Business & 1 1A.& Risk Factors & 40 1B.& Unresolved Staff Comments & 63 2.& Mine Safety Disclosures & 63 & & & & PART II & & & & & & 5.& Directors, Executive Officers, and Corporate Governance & 78 11. XPro1595 for TRD is being prepared for Phase II trials. For example, ovarian cancer patients relapse frequently. Collaborate to maximize the value of our technology. We believe there are two reasons for us to enter collaborations with other companies. Some of these approaches are summarized below. & In brief, sTNF is the “bad” TNF and tmTNF is the “good” TNF. 3 & & Dendritic Cell Therapies. The cost of a single therapy is many hundreds of thousands of dollars. These are best defined in T lymphocytes and include PD-1, CTLA-4, TIM-3 and LAG3. Tumor cells express the ligands to these receptors. Those studies may be performed in the future, but they are not a priority. & The primary role of microglial cells is to protect the neural unit from infection. The trial continues to enroll patients. Neuroimaging data from six patients were presented in the figure below. A large data set of proteins were identified. The CSF proteome data is only partially analyzed. COVID-19 infection causes a cytokine storm in many patients. No data will be released by the DSMB other than the trial should continue or be closed. Once third of TRD patients have peripheral biomarkers to inflammation (elevated CRP). This is a large patient population. Patients will be treated for 6 weeks. Primary end-points include both clinical and neuroimaging measures. These results must be confirmed in humans. & Our first interaction with the regulatory body occurred in March 2018. We do not expect to treat patients in a Phase II trial with INB03 before 2022. & XPro1595 is identical to INB03, Quellor and LIVNate in every way but name. We may also seek to be acquired at this stage. & The peripheral pathologic loop includes obesity and insulin resistance. Patients will be treated with LIVNate for 6 months by once a week subcutaneous injection. This clinical trial has been delayed due to the COVID-19 pandemic. This concept is shown in the schematic form in Figure 1 below. & 14 & & & & & ● The main “job” of a cancer cell is to survive and grow. The first priority for survival is to evade NK cell killing. TpNK are poised to kill any cancer cell that expresses adequate triggering ligands. The results of this study have been published in a medical journal (PLoS One. doi: 10.1371/journal.pone.0123416. At this time, we plan to give INKmune as monotherapy. All manufacturing has been under the direction of Professor Mark Lowdell. We may need additional INKmune for future clinical trials. & And have used that advice to plan both current phase I trials. INKmune primes NK cells to enable them to attack the tumor. The need to educate people of the importance of INB03 is equally challenging. There are at least three ways to classify immunotherapy for cancer. Companies in the personalized immune-oncology business; and & & & & 3. For many of the companies, CAR-T cell therapies is their only business. We have two patent properties pending as of the date of this document. & The agreement with AN terminates on November 29, 2027. Some preclinical testing may continue even after an IND is submitted. We expect all of the Phase I sites to be in London, United Kingdom. To add sites in the US, we will need to file an IND with the FDA. Relapsed refractory is a disease wi
