Scorpius Holdings Inc. · OTC:SCPX
Scorpius — Heat Biologics — Investor Presentation (March 2014)
25 slides from Scorpius's investor presentation, Mar 20, 2014
Slide 1: Heat Biologics Investor Conference Webcast: HS-110 Phase 2 Study in NSCLC
Heat Biologics AND INVESTOR CONFEREN WEBCAST HS-110 PHASE 2 CLINICAL STUDY FOR TREATMENT OF NSCLC
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation includes statements that are, or may be deemed, ‘‘forward-looking statements.’’ In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expec
Slide 3: Agenda
Agenda l Introduction – Jeff Wolf, Chief Executive Officer l Overview of Heat’s ImPACT Technology – Taylor H. Schreiber, M.D., Ph.D., Vice President of Research and Development l Lung Cancer Market and Checkpoint Inhibitors – Justin Stebbing, M.D., Ph.D., Chairman of Clinical Advisory Board and Chie
Slide 4: Introduction
Introducti Jeff Wolf,
Slide 5: Company Highlights
Company Highlights ü Transformative, differentiated Immunotherapy platform generating diverse pipeline with strong patent estate ü Promising clinical data yielding impressive survival supports 2 programs advancing into late-stage studies in 2014 ü Clinical development programs with clear path to reg
Slide 6: Diverse Pipeline with Multiple Registration Opportunities
Diverse Pipeline with Multiple Registration Opportunities From drug discovery to late-stage clinical development
Slide 7: Overview
Overview Ø Management focused on advancing lead development programs HS-110 and HS-410 with proprietary ImPACT Technology Ø Recent groundbreaking clinical development advancements studying checkpoint inhibitors will be important for lung cancer treatment Ø Worked with preeminent KOL’s and advisors t
Slide 8: World Renowned Advisory Boards
World Renowned Advisory Boards Scientific Advisory Board Clinical Advisory Board
Slide 9: Heat's ImPACT Therapy
Heat’s ImPACT Therapy Taylor H. Schreiber, M.D., Ph.D., Vice President of Research and Development Fully-Allogeneic Cell-based Immunotherapy Tumor associated antigens and powerful adjuvant delivered in a single package
Slide 10: Heat Biologics ImPACT Technology
Heat Biologics ‘Impact VEcHWOLOGY Heat Biologics’ proprietary Immune Pan Antigen Cytotoxic Therapy (ImPACT) reprograms live their own antigens bound to heat shook protein gp96 to seek out and destroy a variety of tumors. " eancer cells to continually secrete _— How ImPACT Technology Works . Live all
Slide 11: Introducing gp96 — Immune System's Swiss Army Knife
antigen leash Antigen Introducing gp96 — Immune System’s “Swiss Army Knife”* “Molecular Warning System” * Schild, H. & Rammensee, H. Gp-96 - The Immune System’s Swiss Army Knife . Nature Immunology 2, 100 -101 (2000) gp96 l Natural biological process to deliver proteins (antigens) + gp96 adjuvant to
Slide 12: Severing the leash that binds gp96
l Genetically modify tumor cells by “severing the leash” that binds the gp96 to the endoplasmic reticulum of the cell and replacing it with a sequence that pumps gp96 out of the cell l Enables living cancer cells to “pump-out” their own surface antigens along with their gp96 chaperone – Mimics necro
Slide 13: Immuno-Oncology Vision
CD8 + Vaccines Checkpoint Inhibitors Checkpoint Inhibitors T Cell Co-stimulators / TNFRSF Targets Priming Activation Proliferation Migration/Killing Immuno-Oncology Vision Preclinical data indicate that ImPACT vaccines synergize with checkpoint inhibitors and T cell costimulators. It is anticipated
Slide 14: Advisor presentation
Advisor Heat Biologics
Slide 15: Forecast NSCLC Total US Market
Forecast NSCLC Total US Market (US$) l In 2020 Estimated adeno NSCLC Patients – ~291,000 new cases per year (US alone) l Target US Patient Population in 2020 – ~ 22,000 will receive 3L therapy HS-110 NSCLC Third Line (3L) adenocarcinoma opportunity Source: Catenion Research 3L adv. NSCLC 2L, 1L, Mai
Slide 16: Rationale for Study
Rationale for Study l Address unmet need by offering patients access to investigational agents with presumably a more favorable safety profile than chemo in a setting where there is little approved in 3 rd -line and the efficacy of these agents is minimal l Maximize antigen expression overlap by tes
Slide 17: HS-110 Phase 2 Protocol Design
HS-110 Phase 2 Protocol Design Melissa Price, Ph.D., Vice President of Clinical and Regulatory Affairs
Slide 18: Phase 2 HS-110/CY Combo NSCLC Design
Randomized HS-110 + low-dose CY Vinorelbine OR erlotinib OR gemcitabine OR paclitaxel Endpoints Primary: overall survival Secondary: immune response in blood, PFS, DCR, ORR by irRC and RECIST 6-mo OS, 12-mo OS Pre- and post-treatment biopsy tissue for exploratory biomarker analyses HS-110 + Vinorelb
Slide 19: Key Study Timelines and Milestones
Milestone Target Completion FDA Submission ü 1Q 2014 First patient enrolled Q3 2014 Enrollment complete Q2 2016 Antigen expression readout Q4 2016 Top-line efficacy readout Q3 2017 Phase 3 trial commences Q4 2017 Key Study Timelines and Milestones Phase 2 Clinical Trial for NSCLC
Slide 20: Business Development Opportunity
Business Development Opportunity Anil K. Goyal, Ph.D., Vice President of Business Development
Slide 21: Business Development Strategy
Business Development Strategy Heat’s ImPACT Immunotherapy platform is : – Differentiated from other allogeneic cell-based approaches – Extended half life of antigen release, potentially more effective in generating immune response – Complementary with checkpoint inhibitors and could expand applicati
Slide 22: Summary
Summary _ Jeff Wolf, Chief Executive O
Slide 23: HS-110 Lung Cancer Program Designed for Success
HS-110 Lung Cancer Program Designed for Success ü Transformative, differentiated Immunotherapy platform with clinical data supporting advancement into Phase 2 program ü Revised protocol developed in collaboration with world’s leading KOLs and lung experts ü Program specifically designed with potenti
Slide 24: Q&A
Q&A
Slide 25: Heat Biologics