Intensity Therapeutics (INTS) Q2 2026 Earnings Call Transcript
Intensity Therapeutics (INTS) Q2 2026 Earnings Call Transcript
Motley Fool Transcribing, The Motley FoolWed, August 12, 2026 at 1:57 AM UTC
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Tuesday, Aug. 11, 2026 at 8:00 a.m. ET
CALL PARTICIPANTS -
President and Chief Executive Officer - Lewis H. Bender
Chief Financial Officer - Joseph Talamo
TAKEAWAYS -
Net Loss -- $3 million for the second quarter, representing a 19% increase compared to $2.5 million in the prior-year period.
Research and Development Expenses -- $1.8 million, reflecting a 19% increase driven by clinical trial costs for the Phase 3 INVINCIBLE-3 study.
Clinical Trial Expenses -- $1.2 million, compared with $936,000 in the prior-year period, as the company initiated plans to resume patient enrollment.
General and Administrative Expenses -- $1.3 million, up 7% primarily due to $155,000 in higher franchise costs and $76,000 in increased employee compensation.
Cash and Cash Equivalents -- $9.5 million as of June 30, 2026, providing improved operating flexibility following capital raises.
At-the-Market Facility Proceeds -- $1.6 million in net proceeds raised during the second quarter, with an additional $1.3 million raised after June 30, 2026, under a $60 million facility.
Projected Operating Cash Burn -- $1 million per month on average for the second half of 2026, according to management estimates.
Incremental Capital Requirement -- $30 million to complete the INVINCIBLE-3 study over the next several years, according to CFO Talamo.
INVINCIBLE-4 pCR Rate -- 71% in Cohort A patients who received INT230-6 plus standard of care, compared to 42% in Cohort B patients receiving standard of care alone.
INVINCIBLE-4 Safety Data -- 44% reduction in Grade 3 adverse events in the cohort receiving INT230-6 prior to the standard-of-care immunochemotherapy regimen.
INVINCIBLE-4 Enrollment Target -- Completion expected by the end of 2027, requiring approximately 45 additional patients across sites in Switzerland and France.
INVINCIBLE-3 Protocol Modification -- Implementation of a new exclusion criteria for tumors larger than 15 centimeters after management found such cases were not effectively treatable.
INVINCIBLE-4 Cohort Adjustment -- Addition of seven new patients to Cohort A to replace those treated under the prior dosing regimen to account for the move to a single-injection protocol.
Phase I/II IT-01 Overall Survival -- 12 months for 64 refractory patients, exceeding the 4 to 7 months typically reported for systemic therapies in similar populations.
IT-01 High-Dose Survival -- 18.7 months median overall survival for patients receiving a dose of more than 40% of their visible tumor burden.
Abscopal Effect Rate -- 20% in patients treated with a high-dose monotherapy, a rate management noted is significantly higher than the 1% typically reported for radiation.
IT-01 Disease Control Rate -- 75% for metastatic patients having over 20 types of metastatic cancers, such as colon, pancreatic, and triple-negative breast cancer.
Qualified Clinical Sites -- Over 60 qualified sites in eight countries were contracted or in contract negotiations for the INVINCIBLE-3 study prior to the 2025 pause.
European Expansion -- Five countries targeted for Phase 3 study site activation, including France, Germany, Italy, Poland, and Spain.
Total Capital Raised -- Over $23 million raised since the start of the second quarter of 2025 to stabilize the balance sheet and resume clinical activities.
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RISKS -
Talamo stated, "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," regarding the $30 million required to complete the Phase 3 study.
Bender noted that during the study pause, investigators found "some patients were enrolled with tumors that were just really way too large to be treated effectively with anything," leading to a protocol amendment to exclude tumors larger than 15 centimeters.
Management at **Intensity Therapeutics, Inc.** (NASDAQ:INTS) reported the resumption of clinical activities for its lead programs following a period of fiscal constraints and site pauses. The company has modified protocols for its Phase 3 sarcoma and Phase 2 triple-negative breast cancer trials based on investigator feedback and preliminary safety data, specifically moving to a single-injection regimen in the breast cancer study. Strategic focus remains on site activations across the United States and Europe, supported by capital raised through an at-the-market equity facility. The company also disclosed early-stage partnership discussions with multiple strategic players following significant clinical data publications and participation in a global industry convention.
CEO Bender stated, "Metastatic and refractory cancer, especially for patients with larger tumors, is often a death sentence," highlighting the 10% survival rate for soft tissue sarcoma in the third-line setting.
Bender indicated the company goal is to "make cancer a chronic disease, as has been done with AIDS, where survival now is measured in decades."
Management transitioned the Phase 3 INVINCIBLE-3 study to use a central reading process for scans to ensure consistency in tumor evaluation across international sites.
The company opened a new clinical site in France for the INVINCIBLE-4 study and is preparing documentation to restart the Phase 3 study in five additional European countries.
CEO Bender commented on interest from potential partners, stating, "While early, we're pleased with the interest expressed by many of the companies in our science and our clinical trials."
The company plans to attend the European Society for Medical Oncology conference in October to meet with investigators and discuss trial progress in the European market.
INDUSTRY GLOSSARY -
Abscopal effect: A phenomenon where localized treatment of a tumor causes shrinking of other tumors in the body that were not directly treated.
At-the-market (ATM) facility: A method for a company to raise capital by selling newly issued shares into the secondary trading market over time.
INT230-6: The company's lead drug candidate, which is injected directly into tumors and contains chemotherapy agents combined with a diffusion enhancer.
INVINCIBLE-3: A Phase 3 trial evaluating INT230-6 monotherapy for soft tissue sarcoma.
INVINCIBLE-4: A Phase 2 trial evaluating INT230-6 combined with standard chemotherapy for triple-negative breast cancer.
Pathologic complete response (pCR): The complete disappearance of all invasive cancer in the breast and lymph nodes after treatment, as determined at the time of surgery.
Soft tissue sarcoma: A group of rare cancers that develop in tissues that connect, support, and surround other body structures.
Triple-negative breast cancer (TNBC): A type of breast cancer that does not have receptors for estrogen, progesterone, or HER2 protein, making it more aggressive and difficult to treat.
Full Conference Call Transcript
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.
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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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