Tivic Health accelerates ARS drug development, targeting hundreds of millions in government contracts and broadening oncology market potential.

OPERATOR - (00:00:00)

Please read the safe harbor statement contained in the press release that Tivic Health Systems issued today, as well as the risk factors contained in Tivic Health Systems' filings with the SEC, including its annual report on Form 10K of the year end December 31, 2024 and the Form 10Q to be filed with the SEC today, as well as other company's SEC filings. On today's call we have Tivic Health Systems' Chief Executive Officer Jennifer Ernst and Chief Financial Officer Lisa Wolf. Now let me turn the call over to Jennifer Ernst.

Jennifer Ernst - Chief Executive Officer - (00:00:43)

Thank you and welcome to those of you who are joining us today, before we cover the financial portion of the earnings call, I want to lay the groundwork for those who may have just begun to follow Tivic Health Systems. Over the course of the last six months, we have reshaped the company by expanding TIVIC into the biopharmaceutical sector. We've also been advancing ongoing work with our next generation of vagus nerve stimulation devices. This combination of assets makes TIVIC unique in having the ability to treat disease by addressing both the body's biochemical and bioelectronic systems that regulate immune responses. We believe we now have quite a robust set of opportunities in the pipeline and ones that are able to generate a significant return on investment. In this context, our expansion into drug development with our exclusive licensing of Sotera Biopharma's portfolio, a portfolio of TLR5 agonist assets provides Tivic Health Systems a late stage, highly DE risked phase 3 drug candidate and multiple additional indications. Specifically in Entolimod, the first commercial opportunity of the TLR5 portfolio was developed as a military countermeasure to lethal levels of ionizing radiation. Most governments maintain a national stockpile of emergency use quantities of treatments for ARS to be accessed in the instance of a nuclear event. Now, in addition to that, in addition to the strategic national stockpile, US Defense agencies maintain ARS treatments to protect active duty personnel. This includes, for example, the nearly quarter million military and civilians deployed overseas. Because of the volume and because of these stockpile opportunities, a single contract for ARS has the potential to total several hundred million dollars during the second quarter. And in recent weeks we have made additional progress in validating the US Government's interest in Entolimod for ars. Most recently, we met with key decision makers at the Military Health System Research Symposium MHSRS as it's known in the industry, and these meetings reinforced our belief that both avenues present opportunities for us to generate significant sales of Entolimod and to create value for our shareholders. Which takes us to the regulatory front. We previously met with senior officials at the FDA in the form of an educational meeting in parallel at that point and as we've continued, we've also discussed the potential for an emergency use authorization for Intellimod for ARS which may enable earlier approval of this potentially life saving drug. The FDA has already granted Entolumod a fast Track designation for ARS and an Orphan Drug designation for pediatric ARs. We are now in the process of planning a Type B meeting this year to confirm the final clinical, manufacturing and validation requirements for our plan bla. We will be further discussing these accelerated paths with the FDA as we move towards the filing process. In addition, we are in the process of transferring two existing IND StaTivic Health Systems from Statera. Completion of this transfer will enable us a full formal engagement with the FDA approved under the two fronts of the inds. In May we began work with Scorpius Biomanufacturing on the GMP manufacturing validation of Entolemon for acute radiation syndrome. This is the next step in our process towards preparing a biologic licensing application. Once the first lot of GMP materials has been manufactured at Scorpius, we will begin bioequivalence and biostability testing and the latter of those two can take approximately a year. So as a whole, the second quarter began an aggressive push on the ARS indication for Entolomod. As I mentioned though, this exclusive licensing agreement is helping us build a pipeline. Entolomod and its derivative Entolimod, for which both of which we have a worldwide exclusive license, also have the potential to treat radiation and chemotherapy side effects that are caused by cancer treatments, specifically neutropenia and GI tract damage. According to various market research firms, neutropenia drugs represent anywhere from a 19 to 24 billion dollars market over the next few years. The lion's share of that market is being addressed by colony stimulating factors such as the GCSF drugs. Because emtolimod works upstream in the immune system, it engages not only the GCSF pathway but a much wider range of mechanisms potentially yielding a wider range of benefits. So neutropenia itself is a condition characterized by abnormally low number of neutrophils or white blood cells that reduces the body's ability to combat infections. Entelimod has been shown to prevent cell death or apoptosis such as that seen during radiation treatment and thereby promoting cell preservation. Now at this time we are in the early stages of investigating potential research sites for a future clinical trial program for Emtolomod for neutropenia we have a great deal of flexibility on the timing of any trials. So while we may or may not commence trials this year, we are working to secure the right advisors and research partners. We believe this is now becoming an important part of our strategic pipeline. Our belief is that Entolimod could be a very significant opportunity in the oncology market as it is potentially the only therapy that can both prevent and treat radiation related damage to patients.