Plus Therapeutics, Inc. · NASDAQ:PSTV
Plus Therapeutics — Investor Presentation (March 2024)
39 slides from Plus Therapeutics's investor presentation, Mar 13, 2024
Slide 1: Corporate Presentation March 2024
Exhibit 99.1 Corporate Presentation March 2024
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this presentation other than st
Slide 3: Targeted Radiotherapeutics for CNS Cancers Corporate overview
Targeted Radiotherapeutics for CNS Cancers Corporate overview Compelling Platform Mid 2025 Significant CNS Cancer Survival Data Technology Cash Runway Milestones Focus + Nanoliposome and Rhenium + Aggregate market opportunity of + Completing rGBM Phase 2 + Interim rGBM Phase 2 data + Sufficient to f
Slide 4: Recent Press and Partnerships Highlight Accelerating Interest in Radiopharmaceuticals
Recent Press and Partnerships Highlight Accelerating Interest in Radiopharmaceuticals Innovator Acquirer Date 2/13/2023 4/24/2023 5/10/2023 10/3/2023 12/26/2023 1/9/2024 Deal Type Asset Acquisition License Deal Strategic Collaboration Company Acquisition Company Acquisition License Deal Aggregate Va
Slide 5: Unique Challenges with CNS Cancer Treatment
Unique Challenges with CNS Cancer Treatment Plus’ technology overcomes all key limitations Radiotherapy Limitations Locally Invasive Blood Brain Barrier Only 2% of drugs cross the EBRT dose limited by off target 90% of GBM recurs 2 cm from BBB safety concerns primary tumor Chemoresistance Complex An
Slide 6: Rhenium (186Re) Obisbemeda is a 3-Part Formulation Radiotherapy
186 Rhenium ( Re) Obisbemeda is a 3-Part Formulation Radiotherapy Prolongs persistence at tumor and optimizes convection while sparing healthy tissue Tumor Retention 186 Rhenium-186 ( Re) 60% 186Re-NanoLiposomes 186Re-BMEDA 50% Proprietary formulation 186Re-Perrenate demonstrates persistence in 40%
Slide 7: Direct RT Drug Delivery Strategies for CNS Cancers
Direct RT Drug Delivery Strategies for CNS Cancers Overcomes barriers to CNS drug delivery Convection-Enhanced Delivery (CED) Intraventricular Catheter (Ommaya reservoir) + FDA-approved and utilized for 60+ years + FDA-approved and utilized for 20+ years + Bypasses BBB + Bypasses BBB + Small subcuta
Slide 8: A New Paradigm for CNS Radiotherapy
A New Paradigm for CNS Radiotherapy A direct targeted approach is a step function improvement in CNS radiation delivery Gold Standard New Paradigm External Beam Plus’ Directly Radiation Therapy Targeted RT Delivery + Direct delivery to the tumor site + Standard of care for decades + Key challenges e
Slide 9: Seamless drug supply into patient workflow
Seamless drug supply into patient workflow Highly scalable workflow to meet commercial demand Centralized GMP Standard RAM Shipping and Drug Order and Scheduling Overnight Delivery Manufacturing Receiving Drug order scheduled and timed to The patient’s dose is batch Drug is delivered to hospital via
Slide 10: Therapeutic Product Pipeline
Therapeutic Product Pipeline Status and 2024 milestones IND/ Preclinical Phase 1 Phase 2 Phase 3 Anticipated Milestones 2024 IDE 186 Rhenium ( Re) Obisbemeda 186 Rhenium ( Re) Obisbemeda • Data presentation at SNO Nov 2024 Single dose administration trial ReSPECT-LM Single Dose Trial • Begin P2 in b
Slide 11: Leptomeningeal Metastases
Leptomeningeal Metastases Power and precision in cancer radiotherapeutics
Slide 12: Leptomeningeal Metastases from Solid Tumors
Leptomeningeal Metastases from Solid Tumors Poor prognosis and no FDA-approved treatments LM Treatment LM Diagnosis + Poor survival of 4-6 weeks without + Late-stage cancer complication in which Melanoma treatment cancer cells metastasize from any primary Breast tumor to the CSF space and leptomenin
Slide 13: Leptomeningeal Metastasis Incidence
Leptomeningeal Metastasis Incidence About 250,000 new cases of LM are diagnosed each year in the US U.S. Incidence Standard of Care: Primary Tumor Type (% solid tumors) Median Overall Survival Patients Breast 12-34%* 3.5-4.4 months ~210,000 Lung 10-26%* 3-6 months ~130,000 Melanoma 17-25%* 1.7 to 2.
Slide 14: ReSPECT-LM Phase 1 Single Administration Dose Escalation Trial
ReSPECT-LM Phase 1 Single Administration Dose Escalation Trial 186 Targeted delivery of Rhenium ( Re) Obisbemeda by Ommaya reservoir + Dose escalation: 3+3 modified Fibonacci + Primary objective: Safety and tolerability Single Administration Phase 1 Dose Escalation Plan + Maximum Tolerated Dose / Ma
Slide 15: ReSPECT-LM Safety
ReSPECT-LM Safety MTD/MFD not reached over 5 cohorts Average Absorbed Doses 180 160 140 120 + Generally safe and well tolerated 100 + Complete CSF circulation of drug within hours 80 and duration at least 7 days 60 + No evidence of systemic radiation toxicity 40 20 + Absorbed doses to key therapeuti
Slide 16: ReSPECT-LM Treatment Response Data
ReSPECT-LM Phase 1 Treatment Response Data Median overall survival and percent CSF tumor cell change show effect of treatment Median Overall Survival Average Percent CSF Tumor Cell Change Over Time 150% 100% 50% 0% -50% -100% -150% 0 10 20 30 40 50 Time (Days) + N = 13 evaluable patients + N = 10 pa
Slide 17: ReSPECT-LM Individual Patient Analysis
ReSPECT-LM Individual Patient Analysis Analysis by survival time following single administration Overall Survival By Cohort D28 CSF TC mOS -53% 684 1-02 + N = 18 evaluable patients -6% 558 2-01 0% 411 + 12 of 18 patients alive 2-02 -90% 334 3-02 + Tumors by primary disease -81% 333 3-04 -53% + Lung:
Slide 18: CNSide Tumor Cell Enumeration Assay
CNSide Tumor Cell Enumeration Assay Highly sensitive and specific test of metastatic carcinomas in the CSF Proprietary Technologies Proprietary Testing Process Individual Cell Data CSF collection & transport system Sample Collection 1 • Stabile at ambient temperature (4 days) Shipping & Receiving CE
Slide 19: CNSide Clinical Impact and Next Steps
CNSide Clinical Impact and Next Steps FORESEE clinical feasibility trial enrolled and data readout pending + CNSide test available commercially and reimbursed prior to Q3 2023 + FORESEE Clinical Trial (NCT0541123) CNSide CSF-TC results & treatment status now enrolled + Prospective multicenter trial
Slide 20: ReSPECT-LM and CNSide Pipeline
ReSPECT-LM and CNSide Pipeline Clinical development timelines Therapeutic Pre 2024 2025 2026 2027 2028+ 2024 Phase 2/3: Single dose pivotal trial, Phase 1: Single dose escalation breast cancer basket trial Phase 1: Multidose escalation Phase 2/3: Multidose pivotal trial, basket trial breast cancer P
Slide 21: Recurrent Glioblastoma
Recurrent Glioblastoma Power and precision in cancer radiotherapeutics
Slide 22: Malignant Gliomas
Malignant Gliomas The brain’s most frequent and deadly tumors despite decades of research GBM Treatment GBM Diagnosis Ependymoma Oligodendroglioma + 14,500 patients newly diagnosed GBM + No standard of care following patients in US each year recurrence + Poor survival rate, 7% at 5 years + Only 5 FD
Slide 23: Multiple Therapeutic Opportunities for Rhenium (186Re) Obisbemeda
Multiple Therapeutic Opportuntities for Rhenium (186Re) Obisbemeda Significant clinical & commercial upside for this therapeutic platform Addressable Standard of Care: Proposed Indication U.S. Incidence Patients Median Overall Survival Recurrent Glioblastoma 14,250 8 months 9,500 Primary Glioblastom
Slide 24: Rhenium (186Re) Obisbemeda for Glioblastoma
186 Rhenium ( Re) Obisbemeda for Glioblastoma PLUS’ novel approach overcomes limitations of all 3 current treatment modalities GBM Tumor Pathophysiology Surgery PLUS Extremely Difficult to Treat Obtaining adequate surgical margins nearly impossible 186 Rhenium ( Re) Obisbemeda Systemic Drugs Only 2%
Slide 25: Rhenium (186Re) Obisbemeda Advantage Over EBRT
186 Rhenium ( Re) Obisbemeda Advantage Over EBRT More targeted radiation delivery with 10x increase in max absorbed dose 186 EBRT Rhenium ( Re) Obisbemeda EBRT vs. 186 Rhenium ( Re) Obisbemeda 28.5 Gy 250 Gy Max dose Max dose 5 Gy 5 Gy 25
Slide 26: ReSPECT-GBM Treatment Workflow
ReSPECT-GBM Treatment Workflow Inpatient single administration SoC Biopsy and Catheter Personalized Drug Infusion Patient Monitoring Treatment Planning Placement Day 1 Day 2-3 Day 0 Prior to Treatment MRI imaging to assess Confirmatory biopsy followed by Single ~4-hour infusion Catheter removal, pat
Slide 27: ReSPECT-GBM Phase 1, Single Dose Trial Design
ReSPECT-GBM Phase 1, Single Dose Trial Design 186 Single administration of Rhenium ( Re) Obisbemeda by Convection Enhanced Delivery (CED) Single Administration Phase 1 Dose Escalation Plan + Dose escalation: 3+3 modified Fibonacci, currently enrolling in cohort 8 Administered Administered Administer
Slide 28: ReSPECT-GBM Safety
ReSPECT-GBM Safety MTD/MFD not reached in dose escalation phase Average Absorbed Dose to Tumor by Cohort Tumors >20 mL Tumors <20 mL 450 + Generally safe and well tolerated over 28 patients in 8 dosing 400 cohorts, enrollment ongoing 350 + No evidence of systemic radiation toxicity 300 250 + The ave
Slide 29: ReSPECT-GBM Phase 1 Efficacy
ReSPECT-GBM Phase 1 Efficacy Dichotomous patient stratification of patients based on 100Gy absorbed dose threshold Median Progression Free Survival Median Overall Survival Progression free survival or PFS Median overall survival or mOS + All patients: mPFS 4.0 m (95% CI 2.0-6.0 m, PFS6=0.21±0.11) +
Slide 30: ReSPECT-GBM Phase 2 Efficacy
ReSPECT-GBM Phase 2 Efficacy Phase 2 data similar to Phase 1 data Median Progression Free Survival Median Overall Survival + PFS: 11 months (95% CI 6-11 months) + OS: 13 months (95% CI 5 months-NA) *At time of analysis, November 2023 30
Slide 31: Comparative Survival Data
Comparative Survival Data Overall Survival Comparison ReSPECT-GBM vs. Real World Experience 20 18 + Meta analysis of >700 rGBM patients 16 + Plus and Medidata conducted 2 RWE control 14 arms with propensity match rGBM patients to 12 Plus Phase 1 data 10 + Propensity matching- baseline characteristic
Slide 32: ReSPECT-PBC
ReSPECT-PBC 186 Rhenium ( Re) Obisbemeda for supratentorial recurrent, refractory, or progressive pediatric high-grade glioma and ependymoma + Dose escalation: 3+3 modified Fibonacci, varying Single Administration Phase 1 Dose Escalation Plan administered volume with tumor volume to maximize therape
Slide 33: ReSPECT-GBM and ReSPECT-PBC Pipeline
ReSPECT-GBM and ReSPECT-PBC Pipeline Clinical development timelines Recurrent Glioblastoma Pre 2024 2025 2026 2027 2028+ 2024 Phase 1: Single administration dose escalation MFD/MTD Phase 3: Single administration Phase 2: Single administration tumors < 20 mL vs. Control tumors < 20 mL vs. RWE Phase 2
Slide 34: Selective Internal Radiotherapy (SIRT) for Solid Tumors
Selective Internal Radiotherapy (SIRT) for Solid Tumors Power and precision in cancer radiotherapeutics
Slide 35: SIRT: Rhenium NanoLiposome Biodegradable Alginate Microsphere (RNL-BAM)
SIRT (Selective Internal Radiotherapy) Rhenium NanoLiposome Biodegradable Alginate Microsphere (RNL-BAM) is a next generation SIRT technology Current Market Liposomes & Re-BMEDA (BMEDA = chelator) + Inoperable liver tumors: primary & metastatic disease + Regulated as devices + TheraSpheres and SIR-S
Slide 36: Financials and Milestones
Financials and Milestones Power and precision in cancer radiotherapeutics
Slide 37: Capitalization Summary
Capitalization Summary As of December 31, 2023 Expected Runway Grant Funding Share Count Balance Sheet $17.6M Cash, Grants, and 4.5M CPRIT, with $6.9M Access to Capital $8.6M Basic Common forecast in 2024 to Financing Cash, Cash Shares Sources to Fund Equivalents, and Operations Investments 0.14M NI
Slide 38: Upcoming 2024 Key Milestones
Upcoming 2024 Key Milestones LM Cancer Program & ReSPECT-LM Trial + Complete Phase 1 single dose trial and present data at SNO Nov 2024 + Determine RP2D for Phase 2 single dose trial + Initiate Phase 1 multidose trial 186 + Evaluate combination of Rhenium Re Obisbemeda with PDL1 and PD1 therapies fo
Slide 39: THANK YOU!
THANK YOU! For Our Latest News & Updates: @PlusTxlnc @PlusTherapeutics @PlusTherapeutics PSTV @PlusTherapeutics @PlusTherapeutics
Plus Therapeutics — Investor Presentation (March 2024) on 6ix