Intensity Therapeutics Q2 2026 Earnings Call Transcript

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Provided by Quartr
August 11, 2026

Key Takeaways

  • Positive Sentiment: INVINCIBLE-3 is preparing to restart enrollment at limited U.S. sites within the next few months after FDA review of a revised protocol; European restart preparations are also underway.
  • Positive Sentiment: In the small preliminary INVINCIBLE-4 dataset, INT230-6 plus standard therapy produced a 71% pathological complete response rate versus 42% for standard therapy alone, alongside a potential reduction in severe adverse events. Management cautioned that only 14 prior patients and two patients under the amended regimen have been treated, so the signal remains early.
  • Negative Sentiment: Cash was $9.5 million at June 30, with an estimated operating burn of approximately $1 million per month in the second half of 2026; management said it needs roughly $30 million over several years to complete INVINCIBLE-3 and additional capital before fully reopening sites. Funding is being raised through the ATM facility, which may create shareholder dilution.
  • Neutral Sentiment: Intensity held more than 20 meetings with potential strategic partners at the BIO International Convention and reported interest in its science and clinical programs, but emphasized that discussions are at an early stage with no partnership agreements or timelines established.
AI Generated. May Contain Errors.
Earnings Conference Call
Intensity Therapeutics Q2 2026
00:00 / 00:00

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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.

Operator

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 material 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, they 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
Lewis Bender
President and CEO at Intensity Therapeutics

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. First, I will turn the call over to Joe Talamo to discuss our second quarter of 2026 financial results. Joe?

Joseph Talamo
Joseph Talamo
CFO at Intensity Therapeutics

Thanks, Lew, 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.

Joseph Talamo
Joseph Talamo
CFO at Intensity Therapeutics

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. Lew 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.

Joseph Talamo
Joseph Talamo
CFO at Intensity Therapeutics

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.

Joseph Talamo
Joseph Talamo
CFO at Intensity Therapeutics

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 Lew for a discussion on our clinical programs and business development activities. Lew?

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Thank you, Joe. We're having this call because it's a different way to communicate to stakeholders the information being distributed via 10-Ks and 10-Qs. 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 30, and 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.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

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. The trial had enrolled 21 patients who continued 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.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

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 analysis on whether sites had the resources to conduct the trial were made, and sites were inspected. Over 60 qualified sites in eight countries were either contracted or in contract negotiations at the time of the pause.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

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 three-year survival in the second and third-line treatment setting of less than 10%. The unmet medical need remains high.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

I'll now provide an update on our phase II INVINCIBLE-4 study, a randomized, controlled, open-label, multi-center 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 pathological 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 dose prior to the standard of care. This is cohort A. The second cohort B, is the standard of care alone. Patients are randomized one-to-one 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.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

However, last month, our investigators in Switzerland resumed treating new patients in the INVINCIBLE-4 study following authorization by Swissmedic, the Swiss regulatory authority, and the Swiss Ethics Committees 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. I am excited to report that the same protocol was authorized by the European Medicines Agency, and we opened a site in France for approval. We are currently targeting to complete enrollment by the end of 2027, 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 pathological complete response.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

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 five years after surgery from somewhere around 50% of risk without having a pCR to about 16% with a pCR. It is 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 accelerator conditional approval. Unfortunately, using today's best immunochemotherapy regimen for women with TNBC, only about 50%-65% of patients achieve a pathological 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.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

The early data from our 14 patients, where seven 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% in standard of care. These were patients with a median tumor size that was quite large, of over 2.4 cm 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 a half a percent of women will die from the current standard of care regimen, and 50% of deaths are attributed to the immunotherapy. Why does adding our drug prior to the standard of care potentially reduce adverse events, especially for those that are immune-related?

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Well, if you recall, the Journal of 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. 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. In addition to pathological 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.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

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 will 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 NewYork-Presbyterian/Columbia University Irving Medical Center in New York, Johns Hopkins University in Baltimore, the University of Southern California's Keck School of Medicine in L.A., and Princess Margaret Cancer Centre in Toronto.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

EBioMedicine is a strong quartile one 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 two-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.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

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 four to seven months that many systemic therapies typically report when treating these types of patients, which we believe are 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%.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

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 are 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.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

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. At this time, I'd like to open the call up to questions.

Operator

We will now begin the question-and-answer session. To ask a question, you may press star then one on your touch tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. We ask that you please limit yourself to one question and one follow-up. At this time, we will pause momentarily to assemble our roster. The first question today comes from Swayampakula Ramakanth from H.C. Wainwright. Please go ahead.

Swayampakula Ramakanth
Swayampakula Ramakanth
Analyst at H.C. Wainwright

Thank you. Good morning, Lew and Joe. 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 2026? Which specific operational milestone can the current cash balance get to without assuming additional ATM proceedings?

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Good morning, RK. I'm going to let Joe answer the financial issues and the milestones.

Joseph Talamo
Joseph Talamo
CFO at Intensity Therapeutics

Good morning, RK. You could see with today's guidance, we're estimating a monthly cash burn of $1 million per month for the balance of 2026. That's given where we are today. The INVINCIBLE-3 study, it's about an incremental $30 million to complete that study. Clearly, we don't have the capital today to open all sites and all the regions for enrollment. It's $30 million to get us over the next several years. 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 Lew referenced, we'll be able to accelerate these timelines. But at this point, maintaining the opened enrollment in the limited U.S. sites is what we need to do so as we don't outrun our cash balances.

Joseph Talamo
Joseph Talamo
CFO at Intensity Therapeutics

We'll continue to operate on that premise.

Swayampakula Ramakanth
Swayampakula Ramakanth
Analyst at H.C. Wainwright

Lew, will all the 21 patients that had been enrolled before the pause remain in the primary intent-to-treat analysis? Did the interruption affect anything, especially the anticipated timing or number of overall survival events that need to happen?

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Yeah. 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. 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
Swayampakula Ramakanth
Analyst at H.C. Wainwright

Okay. On INVINCIBLE-4, how many patients have now been randomized and treated, including the first set of patients under the amended regimen?

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Yeah. We've treated a couple under the new protocol and 14 under the prior. We need about 45 more patients or thereabout.

Swayampakula Ramakanth
Swayampakula Ramakanth
Analyst at H.C. Wainwright

Okay. A couple more questions. One is on the TNBC study. How should we think about what you have seen so far, the 71% pCR versus the 42% comparison, and that's from different cohort sizes, right? In terms of tumor stage, status, and other prognostic factors, are they all balanced? Also, what does this tell you?

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Yeah. They're randomized. They're balanced. They're only 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 or something like that. So they're larger tumors. In KEYNOTE-522, half the patients' tumors were under, I think, 2 cm. 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.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Once we have this data from these patients and this 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
Swayampakula Ramakanth
Analyst at H.C. Wainwright

Okay. 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
Lewis Bender
President and CEO at Intensity Therapeutics

Yeah. There are multinational companies that'll probably want global rights that we're talking to. There are regional players that want anything from one country to several countries in their region. All of which can help us in many ways. 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. 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.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

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 in 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.

Swayampakula Ramakanth
Swayampakula Ramakanth
Analyst at H.C. Wainwright

Thank you. Thank you both for taking all my questions.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Thanks, RK.

Operator

The next question comes from James Molloy with Alliance Global Partners. Please go ahead.

James Molloy
James Molloy
Analyst at Alliance Global Partners

Hey, guys. Thank you very much for taking my questions. I just have some more on RK's question on the cash need. 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
Joseph Talamo
CFO at Intensity Therapeutics

The $30 million is what we need over the next several years to really get through the INVINCIBLE-3 study. 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.

Joseph Talamo
Joseph Talamo
CFO at Intensity Therapeutics

Provided we continue to bring in capital on the ATM, we will continue to do so. It is the cheapest cost of capital to us, and that is where we are going. It is 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 are going to have to bring in additional capital before the end of the year, before we can move forward.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Well, we will 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—

James Molloy
James Molloy
Analyst at Alliance Global Partners

Yeah.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Relatively speaking achievable.

James Molloy
James Molloy
Analyst at Alliance Global Partners

Yeah. More than I have sitting in my bank account right now, but yeah, for a biotech, it's certainly not a ton, as you might say.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Exactly. Yeah.

James Molloy
James Molloy
Analyst at Alliance Global Partners

Any anecdotal feedback from the sites you could share on how they're doing with enrollment and 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
Lewis Bender
President and CEO at Intensity Therapeutics

In INVINCIBLE-3, obviously, they keep emailing me, and our vice president of operations, "When are you going to start the study?" 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.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

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
James Molloy
Analyst at Alliance Global Partners

Final question then. I know you guys highlighted a number of effective meetings with BIO CEO San Diego. Is there any way to put any brackets around potential timing of partnerships from these, knowing that that's a hard question to answer?

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Well, it won't be today. It is a hard question to answer. Some companies are moving faster than others. Some have not really even started. 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.

James Molloy
James Molloy
Analyst at Alliance Global Partners

Understood. All right. Thank you very much for taking the questions.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

You are welcome.

Operator

The next question comes from Deepankar Roy with Brookline Capital. Please go ahead.

Deepankar Roy
Deepankar Roy
Analyst at Brookline Capital

Hi. Good morning. Thanks for taking our questions. In terms of INVINCIBLE-4, is there any early observational data that suggests that the new regimen would preserve the good efficacy signal? Or, like, is the ongoing enrollment designed to answer that?

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Yeah. We have not heard any news, good or bad at this point. It is very early in the program. There are two people in. More may be in, we do not get reports all the time. So far, we are 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 have done in the first 14, will be very interesting for them to enroll. I think we are going to have to wait for more enrollment before we can make any conclusions about anything. The first two patients got our drug in, therefore, we will have to see how these come out.

Deepankar Roy
Deepankar Roy
Analyst at Brookline Capital

Thank you. On INVINCIBLE-3, what is the specific blocker on the EU submission for it? Does the fact that the INVINCIBLE-4 approval moved faster than INVINCIBLE-3, which is still under review, suggest anything about the relative complexity or the risk profile for the EU reviewers?

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

I think there. 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 is a lot more complexity in the CTIS, especially with all the five countries that we are working with. Plus, we do not want to get ahead of our capital. So we are preparing all the documents. There is a lot more documentation when you have to translate into five countries' languages of the synopsis, of the informed consent form. There is a significantly larger amount of paperwork to do to get in Europe. In the U.S., it is simple. We have one agency. We filed with the one agency. They reviewed the study, and we go, right? So that is obviously much faster.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

We do not have to translate, we do not have to do a whole bunch of things. But with Europe, when you have five countries in Europe, it gets a lot more complicated. The French study in INVINCIBLE-4 is one country in Europe, and that is 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.

Deepankar Roy
Deepankar Roy
Analyst at Brookline Capital

Understood. Thank you.

Operator

The next question comes from Boris Tolkachev with Freedom Broker. Please go ahead.

Boris Tolkachev
Analyst at Freedom Broker

Good morning, and thanks for taking questions. I'll start with one follow-up on INVINCIBLE-4. INVINCIBLE-4. After single injection regimen was introduced, other than just dose reduction, were there any changes to patient enrollment criteria under that new protocol? Maybe less disease severity or tumor characteristics?

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

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. 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
Analyst at Freedom Broker

Okay. Thank you. Maybe just a quick one on the patient number. You mentioned that there are 44 patients remain to be enrolled. 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 follow up—

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Yeah.

Boris Tolkachev
Analyst at Freedom Broker

Under the single injection regimen?

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Yeah, it's a very good question. Because the dose number has changed, really, and the dose is different, we will add seven additional patients randomized to our drug. We are adding the seven new to replace the seven from the first set of doses, and the standard of care is the same, so there is no real reason to add new patients there. We are going to be adding more patients into the cohort A to replace the ones that are coming out of cohort A.

Boris Tolkachev
Analyst at Freedom Broker

Okay, thanks for clarifying that. I think I will stick with one on INVINCIBLE-3. 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
Lewis Bender
President and CEO at Intensity Therapeutics

Yeah. 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 did not have an exclusion criteria on the size of the tumor, so we excluded some of the patients with tumors above 15 cm. I think this will be on clinicaltrials.gov because you have to have the inclusion criteria. People were coming in with, believe it or not, 39 cm sized tumors. That is just not treatable from any perspective. That was one of the exclusion criteria. 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. The criteria will go through a central reader. There will be a central review that will provide the information on what is happening in the tumors.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

We 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. I think that is the two biggest things, that people coming in with massive tumor burden would not be benefiting from anything. The doctors wanted us to do a central read on the scans for more consistency.

Boris Tolkachev
Analyst at Freedom Broker

Okay, thanks for the answers and congrats on the progress.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

Thank you.

Operator

This concludes our question-and-answer session. I would like to turn the conference back over for any closing remarks.

Lewis Bender
Lewis Bender
President and CEO at Intensity Therapeutics

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.

Executives
    • Lewis Bender
      Lewis Bender
      President and CEO
    • Joseph Talamo
      Joseph Talamo
      CFO
Analysts
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