OSL
Delivery · Highdata caveat$18M—
OncoSil Medical
Oncology
OncoSil phosphorus-32 brachytherapy device for unresectable pancreatic cancer; TGA/CE approved
Data HealthTrials3 of 3 active · stale enrollment
No cash data on fileFigures from ASX filings · not financial advice
[ VITALS ]
Cash on Hand
—
Runway
—Market Cap
$18M
Burn Rate
—
Shares Outstanding
31M
Pipeline Assets
2
Latest Insightprice-sensitive announcements & broker notes
Price-sensitiveRegulatory8 June 2026
OncoSil progresses HDE with US FDA
The FDA confirmed all outstanding questions related to OncoSil Medical's Humanitarian Device Exemption (HDE) application for the OncoSil™ device have been satisfactorily addressed, advancing the application to the final review stage prior to a potential approval decision. The FDA has indicated it intends to complete its review within 45 days of OncoSil's final submission and grant the HDE.
FDA·Distal cholangiocarcinoma (dCCA)·positive
3M Price
OSL.ASX$0.570+0.0% 3M
Low $0.390High $0.575
Pipeline Assets (2)
OncoSil (P-32)Locally advanced pancreatic cancer
Phase 2OncoSil (P-32)Pancreatic cancer (post-market)
ApprovedDiscovery
Preclinical
Ph 1
Ph 1/2
Ph 2
Ph 2/3
Ph 3
NDA
Capital Raises & Buybacks
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No capital raise or buyback data
Other ticker dataInsider activity, holders, grants, publications
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Insider activity, holders, grants, publications
Director Transactions
6 transactionsLast 90dNet Buy
Buys4+4 vs prior
Sells0
Buy Value$129k
warning2 directors bought within 30 days (03-17 – 03-17) — $129k total
Catalysts (6)· 1 upcoming · 5 past
Expectedarrow_upwardHigh23 July 2026
expand_more5 past catalysts
Track RecordDelivery Consistency Index
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Delivery Consistency Index
Historical delivery and spending consistency. Data is limited for recently added companies.
Delivery Consistency Index
Delivery
High83/100(limited data)
Timeline adherence · phase-adjusted tolerance · recency-weighted · min 3 catalysts
Capital discipline
–Insufficient data
0/2 data points needed
Burn rate stability · stage-adjusted thresholds · runway trend · R&D focus
Hit 4 of 4 guided dates· rolling 2yr· of 6 tracked
What drove these scores · rolling 2yr
arrow_drop_up
FDA HDE approval decision for OncoSil — Delivered 45d early
·
OncoSil™ TGA — OncoSil Medical Receives TGA Approval in Australia — Delivered on time
·
OncoSil™ FDA — OncoSil progresses HDE with US FDA — Delivered on time
·
TRIPP-FFX Clinical Trial Meets Co-Primary Endpoints — Delivered on time
·
Limited data adjustment — Score adjusted toward neutral (4/6 data points) — accuracy improves with more completed catalysts
Completed catalysts
✓OncoSil™ TGA — OncoSil Medical Receives TGA Approval in Australia— OncoSil Medical received TGA approval for the OncoSil™ Class III medical device for the treatment of locally advanced pancreatic cancer in Australia, making it the first and only TGA-approved device targeting tumours directly within the pancreas. The device has been included on the Australian Register of Therapeutic Goods (ARTG), enabling commercialisation in the Australian market.
On time
✓OncoSil™ FDA — OncoSil progresses HDE with US FDA— The FDA confirmed all outstanding questions related to OncoSil Medical's Humanitarian Device Exemption (HDE) application for the OncoSil™ device have been satisfactorily addressed, advancing the application to the final review stage prior to a potential approval decision. The FDA has indicated it intends to complete its review within 45 days of OncoSil's final submission and grant the HDE.
On time
✓TRIPP-FFX Clinical Trial Meets Co-Primary Endpoints· readout — subject to clinical uncertainty— The TRIPP-FFX study met both co-primary endpoints of safety/tolerability and local disease control rate (LDCR) at 16 weeks. The OncoSil™ plus FOLFIRINOX arm achieved an 82.2% LDCR at 16 weeks (95% CI 68-92%), exceeding the pre-specified 55% historical benchmark threshold, with the entire confidence interval above 55% and spanning the 75% target. Median overall survival was 18.3 months in the OncoSil™ plus FOLFIRINOX arm versus 15.9 months in the FOLFIRINOX-alone arm, with a partial response rate
On time
✓FDA HDE approval decision for OncoSil— The FDA confirmed all outstanding questions on OncoSil's HDE application for distal cholangiocarcinoma have been satisfactorily addressed, advancing it to final review stage with an indicated 45-day completion timeline.
45d early
Outcome quality (positive/negative readouts) reflects the science, not execution — shown above but excluded from the score.
These metrics reflect historical operational data only. They are not predictive of future performance, do not constitute investment advice, and should not be used as the basis for any investment decision.
Clinical Trials(3)
3 activeClinicalTrials.gov ↗
RecruitingOBSERVATIONALEnrollment stale · 1520d
OSPREY is a Post-market, Global, Multicentre, Observational, Prospective Registry.
Pancreatic Neoplasm · Digestive System Neoplasm · Neoplasms by Site +5 more
18 Years – 90 Years
Primary endpoint Safety and tolerability of Device
ENROL500
no manual snapshots — enter via record_enrollment.py
Not Yet RecruitingOBSERVATIONALEnrollment stale · 741d
OncoSil
OncoSil Pancreatic Cancer Post-marketing Clinical Registry - Italy
Locally Advanced Pancreatic Adenocarcinoma
18 Years+
Primary endpoint Safety and tolerability
ENROL50
no manual snapshots — enter via record_enrollment.py
Ph2Active Not RecruitingEnrollment stale · 1141d
FOLFIRINOX chemotherapyOncoSil™
FOLFIRINOX Versus OncoSil™ in Addition to FOLFIRINOX in Patients With Locally Advanced Pancreatic Adenocarcinoma
Locally Advanced Pancreatic Cancer
RandomizedOpen Label18 Years+
Primary endpoint Safety and Tolerability
ENROL88
no manual snapshots — enter via record_enrollment.py
Announcements(20)
verified
Regulatoryauto_awesome
US FDA HDE and TRIPP-FFX Study Presentation8 June 2026
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