Nkgen Biotech Inc. · OTC:NKGN
Nkgen Biotech — WCN 2025
32 slides from Nkgen Biotech's conference presentation, October 2025
Slide 1: Troculeucel (SNK01) for Neurodegenerative Disease
Troculeucel (SNK01) for Neurodegenerative Disease Paul Y. Song, MD October 2025
Slide 2: Disclosures
Disclosures Company / Honoraria/ | Consulting / Funded Royalties / | Stock Ownership / | Employee Other (Please Name Expense Advisory Research | Patent Options Equity specify) Board Position NKGen Biotech Xx Xx x
Slide 3: Natural Killer Cells Play an Important Role in Overall Human Health
Natural Killer Cells Play an Important Role in Overall Human Health Innate Lymphoi d Cells: • 5 - 20% of circulating lymphocytes (CD3- CD56+) Unlike T cells t hat only ha ve one receptor, NK cells ca n distinguish hea lt hy Cells (self) f rom Dangero us Cells (n on - self) via 40+ receptors: • Abili
Slide 4: Autologous Next Generation Low-Cost Manufacturing
Autologous Next Generation Low-Cost Manufacturing NKGen’s “Off-the-Shelf” Troculeucel Therapy Collection D0 ~D18 ~D30 Manufacturing of all doses for 1-year treatment 1 2 3 4 5 6 7 Collection PBMC Isolation Activation Ex-vivo Harvesting, Drug Product Administration /NK Cell ↑cytotoxicity & Expansion
Slide 5: Troculeucel (SNK01) Mechanism of Action in Neurodegenerative Disease
Troculeucel (SNK01) Mechanism of Action in Neurodegenerative Disease 5
Slide 6: Autoreactive T cells Cause Neuroinflammation And Damage
Autoreactive T cells Cause Neuroinflammation And Damage Chronic protein deposition leads to an autoinflammatory cascade and damage Removing proteins only addresses one aspect of the underlying pathology Activation of Autoreactive CD4+ and CD8+ T cells1-5 which migrate to the brain via CXCR36 is a ve
Slide 7: Increased T cell reactivity to amyloid B protein in older humans and Alzheimer patients
Increased T cell reactivity to amyloid B protein in older humans and patients with Alzheimer disease Alon Monsonego, Victor Zota, Amon Karni, Jeffery I. Krieger, Amit Bar-Or, Gal Bitan, Andrew E, Budson, Reisa Sperling, Dennis J. Selkoe, and Howard L. Weiner Center for Neurologic Diseases, Harvard M
Slide 8: CD4 T cells contribute to neurodegeneration in Lewy body dementia
‘Acta Neuropathologica (2020) 139:855-874 https1/dot.org/10.1007/s00401-020-02126.w CD4: T cells contribute to neurodegeneration in Lewy body ORIGINAL PAPER ® dementia David Gate'?*-, Emma Tapp?*, Olivia Leventhal**t, Marian Shahid?, Tim J. Nonninger*>, ‘Andrew C. Yang*®, Katharina Strempfi®.7®, Mic
Slide 9: T cell responses at diagnosis of ALS predict disease progression
nature communications 38 artile sevthedeahasoupeurianssanes T cell responses at diagnosis of amyotrophic lateral sclerosis predict disease progression Received: 7 December 2021 Solmaz Yazdani™®, Christina Seitz'®, Can Cui", Aniké Lovik’, Lu Pan@™, witan ©, ULE Klippe @*4, Rayomand Press™, Trung Nghi
Slide 10: Autoreactive T cells Cross BBB Via CXCR3
Autoreactive T cells Cross BBB (Blood Brain Barrier) Via CXCR3 CXCR3+ T cells migrate to CXCL10 positive astrocytes that frequently are associated with amyloid deposits.1 CXCR3 has been linked to impaired microglial function, which can hinder the clearance of Aβ plaques. CXCL10 promotes neuroinflamm
Slide 11: The Role of CXCR3 in Neurological Diseases
142 Curren Neuropharmacology, 2019, 17, 142-180 REVIEW ARTICLE The Role of CXCR3 in Neurological Diseases Ya-Qun Zhou'”, Dai-Qiang Liu'?, Shu-Ping Chen!”, Jia Sun'?, Xue-Rong Zhou’, Cui Xing’, Da-Wei Ye" and Yu-Ke Tian‘ ‘Anesthesiology Institute, Tongji Hospital, Tongji Medical College, Huazhong Uni
Slide 12: Epigenetic dysregulation in Alzheimer's disease peripheral immunity; CXC chemokines in ALS
Neuron © CelPress | Progress in Neurobiology Volume 235, April 2024, 102587 Epigenetic dysregulation in Alzheimer’s disease peripheral immunity The multifaceted role of the CXC (purvan Oise ard David Garster Tooke Simonton,’ Milan Perks! Zivang Zhang,’ Victoria Tereguiovs! chemokines and receptors s
Slide 13: Troculeucel Has High CXCR3 Expression And Strong Migration Potential to cross the BBB
Troculeucel Has High CXCR3 Expression And Strong Migration Potential to cross the BBB • Migratory Potential toward cerebrospinal fluid (CSF) and plasma from Alzheimer disease (AD) patients via CXCR3. 13
Slide 14: NK cells identify and eliminate autoreactive T cells via NKG2D and DNAM-1
While most attention has been placed on Tregs, NK cells have been found to play a big role in identifying and eliminating autoreactive T cells in autoimmune disease via NKG2D and DNAM-1. Schleinitz - Immunology, 131, 451–458 Gross - Proceedings of the National Academy of Sciences 113(21):201524924 A
Slide 15: NK Cells Regulate Autoreactive T cells
NK Cells Regulate Autoreactive T cells1-4 Troculeucel has enhanced NKG2D and DNAM-1 expression that helps identify and eliminate autoreactive T cells to reduce auto-immune neuroinflammation. 15
Slide 16: Cytotoxic and degranulation activity of Troculeucel against activated T cells
Cytotoxic and degranulation activity and IFN-γ expression level of Troculeucel when incubated with activated T cells Activated only in presence of activated T cells, not resting T cells. Only targets activated T cells while leaving resting T cells alone. (A) Cytotoxic activity of SNK01 against T cel
Slide 17: NK Cells Play a Protective Role in Protein Deposition
NK Cells Play a Protective Role in Protein Deposition Knockout/Depletion of NK cells in both models caused rapid acceleration of protein deposition 1. Earls RH, Menees KB, Chung J, et al. NK cells clear α-synuclein and the depletion of NK cells exacerbates synuclein pathology in a mouse model of α-s
Slide 18: Functional Characteristics of SNK01 Cells for Alzheimer's Disease (AD)
Functional Characteristics of SNK01 Cells for Alzheimer’s Disease (AD) Uptake and degradation of aggregated amyloid- () proteins (A-E) Intracellular levels of Aβ aggregates in SNK01 and HMC3 cells were analyzed by Western blot analysis. (A) SNK01 cells were treated with varying concentrations of
Slide 19: Uptake and degradation of aggregated α-synuclein proteins
Uptake and degradation of aggregated -synuclein proteins (A-E) Intracellular levels of α-syn aggregates in SNK01 and HMC3 cells were analyzed by Western blot analysis. (A) SNK01 cells were treated with varying concentrations of α-syn aggregates for 1 hour and harvested. (B) SNK01 cells were treated
Slide 20: Therapeutic Mechanism-of-Action: Reduce AD Pathogenesis
Therapeutic Mechanism-of-Action: Reduce AD Pathogenesis via Anti-Neuroinflammation and Protein Reduction Abnormal protein and Neuroinflammation plaque accumulation and BBB leakage Inflammatory T- Troculeucel cells (CD4+/CD8+) Amyloid β plaque CD56bright CD16+ Activated microglia ↑ Inflammatory cytok
Slide 21: Product Testing of Cryopreserved Products in Clinical Trial
1-3. Product Testing of Cryopreserved Products in Clinical Trial (from 3 patients in AD trial) Test Method Specifications Subject 1 Subject 2 Subject 3 Light-yellow cell suspension without cell Appearance Macrographic Observation Pass Pass Pass aggregation or clumping BacT/Alert No microorganism det
Slide 22: Phase I Data - MX04
Phase I Data -MX04 Proof-of-concept Dose Escalation Study: 1 x 109 cells q month x 4 2 x 109 cells q month x 4 4 x 109 cells q month x 4 No drug related SAEs observed! 22
Slide 23: SNK01-MX04 Phase 1: CSF Biomarkers Data
SNK01-MX04 Phase 1: CSF Biomarkers Data pTau 181 α-Synuclein Aβ42/40 ratio Abnormal proteins 10000 50 0.004 Change from the baseline Change from the baseline Change from the baseline 0.003 Improved 5000 25 0.002 0 0 0.001 -25 -5000 0.000 -50 Improved Improved -0.001 -10000 -75 -0.002 SNK01 Q3W -1500
Slide 24: Alzheimer's Disease Composite Score (ADCOMS)
Alzheimer’s Disease Composite Score (ADCOMS) A composite of the Clinical Dementia SNK01 Alzheimer’s Phase I Trial Rating (CDR) scale in its ‘sum of boxes’ incarnation (CDR-sb),with the addition of four memory ADAS-cog (Delayed Word Recall, Orientation, Word Finding Difficulty & Word Recognition), ma
Slide 25: Troculeucel Randomized Phase II trial
Troculeucel IV Q3W, (3+3 dose escalation design - 6x109 cells), 17 doses Moderate AD patients Randomized Phase II trial launched August 2024 25
Slide 26: SNK01-AD01 Study Phase 1: 2/3 Moderate AD Patients Show Improvement in Cognition
SNK01-AD01 Study Phase 1: 2/3 Moderate AD Patients Show Improvement in Cognition SNK01 6x109 cells Q3W (17 doses); n = 3 moderate AD patients: extraordinary improvement in moderate AD No drug-related adverse events. CDR-SB = Clinical Dementia Rating Scale Sum of Boxes; lower score is better. ADCOMS
Slide 27: Plasma Biomarker Data for Phase I patients treated at 6 x 10^9 dose
Plasma Biomarker Data for Phase I patients treated at 6 x 109 dose. 27
Slide 28: CSF Biomarker Data for Phase I patients treated at 6 x 10^9 dose
CSF Biomarker Data for Phase I patients treated at 6 x10 9 dose 28
Slide 29: NKGen Biotech Receives U.S. FDA Fast Track Designation for Troculeucel
<J BioSpace’ NEWS v INSIGHTS JOBS CAREER ADVICE COMPANIES Press Releases NKGen Biotech Receives U.S. FDA Fast Track Designation for Troculeucel for the Treatment of Moderate Alzheimer’s Disease February 13, 2025 | 5 min read
Slide 30: NKGen Biotech Announces FDA Clearance of IND for SNK01 in Parkinson's Disease
NKGen Biotech Announces FDA Clearance of Investigational New Drug (IND) Application for SNKO1 NK Cell Therapy in Parkinson's Disease Published: Apr 29, 2024 NkGen advances its neurodegenerative disease program with FDA IND clearance for its Phase 1/2a SNKO1 Clinical Trial in patients with Parkinson'
Slide 31: NKGen Biotech Doses First FTD Patient With Troculeucel
NKGen Biotech Doses First FTD Patient With Troculeucel Under FDA Compassionate Use February 21, 2025 — 10:31 am EST \Written by RTTNews.com for RTTNews > A patient has received NKGen Biotech's troculeucel (also known as SNKO1), an investigational autologous natural killer (NK) cell therapy, for the
Slide 32: Thank you
Thank you