Intensity Therapeutics, Inc. Common stock H.C. Wainwright 28th Annual Global Investment Conference

Well, good morning, good afternoon, and good evening, depending on when you're looking at this. Thank you very much to the Wainwright people and Sean for the introduction and the opportunity to present. I'm going to talk about our new technology for cancer. We are a late-stage biotech company, and we're developing really a new way to kill cancer, one that causes immunogenic cell death and developed based on the technology that's used in the Wegovy pill to transport molecules safely through tissue. My first slide is, please be aware there's forward-looking statements, and you should read our filings with the SEC. This is a technology that has created a potent cancer-killing agent. It is injected directly into tumors that you can see. You do not have to inject every tumor.

It leads to a diffusion throughout the tumor and a cell penetration of these potent agents that cause an anticancer immune response. We both debulk the tumor and then stimulate a systemic immune response. It is applicable to many solid tumors, not just the ones we are working on, but even cold tumors are applicable. We have treated over 200 patients in two completed clinical trials, one in metastatic disease, one in pre-surgical. We have ongoing phase III study in metastatic sarcoma, a phase II in pre-surgical breast cancer, and those studies are now back in operation and active and enrolling. We have been very excited about some of the early results we have seen in both studies. Everybody on the team is experienced with public companies in phase III development.

We have a robust patent portfolio, 18 issued patents, four in the U.S., and protection in 42 countries, and are very cash efficient. The technology makes use of a molecular transport molecule. We call it SHAO. It has a fat-loving component and a water-loving component, and after a two-year screening process in mice, we identified this formulation of these two very potent cytotoxic agents that each have direct killing and immune-activating mechanisms that are all different. Two direct killing and two immune activating. We simply mix these three ingredients in a vessel, and they form a very unique supramolecular complex. Remember, this is the same similar structure to what is being used commercially in the Wegovy pill. It is a delivery technology that has a huge opportunity for not only the oral delivery of proteins, but also, we believe, for intratumoral administration. This drug is stored frozen.

It is stable for up to four years. We have scaled up the batch multiple times. We are in a phase III study, a randomized controlled study, testing our drug alone, a local therapy treating metastatic disease in sarcoma, three different types. Sarcoma is a deadly cancer. The median survival for second-line, third-line sarcoma is about 14 months. The three-year survival is less than 10%. Our endpoint is overall survival. We are keeping, hopefully, the patients on our arm alive longer than the patients on the standard of care. I will go through the study in a second. The second study is a phase II. It is in pre-surgical triple-negative breast cancer. It is for women who are seeking to have no live cancer at the time of surgery, so they go on this very harsh chemotherapy regimen.

The endpoint is pathological complete response, the absent of all live cancer in the nodes, tumor, or breast. We are randomizing one dose of our drug up front, and then the women will get six months of the standard of care chemo immunotherapy, and compared to the standard of care alone. We have orphan drug status in sarcoma, and we have fast track in metastatic breast cancer from the FDA. This gives you a lot of benefits on both of these regulatory achievements. I am going to explain a little bit about how we thought about cancer when we set this up. Cancer is obviously highly deadly, and the reason for their deadliness is because they are basically like a foreign alien from the movie with Sigourney Weaver. They eat your organs, they kill you, and they are very highly fat dense with very poor vascular.

They do not have a lot of blood vessels. You can see here in a sarcoma patient that there is not a lot of blood vessels here. You can see that this patient whose sarcoma was in the peritoneum, migrated to the liver and started eating the liver, and effectively you die from organ failure. Again, high pressure, high fat, high density, not a lot of amenability for IV because you do not get a lot of drug into these large sarcoma tumors. You see the ability for metastases to even have fewer blood vessels. How do you stop something like this? What we are doing is we are injecting directly into the tumor. Here is some data from our first breast cancer study. What you can see here is this is a woman who had 2 injections of our drug.

She had a very large invasive ductal carcinoma, almost 4 centimeters. This is the resected tumor after 2 doses of our drug. You can see that the dotted line here is the live tumor, black line, and red is what we have killed. We looked at this and we said, "Well, we should really dose more one time or dose less in different places." What we did was we showed that we can now kill a larger tumor. The red line is the necrotic area. The black line is the tumor. Again, you do not see a lot of vascular. These tumors now, for the first time, can be injected with a therapeutic agent that will diffuse through the tumor and cause immunogenic cell death.

If you go on our website, you can see some of the data that supports the fact that there is immunogenic cell death going on, and a number of our papers will talk about that. In the pre-surgical setting, in triple-negative breast cancer, we have a high risk pre or post-menopausal women. Majority of tumors are very highly proliferative. There is not a lot of drugs because they are triple negative. They do not have the cell receptors to really give some of the most potent drugs in this type of disease. Majority of women are diagnosed at late stage II or stage III. That is about 62% of the patients. If you do not get rid of the cancer prior to the surgery with chemo immunotherapy, the risk of the cancer coming back in 5 years is 50%.

If you can eliminate through a treatment process, a systemic treatment process, or, in our case, an injectable plus the systemic treatment, and you can increase the percentage of women who have a path CR, the risk of those women goes down. Unfortunately, in larger tumors, most of the women do not achieve a path CR. Our study is taking women with larger tumors than was done in Merck's KEYNOTE-522 study. With these inclusion criteria, we will provide one injection of our drug, and then the women will go for the standard of care chemotherapy. The endpoint being pathological complete response, which is, as I said, no live cancer in the nodes, breast, or tumor. We will do an analysis comparing the standard of care with our drug, cohort A to cohort B, which is just the standard of care. That will be for safety purposes.

We are actually doing a non-comparative analysis with a hypothesis of achieving a 60% pathological complete response rate. Results so far are very encouraging, even though these are at a higher dose than we are currently running. But 5 out of 7 patients achieved the path CR in the study that is now ongoing. 3 out of the 7 in the standard of care. Remember, these are patients with larger tumors, so 42% versus 71%. That is a major trend to improvement. We had a significant reduction in the higher grade adverse events observed using our drug up front. Now you're going to say, "How do you get better safety when you're adding something to the standard of the care?" That's because our drug targets the immune system to the cancer.

When you kill the cancer in situ, as we do, you get an immune response that is precise to the cancer. What we're seeing, because a lot of the immunotherapy and the chemotherapy are immune activating, and by not down-regulating the immune system and getting it to go to the right place with our drug, we see fewer both systemic immune-related and chemotherapy-related adverse events. In fact, 44% less chemotherapy and immunotherapy. This is important because a half a percent of women will die from the chemotherapy. We're operating in Switzerland, where we've started dosing. We've treated patients in Switzerland now, additional new patients with an amended protocol. We've opened sites in France. We hope to complete enrollment by the end of 2027, but we hope to accelerate that if the data starts to come in pretty exciting.