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Biopharma Tracker
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Product NameIndicationMOAPhasePatentEconomicsClinical TrialsCompetitorShare price$5.20
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Cu64 SARTATENeuroendocrinem, NeuroblastomaDiagnostic - SSTR2 binding agentPhase 2CL01, DISCOCu64 DOTATATE - CuriumMarket Cap$1,620,558,620
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Cu64/67 SARTATENeuroblastoma, MeningiomaTheranostic agent - SSTR2 binding agentPhase 1 2x \ODD, PRVCL04, CL02Shares on Issue311,645,897
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64CU SAR-bisPSMAProstate CancerDiagnostic - PSMA binding agentPhase 22038 (china)PROPELLER, COBRA, X-CALIBURCU64 PSMA - CuriumDebt0Q1 2023Q4 2022Q3 2022Q2 2022Q1 2022Q4 2021Q3 2021
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Cu64/67 SAR-bisPSMAProstate CancerTheranostic - PSMA binding agentPhase 1 2038 (china)SECUREPluvicto (Lu-177) - NovartisCash$66,743,000.00$66,743,000$75,888,000$92,336,000$95,890,000$96,644,000$101,700,000$18,939,000
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Cu64 SAR-BombesinProstate, BreastDiagnostic - GRP receptorPhase 2 SABREPylarify - LantheusQuarterly Exp %12.05%17.81%3.71%0.78%4.97%
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Cu64/67 SAR-BombesinProstateTheranostic - GRP receptorPhase 1 COMBATQuarterly Exp $9,145,000$16,448,000$3,554,000$754,000$5,056,000
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SAR Discovery PlatformUndisclosedRadiopharmaceuticalPre-Clinical
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2022 Spend$20,756,000
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CEODr. Allan Talyor2023 spend$9,145,000
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Non-Executive DirectorCheryl Maley
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CSO
Dr. Jeffrey Norenberg
Barring any collaborations, which could inject cash and a 13M quarterly cash burn, we gave a cash runway from Q2 2024
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Director of Tech (former CSO)
Dr. Matt Harris
Are there any results that could be released during that time?
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Scientific Advisory Board
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24 Jul 2023: SABRE trial reaches 50% recruitment for Phase 2 prostate cancer trial
Jon Stoner
World leadding expert in Cu67 prod
We are looking at a capital raise prior Q1 2023, Q4 2022. Any positive results should be a good news as that'll result in a subsequent capital raise.
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14 Jun 2023: Cu64 supply expansion for P3 trials
Important Q
Diagnostic agents could receive quick approval - do they need a phase 3 trial? Will need to look at development timelines for telix
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Manufacturing: Petnet solutions (siemens Healthineers company) - global positron emission tomography manufacturer in the US
Inevitably, that will be the play. Get revenues for Diagnostic agents of each program as that'll be approved quicker
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MSA and CSA agreement set for 64Cu SAR-bisPSMA effective by 13 Jun 2023. 5 year agreement and potential extension.
then use that cash to fund the theranostic agents moving forward
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initial supply will occur before end of calendar year 2023.
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Expecting Phase 3 trials for 64 Cu SAR-bisPSMA before end of 2023 (Q4 2023)
Will need to look for any collaboration development to inject cash on Q2 2024 or it'll be a capital raise.
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A second phase 3 is planned in 2024
Capital raise would not be too bad if there are positive results and momentum going from there.
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Growing US market for PSMA PET diagnostics, 1B in 2023 for this class
Important Q
Are there any trials pending to be completed between now and Q2 2024?
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logistically easier to work with Cu64 (why didn't everyone start with this? why start with Ga68?)
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It looks like SAR-bisPSMA will be the main money maker for the company.
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09 Jun 2023: Jefferies Healthcare Conference
SARTATE will not generate cash in the future but will generate momentum moving forward
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Pluvicto sales is a good pitch to investors and potential collaborators.
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07 Jun 2023: BOP trial 64Cu-SAR-BBN
Important Q
How fast did telix recruit for its phase 2 and 3 trials?
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Recruitment completion for phase 2 investigator-initiated trial.
Important QHow fast till approval?
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Diagnostic Trial
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Important Q
What are the Pluvicto development timelines
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24 May 2023: Cohort 1 SECuRE trial completed
Important QWhat is their data? cost per vial45000
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6 participants w/ mCRPC completed and enrolled
45K for one vial solution
yearly cost per patient
270000270000270000270000270000270000
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No DLT and recommended for cohort 2 by safety review committtee
patient gets dosed every 6 weeks,
patients100015002000250030004000
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Additional therapy cycles of 67Cu-SAR-bisPSMA have been requested by clinicians under FDA EAP
yearly revenues270,000,000.00405,000,000.00540,000,000.00675,000,000.00810,000,000.001,080,000,000.00
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Early data from EAP indicates positive effects of lowest dose on lesion w/ reduction of PSMA levels
Naxitamab
how many patients are they getting?
net income54,000,000.0081,000,000.00108,000,000.00135,000,000.00162,000,000.00216,000,000.00237600000261360000287496000316245600347870160382657176-60000000-60000000-60000000
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Let's see how Cohort 2 responds
They are being sold for 25K pervial
2700000040500000540000006750000081000000108000000118800000130680000143748000158122800173935080191328588-60000000-60000000-60000000
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Supply disruption for Pluvicto (Lu177 vipvotide tetraxetan) - 211m in revenue ac hieved in 1Q of 2023
dosing seems to be 3 vials per cycle?
£574,184,593.70
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cycle is every 4 weeks, then once PR and CR, 5 additional cycles, then subsequenct cycles has their cycles change to 8 weeks.
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18 Apr 2023: 6.7M R&D Tax incentive refund - will be reflexted in Q2 2023 cash flow statement
theyre getting 20mil a quarter
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Neuroblastoma
patient population is very small
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02 Mar 2023: No supply interruption on 674Cu and 67Cu production
but COGS is very low, SG&A very low too as treatment centres for neuroblastoma are more centralised for pediatric and rare diseases
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R&D is pulling the company down
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2H 2022 Half Yearly Report
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2 agreements have been signed:
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Evergreen Theranostics to include manufacturing and supploy of 67Cu-SAR-BBN for COMBAT in US
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3D Imaging for 67Cu SAR-bisPSMA for Phase 3 trial
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£133.42
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