Alaunos Therapeutics, Inc. · NASDAQ:TCRT
Alaunos Therapeutics — Q3 2022 Earnings Presentation
27 slides from Alaunos Therapeutics's earnings presentation, Nov 14, 2022
Slide 1: Third Quarter 2022 Results
Third Quarter 2022 Results November 14, 2022
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as “may,” “will,
Slide 3: Speakers on Today's Call
Speakers on Today’s Call Kevin S. Boyle, Sr. Drew Deniger, Ph.D. Chief Executive Officer VP, Research & Development Abhishek Srivastava, Ph.D. Mike Wong VP, Technical Operations VP, Finance Melinda Lackey 3
Slide 4: Confirmed Partial Response Following Treatment with Sleeping Beauty TCR-T Cells at First Dose Level
Confirmed Partial Response Following Treatment with Sleeping Beauty TCR-T Cells at First Dose Level TCR-T Library Phase 1/2 Trial Enrolling; Confirmed Partial Response in First Patient (NSCLC); Now Treating at Dose Level 2 1 Increasing cGMP Manufacturing Facility Capacity; Consistently Producing Hig
Slide 5: TCR-T Platform Targeting Hotspot Mutations with Multiple Solid Tumor Programs in Pipeline
TCR-T Platform Targeting Hotspot Mutations with Multiple Solid Tumor Programs in Pipeline PROGRAM TARGETS INDICATION DISCOVERY PRECLINICAL IND-ENABLING PHASE 1 Lung Colon/Rectum Library TCR-T Cell Therapy KRAS, TP53 & EGFR Endometrium Hotspot Mutations Pancreas (Company Sponsored at MDACC - NCT05194
Slide 6: Clinical Update
ALAUNSS” THERAPEUTICS Clinical Update
Slide 7: Encouraging Early Clinical Data for Non-viral TCR-T Therapy
Encouraging Early Clinical Data for Non-viral TCR-T Therapy: Safety, Persistence and Efficacy with 1 Confirmed PR • First in human confirmed response in solid tumor by TCR-T cell therapy using Sleeping Beauty • Patients have been treated with KRAS and TP53 mutation specific cells • Two patients trea
Slide 8: Patient 1: PR in NSCLC
Patient 1: PR in NSCLC Six-month imaging
Slide 9: Durable, Complete Resolution of Right Lower Lobe NSCLC Lesion Through Week 24
Durable, Complete Resolution of Right Lower Lobe NSCLC Lesion Through Week 24 Insert Image Here Insert Image Here Insert Image Here 0 6 12 24 Baseline Week 6 Week 12 Week 24 • Patient 1 had multiple lines of prior therapy and was refractory to checkpoint inhibitors • Treated with 9x109 TCR-T cells (
Slide 10: Sustained Reduction in Right Upper Lobe Lesion through Week 24
Sustained Reduction in Right Upper Lobe Lesion through Week 24 0 6 12 24 Baseline Week 6 Week 12 Week 24 10
Slide 11: Growth of Non-measurable Disease at 24 Weeks; Six Month Progression Free Survival
Growth of Non-measurable Disease at 24 Weeks Relative to Week 12; Six Month Progression Free Survival 0 6 12 24 Baseline Week 6 Week 12 Week 24 Perceived growth of non-measurable disease in orange circles led investigator to request biopsy of this area and additional scan at 28 weeks 11
Slide 12: Best Response is Partial Response, with a Six Month Progression Free Survival
Best Response is Partial Response, with a Six Month Progression Free Survival • Patient 1 had an observed clinical benefit from our TCR-T cell therapy • Persistence of TCR-T cells was observed in the blood at approximately 30% of T-cells at 24 weeks • Elective tumor core biopsy showed continued pres
Slide 13: Patient 2: Colorectal Cancer
Patient 2: Colorectal Cancer
Slide 14: Patient 2: Previously Treated Advanced Colorectal Cancer Achieved Stable Disease
Patient 2: Previously Treated Advanced Colorectal Cancer Achieved Best Overall Response of Stable Disease • Patient 2 received one prior line of therapy and was treated with 64x109 TCR-T cells (dose level 2) targeting TP53- R175H and HLA-A*02:01 • Treatment was well tolerated with manageable safety
Slide 15: Clinical Summary to Date
ALAUNSS” THERAPEUTICS Clinical Summary to Date
Slide 16: Encouraging Clinical Activity from Sleeping Beauty TCR-T Therapy
Encouraging Clinical Activity from Sleeping Beauty TCR-T Therapy Demonstrating Safety, Persistence and Efficacy • Treatment was well tolerated with no DLTs or ICANS in either patient • Persistence of TCR-T cells was noted in both patients to last follow-up • Indications of efficacy observed in both
Slide 17: Manufacturing Update
ALAUNSS” THERAPEUTICS Manufacturing Update
Slide 18: Successful Manufacturing of High Purity Products at Dose Levels 1 and 2
Successful Manufacturing of High Purity Products at Dose Levels 1 and 2 • Successfully manufactured two clinical products by our own employees at our in-house cGMP facility at dose levels 1 and 2 • Produced both KRAS and TP53 mutation-specific TCR-T cells with expected characteristics 18
Slide 19: Execution Against Multipronged Expansion Strategy Has Doubled Manufacturing Capacity
Execution Against Multipronged Expansion Strategy Has Doubled Manufacturing Capacity • Changes in Process & Procedures • Updated SOPs to allow for simultaneous manufacture of multiple products in the cGMP suite • Expect to file IND amendment to move from fresh to cryopreserved product in 4Q 2022 and
Slide 20: R&D Update
ALAUNSS” THERAPEUTICS R&D Update
Slide 21: hunTR Is Differentiated from Competing TCR Discovery Platforms
hunTRTM Is Differentiated from Competing TCR Discovery Platforms Differentiator Alaunos Competition Blood from healthy donors Starting material TILs from patient with target without target Virally transduced donor T cells TCR screening Reporter cell line (fast, universal) (donor-to-donor variability
Slide 22: hunTR Platform for TCR Discovery Expected to Expand Addressable Market
hunTRTM Platform for TCR Discovery Expected to Expand Addressable Market with Exclusive TCRs • Established end-to-end platform from TCR discovery KRAS Focused Screening to clinical translation 4 Focused on key mutations in KRAS, TP53 and EGFR HotSpot TCR Hits 3/60 • 3 genes 2 • Goal to add more muta
Slide 23: Throughput of hunTR Increased to Expand the Number of Patients Who May Benefit
Throughput of hunTR™ Increased to Expand the Number of Patients Who May Benefit from TCR-T Cell Therapy Cancer Type Ovarian (2) • Pre-screened over 250 commercially-sourced tumors for mutation and HLA and 64 are entering hunTR™ queue Colon Lung (28) (16) • Evaluating diverse group of cancer types th
Slide 24: Financial Update
ALAUNSS” THERAPEUTICS Financial Update
Slide 25: Selected Financial Data for the Third Quarter; Over a 50% Reduction in Operating Cash Burn
Selected Financial Data for the Third Quarter; Over a 50% Reduction in Operating Cash Burn Year-Over-Year Revenue Operating Expense Cash & Net Cash • Collaboration revenue of $2.9 • R&D costs decreased 46%: as • Cash: $37.8 million million: primarily related to a result of focused the first commerci
Slide 26: Upcoming Milestones
ALAUNSS” THERAPEUTICS Upcoming Milestones
Slide 27: Continue to Grow Platform to Expand Number of Patients Who May Benefit from Sleeping Beauty TCR-T
Continue to Grow Platform to Expand Number of Patients Who May Benefit from Sleeping Beauty TCR-T Poised for Continued Progress Generating Additional Clinical Data and Building Pipeline 1 Treating Additional Patients on Library TCR-T Cell Clinical Trial 2 Amending IND to Include Two New TCRs and Red