Alpha Tau Medical Ltd · NASDAQ:DRTS
Alpha Tau Medical — Investor Day (January 2025)
84 slides from Alpha Tau Medical's investor day presentation, January 2025
Slide 1: R&D Update Day
(NASDAQ:DRTS) R&D Update Day 1
Slide 2: Disclaimer
Disclaimer This presentation (together with oral statements made in connection herewith, the "Presentation") is for informational purposes only to assist interested parties in making their own evaluation with respect to Alpha Tau Medical Ltd. (“Alpha Tau” or the “Company”). The information contained
Slide 3: Today's Presenters
Today’s Presenters Raphi Levy Robert Den, MD Philip Blumenfeld, MD, MPH Corey Miller, MD, MSc Prof. Aron Popovtzer, MD CFO CMO Radiation Oncologist Endoscopist Head of Oncology Alpha Tau Alpha Tau Hadassah Medical Center McGill University Hadassah Medical Center 3
Slide 4: Agenda
Agenda 1 Introduction Raphi Levy, CFO | Alpha Tau 2 Updated Interim Pancreatic Cancer Data as of Jan 8, 2025 Robert Den, MD, CMO | Alpha Tau 3 Pancreatic Cancer Case Study Philip Blumenfeld, MD, MPH | Hadassah Medical Center 4 Treatment Experience – Endoscopic Delivery to the Pancreas Corey Miller,
Slide 5: The Alpha Tau Mission
The Alpha Tau Mission A novel approach using localized alpha particle radiotherapy designed to precisely destroy solid tumors while sparing surrounding healthy tissue Broad potential applicability for local tumor control, together with signs of compelling immuno-stimulatory activity Platform technol
Slide 6: Alpha Radiation is Focal - Short Range Limits Clinical Use
Alpha Radiation is Focal - Short Range Limits Clinical Use Whereas beta and gamma radiation can penetrate tissue with sufficient range to facilitate tumor coverage (while risking damage to healthy tissue), alpha radiation has short range in tissue (<100 μm), which limits its clinical usefulness in l
Slide 7: Mechanism of Action of the Alpha DaRT Technology
Mechanism of Action of the Alpha DaRT Technology 224Ra Decay Chain Alpha DaRT leverages the innate decay chain of Radium-224 The decay chain of Radium-224 includes four alpha particles Radium-224 has a half-life of ~3.7 days, while the remaining decay chain has a total half-life of approximately 12
Slide 8: Alpha DaRT - Diffusing Alpha-emitters Radiation Therapy
Alpha DaRT - Diffusing Alpha-emitters Radiation Therapy https://www.youtube.com/watch?v=nwfzJHm0fTQ 8
Slide 9: Therapeutic Focus
Therapeutic Focus We are focused on delivering solutions to three markets that we believe would be best served by the unique characteristics of the Alpha DaRT Localized & Unresectable High Unmet Need Metastatic • Localized tumors that are not • Solid tumors that have limited • Alpha DaRT being evalu
Slide 10: Initial Foray into Superficial Tumors
Initial Foray into Superficial Tumors Alpha DaRT first tested in superficial tumors – tumors of the skin or head & neck, due to: • Ease of access • Straightforward control • Ongoing monitoring • Strong initial preclinical data in Squamous Cell Carcinoma (SCC) Treatment of hundreds of tumors to date
Slide 11: Outline of The Multicenter Pivotal Recurrent SCC study
Outline of The Multicenter Pivotal Recurrent SCC study Primary / safety • ORR based on Best Overall Response objectives: • DOR 6 months after initial response • Assess the safety based on statistics of device-related AEs (per CTCAE v5) Secondary objectives: Evaluate O-DOR, local control, PFS and OS
Slide 12: Therapeutic Focus
Therapeutic Focus We are focused on delivering solutions to three markets that we believe would be best served by the unique characteristics of the Alpha DaRT Localized & Unresectable High Unmet Need Metastatic • Localized tumors that are not • Solid tumors that have limited • Alpha DaRT being evalu
Slide 13: Agenda
Agenda 1 Introduction Raphi Levy, CFO | Alpha Tau 2 Updated Interim Pancreatic Cancer Data as of Jan 8, 2025 Robert Den, MD, CMO | Alpha Tau 3 Pancreatic Cancer Case Study Philip Blumenfeld, MD, MPH | Hadassah Medical Center 4 Treatment Experience – Endoscopic Delivery to the Pancreas Corey Miller,
Slide 14: Overview of Trial Design
Overview of Trial Design Three single-arm safety and feasibility trials treating pancreatic cancer patients in parallel: • CTP-PANC-101 monotherapy treatment at 2 sites in Montreal, Canada – up to 37 patients total • CTP-PANC-02 monotherapy treatment at 1 site in Jerusalem, Israel – up to 15 patient
Slide 15: Patient Characteristics
Patient Characteristics Including the first five patients from the interim data released in late 2023, a total of n = 41 patients have been treated thus far with pancreatic cancer across the three trials Canada (n=24) Israel (n=17) Characteristic (n) PANC-101 PANC-02 ALL-00 Total Gender Male 10 7 6
Slide 16: Highlights of Feasibility and Safety
Highlights of Feasibility and Safety 100% success in delivering Alpha DaRT sources (feasibility) Strong safety results • Total of 151 adverse events (AEs) reported • 38 were associated with Alpha DaRT (possibly, probably or definitely related), of which 29 were mild (Grade 1), five were moderate (Gr
Slide 17: Possibly-, Probably- or Definitely-Related Adverse Events (by CTCAE)
Possibly-, Probably- or Definitely-Related Adverse Events (by CTCAE) CTCAE Coded 4 – Life- Term 1 – Mild 2 – Moderate 3 – Severe Threatening 5 – Death Total Abdominal pain 6 1 7 Fatigue 5 2 7 Anorexia 3 1 4 Not yet coded 2 1 1 4 Nausea 3 3 Blood bilirubin 1 1 2 increased Gallbladder 1 1 2 obstructio
Slide 18: High Disease Control Rate Observed
High Disease Control Rate Observed Among the 41 patients treated, 33 had a measured objective response, with 5 patients awaiting response evaluation and 3 who discontinued prior to evaluation. Results are presented below using Best Overall Response (BOR) for those with a measured response. Including
Slide 19: Highlights of Overall Survival (OS) Data
Highlights of Overall Survival (OS) Data Key Caveats: • The data are still relatively immature, but ongoing • Trial designs were focused on feasibility and safety, without the frequent monitoring visits common in studies focused on precise measurement of survival • Five patients treated since Nov 25
Slide 20: Analysis of Overall Survival in Key Sub-Populations (1/3)
Analysis of Overall Survival in Key Sub-Populations (1/3) Newly Diagnosed / Not Eligible for Chemotherapy (n=8) Product-Limit Survival Estimate With Number of Subjects at Risk 1.0 Censored 7.5 Median OS Since Diagnosis Without 0.8 4/8 Patients Still Alive Survival Probability Chemo (months) 0.6 3.5
Slide 21: Analysis of Overall Survival in Key Sub-Populations (2/3)
Analysis of Overall Survival in Key Sub-Populations (2/3) Metastatic (Stage IV) Patients After 1L FOLFIRINOX (n=10) Product-Limit Survival Estimate NR* With Number of Subjects at Risk 8 / 10 Patients Median OS Since Initiation of 1L 1.0 Censored Still Alive FOLFIRINOX (months) 11.1 10.8 0.8 10.1 Sur
Slide 22: Analysis of Overall Survival in Key Sub-Populations (3/3)
Analysis of Overall Survival in Key Sub-Populations (3/3) Progressed After 2L Gemcitabine-Abraxane (n=7) Product-Limit Survival Estimate With Number of Subjects at Risk 1.0 23.0 Censored Median OS Since Initiation of 2L 3 / 7 Patients Gemcitabine + Abraxane Still Alive 0.8 Survival Probability (mont
Slide 23: Pancreatic Cancer Clinical Trial: USA Pilot
Pancreatic Cancer Clinical Trial: USA Pilot 1 Insertion Primary Endpoint: (During Cycles 1-4) Incidence of Treatment- N=12 Emergent Adverse Events 8-12 cycles of mFOLFIRINOX Newly Diagnosed 2 Metastatic Pancreatic Cancer Secondary Endpoints: Overall Survival Progression-Free Survival Pain Improvemen
Slide 24: Pancreatic Cancer Clinical Trial: French Multicenter
Pancreatic Cancer Clinical Trial: French Multicenter 1 Primary Endpoint Safety N=40 2 Capecitabine FOLLOW-UP up to 12 months Secondary Endpoints 850mg/m2 BID until EOT or tumor progression* • Objective Response LAPC Screening (28 days) Rate based on Best Treated with Overall Response mFOLFIRINOX • O
Slide 25: Agenda
Agenda 1 Introduction Raphi Levy, CFO | Alpha Tau 2 Updated Interim Pancreatic Cancer Data as of Jan 8, 2025 Robert Den, MD, CMO | Alpha Tau 3 Pancreatic Cancer Case Study Philip Blumenfeld, MD, MPH | Hadassah Medical Center 4 Treatment Experience – Endoscopic Delivery to the Pancreas Corey Miller,
Slide 26: First Pancreatic Cancer Patient with CR – ALL-00-HA-006
First Pancreatic Cancer Patient with CR – ALL-00-HA-006 • Patient Background: o 70yo male with pancreatic adenocarcinoma metastatic to the liver o Treated by FOLFIRINOX May-Nov 2023 but demonstrated progressive disease o Treated by Gemcibatine + Abraxane from Dec 2023, demonstrated progression at pr
Slide 27: First Pancreatic Cancer Patient with CR – Pancreatic Tumor Response
First Pancreatic Cancer Patient with CR – Pancreatic Tumor Response PET of the pancreatic tumor after 30 days demonstrates minimal SUV uptake at lesion, potential post-treatment inflammation distal to treated lesion. PET after 90 days demonstrates no PET activity and no further inflammation Before >
Slide 28: First Pancreatic Cancer Patient with CR – Liver Metastasis Response
First Pancreatic Cancer Patient with CR – Liver Metastasis Response After 90 days post treatment, the lesion no longer remains evident on PET despite no change in systemic therapy, and cancer markers have dropped significantly >30 Days Post Tx 10-Mar- 2024 >90 Days Post Tx 12-May- 2024 28
Slide 29: Agenda
Agenda 1 Introduction Raphi Levy, CFO | Alpha Tau 2 Updated Interim Pancreatic Cancer Data as of Jan 8, 2025 Robert Den, MD, CMO | Alpha Tau 3 Pancreatic Cancer Case Study Philip Blumenfeld, MD, MPH | Hadassah Medical Center 4 Treatment Experience – Endoscopic Delivery to the Pancreas Corey Miller,
Slide 30: EUS-Guided Alpha DaRT Insertion: A Novel Treatment for Pancreatic Cancer
EUS-Guided Alpha DaRT Insertion: A Novel Treatment for Pancreatic Cancer Disclosures: Consultant for Alpha Tau Medical Consultant for Boston Scientific 30
Slide 31: Background
Background PANCREATIC CANCER • Endoscopic ultrasound provides best access to pancreas and provide pathologic diagnosis • Currently, surgical resection is the only potentially curative treatment, but only 15- 20% of patients are candidates • In non-resectable patients there is NO STANDARD LOCAL TREAT
Slide 32: Alpha Tau Loading Device
Alpha Tau Loading Device https://www.youtube.com/watch?v=Ws6ey-lvo38 https://www.youtube.com/watch?v=Ws6ey-lvo38 32
Slide 33: Procedure Setup
Procedure Setup
Slide 34: Insertion
Insertion Image: Flaticon.com 34
Slide 35: Adjustable Stopper
Adjustable Stopper “Standard” technique User-friendly Same “feel” as standard FNA 35
Slide 36: Retraction Handle
Retraction Handle Allows 4 Alpha DaRT sources to be delivered with one pass Time efficiency Especially when more challenging to reach 36
Slide 37: Endoscopist Experience
Endoscopist Experience Natural extension of EUS-guided biopsy, celiac the skillset of a trained plexus neurolysis EUS specialist Confidence in safety Technique is intuitive outcomes Procedure length not ~45 minutes prohibitive ➔ Room setup only Barrier to adoption is modestly longer after low brief
Slide 38: A Word on Radiation Safety
A Word on Radiation Safety For the endoscopist and technologist directly handling the scope, for the first 5 patients: • The max doses on skin was between 0.8-1.6 µSv • The max dose at 10 mm from skin was between 0.2-0.7 µSv CNSC limits: Equivalent dose to the skin annual limit 500 mSv (i.e., 500,00
Slide 39: Patient Experience
Patient Experience Outpatient procedure Minimally invasive Discharged Same Day 100% discharged after standard endoscopy recovery Good Safety Profile • Few important related adverse events • Mostly minor discomfort • Vast majority with no related symptoms Lack of tumor growth in vast majority Pain re
Slide 40: Grant: Moving Forward
Grant: Moving Forward • Development of an augmented reality-based navigation model that allows the operator to visualize the anatomy of interest, thus enhancing Alpha DaRT delivery. • In collaboration with Concordia University computer science, bioimaging, engineering and Alpha Tau’s Technology team
Slide 41: Team Work Makes the Dream Work!
Team Work Makes the Dream Work!
Slide 42: Final Thoughts
Final Thoughts Endoscopists engage pancreatic cancer patients early on the patient journey The Alpha DaRT insertion is straightforward to integrate into our clinical workflow Given the safety profile, the incorporation of Alpha DaRT insertion into non-resectable cases is quite promising to become st
Slide 43: Agenda
Agenda 1 Introduction Raphi Levy, CFO | Alpha Tau 2 Updated Interim Pancreatic Cancer Data as of Jan 8, 2025 Robert Den, MD, CMO | Alpha Tau 3 Pancreatic Cancer Case Study Philip Blumenfeld, MD, MPH | Hadassah Medical Center 4 Treatment Experience – Endoscopic Delivery to the Pancreas Corey Miller,
Slide 44: Clinical Challenges in Reirradiation
Clinical Challenges in Reirradiation • The treatment of recurrent or new primary cancers within or in close proximity to previously irradiated tissue is a clinically challenging problem due to tissue tolerance concerns: o Reirradiation with SBRT for ultracentral lung tumors (such as the mediastinum)
Slide 45: Current treatment options for recurrent thoracic cancers after previous radiation: SBRT
Current treatment options for recurrent thoracic cancers after previous radiation: SBRT • Sood et al. reported 35% of patients experienced grade 2+ pneumonitis, and 10% had fatal hemorrhage, though likely unrelated to treatment. • Rock et al. found 20% of patients had grade 2+ pneumonitis, and 12% e
Slide 46: Current treatment options for recurrent cancers after previous radiation: Proton Therapy
Current treatment options for recurrent cancers after previous radiation: Proton Therapy • Despite the advantages, proton therapy is not without risks. Chao et al. reported that 42% of patients experienced grade 3 or higher acute and/or late toxicity, with six grade 5 toxicities observed. • Increase
Slide 47: Lung Cancer Case Study
Lung Cancer Case Study 47
Slide 48: Locally Recurrent Lung Cancer Case Study (1/5)
Locally Recurrent Lung Cancer Case Study (1/5) 70-year old male with limited stage small cell lung cancer received external radiation to the lung primary and mediastinum completing August 2023 with concurrent chemotherapy 48
Slide 49: Locally Recurrent Lung Cancer Case Study (2/5)
Locally Recurrent Lung Cancer Case Study (2/5) • Metastatic progression 6 months post treatment s/p chemotherapy and palliative external radiation to several locations with good response • PET-CT in August 2024 demonstrated enlarged and uptake of paratracheal node (mediastinum), SUV 9 which was in r
Slide 50: Locally Recurrent Lung Cancer Case Study (3/5)
Locally Recurrent Lung Cancer Case Study (3/5) Scans of the first patient treated with Diffusing Alpha-emitters Radiation Therapy (Alpha DaRT) for recurrent lung cancer • 10 Alpha DaRT sources were implanted into the paratracheal lymph node (4R station, arrow) • The lymph node’s initial volume was 3
Slide 51: Locally Recurrent Lung Cancer Case Study (4/5)
Locally Recurrent Lung Cancer Case Study (4/5) Post-treatment PET-CT (60 days) Initial reduction in PET SUV to 7 51
Slide 52: Locally Recurrent Lung Cancer Case Study (5/5)
Locally Recurrent Lung Cancer Case Study (5/5) Dose to Normal Organs No treatment-related adverse events following the radiation treatment 52
Slide 53: Rectal Cancer Case Study
Rectal Cancer Case Study 53
Slide 54: Locally Recurrent Rectal Cancer Case Study (1/2)
Locally Recurrent Rectal Cancer Case Study (1/2) 70-year old male presented to our institution after undergoing chemoradiotherapy followed by chemotherapy for a low-lying rectal adenocarcinoma • PET and exam demonstrated residual tumor at the rectum, involving sphincter approximately 3 cm • APR reco
Slide 55: Locally Recurrent Rectal Cancer Case Study (2/2)
Locally Recurrent Rectal Cancer Case Study (2/2) • In September 2022, patient underwent Alpha DaRT insertion • Exam was normal in March 2023 • PET-CT SUV uptake: 4 • Exam was normal in March 2024 • PET-CT SUV uptake: none • Patient denies any bowel or bladder issues No treatment-related adverse even
Slide 56: Conclusion
Conclusion Despite the high risk associated with reirradiation, initial cases of reirradiation of internal organs (lung, rectum) using Alpha DaRT demonstrate high efficacy potential and minimal toxicity 56
Slide 57: Agenda
Agenda 1 Introduction Raphi Levy, CFO | Alpha Tau 2 Updated Interim Pancreatic Cancer Data as of Jan 8, 2025 Robert Den, MD, CMO | Alpha Tau 3 Pancreatic Cancer Case Study Philip Blumenfeld, MD, MPH | Hadassah Medical Center 4 Treatment Experience – Endoscopic Delivery to the Pancreas Corey Miller,
Slide 58: Outline of Liver Metastases Study - CTP-LIV-00
Outline of Liver Metastases Study - CTP-LIV-00 Primary objectives: Evaluate feasibility & safety of Alpha DaRT implanted in liver metastases Secondary / exploratory objectives: Evaluate pathological and radiological response, determine immunological impact, stratify differences in response by histop
Slide 59: Study Schema
Study Schema Liver study Imaging Primary Objective Alpha DaRT insertion Pathology Analysis 59
Slide 60: First Patient Treated for Liver Cancer
First Patient Treated for Liver Cancer • Patient Background: o 48yo male with bilateral liver colorectal metastases o The patient was off chemotherapy for 8 weeks prior to surgery o First stage of two-stage hepatectomy performed on May 9, 2024, with resection of primary colorectal tumor (sigmoidecto
Slide 61: First Patient Treated for Liver Cancer – CT Scans
First Patient Treated for Liver Cancer – CT Scans Treated Lesion Untreated Lesion Before Tx 24-Apr- 2024 Post Tx 23-May- 2024 61
Slide 62: Post-Treatment Clinical Course
Post-Treatment Clinical Course • Second surgery conducted on 17-Jun-2024, 5 weeks after initial operation): right liver was resected, including the Alpha DaRT-treated lesion • No significant complications or unexpected events during the post-operative period • The patient was discharged as planned •
Slide 63: Adaptive Immune Response
Adaptive Immune Response • Increased infiltration of CD8+ T cells in the right liver lesions (both treated and untreated), particularly at the tumor margin of the Alpha DaRT-treated lesion o Despite the temporal distance from chemotherapy • This observation may support our hypothesis that enhanced a
Slide 64: Innate Immune Response
Innate Immune Response • The innate immune response displayed a mixed pattern in the Alpha DaRT-treated tumor, with a notable increase in dendritic cells and neutrophils but a lower abundance of macrophages compared to the untreated tumor • This finding is significant, particularly in light of resea
Slide 65: Case Summary
Case Summary • The implantation of (Alpha DaRT) was performed without significant technical difficulties • No adverse events related to Alpha DaRT treatment were observed throughout the clinical course of the patient • There was no evidence of source migration, and complete removal of all Alpha DaRT
Slide 66: Agenda
Agenda 1 Introduction Raphi Levy, CFO | Alpha Tau 2 Updated Interim Pancreatic Cancer Data as of Jan 8, 2025 Robert Den, MD, CMO | Alpha Tau 3 Pancreatic Cancer Case Study Philip Blumenfeld, MD, MPH | Hadassah Medical Center 4 Treatment Experience – Endoscopic Delivery to the Pancreas Corey Miller,
Slide 67: Outline of Checkpoint Inhibitor Combination Trial – CTP-HNCPI-00
Outline of Checkpoint Inhibitor Combination Trial – CTP-HNCPI-00 Key Eligibility Criteria Trial Objectives Primary objective: Evaluate confirmed Best Overall Response Recurrent unresectable or metastatic head (BOR) per RECIST version 1.1 and neck squamous cell carcinoma (like KEYNOTE-048) Secondary
Slide 68: Treatment Regimen and KEYNOTE-048 Benchmark
Treatment Regimen and KEYNOTE-048 Benchmark Pembrolizumab Pembrolizumab Follow up period cycle cycle Continuous Tumor Response ICF Alpha DaRT Alpha DaRT Every 6 weeks Signature Insertion Removal Continue Pembrolizumab cycles Q3W Screening period Days (-35) – (-17) -16 0 5 15 26 24 Months KEYNOTE-048
Slide 69: Subject Disposition
Subject Disposition Screened N = 10 Screen Failure N=2 • ECOG of 3 • Tumor not amenable to DaRT insertion Enrolled & Treated N=8 Terminated Ongoing Follow-up N=5 N=3 • 3 deaths • 1 withdrew consent • 1 adverse event 69
Slide 70: Demographics and Tumor Characteristics
Demographics and Tumor Characteristics Subject ID Age Sex Stage Alpha DaRT Target Tumor Location Tumor Volume (cm3) HNCPI-00-01-001 74 Male Stage IV Neck 2.6 HNCPI-00-01-002 90 Male Stage IV Tongue 4.7 HNCPI-00-01-003 96 Female Stage IV Mandibular alveolus 7.6 HNCPI-00-01-004 63 Female Stage II Neck
Slide 71: Adverse Events
Adverse Events Subject ID AE # Adverse Event Description SAE Relationship to Device Severity HNCPI-00-01-002 1 Cardiac arrest Yes Not related 5 - Death 2 Weight loss No Not related 1 - Mild 3 Fall No Not related 2 - Moderate HNCPI-00-01-003 1 Skin infection No Not related 2 - Moderate HNCPI-00-01-00
Slide 72: Early Interim Data as of Jan 9, 2025 Show Strong Systemic Responses
Early Interim Data as of Jan 9, 2025 Show Strong Systemic Responses • Patients received an average of 4 cycles of pembrolizumab (range 2-9) • Systemic responses observed: o Three complete responses o Three partial responses o Two patients died prior to evaluation • Only two Alpha DaRT-related advers
Slide 73: HNCPI-00-01-003 Pembrolizumab Combination Case Study
HNCPI-00-01-003 Pembrolizumab Combination Case Study 73
Slide 74: Case Background – HNCPI-00-01-003
Case Background – HNCPI-00-01-003 Age 96 Sex Female Tumor Type SCC Date of First Diagnosis Jul-2022 Location Alveolar ridge & lip plus dermal involvement Prior Treatments None Medical Background • Cardio • Dementia • ECOG3 Cancer Stage • Stage IV • T2N1M1 74
Slide 75: Alpha DaRT Treatment
Alpha DaRT Treatment Alpha DaRT After Alpha DaRT Follow-Up Insertion Removal Sept-2022 Oct-2022 Jan-2023 75
Slide 76: Clinical Follow-Up
Clinical Follow-Up Pre-Treatment Nine Weeks Post Treatment 76
Slide 77: PET Follow-Up
PET Follow-Up Pre-Treatment Post-Treatment Aug-2022 Mar-2024 77
Slide 78: Patient Status
Patient Status Patient stopped Pembrolizumab after 12 months Patient still alive with no evidence of disease at October 2024 followup 78
Slide 79: Agenda
Agenda 1 Introduction Raphi Levy, CFO | Alpha Tau 2 Updated Interim Pancreatic Cancer Data as of Jan 8, 2025 Robert Den, MD, CMO | Alpha Tau 3 Pancreatic Cancer Case Study Philip Blumenfeld, MD, MPH | Hadassah Medical Center 4 Treatment Experience – Endoscopic Delivery to the Pancreas Corey Miller,
Slide 80: Therapeutic Focus
Therapeutic Focus We are focused on delivering solutions to three markets that we believe would be best served by the unique characteristics of the Alpha DaRT Localized & Unresectable High Unmet Need Metastatic • Localized tumors that are not • Solid tumors that have limited • Alpha DaRT being evalu
Slide 81: USA - Proposed Trials For Initiation In 2025
Pancreas – Pilot – Approved USA - Recurrent GBM – Early Feasibility Study Proposed Trials • Under Breakthrough Device Designation + TAP Program For Initiation In 2025 Head & Neck – Combination with Pembrolizumab 81
Slide 82: Anticipated Milestones
Anticipated Milestones Geography Target Indication H1 2025 H2 2025 H1 2026 Completion of Recurrent Data Readout + Potential FDA multi-center pivotal Cutaneous SCC submission trial recruitment Complete United First Patient in Recruitment in Readout from Pilot Pancreatic Cancer Pilot Study Study State
Slide 83: Development Pipeline
Development Pipeline • FDA Breakthrough Device Designation received for certain uses in skin cancer and GBM Pre-Clinical Feasibility Marketing Geography Target Indication Pivotal Trial Anticipated Milestones Research Trial Authorization Rec. Cutaneous SCC U.S. • Complete patient recruitment in Q3 20
Slide 84: Questions?
AlphetAU _ Questions?