Scorpius Holdings Inc. · OTC:SCPX
Scorpius — Heat Biologics — Investor Presentation (May 2014)
28 slides from Scorpius's investor presentation, May 28, 2014
Slide 1: Corporate Presentation
Corporate Presentation May 2014
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: How ImPACT Technology Works
Heat Biologics’ proprietary Immune Pan Antigen Cytotoxic Therapy (ImPACT) reprograms their own antigens bound to heat shock protein gp96 to seek out and destroy a variety o How ImPACT Technology Works Live allogeneic tumor cells are genetically modified to continually “pump-out" their own cancer ant
Slide 4: Investor Highlights
Investor Highlights Ø Transformative, differentiated immunotherapy platform generating diverse pipeline with strong patent estate Ø Promising monotherapy clinical data in lung cancer with impressive survival results Ø 2 clinical development programs advancing into Phase 2 studies in 2014 expected to
Slide 5: Management Team with Proven Track Record
Management Team with Proven Track Record Jeff Wolf Melissa Price, Ph.D. Founder and CEO VP, Clinical and Reg. Affairs • Founder and managing director of Seed-One Ventures • Led numerous oncology programs in both the biotech arena • Co-founder and director, Avigen and the CRO space • Co-founder and C
Slide 6: World Renowned Advisory Boards
World Renowned Advisory Boards Scientific Advisory Board Clinical Advisory Board 6
Slide 7: Diverse Pipeline with Multiple Registration Opportunities
Diverse Pipeline with Multiple Registration Opportunities From drug discovery to late-stage clinical development 7
Slide 8: Broad Issued Patents on ImPACT Platform & Pipeline
Broad Issued Patents on ImPACT Platform & Pipeline IP Estate with Broad and Early Filings ImPACT Platform Technology l US and foreign patents issued for ImPACT technology for the treatment of cancer and viral disease l Additional patents on proprietary cell lines and clinical data Worldwide Filings
Slide 9: Heat's ImPACT Therapy
Heat’s ImPACT Therapy Living Drug Factories Antigen and adjuvant delivery in a single package 9
Slide 10: Introducing gp96 — Immune System's "Swiss Army Knife"
Introducing gp96 — Immune System’s “Swiss Army Knife”* Cell Membrane Antigen “Molecular Warning System” l Natural biological process to deliver proteins (antigens) + gp96 adjuvant to our immune system gp96 l Gp96 “chaperones” newly-created proteins to the cell membrane where they are released and em
Slide 11: ImPACT Therapy — "Severing the Leash"
ImPACT Therapy — “Severing the Leash” Cell Membrane 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 ant
Slide 12: ImPACT Therapy — Process
ImPACT Therapy — Process Non- Killer functional T- Tumor Cell Cell Vaccine Injection Inject living ImPACT cells into the patient 1 Choose cancer of 2 Heat Biologics 3 Scale-up production 4 Inject these living, 5 Secreted proteins interest and creates of these living tumor genetically- activate kille
Slide 13: ImPACT — Highlights
ImPACT — Highlights An “Off-the Shelf” Therapy to Generate a Pan-antigen T-cell Immune Attack Approach • Pan-antigen immune attack • Allogeneic, “off-the-shelf” treatment created from a master cell line • Unleashes an immune attack against a wide variety of known and unknown • No tumor cells, blood
Slide 14: Lung Cancer and HS-110 (Viagenpumatucel-L)
Lung Cancer and HS-110 (Viagenpumatucel-L) Background Lung Cancer is the Second Most Common Cancer in US with No Reliable Treatment Options for Late-Stage Patients “Without any chemotherapy, the average person will live about 4½ months. With chemotherapy most will live longer and some will live a sh
Slide 15: HS-110: Successful Completion of Phase 1 Study
HS-110: Successful Completion of Phase 1 Study Phase 1 NSCLC Trial Design Cohort 1 1 Dose Every 2 WeeksCells) (40,000,000 Stage IIIB/IV NSCLC Safety Disease progressing at time of Enrollment Cohort 2 Immune Response, ½ Strength Dose Tumor Response, Failed multiple lines of prior therapy WeeklyCells)
Slide 16: HS-110 NSCLC Phase 1 Clinical Trial Results
HS-110 NSCLC Phase 1 Clinical Trial Results l Well-tolerated with no overt toxicity l Single agent clinical activity in late-stage 3b and 4 non-small cell lung cancer – 7 of 15 surviving patients exhibited stable disease after single course of therapy l Immune response observed in 73% (11 out of 15)
Slide 17: Immune Response Predictive of Survival
Immune Response Predictive of Survival 1.00 >3x Extension of Median OS for Responders 0.75 Non-Responders (N=4) Responders (N=11) 0.50 Hazard Ratio: 0.021 95% CI: 0.002 - 0.204 0.25 0 6 12 18 24 30 36 Months From Treatment Start In 11 of the 15 patients (73%) completing the first course of therapy w
Slide 18: HS-110 Lung Cancer Phase 2 Clinical Program
HS-110 Lung Cancer Phase 2 Clinical Program Specifically designed in collaboration with leading KOLs to be complementary in combination with next generation oncology treatments 1H 2014 üFinalize Phase 2 protocol üSubmit revised protocol to FDA üAnnounce Phase 2 protocol 2H 2014 §Commence patient enr
Slide 19: Phase 2 Protocol Designed to Complement Next Generation Oncology Treatments
Phase 2 Protocol Designed to Complement Next Generation Oncology Treatments 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 3rd-line and the efficacy of these agents i
Slide 20: Phase 2 HS-110/CY Combo NSCLC Design
Phase 2 HS-110/CY Combo NSCLC Design 3rd-line vs. physician’s choice, continue vaccine in combo with 3L chemo after 1st progression Randomized Endpoints Arm 1; Arm 2; Primary: overall survival N=82 N=41 Secondary: immune response 1 2 Vinorelbine in blood, 3rd-line - Stage HS-110 + low- OR PFS, DCR,
Slide 21: Bladder Cancer and HS-410
Bladder Cancer and HS-410 Background In 2012 Alone, There Were 73,000 New Cases of Bladder Cancer Reported and 15,000 Deaths l Currently-available treatments have high failure rate and are poorly tolerated l Among highest lifetime treatment cost per patient of any cancer due to a high recurrence rat
Slide 22: HS-410: Bladder Cancer Phase 1/2
HS-410: Bladder Cancer Phase 1/2 93 patient, fully-randomized, placebo-controlled trial Weekly injections for 12 weeks followed by 3 monthly injections Phase 1/2 - 2 Stage Adaptive Design HS-410 HS-410 Stage 1 Cohort 1 Trial objectives include safety and Cohort 2 N = 18 Low Dose immune response High
Slide 23: Key Study Timelines and Milestones
Key Study Timelines and Milestones Phase 1/2 Clinical Trial for Bladder Cancer Milestone Target Completion First patient enrolled and dosed ü Q1 2014 Cohort 1 enrollment complete Q3 2014 Cohort 2 enrollment initiates Q4 2014 Cohort 1 safety and antigen profiles Q1 2015 Cohort 2 enrollment complete Q
Slide 24: Business Development Strategy
Business Development Strategy 1. ImPACT Platform Partnerships • Strategy to Partner by indication(s) • Use platform for new product discovery • Product development by partner Selected Immunotherapy 2. Clinical Programs (HS-110, HS-410) Companies Deals Date Financials AZ-Immunocore Jan ‘14 $20M+300M/
Slide 25: Financial Snapshot
Financial Snapshot Financial strength to execute on our business plan Ticker NASDAQ: HTBX Shares Outstanding 6,452,341 Share Price* $4.77 Market Capitalization* ~$30M Cash as of 3/31/14 $19.4M Enterprise Value ~$10M *as of market close on May 22, 2014 25
Slide 26: Multiple Near-Term Milestones Expected to Build Momentum
Multiple Near-Term Milestones Expected to Build Momentum Program 1H 2014 2H 2014 HS-110 ü Submit revised protocol to FDA qInitiate Phase 2 enrollment Lung Cancer Program HS-410 ü Commence patient dosing qComplete Cohort 1 enrollment Bladder Cancer qCohort 1 immune response data Program qInitiate Coh
Slide 27: Summary
Summary Clinical Stage Platform Technology Generating Promising Human Data Transformational Unleashes the immune system against a wide range of Technology Platform cancers • Over a decade of published research and recent clinical data Data to Date Demonstrate: Encouraging • Positive safety profile C
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