Scorpius Holdings Inc. · OTC:SCPX
Scorpius — Heat Biologics — IPO Roadshow (April 2018)
46 slides from Scorpius's IPO roadshow presentation, Apr 20, 2018
Slide 1: Heat Biologics Corporate Presentation
Heat Biologics Corporate PresentationApril 20, 2018
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation includes statements that are, or may be deemed, ‘‘forward-looking statements’’ within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, these forward-looking statements can be identified by the use of forward-
Slide 3: Free Writing Prospectus Statement
3 Free Writing Prospectus StatementThis 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
4 Heat Biologics, Inc. Exchange Ticker NASDAQ: HTBX Offering Size Approximately $15,000,000 (100% Primary) Over Allotment 15% (100% Primary) Use of Proceeds To fund our and our subsidiaries’ clinical and preclinical programs and for working capital and general corporate purposes Sole Book-Running Ma
Slide 5: Our Mission
To activate CD8+ “Killer” T-cells to turn “COLD” tumors “HOT” 5 Our Mission We seek to combine with checkpoint inhibitors and other immunotherapies to dramatically increase their effectiveness 5
Slide 6: What are Hot and Cold Tumors?
6 Cold Tumors Tumors that have not been subject to robust CD8+ “Killer” T-cell attackBiopsied tumors contain minimal CD8+ T-cells Hot Tumors Tumors that have been subject to robust CD8+ “Killer” T-cell attack Biopsied tumors are loaded with CD8+ T-cells HOT tumors are associated with clinical respon
Slide 7: Current NSCLC checkpoint inhibitor treatment
Current NSCLC checkpoint inhibitor treatment Checkpoint Inhibitor Monotherapy Heat BiologicsCombination Therapy Cold Tumor Cold Tumor Hot Tumor Hot Tumor Current Responders Target Responders Goal Unmet medical need in 2nd line NSCLC Combination therapies can improve patient outcomes 7 17% - 20% resp
Slide 8: Immuno-Oncology Combination Therapy
8 Immuno-Oncology Combination Therapy The three legs of an Immuno-Oncology Stool T-cell Activation Co-stimulation Checkpoint Inhibition Heat’s Core Focus Heat’s goal is to dramatically increase the number of patients responding to checkpoint inhibitors
Slide 9: Unlocking the Body's Natural Defenses with a Broad Range of Combination Therapies
Unlocking the Body’s Natural Defenses with a Broad Range of Combination Therapies 9 Combination Therapies T-cell Activation Co-Stimulation Pelican PTX-35Monoclonal AntibodyPelican PTX-15Fusion Protein Checkpoint Inhibitors PD1/PDL1CTLA-4Lag-3TIM-3Plus others Combined with ImPACT® TherapyCell-based D
Slide 10: Introducing gp96: The Immune System's Swiss Army Knife
10 Introducing gp96 The Immune System’s “Swiss Army Knife”* *Schild, H. & Rammensee, H. Gp-96 – The Immune System’s Swiss Army Knife. Nature Immunology 2, 100-101 (2000) “Molecular Warning System” Natural biological process to deliver proteins (antigens) & gp96 adjuvant to our immune systemGp96 “cha
Slide 11: ImPACT Platform: Severing the Leash
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 cellEnables living cancer cells to “pump-out” their own surface antigens along with their gp96 chaperoneMimics necrotic cell
Slide 12: ImPACT: Immune Pan-antigen Cytotoxic Therapy
12 ImPACT®: Immune Pan-antigen Cytotoxic Therapy ImPACT Cell Cancer-killing T-cell ImPACT cells secrete antigens designed to specifically activate patient’s killer T-cells T-cells circulate to destroy patient’s tumor Cluster of five 0.1 mL intradermal injections Activated cells EXPRESS chaperoned an
Slide 13: ImPACT + Opdivo Combination Therapy
ImPACT + Opdivo Combination Therapy 13 Source: BMS images Potential to improve clinical responses and survival, without additional toxicity
Slide 14: Product Pipeline
14 Product Pipeline Combination Therapies Designed to Activate CD8+ T-cells to Fight Cancer T-cell infiltration seen deep inside tumorsPositive safety profile, to-date Clinical proof of mechanism activating an immune responseActivated T-cell immune response seen at 10 weeks Combination Therapies Ind
Slide 15: Phase 1b/2 DURGA Trial of HS-110
A Phase 1b/2 study of Viagenpumatucel-L (HS-110) in Combination with Multiple Treatment Regimens in Patients with Non-Small Cell Lung Cancer (The “DURGA” Trial) Objective Evaluate objective response rate of HS-110 and anti-PD-1 immune checkpoint inhibitor and other agents Patient Population NSCLCAde
Slide 16: TIL Infiltration Associated with Clinical Response
Baseline(Cold) Week 10(Hot) TIL Infiltration Associated with Clinical Response 16 Patient 1:Partial Response at Week 18 High CD8+ TIL (>10%) Patient 2:Partial Response at Week 9 High CD8+ TIL (>10%) Patient 3:Partial Response at Week 18 Low CD8+ TIL (<10%) High CD8+ TIL (>10%) “Killer” CD8+ T-cells
Slide 17: Pre-Specified Patient Populations Analyzed
Pre-Specified Patient Populations Analyzed 17 ITT (n=35)The Intent-to-Treat Population includes all patients enrolled into the study PP (n=26)The Per Protocol Population includes patients who have received at least 6 doses of HS-110 and a pre/post treatment tumor assessment Non-drug related 2 patien
Slide 18: HS-110 Overall Survival
HS-110 Overall Survival 18 ITT survival curve has not yet reached medianMedian OS of nivolumab alone = 12.2 months mOS nivolumab12.2 months* *N Engl J Med 2015; 373: 1627-1639 PP (n=26) is a subset of the ITT population (n=35)
Slide 19: Best Target Lesion Response
19 Change in tumor sizw from Baseline (%) All evaluable ITT patients with a baseline and on-treatment scan (n=27) All enrolled patients (ITT) with a baseline and on-treatment scan Best Target Lesion Response
Slide 20: Durability of Target Lesion Response
Durability of Target Lesion Response Change from Baseline (%) All enrolled patients (ITT) with a baseline and on-treatment scan Days From First Dose Overall target lesion responses are durable and long lasting
Slide 21: Target Lesion Response Based on Initial CD8+ TIL Status
Target Lesion Response Based on Initial CD8+ TIL Status 21 Change from Baseline (%*) CD8+ TIL Evaluable ITT Population Change from Baseline (%*) High CD8+ TIL at Baseline Low CD8+ TIL at Baseline 50% 20% 25% 20% 60% 30% 50% 5% 5% 5% 5% 5% 5% 10% 0% 1% * % of CD8+ T-cells in tumor tissue at baseline
Slide 22: Durable Target Lesion Responses Based on Initial CD8+ TIL Status
Durable Target Lesion Responses Based on Initial CD8+ TIL Status 22 Low CD8+ TIL High CD8+ TIL Change from Baseline (%) Tumor Type at Baseline CD8+ TIL Evaluable ITT Population Days from First Dose Durable target lesion responses (> 6 months) observed in difficult-to-treat low TIL “cold” patients
Slide 23: Encouraging Overall Survival Based on CD8+ TIL Status
Encouraging Overall Survival Based on CD8+ TIL Status 23 HS-110 Treated Patients Days Known to Be Alive Low CD8+ TIL High CD8+ TIL Tumor Type at Baseline Ϯ Reported Death TIL Evaluable ITT Population Ϯ Ϯ PD PD PD PD PD PD PD PD PD PD SD SD SD SD SD PR PR PR PR PD * Ongoing Response CR of Non Target
Slide 24: Target Lesion Response Based on Initial PD-L1 Status
Target Lesion Response Based on Initial PD-L1 Status 24 Change from Baseline (%) PD-L1 Evaluable ITT Population Change from Baseline (%) >1% PD-L1 Tumor Type at Baseline <1% PD-L1 Tumor Type at Baseline Positive PD-L1 Negative PD-L1 5% 50% 10% 1% 20% 50% 5% 60% 15% HS-110 shows effect in low PD-L1 p
Slide 25: Durable Target Lesion Responses Based on Initial PD-L1 Status
Durable Target Lesion Responses Based on Initial PD-L1 Status 25 Change from Baseline (%) PD-L1 Evaluable ITT Population Days from First Dose Change from Baseline (%) Days from First Dose >1% PD-L1 Tumor Type at Baseline <1% PD-L1 Tumor Type at Baseline Positive PD-L1 Negative PD-L1 Durable target l
Slide 26: HS-110 Safety Profile to Date
26 HS-110 Safety Profile to Date ~1,000 HS-110 Doses – No Serious Adverse Reactions ~1,000 doses administered to ~100 patientsOnly one patient ended treatment due to a non-serious adverse reaction*No systemic use of steroids required to treat reactionsNo serious adverse reactions beyond those seen w
Slide 27: Summary of Phase Interim Data
Summary of Phase 2 Interim Data Tumor shrinkage and disease control demonstrated in a majority of evaluable patientsOverall responses are durable and long lastingMedian overall survival has not yet been reachedHS-110 shows effect in difficult-to-treat low TIL and low PD-L1 patients who typically do
Slide 28: Trial Learnings to Enhance Current Design
Trial Learnings to Enhance Current Design Enroll patients with low CD8+ TILEnroll earlier in the treatment course or as front-line maintenance therapyClinical settings that provide maximal time to respond to HS-110Explore potential benefits to anti-PD-1 pre-conditioned treatment environmentModify cu
Slide 29: Heat Biologics Acquires Pelican Therapeutics
29 Heat Biologics Acquires Pelican Therapeutics Unlocking the Body’s Natural Defenses with a Broad Range of Combination Therapies Heat acquired 80% controlling interest in PelicanPre-clinical synergy with Heat’s ImPACT® and checkpoint therapy$15.2M grant award from the Cancer Prevention Research Ins
Slide 30: Highlights from Pelican Pre-clinical Studies
30 Highlights from Pelican Pre-clinical Studies TNFRSF25 is preferentially expressed on CD8+ T-cells compared to other T-cell co-stimulatorsCo-stimulation occurs only in the context of TCR recognition of antigenDrives the development of antigen-specific CD8+ T-cells (mimics TL1A, the specific ligand
Slide 31: Corporate Milestones
Corporate Milestones 31 Interim NSCLC Phase 2 data readout Enroll first patient in HS-130 ComPACT trial IND for Pelican PTX-35 Enroll first patient in PTX-35 Phase 1 trial Complete Phase 2 NSCLC enrollment NSCLC Milestones Pelican and ComPACT Milestones IND for HS-130 ComPACT Trial Receive $6.9M in
Slide 32: Corporate Highlights
32 Corporate Highlights Market Cap$7.0M1 Cash & Equiv.$9.8M2 NasdaqHTBX Shares Outstanding5.66M Share Price$1.221 Grant Funds$15.2M Closing price as of April 18, 2018Reported as of December 31, 2017 32 Corporate Highlights Market Cap$7.0M1 Cash & Equiv.$9.8M2 NasdaqHTBX Shares Outstanding5.66M Share
Slide 33: Investment Highlights
Investment Highlights Potential Best in Class Oncology Treatment - T-cell activating platform (TCAP) produces allogeneic, off-the-shelf therapies designed to activate the immune system to turn immunologically “cold” tumors “hot”Combination Effect - Our therapies are designed to be administered with
Slide 34: Turning COLD Tumors HOT
Cold Tumors Hot Tumors Turning COLD Tumors HOT 34
Slide 35: Appendix
Appendix 35
Slide 36: Management and Advisors
Management and Advisors 36 Jeff WolfFounder & CEO Ann RosarVP of Finance Janice McCourtVP of Business Devt. Lori McDermottVP of Clinical Dev. Gary VinsonVP of Manufacturing Jeff Hutchins, Ph.D.CSO/COO George Peoples, MDChief Medical Advisor Management Scientific Advisors Robert Levy, Ph.D.University
Slide 37: ImPACT Generates an Adaptive Immune Response
ImPact Generates an Adaptive Immune Response Secretion of gp96-Ig carrying tumor specific proteins represented on the patients tumorActivation of APCs (TLR2/4) and cross- presentation of antigens (CD91)Specific T-cell receptor engagementClonal Expansion of Tumor Antigen Specific T cells. 37 2 signal
Slide 38: ImPACT Manufacturing
38 ImPACT® Manufacturing Robust, Multi-antigen T-cell Activation Frozen, fully-diluted single-dose vialFinal drug product: 1 million or 10 million cellsEasily scaled manufacturing Low COG, off-the-shelf alternative to autologous therapies
Slide 39: ELISPOT Activity and Survival
ELISPOT Activity and Survival 39 High = ELISPOT activity above the median of patients tested Low = ELISPOT activity below the median of patients tested A trend of survival benefit is observed higher ELISPOT activity of immune response 203 337 ELISPOT Evaluable ITT Population
Slide 40: Strong supporting pre-clinical data
Strong supporting pre-clinical data 40 Pre-clinical Data Source: Fromm et al. Society for Immunotherapy of Cancer Annual Meeting, 2016 CD8+ T-cell Activation Higher T-cell responses observed in mice treated with ImPACT aloneImPACT® boosted CD+ T-cells to even higher levels when combined with co-stim
Slide 41: ComPACT Platform Technology
41 ComPACT™ Platform Technology gp96-Ig OX40L-Fc The first potential dual-acting immunotherapy designed to deliver T-cell activation andco-stimulation in a single product – combination therapy without additive costs
Slide 42: ComPACT Outperforms OX40 Monoclonal Antibodies in Pre-clinical Models
42 ComPACT™ Outperforms OX40 Monoclonal Antibodies in Pre-clinical Models ComPACT generates ~50% complete tumor rejection compared to ~16% with OX40 agonist antibody combinations Superior primary and memory T-cell response in mouse model Translates into increased overall survival and tumor reduction
Slide 43: PTX-35 Comparative Pre-clinical Anti-tumor Activity
43 PTX-35 Comparative Pre-clinical Anti-tumor Activity Schreiber T. et al. SITC 2014 Activity of agonists TNFRSF25, 4-1BB, OX40 and GITR during nine-day B16-F10 melanoma model TNFRSF25 agonists leads to increased survival compared to other co-stimulatory antibodies 4-1BB and GITR agonists have a mod
Slide 44: Preferential CD8+ T-cell Induction with TNFRSF25
44 Preferential CD8+ T-cell Induction with TNFRSF25 Pre-clinical studies with murine agonist antibody shows preferential CD8+ T-cell Induction; differentiation from other T-cell co-stimulators The frequency of antigen-specific memory CD4+ or memory CD8+ T-cells following treatment of mice with ImPAC
Slide 45: Emerging Target in T-cell Co-stimulation
Many companies are pursuing co-stimulators with less specificity for CD8+ “memory” activation 45 Emerging Target in T-cell Co-stimulation Only Pelican is targeting TNFRSF25, an emerging target in immuno-oncology Target Agonist to Target Clinical Stage Company Comments 4-1BB PF-05082566 (utomilumab)B
Slide 46: Expression of T-cell Co-stimulators
46 Expression of T-cell Co-stimulators TNFRSF25 is preferentially expressed on CD8+ T-cells compared to other T-cell co-stimulators Genomics Institute of the Novartis Research Foundation Su et al. PNAS 2004:101(16);6062-7 (red = high expression)