# Our Data · Salspera Canonical: https://salspera.com/data/ All publicly disclosed data, with sources. All publicly disclosed data, with sources. ## Clinical · Phase 2 ### Phase 2 Clinical Trial - Stage 4 Pancreatic Cancer (mPDAC) Results published (2026) #### Overall survival Median 20.3 vs 11.6 months · HR 0.58 · p=0.063 (log-rank) at the published data cutoff (March 1, 2025) · p<0.05 at the latest data recording (October 2026) Source: J Cell Immunol 2026 - Source: [Batist et al., Cancer Immunol Immunother 2026](https://pmc.ncbi.nlm.nih.gov/articles/PMC12847481/) - Source: [J Cell Immunol 2026](https://www.scientificarchives.com/article/live-biotherapeutic-salmonella-il2-saltikva-plus-folfirinox-for-stag-metastatic-pancreatic-ductal-adenocarcinoma-implications-of-a-phase-2-clinical-trial) #### Progression-free survival Median 15.0 vs 5.7 months · HR 0.34 · p<0.001 (log-rank) Source: Batist et al., Cancer Immunol Immunother 2026 - Source: [Batist et al., Cancer Immunol Immunother 2026](https://pmc.ncbi.nlm.nih.gov/articles/PMC12847481/) - Source: [J Cell Immunol 2026](https://www.scientificarchives.com/article/live-biotherapeutic-salmonella-il2-saltikva-plus-folfirinox-for-stag-metastatic-pancreatic-ductal-adenocarcinoma-implications-of-a-phase-2-clinical-trial) #### Response rate 70% overall response rate (95% CI 45.5–87.9%) · vs 31.6% FOLFIRINOX alone - Source: [Batist et al., Cancer Immunol Immunother 2026](https://pmc.ncbi.nlm.nih.gov/articles/PMC12847481/) - Source: [J Cell Immunol 2026](https://www.scientificarchives.com/article/live-biotherapeutic-salmonella-il2-saltikva-plus-folfirinox-for-stag-metastatic-pancreatic-ductal-adenocarcinoma-implications-of-a-phase-2-clinical-trial) - Benchmark: [Conroy et al., N Engl J Med 2011](https://pubmed.ncbi.nlm.nih.gov/21561347/) #### New metastases 80% progressed without new metastases (post-hoc) - Source: [Batist et al., Cancer Immunol Immunother 2026](https://pmc.ncbi.nlm.nih.gov/articles/PMC12847481/) - Source: [J Cell Immunol 2026](https://www.scientificarchives.com/article/live-biotherapeutic-salmonella-il2-saltikva-plus-folfirinox-for-stag-metastatic-pancreatic-ductal-adenocarcinoma-implications-of-a-phase-2-clinical-trial) #### Safety 0 serious adverse events attributed to Saltikva® by the independent Data Safety Monitoring Committee - Source: [Batist et al., Cancer Immunol Immunother 2026](https://pmc.ncbi.nlm.nih.gov/articles/PMC12847481/) - Source: [J Cell Immunol 2026](https://www.scientificarchives.com/article/live-biotherapeutic-salmonella-il2-saltikva-plus-folfirinox-for-stag-metastatic-pancreatic-ductal-adenocarcinoma-implications-of-a-phase-2-clinical-trial) ## Clinical · Phase 1 ### Safety and oral administration - Finding: Oral Saltikva® was tested in a human Phase 1 dose-escalation safety study. - Participants: 22 - Adverse events: No dose-limiting toxicity (single oral dose up to 10¹⁰ cfu) - Source and methods ↗ [J Immunother 2020](https://pubmed.ncbi.nlm.nih.gov/32554977/) ## Preclinical ### Robust Cancer Kill and Cancer Prevention of New Metastases Antitumor effectiveness across multiple murine tumor models and the companion dog trial. - Colonization: Bacteria collect and grow inside tumors in mouse models. - IL-2 in tumor: Active IL-2 produced within the tumor, in mouse models. - Immune activation: NK cells activated, with CD8 T cells contributing. - Companion dogs: In 19 pet dogs with osteosarcoma treated with amputation and doxorubicin, 22% of dogs given Saltikva® were free of metastases at one year, vs under 10% of comparison dogs ([Fritz et al., Vet Med Sci 2016;2(3):179–190](https://pubmed.ncbi.nlm.nih.gov/29067193/)). - With chemotherapy: In a mouse breast-cancer study, adding Saltikva® let researchers cut the chemotherapy (doxorubicin) dose by 75% and still kill as many tumor cells as the full dose. #### Single Oral Dose Is Highly Effective in Treating Primary and Recurrent Disease Mouse liver photographs · single oral dose - Liver following treatment by saline control - Liver following a single oral dose of Saltikva® Mouse livers following treatment with saline control or a single oral dose of Saltikva®, from the slide titled “Single Oral Dose Is Highly Effective in Treating Primary and Recurrent Disease”. Arrows in the original photographs mark tumor nodules and a large tumor mass in the saline-control liver, and a tumor nodule in the Saltikva® liver. ## Publications ### Peer-reviewed work behind the platform - 2026 · A phase 2 study of orally administered live biotherapeutic salmonella-IL2 with FOLFIRINOX for stage IV pancreatic cancer · Cancer Immunol Immunother 75(2):60 - 2025 · Influence of salmonella-IL2 in combination with FOLFIRINOX on overall and progression-free survival in stage IV metastatic pancreatic cancer · J Clin Oncol 43(16_suppl):2571 (ASCO) - 2020 · A Phase I, Dose Escalation, Single Dose Trial of Oral Attenuated Salmonella typhimurium Containing Human IL-2 in Patients With Metastatic Gastrointestinal Cancers · J Immunother 43(7):217–221 ## Request the data room For qualified investors and partners under a confidentiality agreement.