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(Incorporated in Delaware)
Our company is focused on the development and commercialization of a new class of immunotherapeutics for the treatment of solid tumors. This new class of drugs, sometimes referred to as “live biopharmaceuticals” are genetically modified biological agents which have the capability of expressing select anti-tumoral agents within the tumor’s microenvironment. Our lead program, Saltikva, is an attenuated strain of Salmonella Typhimurium that is non-toxic and orally administered. This strain of Salmonella Typhimurium is engineered to express the human gene interleukin-2, or Salmonella-IL2. The natural activity of IL-2 is to increase populations of NK and CD8+ cytotoxic T cells in tumor microenvironments as well as in the peripheral blood. Both of these cell types have the unique property of indiscriminately killing cancer cells.
Saltikva is being developed for the treatment of multiple oncology indications, including pancreatic cancer and osteosarcoma. To examine the therapeutic potential of Saltikva in pancreatic cancer and osteosarcoma, a prospective phase 1 study in humans to evaluate safety of an orally administered Saltikva (hereinafter referred to as the “Saltikva Phase 1 Study”) was conducted. We conducted a Phase 2 clinical trial in humans for Saltikva for Stage IV metastatic pancreatic cancer, where we observed lower tumor burden and increase Progression Free Survival (“PFS”) and Overall Survival (“OS”) in patients when administered in conjunction with modified chemotherapy, FOLFIRINOX. Our Company is entering into pivotal Phase 3 clinical trials for our Saltikva product in the treatment of Stage IV metastatic pancreatic cancer patients. To date, the median overall survival in stage IV PC patients on standard of care is 10-12 months. Therefore, we believe Saltikva provides a promising therapeutic approach to helping extend the lives of stage IV metastatic pancreatic patients.
In May 2022, we were granted Orphan Drug Designation and the Fast Track Designation by the FDA for Saltikva for Stage IV Pancreatic Cancer. In November 2025, Saltikva was granted Orphan Drug Designation by the FDA for Osteosarcoma. Our intellectual property patent estate for Saltikva consists of three patent families. A first patent family, “Methods of Synergistic Treatment of Cancer,” consists of (1) United States patents issued in February 2023 and September 2024 covering anti-tumor agents (and methods of use) comprised of at least one chemotherapy agent and an attenuated Salmonella typhimurium, (2) a Japanese patent granted in March 2023 covering an antineoplastic agent for treating breast cancer comprising doxorubicin and an attenuated Salmonella typhimurium, (3) a pending European patent application published in 2019 relating to anti-tumor agents (and methods of use) comprised of at least one chemotherapy agent and an attenuated Salmonella typhimurium, and (4) a pending U.S. patent application published in 2024 relating to the same technology.
As part of the business, our company also aims to expand its offerings by developing other products in its pipeline to secure its position as a segment leader. Specifically, we plan to study Saltikva in other solid tumor indications including rare tumors such as osteosarcoma and metastatic colorectal cancer.
(Note: Salspera, Inc. filed its S-1 for its small-cap IPO on Feb. 2, 2026, without disclosing the terms. Estimated proceeds are $50 million, a placeholder figure.)
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