Great. Thanks so much. Appreciate it. Good afternoon, everybody. Thank you for the time today. I would like to focus on our late-stage biopharma assets actually, and discuss how we're gonna move those forward. First and foremost, thank you, and we look forward to going through quickly what our strategy is over the next 12-24 months. We are a biopharma company focused on immune therapies that improve the survival of patients. Also the typical safe harbor statements. Our overview and mandate, we want to use the innate immune system to improve clinical outcomes and save lives. We have late-stage, highly de-risked assets. Our focus is on oncology and oncology support, specifically radiation and chemo side effects, and we believe we have a best-in-class biologic pharmaceutical drug for that as well too.
Multiple indications are available to us. We'll talk about a few of them today, not all of them. Neutropenia, ARS will be our key focus on this call and we'd welcome questions afterwards. Our pipeline currently is, as you see before us, Acute Radiation Syndrome is our furthest along. It's been through phase III testing and we're getting ready to prepare for a BLA submission, which would be biologics license application for approval of use in patients who receive acute amounts of ionizing radiation. Our secondary indication we're going after is neutropenia. That will be ready for phase II. That is, in lay terms, the loss of neutrophils due to myelosuppression, which could be due to radiation or chemotherapy in cancer patients.
As you can see, we have a lot of other indications we plan on going forward with, but we'll save those for another time. First and foremost, we view ourselves as an immunotherapy company that has a platform that can focus on immuno-oncology, supportive care for cancer, and acute radiation syndrome, both gastrointestinal and hematopoietic. Some things I wanna point out, especially on the immunotherapy side, is that immunotherapy touches a lot of disease states, and we believe we have a lot of applications with our technology that are relevant to improving a patient's outcome and a patient's lifespan. Quickly, this platform, it's called TLR5, which stands for Toll-like receptor 5 platform, which is a receptor in the immune system, which allows for activation of certain pathways.
Specifically, we activate anti-apoptotic pathway, hematopoiesis, innate immune activation, which is NK cell and T cell activation, and activation of some stem cells and endothelial repair. This platform has a lot of money invested in it, many studies in both human and animal, and it's over 60 patents pending. We feel very comfortable about this technology and this platform. We've had several meetings with BARDA, which is the government branch that deals with biomedical discovery and also stockpiling for U.S. citizens. We had a meeting on the 26th and the 10th. Both of them were very productive and we look forward to using this drug, as I said, in other adjacent indications. First and foremost, immunotherapy. What does that mean?
Well, that means the immune system, very large market, $183 billion market, by some sources. What we have seen, we've done a phase II study at the Mayo Clinic with our Entolimod or Toll 5 receptor agonist, is that we can reverse immunosenescence. What is immunosenescence? That's simply the deterioration of the immune system as we get older. Natural aging process causes all of us to lose immune activity over time. What we saw in that study is by treating geriatric or elderly populations that are immunocompromised with Entolimod, we're effectively able to reverse the immunosenescence and provide the patient with the ability to live longer and have a fully functioning immune system. A positive thing for all of us as we get older.
Immuno-oncology, we have a very strong focus on immuno-oncology. We believe our drug platform, the TLR5 platform, is very applicable. Obviously, this is a very big market, a lot of big players in it, a lot of strategics, but our TLR5 agonists like Entolimod have a direct response on tumor regression, primarily through the recruitment and enhancement of NK cells and T cells, which can target the cancer cells and go quickly after them, in a short fashion. The other indication that I mentioned from the beginning that we're strongly pursuing is supportive care for cancer. Cancer obviously is a terrible disease, and everybody knows somebody who has had cancer or survived cancer. The market on this is quite large.
60% of all cancer patients, their first-line treatment by their oncologist is typically chemo or radiation therapy or both. What happens when you get chemo or radiation therapy? You get neutropenia, which is the loss of neutrophils and your ability to fight infections. You get cachexia, which is a lack of absorbing nutrients and calories, which causes you to become very, we'll just say unhealthily skinny, and also thrombocytopenia, which is the loss of platelets and your ability to clot. With Entolimod, we believe we can cover all these areas, neutropenia, cachexia, and thrombocytopenia. We feel this is a very interesting market for us and our ability to save and help patients. The last target that we're going after is Acute Radiation Syndrome.
Ironically, this is the farthest one along. We have done our phase III pivotal studies. We're working on manufacturing validation process for commercial launch and those manufacturing materials will have to go through some studies to show bioequivalence to the earlier material that we had. Suffice it to say, a lot of our troops and warfighters down range could be exposed to radiation. We believe our drug would help those soldiers survive a radiation attack, whether that's a nuclear attack or a dirty bomb. Likewise, we think the Strategic National Stockpile would benefit from our drug as well, if there's any such nuclear activity on the mainland here in the U.S. We've had good conversations with the federal government.
We've also had good conversations with other countries worldwide about using our drug as a radiation countermeasure. Moving back to radiation in hospitalization settings or oncology patients, which is our primary focus. Radiation toxicity is the primary limiting factor in cancer treatment. You can only take so much radiation before you start having a lot of side effects, which could lead to hospitalizations, incomplete treatment, noncompliance, and patients just not wanting to deal with the adverse effects of chemo and radiation. We see our drug as a possible solution for medical oncologists to use our drug to mitigate the side effects of radiation and chemotherapy and allow the patients to have a better quality of life and a longer quality of life.
Again, this supports neutrophil growth, bone marrow regeneration, and GI crypt preservation and regeneration. These are all things that help patients survive chemo and radiation therapy and should give them a better quality of life as well, too. Quick focus on the science behind it. Entolimod is a pleiotropic drug, which means a drug that actually targets one receptor but has many subsequent effects. Not only do we see hematopoiesis, which is what the current drugs out there are, NEUPOGEN, Neulasta, LEUKINE, some of the other ones where you see increase in neutrophils and white blood cell count.
We also see an increase in the ability to protect the GI from damage from radiation and chemo, which is a very important aspect for quality of life and also for length of life when you're undergoing radiation and chemotherapy. The therapeutic comparison matrix shows us to the other larger drugs that are out there that are currently used by radiation oncologists. We're not only a therapeutic, but we're a prophylactic. You can give it prior to radiation and chemo and have a positive outcome. Also thrombopoiesis, which is platelet production, leukopoiesis, which is white blood cell production, GI protection. It only takes a single dose, very similar to Neulasta in that regard. We have NK cell activation, which means we have a direct effect on the tumor cells, which is quite interesting.
Our current timeline is what we're looking at right now. We're getting ready to do a GMP production run for verification for our BLA license. The BLA license should occur sometime late 2027, early 2028, and we look forward to interacting with the FDA over the next several months. I'll finish up. We have a strong management team and a lot of people who know the space. We've been around since 2016. We went public in 2021. We have 50 employees. We're on the Nasdaq, and we also just acquired a commercial manufacturing organization down in San Antonio, which we're very proud of. That not only can they produce and manufacture Entolimod, our lead drug, they can also manufacture for other companies, their biologics as well.
It could also be a revenue center for us. Then finally, our focus is again harnessing the immune system to save lives and improve clinical outcomes. We believe in our products. They're late stage, they're highly de-risked, and we should have some very high value inflection points over the next 18-24 months. With that, I'd like to take any questions.
Perfect. Thank you, Michael. Yeah. So let's start with Entolimod. What stage is Entolimod in, and what is the regulatory pathway? What do you think the likelihood of approval is?
Entolimod, great question. Entolimod's passed its phase III. We're currently doing manufacturing validation for commercial launch, and we'll need to do additional testing on the new manufactured material, which are called bioequivalence testing, to show that the new product is the same as the old product. We believe our interactions with the FDA have been very positive at this point, so we feel good about it getting approved.
Perfect. Could Entolimod become a National Stockpile drug?
We believe so. We've had two conversations with the U.S. government on the potential use of our drug as a national stockpiling agent. It requires some additional testing by the government, but they have interest in it. We did announce, I believe it was a week ago, an agreement with NIAID, National Institute of Allergy and Infectious Diseases, that they would help pay for some of those studies to demonstrate that our drug does indeed work as intended in protecting the GI tract and also protecting the bone marrow.
Perfect. Well, thank you, Michael, for this real important update. We appreciate the work you're doing, and we certainly welcome you back on the conference real soon.
Great. Thanks so much. Have a good day.
All right, everyone, we'll be right back.