Anything, especially Dan's anticipated timing or number of overall survival events that need to happen?

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. 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.

Okay. And then on Invin Spill 4, how many patients have now been randomized and treated, you know, including the first set of patients under the amendant regimen?

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

Okay. And then, you know, a couple more questions. One is on the TNBC study, how should we think about, you know, what you have seen so far, the 71% PCR versus the 42% comparison that, and that's from, you know, different cohort sizes, right? And, you know, in terms of tumor stage, status, and, you know, other prognostic factors, are they all balanced?

And also, you know, what does this tell you? Yeah, so they're randomized, they're balanced. They're only triple negative patients. The tumors ranged in size, you know, quite broadly, as you saw. The median was about – 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 patient's 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 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 these studies 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.

The last question is, you know, you certainly seem to be excited coming out of the bio meetings. I know they are early stage, but in general, you know, what sort of partnership format are you thinking of, you know, when you want to go ahead and, you know, continue these discussions? What is it that you're looking for with these potential suitors?

Yeah. So there are multinational companies that will 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. 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 in that many companies requested to meet with us. We had great meetings. So 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.

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

Thanks, RK.

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

Hey, guys. Thank you very much for taking my questions. I just have some more on RK's question on the cash needed. I know that, Joe, you said about $30 million to complete the intensity 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?

So the $30 million is what we need over the next several years to really get through the Invincible III study. So the cash need, what we have today, again, we ended June with just under $10 million in cash. You can see that we had a very successful, brought in over $1 million already since the end of June. So 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. 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.

Well, we'll operate as we are operating, and then if a big bonus comes in, then obviously we can turbocharge the study. And full is meaning $30 million, which is, relatively speaking, you know, achievable.

More than I have sitting in my bank account right now, but, yeah, 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?

In Invincible 3, obviously, they keep emailing me, and our vice president of operations is when you're 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. And 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. So I think, you know, 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, you know, in a little bit more face-to-face, meaningful manner.

On final question, then, I know you guys highlighted a number of effective meetings with BioCEO 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?

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 know, 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, you know, it's very early, Jim, very early.

Well, I thank you very much for taking the questions. You're welcome.

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

Good morning. Thanks for taking our questions. So in terms of Invincible 4, is there any early observational data that suggests that the new regimen would preserve the good efficacy signal, or is the ongoing enrollment designed to answer that?

So we haven't heard any news, good or bad, at this point. It's very early in the program. and there are two, you know, people in. The more maybe in. We don't get reports all the time. And so far, you know, we're waiting to see how these patients come out. And, you know, 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.

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

You know, I think they're – 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 documents. There's a lot more documentation when you have to translate it 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. Now, in the U.S., it's simple. We have one agency. We filed with the one agency. They reviewed 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, 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 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.

I'm sure. Thank you.

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

Good morning, and thanks for taking questions. I'll start with one follow-up on Invisible 4.

So, Invisible 4, after a 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? there was nothing really major to that obviously we had one now injection so we changed some of the timing 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 okay thank you and maybe just a quick one on the patient number.

You mentioned that there are like 44 patients remain to be enrolled and the question my question is are you gonna treat this data from the whole population enrolled or some data separation strategies will be implemented like the first cohorts which already received two doses and And then the second one, which would fall under the single injection regimen.

Yeah, it'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 the cohort A to replace the ones that are coming out of cohort A. Okay, thanks for clarifying that.

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?

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 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 size 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 will 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. So I think 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.

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

Thank you.

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

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. Thank you all for your time again today.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.