Nkgen Biotech Inc. · OTC:NKGN
Nkgen Biotech — Graf Acquisition Corp. IV — SPAC Merger (June 2023)
50 slides from Nkgen Biotech's SPAC merger presentation, Jun 1, 2023
Slide 1: Maximizing Immune Integrity
Confidential Confidential Maximizing Immune Integrity Corporate Presentation May 2023
Slide 2: Disclaimer: Confidentiality and Disclosures
Confidential Disclaimer Confidentiality and Disclosures This investor presentation (this “Presentation”) has been prepared by NKGen Biotech, Inc . (“NKGen,” “NKGen Biotech” or the “Company”) for informational purposes only and to assist interested parties in making their own evaluation with respect
Slide 3: Important Information About the Business Combination and Where to Find It
Confidential Disclaimer Important Information About the Business Combination and Where to Find It The proposed Business Combination will be submitted to stockholders of Graf for their consideration . Graf has filed a registration statement on Form S - 4 , dated May 15 , 2023 (the “Registration State
Slide 4: Forward-Looking Statements
Confidential Disclaimer Forward - Looking Statements This Presentation includes forward - looking statements regarding, among other things, the plans, strategies and prospects, both business and financial, of Graf and the Company . These statements are based on the beliefs and assumptions of the man
Slide 5: NKGen Biotech Is A Clinical Stage Company Focused On Neurodegenerative and Oncological Diseases
Confidential NKGen Biotech Is A Clinical Stage Company Focused On Neurodegenerative and Oncological Diseases With Innovative Natural Killer (NK) Cells • Large expansion capacity, enhanced cytotoxicity, minimal degradation with cryopreservation • Ready - to - scale manufacturing capabilities • Can be
Slide 6: Executive Team
Confidential Executive Team 6 *Board of Directors of NKGen Biotech Sangwoo Park* Founder & Executive Chairman Founder of NKMAX, Korean Parent Company Pierre Gagnon Chief Operating Officer NKMAX, Korean Parent Company Paul Y. Song, MD* CEO and Vice Chairman Jack Tsai, MD, MBA SVP, Business Developmen
Slide 7: NK Cells Remain Challenging To Grow And Freeze
Confidential NK Cells Remain Challenging To Grow And Freeze NK cells expansion limitations Low activity Inability to scale up production Problem #2 Problem #4 SNK ΠSolution: Consistent >95% pure NK cells with robust expansion from healthy and diseased patients Promote high activity during productio
Slide 8: State-Of-The-Art GMP Manufacturing Facility
Confidential State - Of - The - Art GMP Manufacturing Facility Licensed cell therapy manufacturing facility • 25,000 sq ft facility (12,000 sq ft for GMP) completed in 2019 • CAP/CLIA Laboratory • Facility owned and operated by NKGen Biotech 8
Slide 9: SNK01 Superior Expansion, Cytotoxicity, And Activating Receptor Expression
Confidential SNK01 (Autologous) Superior Expansion, Cytotoxicity, And Activating Receptor Expression Cytotoxicity Expansion NK cell activating receptors and ligands Receptor Expression Levels 9 1096 5060 3140 0 2000 4000 6000 FOLD (X) Culture Day Expansion Fold (8 Heathy Donors) 1100 3915 0 2000 400
Slide 10: NKGen Can Produce Over 100,000 Doses And Maintain High Viability And Cytotoxicity
Confidential NKGen Can Produce Over 100,000 Doses And Maintain High Viability And Cytotoxicity 10 98.0 98.0 96.5 94.6 94.7 89.8 0.0 20.0 40.0 60.0 80.0 100.0 after thawing in infusion buffer after 4 hours (%) Viability Trypan blue 7AAD 89.8 67.3 42.1 94.5 74.4 52.0 90.9 62.9 44.5 0.0 20.0 40.0 60.0
Slide 11: NKGen Biotech Pipeline
Confidential NKGen Biotech Pipeline Program Target Indications IND Enabling Pre - Clinical Phase I Clinical Phase II Clinical Estimated Near Term Milestones Autologous SNK01 Neuro Alzheimer’s Disease • Anticipate IND submission 2H2023 • If IND is cleared, plan to initiate Phase I/II trial 2H2023 • I
Slide 12: NKGen's Differentiated CMC Platform
Confidential NKGen’s Differentiated CMC Platform Company with Autologous, Allogeneic, and CAR - NK products Expansion capability demonstrates the potential to produce commercially viable quantities of allogeneic NK cells from a single blood collection – over 100K doses Cryopreservation process that
Slide 13: Scientific/Clinical Advisors And Collaborators
Confidential Scientific/Clinical Advisors And Collaborators Neurology Oncology Craig Blackstone, MD, PhD Advisor Ming Guo, MD, PhD Advisor Anthony T. Reder , MD Advisor Yong Ben, MD, MBA Advisor Evren Alici , MD, PhD Advisor Sant Chawla, MD Collaborator 13
Slide 14: Neuro Program: Alzheimer's and Parkinson's
Confidential Neuro Program Alzheimer’s and Parkinson’s 14
Slide 15: NK Cells In Alzheimer's And Parkinson's
Confidential • Proteins accumulate in the brain. Their chronic deposition leads to an inflammatory cascade involving alterations in the cross talks between glial cells and neurons • T - cells migrate to brain via CXCR3 to CXCL10 positive astrocytes that are associated with protein deposits. T - cell
Slide 16: Market Opportunity in Neurodegenerative Disease
Confidential Market Opportunity in Neurodegenerative Disease NKGen’s SNK01, not yet FDA approved, will seek to address a multi - billion/year market 16 1. https://www.alzint.org/about/dementia - facts - figures/dementia - statistics/. 2. "Global Alzheimer’s Disease Market $6.3 Billion by 2029" and "
Slide 17: Compassionate Case Study: Male With PSEN1 Mutation And Advanced Alzheimer's
Confidential Compassionate Case Study # 1 - 38 Y.O. Male With PSEN1 Mutation And Advanced Alzheimer’s Treated with SNK01 THESE REPORTS OF PATIENT EXPERIENCES AND IMAGES HAVE NOT BEEN VALIDATED. ONLY RANDOMIZED CLINICAL TRIALS CAN SUPPORT BENEFIT FOR PATIENTS. THESE MAY NOT BE PREDICTIVE OF CLINICAL
Slide 18: Compassionate Use Case Study: Advanced Alzheimer's Treated with SNK01
Confidential Compassionate Use Case Study # 2 – 70 Y.O. With Advanced Alzheimer’s Treated with SNK01 18 Patient was originally diagnosed in 2016 at Columbia University Medical Center with Advanced Alzheimer’s Disease. Patient was independently seen and evaluated by Dr. Ming Guo (at UCLA Medical Cent
Slide 19: Patient Was Granted Single Compassionate Use IND Approval By US FDA
Confidential Patient Was Granted Single Compassionate Use IND Approval By US FDA To Resume SNK01 Treatment 19 THESE REPORTS OF PATIENT EXPERIENCES AND IMAGES HAVE NOT BEEN VALIDATED. ONLY RANDOMIZED CLINICAL TRIALS CAN SUPPORT BENEFIT FOR PATIENTS. THESE MAY NOT BE PREDICTIVE OF CLINICAL TRIAL RESUL
Slide 20: Compassionate Case Study: Female With Advanced Alzheimer's Treated with SNK01
Confidential Compassionate Case Study # 3 - Age: 79 Female With Advanced Alzheimer’s Treated with SNK01 Legend MMSE Score Stage ≤12 Severe Dementia 13 - 20 Moderate Dementia 20 - 25 Mild Dementia ≥25 No Cognitive Impairment THESE REPORTS OF PATIENT EXPERIENCES AND IMAGES HAVE NOT BEEN VALIDATED. ONL
Slide 21: Phase I Study Abstract Accepted for the 2023 Alzheimer's Association International Conference
Confidential Phase I Study Abstract Accepted for the 2023 Alzheimer’s Association International Conference in July 2023 Phase I Study Abstract Accepted for the 2023 Alzheimer’s Association International Conference (AAIC) in July 2023 21 No observed SAEs or dose limiting toxicity in this ongoing tria
Slide 22: Dose-Dependent Decreases in Alzheimer's-Related Protein Biomarkers Following SNK01 Treatment
Confidential Dose - Dependent Decreases in Alzheimer’s - Related Protein Biomarkers Following SNK01 Treatment Biomarker Data From MX04 Phase I Study 22 • Following SNK01 treatment, dose - dependent decreases are observed across several protein biomarkers related to Alzheimer’s pathology • 12 weeks a
Slide 23: Dose-Dependent Decreases in Alzheimer's-Related Inflammatory Markers Following SNK01 Treatment
Confidential Dose - Dependent Decreases in Alzheimer’s - Related Inflammatory Markers Following SNK01 Treatment Biomarker Data From MX04 Phase I Study 23 • Following SNK01 treatment, dose - dependent reductions are observed across several neuroinflammation markers related to Alzheimer’s pathology •
Slide 24: Parkinson's Compassionate Case Study: Qualitative Evaluation After Treatment with SNK01
Confidential Parkinson’s Compassionate Case Study # 1 : Qualitative Evaluation of 47 yr. old Man After Treatment with SNK01 Patient was independently seen and evaluated by Dr. Ming Guo (at UCLA Medical Center) 24 SNK dose dates THESE REPORTS OF PATIENT EXPERIENCES AND IMAGES HAVE NOT BEEN VALIDATED.
Slide 25: PD Case Study: Compassionate Use of SNK01 Results in Clinical Improvements
Confidential PD Case Study: Compassionate Use of SNK01 Results in Clinical Improvements* *82 - year - old male patient with advanced PD treated on a compassionate use, single IND approval from US FDA; under the care of ne urologist Dr. Russ Shimizu in Santa Monica, CA THESE REPORTS OF PATIENT EXPERI
Slide 26: Oncology Program
Confidential Oncology Program 26
Slide 27: Improved Survival Rates Following SNK01 Combination Treatment with a PD-L1 Inhibitor
Confidential Improved Survival Rates Following SNK01 Combination Treatment with a PD - L1 Inhibitor 2 - Year PFS 2 - Year Survival SNK01 + pembrolizumab 25% 58.3% Pembrolizumab monotherapy 0% 16.7% Synergistic improvement in 2 - year survival rates following SNK01 combination with pembrolizumab in N
Slide 28: Can SNK Change The TME For PDL1- Tumors?
Confidential Can SNK Change The TME For PDL1 - Tumors? NK cells can positively affect the TME to help make PD - L1 negative tumors respond to ICIs* . Erlinda M. Gordon, et al. (2022). Durable Responses Using SNK01 Autologous Enhanced Natural Killer Cells and Pembrolizumab fo r C hemotherapy - Resist
Slide 29: Effect Of NK Cells On Cetuximab-mediated ADCC
Confidential Effect Of NK Cells On Cetuximab - mediated ADCC Preliminary Phase I data accepted for ASCO 2023 Cetuximab: anti - EGFR antibody. A Study on the Anti - Tumor Activity of SNK01 in EGFR - TKI - Resistant Non - small Cell Lung Cancer, NKMax Co., Ltd., Internal In Vitro Test Report , NKMAX -
Slide 30: NK Cells: The Missing Piece In Cancer Therapeutics?
Confidential NK Cells: The Missing Piece In Cancer Therapeutics? We believe that the future of cancer therapies will be in combination therapies that enable precision targeting, immune activation and immune effector response simultaneously. SNK cells provide the “missing” piece for modular treatment
Slide 31: Why NKGen?
Confidential Why NKGen? 31 NK Cell Expansion Cytotoxicity Cryopreservation Persistence and lymphodepletion Solid tumor penetration Blood brain barrier (BBB) Product Flexibility Overcoming industry challenges with NK cell therapy Limited ex - vivo expansion >100K doses from single peripheral blood dr
Slide 32: Transaction Overview
Confidential Transaction Overview 1 Key transaction Terms • ~$161M transaction equity value 2 • 100% equity rollover • $50M minimum net cash closing condition 3 • Proceeds expected to fund trials and operations into 2025 4 • $25M backstop commitment from majority shareholder 5 • Expected closing in
Slide 33: Thank you
Confidential Confidential Thank you
Slide 34: Appendix
Confidential Appendix 34
Slide 35: Allogeneic NK cell product that does not require lymphodepletion
Confidential Allogeneic NK cell product that does not require lymphodepletion. US Phase I Allogeneic Trial To Begin In 2H2023 35 Confidential
Slide 36: Autologous Next Gen Manufacturing
Confidential Autologous Next Gen Manufacturing NKGen “Off - the - Shelf Autologous” SNK Cell Therapy • Cryopreserved autologous manufacturing process takes ~18 days from NK cell isolation to cryopreserved product release • One - time production for all the doses; SNK cells are frozen and stored on s
Slide 37: Intellectual Property
Confidential Intellectual Property NK Cell Expansion Platform Patents 37 • Highly cytotoxic NK Cells • Consistently large yields (including unhealthy donors) • Granted in key territories -- North America, Asia • Still alive (divisional pending) • Expiry 2033 • Larger yields -- ideal for allogeneic p
Slide 38: Cash Used in Operating Activities
Confidential Cash Used in Operating Activities 38 NKGen expenses 2020 2021 2022 Total cash burn 1 $17.3M $19.9M $22.5M RND - only cash expenses 2 $10.6M $14.0M $15.7M 1. Total cash burn amount equals net cash used in operating activities, which is a GAAP financial measure. 2. R&D - only cash expense
Slide 39: Significant Opportunity With Funding Potential From Partnering Our Platform And In Oncology
Confidential Significant Opportunity With Funding Potential From Partnering Our Platform And In Oncology 39 1. Total market sales US, EU5, JPN, according to Global Data. Parkinson’s (2029) and Alzheimer’s (2028). 2. Total NK market sales WW by 2026, according to Allied Market Research . 3. BiosciDB
Slide 40: Allogeneic Anti-HER2-CAR SNK02
Confidential Allogeneic Anti - HER2 - CAR SNK02 40 (US IND submission anticipated in early 2025) CONFIDENTIAL
Slide 41: NKGen – Engineering, Expansion, And Cryopreservation
Confidential NKGen – Engineering, Expansion, And Cryopreservation 41 Analysis / Final product and cell banking Collection NK cell stimulation Engineering Expansion & Enrichment Collection D0 D3 - 6 D10 - 11 D14 D45 IL - 2 IL - 21 Feeder
Slide 42: Expression Level Of Anti-HER2-CAR on NK Cell
Confidential Expression Level Of Anti - HER2 - CAR on NK Cell 42 42 Anti - HER2 scFv Co - stimulatory CD3 ζ Cytokine leader Hinge TM Promoter P2A 1.11 1.05 2.3 2.47 2.39 1.89 2.42 1.38 1.64 85.67 89.03 87.93 86.31 87.16 86.03 83.03 81.62 82.74 0 10 20 30 40 50 60 70 80 90 100 D10 D14 S1 D6 S1 D10 S1
Slide 43: NK Cell Expansion Rate
Confidential NK Cell Expansion Rate 0 50 100 150 200 250 300 350 400 450 D0 D4 D10 D14 D17 Expansion Rate (P1) SNK Anti-HER2-CAR-SNK 0 200 400 600 800 1000 1200 S1 D0 S1 D6 S1 D10 S1 D14 S1 D17 Expansion Rate (S1) SNK Anti-HER2-CAR SNK 0 500 1000 1500 2000 2500 3000 S2 D0 S2 D6 S2 D10 S2 D14 S2 D17
Slide 44: The Effect Of Freezing/Thawing On CAR Expression & Cytotoxicity
Confidential 1.89 2.42 1.38 1.65 1.29 86.03 83.2 81.6 82.84 84.02 0 10 20 30 40 50 60 70 80 90 100 S2 D6 S2 D10 S2 D14 S2 D17 THAWING Persistence 0 20 40 60 80 10:1 5:1 2.5:1 1.25:1 0.63:1 0.3:1 Thawing (SK - BR3) 0 10 20 30 40 50 10:1 5:1 2.5:1 1.25:1 0.63:1 0.3:1 Thawing (SK - OV3) 0 20 40 60 80 1
Slide 45: Partnerships With Merck And Pfizer
Confidential Partnerships With Merck And Pfizer In September 2020, NKGen (formerly NKMax America) entered into a clinical trial collaboration and supply agreement with Germany - based Merck KGaA to evaluate the safety and tolerability of SNK01, NKGen's autologous NK cell therapy in combination with
Slide 46: SNK01-MX04 Phase I Study
Confidential SNK01 - MX04 Phase I Study Dosing and Administration: To identify the Maximum Tolerated Dose (MTD), the subjects will be given SNK01 in an open - label setting per the following treatment plan, using a 3 + 3 design: • Cohort 1 - 1.0 x 10 9 cells; infusions Q3W, total of four doses. • Co
Slide 47: References For NK Cells And PD-1/PD-L1
Confidential References For NK Cells And PD - 1/PD - L1 • Hasim, M., et al. (2022). When killers become thieves: trogocytosed PD - 1 inhibits NK cells in cancer. ScienceAdvances , 8(15). https://doi.org/10.1126/sciadv.abj3286 • Hsu, J., et al. (2018). Contribution of NK cells to immunotherapy mediat
Slide 48: References For CI Tolerability
Confidential References For CI Tolerability • Trinh, S., et al. (2019). Management of Immune - Related Adverse Events Associated with Immune Checkpoint Inhibitor Therapy: a Min ireview of Current Clinical Guidelines. Asia Pac J Oncol Nurs , 6(2):154 - 160. https://doi.org/10.4103/apjon.apjon_3_19 •
Slide 49: References For Neurodegenerative Disease
Confidential References For Neurodegenerative Disease • Zhou, Y - Q, et al. (2019). The role of CXCR3 in Neurological Diseases. Curr Neuropharmacol , 17(2): 142 - 150. http://dx.doi.org/10.2174/1570159X15666171109161140 • Marsh, S.E., et al. (2016). The adaptive immune system restrains Alzheimer’s d
Slide 50: References Neurodegenerative Disease (Cont.)
Confidential References Neurodegenerative Disease (Cont.) • Earls, R.H., et al., (2020). NK cells clear alpha - synuclein and the depletion of NK cells exacerbates synuclein pathology in a m ouse model of alpha - synucleinopathy . Proc Natl Acad Sci U S A, 117(3):1762 - 1771. https://doi.org/10.1073