilities with all these different players. And as things progress, we'll make decisions on with whom we can partner or not and whatever else these guys want and what we're looking to do with them that meet their needs as well as ours. Operator: The next question comes from James Molloy with Alliance Global Partners. James Molloy: Let's have some more on R.K.'s question on the cash needed. I know that, Joe, you said about $30 million to complete the INVINCIBLE-3. But to get a full restart, are the current funding mechanisms that you have in place enough to get a full restart going here at the end of the year, or is there a bolus that's needed to sort of get that up and running as well? Or is that included in the $3 million per quarter? Joseph Talamo: So the $30 million is what we need over the next several years to really get through the INVINCIBLE-3 study. So the cash need, what we have today, again, we ended June with just under $10 million in cash. You could see that we had a very successful, brought in over $1 million already since the end of June. Provided we continue to bring in capital on the ATM, we'll continue to do so. It's the cheapest cost of capital to us and that's where we're going. It's not enough to open up all the sites immediately. We would need to bring in certainly much more capital before the end of the year before we would open up all the sites by the end of the year. Again, $30 million to run the program. We feel good that we can continue to bring in capital and incrementally open sites and ramp up the enrollment to get this moving. But certainly, we're going to have to bring in additional capital before the end of the year before we can move forward. Lewis Bender: We'll operate as we are operating, and then if a big bolus comes in, then obviously we can turbocharge the study. And big bolus meaning $30 million. Which is relatively speaking achievable. James Molloy: Okay, more than I have sitting in my bank account right now, but yes, for biotech it's certainly not a ton, as you might say. Any anecdotal feedback from the sites you could share on how they're doing with enrollment and sort of how the success they're having in INVINCIBLE-3 and INVINCIBLE-4 in enrolling patients into these trials versus other competing trials out there? Lewis Bender: In INVINCIBLE-3, obviously, they keep emailing me, and our Vice President of Operations going to start the study. So there's obviously a dearth of new drugs out there. There's a lack of effective drugs in this second-, third-line setting. They really want this study to open up. I think they were seeing some very early interesting results in terms of what's happening to the tumors. In INVINCIBLE-4, look, we just started, and we have no feedback yet, but we're going to be meeting with the sites, and the Swiss are arranging those meetings. We'll be at ESMO, we'll be able to meet with those that are attending ESMO, which is in Madrid. And so I think we'll have a much better sense of the excitement or what's happening in the study during that period of time when we actually talk to the sites in a little bit more face-to-face meaningful manner. James Molloy: One final question then, I know you guys highlighted a number of effective meetings with BIO CEO in San Diego. Is there any way to put any brackets around potential timing of partnerships from these, knowing that's a hard question to answer? Lewis Bender: Well, it won't be today, but it is a hard question to answer. Some companies are moving faster than others. Some have not really even started. So you get the bigger companies are slower, the smaller companies are faster. I think anything is possible, really, with this. But we're not saying that things are, it's very early, Jim, very early. Operator: The next question comes from Deepankar Roy with Brookline Capital Markets. Deepankar Roy: In terms of INVINCIBLE-4, is there any early observational data that suggests that the new regimen would preserve the good efficacy signal? And, or like, is the ongoing enrollment designed to answer that? Lewis Bender: Yes, so we haven't heard any news, good or bad, at this point. It's very early in the program. There are two people in. The more maybe in, we don't get reports all the time. And so far, we're waiting to see how these patients come out. Obviously, if the doctors are seeing that the skin irritation issue has been resolved, we think that the potential, based on what we've done in the first 14, will be very interesting for them to enroll. So I think we're going to have to wait for more enrollment before we can make any conclusions about anything, and the first two patients got our drug. And so therefore we'll have to see how these come out. Deepankar Roy: On INVINCIBLE-3, what is the specific blocker on the EU submission for it? Is the fact that the INVINCIBLE-4 approval moved faster than the one that we had, 3 which is still under review, does that suggest anything about the relative complexity or the risk profile for the EU reviewers? Lewis Bender: Yes, I think, well, so the study is only in France and Switzerland, so obviously we filed with the CTIS. The Swiss and the French filed the CTIS. We did not yet file the CTIS because with the Phase III study there's a lot more complexity in the CTIS, especially with all the five countries that we're working with, plus we don't want to get ahead of our capital. So we are preparing all the documentation. There's a lot more documentation when you have to translate into five countries' languages and of the synopsis of the informed consent form. There is a significantly larger amount of paperwork to do to get in Europe now. In the U.S. it's simple, we have one agency, we filed with the one agency, they review the study and we go, right? So that's obviously much faster. We don't have to translate, we don't have to do a whole bunch of things. But with Europe, there's a, we have five countries in Europe, it gets a lot more complicated. The French study in INVINCIBLE-4 is one country in Europe. And it's much quicker to do than the five countries in the United States. So the paperwork complexity in INVINCIBLE-3 is significantly more elevated than it was in the breast cancer study. Operator: The next question comes from Boris Tolkachev with Freedom Broker. Boris Tolkachev: I'll start with one follow-up on INVINCIBLE-4. After single-injection regimen was introduced, other than just dose reduction, were there any changes to patient enrollment criteria under the new protocol? Maybe less disease severity or tumor characteristics? Lewis Bender: There was nothing really major. To that, obviously, we had one now injection, so we changed some of the timing of when they would start the chemotherapy, immunotherapy. But there's no real other change other than dose of any consequence. Some different accessibility, a different specification on needle size, but not really much has changed other than the fact that we went to one injection, really. That's probably the biggest change. Boris Tolkachev: And maybe just a quick one on the patient number. You mentioned that there are like 44 patients who are meant to be enrolled. And my question is, are you going to treat this data from the whole population enrolled or some data separation strategies will be implemented, like first cohorts which already received two doses, and then second one which would fall under the single-injection regimen? Lewis Bender: That's a very good question. So because the dose number has changed, really, and the dose is different, we will add seven additional patients randomized to our drug. So we're adding the seven new to replace the seven from the first set of doses. And standard of care is the same, so there's no real reason to add new patients there. So we're going to be adding more patients into Cohort A to replace the ones that are coming out of Cohort A. Boris Tolkachev: I think I'll stick with one on INVINCIBLE-3. So you mentioned that you received some informative learnings from investigators of the study and that learnings helped to adjust the protocol. Can you give us a little bit of color what were the changes and what were the learnings? Lewis Bender: Yes, the two biggest changes were some patients were enrolled with tumors that were just really way too large to be treated effectively with anything. We didn't have an exclusion criteria on the size of the tumor, so we excluded some of the patients with tumors above 15 centimeters. This will be, I think this might already, will be on clinicaltrials.gov, because you have to have the inclusion criteria. People were coming in with, believe it or not, 39-centimeter-sized tumors. And that's just not treatable from any perspective. And so that was one of the exclusion criteria. And what the doctors wanted us to do, which I think is really good, is they wanted consistency in terms of telling them how to remove patients. So the criteria will go through a central reader. So there'll be a central review that will provide the information on what's happening in the tumors. So we've changed the criteria to go to a central read. I think that was the biggest change that the doctors wanted us to do, especially since we moved to a different criteria for read that the regulatory agencies have looked at. That's the two biggest things, that people coming in with massive tumor burden would not be benefiting from anything. And the doctors wanted us to do a central read on the scans for more consistency. Operator: This concludes our question and answer session. I would like to turn the conference back over for any closing remarks. Lewis Bender: Thank you, thank you, Betsy. Metastatic and refractory cancer, especially for patients with larger tumors, is often a death sentence. Once diagnosed, survival of metastatic cancer is measured in months, or if you're lucky, several years. We need new weapons to make cancer a chronic disease, as has been done with AIDS, where survival now is measured in decades. Our goal is to extend life for cancer patients as best we can. For local disease, we hope to push out the cancer into the future, way into the future so that we can give people higher quality of life and a much longer life expectancy. That's our goal. That's what we believe we have in this new product and this new technology that we use. And we will continue to push for these studies to continue. I thank you all for your time again today. Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect. 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Initiated activities to resume enrollment in a limited number of U.S. sites in the soft tissue sarcoma Phase 3 INVINCIBLE-3 Study by the third quarter of 2026 Patient treatment restarted in the presurgical triple negative breast cancer ("TNBC") Phase 2 INVINCIBLE-4 Study Cash and cash equivalents of $9.5 million as of June 30, 2026 Increased business development activities Conference call begins at 8:00 a.m. Eastern time today SHELTON, Conn., Aug. 11, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, announces second quarter 2026 financial results and provides a business update. Management will host a conference call and live webcast at 8:00 a.m. Eastern time today to review financial results and provide an update. The archived webcast will be available for replay shortly after the close of the call. Conference Call DetailsDate: August 11, 2026Time: 8:00 a.m. Eastern TimeDomestic Dial-In: (866) 652-5200International Dial-In: (412) 317-6060Webcast URL: https://event.choruscall.com/mediaframe/webcast.html?webcastid=bZ7JyAJE Business Update INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared with standard-of-care ("SOC") in second- and third-line treatment of certain soft tissue sarcoma subtypes. In April 2026, the Company initiated activities to resume enrollment in a limited number of U.S. sites in the INVINCIBLE-3 Study using an FDA-reviewed amended protocol based on important learnings from patients previously enrolled in the study. The Company paused new site activations and patient enrollment in March 2025 due to funding constraints. At that time, the trial had enrolled 21 patients, and the Company continued to treat all patients, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its contract research organizations at significantly reduced ongoing costs. In addition, during this pause, the Company obtained important feedback and recommendations about the trial from key investigators and sarcoma thought leaders, and modifications to the protocol were made. The FDA has reviewed the amended protocol, which will be implemented for new patient enrollment. Submission of documentation necessary for restarting in the EU is in progress. Site activation and patient enrollment rates are expected to increase as sufficient funding is obtained. INVINCIBLE-4 Study: Phase 2 open-label, randomized controlled, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before SOC in patients with early-stage, operable TNBC (Cohort A) and SOC alone (Cohort B). In July 2026, the Company restarted patient treatment in the INVINCIBLE-4 Study and is currently targeting complete enrollment by the end of 2027. The Company paused new patient enrollment in September 2025 to revise the dosing regimen for patients receiving INT230-6 in Cohort A due to some patients experiencing localized skin irritation near the tumor site. In March 2026, a protocol amendment was approved by the Swissmedic and the Swiss Ethics Committee to use a lower drug volume per tumor volume ratio and a single injection of INT230-6 in Cohort A. In August 2026, the Company opened its first site in France for accrual following EU submission of the modified protocol. Preliminary data from the first 14 patients (seven in each cohort) showed a 71% pathological complete response ("pCR") in patients receiving INT230-6 in Cohort A and a 42% pCR in patients receiving the SOC alone (Cohort B). There was also a 44% reduction in grade 3 adverse events in Cohort A compared with Cohort B and fewer immune-related adverse events when INT230-6 was added prior to the immunochemotherapy. Capital Raises In March 2026, the Company established a $60 million at-the-market ("ATM") facility. During the second quarter of 2026, the Company raised net proceeds of $1.6 million under the ATM. Subsequent to June 30, 2026, the Company has raised additional net proceeds of $1.3 million under the ATM. "We are pleased that the capital raised in 2025 and to date in 2026 provides the resources to reinitiate the Phase 3 INVINCIBLE-3 Study. In addition, during the 2025 pause, we evaluated and modified the protocol based on feedback from key investigators and sarcoma thought leaders. The FDA-reviewed amended protocol will first be implemented in select U.S. sites," stated Lewis H. Bender, Founder, President and CEO of Intensity. "In the Phase 2 INVINCIBLE-4 Study, early data show potential for an improvement in the pCR rate with a reduction in the number of grade 3 adverse events including immune-related adverse events. These preliminary findings are encouraging, and we are excited that investigators have restarted treatment in patients in Switzerland. We look forward to enrolling new patients in this study in France now that sites are being activated. Lastly, we continue to pursue potential partnerships to advance our programs, and held meetings with potential strategic partners at the BIO International Conference in late June. While early, we are pleased with the interest expressed in our science and clinical trials, and we expect to continue discussions in the second half of 2026." Second Quarter 2026 Financial Results Research and development expenses were $1.8 million for the second quarter of 2026, compared with $1.5 million for the same period in 2025. The increase was primarily due to higher INVINCIBLE-3 Study costs as the Company initiated activities to resume enrollment in a limited number of U.S. sites in April. The Company paused new site activations and patient enrollments in March 2025 due to funding constraints. Research and development expenses also increased due to an estimated bonus accrual during the second quarter of 2026 compared with no bonus accrual during the second quarter of 2025, which was partially offset by lower stock-based compensation. General and administrative expenses were $1.3 million for the second quarter of 2026, compared with $1.2 million for the same period in 2025. The increase was due to an estimated bonus accrual during the 2026 quarter compared with no bonus accrual during 2025 quarter, and higher Delaware franchise costs. These increases were partially offset by lower stock-based compensation as no stock-based compensation awards were granted during the first half of 2026. Net loss was $3.0 million for the second quarter of 2026, compared with a net loss of $2.5 million for the second quarter of 2025. As of June 30, 2026, cash and cash equivalents totaled $9.5 million. During the second quarter of 2026, the Company raised $1.7 million under the ATM, for net proceeds of $1.6 million. About Triple Negative Breast Cancer in the Presurgical Setting Women with aggressive forms of breast cancer, such as TNBC, are often counseled to undergo neoadjuvant (presurgical) systemic therapy to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of disease recurrence from 50% to 16% at 5 years. Approximately 11% to 17% of breast cancers test negative for estrogen receptors ("ER"), progesterone receptors ("PR"), and overexpression of human epidermal growth factor receptor 2 ("HER2") protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 worldwide diagnosed each year, 85% of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immunochemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates range from 50% to 65%, depending on tumor size. Rates are generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 77% of patients experiencing grade 3 or higher treatment-related adverse events, including treatment-related adverse events that lead to death in 0.5% of patients. About Sarcoma Soft tissue sarcoma is a rare type of cancer that starts with the growth of cells in the body's soft tissue, such as muscle, fat, blood vessels, nerves, tendons, and linings of the joints. The disease mostly occurs in the arms, legs and abdomen. There are 197,000 patients in the US living with sarcoma and more than 100 types of soft tissue sarcoma, the treatment of which first involves surgery. Other treatments might include radiation therapy and then chemotherapy. Using the U.S. SEER database, the Company estimated that 14,400 patients have regional or distal (metastatic) leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma. About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases, even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose-escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized controlled clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second- or third-line monotherapy compared with SOC, with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, formerly SAKK and now the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573), as part of a Phase 2/3 program evaluating INT230-6 followed by SOC immunochemotherapy and SOC alone for patients with presurgical triple-negative breast cancer. pCR is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com or review our SEC filings. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. 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. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and in the Company's subsequent SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact:Justin KulikCORE [email protected] (516) 222-2560 Media Contact:Matt CosselCORE [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-reports-second-quarter-2026-financial-results-and-provides-business-update-302847626.html

Company to hold a conference call at 8AM ET on August 11, 2026 to review results and provide a corporate update SHELTON, Conn., Aug. 4, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, today announced that it will report financial results for the second quarter ended June 30, 2026, before the market opens on August 11, 2026. Company management will host a conference call and live webcast at 8:00 AM Eastern Time that day to review financial results and provide a corporate update. The archived webcast will be available for replay shortly after the close of the call. Conference Call Details Date: August 11, 2026 Time: 8:00 a.m. Eastern Time Domestic Dial-In: (866) 652-5200 International Dial-In: (412) 317-6060 Webcast URL: https://event.choruscall.com/mediaframe/webcast.html?webcastid=bZ7JyAJE About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the SOC with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. pCR is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com or review our SEC filings. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. 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. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and in the Company's subsequent SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact:Justin KulikCORE [email protected] (516) 222-2560 Media Contact:Matt CosselCORE [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-to-announce-second-quarter-2026-financial-results-on-august-11-2026-302842316.html

Cash and cash equivalents of $10.2 million as of March 31, 2026 Favorable efficacy and safety reported in a small sample of triple negative breast cancer ("TNBC") patients receiving INT230-6 prior to the standard of care ("SOC") compared to SOC alone in the INVINCIBLE-4 Study (as defined below) Approval to resume enrollment obtained in the INVINCIBLE-4 Study; plans to resume enrollment in the second quarter of 2026 Decision to resume enrollment in a limited number of U.S. sites in the INVINCIBLE-3 Study (as defined below) by the third quarter of 2026 SHELTON, Conn., May 7, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, announces first quarter 2026 financial results and provides a corporate update. Corporate Update INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple negative breast cancer and SOC alone. In March 2026, the Company reported the following: Preliminary observations of the INVINCIBLE-4 Study showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to SOC ("Cohort A") achieved a pathological complete response ("pCR") whereas two (2) out of six (6) (33%) patients in the SOC arm alone ("Cohort B") achieved a pCR, with one patient still to be evaluated. Forty-four percent (44%) fewer grade 3 or higher adverse events were observed in Cohort A compared to Cohort B. A protocol amendment was submitted to Swissmedic, Switzerland's regulatory authority, and the Switzerland Ethics Committee to resume enrollment. Full approval to resume enrollment was granted on March 26, 2026. The Company plans to resume enrollment in the second quarter of 2026. The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference. INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes. In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Before this pause, the trial had enrolled 21 patients. The Company has continued to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its third-party contract research organizations at significantly reduced ongoing costs during this pause. In April 2026, the Company decided to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites by the third quarter of 2026, and has prioritized commencing full patient enrollment and site activations in this study once sufficient incremental funding is obtained. Lewis H. Bender, Founder, President, and CEO, stated, "The Company made excellent progress in the first quarter. We announced early data from the INVINCIBLE-4 Study, our randomized controlled study in TNBC, showing the possibilities for INT230-6 to increase efficacy while also potentially improving safety. We are now seeking additional patients in our INVINCIBLE-4 Study in Switzerland and expect to initiate enrollment in France in the second or third quarter of 2026. Further, after a successful funding campaign in 2025 and the establishment of a $60 million ATM facility in March 2026, we have made the decision to reinitiate enrollment of our INVINCIBLE-3 Study and plan to manage our cash burn judiciously. Both of our clinical trials focus on indications with high unmet medical need." First Quarter 2026 Financial Results Research and development expenses were $1.2 million for the three months ended March 31, 2026, compared to $2.2 million for the same period in 2025. The decrease was primarily due to lower INVINCIBLE-3 Study costs. In March 2025, the Company paused new site activations and patient enrollments in the INVINCIBLE-3 Study due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. The Company has continued to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause. The Company plans to resume enrollment in the INVINCIBLE-3 Study in a limited number of U.S. sites by the third quarter of 2026, and has prioritized commencing full patient enrollment and site activations once sufficient funding is obtained. In addition, lower headcount-related costs in 2026 were entirely offset by an estimated bonus accrual during the three months ended March 31, 2026 compared to no bonus accrual during the three months ended March 31, 2025. General and administrative expenses were $1.3 million for the three months ended March 31, 2026, compared to $1.2 million for the same period in 2025. The increase was due to an estimated bonus accrual during the three months ended March 31, 2026 compared to no bonus accrual during the three months ended March 31, 2025. This increase was partially offset by lower stock-based compensation and one-time expenses related to our reverse stock split in February 2026. Overall, net loss was $2.4 million for the three months ended March 31, 2026, compared to a net loss of $3.3 million for the three months ended March 31, 2025. As of March 31, 2026, cash and cash equivalents totaled $10.2 million. About Triple Negative Breast Cancer in the Presurgical Setting Women with aggressive forms of breast cancer, such as Triple Negative Breast Cancer ("TNBC"), are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of disease recurrence from 50% to 16% at 5 years. Approximately 11 to 17% of breast cancers test negative for estrogen receptors ("ER"), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 ("HER2") protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 worldwide diagnosed each year, 85% of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immunochemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates range from 50 to 65%, depending on tumor size. Rates are generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 77% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients. About Sarcoma Soft tissue sarcoma is a rare type of cancer that starts with the growth of cells in the body's soft tissue, such as muscle, fat, blood vessels, nerves, tendons, and linings of the joints. The disease mostly occurs in the arms, legs and belly. There are 197,000 patients in the US living with sarcoma and more than 100 types of soft tissue sarcoma, the treatment of which first involves surgery. Other treatments might include radiation therapy and then chemotherapy. Using the U.S. SEER database, the Company estimated that 14,400 patients have regional or distal (metastatic) leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma. About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the SOC with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, formerly SAKK, now the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. pCR is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com or review our SEC filings. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. 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. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and in the Company's subsequent SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik CORE IR [email protected] (516) 222-2560 Media Contact: Matt Cossel CORE IR [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-reports-first-quarter-2026-financial-results-and-provides-corporate-update-302766229.html

Raised over $20 million in gross proceeds in 2025 and held $11.9 million in cash and cash equivalents as of December 31, 2025, with a cash runway into the second quarter of 2027 IT-01 Study manuscript of INT230-6 used alone in 64 refractory metastatic cancer patients published in the Lancet's journal eBioMedicine, including data for disease control rate, overall survival, immune activation, abscopal effects, tumor necrosis, dose ranging, and safety Favorable efficacy and safety reported in a small sample of triple negative breast cancer ("TNBC") patients receiving INT230-6 prior to the standard of care ("SOC") compared to SOC alone in the INVINCIBLE-4 Study SHELTON, Conn., March 27, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, announces 2025 year-end financial results and highlights, and provides a corporate update. Corporate Update INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple negative breast cancer and SOC alone. In March 2026, the Company reported the following: Preliminary observations of the INVINCIBLE-4 Study showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to SOC ("Cohort A") achieved a pathological complete response ("pCR") whereas two (2) out of six (6) (33%) patients in the SOC arm alone ("Cohort B") achieved a pCR, with one patient still to be evaluated. Forty-four percent (44%) fewer grade 3 or higher adverse events were observed in Cohort A compared to Cohort B. A protocol amendment was submitted to Swissmedic, Switzerland's regulatory authority, and the Switzerland Ethics Committee to resume enrollment. Full approval to resume enrollment was granted on March 26, 2026. The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference. INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes. In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Before this pause, the trial had enrolled 21 patients. The Company continues to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance, and conduct other study-related activities in cooperation with its third-party contract research organizations at significantly reduced ongoing costs during this pause. The Company has prioritized reinitiating patient enrollment and site activations during 2026 once sufficient funding is obtained. IT-01 Study Manuscript Publication In October 2025, the Company reported that eBioMedicine, a Lancet Discovery Science journal, published the Company's phase 1/2 IT-01 clinical study manuscript, "Safety and Efficacy of Intratumourally Administered INT230-6 in Adult Patients with Advanced Solid Tumours: Results from an Open-Label Phase 1/2 Dose Escalation Study," for the treatment of metastatic or refractory cancers. The manuscript included the following data results: In heavily pretreated patients with advanced disease having over 20 different types of cancer who had progressed following multiple prior lines of therapy, intratumoral INT230-6 achieved: A disease control rate of 75% (48/64 patients) and median overall survival ("mOS") of 11.9 months; these results compare favorably in phase 1/2 studies that historically reported an mOS of 4 to 7 months In a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 months In an exploratory analysis comparing patients receiving INT230-6 at a total dose (in mL) that treated greater than 40% of the patient's total tumor burden ("TTB") compared to those treated with less than 40% of their TTB, the: Disease control rate was 83.3% (40/48) compared to 50% (8/16) Median overall survival was 18.7 months (95% CI: 11.5–23.5) compared to 3.1 months (95% CI: 1.6–5.9) with a hazard ratio (HR) of 0.17 (95% CI: 0.081–0.342); P<0.0001 Improved survival was consistent across a range of low to high tumor burden and tumor sizes Approximately 20% of patients in the >40% group had uninjected tumors shrink, abscopal effects Fifteen of 64 patients survived for more than 21 months INT230-6 induced a qualitative decrease in proliferating cancer cells in injected tumors and a qualitative increase in activated T-cells infiltrating the tumor microenvironment No dose-limiting toxicities were reported among 64 monotherapy patients; seven patients had a grade 3 (10.9%) with no grade 4 or 5 treatment-related adverse events Pharmacokinetic results showed that greater than 95% of the active cytotoxic agents remained in the injected tumors Cash and Cash Runway In 2025, the Company raised over $20 million in gross proceeds through two public offerings, one registered direct offering, and ATM issuances. These successful capital-raising efforts strengthened Intensity's balance sheet with cash and cash equivalents of $11.9 million as of December 31, 2025, and extended its current operating runway into the second quarter of 2027. Lewis H. Bender, Founder, President, and CEO, stated, "Our data published in the Lancet's eBioMedicine journal for the treatment of metastatic disease, and the results reported on the safety and efficacy in the INVINCIBLE-4 study were promising and unique for a locally-delivered oncology drug. With the capital raised in 2025 and an unused $60 million ATM facility in place, we intend to resume patient enrollment in both studies as soon as possible. The American Cancer Society ("ACS") estimates that roughly 6,400 more deaths occurred in 2025 than in 2024, a trend that continues every year. Intensity remains committed to helping patients live longer, healthier lives with less toxicity. The ACS data supports the conclusion that today's cancer treatments have many limitations, and that the unmet medical need for new ideas and better cancer therapies remains as strong as ever." 2025 Year End Financial Results Research and development expenses were $6.8 million for the year ended December 31, 2025, compared to $10.5 million for the same period in 2024. Clinical trial expenses decreased $2.8 million primarily due to lower INVINCIBLE-3 Study costs. In March 2025, the Company paused new site activations and patient enrollments in the INVINCIBLE-3 Study due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. The Company will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause, and the Company plans to restart site activations and patient enrollment as soon as possible. Contract manufacturing costs declined by $0.6 million, as there were no new manufacturing batches of INT230-6 in 2025, along with $0.5 million of lower stock-based compensation. These decreases were partially offset by $0.3 million of bonus accruals for 2025 compared to zero bonus accruals for 2024. General and administrative expenses were $5.2 million for the year ended December 31, 2025, compared to $6.1 million for the same period in 2024. Stock-based compensation decreased $0.6 million in 2025, and legal, audit, consulting, insurance and other general & administrative costs decreased due to cost efficiencies and less corporate development activity compared to the prior year period. These decreases were partially offset by $0.5 million of bonus accruals for 2025 compared to zero bonus accruals for 2024. Overall, net loss was $11.6 million for the year ended December 31, 2025, compared to a net loss of $16.3 million for the year ended December 31, 2024. As of December 31, 2025, cash and cash equivalents totaled $11.9 million. About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the SOC with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, formerly SAKK, now the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. pCR is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com or review our SEC filings. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. 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. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and in the Company's subsequent SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik CORE IR [email protected] (516) 222-2560 Media Contact: Matt Cossel CORE IR [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-reports-2025-year-end-financial-results-and-highlights-and-provides-corporate-update-302727626.html

The Company expects to file a protocol amendment in the INVINCIBLE-4 Study to revise the dosing regimen for the INT230-6 treatment cohort, and to reinitiate patient enrollment in the first quarter of 2026 IT-01 Study manuscript published, featuring a comprehensive evaluation of data, including disease control rate, overall survival, immune activation, abscopal effects, tumor necrosis, dose ranging, and safety $7.1 million cash and cash equivalents as of September 30, 2025, with an incremental $6.1 million raised in the fourth quarter of 2025 Cash runway extended until the end of the first quarter of 2027 SHELTON, Conn., Nov. 6, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, announces third quarter 2025 financial results and provides a corporate update. Corporate Update INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. In October 2024, in collaboration with the Swiss Cancer Group, formerly the Swiss Cancer Group for Clinical Cancer Research (SAKK), the Company initiated and dosed our first patient in the INVINCIBLE-4 Study. In September 2025, the Company paused new patient enrollment to revise the dosing regimen for patients receiving INT230-6 in cohort A due to some patients in Cohort A experiencing localized skin irritation near the tumor site. The Company plans to file a protocol amendment for this revision in dosing in the first quarter of 2026, and expects to reinitiate enrollment for the 54-patient study in the first quarter of 2026. The Company is targeting to complete enrollment by the end of 2026 and will likely add resources to help sites enroll. INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes. This study has been authorized by the US FDA, Health Canada, the European Medicines Agency (for France, Germany, Italy, Poland, and Spain), and Australia's Therapeutic Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival. In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. The Company continues to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance and other study related activities in cooperation with its third-party contract research organizations to reduce ongoing costs during this pause. Once sufficient funding is obtained, the Company plans to restart site activations and patient enrollment in the INVINCIBLE-3 Study. IT-01 Study Manuscript Publication: On October 29, 2025, eBioMedicine, a Lancet Discovery Science journal, published the Company's phase 1/2 IT-01 clinical study manuscript, "Safety and Efficacy of Intratumourally Administered INT230-6 in Adult Patients with Advanced Solid Tumours: Results from an Open-Label Phase 1/2 Dose Escalation Study," for the treatment of metastatic or refractory cancers. The manuscript included the following data results: In heavily pretreated patients with advanced disease having over 20 different types of cancer who had progressed following multiple prior lines of therapy, intratumoral INT230-6 achieved: A disease control rate of 75% (48/64 patients) and median overall survival (mOS) of 11.9 months; these results compare favorably in phase 1/2 studies that historically reported an mOS of 4 to 7 months In a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 months In an exploratory analysis comparing patients receiving INT230-6 at a total dose (in mL) that treated greater than 40% of the patient's total tumor burden ("TTB") compared to those treated with less than 40% of their TTB, the: Disease control rate was 83.3% (40/48) compared to 50% (8/16) Median overall survival was 18.7 months (95% CI: 11.5–23.5) compared to 3.1 months (95% CI: 1.6–5.9) with a hazard ratio (HR) of 0.17 (95% CI: 0.081–0.342); P<0.0001 Improved survival was consistent across a range of low to high tumor burden and tumor sizes Approximately 20% of patients in the >40% group had uninjected tumors shrink, abscopal effects Fifteen of 64 patients survived for more than 21 months INT230-6 induced a qualitative decrease in proliferating cancer cells in injected tumors and a qualitative increase in activated T-cells infiltrating the tumor microenvironment No dose-limiting toxicities were reported among 64 monotherapy patients; seven patients had a grade 3 (10.9%) with no grade 4 or 5 treatment-related adverse events Pharmacokinetic results showed that greater than 95% of the active cytotoxic agents remained in the injected tumors Capital Raises and Cash Runway: the Company has raised $13.6 million in gross proceeds since the beginning of the third quarter of 2025. $7.5 million raised in the third quarter of 2025 via the Company's ATM (net proceeds of $7.2 million). $2.1 million raised in October 2025 via the Company's ATM (net proceeds of $2.0 million). $4.0 million raised in October 2025 in a registered direct offering with an institutional investor, before deducting the placement agent's fees and related offering expenses (net proceeds of $3.7 million). With the capital raised to date, the Company has extended its cash runway until the end of the first quarter of 2027. "In the past four months, we were able to substantially improve our balance sheet with multiple fundraising transactions. In particular, the October 2025 registered direct offering was significant, as this brought in a new long-term fundamental, healthcare-savvy investor. The new capital raised in 2025 enables us to execute on our business strategy until the end of the first quarter of 2027 without any additional funds. In addition, our peer-reviewed paper published in the Lancet Discovery Group's journal, eBioMedicine, provides another level of validation of the potential of our lead drug INT230-6, injected directly into tumors, to treat multiple types of cancer in both the metastatic and local disease settings. We believe this is the first peer-review publication of a local therapy alone to report disease control rate, the potential for an overall survival benefit and a 20% patient abscopal rate in metastatic disease," stated Lewis H. Bender, Intensity Founder, President and CEO. "Lastly, working with our collaboration partners at the Swiss Cancer Institute, we analyzed the data from the patients in the Phase 2 randomized controlled INVINCIBLE-4 study, and have identified a path forward to restarting the study, which is expected to be in the first quarter of 2026. The endpoint will remain pathological complete response, which is accepted by FDA for accelerated approval." Third Quarter 2025 Financial Results Research and development expenses were $1.6 million for the three months ended September 30, 2025, compared to $2.2 million for the same period in 2024. Clinical trial expenses decreased $0.4 million primarily due to lower INVINCIBLE-3 Study costs. In March 2025, the Company paused new site activations and patient enrollments in the INVINCIBLE-3 Study, due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. The Company will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause, and once sufficient funding is obtained, the Company plans to restart site activations and patient enrollment. General and administrative expenses were $1.2 million for the three months ended September 30, 2025, compared to $1.4 million for the same period in 2024. Consulting expense decreased due to less business development activity compared to the prior year period. Overall, net loss was $2.7 million for the three months ended September 30, 2025, compared to a net loss of $3.5 million for the three months ended September 30, 2024. As of September 30, 2025, cash and cash equivalents totaled $7.1 million. About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that facilitates the dispersion of potent cytotoxic drugs throughout tumors, allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6; a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study (the "INVINCIBLE-4 Study") (NCT06358573) in collaboration with the Swiss Cancer Group, formerly the Swiss Group for Clinical Cancer Research SAKK, as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. 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. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in the Company's subsequent SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik [email protected] (516) 222-2560 Media Contact: Matt Cossel CORE IR [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-reports-third-quarter-2025-financial-results-and-provides-corporate-update-302607692.html

The paper features a comprehensive evaluation of data, including disease control rate, overall survival, immune activation, abscopal effects, tumor necrosis, dose ranging, and safety The manuscript is open access The Company will host a webinar with the paper's lead and senior authors from the University of Southern California to discuss the results on Friday, October 31, 2025, at 9:00 AM (see below) SHELTON, Conn., Oct. 30, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, announces that eBioMedicine, a Lancet Discovery Science journal, has published the Company's phase 1/2 IT-01 clinical study manuscript for the treatment of metastatic or refractory cancers. The full text article, "Safety and Efficacy of Intratumourally Administered INT230-6 in Adult Patients with Advanced Solid Tumours: Results from an Open-Label Phase 1/2 Dose Escalation Study," can be viewed via Online First 105980 October 29, 2025. Jacob Stephen Thomas, M.D. Assistant Professor of Clinical Medicine at Keck School of Medicine of the University of Southern California (USC) and medical oncologist with USC's Norris Comprehensive Cancer Center, is the first author. Anthony El-Khoueiry, M.D., Associate Director for Clinical Research and Chief of Section of Developmental Therapeutics/Phase I Program at USC Norris, is the senior and corresponding author. The manuscript includes the following data results: In heavily pretreated patients with advanced disease having over 20 different types of cancer who had progressed following multiple prior lines of therapy, intratumoral INT230-6 achieved: A disease control rate of 75% (48/64 patients) and median overall survival (mOS) of 11.9 months; these results compare favorably in phase 1/2 studies that historically reported an mOS of 4 to 7 months In a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 months In an exploratory analysis comparing patients receiving INT230-6 at a total dose (in mL) that treated greater than 40% of the patient's total tumour burden ("TTB") compared to those treated with less than 40% of their TTB, the: Disease control rate was 83.3% (40/48) compared to 50% (8/16) Median overall survival was 18.7 months (95% CI: 11.5–23.5) compared to 3.1 months (95% CI: 1.6–5.9) with a hazard ratio (HR) of 0.17 (95% CI: 0.081–0.342); P<0.0001 (see Figure 1 below) Improved survival was consistent across a range of low to high tumor burden and tumor sizes Approximately 20% of patients in the >40% group had uninjected tumors shrink, abscopal effects Fifteen of 64 patients survived for more than 21 months INT230-6 induced a qualitative decrease in proliferating cancer cells in injected tumors and a qualitative increase in activated T-cells infiltrating the tumor microenvironment No dose-limiting toxicities were reported among 64 monotherapy patients; seven patients had a grade 3 (10.9%) with no grade 4 or 5 treatment-related adverse events Pharmacokinetic results showed that greater than 95% of the active cytotoxic agents remained in the injected tumors "INT230-6 is a local treatment that kills cancer using a diffusion process following direct injection into tumors. The trial demonstrated favorable safety and promising efficacy in patients with advanced metastatic cancers who had failed a median of three prior lines of therapy. The disease control rates and median survival compare favorably to those historically seen for such a diverse set of refractory cancer types in a phase 1/2 study," said Jacob S. Thomas, M.D. "There were also several learnings about INT230-6 dosing and safety gained during this trial. The pharmacokinetic data indicated that high rates of the drug are absorbed by the injected tumor, with minimal leakage, even at doses as high as 175 mL administered to a single tumor. These results are consistent with the low incidence of grade 3 adverse events observed." "The mechanism by which cancer is killed through the diffusion of cytotoxic agents following intratumoral injection of INT230-6 and systemic immune activation, as observed in preclinical models, translated well in the human setting. Uninjected tumors shrinking from a locally administered therapy, referred to as abscopal effects, are generally rare for local therapies. Yet, an abscopal effect was observed in at least 20% of 48 patients who received drug volumes above 40% of their tumor burden. In addition, in thirteen of fourteen matched pair biopsy slides, a notable increase in activated CD4+ and CD8+ T cells was observed in the tumor microenvironment in response to INT230-6 treatment. Representative images can be found in the paper," said Anthony El-Khoueiry M.D. "The abscopal effects and immune cell infiltration observed in this study highlight this intratumoral therapy's potential to drive both a local and systemic anti-cancer activity." "This comprehensive paper is the culmination of over a decade of nonclinical and clinical research. The article describes the development of a new technology to destroy tumors using molecular agents that can disperse potent anti-cancer compounds within injected tumors and deliver them into cancer cells. We believe these are the first clinical results where a locally administered therapy used alone could potentially extend survival for patients with metastatic disease," said Lewis H. Bender, Founder, President, and CEO of Intensity Therapeutics, Inc. "As Drs. Thomas and El-Khoueiry noted, our paper reports that INT230-6 injected into visible tumors in metastatic patients at an amount based on the size of the injected tumors supports the hypothesis that INT230-6 causes immunologic cancer cell death, even in cancers that are considered immunologically cold. Given the drug's mechanism of action and the data reported in this paper from over 20 types of metastatic solid cancers, such as breast, sarcoma, pancreatic, lung, and head and neck, we believe the study results show the potential of INT230-6 to achieve clinical benefit for metastatic patients of multiple cancer types with or without the use of radiation, systemic drugs or immunotherapy. As a result, we have initiated randomized controlled studies, including a Phase 3 study in sarcoma (NCT06263231)." The Company will be hosting a conference call featuring two key authors of the study on Friday, October 31, 2025 at 9:00AM ET to discuss the results. Interested parties can access the call by clicking here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=6uG6ARFf. Participants are encouraged to log on at least 10 minutes prior to the start of the event. About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy. About Study Intensity's Clinical Study IT-01 IT-01 was Intensity's first-in-human, open-label, single-arm phase 1/2 study (NCT03058289) using INT230-6. The study was conducted in patients with advanced, refractory, or metastatic solid tumors at six clinical sites in addition to USC. Other investigators were from Johns Hopkins University, Princess Margaret Hospital in Toronto, Columbia Presbyterian in New York, The Fox Chase Cancer Center in Philadelphia, Houston Methodist, and UMass Memorial. The study was comprised of adults with histologically or cytologically confirmed advanced or metastatic solid tumors who did not respond to or were not candidates for standard therapies and had accessible superficial and/or deep tumors for injection. Dose escalation was achieved by increasing the initial and subsequent total dose volumes (total injected amount), the maximum injected volume per any single tumor, the ratio of drug-volume to tumor-size, the number of injected tumors per session, and the dose frequency (once per month vs. every 2 weeks). Maintenance dosing was added in protocol amendments. A tumor's dose was set as a percentage of the volume of the target tumor, which was calculated from radiologic measurements. There were six monotherapy dose cohorts. About eBioMedicine eBioMedicine is a leading open-access translational research journal within the Lancet Discovery Group of journals. eBioMedicine encompasses the spectrum of biomedical research, ranging from preclinical studies with clear human relevance to proof-of-concept, first-in-human studies, and early-phase clinical trials. The journal's editors are dedicated to publishing original research that investigates the basic determinants of human health and disease, the discovery and characterization of new therapeutic targets and treatments, and the identification of biomarkers and diagnostic tools that may help researchers and clinicians better understand and monitor disease. The Journal welcomes studies that elucidate, or aims to modify, disease pathways and mechanisms—to advance knowledge in any biomedical discipline with relevance to human health. The Impact Factor of eBioMedicine is 10.8, according to The Lancet. This indicates that the journal's content is highly cited within the scientific community, particularly within the two years preceding the Journal Citation Reports year. About Intensity Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, formerly SAKK, now the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com or review our SEC filings. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. 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. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in the Company's subsequent SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik [email protected] CORE IR (516) 222-2560 Media Contact: Matt Cossel CORE IR [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-inc-announces-publication-of-clinical-results-of-int230-6-for-the-treatment-of-metastatic-or-refractory-cancers-in-ebiomedicine-a-lancet-discovery-science-journal-302599519.html

Over $11 million raised since the beginning of 2Q 2025 Cash runway extended into the second half of 2026 In the INVINCIBLE-4 Study, patients receiving INT230-6 prior to the start of standard of care achieved high levels of tumor necrosis in 8 days INT230-6 achieved 100% complete response rate in preclinical models of malignant peripheral nerve sheath tumors SHELTON, Conn., Aug. 7, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, announces second quarter 2025 financial results and provides a corporate update. Corporate Update INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. In April, the European Medicines Agency authorized the initiation of the INVINCIBLE-4 Study in France in collaboration with Unicancer (UCBG), the French referent cooperative group in breast cancer accredited by the French National Cancer Institute (INCa). The INVINCIBLE-4 Study is currently recruiting patients in Switzerland and France. The expected total is 54 patients. In June 2025 we showed images from the trial of a patient who received two doses of INT230-6. Prior to the injections, the tumor was active. In the post INT230-6 injection scans, the tumor became dark with only diminished live cancer observed at the interface of the healthy tissue and necrotic tumor. INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for specific soft tissue sarcoma subtypes. This study has been authorized by the US FDA, Health Canada, the European Medicines Agency (for France, Germany, Italy, Poland, and Spain), and Australia's Therapeutic Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival. In March 2025, new patient enrollment and site activations were paused due to funding issues; however, patients who were already enrolled continue to be dosed, followed and monitored. Capital Raises and Cash Runway: Since the beginning of the second quarter of 2025, the Company has raised an aggregate of $11.3 million, with net proceeds of approximately $10.1 million in two public offerings and At-the Market offerings (the "ATM"), and has extended its cash runway into the second half of 2026. In April 2025, the Company entered into a Securities Purchase Agreement with certain institutional investors participating in a public offering and raised an aggregate of $2.35 million, with net proceeds after deducting the fees and expenses of approximately $1.9 million. In June 2025, the Company entered into an Underwriting Agreement with ThinkEquity LLC in a public offering and raised an aggregate of $2.3 million, with net proceeds after deducting the fees and expenses of approximately $1.8 million. In July 2025, the Company raised an aggregate of $6.6 million via its ATM, with net proceeds after deducting the fees and expenses of approximately $6.3 million. "In a challenging financial market, we were able to raise capital and lower our burn rate during the second quarter to continue to treat patients in our two studies, and in July 2025, high liquidity in our stock allowed us to raise additional gross proceeds of $6.6 million at a lower incremental cost. This new capital extends our operating runway considerably, with the remaining capacity under the ATM facility to be used selectively and strategically. Given the capital raised to date, we also believe that we are now compliant with Nasdaq's minimum stockholders' equity listing requirements, pending Nasdaq's confirmation," stated Lewis H. Bender, Intensity Founder, President, and CEO. "In the INVINCIBLE-4 Study, scan images indicate a substantial decrease in tumor activity following two doses of our drug as patients begin their immune-chemo regimen. Based on our prior studies, we believe this effect should be beneficial in increasing the pathological response rate in the cohort of patients receiving our drug and expect to obtain pathology data in 2H of 2026. Lastly, as always, the Company is driven by a focus on patients. This quarter, we strengthen that commitment by forming a collaboration with the author, model, executive producer, speaker, and breast cancer survivor Christine Handy to raise patient awareness of new treatment options on the horizon for patients with early-stage disease." Second Quarter 2025 Financial Results Research and development expenses were $1.5 million for the three months ended June 30, 2025, compared to $3.6 million for the same period in 2024. Clinical trial expenses decreased $1.5 million primarily due to lower INVINCIBLE-3 Study costs. In March 2025, the Company paused new site activations and patient enrollments in the INVINCIBLE-3 Study, due to funding constraints. Prior to this pause, the trial had enrolled 23 patients. The Company will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause, and once sufficient funding is obtained, the Company plans to restart site activations and patient enrollment. General and administrative expenses were $1.2 million for the three months ended June 30, 2025, compared to $1.5 million for the same period in 2024. Insurance expense decreased due to the favorable directors and officers insurance renewal terms compared to the prior policy year, and legal and other expenses decreased as a result of cost saving from the integration of new systems in the administrative areas. Overall, net loss was $2.5 million for the three months ended June 30, 2025, compared to a net loss of $5.0 million for the three months ended June 30, 2024. As of June 30, 2025, cash and cash equivalents totaled $2.2 million. About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that facilitates the dispersion of potent cytotoxic drugs throughout tumors, allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6; a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study (the "INVINCIBLE-4 Study") (NCT06358573) in collaboration with the Swiss Cancer Group, formerly the Swiss Group for Clinical Cancer Research SAKK, as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. 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. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and in the Company's subsequent SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik [email protected] (558) 230-6401 Media Contact: Jules Abraham CORE IR [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-reports-second-quarter-2025-financial-results-and-provides-corporate-update-302524797.html SOURCE Intensity Therapeutics Inc.

Eight Swiss sites are activated in the INVINCIBLE-4 Study, and several patients have been treated European Medicines Agency Authorization to initiate INVINCIBLE-4-Study in France SHELTON, Conn., May 13, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, announces first quarter 2025 financial results and provides a corporate update. Corporate Update INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer ("TNBC") and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. The INVINCIBLE-4 Study is recruiting patients in Switzerland and is expected to enroll 54 patients across Switzerland and France. In April 2025, the Company and The Swiss Group for Clinical Cancer Research SAKK, a decentralized academic research institute that has been conducting clinical trials of cancer treatments in all major Swiss hospitals since 1965, announced that the European Medicines Agency has authorized the initiation of the INVINCIBLE-4 Study in France in collaboration with Unicancer. The Unicancer French breast intergroup (UCBG) is the French referent cooperative group in breast cancer. The French National Cancer Institute (INCa) accredited the group in 2013, thus acknowledging its academic excellence and operational capability. Since its creation, the group has conducted more than 40 national and international multicenter clinical trials, as well as various translational research projects. INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority (for France, Germany, Italy, Poland and Spain), and Australia's Therapeutics Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival. In March 2025, the Company paused new site activations and patient enrollments due to funding constraints, and prioritized funding for the INVINCIBLE-4 Study. Prior to this pause, the trial had enrolled 23 patients. The Company will continue to treat all patients enrolled in this study in cooperation with its third-party contract research organizations to reduce ongoing costs during this pause. April 2025 Public Offering: In April 2025, the Company entered into a Securities Purchase Agreement with certain institutional investors participating in a public offering and raised an aggregate of $2.35 million, with net proceeds after deducting the fees and expenses of approximately $1.9 million. "The first quarter saw continued progress in our important programs despite high volatility in the markets and funding constraints," stated Lewis H. Bender, Intensity Founder, President, and CEO. "Several patients in our sarcoma study had their first follow-up scans, which showed high levels of necrosis in the injected tumors. Site contracting, site activation and patient enrollment were increasing nicely. However, due to cash needs, we made the necessary decision to pause the Phase 3 sarcoma enrollment and site activation until additional funding becomes available. We are working closely with our vendors and sites to treat those patients enrolled in INVINCIBLE-3, while maintaining the pharmacovigilance, site monitoring and the study database. Meanwhile, our partners SAKK and Unicancer will continue to work with the leading hospitals in Switzerland and France to seek patients for our breast cancer trial, INVINCIBLE-4. We believe in the potential for our drug to positively impact the lives of metastatic sarcoma and presurgical breast cancer patients worldwide. As cancer deaths increase, new and improved alternatives to current therapies are needed now more than ever." First Quarter 2025 Financial Results Research and development expenses were $2.2 million for the three months ended March 31, 2025, compared to $2.8 million for the same period in 2024. Clinical trial expenses increased marginally by $0.1 million due to the ongoing site initiations and patient enrollment of the INVINCIBLE-03 Study. Contract manufacturing costs declined by $0.2 million, as there were no manufacturing batches of INT230-6 in the first quarter of 2025. In addition, stock-based compensation was $0.4 million lower as no new equity grants were awarded in the first quarter of 2025. General and administrative expenses were $1.2 million for the three months ended March 31, 2025, compared to $1.9 million for the same period in 2024. Legal, audit and other expenses decreased as a result of cost saving from the integration of new systems in the administrative areas. In addition, stock-based compensation was $0.3 million lower as no new equity grants were awarded in the first quarter of 2025. Overall, net loss was $3.3 million for the three months ended March 31, 2025, compared to a net loss of $4.6 million for the three months ended March 31, 2024. As of March 31, 2025, cash and cash equivalents totaled $0.9 million. About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6; a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research SAKK (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. 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. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik [email protected] (558) 230-6401 Media Contact: Jules Abraham CORE IR [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-reports-first-quarter-2025-financial-results-and-provides-corporate-update-302454456.html SOURCE Intensity Therapeutics Inc.

32 sites are currently contracted in the INVINCIBLE-3 Study, and 25 patients have been screened Eight Swiss sites are activated in the INVINCIBLE-4 Study, and several patients have been screened Final sarcoma data from our first metastatic study and our INVINCIBLE-3 Study design was presented at the annual Connective Tissue Oncology Society Meeting in November 2024 Final data from our first neoadjuvant breast cancer study and our INVINCIBLE-4 Study design was presented at the annual San Antonio Breast Cancer Society Meeting in December 2024 SHELTON, Conn., March 13, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, announces 2024 year-end financial results and provides a corporate update. Corporate Update INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the standard of care ("SOC") drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority (for France, Germany, Italy, Poland and Spain), and Australia's Therapeutics Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival. In July 2024, the Company initiated and dosed its first patient in the INVINCIBLE-3 Study. The trial is actively enrolling patients across the US, Canada, Europe and Australia. Up to 60 sarcoma-focused institutions are expected to participate from these regions. The Company has contracted 32 sites with 25 patients screened to date. The Company expects to complete enrollment in the first half of 2026. INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple-negative breast cancer ("TNBC") and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. The INVINCIBLE-4 Study is expected to enroll approximately 54 patients in Switzerland and France. In October 2024, in collaboration with The Swiss Group for Cancer Research SAKK ("SAKK"), the Company initiated and dosed its first patient in Switzerland in the INVINCIBLE-4 Study. To date, the Company has activated eight sites in Switzerland and treated several patients. The Company expects to activate additional sites in Switzerland and France in the first half of 2025 and complete enrollment by the end of the first quarter of 2026. "In 2024, Intensity Therapeutics finalized both Phase 3 and Phase 2 protocols, engaged leading hospitals around the world, and obtained regulatory authorization to recruit patients in 9 countries to initiate treatment," stated Lewis H. Bender, Intensity Founder, President, and CEO. "Our programs were again selected for presentation at major sarcoma and breast cancer societies. Many of the best sarcoma treatment centers from the US, Canada, Europe and Australia are either participating now or in contract discussions. For our breast cancer trial, our partners at SAKK have recruited interest by the leading hospitals in Switzerland and France to participate. Physicians are screening patients at an increasing rate. We believe in the potential for our drug to have a positive impact on the lives of metastatic sarcoma and presurgical breast cancer patients around the world, who so desperately need improved alternatives to current therapies." 2024 Year End Financial Results Research and development expenses were $10.5 million for the year ended December 31, 2024, compared to $4.8 million for the year ended December 31, 2023. The increase was primarily due to an increase of $5.6 million in the INVINCIBLE-3 Study in 2024, in which we enrolled our first patient in the third quarter of 2024, and to a lesser extent, an increase of $0.5 million in the INVINCIBLE-4 Study, in which we enrolled and dosed our first patient in the fourth quarter of 2024. These increases were partially offset by a decrease of $1.1 million in our IT-01 Study due to the completion of enrollment in this study in mid-2022 and the completion of study-related costs in 2023. Research and development also increased due to higher salary, benefits, and stock-based compensation. General and administrative expenses were $6.1 million for the year ended December 31, 2024, compared to $3.5 million for the year ended December 31, 2023. The increase was primarily due to increased expenses related to salary, benefits and stock-based compensation, higher legal and consulting fees, and higher directors and officers insurance. Overall, net loss was $16.3 million for the year ended December 31, 2024, compared to a net loss of $10.5 million for the year ended December 31, 2023. As of December 31, 2024, cash and cash equivalents totaled $2.6 million. About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6; a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research SAKK (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. 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. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik [email protected] (558) 230-6401 Media Contact: Jules Abraham CORE IR [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-reports-2024-year-end-financial-results-and-provides-corporate-update-302401485.html SOURCE Intensity Therapeutics Inc.