Kalaris Therapeutics, Inc. · NASDAQ:KLRS
Kalaris Therapeutics — Investor Presentation (September 2026)
56 slides from Kalaris Therapeutics's investor presentation, September 2026
Slide 1: Kalaris Company Overview
Kalaris Company Overview September 2026 1
Slide 2: Forward-Looking Statements & Disclaimer
Forward-Looking Statements & Disclaimer This presentation contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risk and uncertainties. All sta
Slide 3: Your Vision, Our Mission
Your Vision Our Mission Kalaris is a clinical stage biopharmaceutical company dedicated to the development and commercialization of treatments for prevalent retinal diseases Our lead asset, TH103, was invented by Dr. Napoleone Ferrara, whose pioneering research established the anti-VEGF class of the
Slide 4: Potential best in class, dual-action, anti-VEGF therapeutic
Potential best in class, dual- action, anti- ✓ >$15 Billion1 and growing retinal neovascular / exudative disease global branded market, with significant remaining unmet need VEGF Invented by VEGF pioneer and scientific co-founder Dr. Napoleone Ferrara, therapeutic ✓ TH103 is a dual-action biologic t
Slide 5: TH103
TH103 Engineered to improve upon a drug class that has helped millions of patients, with optimization built directly into the molecule itself. Fully humanized, recombinant fusion protein designed for intravitreal delivery, with potential to be best-in- class for neovascular and exudative retinal dis
Slide 6: Anti-VEGF Therapeutics Background
Anti-VEGF Therapeutics Background 6
Slide 7: Anti-VEGF therapy has revolutionized treatment for major retinal diseases
Anti-VEGF therapy has revolutionized treatment for major retinal diseases, a global market projected to grow to over $18B by 2029 2004 2006 2019 2023 Dawn of anti-VEGF era → Expansion of anti-VEGF therapeutics market NEXT-GEN ANTI-VEGF 2005 (off-label use) 2011 2022 TH103 Kalaris is focused on drivi
Slide 8: Unmet need remains high, with suboptimal real-world outcomes
Unmet need remains high, with suboptimal real-world outcomes Best outcomes may require clinic visits as Onerous visit “Although multiple anti-VEGF therapies frequently as every 1-2 months for frequency exist, unmet need remains high owing to monitoring and injections. treatment underutilization…”1 P
Slide 9: Our lead asset was developed by VEGF pioneering scientist, Napoleone Ferrara
Recognizing persistent unmet need, our lead asset was developed by VEGF pioneering scientist, Napoleone Ferrara • Co-discoverer of VEGF and VEGF isoforms while at Genentech • Scientist behind Anti-VEGF Agents: TH103 • Winner of Major Awards including Lasker Award, Champalimaud Vision Award and Break
Slide 10: Our Solution: TH103
erapeutics Our Solution: TH103
Slide 11: TH103: Dual-targeting, next generation drug engineered to address unmet needs
TH103: Dual-targeting, next generation drug engineered to address major unmet needs in retina disease Optimized VEGF Binding: Leverages higher-affinity VEGFR11, potentially leading to enhanced VEGF inhibition Extended Ocular Retention: Leverages high-affinity binding to HSPG2, potentially providing
Slide 12: VEGF-A is the primary mediator of neovascularization and exudation
VEGF-A is the primary mediator of neovascularization and exudation VEGF-B VEGF-A VEGF-C VEGF-D PlGF VEGFR1 VEGFR2 VEGFR3 VASCULAR ENDOTHELIAL CELL LYMPHATIC ENDOTHELIAL CELL R# = Receptor 1, 2, and 3 Source: Karkkainen, M. J., & Petrova, T. V. (2000). Vascular endothelial growth factor receptors in
Slide 13: VEGF binds to Receptor 1 with ≥10-fold greater affinity than Receptor 2
VEGF binds to Receptor 1 with ≥10-fold VEGF-A greater affinity than ≥10x binding Receptor 2 VEGFR1 VEGFR2 Sources: Karkkainen, M. J., & Petrova, T. V. (2000). Vascular endothelial growth VASCULAR ENDOTHELIAL CELL factor receptors in the regulation of angiogenesis and lymphangiogenesis. Oncogene, 19(
Slide 14: TH103 leverages the key binding domains from VEGFR1
TH103 leverages the key binding Domain 2 domains from VEGFR1 Domain 3 IgG= Immunoglobulin G; Fc =Fragment Crystallizable Region Fc Source: Xin, H., Biswas, N., Li, P., Zhong, C., Chan, T. C., Nudleman, E., & Ferrara, N. (2021). Heparin-binding VEGFR1 variants as long-acting VEGF inhibitors for treat
Slide 15: Using higher affinity VEGFR1 may confer enhanced VEGF inhibition
Using higher affinity VEGFR1 may confer enhanced VEGF inhibition Source: Xin, H., Biswas, N., Li, P., Zhong, C., Chan, T. C., Nudleman, E., & Ferrara, N. (2021). Heparin-binding VEGFR1 variants as long-acting VEGF inhibitors for treatment of intraocular neovascular disorders. Proceedings of the Nati
Slide 16: VEGFR1 domain 3 enables potential TH103 binding to retina
VEGFR1 domain 3 enables potential TH103 binding to retina TH103 aflibercept Domain 3 from VEGFR1: In contrast, domain 3 from VEGFR2: Binds strongly to HSPG which are present Binds less strongly to HSPG, leading to in all retinal layers, thereby reduced tissue sequestration (preferred for sequesterin
Slide 17: HSPG is present throughout the retinal layers
HSPG is present throughout the retinal layers1 Adult human retina cross section HSPG has been shown to be highly concentrated near CNV lesions2, potentially prolonging ocular retention precisely at the site of disease activity Green: Heparan sulfate antibody Blue: DAPI staining of cell nuclei Source
Slide 18: Preclinical Data Review & Phase 1a Clinical Data
Preclinical Data Review & Phase 1a Clinical Data 18
Slide 19: TH103: Increased VEGF-inhibitory activity vs. aflibercept in preclinical studies
TH103: Increased VEGF-inhibitory activity vs. aflibercept in preclinical studies TH103 achieved 100% inhibition vs. aflibercept 80% inhibition of TH103 increased reduction in mean choroidal neovascularization VEGF-induced endothelial cell proliferation (CNV) area after administration at Day -12 (in
Slide 20: TH103: Demonstrated prolonged retinal retention vs. aflibercept in preclinical studies
TH103: Demonstrated prolonged retinal retention vs. aflibercept in preclinical studies TH103 demonstrated increased retention in the retina as compared to TH103 demonstrated reduced systemic exposure after aflibercept at two weeks post-injection intravitreal administration1 (in vivo, rabbit model) (
Slide 21: TH103: Demonstrated prolonged bioactivity vs. aflibercept in an animal model
TH103: Demonstrated prolonged bioactivity vs. aflibercept in an animal model Mean CNV Area In a second murine experiment, rather Standard error = than at Day -1, TH103 and aflibercept (ratio to IgG control) were administered at Day -14 prior to Mean CNV Area laser injury to assess durability of trea
Slide 22: Phase 1a SAD data summary
Phase 1a SAD data summary ✓ Efficacy: rapid, robust response on BCVA and OCT parameters observed across dose levels at one month ✓ Safety: TH103 generally well tolerated, supporting exploration of multi-dose regimen ✓ Durability: - PK analysis consistent with greater TH103 intraocular retention vs.
Slide 23: Phase 1a Single Ascending Dose (SAD) Study in Treatment-Naïve nAMD
Phase 1a Single Ascending Dose TH103 5.0 mg (SAD) Study in TH103 Treatment-Naïve TH103 2.5 mg nAMD TH103 1.5 mg Multi-center U.S. study to 0.5 mg evaluate safety, tolerability, pharmacokinetics, and anti- Study Details VEGF activity following a single ● Primary timepoint for analysis at Month 1 inje
Slide 24: Key baseline characteristics of patients in Phase 1a SAD trial of TH103
Key baseline characteristics of patients in Phase 1a SAD trial of TH103 Tx.-Naïve (efficacy analysis population) Including Tx-Experienced Additional Tx- Dec. 2025 Data All Tx.-Naïve Tx.-Experienced2 All Patients2 Naïve Patients Release (n=13) Patients (n=17) (n=3) (n=20) (n=4)4 Age (mean) 78 76 78 8
Slide 25: Phase 1a SAD data summary
Phase 1a SAD data summary ✓ Efficacy: rapid, robust response on BCVA and OCT parameters observed across dose levels at one month 25
Slide 26: Mean 9.2 letter gain in BCVA after a single TH103 injection at Month 1
Mean 9.2 letter gain in BCVA letter score after a single TH103 injection at Month 1 Mean BCVA Change Over Time 10 +9.2 letters 9 8 7 ETDRS Letters 6 5 4 53% ≥10 letter gain 3 2 1 0 D1 D2 D4 W1 W2 M1 Time ETDRS = Early Treatment Diabetic Retinopathy Study Note: n = 17 at all timepoints except Month 1
Slide 27: Change in mean visual acuity in treatment-naïve nAMD patients for market-leading agents
Change in mean visual acuity in treatment-naïve nAMD patients for current market-leading agents at Month 1 Mean Change in BCVA at Month 1 in Tx-Naive nAMD patients (ETDRS letters) 12 ETDRS Letter Change 10 8 6 4 2 0 Eylea (VIEW 1&2) Eylea (T&L) Eylea (PULSAR) Eylea HD Vabysmo Eylea (VIEW 1&2) BCVA B
Slide 28: Rapid, robust improvement in CST and total retinal fluid volume
Rapid, robust improvement in CST and total retinal fluid (TRF) volume at Week 1 and Month 1 Mean CST Change Over Time1 Case Example (1.5 mg) 0 -20 -40 Mean ~89% resolution of TRF by Week 1 CST Change (𝛍m) maintained at Month 12 -60 Single Dose TH103 -80 -100 -120 -118𝛍m -140 mean CST change Month…
Slide 29: Change in mean CST in treatment-naïve nAMD patients for market-leading agents
Change in mean CST in treatment-naïve nAMD patients for current market-leading agents at Month 1 Mean Change in CST at Month 1 in Tx-Naive nAMD patients (𝛍m) Eylea (VIEW 1&2) Eylea (T&L) Eylea (PULSAR) Eylea HD Vabysmo -100 -105 CST Change (𝛍m) -110 -115 -120 -125 -130 -135 Eylea (VIEW 1&2) CST…
Slide 30: Rapid and consistent resolution of intraretinal fluid volume across doses
Rapid and consistent resolution of intraretinal fluid (IRF) volume observed across doses Case Example (2.5 mg) 160 IRF Volume Over Time (nL) 140 by Patient Central Subfield IRF Volume (nL) 120 Single Dose TH103 100 80 60 Mean ~93% IRF resolution at Mean ~99% IRF Week 1 40 Month 1 resolution by Week
Slide 31: Phase 1a SAD data summary
Phase 1a SAD data summary ✓ Efficacy: rapid, robust response on BCVA and OCT parameters observed across dose levels at one month ✓ Safety: TH103 generally well tolerated, supporting exploration of multi-dose regimen 31
Slide 32: Safety Summary from Phase 1a SAD Trial
Safety Summary from Phase 1a SAD Trial1 ● No dose limiting toxicity (DLT) or treatment-emergent serious adverse events (SAEs) observed ● Transient, mild-moderate intraocular inflammation (IOI) presented at Day 4 in 2 patients dosed at 2.5mg with TH103 manufacturing batch #12 ● No cases of IOI in 6 p
Slide 33: Phase 1a SAD data summary
Phase 1a SAD data summary ✓ Efficacy: rapid, robust response on BCVA and OCT parameters observed across dose levels at one month ✓ Safety: TH103 generally well tolerated, supporting exploration of multi-dose regimen ✓ Durability: - PK analysis consistent with greater TH103 intraocular retention vs.
Slide 34: PK data consistent with greater TH103 intraocular retention
PK data consistent with greater TH103 intraocular retention Plasma Drug Levels 40 TH103 2.5 mg Plasma Levels 35 (Cmax/Dose): Cmax/Dose* (nM/mmol) 30 27x lower than Eylea 2mg 25 20 42x lower than Eylea HD 15 10 53x lower than Vabysmo 5 0 Eylea 22 mg mg11 Eylea Eylea HD mg2 HD 8 mg 2 Vabysmo Vabysmo 6
Slide 35: Single-dose durability signal suggests potential for stronger durability outcomes
Single-dose durability signal suggests Phase 1a Single-Dose Time to Retreatment (n = 17, Tx-naïve) potential for stronger durability outcomes Time to first retreatment 41% ≥ 4M after standard four- dose loading regimen, Time to first retreatment 35% ≥ 5M currently being evaluated in ongoing Ph 1b/2
Slide 36: Case Example: TH103 single-injection durable response past Month 6
Case Example: TH103 single-injection durable response past Month 6 CST Change Over Time 550 Single Dose TH103 (0.5mg) 500 CST (𝛍m) 450 Week 1 400 234 𝛍m improvement at Month 6 Month 1 350 300 Month 6 250 W1 W2 M1 M2 M3 M4 M5 M6 Time Source: As measured by independent reading center 36
Slide 37: Phase 1a SAD data continue to support TH103's potential as best-in-class
Phase 1a SAD data continue to support TH103’s potential as best-in- class, first-line treatment for retinal vascular diseases ✓ Efficacy: rapid, robust response on BCVA and OCT parameters observed across dose levels at one month - Mean 9.2-letter BCVA improvement at Month 1 after one TH103 injection
Slide 38: TH103 Ongoing Development Program
TH103 Ongoing Development Program 38
Slide 39: TH103 Clinical Development Program
TH103 Clinical Development Program Ongoing Phase 1b/2 Trial in nAMD Anticipated Milestones Open label, multiple ascending dose design followed by randomized, Enrollment continues in Phase 1b/2 masked, multi-dose cohort-expansion phase; potential dosing up to 5.0mg MAD study – preliminary data expect
Slide 40: Planned expansions beyond nAMD into other VEGF-mediated diseases
Planned expansions beyond nAMD into other prevalent VEGF- mediated diseases such as DME, DR, and RVO Product Indication Discovery IND Enabling Phase 1 Phase 2 Phase 3 Candidate TH103 nAMD* TH103 DME / DR** TH103 RVO** DME = Diabetic Macular Edema DR = Diabetic Retinopathy RVO = Retinal Vein Occlusio
Slide 41: Corporate
S)Kalaris F Therapeutics Corporate
Slide 42: Ongoing manufacturing process refinements continue to drive down host cell protein
Ongoing manufacturing process refinements continue to drive down levels of product host cell protein TH103 Manufacturing TH103 Manufacturing TH103 Manufacturing Future TH103 Batch #1 Batch #2 Batch #3 (Current) Manufacturing Batches • Fusion protein produced • Added reagents to • Advanced analytical
Slide 43: Intellectual Property
TH103 Compositions of Matter 1 - Issued/allowed in United States, Japan, China, and at least 9 other jurisdictions - Pending in Europe (examiner identified allowable compositions) and at least 3 other jurisdictions TH103 Methods of Use Intellectual 2 - Issued/allowed in United States, Japan, China,
Slide 44: Experienced Board & Management Team
Experienced Board & Management Team Select Key Accomplishments Board of Directors Management Team Discoverer of VEGF, VEGF receptors, VEGF isoforms David Hallal Andrew Oxtoby Board Chairman CEO Anthony Adamis, MD Leadership involved in developing first two Director Matthew Feinsod, MD FDA approved a
Slide 45: TH103 Advantage: Established yet Differentiated
TH103 Advantage: Established yet Differentiated ESTABLISHED DIFFERENTIATED 1 Part of a Proven Class TH103 Innovation ✓ Targets VEGF-A, primary mediator of disease activity in + Optimized dual target (VEGF + HSPG), with novel HSPG the retina pathway disruption ✓ Soluble decoy receptor MoA2 + Leverage
Slide 46: Potential best in class, dual-action, anti-VEGF therapeutic
Potential best in class, dual- action, anti- ✓ >$15 Billion1 and growing retinal neovascular / exudative disease global branded market, with significant remaining unmet need VEGF Invented by VEGF pioneer and scientific co-founder Dr. Napoleone Ferrara, therapeutic ✓ TH103 is a dual-action biologic t
Slide 47: Kalaris Therapeutics
S Kalaris Therapeutics
Slide 48: Glossary
S)Kalaris F Therapeutics Glossary
Slide 49: Glossary
Glossary ETDRS: Early Treatment Diabetic OCT: Optical Coherence BCVA: Best Corrected Visual Acuity Retinopathy Study Tomography Cmax: Maximum Plasma HCP: Host Cell Protein PK: Pharmacokinetics Concentration HSPG: Heparan Sulfate CNV: choroidal Neovascularization RVO: Retinal Vein Occlusion Proteogly
Slide 50: Anti-VEGF Therapeutics Background
Anti-VEGF Therapeutics Background 50
Slide 51: Lessons from over two decades of using Anti-VEGF to treat retinal disease
Lessons from over two decades of using Anti-VEGF to treat retinal disease VEGF is the primary mediator and Anti-VEGF therapy has VEGF has been the primary target the key target for pathologic revolutionized treatment for major for neovascular / exudative retinal angiogenesis and exudation retinal di
Slide 52: VEGF is the primary mediator and key target for pathologic angiogenesis
VEGF is the primary mediator Normal Retina Macular Degeneration and the key target for pathologic angiogenesis and exudation (permeability) in retinal disease Pathologic exudation Growth and leakage from abnormal vessels and angiogenesis leads to visual impairment in diseases such as nAMD, DME, and
Slide 53: Anti-VEGF therapy has revolutionized treatment for major retinal diseases
Anti-VEGF therapy has revolutionized treatment for major retinal diseases Pre-Anti-VEGF Treatment • Anti-VEGFs have a potent anti-permeability effect, causing reduction or resolution of pathological fluid, often leading to visual acuity improvements • Retinal neovascular diseases treated with anti-V
Slide 54: VEGF has been the primary target for neovascular / exudative retinal diseases
VEGF has been the primary target for neovascular / exudative retinal diseases for over 20 years Bevacizumab Ranibizumab Aflibercept Faricimab VEGF-R1 VEGF-R1 VEGF-R2 VEGF-R2 Anti-VEGF Anti-Ang-2 VL VH Fab Fab IgG Fc IgG Fc Modified IgG Fc Type: Fab fragment Type: Decoy Receptor Type: Bi-specific mAb
Slide 55: >$15B global branded anti-VEGF market in 2024
>$15B global branded anti-VEGF market in 2024, projected to grow to approximately $18B by 20291,2 Global Anti-VEGF Units in Branded Anti-VEGF Therapies 2024 Global Sales2 Retinal Disease (2024)1 $16B $14B faricimab $12B Compounded aflibercept HD bevacizumab $10B (~25%) Branded + $8B biosimilar anti-
Slide 56: Suboptimal real-world outcomes as compared to clinical trial results
Suboptimal Real-World outcomes as compared to clinical trial results1,2,3,4,5 Registrational Clinical Trial6 Real World Study7 0.5 mg of ranibizumab 0.3 mg of ranibizumab Mean Visual Activity Difference from Baseline (LOCF) (letters) Mean Change in Visual Acuity (no. of letters) Day 7 Month Month Mo
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