Statera Biopharma, Inc. · OTC:STAB
Statera Biopharma — Investor Presentation (October 2021)
26 slides from Statera Biopharma's investor presentation, October 2021
Slide 1: Restoring Immune Health
(NASDAQ: STAB) Restoring Immune Health October 2021 Corporate Presentation 1 October 2021
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS This presentation contains forward-looking statements that involve risks and uncertainties. All statements other than statements of current or historical fact contained in this presentation, including statements regarding the expected clinical development timeline for the
Slide 3: History
HISTORY • Legacy Cleveland Biolabs spun off • Closing of merger between legacy from The Cleveland Clinic in 2003 Cleveland BioLabs (NASDAQ: CBLI) and • Legacy Cytocom spun off from formerly private Cytocom on July 28, Immune Therapeutics in late 2014 2021 • Approach to drug development is • Treat mu
Slide 4: Restoring Immune Health
RESTORING IMMUNE HEALTH Statera Biopharma intends to become the leader in developing and commercializing therapies that help restore the immune system and keep it in homeostasis which we believe is safer and more effective. § Phase 3 Crohn’s Study with STAT-201 § Clinical Hematology Study with entol
Slide 5: Leadership Team
LEADERSHIP TEAM Michael Handley President & CEO Taunia Markvicka, Pharm.D. Peter Aronstam, Ph.D. Steve Wilson, Ph.D. Leadership Chief Financial Officer Global Head of Innovation Chief Operating Officer Cozette McAvoy, J.D. Clifford Selsky, M.D., Ph.D. Robert Buckheit, Ph.D. Chief Legal Officer & Chi
Slide 6: Rethinking Immunotherapies
RETHINKING IMMUNOTHERAPIES Developing immunotherapies that restore dysfunctional immune systems to a Our state of homeostasis evolutionarily designed to fight cancers, emerging viruses Approach and not result in autoimmune disease (overactive immune system) Horwitz et al., Rebalancing Immune Homeost
Slide 7: Pipeline Focus
PIPELINE FOCUS Initially targeting Autoimmune, Oncology and Hematology Autoimmune Oncology Hematology Acute Neutropenia & Crohn’s Disease Pancreatic Cancer Anemia (STAT-201) (STAT-401) (Entolimod™) Chronic Neutropenia & Multiple Sclerosis Hepatocellular Cancer Anemia (STAT-203) (STAT-402) (GP532) 7
Slide 8: Development Pipeline
DEVELOPMENT PIPELINE Lead Programs Designation Indication Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 NDA Optimization STAT-201 Crohn’s Disease STAT-200 Program STAT-202 Fibromyalgia noroxymorphone-n-substituted- methyl cyclopropyl STAT-203 MS STAT-205 COVID STAT-200 Development Autoimmune & Emer
Slide 9: Intellectual Property
INTELLECTUAL PROPERTY Programs Family Principal Patent #s Title STAT-0010 8,633,150 Method for Inducing a Sustained Immune Response 10,111,870, 10,695,343, Application STAT-200 Patents STAT-0011 Method for Inducing a Sustained Immune Response 16/898,557 noroxymorphone-n-substituted- methyl cycloprop
Slide 10: STAT-201: Crohn's Disease Opportunity
STAT-201: CROHN’S DISEASE OPPORTUNITY Position: Oral therapy with long-term safety at low doses for early intervention to maintain prolonged remission through mucosal healing leading to improved outcomes Sequential Therapies for Crohn’s Disease Phase 2 study supporting proof of concept and safety ST
Slide 11: STAT-401: Pancreatic Cancer Opportunity
STAT-401: PANCREATIC CANCER OPPORTUNITY Position: Adjunct to standard of care to prolong survival by stabilizing disease or slowing progression Survival of Metastatic Pancreatic Cancer is Improved with STAT-401 20 19 Phase 1b/2 PK and safety study expected to 18 initiate 1H22 16 Clinical benefit res
Slide 12: 2021-2022 Potential Catalysts
2021-2022 POTENTIAL CATALYSTS Potential Catalysts *Near Term (12-24 Months) *Long Term (>24 months) • Phase 3 Crohn’s Study with STAT-201 expected 4Q21 • Expect to begin patient enrollment in 4Q21 • Clinical Hematology Study with Entolimod • Phase 2 COVID Study with STAT-205 • Multiple Sclerosis Exp
Slide 13: Appendix
STATERA BIOPHARMA Appendix
Slide 14: COVID-19 Regulatory & Clinical Update
COVID-19 Regulatory & Clinical Update 14 October 2021
Slide 15: STAT-205: COVID Update
STAT-205: COVID UPDATE Active IND for STAT-205 in COVID-19 Expanding IND to Post-Acute COVID-19 Initiating PK/biomarker and safety study in acute COVID-19 in the 4Q21 Phase 2 clinical trial in the post-acute in the 4Q21 to evaluate safety and ability to improve disease progression or resolve long-te
Slide 16: Crohn's Disease Regulatory & Clinical Update
Crohn’s Disease Regulatory & Clinical Update 16 October 2021
Slide 17: Crohn's Disease Opportunity
CROHN’S DISEASE OPPORTUNITY Diagnosed Prevalent cases of CD in 2019 Global Crohn’s Disease market expected Canada AGR to 2029 to grow from $7.4B in 2019 to $12.6B by 97,764 0.62% 2029, CAGR of 5.5%* UK Germany High percentage (~30%) of patients on 95,495 206,384 0.50% Japan anti-tumor necrosis facto
Slide 18: STAT-201: Crohn's Disease Opportunity
STAT-201: CROHN’S DISEASE OPPORTUNITY Position: Oral therapy with long-term safety at low doses for early intervention to maintain prolonged remission through mucosal healing leading to improved outcomes Sequential Therapies for Crohn’s Disease Phase 2 study supporting proof of concept and safety ST
Slide 19: STAT-201: Crohn's Disease Clinical Snapshot
STAT-201: CROHN’S DISEASE CLINICAL SNAPSHOT A pilot clinical trial was conducted in children with moderate to severe Crohn’s disease and concluded therapy seems safe with limited toxicity when given to children with Crohn’s disease and may reduce disease activity. * In a double-blind placebo-control
Slide 20: STAT-201: Crohn's Disease Endoscopic Results
STAT-201: CROHN’S DISEASE ENDOSCOPIC RESULTS STAT-201 promotes mucosal healing in Crohn’s disease. The endoscopic appearance of representative patients’ colonic mucosa is shown at baseline (a, c) demonstrating erythema, edema, ulceration, and loss of vascularity. Corresponding H & E histologic secti
Slide 21: STAT-201 (Crohn's): Highlights
STAT-201 (CROHN’S): HIGHLIGHTS Orphan Drug Designation for the treatment of Crohn’s disease in pediatric patients Novel therapy for immune modulation Good safety profile and well tolerated in clinical studies Once-daily oral dosing Expect to enter Phase 3 development by year-end 2021 21 October 2021
Slide 22: Pancreatic Cancer Regulatory & Clinical Update
Pancreatic Cancer Regulatory & Clinical Update 22 October 2021
Slide 23: Pancreatic Cancer Opportunity
PANCREATIC CANCER OPPORTUNITY Global pancreatic cancer market expected to grow to $5.4B 2019–2029* In 2019, the US accounted for 24.61% of the diagnosed incident cases of pancreatic cancer Prevalent pancreatic cancer cases expected to grow to 264,434 at an annual growth rate (AGR) of 2.62% by 2029**
Slide 24: STAT-401: Pancreatic Cancer Opportunity
STAT-401: PANCREATIC CANCER OPPORTUNITY Position: Adjunct to standard of care to prolong survival by stabilizing disease or slowing progression Survival of Metastatic Pancreatic Cancer is Improved with STAT-401 20 19 Phase 1b/2 PK and safety study expected to 18 initiate 1H22 16 Clinical benefit res
Slide 25: STAT-401: Clinical Snapshot
STAT-401: CLINICAL SNAPSHOT STAT-401: synthetic peptide that activates natural killer (“NK”) cells of the immune system to seek and destroy cancer cells Phase 1 study (dose escalation: 21 subjects; chronic: 16 subjects) showed the mean survival was 9.1 months for both the i.v. and s.c. routes in chr
Slide 26: STAT-401 (Pancreatic Cancer): Highlights
STAT-401 (PANCREATIC CANCER ): HIGHLIGHTS Synthetic peptide that activates natural killer (“NK”) cells of the immune system to seek and destroy cancer Good safety profile and well tolerated in clinical studies Subjects survived nearly twice as long as those historically treated with 5-FU or gemcitab
Statera Biopharma — Investor Presentation (October 2021) on 6ix