Scorpius Holdings Inc. · OTC:SCPX
Scorpius — Heat Biologics — IPO Roadshow (July 2013)
30 slides from Scorpius's IPO roadshow presentation, Jul 8, 2013
Slide 1: Corporate Presentation
Issuer Free Writing Prospectus Filed pursuant to Rule 433 Registration No. 333-188365 July 8, 2013 Corporate Presentation July 2013
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: Free Writing Prospectus Statement
Free Writing Prospectus Statement This presentation highlights basic information about us and the offering. Because it is a summary, it does not contain all of the information that you should consider before investing. We have filed a registration statement (including a preliminary prospectus) with
Slide 4: Offering Summary
Offering Summary Deal Terms SHARES OFFERED 2,272,727 (100% Primary) PRICE RANGE $10.00 - $12.00 per Share EXCHANGE / TICKER NASDAQ Capital Market / HTBX OVER-ALLOTMENT 15% or 340,909 (100% Primary) Clinical Development of HS-110 and HS-410 and USE OF PROCEEDS Other General Corporate Purposes SOLE BO
Slide 5: The Heat Biologics Team
The Heat Biologics Team Jeffrey Wolf • Founded Heat Biologics and advanced company Founder, Chairman and CEO to current clinical stage Scientific Advisory Board • Founder/CEO of several biotech companies including Elusys Therapeutics (founder/Chairman/CEO), TyRx Pharma (co-founder/Chairman), Avigen
Slide 6: How ImPACT Technology Works
qe Heat Biologics’ proprietary Immune Pan Antigen Cytotoxic Therapy (imPACT) reprograms live “allogs their own antigens bound to heat shock protein gp96 to seek out and destroy a variety of tumors. How ImPACT Technology Works Live allogeneic tumor cells are genetically modified to continually *pump-
Slide 7: Heat Biologics Highlights
Heat Biologics Highlights Broad-based l Transformative immunotherapy platform that unleashes a robust pan-antigen T-cell attack against a wide range of cancers Immunotherapy l Fully-allogeneic, “off-the-shelf” drugs with COGS < 5% of autologous cancer vaccine approaches Platform l Multiple near-term
Slide 8: Heat's ImPACT Therapy
Heat’s ImPACT Therapy Living Drug Factories Antigen and adjuvant delivery in a single package 8
Slide 9: • Chairman, Dept. of Immunology University of Miami • Discover of Perforin • Inventor
• Chairman, Dept. of Immunology University of Miami • Discover of Perforin • Inventor of Seattle Genetics CD30 antibody (Adcetris®) recently approved by FDA for Hodgkin Lymphoma • Inventor of Heat’s ImPACT Technology Cutting Edge: Tumor Secreted Heat Shock-Fusion Gp96SIV Ig immunization induces pote
Slide 10: Introducing gp96 — Immune System's Swiss Army Knife
Introducing gp96 — Immune System’s “Swiss Army Knife”* gp96 “Molecular Warning System” l “Chaperone” protein expressed in all our cells and antigen variety of tumors l Activates a pan-antigen T-cell response by enabling MHC I antigen cross-presentation to CD8+ T-cells l Gp96 + client protein natural
Slide 11: ImPACT Therapy — Severing the Leash
ImPACT Therapy — “Severing the Leash” Heat Biologics ImPACT technology removes the leash that binds gp96 to the cell, creating cells that continually secrete gp96 11
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 of 4 Inject these living, 5 Secreted proteins interest and creates genetically these living tumor cells genetical
Slide 13: Fully-Allogeneic Approach
Fully-Allogeneic Approach An Off-the Shelf Therapy Approach • Allogeneic, “off-the-shelf” treatment created from a master cell line • No tumor cells, blood or anything else extracted from the patient • Non-invasive Benefits • Unlimited drug supply enables immediate treatment and frequent administrat
Slide 14: Strong Intellectual Property Protection
Strong Intellectual Property Protection 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 l 5 patent
Slide 15: Lung Cancer and HS-110
Lung Cancer and HS-110 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 shorter time. More rec
Slide 16: HS-110: Phase 1 Lung Cancer Trial Design
HS-110: Phase 1 Lung Cancer Trial Design Cohort 1 1 Dose Every 2 WeeksCells) (40,000,000 Stage IIIB/IV NSCLC Safety Median 7 Prior Therapies & Cohort 2 Immune Response, Progressive ½ Strength Dose Tumor Response, Alternating After Disease First 8 Patients at Enrollment WeeklyCells) (20,000,000 Overa
Slide 17: HS-110 NSCLC Phase 1 Clinical Trial Results
HS-110 NSCLC Phase 1 Clinical Trial Results l Well-tolerated with no overt toxicity and no treatment-related SAEs l 18 patients treated, 15 patients completed first course of therapy, 2 patients completed 3 courses of therapy l Single agent clinical activity in late-stage 3b and 4 lung cancer • As i
Slide 18: Highly Activated Immune Response
Highly Activated Immune Response 1000 Methodology • Samples collected for immune response at baseline and after a minimum of one 6-week course of 1016 therapy were analyzed Cohort 1 (n=9) • To determine the frequency of CD8 100 Cohort 2 IFN-γ, purified CD8 T cells 1003 collected + (n=3) from patient
Slide 19: 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 20: Phase 2 NSCLC Trial Design
Phase 2 NSCLC Trial Design Phase 2 - 2 Stage Adaptive Design Stage 1 HS-110 HS-110 Placebo N = 30 Low Dose N = High Dose N= N=6 Dose 12 cells 2,000,000 12 cells 10,000,000 Finding Proceed with Optimal Dose Stage 2 HS-110 Placebo N = 90 Proof of Optimal dose N = N = 30 60 Concept Inclusion Criteria T
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: Phase 1/2 Clinical Trial Design
HS-410: Phase 1/2 Clinical Trial Design Bladder Cancer Dose Optimal Ranging Dose HS-410 HS- LD 410 N=9 N = 50 Stage 1/2a 1:1 Randomization Cancer Surgical 12 Weekly Resection Injections; Followed N = by 93 BCG Then Monthly X 3 HS-410 Placebo HD N = 25 N=9 Trial Trial l Objectives Safety and tolerabi
Slide 23: Diverse Product Pipeline
Diverse Product Pipeline Planned Planned* Planned *Investigator-sponsored, grant-funded study 23
Slide 24: IPO Milestones and Upcoming Events
IPO Milestones and Upcoming Events 2013 2014 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 HS-110 Phase 2 Clinical Trial Lung Cancer ~120 Patients 2014 Milestones HS-410 Phase 1/2 Clinical Trial Bladder Cancer ~100 Patients qHS-110 lung cancer qStage 1 enrollment completes IPO funds will be used to 2013 Milestones qImmun
Slide 25: Immunotherapy Gaining Momentum
Immunotherapy Gaining Momentum Immunotherapy on the cusp of great industry breakthroughs with several BLA approvals anticipated l“Technology in coming ripening” period years for immunotherapies may be similar to antibodies Highly-novel approach to activate cytotoxic T-cells against multiple tumor an
Slide 26: Select Immunotherapy and Oncology-Focused Comparables
Select Immunotherapy and Oncology-Focused Comparables STAGE OF COMPANY FOCUS LEAD DEVT. VALUATION* CATEGORY Phase 2 (Post Heat Biologics Live T-cell vaccine platform NSCLC ~$70M IPO) Newlink Genetics Live-cell vaccines Pancreatic Phase 3 $556M Stemline Cancer stem cells Leukemia Phase 1/2 $304M Vera
Slide 27: Capitalization Structure
Capitalization Structure CAPITALIZATION (as of 5/21/13) SHARES % OUTSTANDING OUTSTANDING Common Stock* 3,583,654 84% Stock Options 662,543 15% Warrants 53,159 1% Fully Diluted Shares Outstanding 4,299,356 100% *Assuming all preferred stock converts to common stock as of May 21, 2013 27
Slide 28: 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: •Positive safety profile Encouraging •Po
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