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#Management
stale
Added 3 years ago

I am trying to track this one after OSL fell from highs. I have hopes for the new CEO but I am not sure how good is the product but management has done this in previous jobs and roles. I will watch the revenue and costs closely. I also think they will have to raise capital in < 12 months from now (maybe 6 months).  They have approx 12 mils left and spending 3 mils every qtr.

 

26 February 2021 Business update call transcript - Notes 

Able to assemble an experienced commercial team in Europe and the United States
Approved by the central ethics committee in the UK, which means we can commence with patient treatments

FDA in support of the HDE application. Furthermore, TGA had made an additional request which the team
has completed and forwarded back to TGA last month. 

Our immediate focus is on short-term revenue growth and generating cash flow.
I’m confident that we will get first patient dose sales in the
first half of 2021 in Europe, and of course this is going to be in the UK

29 April 2021
Quarterly Activities & Cash Flow Report
Quarter ended 31 March 2021


Additional sales in New Zealand: Following OncoSil’s first ever commercial sale, OncoSil has
achieved further sales in New Zealand
• Cash position: Cash balance of $15.3 million as at 31 March 2021

Europe and UK: 9 hospitals in UK have received ethics approval

In July 2020, the Company filed an application with the Therapeutic Goods Administration (TGA) in
Australia. On 11 January 2021, OncoSil submitted additional data in response to the TGA’s request. 


4 May 2021
OncoSil receives regulatory approval from Hong Kong
The approval marks a key step in OncoSil’s commercialisation strategy in Asia, following the approvals
received in Singapore and Malaysia last year

2 June 2021 
Australian TGA Update - While Australia is a strategic market in the
future, we remain focused on the European and US markets, where our long-term and material growth
opportunities lie.

20 July 2021
Otto Buttula appointed to the Board of OncoSil


26 July 2021
Quarterly Activities & Cash Flow Report
Quarter ended 30 June 2021

Cash position: Cash balance of $12.2 million as at 30 June 2021.
Europe and UK: Patient screening has been activated at the London Clinic

Germany: The team is targeting 15 leading centers involved in the
treatment of pancreatic cancer. 

Spain, the sales team is targeting 6 key hospitals where approval for the Osprey
registry is currently underway. In Italy and Spain, funding for the OncoSil device is expected to occur
through annual allocations of public hospital budgets at a site level, and through the private payer market
in private hospitals. 

In Luxembourg, one centre has been identified to adopt the OncoSil device. We anticipate full approval by
the end of October 2021

US: Bile Duct Cancer or Distal Cholangiocarcinoma (DCC) - delays because of covid.
Dr Chris Roberts and Mr Michael Bassett intend to step down from the Board at the time of OncoSil’s Annual General
Meeting, expected to be held in October 2021.

#Business Model/Strategy
stale
Added 3 years ago

21 January 2021 - Appointment of Chief Executive Officer -  Mr Nigel Lange - ex-ceo of Sirtex’s European business
 Responsible for establishing their brachytherapy device in over 300 centres across Europe and Middle East

10 Feb 2021 - appointment of Dr. Ralph Peters as Chief Medical Officer and Mr. David Turner
as Head of Medical Affairs. Both of them are ex-Sirtex Medical Limited

23 February 2021 Financial Report – Half-Year ended 31 December 2020
First commercial sale, with a patient implanted with the OncoSilTM device in New Zealand in October 2020 with $93k revenue

Key operational milestones include the following:
• Recorded first commercial sale with a patient implanted with the OncoSilTM device in New Zealand
• Continued to progress establishing the Osprey Registry across Europe, including formal approval
received from HRA and REC in UK for 9 sites
• Submission of the Humanitarian Device Exemption (HDE) filing with the FDA for distal
cholangiocarcinoma (bile duct cancer)
• Preparing updated data package to support the HDE application, as requested by the FDA
• Submission of regulatory filing to the Therapeutic Goods Administration (TGA) in Australia

CEO Comments:  Pleasingly, we continue to press forward where possible and we are in the final stages 
of commercializing the 9 sites in the UK.Huge impact by covid. 

The Covid-19 pandemic has resulted in a delay of full commercial launch which is expected to occur this financial year ending 30 June 2021. It is not practicable to estimate the potential impact, positive or negative, after the reporting date.

Shares Outstanding: 31 December 2020 815,881,756 ( 815 Million - which seems too much to me)