Marker Therapeutics, Inc. · NASDAQ:MRKR
Marker Therapeutics — Investor Presentation (April 2019)
58 slides from Marker Therapeutics's investor presentation, April 2019
Slide 1: A Major Leap Forward in Cell Therapy
A MAJOR LEAP FORWARD IN CELL THERAPY l mHERAPEUTICS
Slide 2: Forward Looking Statement
eee FORWARD LOOKING STATEMENT Certain statements contained herein are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, that involve risks and uncertainties. All statements other
Slide 3: Investment Highlights
mmm INVESTMENT HIGHLIGHTS TRANSFORMATIONAL T CELL THERAPIES Unique and highly differentiated approach that addresses the major challenges faced by CAR and TCR approaches MULTI-ANTIGEN APPROACH DRIVES ENHANCED Durable responses with clear evidence of epitope EFFICACY spreading targeting multiple tumo
Slide 4: Gene Modified T Cell Therapy: What We Now Know
mmm GENE MODIFIED T CELL THERAPY: WHAT WE NOW KNOW CAR-T, TCR, and NK therapies have made headway in treating cancer, but data underscores the many hazards and limitations CLINICAL IMPACT X Limited durability of response . Treatment limited to targeted antigen agp a apse High relapse rate due to ant
Slide 5: Multi Tumor-Associated Antigen (multiTAA) Cell Therapy
MULTI TUMOR-ASSOCIATED ANTIGEN (MULTITAA) CELL THERAPY Multiple Antigens @ Heterogeneous Tumor Target expression of multiple tumor antigens thereby targeting more ce tumor cells Gy Clinical Safety no-Specifi No related SAEs or CRS in 70+ patients Mono Sone’ e No Genetic Modification 2) Native peptid
Slide 6: Current Cell Therapy Landscape
eee CURRENT CELL THERAPY LANDSCAPE Marker technology addresses the limitations of current known CAR T and TCR cell therapy programs ma * MARKER Qciead NY THerareurics eaerere x x x x x v EPITOPE SPREADING x x x x x J NO GENETIC MODIFICATION x x x xX x J NO FATALITIES CAUSED BY THERAPY x< x x x x J O
Slide 7: multiTAA T Cell Manufacturing Process
MULTITAA T CELL MANUFACTURING PROCESS products etood oraw/ acc e,e*e a Allogeneic Autologous Apheresis _ a _ A eta +pepmix e @ = +cytokines LAPP MAPP wl PRAME ( PRAME MAGEA4 | 10+ Days Survivin SSX2 NY-ESO-1 Survivin NY-ESO-1 MultiTAA T Cell Infusion +pepmix +cytokines Wash & Freeze
Slide 8: TCR Profile - WT1 Reactive Cells
TCR PROFILE - WTI REACTIVE CELLS Circulating T Cells Gamma Capture Dominant Clonotypes = - al Undiscovered “Unique” TCR 2 | Undiscovered “Unique” TCR 1 =| Rm Deep Sequencing CR A @ wr | serwivin & ny-€s01 @ Prame [ Undiscovered “Unique” TCR 3 Ew
Slide 9: Profile and Specificity of multiTAA T Cells
eee PROFILE AND SPECIFICITY OF MULTITAA T CELLS Cell Phenotype Peptide-Specific Responses 100% 1000 5 8 = $ g x 80% ao ¥ . @ 8 Ad Pr s 8 6 [= o 60% e & 6 roy 100 ® A a a x 5 R x x x 2 40% 8 5 + ¢ x & . % 2 iL x a é ° 8 @ n 40 ry . e } S 20% 4 t A 4 4 5 a Q - + a 0% 4 = & a * CD3+ CD4+ CD8+ RO#/ ROH
Slide 10: CD19 CAR-T Results: Duration of Response
eee CD19 CAR-T RESULTS: DURATION OF RESPONSE 100 90 4 80 4 70 4 g & 6o4 2 c¢ S04 2 $ 404 o © 304 Median (95% Cl) mo 204 Complete Response NR (NE-NE) 17 4 Objective Response 11.1 (3.9-NE) Partial Response 1.9 (1.4-2.1) ° T T qT T T T T T T T qT T T T T T T T T T T T T T T T 1 o 1 2 3 4 5 6 7 8 9 0 N
Slide 11: CD19 CAR-T Results: Toxicity Rates
mmm CcbDi9 CAR-T RESULTS: TOXICITY RATES Event Any Grade 101 (100 95 (@4) 6059) 34.04) Broo) Ban san nan 94.93) 77.78) aan 22022) aan 2020) 56) Grade tor 2 Grade > 3 Event Any Grade Grade Yor 2 Grade > 3 Neurologic Event Any 65 (64) 370 20 (2a) Encephalopathy G4) way aan ‘Confusional State 29(29) 20
Slide 12: Lymphoma
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Slide 13: Active Lymphoma Clinical Trial Outcomes
ACTIVE LYMPHOMA CLINICAL TRIAL OUTCOMES ID Age/G therelies 2 4 6 8 10 ; 14 16 18 20 22 Y 34/F ca >>> >> >> 7 2 S/F 3 >>> > > > J 3 35/M 7 >> >>> >> > > >> > > > > > > »> > > > > > > > >» D> D> D> D> D> D> D> D> D> D> DD DD DD DD 4 43/F 4 >>> >>> >>> >> > > > > > >> > > > > >> > > > D> > > D> D> D> D
Slide 14: Active Lymphoma Patients Profiles
ACTIVE LYMPHOMA PATIENTS PROFILES ID ' 2* 3* 4 Age/G 34/F 55/F 35/M 43/F 48/M 47/F 3VF 69/M 54/M 18/F 48/M 49/M 54/M 64/M 68/M Disease HL HL/NHL HL HL HL DLBCL HL NHL DLBCL HL DLBCL HL DLBCL DLBCL DLBCL Prior Therapies ABVD P ICE ® Cis-Gem > XRT ® ASCT ® EBV T Cells ® Brentuximab ® Yttrium90 ® CAR-T
Slide 15: Adjuvant Lymphoma Clinical Trial Outcomes
ADJUVANT LYMPHOMA CLINICAL TRIAL OUTCOMES Months Prior Response to T Cell ID Age/G therapies 8 12 16 20 24 28 32 36 40 vherag vr 3e/m 3 D>>>>>DDPPPPPPPDPPDDPPPPPPPPPPPDDPIPPP? CCR (5 years) 2 78/F 2 >>>>)>>)>D Relapsed After 8 Months 3 78/F 4 DPDIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII>>> CCR (5 years) 4 2
Slide 16: Adjuvant Lymphoma Patients Profiles
ADJUVANT LYMPHOMA PATIENTS PROFILES Age/G Disease Prior Therapies r 38/M HL & OLBCL ABVD PRICE ®ASCT 2 78/F OLBCL R PRCHOP z 78/F DLBCL RP RCHOP P multiTAA T cells B R-Bendamustine 4 21/M HL ABVD P Brentuximab » Nav/Gem P» ASCT 5 36/M HL ABVD BP ICE BASCT + XRT ® Brentuximab 6 54/M DLBCL RCHOP ® R-E
Slide 17: Active Lymphoma Outcomes vs. CD19 CAR-T
mmm ACTIVE LYMPHOMA OUTCOMES VS. CDI9 CAR-T 15 patients treated for active disease Duration of Response 100 MARKER Response (%) a Co l MARKER sD 20 ~ Kite PR 10 4 ° T T T T T T T T T T T T T T T T T T T T T T T T T T T T T T 0 2 4 6 8 10 12 14 6 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52
Slide 18: Case #1: Response in Lymphoma Trial of Patient
CASE #1: RESPONSE IN LYMPHOMA TRIAL OF PATIENT 5 Data demonstrates clinical benefit as post-infusion T cells exhibit antigen spreading Pre-Infusion Targeted Antigens 350 300 P 250 200 @ rane 60 @ ssx @ vaceas wo @ w-es04 50 SURVIVIN ° Pre Post Non-Targeted Antigens 70 SFC/2x10° Post-Infusion 60 50 '
Slide 19: Case #2: Response in Lymphoma Trial of Patient
CASE #2: RESPONSE IN LYMPHOMA TRIAL OF PATIENT 2 Many patients in this study received less than full product due to required escalation of antigens included in the product infused Pre-Infusion Targeted Antigens SFC/2x10° Pre Non-Targeted Antigens SFC/2x10° - || —_ a Pre Post 17
Slide 20: Case #3: Response in Lymphoma Trial of Patient
CASE #3: RESPONSE IN LYMPHOMA TRIAL OF PATIENT 6 Marker T cell expansion changes over time to match antigen expression on tumor Pre-infusion Post-infusion month 3 Post-infusion month 9 Targeted Antigens Non-Targeted Antigens 4 SFC/2x10°* SFC/2x10° ose - ¢ ) =< “A> Pre Mth3 Mtho o* Pre Mths Mth Ly 18
Slide 21: Acute Myeloid Leukemia
. Ps > 2 & * ACUTE MYELOID > \LEUKEMIA
Slide 22: Therapeutic Pathway for an AML Patient
THERAPEUTIC PATHWAY FOR AN AML PATIENT Adverse Risk/ Relapsed AML ~26,000/yr >CR2 Complex Cytogenetics Monosomy 7 MDS AML t-AML MLL-r FLT3/DNMT3A etc “a4 Source: Koreth J et al, DeAngelo DJ JAMA 2009 ‘\ All Other Approved AML Therapies 19
Slide 23: Outcomes of AML/MDS Patients Post Allo-HSCT
mmm OUTCOMES OF AML/MDS PATIENTS POST ALLO-HSCT 46% Dead - 54% TRM: 25%, AML Relapse 75% 0% 50% 100% Outcome at 5 years Overall survival after relapse: 4.5 months S t ‘ 20
Slide 24: Post-Transplant AML
eee POST-TRANSPLANT AML e Once an AML patient progresses to transplant, treatment options are very limited e Other AML therapies, such as FLT3/IDH inhibitors, are currently approved for pre-transplant use e CAR-T candidates, such as CD123 and CD33, target antigens which are prevalent on hematopoieti
Slide 25: Active AML/MDS Clinical Trial Outcomes
ACTIVE AML/ MDS CLINICAL TRIAL OUTCOMES Months ID Age/G 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 3 70/M >>>) Isolated relapse in skin 4 16/M »»> a >>> >> >> >>> >>>) >>) >>> Seas 8 SS/M DPPPPH °2'tia! remission - Reduction in blasts from 50% to 15% 9 23M PDD Received 2” dose of cells, but progressed
Slide 26: Active AML/MDS Patients Profiles
ACTIVE AML/MDS PATIENTS PROFILES ID Age/ 7 70/M 16/M S7/F 55/M 23/M 20/F Disease IDHImut MDS > AML FLT3-ITD Induc. Failure Del 17p FLT3-ITD Prior Therap: 7+3 Decitabine PIDH inhib ® Cutis Relapse ® CIA PRIC-SCT P Relapse Double cord SCT DAML Relapse PC P Haplo-SCTx2 P Relapse CIA & Sorafenib > CIAx2
Slide 27: Adjuvant AML/MDS Clinical Trial Outcomes
ADJUVANT AML/ MDS CLINICAL TRIAL OUTCOMES 1D Age/G Noon GS 57/F 18/F 55/F 70/F 53/F 65/M SS/M 45/M 5V/F 54/F 58/M 53/F 18/F 2 4 6 8 10 DPPPP %elepsec, Treated on Group 8 DIDIIIIIIIIIIIIIIIIIIII III III III III III III III>»I>> DIDIIIIIIIIIIIIIII III III IIIIIIIIIIIII»»> DIDIIIIIIIIIIIIIIIIIII>I>III»
Slide 28: Adjuvant AML/MDS Patients Profiles
ADJUVANT AML/MDS PATIENTS PROFILES 1D Age/G + 2 S7/F 18/F 55/F 70/F 53/F 65/M 55/M 45/M S/F 54/F 58/M 53/F 18/F Disease FLT3-ITD FLT3-ITD MLL-r AML CR3 DNMT3a MLL-r t-AML Ph+AML AML CR2 Complex-riPSS: Int-2 RAEB-1 rIPSS: Int-2 CR2 (MRD+) FLT3-ITO/MRD+ Prior Therapies CIA & Sorafenib P CIAx2 PB RIC-S
Slide 29: Clinical Course of Patient
CLINICAL COURSE OF PATIENT 10 TAA Expression Intensity 60 55% PRAME SURVIVIN « © 40 35% NY-ESO-1 Fa a wml ° ¢ 7 a # 20 15% 0 1 Pre-inf Mo.1 0% @ wl survivin @ NY-ESO-1 e@ PRAME * Patient saw significant reduction in circulating blasts from 40% to 15% ¢ Patient had no normal hematopoiesis o After inf
Slide 30: Clinical Course of Patient
CLINICAL COURSE OF PATIENT | Tumor \ » T Cells Elevated Liver Decitabine Enzymes MultiTAA T Eells MultiTAA T Cells Sib. alloHSCT Bony Relapse CR Mo10 Moll 0.08% 2 — S 0.06% s z g s 3 002 8 5 = 0.00% Relapse (Month 4) PR (Month 5) Post-Decitabine CR Post T Cell (Month 7) M (Month 11) Pre-Inf 57yo fem
Slide 31: Acute Lymphoblastic Leukemia
ACUTE LYMPHOBLASTIC LEUKEMIA bh \ - y Lo e
Slide 32: Acute Lymphoblastic Leukemia Background
eee ACUTE LYMPHOBLASTIC LEUKEMIA BACKGROUND e Leukemic relapse remains the major cause of treatment failure in hematopoietic stem cell transplant CHSCT) recipients ¢ Donor lymphocyte infusions (DLIs) are not always effective and are associated with the risk of life-threatening graft-versus-host dise
Slide 33: Antigen Expression in Acute Lymphoblastic Leukemia
eee ANTIGEN EXPRESSION IN ACUTE LYMPHOBLASTIC LEUKEMIA Choosing Optimal TAA We choose the following tumor associated antigens that are over expressed on the surface of leukemic cells Function Expression in Leukemia WT Zn Finger Transcription Factor ALL: 70-90% SURVIVIN Inhibitor of Apoptosis ALL: 65
Slide 34: Acute Lymphoblastic Leukemia Clinical Outcomes
eee ACUTE LYMPHOBLASTIC LEUKEMIA CLINICAL OUTCOMES ID Age/G Therapies 2 ; 8 ; - s ay SC) 1 S/F 3 Not Evaluable* 2 18/F 3 DPPIP PPP} Mixed chimerism after transplant CR (6mo) 3 18/F 56 DDDIIIIIIIIIIIIIIIIIIIIIIIII>II>II>> CER ca2mo) 4 aie 2 DDDIDIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIII III» CER (28mo) 5 8/M
Slide 35: Acute Lymphoblastic Leukemia Patients Profiles
ACUTE LYMPHOBLASTIC LEUKEMIA PATIENTS PROFILES ID Age/ Disease DL Prior Therapies 1 5/F Ph+ ALL 1 Induction Chemo ® Primary Induction Failure » MRD SCT 2 18/F HR-ALL 1 Completed Therapy for HR- ALL Relapse PB MRD SCT 3 18/F Ph+ ALL 1 Completed Therapy for HR- ALL ® Relapse B® MRD SCT ® Relapse ® Che
Slide 36: Characterization of multiTAA Specific T Cells
mmm CHARACTERIZATION OF MULTITAA SPECIFIC T CELLS Phenotype Specificity 120% 1000 100% 2 : " WD 80% o ‘S) > © 100 2 60% x . = g ° 3 e) s H ° O 40% re 10 x a e e s 20% é a A st 0% 1 cps D4 cps CD3+/RO+/62L+ CD3+/RO+/62L- PRAME SuRVIVIN. wrt Fig 2. Donor-derived multi TAA specific T cell lines are Fig
Slide 37: Multiple Myeloma
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Slide 38: Antigen Expression in Multiple Myeloma
mmm ANTIGEN EXPRESSION IN MULTIPLE MYELOMA TAA Overepression SURVIVIN 90-100%' SSX2 35-61%? PRAME 36-48%? NY-ESO=I 25-31% MAGE-A4 17-30% > 1.) Romagnoli et al, Leukemia 2007; 2.) Taylor et al, J Immunother. 2005; 3.) Van Baren et al, Blood 1991 ‘ 33
Slide 39: Active Multiple Myeloma Clinical Trial Outcomes
ACTIVE MULTIPLE MYELOMA CLINICAL TRIAL OUTCOMES ID Age/G 53/M 47/M 65/F 3VF 69/F 70/M 40/M 76/M 45/F S7/M Months 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 DIDIIIIIIIIIIIIIIIIIII>> »d>>>> >>> >> >> >> >> >> >) J DIIIIIDIIIIIIIIIII>>> >> >>> >> >> > > J »»»> DIDIIIIIIPIIIIIIIIIIIIPIPIIIPIIIIII
Slide 40: Active Multiple Myeloma Patients Profiles
ACTIVE MULTIPLE MYELOMA PATIENTS PROFILES 1D Age/G 1 53/M 6M 44/M 47/™ 65/F 3VF 69/F 70/M 40/M 50/F 57/F Status Active In Remission In Remission Active Active Active Active Active Active In Remission Active Disease IgG-kappa \gG-kappa IgG-kappa \gG-kappa IgG-kappa IgG-kappa IgG-kappa IgA-kappa Free
Slide 41: Adjuvant Multiple Myeloma Clinical Trial Outcomes
ADJUVANT MULTIPLE MYELOMA CLINICAL TRIAL OUTCOMES Months Age/G 2 4a 6 8 10 12 16 18 20 22 24 26 28 30 32 34 36 8 51M SSS a >> >>> >>> >>> > > > > > > > 7 aD >>> > >>> >>> > 7 12 54M DP DDIIIIIIID> 5 GVM PDDDIDIDIIIIIIIIIIIIIIIIIIIIIIIIIIIII>> 7 44M YDDDIIIIDIDIIIIIIIIIIIIIIIII> ae >> >>> >>> > 4 CD
Slide 42: Adjuvant Multiple Myeloma Patients Profiles
ADJUVANT MULTIPLE MYELOMA PATIENTS PROFILES ID Ag 2° 40/M 3 65/F 5 76/M 8 57/M 9 50/F " 53/M 12 54/M 7 44/F 19 = -70/M Status Active Active Active In Remission In Remission In Remission In Remission Active In Remission Disease Prior Therapies Free lambda RVD) ASCT pPom/Cart/D ® ASCT IgG-kappa IgG-ka
Slide 43: Clinical Course of Patient
eee CLINICAL COURSE OF PATIENT 2 Patient #2 received prior treatments including two stem cell transplants. After receiving a dose of Marker’s T cells, the patient has been in complete remission 10000 4 Ist Line 1000 = in DI Neg 2nd Line 2nd ASCT Ist ASCT 100 + NOrmal |+nnseeneneneee nee neeeeneenene
Slide 44: Clinical Course of Patient (Cont'd)
CLINICAL COURSE OF PATIENT 2 (CONT’D) Pre-Infusion (MAGE A4) . ao ae am PBMCs - Targeted Antigens gas 300 k saa S 250 200 3+ Intensity SFC/2x10° a co} . [| of J - Wk4 Wk6 8 Week Post-Infusion (MAGE A4) PALO Marrow yay ae i jh* res 180 1+ Intensity 120 SFC/2x10° 60 Mo3 8 Week Post 39
Slide 45: Breast & Ovarian
BREAST & OVARIAN
Slide 46: TPIV200 Folate Receptor-α Multipeptide Vaccine
TPIV200 FOLATE RECEPTOR-c MULTIPEPTIDE VACCINE TPIV200 Overview Phase | Results @ This new vaccine approach was developed by Dr. Keith Knutson at e Patient Profile: advanced ovarian and breast cancer patients who the Mayo Clinic and is designed to activate both the CD4+ and completed systematic chem
Slide 47: TPIV200 Phase I Trial Update
TPIV200 PHASE I TRIAL UPDATE Safety/Immunogenicity of Ovarian Cancer (2 Year Patient Follow-Up) Vaccine generated robust immune responses and was well tolerated by all patients, with only one Grade 3+ AE related to vaccination @ Ovarian cancer patients (n=10) showed longer median progression-free su
Slide 48: TPIV200 Phase II Dosing Study
mmm TPIV200 PHASE II DOSING STUDY Study vaccine dosing / Regimen to maximize immune response Advanced Triple-Negative Breast Cancer Patients * Stage | Tic-Ill patients, no metastases ¢@ Within 1 year of surgery and radio/chemotherapy; Prior to first recurrence Study Highlights e Four-arm study to ev
Slide 49: TPIV200 Phase II Maintenance Therapy Study
mms TPIV200 PHASE II MAINTENANCE THERAPY STUDY Exploring recurrent disease After successful platinum therapy Currently enrolling platinum-sensitive ovarian cancer patients in 1% remission e Study focuses on women with stage 3 and 4 ovarian cancer who are in remission following their first round of s
Slide 50: PolyStart™
POLYSTART™
Slide 51: PolyStart™: Nucleic Acid-Based CD8+ T Cell Stimulation
POLYSTART™: NUCLEIC ACID-BASED CD8:+ T CELL SIMULATION PolyStart™ Platform Enhanced antigen expression for DNA-based vaccines Proprietary technology invented and owned by Marker Therapeutics Potential to monetize via out-licensing to partners Readily adapted for multiple oncology and infectious dise
Slide 52: PolyStart™ and Poly-Antigen Array (PAA)
POLYSTART™ AND POLY-ANTIGEN ARRAY (PAA) Antigen expression is a key component DNA-based vaccines, but protein expression is variable to poor Normally: 1 DNA 33331 RNA 33321 Protein PolyStart™: 1 DNA + PolyStart™ 232» 4 or more Proteins PAA Portion ™ ao (T Cell Epitopes) mRNA / won Tere/neu Fa NERS c
Slide 53: A Leading Oncology Pipeline
mmm A LEADING ONCOLOGY PIPELINE OO OO@O@O CCC CEULL 3 Nays Chal aw “‘ 46
Slide 54: Strong Management Team
STRONG MANAGEMENT TEAM Peter L. Hoang President & Chief Executive Officer Mr. Hoang has 20 years of immuno-oncology, investment banking, venture capital, and public company executive management experience. He has focused on the development of novel cell therapies of oncology for the last 6 years. Pr
Slide 55: Scientific Advisors
Jim Allison, PH.D Dr. Allison, a recent recipient of the 2018 Nobel Prize in Medicine, is a globally recognized tumor immunologist whose research led to the clinical development of the first FDA-approved cancer immunotherapy, ipilimumab (Yervoy"). Dr. Allison is also a member of the National Academy
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Slide 57: Patient #9 Multiple Myeloma Clinical Response
PATIENT #9 MULTIPLE MYELOMA CLINICAL RESPONSE 2 g Da .) 4 Qa ° = 1 . . MultiTAA Repeated MultiTAA 2 T Cells T Cells oy 4 vvv < 1U) Da Diagnosis Pre-HSCT Pre- T Cell Wks Mo3 Mo6 Mog Mol2 (ay +104) 49
Slide 58: Patient #9 Multiple Myeloma Clinical Response
PATIENT #9 MULTIPLE MYELOMA CLINICAL RESPONSE Targeted Non-Targeted 250 1000 200 800 150 600 100 400 s0 200 ° P Wk6 ~— Mo3 Mo6 Mo9 fe) re ° ° ° Pre Wk6 Mo3. Mo6 _Mo9 t ) PRAME (a) SSX2 @ MAGE A4 @ NYESO-1 SURVIVIN & AFP 6 MARTI oO MAGE C1 & MAGE A3 e@ MAGE A2B @ MAGE Al @ wml
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