Welcome back, everyone. We have an update today. We have Jennifer Ernst, CEO of Tivic Health. It trades on the Nasdaq under the symbol TIVC, and on this update segment, Jennifer will cover recent corporate milestones, including acceleration of manufacturing readiness for Entolimod. Happy to welcome Jennifer. Nice to see you today, Jennifer.
Thank you. Thank you. I'd love to share with the audience that last time I spoke at the Emerging Growth Conference, we were in the middle of a transformation of the company, middle of 2025. Tivic has now completed a major overhaul of our business, moving into a biopharmaceutical company with late-stage assets and fully provisioned for manufacturing. So I'm going to take you through the full story of the drugs that we have and the recent developments around our manufacturing capabilities and commercial opportunities. So let me start by saying Tivic is focused on harnessing the immune system to save lives and improve clinical outcomes. Our late-stage assets are focused on radiation treatment. And of course, our requisite safe harbor. And I'd like to start out by sharing what the radiation problem really is.
When we talk about ionizing radiation, it's often used in cancer therapeutics, but you'll also experience it in, for example, a nuclear attack or a nuclear disaster. Now, ionizing radiation destroys fast-growing cells. That's great if you're treating cancer and you want to destroy the cancer cells. But while you're doing that, you are also destroying the healthy cells in the body, the fast-growing healthy cells like the blood system, the bone marrow, stem cells, the GI tract, and the very structures that are used to create those type of fast-growing cells. Earlier this year, we in-licensed a drug called Entolimod. Let me start with this. We licensed a drug called Entolimod that has had a significant amount of prior investment in it. It was originally developed as a treatment for acute radiation syndrome, $140 million previously invested, and U.S. government agencies spent $36 million plus in supporting the development.
After we licensed this in, we began discussions with the government, the Biomedical Advanced Research and Development Authority, Department of Defense, and the White House. Very quickly got traction. We're invited to a BARDA TechWatch meeting. This is an update from last time. Upcoming on this Monday, January 26, we have an invited presentation to a significant body of BARDA and the Department of Defense. Now, the exciting thing about this drug is not only the near-term opportunities in acute radiation syndrome, but also that there are extremely lucrative opportunities and adjacent opportunities in the oncology space. Quickly, this is an extremely well-characterized drug. For the scientists that may be listening, 40-plus studies, very well-characterized mechanism of action.
For investors, though, the exciting part of this is the current standard of care is a $9.4 billion market that only covers that very little section, only addresses the blood disorders associated with radiation exposure, and in fact, every drug that is approved for acute radiation syndrome is also approved for use in oncology as its primary market, so we have a very real opportunity with a broad-based mechanism of action to provide a solution that treats not only the blood, but also the GI tract, that not only mitigates damage after treatment, but can either be used after treatment for mitigation, offers protective benefits, and has been shown to support regeneration of the very structures that create the fast-growing cells. All of the trials have been conducted with no supportive care.
When we talk about supportive care in this particular market, that would mean things like transfusions and bone marrow transplants. A $9.4 billion-$9.5 billion market that exists today is under attack from biosimilars led by companies such as Amgen, Novartis, and Sanofi. Entolimod would be an opportunity for companies such as those to renew their market leadership. As we begin demonstrating the acute radiation syndrome and government opportunities, I would also want to highlight that this could become a new standard of care replacing G-CSF drugs. As we look along the competitive market, some very familiar brand names, Entolimod is the only drug that has demonstrated in the research studies and as we move forward towards our BLA, both the therapeutic effects, the protective benefits, and the regenerative effects across the neutrophils of the blood, the platelets of the blood, and providing gastrointestinal repair.
As I look forward in our commercialization milestones, earlier this year, we completed cell line verification, bringing a cell line that had been dormant for about 15 years back to life. It had been stored. We've scaled up the manufacturing, and we recently announced that we had gone from small batch to a 200x scale up of the proteins, maintaining, actually exceeding prior purity levels, potency, and our yields necessary for commercial manufacturing. So as we complete our trials, our first cGMP lot becomes our next milestone. Once we complete a cGMP production lot, we then put materials on biostability. That is a year-long process. And meanwhile, we are drafting our BLA, moving towards filing with the FDA. Once the BLA is granted, and by the way, we already have Fast Track and Orphan Drug Designation, we could begin taking stockpile orders.
As I mentioned, the government has a significant interest in this technology as a medical countermeasure protecting the United States in the event of a nuclear disaster. However, the real opportunity is in oncology. As we move from acute radiation syndrome, this year, we anticipate starting, we are talking with sites at this time to run investigator-led trials in the oncology applications. In this space, Entolimod would be a first-in-class home protection platform. And based on the mechanism of action, we anticipate that the value would be not only in treating the symptoms, but in what doing that means. As we begin treating the severe treatment-limiting issues around radiation and their toxicities, we can preserve the value of the therapeutics. There are many, many very good therapeutics in cancer, but the side effects limit the treatment windows.
We believe that there is an opportunity with Entolimod to broaden the treatment windows, mitigating the side effects, limiting the downstream effects of hospitalization, treatment interruptions, and be able to keep patients on therapeutics longer. If I put this in a summary, we support all of the necessary aspects, and Entolimod is intended to protect the patient so that the standard and advanced cancer therapies can be delivered as intended. This creates very real partnering opportunities for us as we move through the acute radiation syndrome area and into the oncology space. And in support of all of this, and particularly our production requirements, we recently announced that we have acquired the assets of our manufacturing partner. This has allowed us to bring production in-house, guarantees absolute guarantees our access to cGMP manufacturing, no waiting in line, no waiting in the queues. It accelerates our time to market.
We're able to set aggressive timelines with the support of our in-house production capability. And we have set this up as a CDMO, as a new contract development and manufacturing organization for phase I, phase II biologics, allowing us to create an additional revenue stream inside of Tivic. So the combination of acceleration, being able to bring new formulations to market faster, being able to test and develop a second molecule that is also in our pipeline as part of our acquisition, this has been a significant strategic move to strengthen the company. And I will note that San Antonio is an excellent opportunity to serve the U.S. government requirements as there are five military bases and two airports to be able to transport product out of this area in the event of a national emergency.
So with the two applications, having both the military countermeasures and the fact that every drug approved for acute radiation syndrome is also a cornerstone of oncology treatments in a $9.5 billion market, this is an opportunity for investment that has not yet been absorbed by the market. We have strong financing behind us. We recently closed a package that allows us access up to $75 million of capital. And we are targeting multiple high-value therapeutic inflection points within the next 18 to 24 months. And with that, I'm happy to close out or take questions.
Perfect. Thank you, Jennifer. All right, we are out of time today, but we thank you for joining us with this update, and we would love to see you again real soon.
Thank you.
All right, everyone, we'll be right back.